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The NHS Priorities/CAMEOL Project

Final project report: November 2007

RCCM Information Resource in Complementary Medicine ‘NHS Priorities / CAMEOL Project’ Funded by the Department of Health, UK

(March 2003 – September 2007)

Final Project Report

November 2007

Janet Richardson (Project Director) Professor of Health Service Research Faculty of Health and Social Work University of Plymouth Drake Circus Plymouth

Karen Pilkington (Project Manager) Senior Research Fellow RCCM/University of Westminster School of Integrated Health University of Westminster London

In association with

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The NHS Priorities/CAMEOL Project

Final project report: November 2007

Executive Summary Background This project involved the appraisal and review of the research evidence on complementary therapies in the NHS priority areas as defined by Government policy prior to the start of the project. These areas were: cancer, mental health, heart disease and stroke, and chronic conditions (arthritis, asthma, chronic back pain, diabetes, multiple sclerosis). The therapies included in the project were acupuncture, Alexander technique, aromatherapy, chiropractic, homeopathy, herbal medicine (specific products), hypnotherapy, massage, meditation, osteopathy, reflexology and yoga.

Aims • To carry out a detailed review and critical appraisal of the published research on specific complementary therapies • To make this information available to health care professionals, researchers and the public via the Internet • To maintain an evidence-based information resource that reflects current research evidence Project organisation The main project team consisted of a project director, project manager, 2 research assistants and an information specialist. An advisory group consisting of representatives from the National Library for Health, Cochrane Collaboration, NHS Centre for Reviews and Dissemination, a complementary and alternative medicine (CAM) organisation and a patient organisation provided advice on overall strategy and methods. Clinicians and therapists were recruited to provide condition and therapy specific advice and to comment on the clinical relevance of studies. External experts were consulted on specific aspects of the topics and to provide overall comments on each review. Methods The scale and complexity of the project required a range of processes and methods to be developed and tested. The methods used for each of the reviews involved comprehensive searches of electronic databases which were followed by the filtering and categorising of articles according to the study design. Basic methodology of relevant articles was appraised, and commentaries provided by clinical specialists. Reviews were sent for external comment and then either submitted for publication in peer-reviewed journals with a summary on the CAMEOL (Complementary and Alternative Medicine Evidence OnLine) database, or published in full on CAMEOL. The later stages of the project required planning for the integration of the methods and outcomes of the work into the newly established National Library for Health (NLH) CAM Specialist Library (www.library.nhs.uk/cam).

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Outcomes This project succeeded in bringing together a wide range of research literature on complementary therapies in chronic and life-threatening illnesses in a short space of time. The main outcome was a new resource, the CAMEOL database, providing access to summaries and full details of the research on each topic including unpublished and ongoing studies, tables of studies incorporating methodological appraisals and clinical comments, and links to relevant evidence. Supplementary outcomes included: a review of currently available electronic sources of CAM information, development of search strategies for a range of CAM therapies, investigations into the contribution of non-English language and qualitative research and into the quality of reporting of CAM interventions in research studies. Furthermore, the project established a framework and system for ensuring that evidence-based knowledge of CAM can be available to both professionals and the public. An evaluation of the search methods has been conducted and the results published. The overall methods for the cancer reviews have also been evaluated in collaboration with the Penny Brohn Cancer Centre and the resulting recommendations incorporated into development of a cancer-specific information service. Knowledge generated by the project has been shared with/transferred to other organisations including the CRD and Cochrane Collaboration. The majority of the work has been or will be integrated in the near future into the NLH CAM Specialist Library by means of National Knowledge Weeks (NKW) and Annual Evidence Updates (AEU). These are initiatives carried out by the Specialist Libraries aimed at highlighting the ‘best current evidence for selected healthcare topics’ (www.library.nhs.uk/specialistlibraries/). The work on cancer is being progressed through a project by the University of Plymouth in collaboration with the Penny Brohn Cancer Centre while it is anticipated that work on the other major area, mental health, will continue at the University of Westminster. The supplementary study on qualitative research will continue as part of a project led by colleagues at the Peninsula College of Medicine and Dentistry School (Universities of Exeter and Plymouth). Summary of the outputs • 12 systematic reviews and overviews published in journals and 27 systematic reviews and overviews published on CAMEOL • 13 reviews of reviews transferred to the NLH CAM Specialist Library • 3 published papers relating to the methods • 3 published papers on the overall project • Ongoing projects based on the work on cancer, mental health and qualitative research in CAM • Collaborative information-based projects (an international collaboration, an initiative to establish a European CAM information centre, development of the NLH CAM Specialist Library)

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Final project report: November 2007

Contents Executive summary

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1

Background and context

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2

Overall aims of the project

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3

Project organisation

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3.1 3.2 3.3 3.4 3.5

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4

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Project team Project Advisory Group (PAG) Specialist Advisory Groups and Specialist Advisors Clinical commentators External experts

Methods

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4.1

Preliminary work and development of methods 4.1.1 Review of sources 4.1.2 Development of search strategies 4.1.3 Testing of the filtering process 4.1.4 The appraisal process 4.1.5 Clinical commentaries 4.1.6 Pilot study 4.1.7 Mapping

10 10 10 11 11 11 12 13

4.2

Systematic review methods 4.2.1 Searches 4.2.2 Filtering 4.2.3 Data extraction and appraisal 4.2.4 Clinical commentaries 4.2.5 Expert review

14 14 15 15 16 16

4.3

Supporting work 4.3.1 Languages other than English (LOE) study 4.3.2 Qualitative research studies 4.3.3 STRICTA study 4.3.4 Safety study

16 16 16 17 18

4.4

CAMEOL database development and testing

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Results

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5.1

19 19

Summary of progress 5.1.1 Year 1

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5.1.2 Year 2 5.1.3 Year 3 5.1.4 Years 4 and 5

19 20 20

5.2

The review areas 5.2.1 Cancer 5.2.2 Mental health 5.2.3 Multiple sclerosis 5.2.4 Coronary heart disease and stroke 5.2.5 Arthritis 5.2.6 Asthma 5.2.7 Diabetes 5.2.9 Chronic low back pain

21 21 23 24 25 25 26 26 27

5.3 5.4

Other collaborative work Other achievements

27 28

6

Challenges encountered 6.1 Process 6.2 Communication 6.3 Publishing 6.4 Website development

29 29 29 29 30

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Evaluation of the methods

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8

Dissemination

32

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Updating and sustainability

34

10

Conclusions

36

References Appendix 1 Appendix 2 Appendix 3 Appendix 4 Appendix 5 Appendix 6 Appendix 7 Appendix 8 Appendix 9 Appendix 10 Appendix 11 Appendix 12 Appendix 13

37 The Project Team Project Advisory Groups and other contributors CAM knowledge base portfolio proforma Flowchart for categorising different study types Data extraction and critical appraisal templates Clinical commentary proforma Mapping Search strategies Languages other than English (LOE) study New trials listed on Cochrane CENTRAL Publications and presentations Summaries of the CAMEOL reviews The published papers

40 41 47 48 50 61 63 65 71 72 73 78 153

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Final project report: November 2007

Background and context

The general public increasingly rely on the Internet for health information and, in particular, information about complementary and alternative medicine (CAM). For example, the National Centre for Complementary and Alternative Medicine web site (http://www.nccam.nih.gov/) received over 600,000 hits per month (Beckner and Berman, 2003). This is a US-based site but it is unlikely that the situation in the UK is very different. However, finding reputable information is not a simple matter. There are two main reasons for this. The first problem is related to lack of an agreed definition for CAM which is comprised of a diverse range of different disciplines, practices and even philosophies. A whole spectrum of therapies exists ranging, for example, from the widely used and relatively accepted therapies, such as osteopathy and acupuncture, to those for which there is limited research such as crystal therapy and dowsing. All can be considered to be complementary or alternative. The second problem in finding reliable information is the extensive number of web sites addressing CAM, many of which are commercial sites or those based on personal anecdote. In searches conducted in 2003, the number of hits obtained using the search term alternative medicine in a general search engine (Google) was in excess of 800,000 while using the search term complementary medicine resulted in approximately 150,000 hits (Pilkington and Richardson, 2003). When these searches were rerun in 2005, the results were in excess of 5 million hits for complementary medicine and over 20 million hits for alternative medicine (searches conducted 26th August 2005 - unpublished data). Searching for information on a specific therapy does not solve the problem. In the more recent searches, nearly 3 million web-pages were listed for acupuncture, a situation mirrored for chiropractic, while for yoga over 10 million ‘hits’ were retrieved. In order to advise and support patients who choose complementary therapy approaches practitioners and health professionals require a readily accessible, user-friendly database that includes details of safety issues as well as evidence for effectiveness (and ineffectiveness). These groups also need to be able to access simple and straightforward information that provides details of study types as well as a synopsis of the research and its relevance to clinical practice. The House of Lords Select Committee on Science and Technology report on Complementary and Alternative Medicine (HL Paper 123, 2000) acknowledged the increasing public and professional interest in complementary therapies. It also pointed to the need for research evidence, as well as wider access to research-based information. Over two million articles are published annually in over 20,000 biomedical journals (Mulrow,1995). MEDLINE, for example, contains citations to articles published in over 5,000 journals from over 70 countries, from 1950 onwards. A number of other databases cover specialist subjects including complementary

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therapies (Richardson et al, 2001). The Research Council for Complementary Medicine (RCCM) recognised the challenges of searching for evidence in CAM more than 10 years ago and produced a comprehensive guide to searching for published information in complementary medicine (Rees, 1995; Rees, 2001; Richardson et al, 2001). The RCCM also developed a specialist complementary therapy database (CISCOM) and search service. CISCOM (followed by MEDLINE) was found to be the most effective database for searching for controlled clinical trials in complementary therapy (White et al, 1995). Other sources such as the Cochrane controlled trials register (CENTRAL) provide a specialist source of information regarding clinical trials in complementary medicine. The National Centre for Complementary and Alternative Medicine (NCCAM) in the USA and the National Library of Medicine (NLM) recently developed a further source of information, CAM on PubMed. This is a subset of the NLM bibliographic citations including MEDLINE citations and offers links to more than 1,700 journals. CAM on PubMed 'features more than 230,000 references to CAM-related articles and reports' (NCCAM Newsletter, 2001). However a search on this subset may produce irrelevant articles that need to be filtered out on the basis of the titles or abstracts. Furthermore, health professionals require information that has been synthesised and appraised in order that it is quick and easy to access. Researchers (and funders) need to know where the ‘evidence gaps’ are in order to plan and conduct future research of relevance. This current project resulted from recommendations that ‘The NHS Centre for Reviews and Dissemination work with the RCCM, the UK Cochrane Centre and the British Library to develop a comprehensive information source with the help of the CISCOM database, in order to provide a comprehensive and publicly available information source on CAM research…’(HL Paper 123, 2000, p115). Discussions with the Department of Health (Research and Development Directorate) guided the focus of the project towards areas of health that were of particular concern to Government policy at the time: cancer, mental health, heart disease and stroke and chronic conditions (arthritis, asthma, chronic back pain, diabetes, multiple sclerosis). Therapies were selected on the basis of those frequently sought by patients (HL Paper 123, 2000, pp12-14), and those that have the potential to provide a component of self-management: Acupuncture, Alexander Technique, Herbalism (Western), Homeopathy, Hypnotherapy, Massage and Aromatherapy, Meditation, Osteopathy / Chiropractic, Reflexology, Yoga, the final list being agreed with representatives from the Department of Health.

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Overall aims of the project •

To carry out a detailed review and critical appraisal of the published research in specific complementary therapies, focussing on key areas of NHS priority: cancer, mental health, heart disease and stroke and chronic conditions (arthritis, asthma, chronic back pain, diabetes, multiple sclerosis).



To make this information available to health care professionals, researchers and the public via the Internet.



To maintain an evidence-based information resource that reflects current research evidence and to establish an ongoing process for updating this information.

Further objectives related to the third aim: •

To develop a process for updating of the reviews.



To integrate the development of the NLH CAM Specialist Library and the CAMEOL database.



To review methods used in the project and produce recommendations on search strategies and other relevant aspects.

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3. Project organisation A small project team was supported by several advisory groups and a range of external experts as described below. Further details of the project team are included in Appendix 1 and a full list of all the individuals contributing to the project is included in Appendix 2. 3.1 Project team The project team consisted of a project director, project manager, 2 research assistants (each employed for an 18 month period) and an information specialist. The research assistants were appointed in October 2003 and received training on software and reference management systems, basic searching techniques, CAM and patient involvement. The CAM and patient involvement training were provided by attendance at standalone modules on MSc courses at the University of Westminster. Additional research assistant support was obtained for the diabetes review. 3.2 Project Advisory Group (PAG) The PAG provided advice to the whole project on strategic issues including: • The composition of the NHS priority specialist advisory groups • The relationship of the project to other information management systems • The development of appropriate links with other information systems • Income generation for the sustainability • Advertising and marketing The group included representatives from the NHS Centre for Reviews and Dissemination at York (CRD), National Library for Health (NLH), Cochrane Collaboration, CAM practitioners and a patient organisation. 3.3 Specialist Advisory Groups and Specialist Advisors The Cancer and Mental Health Specialist Advisory Groups advised on aspects of the project specifically related to the particular condition. Each group consisted of clinicians and therapists with expertise in the specific clinical area. For the other topics, specialist advisory groups were not established but appropriately qualified individuals within the specific field were identified and worked with the project team on producing the reviews. 3.4 Clinical commentators For each individual review, one or more specialists in the therapy and/or condition were identified and subsequently provided comments on the clinical relevance of each study. For the majority of reviews, the clinical commentators were also involved in co-authoring the review. 3.5 External experts A number of external experts provided advice or support on specific aspects, for example, statistics, or commented on completed reviews.

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4

Methods

4.1

Preliminary work and development of methods

4.1.1 Review of sources In the initial stages of the project, a review and assessment of CAM knowledge systems (other relevant electronic sources) was completed. Relevant websites were identified using a range of sources including the RCCM’s CISCOM team, journal articles and books. For each website, a proforma was completed describing the site, its scope and the information presented. A copy of the proforma is included in Appendix 3. A portfolio was prepared and a summary report presented to the Advisory Groups. The findings of this review also guided the development of the Complementary and Alternative Medicine Evidence OnLine (CAMEOL) database. However, there were two additional outcomes of this work: • A short paper on the topic of evidence based CAM resources on the internet was submitted subsequently published in the journal Health Information on the Internet (Pilkington and Richardson, 2003*). • All links were cross-checked against those on the RCCM website (www.rccm.org.uk) and any additional links added to the website to support users of the website and members of the RCCM CAM Researcher Network (CAMRN). *Citations to articles produced as part of the project are shown in the text in bold italics. A reference list of all publications and presentations related to this project is included in Appendix 11.

4.1.2 Development of search strategies (sources and search terms) An analysis of the potential sources (databases) for retrieval of appropriate research was completed. The analysis was based on a comparison of the search strategies used for all CAM reviews in the Cochrane Database of Systematic Reviews (CDSR, May 2003) and the reference Complementary Therapies on the Internet (Beckner and Berman, 2003). Generic strategies consisting of a range of index terms and text words were developed for each therapy and each condition. Development of each strategy required inspection of the thesauri from major biomedical databases and the CAM specialist thesaurus (RCCM, 2003). The following were also examined: • Search strategies used in Cochrane reviews • Search strategies used in other recent systematic reviews • PubMed CAM filter 10

The NHS Priorities/CAMEOL Project

Final project report: November 2007

Testing of two of the strategies, for one therapy (acupuncture) and one condition (cancer), was incorporated into the pilot study (4.1.6) on the basis of this work an article on the challenges of searching for acupuncture studies was submitted and subsequently published (Pilkington and Richardson, 2004).

4.1.3 Testing of the filtering process An analysis of research study types in CAM and associated indexing processes was completed with the collaboration of the RCCM’s CISCOM team. Four researchers assigned study type categories to a total of 30 articles and the categories assigned were compared for discrepancies. As a result of this work, guidelines in the form of a flow-chart (Appendix 4) were developed in order to aid initial filtering and categorisation of citations. The process for filtering the initial searches for relevant articles was then tested by two reviewers independently selecting references and cross-checking for agreement. This work was necessary because the aim was to include a range of studies, examining the ‘best available’ evidence, not only randomised controlled trials, and including qualitative studies where relevant due to the different and rich data they provide regarding patient experience.

4.1.4 The appraisal process Critical appraisal frameworks and checklists already available were collected and evaluated. A training programme for potential appraisers/reviewers from the CAM field took place during July 2003 and a panel of practitioners was recruited to contribute to the appraisal and clinical commentary. The appraisal process was revised to address issues arising from this training programme and from discussions with a number of CAM practitioners and clinicians in the field. Data extraction and appraisal frameworks/templates were developed, tested and revised (Appendix 5). The clinical trial template was based on those published by the Centre for Reviews and Dissemination at York (CRD, 2001) with some adaptations and additions relevant to CAM interventions. The template for systematic reviews was that developed by Oxman and Guyatt (Oxman and Guyatt, 1988; Shea et al, 1995) and that for qualitative research was based on a combination of the guidance provided by the Critical Appraisal Skills Programme (CASP, 2002) and Mays and Pope (1995; 2000).

4.1.5 Clinical commentaries The clinical commentary process was the process whereby clinicians and practitioners (CAM and conventional) provided an assessment of the clinical aspects and overall relevance to practice of each study included in a review. A

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template was developed (Appendix 6) and this was piloted for the first three review topics. The template was reviewed in the light of the feedback received and from clinicians and the outcomes it produced. No significant amendments were required.

4.1.6 Pilot study A pilot study of the processes and procedures which had been developed, took place over July/August 2003. An experienced systematic reviewer (independent of the project team who had previously conducted a number of Cochrane reviews) contributed to the process. The aim was to test the search strategies and the processes for the appraisal and review of complementary therapies, and to assess potential timescales for producing the reviews. The pilot study, using acupuncture and cancer as the therapy and condition respectively, was carried out as follows: •

A comprehensive search of the databases using the strategy specifically developed for the project



An assessment of the effectiveness of the searches by comparison with articles referenced in a number of printed evidence based sources and published review articles



Filtering of articles according to set criteria and categorising according to the study design



Copies of relevant articles obtained



An appraisal of the basic study methodology by the research assistant/reviewer in collaboration with the Project Manager



Selection of articles to be sent for clinical commentaries by cancer and CAM clinical specialists



A report on the findings and recommendations of this study presented to the advisory groups for discussion

The results indicated that the search strategies that had been developed were highly sensitive but low in specificity indicating that filtering of relevant articles would be a more substantial task than had been anticipated. Additional challenges related to the lack of abstracts for many citations, potential difficulties in accessing the relevant journals and managing the literature in languages other than English. The pilot study indicated that the study type flow chart and appraisal process required minor amendment in the form of additional guidance notes. It was also clear that further discussions were required with the Advisory

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Groups on the extent of reviews and on areas in which there was overlap between topics. Further work was required to address the literature in languages other than English (section 4.3.1). The discussions on the findings of the pilot study resulted in a review of priority areas for the project and in established procedures for searching, filtering and categorising and appraising a range of study types. The pilot study was also presented at the 10th Annual Symposium on Complementary Health Care in November 2003 at the Royal College of Physicians (Pilkington, 2003). The feedback received was considered and incorporated into the process.

4.1.7 Mapping In order to prioritise and focus efforts within the project and to ensure that the project remained achievable, in consultation with the advisory groups, a preliminary mapping exercise was carried out for each condition area. In response to guidance from the Specialist Advisory Groups, this work had a slightly different focus within the two major areas of cancer and mental health. The focus for the mental health area included assessing prevalence, usage and evidence, while that for cancer focused on mapping of evidence against relevant symptoms followed by a consensus process to agree priorities for the review. Additional work was required specifically on the topic of herbal medicine in order to identify which of the herbs should be addressed within the reviews (Appendix 7). For the remaining condition areas, the mapping exercises focused on identifying the potential level of evidence within the area. This required identifying any systematic reviews that had been conducted or were underway and the potential number of clinical trials. Based on the findings of these exercises and discussion within the Specialist Advisory Groups, it was concluded that the mental health work should focus primarily on anxiety and depression and related conditions, and cancer reviews should focus primarily on relief of a limited number of cancer related symptoms (pain, nausea and vomiting, hot flushes, breathlessness, fatigue). The findings of the remaining mapping exercises indicated that the reviews of arthritis, asthma and chronic back pain should focus on identifying and appraising systematic reviews, as considerable work had already been conducted within these areas. It was agreed that the reviews of multiple sclerosis, coronary heart disease and stroke, and diabetes should focus on reviews of the primary research (clinical studies) as reviews in these areas either had not yet been conducted or were out of date.

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4.2

Final project report: November 2007

Systematic review methods

The following is an outline of the processes that were developed and tested as described above and subsequently used for the production of the reviews. 4.2.1 Searches Comprehensive searches of the following databases were conducted for each review: Major biomedical databases: • ClNAHL • Cochrane CENTRAL Register of Controlled Trials • Cochrane Database of Systematic Reviews • DARE (Database of Abstracts of Reviews of Effects) • EMBASE • MEDLINE (and PubMed) • PsycINFO Specialist CAM databases • AMED • CISCOM • Cochrane Complementary Medicine Field Registry Specialist therapy databases were used as appropriate to the topic: • Acubriefs (acupuncture reviews) • HerbMed (herbal reviews) • Hom-Inform (homeopathy reviews) • International Association of Yoga Therapists (yoga reviews) • Yoga Biomedical Trust (yoga reviews) Specialist condition based databases and sources were also used as appropriate to the topic: • Specialist mental health websites: MIND, Mental Health Foundation • Cochrane Collaborative Group on Depression, Anxiety and Neurosis register • Cochrane Pain, Palliative and Supportive Care Group Register • Cochrane Stroke Group Register • Cochrane Musculoskeletal Group Register Note. The relevant Cochrane group was contacted for each review area where original research studies were being sought. Several groups recommended searching only CENTRAL as their own databases were either not sufficiently developed or all studies included in their databases were available on CENTRAL. The remaining groups agreed to conduct searches of their specialist databases.

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Efforts were also made to identify unpublished and ongoing research via the UK National Research Register (www.nrr.nhs.uk), the US site Clinicaltrials.gov (www.clinicaltrials.gov), and experts in the field where possible. Lists of the sources used for each review are specified in the methods section of each review. Search strategies included terms relevant to the condition (and symptom if necessary) and to the therapy. Search strategies are included in Appendix 8.

4.2.2 Filtering Potential research articles were noted for retrieval and given a preliminary 'study type' category according to the flow-chart system developed for this project. The basic study type categories included systematic reviews, randomised controlled trials, controlled clinical trials, uncontrolled studies and qualitative studies. Animal research and basic laboratory-based research were not included in the categorisation process. No language limitations were imposed at the filtering stage. Two reviewers carried out this process independently, notes were compared and in cases of disagreement these articles were also retrieved. Where filtering identified only a small number of studies all research studies that included clinical outcome measures were selected for inclusion in a review (with the exception of single case reports). In all cases, total numbers of all the above studies located for each topic were included on the CAMEOL records.

4.2.3 Data extraction and appraisal Relevant research was appraised according to study design. Studies were appraised and their methodological quality assessed using standardised data extraction and critical appraisal forms. Data extracted included details of selection criteria and procedure, the participants, the intervention and any comparison or control intervention, aspects of the methodology and outcome measures and results. As described in section 4.1.4, clinical trials were appraised using a standardised appraisal framework specifically developed for this project and based on a template published by the Centre for Reviews and Dissemination (CRD, 2001). Evaluation criteria included method of randomisation, allocation concealment and level of blinding (if relevant), loss to follow-up/withdrawals, measures of compliance and outcomes measures reported. Systematic reviews were appraised using a standardised template based on Oxman and Guyatt’s index of the scientific quality of research overviews (Oxman and Guyatt, 1988; Shea et al, 1995) while qualitative studies were appraised using a combination of the quality criteria recommended by the Critical Appraisal Skills Programme (CASP, 2002) and Mays and Pope (1995; 2000).

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Data extraction and appraisal were conducted independently by two researchers for each study and any disagreements or discrepancies were resolved by discussion. Where consensus could not be obtained, a third reviewer was available for consultation.

4.2.4 Clinical commentaries Clinicians with relevant training and experience were asked to comment on each study focusing on clinical relevance and practical issues. A clinical commentary framework, incorporating open and closed questions, was developed specifically for this. Each clinical study reporting patient outcomes was forwarded together with the methodological appraisal and clinical commentary form. Clinical comments were incorporated into the narrative review and summaries were provided in the tables of studies.

4.2.5 Expert review External experts were consulted for a variety of reasons; for advice on specific aspects such as statistics or for more information about a particular therapy and to provide peer-reviews of completed reviews.

4.3

Supporting work

4.3.1 Languages other than English (LOE) study The exclusion of studies in languages other than English had previously been raised as a potential weakness within reviews of complementary therapies (Moher et al, 2003). In order to investigate this, a supplementary study was conducted in which the literature in the field was reviewed. Work on this topic indicated that studies in languages other than English were of particular importance in two areas, acupuncture and homeopathy. A more detailed report of this study is included in Appendix 9. One aspect of this supplementary study, the coverage of LOE journals by the major databases, was subsequently published (Pilkington et al, 2005).

4.3.2 Qualitative research studies Systematic searching for qualitative studies in selected complementary therapies was undertaken using three methods: A. index terms only B. free text words suggested by Grant (2001)

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C. a combination of indexing terms for qualitative research, text words (obtained from considering the indexing of previously located qualitative research papers) and complementary therapy terms. In addition, grey literature searches were undertaken. The total numbers of studies located from each strategy were compared. Results from search strategy C were compared on a therapy by therapy basis to identify differences in the levels of qualitative evidence available for different complementary therapies. Citations were filtered independently by two reviewers. All relevant studies (studies including a qualitative approach to explore patient experiences of CAM in cancer) were retrieved for analysis and appraisal. From the relevant studies located, patient experiences of the intervention were coded into themes independently by two reviewers. Data were extracted in order to establish what (if anything) the qualitative research added to the evidence of specific CAM therapies for cancer patients. Themes were compared and thematic categories confirmed by consensus discussion. The methodological quality of studies was evaluated by two independent reviewers, using a combination of the criteria outlined by CASP (2002) and Mays and Pope (1995; 2000). Any discrepancies were discussed until consensus was reached. A third independent reviewer also appraised the studies as an additional check. The findings indicated that using a combination of indexing terms and text words (strategy C) would be the optimal strategy for use in the current study. The potential value of including the findings of qualitative research in reviews was also reported (Richardson et al, 2004). All qualitative studies identified by the CAMEOL project will be included in a specific section of the NLH CAM Specialist Library.

4.3.3 STRICTA study An investigation was conducted into the standard of reporting and details of type and range of acupuncture interventions used in studies which had been retrieved during the review process. Preliminary findings suggested that researchers did not report on all areas covered by the STRICTA (STandards for Reporting Interventions in Controlled Trials of Acupuncture, MacPherson et al, 2001) guidelines. In particular, the following aspects were inadequately reported: • Needling details • Practitioner background • Control interventions Initial results implied that there were no clear differences in the level of reporting between trials for different indications or between traditional Chinese medicine (TCM) and Western based research perspectives. The findings also demonstrated that the interventions used within each indication varied

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significantly in terms of the type of acupuncture, treatment principles, treatment regiment and points selected. The study was reported at a national CAM conference (Smith and Pilkington, 2004).

4.3.4 Safety study Information about safety aspects including adverse effects of the therapies that had been reported in the original studies was included in the reviews. In addition to this, work was initiated to identify systematic reviews and other quality sources of information on safety. A search was carried out for systematic reviews on the safety of acupuncture, homeopathy, meditation and yoga. The results were filtered independently by 2 reviewers. Where possible, links to relevant information were included under the Further Resources section of each CAMEOL record. However, further development of this study was required and this work has now been incorporated into the development of the NLH CAM Specialist Library.

4.4

CAMEOL database development and testing

One of the main deliverables of the project was to make the information available to health professionals, researchers and the public via the Internet. To achieve this, the material produced needed to be organised and categorised and a website generated that was easy to search and browse. In order to achieve the objectives, the information was organised in relational data storage and published on the web via dynamic web interfaces. A demonstration interface was developed based on the initial specification and presented to the advisory groups and representatives of 2 patient organisations for comments. A pilot version of the database was then developed and tested by the project team and by members of the advisory groups. The online database, CAMEOL (CAM Evidence OnLine) was subsequently developed, tested and the information uploaded. The database was initially available on a restricted basis to a limited number of individuals including members of the advisory groups for a two month period and feedback collected. Relevant changes were made and CAMEOL became openly available via the Internet at the end of May 2005 (http://www.rccm.org.uk/cameol).

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5

Results

5.1

Summary of progress

Final project report: November 2007

5.1.1 Year 1 (March 2003 – March 2004) The main objectives for Year 1 were to establish the advisory groups, develop and test the processes required to conduct the review and to begin work on the reviews in the areas of cancer and mental health. The groups were established and met on a regular basis to provide valuable advice and support on the processes and scope of the review. Development and testing of processes began with the appointment of the project manager and was continued and extended following the appointment of the research assistants. A pilot study was conducted and the findings resulting from this work confirmed that the development of robust systems for filtering and categorising the literature in the field was essential. The scale and complexity of the task in an area in which the research is widely scattered presented a challenge. To ensure that the project was achievable, in consultation with the specialist advisory groups, two mapping exercises were completed in order to set priorities for the specific topics to be addressed within the reviews. In addition, the review process was adapted for those areas in which substantial work on reviewing the evidence had already been undertaken or was in progress by groups such as the Cochrane Collaboration to include reviews of the secondary research (reviews) rather than the primary studies. The advisory groups continued to be involved in reviewing and advising on priorities. Work began on a range of specific topic areas, most of which were to undergo a full review of the primary research. It became apparent that a number of supplementary outcomes would also result from the work on this project. These were particularly related to several of the processes used. For example: • specialised search strategies • identification of the most valuable sources of research • methods for appraising specific therapeutic interventions • an overall picture of the pattern of research publications in the fields. All these ‘outcomes’ were available to other researchers and practitioners via the CAMEOL web site. Additionally, a number of links were established between this project and other relevant work by drawing on existing expertise and by contributing to related projects.

5.1.2 Year 2 (March 2004 – March 2005) The main objectives for Year 2 were to complete work on the reviews in the areas of cancer and mental health and to begin work on the other condition areas

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(arthritis, asthma, back pain, coronary heart disease, diabetes, multiple sclerosis and stroke). As a result of adaptations to the process described in the Year 1 summary above, it was possible to complete the majority of the work on the first two areas, cancer and mental health. In addition, work started on the other condition areas, beginning with multiple sclerosis, arthritis and stroke. Initial scoping of all areas was carried out and, as with the first two topics, the review process was adapted for those topics in which substantial work on reviewing the evidence had already been undertaken. For the other conditions, searching, filtering and appraising were completed and work on preparation of the reviews was scheduled for year 3. Development of the online database, CAMEOL (CAM Evidence OnLine) took place followed by testing of the system. The process of uploading the information also began. The database was initially available on a restricted access basis to individuals including members of the advisory groups.

5.1.3 Year 3 (March 2005 – March 2006) The CAMEOL database became open access on the Internet from May 2005 after uploading of the completed cancer and mental health reviews. Additional reviews were added to the database as they were completed.

5.1.4 Years 4 and 5 (March 2006 – September 2007) Work continued on the remaining review topics and several further systematic reviews were submitted for publication together with a summary of the work on depression (Pilkington et al, 2006). Two chapters for books on complementary therapies aimed at health professionals were prepared based on the work in cancer and mental health respectively (Pilkington and Richardson, 2007; Pilkington and Rampes, in press). A comprehensive evaluation of the search methods was conducted resulting in the publication of a paper including preliminary recommendations on optimum search strategies for specific therapies (Pilkington, 2007). An investigation into the potential work required for updating reviews was carried out and the searches for several cancer reviews were updated. An analysis and comparison of methods used in the CAMEOL project and those used by the Penny Brohn Cancer Centre resulted in preparation of a document proposing a strategy to be used for preparation of a wide range of patient information on complementary therapies in cancer. The project was presented at national conferences on complementary medicine, nursing and pharmacy. As described in the relevant sections, methods and outcomes of the project have been incorporated into the development of the NLH CAM Specialist Library. The experience gained through the project has been or will be shared

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with colleagues providing or planning to provide similar CAM information services across Europe through the EICCAM working group and the ICCR (see 5.3)

5.2

The review areas

Reviews that have been published in peer reviewed journals are shown in bold in the following section. 5.2.1 Cancer Completed reviews: Acupuncture for dyspnoea (breathlessness) Acupuncture for hot flushes Acupuncture for pain relief (review of reviews) Aloe vera for radiation-induced skin reactions Aromatherapy and massage (review of reviews) Black cohosh for hot flushes Essiac in cancer Homeopathy for symptom relief in cancer Hypnosis for nausea and vomiting in cancer chemotherapy Hypnotherapy for procedure related pain and distress Mindfulness-based stress reduction programmes for symptom relief in cancer Mistletoe in cancer Meditation for symptom relief in cancer Yoga for symptom relief in cancer Note. Searches were also conducted for studies on evening primrose oil and carctol in cancer patients. No relevant trials were located. Additional publications: Evaluation of benefits and risks (Chapter in Enhancing Cancer Care: Complementary Therapy and Support, J Barraclough, Ed., 2007, Oxford University Press).

Collaborative work on cancer • The project team collaborated with researchers working on a Department of Health funded study at the University of Bristol. The study was of male cancer patients' CAM use and the collaboration involved identification of relevant studies to support the work at Bristol in exchange for data on patients’ use of the internet as a source of information. The findings were subsequently reported (Richardson and Britten 2003).

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The project team was in contact with the CAM-CANCER European project to discuss areas of potential duplication of effort. The Norwegian National Research Centre in Complementary and Alternative Medicine (NAFKAM) is now coordinating this project and the CAMEOL project team will be contributing to the future development of this work.



The project team was contacted by the Bristol Cancer Help Centre (now Penny Brohn Cancer Centre) to discuss methods of identifying evidence for the preparation of patient information leaflets. This work is ongoing (see below).



Collaboration with the authors of the proposed Cochrane review on homeopathy for symptom relief in cancer patients to produce a CAMEOL review which addressed a wider range of study types.



A presentation to the NCRI Complementary Therapies CSG (clinical studies group) in 2004 and at the NCRI conference in 2005 in order to provide input on potential topics for research in CAM and cancer based on the reviews we have conducted in this area.

Ongoing development of the work: The procedures and cancer reviews developed by this current project form the basis of a collaborative project between the University of Plymouth and Penny Brohn Cancer Care (previously the Bristol Cancer Help Centre). This collaborative 30 month project secured ESRC funding as a Knowledge Transfer Partnership (KTP) to develop an evidence-based resource in complementary therapies for people affected by cancer, and will embed an evidence-focused approach within Penny Brohn Cancer Care. A KTP Associate began working on the project in January 2007; data collected and systems developed form the basis of the KTP Associate’s PhD. Thus far one paper has been submitted for publication and two posters accepted for conference presentations.

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5.2.2 Mental health Completed reviews: Acupuncture for anxiety Aromatherapy and massage for anxiety Aromatherapy and massage for depression Homeopathy in anxiety Homeopathy in depression Meditation for anxiety Meditation for depression Reflexology for anxiety Reflexology for depression St John’s wort in depression (review of reviews) Yoga in anxiety Yoga in depression Additional publications • Complementary medicine for depression (Pilkington et al, 2006, invited review paper) • Complementary and alternative therapies (Rampes and Pilkington, Chapter in The Art and Science of Mental Health Nursing: A Textbook of Principles, I Norman and I Ryrie (Eds) (in press).

Collaborative work on mental health • Cochrane Depression, Anxiety and Neurosis group (CCDAN), who also act as contact point with other mental health-related Cochrane groups. Searches of the CCDAN database supported the searches carried out within the project. Studies identified within the project were forwarded to the CCDAN group for inclusion in the Registry and ultimately the Cochrane Library. Details of search strategies and studies identified were forwarded to the authors of the Cochrane review on meditation for anxiety disorders (Krisanaprakornkit et al. 2006, acknowledged in the review by the authors)

Related work - Expert Topic Paper (CAM in Anxiety and Depression) The RCCM was approached by the Department of Health Policy Research Programme Standards & Quality Group regarding a proposal for an expert topic paper on 'Complementary Therapies for Anxiety & Depression’. The work was part of a set of short-term projects to assemble and assess evidence relating to a set of topics of current policy priority. The work required the following: 

Reviewing findings from existing research

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Final project report: November 2007

Drawing on relevant information from other sources - including the views of users of complementary therapies Assessing the different levels of available evidence Preparing a topic paper that points to best evidence, and identifying where evidence is weak and further research is required

As the RCCM was already undertaking work, funded by the DH, providing a review of complementary therapies for anxiety and depression, the suggestion was that, with some additional funding, the RCCM could successfully build on this work. Additionally the views and experiences of people with anxiety and/or depression who use complementary therapies would be sought via focus groups and questionnaires. The provision of complementary therapies by mental health trusts would be ascertained using a survey approach. The proposal was submitted to the Department of Health Policy Research Programme in February 2005 but due to an unprecedented demand on the Policy Research Programme budget, the department was unable to take forward any work on the expert mental health topic reviews.

Ongoing development of the work: • An investigation into how research evidence on CAM in mental health is presented on the Internet is planned by one of the project team members at the University of Westminster. An application for funding is in preparation. • A National Knowledge Week on depression is planned for the NLH CAM Specialist Library in 2008.

5.2.3 Multiple sclerosis Completed reviews: Acupuncture in multiple sclerosis Aromatherapy in multiple sclerosis Massage in multiple sclerosis Meditation (and Tai Chi) in multiple sclerosis Osteopathy in multiple sclerosis Reflexology in multiple sclerosis Yoga in multiple sclerosis No studies were located on Alexander technique, chiropractic, homeopathy or hypnotherapy.

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Collaborative work on multiple sclerosis • The project team collaborated with the Multiple Sclerosis (MS) Society on this set of reviews. A number of joint meetings were held to discuss strategy and seek advice from the MS Society with respect to our approach. The MS Society commented on all the MS reviews and made a significant contribution to providing the background information on the condition. The full reviews were available to the MS Society who recently produced an ‘MS Essentials’ guide to MS and complementary therapies which one of the project team was invited to comment on in its draft version.

5.2.4 Coronary heart disease and stroke This work focused on the management of the post-stroke phase. Completed reviews: Acupuncture in stroke (review of reviews) Homeopathy in stroke Hypnotherapy in stroke Massage in stroke No studies were located on Alexander technique, aromatherapy, chiropractic, meditation, osteopathy, reflexology or yoga.

Collaborative work on stroke • The Cochrane Stroke group conducted a series of searches on their database and the results have been incorporated into the reviews.

Ongoing development of the work The work of identifying previously published systematic reviews on herbal medicines in stroke was transferred to the NLH CAM Specialist Library. It is anticipated that the work on stroke will form part of a future National Knowledge Week.

5.2.5 Arthritis Completed reviews of reviews: Acupuncture for osteoarthritis Homeopathy for osteoarthritis Herbal medicine (specific plant preparations) for osteoarthritis

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Acupuncture for rheumatoid arthritis Homeopathy for rheumatoid arthritis Herbal (plant preparations) for rheumatoid arthritis

Collaborative/ongoing work • The work on rheumatoid arthritis formed the basis of a review of the evidence on complementary therapies undertaken by the NLH CAM Specialist Library for a National Knowledge Week in May 2007 led by the Musculoskeletal Library. The searches were repeated in 2007 and the outcome of this work can be seen at: http://www.library.nhs.uk/musculoskeletal/ViewResource.aspx?resID=259 217&tabID=290. It is anticipated a similar process will be used in a similar National Knowledge Week on osteoarthritis.

5.2.6 Asthma Completed reviews of reviews: Acupuncture for asthma Alexander technique for asthma Chiropractic for asthma Herbs for asthma Hypnosis for asthma Reflexology for asthma Yoga for asthma

Collaborative/ongoing work: • These reviews of reviews will form the basis of a National Knowledge Week in 2008 on allergy including asthma possibly in collaboration with the Respiratory and Skin Specialist Libraries.

5.2.7 Diabetes Completed reviews: Acupuncture in diabetes Herbal therapy in diabetes (review of reviews) Homeopathy in diabetes Hypnotherapy in diabetes Massage in diabetes Yoga in diabetes

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Note: The above reviews were included together with a summary of other relevant systematic reviews in a paper on the topic of Complementary Therapies in Diabetes (Pilkington et al, 2007)

Collaborative/ongoing work As a result of this work, a pilot study was undertaken in collaboration with Dr Stenhouse (University of Plymouth) in order to examine use of complementary therapies in women with gestational diabetes. The study was presented as a National Diabetes Conference (Stenhouse et al, 2007). A large study is planned to build on this initial work.

5.2.8 Chronic low back pain Preparatory work including development of search strategies was conducted. Further work was undertaken in preparation for a National Knowledge Week on low back pain presented on the NLH CAM Specialist Library in October 2007 (http://www.library.nhs.uk/cam/Page.aspx?pagename=NKWLBP).

5.3

Other collaborative work



A final assessment of all systematic reviews identified during the project was conducted and the full list has been forwarded to the Centre for Reviews and Dissemination at York via the NLH CAM Specialist Library.



Initial collaborative work with the British Medical Acupuncture Society and the Acupuncture Research Resource Centre (ARRC) to develop standardised background information on acupuncture resulted in preparation of an Introductory Article for inclusion on the NLH CAM Specialist Library. Background information on other therapies has also formed the basis of an Introductory Article on homeopathy. Further similar articles are underway.

• The project team was approached by the New Zealand Guidelines Group regarding potential collaboration. Initially the group planned to adopt the same methodology for their CAM reviews, so that the structure necessary for collaboration was in place. In the long term, the NZ group proposed to work towards the establishment of one international central point producing evidence reports on CAM. The first step in achieving this has taken place through the establishment of the ICCR (see below).

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ICCR (International Collaboration on Complementary Medicine Resources). Discussions have taken place with several other providers of National (and / or Government funded) Internet-based resources on complementary and alternative medicine (CAM) in order to facilitate the sharing and further development of these resources. The first formal meeting took place in September 2007 and collaborative work on several aspects of provision of CAM information are underway. A follow-up meeting has been scheduled for December 2007.



EICCAM. A working group has been established to produce a proposal for a “European Information Centre on Complementary and Alternative Medicine (EICCAM)”. The aim of this centre is the communication of scientific and health care related information on CAM to the media, politicians, legislators and other stakeholders in a way appropriate to the needs of the target groups. This information should be independent, comprehensive, understandable and quality assured in order to contribute to informed decision-making. Advice on aspects related to information and transparency of the process has been provided through the input of the project manager to the CAMEOL project and is based on experience gained through this project.

5.4. Other achievements On the basis of the work in developing the methods and conducting the mental health reviews, one member of the team (K Pilkington) has been awarded a PhD by publication (Pilkington K 2007). A second member of the team (A Boshnakova) was appointed as Information Specialist to the NLH CAM Specialist Library.

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6

Challenges encountered

6.1

Process

Final project report: November 2007

In conducting this study, it was necessary to develop and test several of the methods used. The majority of published systematic reviews focus only on randomised controlled trials. However, it was the intention of this study to also map other types of clinical studies, therefore a system for identifying and categorising CAM research had to be developed. There are currently no standardised strategies for searching for specific therapies and the major databases vary in the terms used and the level of detail given. Thus, each search strategy was specifically developed for the project and was adapted for the different databases. In addition, it was important to identify any specialised sources for each therapy and condition included in the project. Finally, the appraisal of a range of study types required several different appraisal templates and although these were based on existing documents, amendments were necessary in order to ascertain the relevant detail for each of the interventions. This was considered essential in providing a comprehensive review of each study.

6.2

Communication

The project incorporated an extremely wide range of therapies and conditions and this required gaining support and advice from a large number of individuals. Maintaining regular contact with each group and external experts proved a significant aspect of the project. The inclusion of clinical comments for each of the studies also added to the complexity, and thereby increased the time scale for preparation of each review. By definition, the clinical commentators were individuals with extensive clinical commitments and the work we requested added to this. Addressing the specific aspects and perspectives of a wide range of CAM and conventional practitioners also proved a challenge.

6.3

Publishing

In order to raise the profile of the project and disseminate the findings, it was important to aim to publish a selection of the reviews in peer-reviewed journals. This conflicted with the need to prepare reviews in a format suitable for publication on a website. In addition, the adaptation of the various reviews for different audiences and the delays between submission of an article and final publication added an unanticipated burden to the project team.

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6.4

Final project report: November 2007

Website development

Preparation of the reviews in their final form required information on the structure and design of the database on which they would be held. In the early stages of the project it was anticipated that the reviews could be disseminated via the proposed NLH CAM Specialist Library. However, a delay in the tendering and contract awarding process for this Specialist Library took place. This meant that it was difficult to prepare the final versions of the reviews and eventually the CAMEOL database was developed to ensure that the reviews were made available while still current. The work required to produce a specification, develop and test the database then needed to be incorporated into the work plan for the reviews.

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7

Final project report: November 2007

Evaluation of the methods

In order to ensure the reviews were comprehensive, search strategies were developed specifically for the project using a rigorous process. Search strategies such as those of the Cochrane Complementary Medicine Field (Berman, 2006) and the CAM filter on PubMed (Nahin 2001) aim to identify all possible CAM studies but strategies for specific therapies had not previously been the focus of research. The effectiveness of the strategies that had been developed for the project was tested initially by focusing on the topic of acupuncture in cancer (Pilkington and Richardson, 2004). A more detailed evaluation provided further indication of possible improvements and enabled the development of potentially optimum search strategies for identifying trials of specific complementary therapies (Pilkington, 2007). The initial evaluation provided a guide to the range of terms by which each therapy is indexed and to the specialist sources likely to enhance the comprehensiveness of each search (Pilkington and Richardson, 2004). The subsequent study revealed that, for example, while index terms were effective in locating studies on acupuncture, individual herbs, hypnosis, massage and yoga, for the remaining therapies, use of text word search terms was important and particularly so for homeopathy, meditation and reflexology (Pilkington, 2007). The findings also demonstrated that Cochrane CENTRAL listed the highest proportion of trials for all therapies but no database listed all studies and at least one unique study was listed on all databases except MEDLINE. Several studies were not found on any of the major databases.

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8

Final project report: November 2007

Dissemination

The following methods and routes of dissemination were utilised. Full publications as listed in Appendix 11 Presentations and posters at: • 10th Annual Symposium on Complementary Health Care, November 2003, London. • Mental Health and Complementary Therapies, March 2004, Stafford. Organised by the Prince of Wales’ Foundation for Integrated Health and the Alternative and Complementary Collaborative on Research and Development (ACCoRD). • Developing Research Strategies Conference, May 2004, Southampton. • Complementary Therapies and Cancer Care: A Research Symposium, June 2004, London. Organised by Complementary Cancer Care Charities Partnership. • Institute for Clinical Research Symposium, June 2004, London. • Diversity and Debate in Alternative and Complementary Medicine, July 2004, Nottingham. Organised by the Alternative & Complementary Health Research Network. • Bromley Primary Care Trust, September 2004. • National Cancer Research Institute (NCRI) Complementary Therapies CSG (clinical studies group), September 2004, London. • 11th Annual Symposium on Complementary Health Care, November 2004, Exeter. • Diversity and Debate in Alternative and Complementary Medicine, July 2005, Nottingham. Organised by the Alternative & Complementary Health Research Network. • Cochrane Complementary Medicine Field meeting, October 2005, Melbourne, Australia (by member of cancer SpAG). • National Cancer Research Institute (NCRI) Annual Conference, October 2005, Birmingham. • Bristol Oncology and Haematology Centre, September 2006. • Bromley Primary Care Trust, March 2007. • Royal College of Nursing International Research Conference, May 2007. Demonstrations/stands etc: • 12th Annual Symposium on Complementary Health Care, Exeter (Peninsula Medical School), (2005) • Diversity & Debate in Alternative and Complementary Medicine conference (2005) • Royal London Homeopathic Hospital re-opening (2005)

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Circulation of details (either by the Project Team or on our behalf): • Alternative and Complementary Healthcare Research Network (ACHRN) • RCCM CAM Researcher Network (CAMRN) • Department of Health CAM fellowship award holders • IN-CAM (Canadian CAM research network) • International Society for Complementary Medicine Research (ISCMR) network • MS (multiple sclerosis) Society • National Institute for Mental Health in England (NIMHE) Experts by Experience • PRIMHE (Primary care mental health and education) Mental Health taskforce • Project and specialist advisory groups • RDInfo (Dept of Health) • Relevant Cochrane Collaborative Groups • Research Council for Complementary Medicine (RCCM) trustees • Royal College of General Practitioners Complementary and Alternative Action Group • School of Integrated Health, University of Westminster Feedback The project team received positive feedback and constructive comments from a number of individuals and organisations either directly or in response to presentations. An audit of usage was planned for early 2006 supported by further development of the CAMEOL website but was superseded by the decision to incorporate the work into the NLH CAM Specialist Library.

Future and ongoing dissemination The main method of dissemination of the work will be via the National Library for Health. The RCCM, in collaboration with the Royal London Homoeopathic Hospital and the School of Integrated Health at the University of Westminster, was awarded the tender to develop a Specialist Library on Complementary and Alternative Medicine (CAM-SL) for the National Library for Health. The findings of the current project will be disseminated via this Specialist Library. The development of the library mirrored the development of CAMEOL as the therapies and conditions addressed were those included in CAMEOL and methods used for CAMEOL were used in developing the library. The CAMEOL project director and project manager are both members of the project team for the development of the CAM-SL and this has ensured that there had been appropriate integration of the two projects and that duplication of effort is avoided where possible.

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9

Final project report: November 2007

Updating and sustainability

The initial application for funding incorporated a proposal for the maintenance and updating of the database relating to Objective 3. Following the initial 3 year period, further funding was made available for consolidation of the work and to investigate and test possible strategies for sustainability. This is a major piece of work that has the potential to make an important contribution to setting the research agenda in complementary and alternative medicine (CAM). The outcomes and research recommendations should form the basis of discussions in the Department of Health to bring together stakeholders to co-ordinate research capacity development in all aspects of complementary and alternative therapies. Furthermore, the research recommendations and potential ongoing work could be invaluable to funding organisations attempting to set priorities for the future funding of CAM research. A recent report on ‘The Role of Complementary and Alternative Medicine in the NHS’ (Smallwood, 2005) suggests that the areas where CAM therapies have the potential to be most useful are those poorly served at present by conventional medicine. These conditions (such as back pain and arthritis) are consistent with the chronic and disabling conditions addressed in this current project. Smallwood goes on to recommend that ‘Health Ministers should invite the National Institute for Health and Clinical Excellence (NICE) to carry out a full assessment of the cost-effectiveness of the therapies which we have identified and their potential role within the NHS ….’. This current project could form the basis of such an assessment. As a result of this project, as described above, the RCCM (together with the Royal London Homeopathic Hospital and the University of Westminster) placed a successful tender for the contract to establish and run the NHS National Library for Health CAM Specialist Library (SL). The aim of this SL is to identify and catalogue research and information sources in CAM thus meeting the recommendation above. The funding available for the CAM SL will enable a limited amount of updating to CAMEOL in the form of adding any subsequent systematic reviews. In order for CAMEOL reviews to continue to be of use to practitioners and researchers they will need to be updated on a regular basis with relevant primary studies using a rigorous appraisal process. Therefore, during the second phase of the project, pilot studies were conducted on aromatherapy, Essiac, massage, meditation, reflexology and yoga in cancer to assess the extent of work required to update each review. These pilot studies suggested that a considerable amount of work is required to conduct updated searches and filter the results. However, few studies were found and none that would significantly alter the initial conclusions. The only exception to this was in the case of aromatherapy and massage which is already addressed within a Cochrane review. Further work

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was conducted to map the development of the evidence in terms of the number of trials published on other CAMEOL topics (Appendix 10). This work demonstrated that the key areas of rapid development were within cancer, mental health and low back pain. The work on cancer is being progressed through a project by the University of Plymouth in collaboration with the Penny Brohn Cancer Centre. It is anticipated that work on the other major area, mental health, will continue at the University of Westminster. Low back pain was addressed in a National Knowledge Week on the NLH CAM Specialist Library in October 2007 and will now be updated annually. Other topics will be addressed in future National Knowledge Weeks. The supplementary study on qualitative research will be progressed through a project led by Peninsula College of Medicine and Dentistry (Universities of Exeter and Plymouth). For the other areas, where possible, the findings and/or methods that were developed will be integrated into the NLH CAM Specialist Library. However, there will not be sufficient resources to fully update each review of the primary research in all areas.

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10

Final project report: November 2007

Conclusions

Over the duration of the project a number of significant outcomes have resulted, providing a clearer picture of the extent of the evidence on complementary therapies. A series of reviews have been completed on a range of therapies and conditions, each of which provides a guide to published and ongoing research on the topic. The development of appropriate methods for the searching and appraisal proved challenging. A pilot study was conducted and the findings resulting from this work confirmed that the establishment of robust systems for filtering and categorising the literature in the field was essential. The scale and complexity of the task in an area in which the research is widely scattered presented a challenge. To ensure that the project was achievable, in consultation with the specialist advisory groups, two mapping exercises were completed in order to set priorities for the specific topics to be addressed within the reviews. In addition, the review process was adapted for those areas in which substantial work on reviewing the evidence had already been undertaken or was in progress by groups such as the Cochrane Collaboration to include reviews of the secondary research (reviews) rather than the primary studies. The main outcome initially was the CAMEOL database which provided access to summaries of the research on each topic including unpublished and ongoing studies, tables of studies incorporating methodological appraisals and clinical comments and links to relevant evidence. Supplementary outcomes included a review of currently available electronic sources of CAM information, development of search strategies for a range of CAM therapies, investigations into the contribution of non-English language and qualitative research and into the quality of reporting of CAM interventions in research studies. The work is now being integrated where possible into the development of a National Library for Health CAM Specialist Library which will become the primary source of CAM information for the NHS (and the CAM community). Several specific areas are being taken forward in projects by members of the project team or in collaboration with other colleagues in the CAM field.

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References Beckner W.M. and Berman B.M. (2003) Complementary Therapies on the Internet. Edinburgh: Churchill Livingstone. Berman B.M. (2006) Cochrane Complementary Medicine Field. About The Cochrane Collaboration (Fields), Issue 1. Art. No.: CE000052. Available at: http://www.mrw.interscience.wiley.com/cochrane/clabout/articles/CE000052/fram e.html [Accessed 31 Oct 2006] CASP (Critical Appraisal Skills Programme) (2002) 10 questions to help you make sense of qualitative research. Milton Keynes Primary Care Trust. Available at: http://www.phru.nhs.uk/casp/qualitat.htm [Accessed 31 Oct 2005]. Centre for Reviews and Dissemination (CRD). (2001) Report Number 4 (2nd edition), Undertaking Systematic Reviews of Research on Effectiveness. York: CRD. Grant M.J. (2001) Searching for qualitative research studies on the Medline database [oral presentation], Qualitative Evidence Based Practice Conference, Coventry, 14th-16th May 2001, Coventry University. Available at: http://www.fhsc.salford.ac.uk/hcprdu/projects/qebp_2001.ppt [Accessed 31 Oct 2005]. HL Paper 123.(2000) House of Lords Select Committee on Science and Technology. Session 1999-2000, 6th Report, Complementary and Alternative Medicine. London: Her Majesty's Stationary Office. Krisanaprakornkit T., Krisanaprakornkit W., Piyavhatkul N., Laopaiboon M. (2006) Meditation therapy for anxiety disorders. Cochrane Database of Systematic Reviews Issue 1. Art. No.: CD004998. DOI: 10.1002/14651858.CD004998.pub2. MacPherson H., White A., Cummings M., Jobst K., Rose K., Niemtzow R. (2001) Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complementary Therapies in Medicine, 9(4):246-9. Mays N. and Pope C. (1995) Qualitative research: rigour and qualitative research. British Medical Journal, 311(6997):109-112. Mays N. and Pope C. (2000) Qualitative research in health care. Assessing quality in qualitative research. British Medical Journal, 320(7226):50-52. Moher D., Pham B., Lawson M.L., Klassen T.P. (2003) The inclusion of reports of randomised trials published in languages other than English in systematic reviews. Health Technology Assessment, 7(41):1-90.

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Mulrow C.D. (1995) Rationale for systematic reviews. In: I. Chalmers and D. Altman (eds). Systematic Reviews. London: BMJ Publishing Group. Nahin AM. Complementary Medicine - New PubMed Subset. NLM Tech Bull. 2001 Jan-Feb;(318):e7. National Centre for Complementary and Alternative Medicine (NCCAM) (2001) Complementary & Alternative Medicine at the NIH. Vol VIII, Number 2. Oxman A.D. and Guyatt G. (1988) Guidelines for reading literature reviews. Canadian Medical Association Journal, 138:697-703. Pilkington K. (2003) In search of the evidence: a pilot study of acupuncture in cancer. Presentation at the 10th Annual Symposium on Complementary Health Care, November 2003, London. Pilkington K. (2007) Searching for CAM evidence: an evaluation of therapyspecific search strategies. Journal of Complementary and Alternative Medicine, 13(4):451-9. Pilkington K. and Richardson J. (2003) Evidence-based complementary (and alternative) medicine on the Internet. [email protected] Information on the Internet, 34(1): 7-9. Pilkington K. and Richardson J. (2004) Exploring the evidence: the challenges of searching for research on acupuncture, Journal of Complementary and Alternative Medicine, 10(3): 587-90. Pilkington K., Boshnakova A., Clarke M., Richardson J. (2005) “No language restrictions” in database searches – what does this really mean? Journal of Complementary and Alternative Medicine, 11(1):205-7. Pilkington K., Rampes H. and Richardson J. (2006) Complementary medicine for depression. Expert Review of Neurotherapeutics, 6(11):1741-1751. Pilkington K., Stenhouse E., Kirkwood G., Richardson J. (2007) Diabetes and complementary therapies: mapping the evidence. Practical Diabetes International, 24(7):371-376. MacPherson H., White A., Cummings M., Jobst K., Rose K., Niemtzow R. (2001) Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complementary Therapies in Medicine, 9(4):246-9. Rees R.W. (1995) CISCOM, the Centralised Information Service for Complementary Medicine. Complementary Therapies in Medicine, 3:183-186.

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Rees R.W. (2001) Researching complementary therapies in cancer care. In: Barraclough J. Integrated Cancer Care: Holistic, complementary and creative approaches. Oxford: Oxford University Press. Research Council for Complementary Medicine (RCCM). (2003) Complementary and Alternative Medicine Thesaurus 2003. London: RCCM. Richardson J. and Britten N. (2003) Evidence-based patient choice in complementary therapy: myth or reality? Proceedings of the 10th Annual Symposium on Complementary Health Care published in FACT (Focus on Alternative and Complementary Therapies), 8(4): 533. Richardson J., Jones C. and Pilkington K. (2001) Complementary therapies: what is the evidence for their use? Professional Nurse, 17(2):96-99 Richardson J., Smith J. and Pilkington K. (2004) Qualitative research in complementary therapies: is it of any value? FACT (Focus on Alternative and Complementary Therapies), 9(1):43. Shea B., Dube C. and Moher D. (1995) Assessing the quality of reports of systematic reviews: the QUORUM statement compared to other tools. In M. Egger, G. Davey Smith and D. G. Altman (eds), Systematic reviews in health care: meta-analysis in context. London: BMJ Publishing. pp 122-139. Smallwood C. (2005) The Role of Complementary and Alternative Medicine on the NHS: An investigation into the potential contribution of mainstream complementary therapies to healthcare in the UK. Available at: http://www.freshminds.co.uk/aboutus/chr.htm [Accessed 31 Oct 2005]. Smith J. and Pilkington K. (2004) Acupuncture therapy – why and how is it used in cancer patients? Presentation at the Developing Research Strategies Conference, May 2004, Southampton. Stenhouse E., Millward A., Wheeler P., Richardson J. (2007) The use of complementary and alternative medicines in pregnancies complicated by diabetes. Diabetic Medicine, 24 (Suppl. 1):88. White A., Resch K.L. and Ernst E. (1995) Searching for acupuncture trials: which database? Acupuncture in Medicine, 13(2):97-99.

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Appendix 1

Final project report: November 2007

The Project Team

Project Director Janet Richardson BSc, PhD, RN, CPsychol, PGCE., RNT Professor of Health Service Research Faculty of Health and Social Work University of Plymouth Drake Circus Plymouth Devon PL4 8AA and Trustee, Research Council for Complementary Medicine, London Email: [email protected] Project Manager Karen Pilkington BPharm(Hons), MSc, PhD, MRPharmS Project Manager/Senior Research Fellow School of Integrated Health University of Westminster 115 New Cavendish Street London W1W 6UW Email: [email protected] Research Assistants Graham Kirkwood MSc, RNLD Research Assistant (CAM in Mental Health) NHSP / CAMEOL Project (to June 2005) Joanna E Smith BA, MSc Research Assistant (CAM in Cancer) NHSP/CAMEOL Project (to April 2005) Elizabeth Stenhouse Research Fellow (CAM in Diabetes) Faculty of Health and Social Work University of Plymouth (Sept – Nov 2005) Information Specialist Anelia Boshnakova MA, MLS (to April 2005) Currently: Information Specialist, NHS National Library for Health Specialist Library on Complementary & Alternative Medicine

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Appendix 2

Final project report: November 2007

Project Advisory Groups and other contributors

The Project Team acknowledge the advice and support of the following individuals and groups. The titles reflect those at the time of involvement in the project:

Project Advisory Group Sir J A Muir Gray

Director, National electronic Library for Health

Prof Jianping Liu

Previously Member of Cochrane Complementary Medicine Field Advisory Board & Lecturer in Research Synthesis, Liverpool School of Tropical Medicine Currently Founding Professor, Evidence-Based Chinese Medicine Center for Clinical Research and Evaluation, Beijing University of Chinese Medicine, China

Michael Mcintyre

Chairman, European Herbal Practitioners Association

Claire Rayner

President, Patients Association

Paul Wilson

Dissemination Officer, CRD (Centre for Reviews & Dissemination), University of York

Anne Brice

Specialist Libraries Development Manager, National electronic Library for Health (joined)

Specialist Advisory Group (SpAG) – Cancer Claire Allen

Consumer Representative, Cochrane Complementary Medicine Field

Dr Karen Broadley

Consultant in Palliative Medicine, Royal Marsden Hospital, London

Dr Stephen Falk

Consultant Clinical Oncologist, United Bristol Healthcare NHS Trust/Bristol Oncology Centre

Caroline Hoffman

Therapy Leader, The Haven Trust, London

Dr Sosie Kassab

Director of Complementary Cancer Services, The Royal London Homoeopathic Hospital,

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Dr Michelle Kohn

Complementary Therapies Medical Advisor, Macmillan Cancer Relief

Prof Alison Richardson

The Florence Nightingale School of Nursing and Midwifery, King's College London

Dr Rob Thomas

Consultant Oncologist, Addenbrooke’s and Bedford Hospitals.

Specialist Advisory Group – Mental Health Prof Terry Brugha

Professor of Psychiatry, Section of Social and Epidemiological Psychiatry, University of Leicester

Dr Rachel Churchill

Coordinating Editor, Cochrane Depression, Anxiety and Neurosis Group

Prof Rachel Jenkins

Director, WHO Collaborating Centre, Institute of Psychiatry

Carol Paton

Chief Pharmacist, Oxleas NHS Trust,

Dr Hagen Rampes

Consultant Psychiatrist & Hon Clinical Senior Lecturer, West London Mental Health NHS Trust

Jan Wallcraft

Research Dept, Sainsbury Centre for Mental Health

The Project Team also acknowledge the advice and input provided by the following organisations: • • • • • •

Cochrane Collaborative Group on Depression, Anxiety and Neurosis Cochrane Musculoskeletal Group Cochrane Pain, Palliative and Supportive Care Group Cochrane Stroke Group MS Society Trustees of the Research Council for Complementary Medicine

Finally, the Project Team acknowledge the contributions of time, effort and expertise by the following individuals:

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Clinical commentators and co-authors Rhoda Allson, Consultant Physiotherapist for stroke, Newton Abbot Hospital Mark Bovey, Co-ordinator, Acupuncture Research Resource Centre (ARRC), Thames Valley University, London Catherine Coleman, Massage Therapist, Physical Therapies Department, Springfield Psychiatric Hospital, London Dr Mike Cummings, Medical Director, British Medical Acupuncture Society Dr Jacqueline Filshie, Consultant in Anaesthesia and Pain Management, Royal Marsden Hospital, London and Surrey Dr Peter Fisher, Director of Research, Royal London Homoeopathic Hospital, London and Clinical Lead, National Library for Health Complementary and Alternative Medicine Specialist Library Dr Jenny Freeman, Reader in Rehabilitation, Faculty of Health and Social Work University of Plymouth; Lecturer, Institute of Neurology, Queen Square, London. Caroline Hoffman, Therapy Leader, The Haven Trust, London Dr Sosie Kassab, Director of Complementary Cancer Services, Royal London Homoeopathic Hospital, London Prof Irving Kirsch, Professor of Psychology, Faculty of Health and Social Work, University of Plymouth Felicity Moir, Principal Lecturer and TCM Course Leader, School of Integrated Health, University of Westminster, London Gill McCall, Senior Research Radiographer & Psychological Support South East London Cancer Centre, St Thomas’ Hospital, London Michael Mcintyre, Chairman, European Herbal Practitioners Association Dr Hagen Rampes, Consultant Psychiatrist & Hon Clinical Senior Lecturer, West London Mental Health NHS Trust Prof Alison Richardson, The Florence Nightingale School of Nursing and Midwifery, King's College, London Dr Juliet Spiller, Consultant in Palliative Medicine, Marie Curie Hospice, Edinburgh

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Maria Tighe, DH Research Capacity PhD student, Brunel University, London Dr Rob Thomas, Consultant Oncologist, Addenbrooke’s and Bedford Hospitals Dr Veronica Tuffrey, Senior Lecturer, School of Integrated Health, University of Westminster, London Dr Jane Upton, Research Project Manager, National Respiratory Training Centre, Warwick

Advice on specific therapies or conditions (in addition to those listed above) Beverley de Valois, Linda Jackson Cancer Centre and Thames Valley University Dr Peter Hanrath, NHS GP Principal, Maidstone and Weald PCT Dr Hugh MacPherson, DH Research Capacity Post-Doctoral award-holder, University of York Dr Maurice Orange, GP, Park Attwood Clinic Prof Leslie Walker, Director of Institute of Rehabilitations and Professor of Cancer Rehabilitation, University of Hull Jane Wilson, Senior Lecturer (TCM), School of Integrated Health, University of Westminster, London

Interpretation of non-English language studies Hugh Maguire, Trials Search Co-ordinator, Cochrane Depression, Anxiety and Neurosis Group, King’s College Institute of Psychiatry, London Annette Gamblin, Senior Lecturer, School of Integrated Health, University of Westminster Professor Jianping Liu, Founding Director, Evidence-Based Chinese Medicine Center for Clinical Research and Evaluation, School of Preclinical Medicine, Beijing University of Chinese Medicine, China Dr Volker Scheid, DH Research Capacity Post-Doctoral award-holder School of Integrated Health, University of Westminster, London

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Dr Fei Yutong, Postdoctoral researcher, Evidence-Based Chinese Medicine Center for Clinical Research and Evaluation, School of Preclinical Medicine, Beijing University of Chinese Medicine, China

Feedback on draft reviews (other than as a clinical commentator or coauthor on the review) Prof Irving Kirsch, Professor of Psychology, Faculty of Health and Social Work, University of Plymouth Reinhard Kowalski, Consultant Clinical Psychologist and Accredited Psychotherapist Hugh Maguire, Trials Search Co-ordinator, Cochrane Depression, Anxiety and Neurosis Group, King’s College Institute of Psychiatry, London Simon Mills, Teaching Fellow in Integrated Health, Peninsula Medical School, Universities of Exeter and Plymouth Dr Sunita Vohra, Associate Professor of Pediatrics, Stollery Children's Hospital, University of Alberta, Canada Dr Ursula Werneke, Consultant Psychiatrist, Homerton Hospital and Honorary Senior Lecturer, Institute of Psychiatry, King’s College, London Prof Mark Williams, Wellcome Principal Research Fellow, Oxford University, Department of Psychiatry, Warneford Hospital, Oxford

Specialist advice and support Julie Glanville, Associate Director/Information Services Manager, NHS Centre for Reviews and Dissemination, York (search methods) Dr Mike Clarke, Director, UK Cochrane Centre (methods) Dr Peter Davies, Dean of the School of Integrated Health, University of Westminster (website) Dr Katherine Deane, Senior Lecturer (Research), School of Health, Community and Education Studies, Northumbria University

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Prof Edzard Ernst, Director, Complementary Medicine, Peninsula Medical School, Universities of Exeter and Plymouth (methods) Dr Alex Iacconi, Web Manager, University of Westminster (website) Liz Mayhew, previously freelance acupuncturist (acupuncture filtering) Mary O’Meara, Research Council for Complementary Medicine (website) Dr Veronica Tuffrey, Senior Lecturer, School of Integrated Health, University of Westminster, London (statistics) Maxine Winter, Research Council for Complementary Medicine Administrator

There are also a large number of other individuals with whom we have had informal discussions which have contributed to the project, including a number of the researchers, who conducted the studies included in the reviews.

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Appendix 3

Final project report: November 2007

CAM knowledge base portfolio proforma

Name Type of resource Produced by Contains (type of info) Coverage (topics) Coverage (dates) How produced Information format Information evaluated Size Update frequency How to access How to search URL Further info Notes

Comment:

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Appendix 4

Final project report: November 2007

Flowchart for categorising different study types

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Appendix 5 – Data Extraction and Critical Appraisal templates DECA (Clinical trials/ studies) Based on the NHS Centre for Reviews and Disseminations guidance (CRD, 2001) Reference: Review topic: Therapy: Reviewer 1:

Reviewer 2:

Date appraised: Summary of the study:

METHODS Type of study Duration No/location of centres Ethical consent Power calculation Method of randomisation Concealment of allocation Prestratification Level of blinding Blinding of assessors Blinded of care givers Blinding of patients Check on blinding Intention to treat analysis Missing values PARTICIPANTS Indications Total number/how selected No in each group Incl/excl. criteria 50

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Baseline characteristics Loss to followup/withdrawals INTERVENTIONS Dose/ description of treatment Frequency of dose / treatments Treatment given by Compliance with treatment Co-interventions OUTCOMES Outcome measures Primary outcomes Secondary outcomes Negative outcome NOTES

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DECA (Clinical trials/ studies including guidance notes) Based on the NHS Centre for Reviews and Disseminations guidance (CRD, 2001) Reference: Review Topic: Therapy: Reviewer 1:

Reviewer 2:

Date appraised: Summary of the study:

METHODS Type of study Duration No/location of trial centres Ethics Power calculation Method of randomisation

Concealment of allocation

Use terms from flow chart (RCT, UCT) For this paper GP, outpatients, inpatients, specialist hospital, UK, US What is written about ethics committees or informed consent? Yes/No - if yes, report the minimum required Adequate: random numbers table or computer and central office or coded packages. Partial: (sealed) envelopes without further description or serially numbered opaque, sealed envelopes. Inadequate: alternation, case record number, birth date, or similar procedures. Unknown: Just the statement ‘randomised’ or ‘randomly allocated’ etc. State what is written about the method (e.g. computer generated) Adequate: when a paper convinces you that allocation cannot be predicted (separate persons, placebo really indistinguishable, clever use of block sizes (large or variable). Adequate approaches might include centralised or pharmacy-controlled randomisation, serially numbered identical

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containers, on-site computer based system with a randomisation sequence that is not readable until allocation, and other approaches with robust methods to prevent foreknowledge of the allocation sequence to clinicians and patients. Inadequate: this opinion is often difficult. You have to visualise the procedure and think how people might be able to circumvent it. Inadequate approaches might include the use of alternation, case record numbers, birth dates or week days, open random number lists, serially numbered envelopes (even sealed opaque envelopes can be subjected to manipulation) and any other measure that cannot prevent foreknowledge of group allocation. Unknown: no details in the text. Disagreements or lack of clarity should be discussed in the review team.

Prestratification

State what is written in the text on methods used. Do not rate as according to York: state Yes or No, and details if Yes.

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Method of Blinding

Rate each (if applicable) and state method

Blinding of assessors

Adequate: independent person or panel or (self) assessments in watertight double-blind conditions. Inadequate: clinician is assessor in trial on drugs with clear side effects or a different influence on lab results, ECGs etc. Unknown: no statements on procedures and not deducible.

Blinded of care givers

Adequate: placebo described as ‘indistinguishable’ and procedures watertight. Partial: just ‘double-blind’ in text and no further description of procedures or nature of the placebo Inadequate: wrong placebo Unknown: no details in the text

Blinding of patients

Adequate: Placebo described as ‘indistinguishable’ and procedures watertight. Partial: just ‘double blind’ in the text and no further description of procedures or the nature of the placebo. Inadequate: wrong placebo Unknown: no details in the text Reported/ unknown: reviewer decides. State what is written if checks were done. Adequate/ inadequate: reviewers should not just look for the term ITT but assure themselves that calculations were done according to the ITT principle. Adequate: Percentage of missing values and distribution over the groups and procedure of handling this stated. Partial: some statement on numbers or percentages Inadequate: wrong procedure (a matter of debate). Unknown: no mentioning at all and not deducible from the tables.

Check on blinding Intention to treat analysis

Dealing with Missing values

State how handling of missing values was conducted if this is reported. PARTICIPANTS Indications

State symptoms

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Total number / how selected

No in each group Incl/excl. criteria Baseline characteristics

Loss to followup/withdrawals

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Total number recruited. How were the study group recruited? e.g consecutive patients, volunteers. Document any refusals and reasons given if present At baseline State what is written Reported/ unknown Reviewer decides. Consider age, sex, disease type, disease severity, disease severity, duration, other treatments, doses of medications and treatments etc. State the key factors which are reported Adequate: number randomised must be stated. Number(s) lost to follow up (dropped out) stated or deducible (from tables) for each group and reasons summarised for each group. Partial: numbers, but not the reasons (or vice versa). Inadequate: numbers randomised not stated or not specified for each group. Unknown: no details in the text. Follow up refers to whatever groups are present - i.e. the data might be adequate for one group in an UCT. State the number that withdrew from each group- preferably with a subset of numbers of those who withdrew due to adverse effects.

INTERVENTIONS Dose/ description of treatment Frequency of dose / treatments Treatment given by

State what is written for both the treatment and control groups. Include time with therapist, acupuncture points used if stated. State the intervention duration for treatment and control groups Details of practitioner(s), experience, traininge.g. homeopath/ traditional or Western acupuncturist?

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Compliance with treatment

Co-interventions

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Adequate: Medication Event Monitoring System (MEMS or eDEM) Partial: blood samples , urine samples (use of indicator substances) Inadequate: pill count or self report Unknown: not mentioned State details on checks if they are done Adequate: percentages of all relevant interventions in all groups Partial: one or more interventions omitted or omission of percentages in each group Inadequate: not deducible Unknown: no statements State what is written - or unknown

OUTCOMES

Outcome measures

Primary outcomes

Secondary outcomes Negative outcome

(n.b. in the review you will just use a few key outcomes measures that are of use to the patients) How State methods used - e.g. POMS, Hamilton scores. If abbreviated, write in full in the notes When (e.g. at baseline, after treatment completion and after 6 months) (Clinical commentators to appraise appropriateness) Adequate: mean outcome in each group together with mean difference and its standard error (SE) or standard deviation (SD) or any CI around it or the possibility to calculate those from the paper. Survival curve with logrank test and patient numbers at later time points Partial: partially reported Inadequate: no SE or SD, or SD without N Unknown: very unlikely (state as defined by the authors of the study) State as according to the abstract and add other important information. Include some indication of confidence intervals. List them all Adverse effects to be stated - include number that suffered such effects if known.

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NOTES

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i.e. thesis, abstract available only. Specific type of intervention where appropriate - i.e. moxibustion, electro-acupuncture. Comments

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DECA-SR (Systematic reviews) Based on Oxman and Guyatt’s index of the scientific quality of research overviews (Oxman and Guyatt, 1988; Shea et al, 1995). Review topic: Reference: Reviewed by:

Date:

1. Were the search methods used to find the evidence (original research) on the primary questions(s) stated? Notes: databases, terms and time period of search specified

Yes

Partially

No

2. Was the search for evidence reasonably comprehensive? Notes: All relevant databases, citation checking, other sources e.g. experts, grey literature

Yes

Can’t tell

No

3. Were the criteria used for deciding which studies to include in the overview reported? Notes: types of studies, participants, interventions and outcomes specified

Yes

Partially

No

4. Was bias in the selection of studies avoided? Notes: Number of researchers – more than one? Conflict of interest?

Yes

Can’t tell

5. Were the criteria used for assessing reported?

No

the validity of the included studies

Notes: Developed by authors? Referenced by authors? Validated?

Yes

Partially

No

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6. Was the validity of all studies referred to in the text assessed using appropriate criteria (either in selecting studies for inclusion or in analysing the studies that are cited?) Notes:

Yes

Can’t tell

No

7. Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported? Notes: was a meta-analysis or qualitative synthesis reported? (state)

Yes

Partially

No

8. Were the findings of the relevant studies combined appropriately relative to the primary question the overview addresses? Notes: Were results tabulated? Was it appropriate to undertake a meta-analysis and if not? Why not? What was the result of the meta analysis?

Yes

Can’t tell

No

For question 8, if no attempt to combine the findings and no statement is made regarding the inappropriateness of combining the findings, check “no”. If a summary (general) estimate is given anywhere in the abstract, the discussion, or summary of the paper, and it is not reported how the estimate is derived, mark “no” even if there is a statement regarding the limitations of combining the finding of the studies reviewed. If in doubt, mark “can’t tell”

9. Were the conclusions made by the author(s) supported by the data and/ or analysis reported in the overview? Yes Partially No

10. How would you rate the scientific quality of the overview? Extensive Flaws

1

2

major flaws

3

4

minor flaws

5

6

minimal flaws

7

The answer for question 10 should be based on your answers to the first 9 questions. If ‘can’t tell’ is used once or more, the review is likely to have minor flaws at best and major flaws cannot be ruled out (ie score of 4 or less). If ‘no’ is used on question 2,4,6 or 8, the review is likely to have major flaws (ie a score of 3 or less, depending on the number and degree of flaws)

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DECA-Q (Qualitative studies) CASP 1. Aims clear, relevant, important 2. Qualitative methodology appropriate 3. Research design - Design appropriate and justified 4. Sampling Recruit appropriate – who, why, why people didn’t take part 5. Data collection – appropriate – setting, method justified and explicit, modified and if so why, form, saturation of data 6. Reflexivity - Relationship between researcher and participants – own role, potential bias, influence, response to events 7. Ethical issues – sufficient details, issues raised, ethics approval 8. Data analysis – rigorous – indepth description, how themes derived, data selection, sufficient presented, contradictory data, own role 9. Findings – clear – for/against, credibility, related to aims 10 Value – relation to current knowledge, new areas, transfer/use

Mays and Pope Clarity of research questions

Appropriateness of research design Sampling – full range, extended

Context or setting Data collection systematic, audit trail Reflexivity

Data analysis systematic

Worth or relevance

References: CASP (Critical Appraisal Skills Programme) (2002) 10 questions to help you make sense of qualitative research. Milton Keynes Primary Care Trust. Available at: http://www.phru.nhs.uk/casp/qualitat.htm [Accessed 31 Oct 2005]. Mays N. and Pope C. (1995) Qualitative research: rigour and qualitative research. BMJ, 311(6997):109-112. Mays N. and Pope C. (2000). Qualitative research in health care: assessing quality in qualitative research. BMJ, 320(7226): 50-52.

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Appendix 6

Final project report: November 2007

Clinical commentary proforma

Clinical commentary on (reference): Reviewer: Date: Please comment on the following aspects of the study – the following are the main questions, but please add any detail that you feel necessary: Intervention • Is this appropriate in these patients?



Is it appropriately used?

Control/placebo • Is the control group appropriate?

Y

N

Y

N

Y

N



Is the placebo appropriate?

Y

N



Is it likely to elicit any response?

Y

N

Outcomes • Are the outcomes reported appropriate?

Y

N

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Are the measures used appropriate?

Y

N



Are there any outcomes which have been omitted?

Y

N



Was the length of monitoring/follow-up appropriate?

Y

N

Comment on the overall relevance of this study and the findings to clinical practice:

Any other comments you would like to add?

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Appendix 7

Final project report: November 2007

Mapping

Mapping (or scoping) searches were conducted for all conditions areas prior to comprehensive searches. The results of these mapping searches are available from the Project Team. The following is a summary of the additional searches that were required for the cancer and mental health reviews in order to assess which specific herbal products should be addressed. Strategy for herbal medicine for cancer and mental health 1.

To carry out a series of scoping searches to gain an overview of the extent of evidence in this area

2.

To identify all relevant systematic reviews on the effectiveness of herbal medicines in cancer and the mental health areas • Cochrane systematic reviews • Reviews on the DARE database • Ongoing systematic reviews (Cochrane protocols)

3.

To produce an overview of the above

4.

To run a preliminary scoping search for RCTs using CENTRAL

5.

To categorise RCTs by indication

Results A series of scoping searches were carried out and evidence from systematic reviews and controlled trials tabulated. These tables indicated that the following areas were likely to be most productive in terms of the published research. Depression: St John’s wort (Hypericum perforatum) Chinese herbs Anxiety Kava (Piper methysticum) German chamomile (Matricaria recutita L.) Lemon balm (Melissa officinalis) Passion flower (Passiflora incarnata) Valerian (Valeriana officinalis) Cancer treatment – a range including the following: Mistletoe Essiac PC-SPES 63

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Chinese herbals St John’s wort PSK Chlorella Evening primrose oil

Cancer symptom control Alzoon Ginger Herbal medicine for anxiety, depression (Kava, Hypericum etc.)

Preliminary searches of CENTRAL trials database indicated that the areas in which there was some evidence were: •

Mistletoe (but 2 systematic reviews already published, 1 recent and Cochrane review underway)



Black cohosh (Cimicifuga) in hot flushes in breast cancer patients (but included in review of menopausal symptoms)



Ginger in nausea and vomiting (systematic review of N & V in general already published)



Herbs for psychological symptoms i.e. anxiety and depression (covered by mental health review)



Various herbs in reducing adverse effects related to radiotherapy (Aloe vera, Esberitox, Calendula – esp. skin reactions)



Various herbs in reducing adverse effects of chemotherapy (Astralagus, Echinacea)

Final decisions on the list of herbal products reviewed were made in consultation with the Specialist Advisory Groups and based on the above work together with information on the products used or requested in current clinical practice.

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Appendix 8

Final project report: November 2007

Search strategies

The search strategies were developed for each therapy and condition and then adapted as appropriate for each of the databases searched. The following is a summary of the generic strategies with the example of how these were adapted for a specific database (Medline, DIALOG version). Strategies for the retrieval of specific types of studies (systematic reviews and qualitative research) are also included.

1. Condition terms Cancer terms neoplasms (exp) or neoplas* or tumor* or tumour* or melanoma* or cancer* or malignan* or leukemia* or leukaemia* or carcin* or metastas* or sarcoma* or antineoplastic agents (exp) or chemotherapy or palliative care or palliative care (exp) or palliative treatment (exp) or palliative therapy (exp) or terminal care or terminal care (exp) Additional cancer terms used in several reviews as appropriate terminally ill patients or antineoplastic drugs (exp) or oncologic care (exp) or oncologic nursing (exp) or hospice care (exp) or radiotherapy (exp) or radiotherapy or cancer-radiotherapy (exp) Specific cancer-related symptoms Breathlessness Breathlessness or dyspnoea or dyspnea or dyspnea (exp) or breath* or shortness of breath Hot flushes hot flush* or hot flash* or hot flashes (exp) or menopaus* or menopause (exp) or climacteric or climacteric (exp) or menopause or climacterium (exp) or premenopaus* or postmenopaus* or perimenopaus* or climacteri* or vasomotor symptom* or andropaus*. Xerostomia xerostomia or xerostomia (exp) or asialia or hyposalivation or mouth dryness Nausea & Vomiting The search strategy for this review included a combination of terms and text words for cancer and hypnosis. The cancer search strategy is broad and covers palliative and terminal care as well. Using this strategy, relevant citations for cancer-related nausea and vomiting have been identified.

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Specific symptom terms or text words for nausea and vomiting were not included since they would have resulted in a lot of irrelevant citations for other conditions (for example, migraine, depression, pregnancy, IBS, surgery-related symptoms, etc). An additional search including the symptom terms and text words on PubMed and EMBASE identified a lot of irrelevant records and showed that any publications discussing these symptoms in cancer patients would have been retrieved by the cancer search strategy.

Mental health Depression depression (exp) OR depressive disorder(s) (exp) OR dysthymia (exp) or dysthymic disorder(s) (exp) or depress* OR dysthym* OR mood OR affective disorder(s) (exp) Anxiety anxiety (exp) or anxiety disorders (exp) or anx* Additional terms used for specific databases where necessary: anx* or agoraph* or obsessive compulsive or obsessive-compulsive or panic or phobic or combat disorders or stress disorders

Other conditions Arthritis arthritis or arthritis (exp) or osteoarthritis or polyarthritis

Asthma asthma* or asthma (exp) or anti-asthma*or antiasthma*or anti-asthmatic agent

Coronary heart disease coronary heart disease or coronary disease (exp) or coronary artery disease or coronary disease or coronary occlusion or angina or angina pectoris (exp) or angor pectoris or stenocardia or coronary aneurysm or coronary stenosis or arteriosclerosis or atherosclerosis or arteriosclero* or atherosclero* or coronary artery stenosis or coronary thrombosis or coronary vasospasm or myocardial infarction or myocardial infarction (exp) myocardial infarct or heart attack or heart infarct* or myocardial ischemia or myocardial ischemia (exp) or myocardial ischaemia or cardiac ischemia or cardiac ischaemia or ischemic heart disease or ischaemic heart disease or chest pain or chest pain (exp) or acute coronary syndrome or ischemic cardiomyopathy

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Diabetes diabetes mellitus or diabetes mellitus (exp) OR diabet* OR IDDM OR NIDDM OR MODY NOT diabetes insipidus or diabetes insipidus (exp)

Multiple Sclerosis multiple sclerosis or multiple sclerosis (exp) or neuromyelitis optica or devic

Stroke stroke or cerebrovascular accident (exp) or cerebrovascular disorders (do not exp) or brain infarction or brain infarction (exp) or cerebral infarction or cerebral infarction (exp) or cva or apoplexy or poststroke or post-stroke or cerebrovascular or cerebro-vascular or cerebral vascular

2. CAM Therapies Acupuncture acupuncture or acupuncture (exp) or acupuncture therapy (exp) or acupressure or acupressure (exp) or electroacupuncture or auricular therapy or auriculotherapy Alexander technique Alexander technique or Alexander principle Aloe vera aloe or aloe (exp) or aloe vera or aloe vera (exp) or aloe vera extract (exp) Aromatherapy aromatherapy or aromatherapy (exp) or aroma therapy or aroma therapy (exp) or essential oil* or volatile oil* or oils, volatile (exp) Black cohosh cimicifuga or cimicifuga racemosa or cimicifuga (exp) or cimicifuga racemosa (exp) or cimicifuga racemosa extract (exp) or black cohosh (exp) or black cohosh Chiropractic chiropractic OR manipulation chiropractic (exp) or chiropractic (exp) or manipulation spinal (exp) or subluxation Homeopathy homeopathy (exp) or homeopathic drugs (exp) or homeop* or homoeop*

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Hypnosis hypnosis or hypnosis (exp) or hypnotiz* or hypnotis* or hypnotherapy or hypnotizability or hypnotisability or hypnotic susceptibility or hypnoticsusceptibility (exp) or suggestability (exp) or autosuggestion or autosuggestion (exp) or suggestion (exp) or autohypnosis (exp) or self-hypnosis or posthypnotic or posthypnotic suggestions or posthypnotic suggestions (exp) or autogenic or autogenic training (exp) Massage massage OR massage (exp) MBSR (terms used in addition to those for meditation and yoga) mindfulness or MBSR Meditation meditation (exp) or meditat* or transcendental meditation (exp) or yoga or yogic or asanas or dhyana or pranayama Mistletoe mistletoe or mistletoe (exp) or viscum or viscum album (exp) or viscum album lectin (exp) or viscum album extract (exp) or iscador or plenosol or eurixor or helixor or isorel Osteopathy osteopath* or osteopathic medicine (exp) or manipulation osteopathic (exp) or manipulation orthopaedic (exp) Reflexology massage OR massage (exp) OR reflexolog* OR zone therapy OR reflexotherapy St John’s wort hypericum (exp) or hypericum perforatum (exp) or Hypericum Perforatum Extract (exp) or st john's wort.mp. or hypericum.mp. or johanniskraut.mp. Yoga yoga or yoga (exp) or yogic or asanas or dhyana or pranayama

3. Methodological filters Qualitative studies focus group* or interview* or interviews (exp) or grounded theory or ethno* or phenomenolog* or qualitative or qualitative research (exp) or qualitative analysis (exp)

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Systematic reviews (OVID) • meta-analysis.pt. • meta-analysis.mp. • systematic review.pt. • systematic review.mp. • systematic overview.mp. • research synthesis.mp. • medline.mp. Systematic reviews (Dialog MEDLINE) meta-analysis OR META-ANALYSIS#.DE. OR PT=META-ANALYSIS OR metaanaly$ OR metanaly$ OR meta analy$ OR systematic review$ OR systematic overview OR MEDLINE OR research synthesis

Example of adaptation of strategies for a specific database and interface MEDLINE (DIALOG) Acupuncture acupuncture OR ACUPUNCTURE#.W..DE. OR ACUPUNCTURETHERAPY#.DE. OR acupressure OR electroacupuncture OR auricular therapy OR auriculotherapy Alexander alexander technique OR alexander principle Aromatherapy – Massage - Reflexology aromatherapy OR AROMATHERAPY.W..DE. OR aroma therapy OR essential oil$ OR volatile oil$ OR OILS-VOLATILE#.DE. OR massage OR MASSAGE#.W..DE. OR reflexolog$ OR zone therapy OR reflexotherapy Chiropractic chiropractic OR MANIPULATION-CHIROPRACTIC#.DE. OR CHIROPRACTIC#.W..DE. OR MANIPULATION-SPINAL#.DE. OR subluxation Homeopathy homeop$ OR homoeop$ OR Homeopathy#.W..DE. HYPNOSIS hypnosis OR HYPNOSIS#.W..DE. OR hypnotherapy OR hypnotizability OR hypnotisability OR autosuggestion OR autogenic training OR hypnotic susceptibility

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MEDITATION meditation OR MEDITATION#.W..DE. OR MEDITAT$ Osteopathy osteopath$ OR OSTEOPATHIC-MEDICINE#.DE. OR MANIPULATIONOSTEOPATHIC#.DE. OR MANIPULATION-ORTHOPEDIC#.DE. Yoga yoga OR YOGA.W..DE. OR pranayama OR dhyana OR asanas OR yogic Herbal herb$ OR DRUGS-CHINESE-HERBAL#.DE. OR PHYTOTHERAPY#.W..DE. OR PLANT-EXTRACTS#.DE. OR PLANTS-MEDICINAL#.DE. OR PLANTPREPARATIONS#.DE. OR MEDICINE-HERBAL#.DE.

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Appendix 9

Final project report: November 2007

Languages other than English (LOE) study Investigating the non-English literature in CAM

Methods 1. Searches of MEDLINE, EMBASE and Cochrane for articles on the topic of the effect of inclusion and/or exclusion of non-English language literature were conducted and a review of the literature on the topic completed 2. The number of LOE publications listed on the major databases were compared with those listed for each language in Ulrich’s Periodicals Directory 3. A selection of Cochrane reviews were checked for information on nonEnglish language studies (retrieved, included, contributed to findings). An analysis of Cochrane CAM reviews strategies with regard to LOE studies was completed for acupuncture, homeopathy and yoga 4. Searches of 3 Chinese databases (on one of topics already carried out e.g. hot flushes/flashes, xerostomia, depression) were arranged. The results from Chinese databases were compared with those already carried out. • • •

1st database – no studies with English titles 2nd database – 79 hits, 3 potential RCTs Comparison with comprehensive searches on English language databases – 1 of these retrieved, 2 not identified

5. Searches carried out to date were analysed to investigate the proportions of non-English language literature represented, the number of research studies or potential studies (based on titles, abstracts and index terms) and which languages were represented. 6. Mike Clarke, Director of the UK Cochrane Centre was contacted for discussion of the results and advice on strategies Note Stages 1, 5 and 6 informed the development of the methods for conducting the reviews. However, to date (October 2005) only the results of stage 2 have been reported in full (Pilkington et al, 2005).

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Appendix 10

Final project report: November 2007

New trials (controlled trials from 2005 – May 2007) listed on Cochrane Central (1135 in total) Cancer

Anxiety

Depression

MS

Stroke

Asthma

Arthritis

Back pain

Diabetes

Total

Acupuncture

36

Acupressure

6

Alexander technique Aromatherapy

0 2

Chiropractic

?

?

Herbal medicine

57

Homeopathy

3

Hypnosis

3

Massage

6

Meditation

4

Osteopathy

?

?

Reflexology

1

Yoga Total

26

19

21

4

10

+1 breath. exercise 5

14

20+

1 breath. exercise 13

7

Key: red – hot topics (5 or more trials published); orange – some research interest (2–4 trials): blue – single trials only

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Appendix 11

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Publications and presentations

Invited chapters and reviews Pilkington K and Rampes H. Complementary and alternative therapies. In Norman I J, Ryrie I (Eds), The Art and Science of Mental Health Nursing, 2nd edition, Open University Press, 2008. Richardson J and Pilkington K. (2007) Evaluating complementary therapies. In J. Barraclough (Ed) Enhancing Cancer Care: complementary therapy and support. 2nd edition, Oxford: Oxford University Press. Pilkington K, Rampes H and Richardson J. (2006c) Complementary medicine for depression. Expert Review of Neurotherapeutics 6(11): 1741-1751. Full papers 2007 Pilkington K., Stenhouse E., Kirkwood G., Richardson J. (2007) Diabetes and complementary therapies: mapping the evidence. Practical Diabetes International, 24(7):371-376. Richardson J., Smith J.E., McCall G., Richardson A., Pilkington K., Kirsch I. (2007) Hypnosis for nausea and vomiting in cancer chemotherapy: a systematic review of the research evidence. European Journal of Cancer Care, 16: 402-412. Pilkington K. (2007) Searching for CAM evidence: an evaluation of therapyspecific search strategies. Journal of Complementary and Alternative Medicine, 13(4):451-9. Pilkington K., Kirkwood G., Rampes H., Cummings M., Richardson J. (2007) Acupuncture for anxiety and anxiety disorders: a systematic literature review. Acupuncture in Medicine, 25(1-2):1-10. Richardson J. and Pilkington K. (2007) Complementary therapies in life-limiting conditions: A systematic review of the research. Nursing Times, 103(32):32-33. 2006 Pilkington K., Boshnakova A. and Richardson J. (2006) St John’s wort for depression: time for a different perspective? Complementary Therapies in Medicine, 14(4):268-281. Pilkington K., Kirkwood G., Rampes H., Fisher P., Richardson J. (2006) Homeopathy for anxiety and anxiety disorders: a systematic review of the research. Homeopathy, 95:151-162.

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Richardson J., Smith J.E., McCall G., Pilkington K. (2006) Hypnosis for procedure-related pain and distress in paediatric cancer patients: A systematic literature review. Journal of Pain and Symptom Management, 31(1):70-84. 2005 Kirkwood G., Pilkington K., Rampes H., Richardson J. (2005) Yoga for anxiety: a systematic review of the research evidence. British Journal of Sports Medicine, 39:884-891. Pilkington K., Boshnakova A., Clarke M., Richardson J. (2005) “No language restrictions” in database searches – what does this really mean? Journal of Complementary and Alternative Medicine, 11(1):205-7. Pilkington K., Kirkwood G., Rampes H., Fisher P., Richardson J. (2005) Homeopathy for depression: a systematic review of the research evidence. Homeopathy, 94:153-163. Pilkington K., Kirkwood G., Rampes H., Richardson J. (2005) Yoga for depression: a systematic review of the research evidence. Journal of Affective Disorders, 89:13-24. Richardson J., Pilkington K. and Thomas R. (2005) Complementary and Alternative Medicine Evidence On-Line (CAMEOL) for cancer. British Journal of Cancer Management, 2(2):9-11. Richardson J., Smith J., McIntyre M., Thomas R., Pilkington K. (2005) Aloe vera for preventing radiation-induced skin reactions: A systematic literature review. Clinical Oncology, 17:478-484. Smith J., Richardson J., Hoffman C., Pilkington K. (2005) Mindfulness Based Stress Reduction (MBSR) as supportive therapy in cancer care: A systematic review. Journal of Advanced Nursing, 52(3):315-327. 2004 Pilkington K. and Richardson J. (2004) Exploring the evidence: the challenges of searching for research on acupuncture, Journal of Complementary and Alternative Medicine, 10(3):587-90. 2003 Pilkington K. and Richardson J. (2003) Evidence-based complementary (and alternative) medicine on the Internet. [email protected] Information on the Internet, 34(1):79.

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Abstracts 2004 Kirkwood G. and Pilkington K. (2004) Homeopathy for depression and anxiety – comparing the evidence. Proceedings of the Developing Research Strategies Conference published in Complementary Therapies in Medicine; 12(2-3):151. Pilkington K., Smith J. and Richardson J. (2004) Developing CAMEO (CAM) Evidence Online for Cancer. Proceedings of the 11th Annual Symposium on Complementary Health Care – Abstracts. FACT (Focus on Alternative and Complementary Therapies), 9(Suppl 1):39. Richardson J. (2004) Research Issues in Complementary Therapy. Clinical Research Focus: The Journal of the Institute of Clinical Research 15(3):7-12. Richardson J., Smith J. and Pilkington K. (2004) Qualitative research in complementary therapies- is it of any value? Proceedings of the 11th Annual Symposium on Complementary Health Care – Abstracts. FACT (Focus on Alternative and Complementary Therapies), 9(Suppl 1):43. Smith J. and Pilkington K. (2004) Acupuncture therapy – why and how is it used in cancer patients? Proceedings of the Developing Research Strategies Conference published in Complementary Therapies in Medicine; 12(2-3):153154. 2003 Pilkington K. (2003) In search of the evidence: a pilot study of acupuncture in cancer. Proceedings of the 10th Annual Symposium on Complementary Health Care published in FACT (Focus on Alternative and Complementary Therapies), 8 (4):529. Richardson J. and Britten N. (2003) Evidence-based patient choice in complementary therapy: myth or reality? Proceedings of the 10th Annual Symposium on Complementary Health Care published in FACT (Focus on Alternative and Complementary Therapies), 8(4): 533.

Presentations and posters 2007 Pilkington K. CAMEOL and the CAM Specialist Library. Presentation. Bromley Primary Care Trust, March 2007. Pilkington K. CAM in anxiety and depression: creating a picture of the evidence. Presentation to the ACHRN, London, September 2007.

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Pilkington K. Complementary therapies for depression: what is the evidence and how does it compare with the advice?. Poster at the Guild of Hospital Pharmacists/UKClinical Pharmacy Association conference, Brighton, April 2007. Richardson J and Pilkington K. Assessing the evidence for the effectiveness of complementary therapies in life-limiting conditions. Poster at Royal College of Nursing International Research Conference, Dundee, May 2007. Stenhouse E, Kirkwood G, Pilkington K, Richardson J. Complementary and Alternative Medicine in Diabetes: the evidence base. Poster at Royal College of Nursing International Research Conference, Dundee, May 2007. 2006 Richardson J. Presentation on the CAMEOL cancer project. Bristol Oncology and Haematology Centre, September 2006.

2005 Pilkington K. and Richardson J. The long and winding road: tracking down the evidence on CAM in cancer. Presentation at NCRI Cancer Conference, October 2005, Birmingham. National Cancer Research Institute (NCRI) Annual Conference, October 2005, Birmingham. Diversity and Debate in Alternative and Complementary Medicine, July 2005, Nottingham. Organised by the Alternative & Complementary Health Research Network. 2004 Kirkwood G. and Pilkington K. Homeopathy for depression and anxiety – comparing the evidence. Poster presented at the Developing Research Strategies Conference, May 2004, Southampton. Kirkwood G. and Pilkington K. Mapping knowledge of evidence and usage of CAM in mental health. Presentation given at the conference: Diversity and Debate in Alternative and Complementary Medicine, July 2004, Nottingham. Organised by the Alternative & Complementary Health Research Network. Pilkington K. Maps and CAMEOs in complementary medicine. Presentation at Bromley Primary Care Trust, September 2004. Pilkington K. and Kirkwood G. A close look at the evidence for homeopathy in depression. Poster presented at the conference: Mental Health and Complementary Therapies, March 2004, Stafford. Organised by the Prince of

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Wales’ Foundation for Integrated Health and the Alternative and Complementary Collaborative on Research and Development (ACCoRD). Pilkington K. and Richardson J. Assessing the evidence on complementary therapies in cancer care. Presentation to NCRI Complementary Therapies Clinical Studies Group, September 2004, London. Pilkington K., Smith J. and Richardson J. Developing CAMEO for cancer (Complementary and Alternative Medicine Evidence Online for cancer). Poster presented at the conference: Complementary Therapies and Cancer Care: A Research Symposium, June 2004, London. Organised by Complementary Cancer Care Charities Partnership. Pilkington K., Smith J. and Richardson J. Developing CAMEO (CAM) Evidence Online for Cancer. Poster presented at the 11th Annual Symposium on Complementary Health Care, November 2004, Exeter. Richardson J. Research in Complementary and Alternative Medicine. Presentation to the Institute for Clinical Research Symposium, June 2004, London. Richardson J., Smith J. and Pilkington K. Qualitative research in complementary therapies - is it of any value? Presentation at the 11th Annual Symposium on Complementary Health Care, November 2004, Exeter. Smith J. and Pilkington K. Acupuncture therapy – why and how is it used in cancer patients? Presentation at the Developing Research Strategies Conference, May 2004, Southampton. Smith J. and Pilkington K. What does qualitative research add to the evidence on complementary therapies? Presentation given at the conference: Diversity and Debate in Alternative and Complementary Medicine, July 2004, Nottingham, Organised by the Alternative & Complementary Health Research Network. 2003 Pilkington K. In search of the evidence: a pilot study of acupuncture in cancer. Presentation at the 10th Annual Symposium on Complementary Health Care, November 2003, London. Richardson J. and Britten N. Evidence-based patient choice in complementary therapy: myth or reality? Presentation at the 10th Annual Symposium on Complementary Health Care, November 2003, London.

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Appendix 12

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Summaries of the reviews on CAMEOL Acupuncture for cancer pain

Summary Background Pain is a common symptom associated with cancer and may be difficult to manage particularly if associated with metastases in bony tissue. Acupuncture has been used for chronic pain such as that in the low back and shoulder but the evidence on its role in cancer-related pain requires evaluation. Aim To systematically review the research evidence on the effectiveness of acupuncture for the management of pain in cancer patients. Methods Comprehensive searches of the following databases were conducted initially in 2003 then repeated in May 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, Acubriefs, Cochrane Complementary Medicine Field Register Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK) and Clinicaltrials.gov (US). Search strategies included terms for acupuncture and cancer. Relevant research was systematically categorised by study type. After initial searching a recent systematic review of the evidence for acupuncture for cancer-related pain was located. This systematic review was therefore systematically appraised and data was extracted. Results The systematic review found provides a methodologically rigorous overview of the evidence from clinical trials, both controlled and uncontrolled, on acupuncture for pain in cancer patients. Additional searching did not reveal any further published randomised controlled trials but two trials are ongoing. Studies located Systematic review: RCT: CCT: UC studies:

1 3 (included in above systematic review) plus 2 ongoing 0 4 (included in above systematic review)

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Conclusions The systematic review of the evidence of acupuncture for cancer patients concluded that “ …the notion that acupuncture may be an effective analgesic adjunctive method for cancer patients is not supported by the data currently available from the majority of rigorous clinical trials. Because of its widespread acceptance, appropriately powered RCTs are needed” (Lee et al. In press) Note: The most recent and rigorous study located did report positive results. Research recommendations • There is a need to compare the effectiveness of the different forms of acupuncture (electroacupuncture, classical acupuncture, auriculotherapy) and the approach taken (individualized or standardized) for this group of patients. • Comparison of effectiveness with different locations of pain in cancer patients. • When reviewing studies, comments should be made on the appropriateness of the intervention used and on the relevance to practice from a clinical expert. Authors Janet Richardson, Joanna Smith, Karen Pilkington Acknowledgements Anelia Boshnakova (support with search strategies and searches) Mark Bovey, Mike Cummings (background information on acupuncture) Studies located Systematic reviews Lee H., Schmidt K., Ernst E. (2004) Acupuncture for the relief of cancer-related pain - a systematic review. European Journal of Pain. 9 (4): 437-444. Randomised controlled trials (ongoing) Kasten-Sportes, C. (unpublished) Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation http://www.clinicaltrials.gov/ct/show/NCT00060021?order=1 Redinbaugh E. (unpublished) Acupuncture to Reduce Symptoms of Advanced Colorectal Cancer. http://www.clinicaltrials.gov/ct/show/NCT00034034?order=1

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Acupuncture for cancer-related breathlessness Summary Background Breathlessness (dyspnoea) is a common symptom in patients with advanced cancer. Drug therapy used for irreversible breathlessness (opioids and benzodiazepines) often causes an unacceptable level of sedation or other side effects. Acupuncture is one non-conventional technique that has been used in practice for the symptomatic treatment of breathlessness. Aim To systematically review the research evidence on the effectiveness of acupuncture for cancer-related breathlessness. Methods Comprehensive searches of the following databases were conducted in July 2004: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, Acubriefs, Cochrane Complementary Medicine Field Registry and Cochrane Pain and Palliative Care Group Register Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for acupuncture, breathlessness and cancer. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. A second search of CENTRAL and Acubriefs was conducted in May 2005 – no further studies located Most recent search of CENTRAL and Acubriefs – January 2006. Results One systematic review of CAM therapies for the management of pain, dyspnoea, and nausea and vomiting near the end of life published in 2000 included the evidence on acupuncture for dyspnoea (1 study). Few studies have been undertaken since this review. Symptomatic benefit from treatment, with changes in breathlessness, relaxation and anxiety was reported by patients in 1 small uncontrolled trial. Two randomised controlled trials (RCTs) were also located but as neither has yet been published few details are available.* see update below No adverse effects were reported in the studies included in this review. However, patient numbers were small.

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Studies located Systematic Review: RCT: CCT: UC studies: Other:

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1 (CAM therapies in palliative care) 2 (unpublished)* see update below 1 (within patient cross-over, unpublished) 1 1 audit (abstract only)

Conclusion Evidence to support the use of acupuncture in breathlessness in cancer patients is currently limited and there is insufficient evidence to draw conclusions on effectiveness. The results of well-designed trials including those from the two unpublished RCTs are required.* see update below Research recommendations • Further evaluation using well-designed trials would be valuable (pending the results of the unpublished RCTs). • Safety of acupuncture for dyspnoea in cancer patients requires further assessment Further information For the abstract to the above systematic review: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Retrieve&list_ui ds=0011068159&dopt=Citation Update: One of the RCTs has now been published (not appraised for this review): Vickers AJ, Feinstein MB, Deng GE, Cassileth BR. (2005) Acupuncture for dyspnea in advanced cancer: a randomized, placebo-controlled pilot trial [ISRCTN89462491]. BMC Palliative Care. 18; 4:5. Authors Janet Richardson, Joanna Smith, Karen Pilkington Acknowledgements Anelia Boshnakova (support with search strategies and searches) Mark Bovey, Mike Cummings (background information on acupuncture) Juliet Spiller (clinical commentaries) Cochrane Pain, Palliative and Supportive Care Group (searches of group’s database) Studies located Systematic Reviews Pan C.X., Morrison R.S., Ness J., Fugh-Berman A., Leipzig R.M. (2000) Complementary and alternative medicine in the management of pain, dyspnea, and nausea and vomiting near the end of Life: A systematic review. Journal of Pain and Symptom Management, 20(5): 374-387.

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Randomised Controlled Trials Feinsten M. (published in 2005 – see above) Acupuncture for Shortness of Breath in Cancer Patients. Available at: http://www.clinicaltrials.gov/ct/show/NCT00067691?order=1 [Accessed 24 Jun 2005]. Filshie J. (not yet published) Acupuncture in the Treatment of Dyspnoea in Patients with Disabling Cancer Related Breathlessness. Available at: http://www.nrr.nhs.uk/ViewDocument.asp?ID=N0258082793 [Accessed 24 Jun 2005]. Controlled studies Filshie J. (not yet published) Acupuncture in the Treatment of Dyspnoea in Patients with Disabling Cancer Related Breathlessness (within patient cross over study) Available at: http://www.nrr.nhs.uk/ViewDocument.asp?ID=N0258073235 [Accessed 24 Jun 2005]. Uncontrolled Studies Filshie J., Penn K., Ashley S., Davis C.L. (1996) Acupuncture for the relief of cancer-related breathlessness. Palliative Medicine, 10(2): 145-150. Taylor R. (2003) ASAD points in cancer patients with dyspnoea (abstract). Paper presented at the British Medical Acupuncture Society Meeting 26th-27th April 2003. Available at: www.medical-acupuncture.co.uk/meetings/2003_april.doc [Accessed 24 Jun 2005].

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Acupuncture for hot flushes as a result of cancer treatment Summary Background Women with breast cancer are at an increased risk of experiencing menopausal symptoms and men with prostate cancer may also suffer from these symptoms as a result of treatment. Acupuncture has been reported to be beneficial in menopausal symptoms in women without a cancer diagnosis but there are no published systematic reviews on acupuncture for hot flushes in cancer patients. Aim To systematically review the research evidence on the effectiveness of acupuncture for the treatment of hot flushes in cancer patients. Methods Comprehensive searches of the following databases were conducted between March and May 2004: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, Acubriefs, Cochrane Complementary Medicine Field Register, Cochrane Pain and Palliative Care Group Register Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for acupuncture, hot flushes and cancer. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results No systematic reviews that focused specifically on acupuncture for cancerrelated hot flushes were found. A lack of randomised controlled trials was identified. However, a number of uncontrolled studies were located. No serious adverse effects were reported in the trials included in this review. However, patient numbers were small. Studies located Systematic review: RCT: CCT: UC studies: Other:

0 3 (2 unpublished - abstracts only) 0 9 (7 completed, 2 ongoing) 1 qualitative study

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Conclusion Uncontrolled studies suggest that acupuncture may show benefits for the alleviation of hot flush symptoms resulting from tamoxifen use in women or from castration therapy in men. In light of the limited controlled research available, however, firm conclusions on efficacy cannot be reached. Heterogeneity of acupuncture interventions and outcomes measures makes comparison between studies difficult. Flaws in the reporting of interventions and the findings were present in the majority of studies. Research recommendations • Appropriately powered randomised controlled trials in the benefits of acupuncture for hot flushes in cancer patients. • Comparisons of different acupuncture interventions. • Research to include symptom severity and quality of life as outcomes measures. • Further research on males with vasomotor symptoms and the evaluation of the relevance, validity, and applicability of standardised vasomotor symptom instruments for this group. • Standardised outcomes measures and times for reporting in diaries. • Longer follow up. • Full reporting of clinical studies according to STRICTA guidelines. Authors Joanna Smith, Janet Richardson, Jackie Filshie, Rob Thomas, Felicity Moir, Karen Pilkington Acknowledgements Anelia Boshnakova (support with search strategies and searches) Mark Bovey, Mike Cummings (background information on acupuncture Cochrane Pain, Palliative and Supportive Care Group (searches of group’s database) Studies located Randomised Controlled Trials (RCT) Cassileth B. (unpublished) Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients. Available at: http://clinicaltrials.gov/ct/show/NCT00081965?order=1 [Accessed Dec 20, 2004]. Cohen S.M. (unpublished) Menopausal Symptom Relief for Women with Breast Cancer. CRISP 2002, at the CRISP Query page [reference not accessible on CRISP Query page, 25 May 2005]. Davies F.M. (2001) The effect of acupuncture treatment on the incidence and severity of hot flushes experienced by women following treatment for breast cancer: a comparison of traditional and minimal acupuncture. Paper presented at

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the European Cancer Conference, Lisbon, 21-25 October 2001. European Journal of Cancer, 37 Suppl 6:S1-488. Uncontrolled Studies Beer T. (unpublished) Acupuncture for Hot Flashes in Prostate Cancer Patients. Available at: http://crisp.cit.nih.gov/crisp/CRISP_LIB.getdoc?textkey=6776431&p_grant_num= 5R21CA09840602&p_query=(acupuncture)&ticket=14822151&p_audit_session_id=67502595&p _audit_score=100&p_audit_numfound=5&p_keywords=acupuncture [Accessed 25 May 2005]. Cumins S.M. and Brunt A.M. (2000) Does acupuncture influence the vasomotor symptoms experienced by breast cancer patients taking tamoxifen? Acupuncture in Medicine, 18(1):28. de Valois B., Young T., Hunter M., Lucey R., Maher E.J. (2003a) Using traditional acupuncture for hot flushes and night sweats in women taking tamoxifen- a pilot study. Focus on Alternative and Complementary Therapies, 8(1):134-135. de Valois B., Young T., Hunter M., Maher E.J. (2003b) Evaluating physical and emotional well-being in women using traditional acupuncture to manage tamoxifen side-effects. Focus on Alternative and Complementary Therapies, 8(4):492. de Valois B., Young T., Robinson N., McCourt C., Ashford R., Maher E.J. (2004) Using the NADA protocol to manage menopausal side-effects in women with early breast cancer. Focus on Alternative and Complementary Therapies, 9(S1):9-10. Hammar M., Frisk J., Grimas O., Hook M., Spetz A.-C., Wyon Y. (1999) Acupuncture treatment of vasomotor symptoms in men with prostatic carcinoma: a pilot study. Journal of Urology, 161(3):853-6. Johnstone P.A.S. (2004) Electroacupuncture for hot flashes secondary to cancer therapy: Results of treating the eastern diagnosis of kidney water exhausted. (Pilot study) Medical Acupuncture, [online] 15(1) article 4. Available at: http://www.medicalacupuncture.org/aama_marf/journal/vol15_1/vol_15_num_1_a rticle_4.html [Accessed Dec 17, 2004]. Porzio G., Trapasso T., Martelli S., Sallusti E., Piccone C., Mattei A., Di Stanislao C., Ficorella C., Marchetti P. (2002) Acupuncture in the treatment of menopauserelated symptoms in women taking tamoxifen. Tumori, 88(2):128-30.

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Towlerton G., Filshie J., O'Brien M. and Duncan A. (1999) Acupuncture in the control of vasomotor symptoms caused by tamoxifen. Palliative Medicine, 13(5):445. Tukmachi E. (2000a) Treatment of hot flushes in breast cancer patients with acupuncture. Acupuncture in Medicine, 18(1):22-27. Tukmachi E. (2000b) Treatment by acupuncture and dietary modification: Hot flushes in breast cancer patients. Journal of Chinese Medicine, 64:22-31. Qualitative studies Walker G., de Valois B., Young T., Davies R., Maher J. (2004) The experience of receiving Traditional Chinese Acupuncture. European Journal of Oriental Medicine, 4(5): 59-65.

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Acupuncture and multiple sclerosis Summary Background Multiple sclerosis (MS) is a chronic disease of the central nervous system. The multiplicity of symptoms which arises as a direct consequence of the disease means that the physical, cognitive and psychosocial problems experienced are wide ranging, variable, unpredictable and often complex. Symptoms can also arise as an indirect consequence of MS, for example poor posture in a wheelchair can exacerbate spasticity. People try complementary therapies, such as acupuncture, to help to manage their MS, relieve symptoms and support or promote well-being. Aim To systematically review the research evidence on the effectiveness of acupuncture in the supportive treatment of multiple sclerosis (MS). Methods Comprehensive searches of the following databases were conducted between January and February 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM and Acubriefs Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. The Cochrane Multiple Sclerosis Group was also contacted. Search strategies included terms for multiple sclerosis and acupuncture. Relevant research was systematically categorised by study type and appraised according to study design. Where appropriate, clinical commentaries were obtained for each study included in the review. Results One systematic review of complementary therapies and MS was found (Huntley and Ernst 2000) but no studies of patients treated with acupuncture were reported. Two randomised controlled trials (RCTs) and three uncontrolled studies (UC) of acupuncture and MS were found and were critically appraised. Details of outcome and benefits are limited by lack of studies and limited sample sizes. Studies located Systematic review RCT

1 (on CAM general, no studies of acupuncture) 2

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UC studies Other

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3 (including 1 case series incorporating qualitative data) 0

Conclusions Evidence to support the use of acupuncture in the treatment of MS-specific symptoms is currently not available due to a lack of well-conducted studies. In order to draw conclusions about the effectiveness of acupuncture in the treatment and support of MS symptoms, well-designed trials that use validated outcome measures are required. Research recommendations • Qualitative studies in order to understand the experience of MS patients who use acupuncture, and to explore the feasibility of acupuncture interventions, appropriateness of outcome measures, and trial methodology. • Well-designed trials that use validated outcome measures and focus on MS specific symptoms. • Trials that evaluate the effectiveness of acupuncture on MS spasticity, pain, fatigue, activities of daily living, and quality of life Authors / Contributors Janet Richardson, Karen Pilkington, Joanna Smith, Jane Wilson, Jenny Freeman Acknowledgements Anelia Boshnakova (support with search strategies, searches and proof-reading) Multiple Sclerosis Society (reading and commenting on drafts of this review). Studies located Systematic Reviews Huntley A. and Ernst E. (2000) Complementary and alternative therapies for treating multiple sclerosis symptoms: a systematic review. Complementary Therapies in Medicine, 8(2):97-105. Randomised Controlled Trials Farinelli M., Baratto L., Betti E., Morasso P., Capra R., Spada G. (1999) Acupuncture improves postural control in patients with lower limbs spasticity: A randomized controlled trial. Giornale Italiano di Riflessoterapia Ed Agopuntura, 11(2):71-74. Miller R.E. (1996) An investigation into the management of the spasticity experienced by some patients with multiple sclerosis using acupuncture based on traditional Chinese medicine. Complementary Therapies in Medicine, 4(1):5862.

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Uncontrolled Studies Iljas J.M. (2001) Effects of Chinese scalp acupuncture and basic qi gung exercises on the experiences of multiple sclerosis: Three case studies. Dissertation. California Institute of Integral Studies. Wang X.G. (2003) Treatment of ninety-five cases of multiple sclerosis with acupuncture. Shanghai Journal of Acupuncture and Moxibustion, 13(1):46-49. Zhao-gang Y. (1997) Treatment of multiple sclerosis with acupuncture. International Journal of Clinical Acupuncture, 8(1): 61-64.

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Acupuncture for stroke Summary

Aim To systematically review the evidence on the effectiveness of acupuncture in stroke patients (acute and rehabilitation phases) Methods Comprehensive searches of the following databases were conducted between February and March 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, Cochrane Stroke Group Register Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK) and Clinicaltrials.gov (US). Search strategies included terms for stroke and acupuncture. Relevant research was systematically categorised by study type. Relevant systematic reviews were appraised by two reviewers using a data extraction form designed specifically for the project and a review appraisal template validated with the project team. Results Four systematic reviews were located all of which have been rigorously conducted. Three reviews included randomised controlled trials only and one included quasi-randomised controlled trials. All compared acupuncture in its various forms: involving needling, classical or contemporary, manual, electrical or laser to a range of interventions (placebo acupuncture, sham treatment, no treatment or other treatment). No review provided conclusive evidence of the effectiveness of acupuncture in stroke patients although one concluded that acupuncture appeared to be safe. Studies located Systematic review: 4 published (1 ongoing) RCT: Between 7 and 14 included in the reviews CCT: UC studies: Other: Conclusion A series of systematic reviews have investigated the effectiveness of acupuncture in stroke and while the number of studies published and included

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has increased, currently the evidence from controlled trials of the effectiveness of acupuncture in stroke patients is not conclusive. Research recommendations • Further well-designed studies are required with sufficient power, clear protocols for the intervention including the specific acupuncture approach, appropriate control interventions and valid outcome measures. Further information The Cochrane review of acupuncture in acute stroke (the most recent review) is available in full at: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD003317/fra me.html A further Cochrane review of acupuncture for stroke rehabilitation is underway. The protocol is available at: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD004131/fra me.html Authors Karen Pilkington, Graham Kirkwood, Janet Richardson Acknowledgements Anelia Boshnakova (support with search strategies and searches) Studies located Systematic reviews Park J, Hopwood V, White AR and Ernst E. (2001) Effectiveness of acupuncture for stroke: a systematic review. Journal of Neurology, 248: 556-563. Smith LA, Moore OA, McQuay HJ and Moore A. (2001). Assessing the evidence of effectiveness of acupuncture for stroke rehabilitation: stepped assessment of likelihood of bias. Bandolier. Available at: http://www.jr2.ox.ac.uk/bandolier/booth/alternat/ACstroke.html. Sze FK, Wong E, Or KKH, Lau J and Woo J. (2002) Does acupuncture improve motor recovery after stroke? A meta-analysis of randomized controlled trials. Stroke, 33: 2604-2619. Tang JL, Wu HM, Lin XP, Zhang YL, Lau J, Leung PC, Woo J, Li YP. Acupuncture for stroke rehabilitation. The Cochrane Database of Systematic Reviews: Protocols 2002 Issue 4 John Wiley & Sons, Ltd Chichester, UK DOI: 10.1002/14651858.CD004131 (ongoing study)

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Zhang SH, Liu M, Asplund K and Li L (2005) Acupuncture for acute stroke. The Cochrane Database of Systematic Reviews Issue 2. Art No CD003317.pub2. DOI: 10.1002/14651858.CD003317.pub2.

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Aromatherapy and massage for anxiety Summary Aim To systematically review the research evidence on the effectiveness of aromatherapy and/or massage for anxiety. Methods Comprehensive searches of the following databases were conducted between August and October 2004: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM. Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK) and Clinicaltrials.gov (US). Search strategies included terms for aromatherapy, massage, anxiety and anxiety disorders. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results A total of 7 randomised (RCT) and 1 nonrandomised (CCT) controlled trials were located. Four RCTs assessed massage only, 1 assessed foot massage (also included in reflexology review), 1 assessed aromatherapy without massage and 1 assessed aromatherapy combined with massage. Two qualitative studies were also identified. Studies located Systematic review RCT CCT/UCT Other

0 7 0 2 qualitative studies

Conclusions • Massage appears superior to no treatment or relaxation-based control based on self-assessment with validated instrument (STAI) in range of situations (anxious elderly, post-traumatic stress disorder in children, pre menstrual dysphoria disorder and pre-operatively). • The influence of the presence of a therapist and distraction from the cause of the anxiety cannot be dismissed in studies when massage is compared against no treatment or no individual attention. This aspect may prove to be a valuable component of the effectiveness. However, effects were seen even when massage was compared against other interventions such as conversation with staff or relaxation therapy.

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• • • •

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Little information was provided on the training and experience of the therapist or about the environment, both of which are likely to affect any outcome One small study suggests that combining massage with aromatherapy is more effective that massage with carrier oil only The contribution of massage to complex interventions is impossible to assess Results for aromatherapy without massage were not convincing

Research recommendations: • Further investigation of the potentially positive effects in specific anxietyrelated conditions. In particular, the place of massage therapy as a supportive measure appears worthy of attention • In reporting studies in this field, information about the massage environment and the therapist should be provided Additional information: A Cochrane review on aromatherapy and massage on symptom relief in patients with cancer addresses effects on anxiety and depression in this context. For further information, see the full Cochrane review at: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD002287/fra me.html Authors Karen Pilkington, Graham Kirkwood, Hagen Rampes, Janet Richardson Acknowledgements Anelia Boshnakova (support with search strategies and searches) Kate Coleman (clinical commentaries) Studies located Systematic review Fellowes D, Barnes K, Wilkinson S. (2004) Aromatherapy and massage for symptom relief in patients with cancer. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD002287. DOI: 10.1002/14651858.CD002287.pub2. Randomised controlled trials Field, T., C. Morrow, et al. (1992) Massage reduces anxiety in child and adolescent psychiatric patients. Journal of the American Academy of Child and Adolescent Psychiatry 31(1): 125-31. Field, T., S. Seligman, et al. (1996) Alleviating posttraumatic stress in children following Hurricane Andrew. Journal of Applied Developmental Psychology 17(1): 37-50. Hernandez Reif, M., A. Martinez, et al. (2000) Premenstrual symptoms are

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relieved by massage therapy. Journal of psychosomatic obstetrics and gynaecology 21(1): 9-15. Lemon, K. (2004) An assessment of treating depression and anxiety with aromatherapy. International Journal of Aromatherapy 14(2): 63-9. Spector, I. P., M. P. Carey, et al. (1993) Cue-controlled relaxation and 'aromatherapy' in the treatment of speech anxiety. Behavioural Psychotherapy 21(3): 239-253. Thomas, M. (1989) Fancy footwork. Nursing times 85(41): 42-4. Van der Riet, P. (1993) Effects of therapeutic massage on pre-operative anxiety in a rural hospital... part 1. Australian Journal of Rural Health 1(4): 11-6. Non-randomised controlled trials Platania-Solazzo A, Field TM, Blank J, Seligman F, Kuhn C, Schanberg S, Saab P (1992) Relaxation therapy reduces anxiety in child and adolescent psychiatric patients. Acta Paedopsychiatrica, 5(2):115-20. Qualitative Studies Smith MC, Stallings MA, Mariner S and Burrall M. (1999) Benefits of massage therapy for hospitalized patients: a descriptive and qualitative evaluation. Alternative Therapies in Health and Medicine, 5(4):64-71. Van der Riet, P. (1993) Effects of therapeutic massage on pre-operative anxiety in a rural hospital... part 2. Australian Journal of Rural Health 1(4):17-21.

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Aromatherapy and massage for cancer symptom management Summary Aim To systematically review the research evidence on the effectiveness of aromatherapy and/or massage for cancer symptom management. Methods After initial searching a Cochrane systematic review of the evidence for aromatherapy and/ or massage for symptom relief in patients with cancer was located. Further searches focused on identifying relevant qualitative studies and were conducted in October 2004. The Cochrane review and qualitative studies were systematically appraised and data was extracted. Results The Cochrane review provides a methodologically rigorous overview of the evidence from randomised controlled clinical trials (RCTs) on aromatherapy and/ or massage for symptom relief in cancer patients. Searches for RCTs for the Cochrane review were conducted up to March/May 2002. Additional searches for qualitative studies were conducted up to September 2004. Two relevant qualitative studies and one RCT including qualitative methods of data collection and analysis were located. Studies located Systematic review RCT CCT/UCT Other

1 Cochrane review (other reviews not searched for) 10 included in Cochrane review not included in Cochrane review 3 qualitative studies

Conclusions The Cochrane systematic review of the evidence of aromatherapy/massage for cancer patients concluded that: “Massage and aromatherapy massage confer short term benefits on psychological wellbeing, with the effect on anxiety supported by limited evidence. Effects on physical symptoms may also occur. Evidence is mixed as to whether aromatherapy enhances the effects of massage”. The qualitative evidence further contributes to the knowledge of patient selfperceived benefits of aromatherapy / massage and prompts themes for further research.

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Research recommendations The Cochrane review made the following recommendations: • Further RCTs with longer follow up times. • More research to determine the relative benefits of the addition of aromatherapy to massage, the most advantageous number of massages, and the areas of the body to be massaged, would be valuable in developing a consensus on the most appropriate therapy to offer. • For the full recommendations see the Cochrane review. Further suggestions for future research: • Research into the feasibility of teaching massage techniques to partners of persons with cancer. • Evaluation and appraisal of the evidence on massage aimed at a specific localised physical effect such as lymphatic drainage. • The potential use of massage for women with body image issues such as those post-mastectomy. Additional information: The link below provides access to the full Cochrane review: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD002287/fra me.html Searches for the Cochrane review were conducted up to March/May 2002 and full searches for studies published since have not yet been conducted. Brief searches of PubMed have located a number of recent randomised controlled trials. For details see list of recent aromatherapy studies below. Authors Janet Richardson, Joanna Smith, Karen Pilkington Acknowledgements Anelia Boshnakova (support with search strategies and searches) Studies located Systematic review Fellowes D, Barnes K, Wilkinson S. (2004) Aromatherapy and massage for symptom relief in patients with cancer. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD002287. DOI: 10.1002/14651858.CD002287.pub2. Qualitative Studies Billhult A. and Dahlberg K. (2001) A meaningful relief from suffering: Experiences of massage in cancer care. Cancer Nursing, 24(3): 180-184. Bredin M. (1999) Mastectomy, body image and therapeutic massage: a qualitative study of women's experience. Journal of Advanced Nursing, 29(5): 1113-20.

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Dunwoody L., Smyth A., Davidson R. (2002) Cancer patients' experiences and evaluations of aromatherapy massage in palliative care. International Journal of Palliative Nursing, 8(10): 497-504. Henry V., Berggren L., Boyd C.G. (2000) A qualitative study on the benefits of massage for palliative care patients. Transplant Nurses’ Journal, 9(2):13-16.

RCTs (published since the Cochrane review searches were completed) Recent aromatherapy studies (not appraised) Graham P.H., Browne L., Cox H., Graham J. (2003) Inhalation aromatherapy during radiotherapy: results of a placebo-controlled double-blind randomized trial. Journal of Clinical Oncology, 21(12):2372-6. Soden K., Vincent K., Craske S., Lucas C., Ashley S. (2004) A randomized controlled trial of aromatherapy massage in a hospice setting. Palliative Medicine, 18(2):87-92. Westcombe A.M., Gambles M.A., Wilkinson S.M., Barnes K., Fellowes D., Maher E.J., Young T., Love S.B., Lucey R.A., Cubbin S., Ramirez A.J.(2003) Learning the hard way! Setting up an RCT of aromatherapy massage for patients with advanced cancer. Palliative Medicine, 17(4): 300-7. Wilcock A., Manderson C., Weller R., Walker G., Carr D., Carey A.M., Broadhurst D., Mew J., Ernst E. (2004) Does aromatherapy massage benefit patients with cancer attending a specialist palliative care day centre? Palliative Medicine, 18(4): 287-90. Recent massage studies (not appraised) Hernandez-Reif M., Ironson G., Field T., Hurley J., Katz G., Diego M., Weiss S., Fletcher M.A., Schanberg S., Kuhn C., Burman I. (2004) Breast cancer patients have improved immune and neuroendocrine functions following massage therapy. Journal of Psychosomatic Research, 57(1): 45-52. McNeely M.L., Magee D.J., Lees A.W., Bagnall K.M., Haykowsky M., Hanson J. (2004) The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. Breast Cancer Research and Treatment, 86(2): 95-106. Post-White J., Kinney M.E., Savik K., Gau J.B., Wilcox C., Lerner I. (2003) Therapeutic massage and healing touch improve symptoms in cancer. Integrative Cancer Therapies, 2(4): 332-44.

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Aromatherapy and massage for depression Summary Aim To systematically review the research evidence on the effectiveness of aromatherapy and/or massage for depression. Methods Comprehensive searches of the following databases were conducted between August and October 2004: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM. Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK) and Clinicaltrials.gov (US). Search strategies included terms for aromatherapy, massage, depression and depressive disorders. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results Four randomised (RCT) and 2 nonrandomised (CCT) controlled trials were included in this review. Four of the studies were of massage (ranging from shoulder/back massage to full body massage), one was of aromatherapy with massage and one of aromatherapy alone (inhalation of essential oils). The RCTs of massage therapy were conducted in hospitalised children and adolescents with depression, adolescent mothers with depressive symptoms and women with postnatal depression. Results of these studies were positive with massage therapy found to compare favourably with relaxing activities such as viewing a videotape, yoga plus progressive muscular relaxation or no treatment. One recent small RCT suggested promising results of individualised aromatherapy massage compared with massage alone in elderly patients with anxiety and/or depression. Relevant details such as method of randomisation and details of attrition were unreported for most studies. Other problems in interpretation of the results arise from the nature of the intervention which precludes blinding of either patient or carer. Studies in which massage was incorporated into complex interventions were also located but the contribution of the massage component was impossible to assess. Studies located Systematic review RCT CCT UCT

0 4 2 0

(3 massage only, 1 aromatherapy only) (1 massage only, 1 aromatherapy massage)

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Conclusions The studies located provide limited evidence of positive effects of massage therapy in depression although there is currently insufficient research evidence on any single intervention or patient group for firm conclusions on effectiveness, role or long-term outcomes to be drawn. Massage interventions can be delivered in a number of settings and there may be a potential role for interventions such as these in, for example, mild depression where use of antidepressants as first line treatment is discouraged (NICE 2004) particularly in patient groups in which use of antidepressants is problematic (elderly, depressed mothers, hospitalised children). The added benefits of incorporating essential oils into the massage treatment suggested by the single study require further evaluation. Safety considerations relate to the selection of appropriate massage techniques and of suitable essential oils if these are to be incorporated into therapy. These aspects of treatment also require further evaluation. Research recommendations • The differential effects of the various massage interventions, of incorporating essential oils in massage therapy and of the different essential oils require investigation. • Future studies should have clear inclusion criteria, be adequately powered and where feasible address longer-term outcomes. • Control interventions should address the additional interpersonal interaction and attention received by patients during treatment which is likely to contribute to the response. • Reporting of studies should include attrition rates and reasons for drop-out together with details of the therapist and the massage environment. Additional information: A Cochrane review on aromatherapy and massage on symptom relief in patients with cancer addresses effects on anxiety and depression in this context. For further information, see the full Cochrane review at: http://www.mrw.interscience.wiley.com/cochrane/clsysrev/articles/CD002287/fra me.html Authors Karen Pilkington, Graham Kirkwood, Hagen Rampes, Janet Richardson Acknowledgements Anelia Boshnakova (support with search strategies and searches) Kate Coleman (clinical commentary) Studies located Systematic review Fellowes D, Barnes K, Wilkinson S. (2004) Aromatherapy and massage for symptom relief in patients with cancer. The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD002287. DOI: 10.1002/14651858.CD002287.pub2.

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Randomised controlled trials Field T, Morrow C, Valdeon C, Larson S, Kuhn C and Schanberg S. (1992) Massage reduces anxiety in child and adolescent psychiatric patients. Journal of the American Academy of Child and Adolescent Psychiatry 31(1): 125-131. Field T, Grizzle N, Scafidi F and Schanberg S. (1996) Massage and relaxation therapies’ effects on depressed adolescent mothers. Adolescence 31(124): 903911. Lemon K. (2004) An assessment of treating depression and anxiety with aromatherapy. International Journal of Aromatherapy 14(2): 63-9. Onozawa K, Glover V, Adams D, Modi N and Kumar RC.(2001) Infant massage improves mother-infant interaction for mothers with postnatal depression. Journal of Affective Disorders 63(1-3): 201-7. Non randomised controlled trials Komori T, Fujiwara R, Tanida M, Nomura J and Yokoyama MM. (1995) Effects of citrus fragrance on immune function and depressive states. Neuroimmunomodulation 2(3): 174-180. Rowlands, D. (1984)."Therapeutic touch: its effects on the depressed elderly.The Australian Nurses' Journal 13(11): 45-6.

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Aromatherapy and multiple sclerosis Summary Background Multiple sclerosis (MS) is a chronic disease of the central nervous system. The multiplicity of symptoms which arises as a direct consequence of the disease means that the physical, cognitive and psychosocial problems experienced are wide ranging, variable, unpredictable and often complex. Symptoms can also arise as an indirect consequence of MS, for example poor posture in a wheelchair can exacerbate spasticity. People try complementary therapies to help to manage their MS, relieve symptoms and support or promote well-being. Aim To systematically review the research evidence on the effectiveness of aromatherapy in the supportive treatment of multiple sclerosis (MS). Methods Comprehensive searches of the following databases were conducted between January and February 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. The Cochrane Multiple Sclerosis Group was also contacted. Search strategies included terms for multiple sclerosis, aromatherapy and massage. Relevant research was systematically categorised by study type and appraised according to study design. Where appropriate, clinical commentaries were obtained for each study included in the review. Results One systematic review of complementary therapies and MS was found (Huntley and Ernst 2000), but no studies of patients treated with aromatherapy were reported. One randomised controlled trial (RCT) and two uncontrolled (UC) studies (one qualitative) of aromatherapy and MS were found and were critically appraised. Details of outcome and benefits are limited by lack of studies and limited sample sizes. Studies located SR RCT UC studies Other

1 (on CAM general, no studies of aromatherapy) 1 (pilot) 1 (audit) 1 (qualitative study)

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Conclusions Evidence to support the use of aromatherapy in the treatment of MS-specific symptoms is currently not available due to a lack of well-conducted studies. In order to draw conclusions about the effectiveness of aromatherapy in the treatment and support of MS symptoms, well-designed trials that use validated outcome measures are required. Research recommendations • Further qualitative studies in order to understand the experience of MS patients who use aromatherapy massage, and to explore the potential relationship between different MS symptoms (i.e., pain, sleep, general well-being). • Qualitative studies to assess the feasibility of aromatherapy as an intervention, and explore appropriate outcome measures and trial methodology. • Well-designed randomised controlled trials that evaluate the effectiveness of aromatherapy on MS pain, sleep, physical and emotional well-being, relaxation and mobility that use validated outcome measures • Randomised controlled trials that evaluate and compare the effectiveness of specific essential oil preparations on the above symptoms. Authors / Contributors Janet Richardson, Jenny Freeman, Karen Pilkington, Joanna Smith Acknowledgements Anelia Boshnakova (support with search strategies and searches) Multiple Sclerosis Society for reading and commenting on drafts of this review. Studies located Systematic reviews Huntley A. and Ernst E. (2000) Complementary and alternative therapies for treating multiple sclerosis symptoms: a systematic review. Complementary Therapies in Medicine, 8(2):97-105. Randomised controlled trials Walsh E. and Wilson C. (1999) Complementary therapies in long-stay neurology in-patient settings. Nursing Standard, 13(32):32-35. Uncontrolled studies Howarth A.L. (2002) Will aromatherapy be a useful treatment strategy for people with multiple sclerosis who experience pain? Complementary Therapies in Nursing and Midwifery, 8(3):138-141.

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Qualitative studies Howarth A.L. and Freshwater D. (2004) Examining the benefits of aromatherapy massage as a pain management strategy for patients with multiple sclerosis. Nursing Times Research, 9(2):120-128.

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Black cohosh for menopausal symptoms in women with breast cancer Summary Background Women with breast cancer are at an increased risk for experiencing menopausal symptoms as a result of treatment. Black cohosh (Actaea racemosa, previously termed Cimicifuga racemosa) has been used as an alternative to hormonal therapy but there has not been a systematic review focusing on black cohosh for hot flushes in cancer patients. Aim To systematically review the evidence on the effectiveness of black cohosh for the treatment of hot flushes resulting from cancer therapy. Methods Comprehensive searches of the following databases were conducted between July and August 2004: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) • Specialist databases: AMED, CISCOM, BIOSIS Previews, HerbMed, Natural Medicines Comprehensive Database, Natural Standard Database Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for black cohosh, hot flushes and cancer. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results No systematic reviews that focused specifically on black cohosh for cancerrelated hot flushes were found. Two published randomised controlled trials (RCTs) and 1 ongoing RCT were located. No other relevant studies were found. One trial reports positive effects of black cohosh on hot flushes while the other reports positive outcomes for sweating only. Trials had some methodological limitations including a lack of reporting of several details. Studies located Systematic review: RCT: CCT: UC studies: Other:

0 3 (2 published, 1 ongoing) 0 0 0

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Conclusion There is limited evidence on the effectiveness of black cohosh for hot flushes in cancer patients. Further well-conducted randomised controlled trials are required before firm conclusions can be drawn about effectiveness in women with cancer suffering from menopausal symptoms. Previous reports have suggested that the efficacy of or adverse effects from black cohosh alone or in combination with tamoxifen are unclear and the findings from this review support this statement. See note on safety below Research recommendations Assuming no further safety issues arise: • Further methodologically rigorous randomised controlled trials with sufficient follow up times investigating the efficacy and safety of the use of black cohosh in cancer patients. • Prescriptions and doses should be fully reported, as should details of product quality assurance. • In addition, the safety of black cohosh should be monitored. • It is hoped that the forthcoming trial will report the methods used and results in sufficient detail in order that the intervention and study design may be appropriately assessed. Safety The Medicines and Healthcare Products Regulatory Agency (MHRA) has recently conduced a review of the safety of black cohosh particularly related to reports of hepatotoxicity (liver problems). The results of this review are available at the following web address: http://medicines.mhra.gov.uk/ourwork/licensingmeds/herbalmeds/herbalsafety.ht m#black However, the MHRA is continuing to keep black cohosh under review (2005). Several studies have focused on safety of black cohosh in breast cancer patients but the results are not conclusive. The National Institutes of Health Office of Dietary Supplements information sheet on black cohosh states that “Women with breast cancer may want to avoid black cohosh until its effects on breast tissue are understood.” (Available at: http://ods.od.nih.gov/factsheets/BlackCohosh.asp 2005) Authors Joanna Smith, Janet Richardson, Michael McIntyre, Rob Thomas, Karen Pilkington Acknowledgements Anelia Boshnakova (support with search strategies and searches)

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Studies located Randomised Controlled Trials Hernandez Munoz, G. and Pluchino S. (2003) Cimicifuga racemosa for the treatment of hot flushes in women surviving breast cancer. Maturitas, 44 Suppl. 1: S59-65. Jacobson J.S., Troxel A.B., Evans J., Klaus L., Vahdat L., Kinne D., Lo K.M., Moore A., Rosenman P.J., Kaufman E.L., Neugut A.I., Grann V.R. (2001) Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology, 19(10): 2739-2745. Pockaj B.A. (ongoing) Black cohosh in treating hot flushes on women who have or are at risk of developing breast cancer. Available at: http://www.clinicaltrials.gov/ct/show/NCT00060320?order=28 [Accessed 27 May 2005]. Uncontrolled Studies None located

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Essiac in cancer Summary Background Essiac is a herbal tea mixture originally developed in Canada. It has been claimed that Essiac can help detoxify the body and strengthen the immune system. It is reported to contain 4 herbs: burdock root (Arctium lappa), Indian rhubarb root (Rheum palmatum, sometimes known as Turkish rhubarb), sheep sorrel (Rumex acetosella), and the inner bark of slippery elm (Ulmus fulva or Ulmus rubra). Aim To systematically review the research evidence on the effectiveness of Essiac in cancer. Methods Comprehensive searches of the following databases were conducted in June 2004 and repeated in June 2006: • Major biomedical and nursing databases: BIOSIS Previews, British Nursing Index, ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, IPAB, MEDLINE (Ovid MEDLINE(R) InProcess, Other Non-Indexed Citations, Ovid OLDMEDLINE(R) and PubMed) • Specialist databases: AMED, CISCOM, Cochrane Complementary Medicine Field Register, HerbMed Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK) and Clinicaltrials.gov (US). Search strategies included the terms for Essiac only. No relevant research was located. Results No published clinical studies were located. Conclusion Comprehensive searches of a range of sources have not identified any published clinical studies on Essiac in cancer patients. Further information A review of Essiac in cancer has been published but this review has not been appraised for this project. For full text of this review: http://www.cmaj.ca/cgi/reprint/158/7/897 Link to National Cancer Institute information for health professionals: http://www.nci.nih.gov/cancertopics/pdq/cam/essiac/HealthProfessional/page1

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Authors Karen Pilkington, Janet Richardson Acknowledgements Anelia Boshnakova (support with search strategies and searches)

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Homeopathy for cancer supportive care Summary Background Homeopathy is a complementary therapy that is used to treat various cancerrelated symptoms. Previous systematic reviews on homeopathy for a variety of conditions have produced inconsistent and inconclusive results, showing that studies suffer from methodological limitations. A Cochrane review is presently underway to assess the effectiveness and safety of homeopathic interventions for adverse effects of cancer management. This review aims to supplement the Cochrane review by looking at the wider application of homeopathy in cancer supportive care and includes a broader range of study designs. Aim To systematically review and critically appraise the effectiveness of homeopathy for cancer supportive care. Methods Comprehensive searches of the following databases were conducted between March and May 2004: • Major medical databases: BNI, ClNAHL, Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed), PsycINFO • Specialist databases: AMED, CISCOM, Cochrane Complementary Medicine Field Registry, HomInform. Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for cancer and homeopathy. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results One Cochrane review of homeopathy for cancer management is presently underway. Four randomised controlled trials (RCTs) were located. The studies focussed on chemotherapy-induced nausea and vomiting; chemotherapyinduced mucositis and radiotherapy induced skin reactions. One non-randomised controlled trial (CCT) was also identified. Four uncontrolled studies were located addressing symptoms of oestrogen withdrawal, hot flushes or a range of symptoms. Studies located Systematic reviews RCTs

1 (Cochrane review underway) 4

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CCTs UC studies Other

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1 4 0

Since completion of this review 2 further RCTs have been published (Thompson et al. 2005 and Jacobs et al. 2005, which reports the findings of Jacobs 1999) and a systematic review (Milazzo et al. 2006) Conclusions The evidence for homeopathy is limited due to the fact that only a small number of RCTs have been conducted. However, one small RCT indicates that the homeopathic mouth rinse preparation TRAUMEEL S may significantly reduce chemotherapy-induced mucositis in children undergoing bone marrow transplantation. The two RCTs of homeopathy in radiation-induced skin reactions are inconclusive. Conclusions regarding the effects of homeopathy on chemotherapy-induced nausea and vomiting cannot be drawn due to the limited reporting of study results. Positive results from non randomised studies indicate a need to conduct well-designed RCTs to examine the effectiveness of homeopathy for hot flushes in breast cancer. There were no serious adverse effects reported in the literature included in this review. In light of the methodological problems present in the studies included in this review, there is insufficient evidence to confirm the efficacy of homeopathy for any particular symptom in cancer supportive care. Research recommendations  Further methodologically rigorous and sufficiently powered RCTs are required to establish the efficacy of homeopathy for cancer supportive care.  Studies should include sufficiently powered methodologically rigorous RCTs with adequate checks on concealment of allocation and blinding, and appropriate follow up times.  Co-interventions, in particular other complementary therapies, should be adequately reported.  Further, appropriately powered RCTs of TRAUMEEL S for the prevention and alleviation of chemotherapy-induced mucositis should be conducted.  Appropriately powered RCTs of homeopathy for hot flushes and other symptoms of oestrogen withdrawal should be conducted in light of the initial positive results from uncontrolled studies.  Further research into the safety of homeopathic interventions for cancer patients is required.  Qualitative research into patients’ subjective experience with the homeopathic intervention would be of clinical interest. Authors / Contributors Janet Richardson, Joanna Smith, Sosie Kassab, Karen Pilkington

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Acknowledgements Anelia Boshnakova (support with search strategies and searches) Rob Thomas (clinical commentaries and professional advice) Studies located Systematic review (underway) Kassab S., van Haselen R., Fisher P., McCarney R. (2004) Homeopathy for adverse effects of cancer management. (Protocol) The Cochrane Database of Systematic Reviews, Issue 3. Art. No.: CD004845. DOI: 10.1002/14651858.CD004845. Randomised controlled trials (RCTs) Balzarini A., Felisi E., Martini A., De Conno F. (2000) Efficacy of homeopathic treatment of skin reactions during radiotherapy breast cancer: a randomized, double-blind clinical trial. British Homeopathic Journal, 89(1): 8-12. Genre D., Tarpin C., Braud A.C., Camerlo J., Protiere C., Eisinger F., Viens P. (2003) Randomized, double-blind study comparing homeopathy (cocculine) to placebo in prevention of nausea/vomiting among patients receiving adjuvent chemotherapy for breast cancer. The 26th Annual San Antonio Breast Cancer Symposium (SABCS) Dec. 3-6. Available at: http://www.abstracts2view.com/bcs03/sessionindex.php?p=3 [Accessed 10 Oct 2005]. Kulkarni A., Nagarkar B.M., Burde G.S. (1988) Radiation protection by use of homoeopathic medicines. Hahnemannian Homoeopathic Sandesh, 12(1): 20-23. Oberbaum M., Yaniv I., Ben-Gal Y., Stein J., Ben-Zvi N., Freedman L.S., Branski D. (2001) A randomized controlled clinical trial of the homeopathic medication TRAUMEEL S in the treatment of chemotherapy-induced stomatitis in children undergoing stem cell transplantation. Cancer, 92(3): 684-690. Jacobs J. (1999). Is homeopathy effective for hot flashes and other estrogenwithdrawal symptoms in breast cancer survivors? Journal of the American Institute of Homeopathy, 92(2): 72-77. (proposal for an RCT) Controlled clinical trial (CCT) Srihari U., and Raghunadha D. (1995) The Ipecac trial. Book of Proceedings, 49th LMHI Congress, New Delhi, Vol 1, 307-312. Uncontrolled studies Clover A., Last P., Fisher P., Wright S., Boyle H. (1995) Complementary cancer therapy: a pilot study of patients, therapies and quality of life. Complementary Therapies in Medicine, 3(3): 129-133.

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Clover A. and Ratsey D. (2002) Homeopathic treatment of hot flushes: a pilot study. Homeopathy, 91(2): 75-79. Thompson E.A. and Reilly D. (2002) The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliative Medicine, 16(3) :227-233. Thompson E.A. and Reilly D. (2003) The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy, 92(3): 131-134.

NOTE: Since completion of this review one systematic review and two further RCTs have been published (Thompson et al. 2005, Jacobs et al. 2005 - reports the findings of Jacobs 1999) Milazzo S, Russell N, Ernst E. (2006) Efficacy of homeopathic therapy in cancer treatment. European Journal of Cancer, 42:282-9. Jacobs J., Herman P., Heron K., Olsen S., Vaughters L. (2005) Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial. Journal of Alternative and Complementary Medicine, 11(1): 2127. Thompson E.A., Montgomery A., Douglas D., Reilly D. (2005) A pilot randomized, double-blinded, placebo-controlled trial of individualized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. Journal of Alternative and Complementary Medicine, 11(1): 13-20.

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Homeopathy in stroke Summary Aim To systematically review the evidence on the effectiveness of homeopathy in stroke patients (acute and rehabilitation phases). Methods Comprehensive searches of the following databases were conducted between February and March 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, HomInform, Cochrane Stroke Group Registry Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for stroke and homeopathy. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results Only 2 randomised controlled trials were found, both trials of homeopathic Arnica Montana in acute stroke conducted some time ago. No difference in mortality over three months or on level of care required at three months between the group treated with Arnica or that treated with placebo was demonstrated in either study. Only 3 patients in the first study and 1 in the second had clinical features of the kind of patient expected to benefit from this particular remedy. Neither study reported any power calculation, therefore it is possible that both studies were underpowered. Studies located Systematic review: RCT: CCT: UC studies: Other:

0 2 0 0 1 (retrospective comparative study)

Conclusion There is currently little research evidence on the effectiveness of homeopathy or homeopathic remedies in stroke patients. Only two randomised controlled trials have been published both of which assessed the effects of a single remedy,

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Arnica, on mortality and severity of stroke. Both reported inconclusive results but were small, possibly underpowered, studies. Research recommendations • Further well-designed studies are required to assess homeopathy (use of a homeopathic approach with individualised prescribing or limited list of remedies) as opposed to a single homeopathic remedy. • These studies could focus on specific problems related to stroke rather than mortality or severity of the condition. Authors Karen Pilkington, Graham Kirkwood, Rhoda Allison, Janet Richardson Acknowledgements Anelia Boshnakova (support for search strategies and searches) Studies located Randomised Controlled Trials Savage RH and Roe PF. (1977) A double blind trial to assess the benefit of Arnica Montana in acute stroke illness. The British Homoeopathic Journal, 67, 207-220. Savage RH and Roe PF. (1978) A further double blind trial to assess the benefit of Arnica Montana in acute stroke illness. The British Homoeopathic Journal, 67, 210-222. Other Studies Wilkens J, Ludtke R, Stein F, Schuwirth W and Karenovic A. (2002) Vergleichende Untersuchung zur Behanlung des Schlaganfalls mit homoopathischen und anthroposophischen Arzneimittein in einer geriatrischen Reha-Klinik. Erfahrungsheilkunde, 51(6): 397-404. Wilkens J, Ludtke R, Stein F, Schuwirth W and Karenovic A. (2003) Comparative study of the therapy of stroke syndrome with homeopathic and anthroposophic remedies in a geriatric centre. Merkurstab, 56(1): 22-7. (duplicate publication of above study)

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Hypnotherapy in stroke Summary Aim To systematically review the evidence on the effectiveness of hypnotherapy in stroke patients (acute and rehabilitation phases) Methods Comprehensive searches of the following databases were conducted between February and March 2005: • Major biomedical and nursing databases: ClNAHL, CENTRAL, Cochrane Database of Systematic Reviews, DARE, EMBASE, MEDLINE (and PubMed) and PsycINFO • Specialist databases: AMED, CISCOM, Cochrane Stroke Group Registry Efforts were also made to identify unpublished and ongoing research via the National Research Register (UK), Clinicaltrials.gov (US), and experts in the field. Search strategies included terms for stroke and hypnotherapy. Relevant research was systematically categorised by study type and appraised according to study design. Clinical commentaries were obtained for each study included in the review. Results Only one randomised controlled study was located, published as an abstract. Significantly better performance (p