Eur Arch Otorhinolaryngol (2010) 267:51–56 DOI 10.1007/s00405-009-1015-7
OTOLOGY
Personal experience with tinnitus retraining therapy Egisto Molini · Mario Faralli · Claudio Calenti · Giampietro Ricci · Fabrizio Longari · Antonio Frenguelli
Received: 9 February 2009 / Accepted: 5 June 2009 / Published online: 19 June 2009 © Springer-Verlag 2009
Abstract We present the results of tinnitus retraining therapy (TRT) in a group of patients suVering from tinnitus and/or hyperacusia. Based on the scores from a speciWc questionnaire and the Tinnitus Handicap Inventory (THI), the patients were classiWed into Wve categories and began therapy according to JastreboV’s criteria. Depending on the individual case, therapy envisaged counselling sessions, ambient sound enrichment, sound generators and hearing aids. At the end of the 18-month period, therapeutic success was observed in 79% of the patients. The initial numerical values of the scale of the symptoms and the THI seem predictive of treatment outcome. The use of instruments (sound generators) increases the success rate, but the study also demonstrates the eVectiveness of counselling and ambient sound enrichment. Failures mainly involved patients with hypacusia who refused to wear hearing aids, as this inXuenced the eVectiveness of ambient sound enrichment and counselling. Paralleling the data in the literature, the results demonstrate the eVectiveness of TRT, which cannot be attributed to a placebo eVect given the extended duration of treatment. Keywords Tinnitus · Hypacusia · Hyperacusia · Tinnitus retraining therapy
E. Molini · M. Faralli (&) · C. Calenti · G. Ricci · F. Longari · A. Frenguelli Otolaryngology and Cervicofacial Surgery Clinic, University of Perugia, Perugia, Italy e-mail:
[email protected];
[email protected]
Introduction Tinnitus can be classiWed into two categories, based on pathogenesis. Objective tinnitus is produced by sound occurring within the human body, which can be measured and, in some cases, even heard by the examiner. It is described with reference to the source that generates it (fasciculation, noise produced by altered blood Xow, etc.) [4]; subjective tinnitus is derived from the perception of a sound that depends exclusively on the activity of the nervous system, without any type of mechanical or vibratory activity of the cochlea and independent of any external stimulation [5]. In turn, subjective tinnitus can be classiWed based on whether the symptoms are caused by discernible disorders of the ear or acoustic nerve temporally associated with lateralised tinnitus on the side of the diseased ear (“otic” tinnitus) or whether the origins are unclear, as there is no association with evident disorders of the ear or acoustic nerve (“non-otic” or “essential” tinnitus) [11]. From a qualitative standpoint, non-otic subjective tinnitus is usually represented by a tonal noise or a complex noise that, while similar to known sounds, is never the same as an ambient sound. It originates from the subcortical auditory pathways that do not passively transmit sound signals, but instead regulate their intensity automatically (central auditory gain) and process the evoked neural activity [6]. According to various case studies, the rate of tinnitus varies from 6 to 30% of the general population [1, 2]. Most people with tinnitus present a natural history characterised by habituation and tolerance to the “disorder”. Nevertheless, in 1% of these cases, tinnitus becomes a disabling condition, based on the level of activation of the limbic and autonomic nervous systems, and requires treatment. The theory of the involvement of the limbic and autonomic
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nervous systems in tinnitus can be attributed to P. J. JastreboV [5], who devised the neurophysiological model of tinnitus and the ensuing treatment strategy: tinnitus retraining therapy (TRT), which can ameliorate symptoms in more than 80% of cases [7, 9]. The goal of this study was to evaluate the results of TRT 6.5 years after its introduction as a treatment protocol for tinnitus at our clinic.
Materials and methods Between 1 January 2002 and 30 June 2006 we progressively examined 117 subjects who were considered for treatment; the subjects had tinnitus and/or hyperacusia for 7.6 § 8.3 years (minimum 1 year, maximum 41 years) (Fig. 1). The patients who were selected and then enrolled in the study were monitored for at least 18 months, at monthly intervals for the Wrst 3 months and then every 3 months, and the study was extended to January 2008. All the subjects underwent an initial evaluation composed of an otolaryngological examination, internal medicine checkup and an examination of case history, guided by a speciWc questionnaire regarding not only the patient’s general state of health, but also the characteristics of tinnitus, hypacusia and/or hyperacusia (onset period, onset conditions, site, etc.). Once the initial evaluation phase was completed, if the candidate was considered suitable for the diagnostic and treatment process, we moved on to the next phase. It involved having the patient complete a speciWc questionnaire with answers that were quantiWable with numerical values, allowing us to calculate the percentage of awareness of tinnitus during daytime wakefulness, the severity of symptoms, the loudness discomfort level caused by the
25 males
N° patients
20
females
15 10 5
ca
t.
4
3 t. ca
ca
t.
2
1 t. ca
ca
t.
0
0
categories Fig. 1 Distribution by gender and category of the 81 patients enrolled between 1 January 2002 and 30 June 2006, and who completed the study
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disorder and its inXuence on the quality of life, and to register the activities that were inhibited or altered by the presence of these symptoms [8]. This questionnaire was supplemented by another one (the Tinnitus Handicap Inventory [THI]) [12–14] composed of 25 questions with three possible answers and a Wnal numerical score that allowed us to assign each patient to the corresponding level of hardship caused by tinnitus (Wve grades in increasing order of gravity) [10]. Compilation of the previous questionnaires allowed us to classify the patients into JastreboV’s six categories, represented as follows: (0) tinnitus is a minimal problem; (1) tinnitus is an important problem, hypacusia is not a subjectively signiWcant problem; (2) tinnitus is an important problem, hypacusia is a subjectively signiWcant problem; (3) hyperacusia is an important problem with and without signiWcantly important tinnitus, hypacusia is irrelevant; (4) hyperacusia (H) with or without tinnitus (T) with prolonged accentuation after exposure to noises, hypacusia is irrelevant [8]. To quantify the tinnitus problem as “minimal” or “important” and thus assign the patient to the corresponding category, we arbitrarily introduced the criterion indicated below. Tinnitus was considered a “minimal” problem when it did not force the patient to suspend any activities and was accompanied by a THI of Grade 1. Tinnitus was considered an “important” problem when it caused the patient to suspend at least one activity or interfered with it, and was accompanied by a THI of more than Grade 1. With regard to hyperacusia and hypacusia, which could be assessed only with a questionnaire, the importance was established based on the criterion of the presence or absence of the disorder. After the questionnaires were Wlled out, an audiological assessment was conducted. The patients who were selected through this second level of evaluation were sent to therapy (TRT) following the procedures described by JastreboV, according to the criteria described below. Category 0: counselling session with information on the neurophysiological model, accompanied by instructions to avoid silence, information on daytime sound enrichment and a recommendation of a sound generator at night. Category 1: counselling session with information on the neurophysiological model, daytime and night sound enrichment and a recommendation of sound generators. Category 2: use of a hearing aid, the same counselling as in Category 1, but focusing on the characteristics of the hearing aid, sound enrichment with the hearing aid, and day and night sound generators. Category 3: counselling for hyperacusia, bilateral open-Wtting sound generators, and acoustic training with pleasant sounds at increasing intensities. Category 4: intensive counselling for hyperacusia (usually dominant), bilateral sound generators, starting at
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extremely low intensities and increasing very slowly, and acoustic training with pleasant sounds at increasing intensities [8]. The results were evaluated at intervals of 6 months (possible placebo eVect before 6 months) [8], 12 and 18 months; the therapeutic beneWt indexes were calculated by repeating the JastreboV questionnaire and the THI. Therapeutic beneWt was quantiWed in the Wrst 12 months based on conventional numerical parameters, indicating the results as “signiWcant improvement” (resumption of at least one previously suspended activity associated with a change in numerical values of at least 20% with respect to the initial values in at least two of the measured variables: loudness discomfort level, severity, awareness, eVect on quality of life), “unvaried symptoms” (some improvement reported, but very slow progress; the patients stop TRT and have relapses) and “worse symptoms” (the numerical values and the number of suspended activities increase) [8]. In our study, with regard to the 18-month checkup, we applied the criteria used to suspend treatment, deWning them as “success” or “failure” of the treatment [8]. We considered “success” to be a decrease of 2 or less of the score on the scale of symptoms, associated with a THI with Grade 1 and an awareness value of the presence of tinnitus of less than or equal to 10% of the patient’s wakefulness, with no inhibited activities. If these values were not achieved within this time frame, we considered the treatment to be a failure. The patients were monitored by evaluating the improvement of symptoms, but assessment of success or failure was based on the end parameters of the treatment.
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males), 32 as Category 1 (11 females and 21 males), 28 as Category 2 (11 females and 17 males), 10 as Category 3 (3 females and 7 males) and 1 female as Category 4H. None of the patients were classiWed as 4T (Fig. 1). Therapeutic success was observed at the end of 18 months, the term set for the duration of therapy, in 64 patients (79%); the other cases (17) were considered failures due to the fact that the necessary parameters, described above, were not achieved within the set time frame (Fig. 2). If we analyse the results based on the individual categories, we can see that the patients from Categories 0 and 4 achieved therapeutic success that was preceded by signiWcant improvement noted during regular checkups (Figs. 3, 4). One subject of the 32 in Category 1 and 1 subject from Category 3 did not achieve therapeutic success. However, treatment failure was observed in 15 of the 28 subjects from Category 2 (Fig. 3). While a comparison of the mean values of the initial indexes of the subjects who did not achieve therapeutic success with respect to the Wnal values revealed signiWcant improvement, this improvement did not meet the required parameters (Fig. 4). Analysis of the mean THI values (Fig. 5) shows that patients who did not achieve therapeutic success presented a more serious initial grade. In fact, while the subjects who achieved therapeutic success presented mean THI values comparable to Grade 2 (mild; easily masked by environmental sounds and easily forgotten with activities), those who did not achieve therapeutic success scored an average of Grade 3 (moderate; noticed in the presence of background noise, although daily activities can still be performed) [12]. The diVerence in magnitude compared to the initial mean THI values between successes and failures, i.e.
Results
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Of the 117 subjects who were candidates for treatment, 36 were excluded; 11 refused to undergo the recommended programme, saying they were sceptical of the method; 8 showed a regression of tinnitus following changes in the dosages of an association of drugs they were taking [e.g. alfuzosin (alpha blocker) + quinapril (ACE inhibitor) in one case] or after an initial interview; 10 had associated psychiatric problems (auditory hallucinations, etc.) or THI values (Grades 4 and 5) that led to such an assessment, and did not return for hearing treatment; 4 could not be re-contacted following the interview and initial assessments; 2 opted for alternative treatment (acupuncture, homeopathy); and 1 patient died during retraining treatment for other reasons. Of the 81 treated patients (50 males with a mean age of 52.1 § 11.6, minimum 34–maximum 75, and 30 females with a mean age of 46.6 § 15.2, minimum 26–maximum 77), 10 were classiWed as Category 0 (3 females and 7
30
patients successes instruments
N° patients
25 20 15 10 5
4 t. ca
t. 3 ca
2 t. ca
t. ca
ca
t.
0
1
0
categories Fig. 2 Distribution of the results at the end of treatment, based on category and willingness to use instruments (sound generators and hearing aids
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50 quality of life intensity discomfort awareness
8 7
40 35
6
30
5 4
25
3
20
2
15
1
10
0 start
6 months
12 months
18 months
Fig. 3 Parameters examined periodically in the 64 patients in whom Wnal therapeutic success was observed: a “signiWcant improvement” can be observed not only between the beginning and the end of treatment, but also from one checkup to the next 10
5 0 start
6 months
12 months
18 months
Fig. 5 Mean THI values in patients who did and did not achieve therapeutic success. The values are higher on a statistically signiWcant level and remain stable from the 6th to 18th month of treatment in patients who ultimately showed therapeutic failure
quality of life
9
Visual Analogue Scale
success failure
45
THI
Visual Analogue Scale
9
intensity
8
discomfort
7
awareness
6
Table 1 Statistical comparison (ANOVA test) between the numeric values prior to the start of treatment for the parameters considered in the subject who achieved therapeutic success with respect to failures
5
Quality of life: 3.15 § 2.52/7.87 § 1.6
P = 0.000
4
Intensity: 5.98 § 1.72/7.56 § 2.41
P = 0.033
3
Discomfort: 6.4 § 2.02/8.06 § 1.82
P = 0.038
2
Awareness: 68.02 § 31.8/84 § 29.2
P = 0.253
1
THI: 27.88 § 14.12/47.37 § 15.5
P = 0.001
0 start
6 months
12 months
18 months
Fig. 4 Parameters examined periodically in the 17 patients in whom Wnal therapeutic failure was observed: a “signiWcant improvement” is not seen from one checkup to the next
§1 standard deviation, seems statistically signiWcant, indicating that the patients who achieved Wnal success presented less serious initial symptoms (Fig. 5). Likewise, statistical comparison of the initial numerical values, attributed to the parameters used to monitor the patients from the two populations that were examined (successes and failures), shows a statistically signiWcant diVerence in the values of three of the four selected parameters. In fact, quality of life, intensity of tinnitus and subjective loudness discomfort level were more impaired in patients who did not achieve therapeutic success. The percentage of the awareness of tinnitus did not show statistically signiWcant diVerences between the two populations (Table 1). Lastly, analysis of treatment compliance in patients requiring counselling and hearing aids or sound generators (thus excluding Category 0) shows that 91.6% of the patients who underwent the advised treatment achieved therapeutic success, whereas the success rate amongst patients who used only counselling and ambient sound enrichment dropped to about 73%. Moreover, whereas the
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combination of counselling, daytime sound generators and sound enrichment at night had positive results in 100% of the patients, the use of hearing aids, combined with counselling and sound enrichment at night, was successful in only 80% of the cases (Figs. 6, 7).
Discussion and conclusions The overall results of our study prove the eVectiveness of TRT in the examined population (79%), a rate paralleling the data in the literature [3, 15], and it cannot be attributed to a placebo eVect, given the extended duration of treatment. We examined our results, leaving out the subjects from Category 0 (10 patients), all of whom achieved therapeutic success and who represent a category entailing a lower level of commitment because their symptoms were not as serious. Initial analysis showed that treatment success was achieved by 43 non-compliant patients (26 from Category 1, 9 from Category 2, 7 from Category 3 and 1 from Category 4) of the 59, who were supposed to use instruments, hearing aids and sound generators, associated with counselling and
Eur Arch Otorhinolaryngol (2010) 267:51–56 100
55
success failure
90 80
% patients
70 60 50 40 30 20 10 0 counseling sound enrichment sound generator
counseling sound enrichment hearing aid
counseling sound enrichment
counseling sound enrichment sound generator hearin aid
total 81 pts
Fig. 6 Percentage distribution of the results achieved based on compliance versus treatment in all categories examined (0–4) 100 success failures
90 80
% patients
70 60 50 40 30 20 10 0 counseling sound enrichment sound generator
counseling sound enrichment hearing aid
counseling sound enrichment
counseling sound enrichment sound generator hearing aid
total 81 pts (100%)
Fig. 7 Percentage distribution of the results achieved based on compliance versus treatment in all examined categories (1–4), excluding Category 0, which does not envisage the use of portable sound generators
ambient sound enrichment, in accordance with their category, and thus representing 72.8% of cases. Instead, of the 12 patients who complied correctly with the performed treatment (counselling, sound generators or hearing aids and ambient sound enrichment), 11 attained therapeutic success (91.6% of the cases). These seemingly predictable results conWrm the trend of the best treatment outcome in subjects who fully complete it; the subjects who used sound generators (seven patients from Categories 1, 3 and 4) attained therapeutic success in 100% of cases, whereas amongst the
Wve subjects from Category 2, hearing aids permitted favourable results in four (80%) of the hearing-impaired subjects who used them. The patients who did not agree to complete all the therapy were treated exclusively with counselling and ambient sound enrichment, and thus without the use of instruments. They pertain to all the categories, with the exception of Category 0, which does not envisage the use of instruments. The 16 therapeutic failures (27.1%) amongst the patients who partially completed the treatment are represented by two cases, patients from Categories 1 and 3, respectively, and 14 patients from Category 2. Therefore, in the face of a high percentage of overall success, it seems evident that Category 2 has a high failure rate, above all if the patients did not use hearing aids. This contributed negatively and signiWcantly to the Wnal result, so much so that if this category could be eliminated from the statistical calculation, the therapeutic success rate would be close to around 96%. To explain this, we must consider the unique clinical, diagnostic and therapeutic characteristics of Category 2. The basic element that distinguishes this category from the others is the presence of subjectively important hypacusia. The study of liminar tonal audiometry exams in the hearing-impaired subjects from Category 2, who beneWted from therapy, shows a mean hearing loss that was lower than that of those who did not beneWt from treatment. The mean audiometric curves of the subjects who did not attain therapeutic success show greater hearing loss than the subjects who attained success. Nevertheless, a statistical comparison between the two mean hearing loss values, conducted with one-way ANOVA, did not show any signiWcant diVerences. In order to achieve good treatment results, it is fundamental to reduce the signal-to-noise ratio, in which “signal” is intended as tinnitus. Re-establishing the hearing-impaired subject’s auditory acuity to levels that approach the norm as closely as possible should create the acoustic conditions needed to maximise ambient sound therapy and reduce the subjective intensity of tinnitus, raising the background noise and decreasing central auditory gain so that, by reducing the absolute and relative intensity of tinnitus, habituation can occur. In normally hearing subjects, the signal-to-noise ratio is modiWed by increasing the intensity of the latter. In hearing-impaired subjects the reduced intensity of tinnitus is more easily achieved by improving auditory acuity using a hearing aid, rather than by increasing background noise. This is because the intensity of the background noise needed to reduce the intensity of tinnitus is hard to achieve without using hearing aids. Nevertheless, patients were sceptical towards acquiring sound generators and hearing aids, and most refused to do so. In fact, only about 16% of the subjects (7 of 43) from Categories 1, 3 and 4 agreed to use the broadband sound
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generators that are indicated for such cases. Likewise, only 17% of the patients from Category 5 (5 out of 28) agreed to use hearing aids, despite that all of them considered their hearing deWcit to be somewhat serious (subjectively important). The refusal to use therapeutic instruments led to unexpected consequences in the Wnal results, allowing us to theorise that the equipment played two diVerent roles. While directive counselling, associated with ambient sound enrichment during the day and at night, seemed to yield excellent results in normally hearing subjects, even without the use of a portable sound generator, it seemed that it could not do the same thing in subjects who needed hearing aids. As a demonstration of the non-binding eVect of the use of sound generators on treatment, we can also cite the important therapeutic success achieved in Category 3, in which only two of ten subjects used the sound generator. Furthermore, the only subject from Category 4 refused to use the sound generator, but attained therapeutic success, which was also achieved in all the subjects from Category 0 for whom no equipment was envisaged. Given the small number of patients in certain categories and the fact that there was only partial compliance in many cases, we could not draw deWnitive conclusions. Nevertheless, we feel that signiWcant information worthy of further study has emerged. In particular, the numerical values of the scales of initial symptoms seem to be predictive of the Wnal outcome of treatment, as a more serious initial clinical picture corresponds to a lower probability of therapeutic success. The only value amongst those selected that does not seem predictive of the outcome of therapy is represented by the daily duration of the awareness of tinnitus. In fact, both the patients destined for therapeutic success as well as those destined for failure reported that they perceived tinnitus to an equal extent. On the whole, the failure to use instruments only partially inXuenced the results of our case study, which reXect those reported in the literature. This is probably due to the eVectiveness of counselling and ambient sound enrichment, which somehow managed to compensate for the failure to use portable instruments, particularly amongst patients with normal hearing. In our experience, Category 2 had the highest failure rate, due probably to the rarity of Category 4 (only one recorded case), which would usually have been more diYcult to treat. The higher number of failures in this category was probably due not only to the greater diYculty in reducing the relative intensity of tinnitus, but also to greater diYculty in conducting appropriate counselling. Indeed, while it is true that habituation stems from the conviction that a given symptom is not correlatable with a given disease, the diYculty in convincing a patient with subjectively important deafness that tinnitus has developed independently of this disorder is equally evident.
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The results derived from the review of our cases have nevertheless inXuenced our behaviour towards patients for whom rehabilitation treatment is proposed. We accept patients without hypacusia who refuse to use portable sound generators, informing them that treatment might last longer and that there are cases of failure. But, we no longer agree to treat hearingdeWcient patients with signiWcant hypacusia who refuse to use a hearing aid, as, based on our experience, we are convinced that in such cases TRT is indispensable. ConXict of interest statement The authors declare that they have no conXict of interest with any Wnancial support or any commercial source that may, directly or indirectly, interfere with the results reported in the present article.
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