bination is composed of standardised extracts from valerian root, hops strobiles and passionflower herb. Due to the known tolerability problems of BZDs, the ...
Can a triple herbal combination be an effective alternative to benzodiazepines? Isabelle Hörner1, Christiane Staiger1, Tankred Wegener2, Marion Tschaikin1 1 Merck Selbstmedikation GmbH, Darmstadt, Germany · 2Consulting HMP, Weinheim, Germany
Method:
In a prospective, multicenter observational cohort study the safety and tolerability of Kytta-Sedativum® Dragees in patients with non-organic sleep disorders were recorded. Throughout an observational period of about six weeks, five physicians collected the data of a total of 107 patients during the screening, intermediate and final visits. During a phase of BZD withdrawal (approx. 2 weeks), followed by therapy with Kytta-Sedativum® Dragees (for another approx. 4 weeks) clinical findings comprised the symptoms “general unrest”, “concentration disorders”, “depressiveness”, “pronounced tiredness” and “impaired general state of well-being” were assessed by means of a fivegrade scale. The patients judged their well-being regarding quality of sleep and day-time well-being. The observational cohort study was performed pursuant to § 67 (6) of the German Drug Law (AMG) and conformed with the recommendations for observational studies issued by the Federal Institute for Drugs and Medical Devices (BfArM), the German Society for Phytotherapy (GPHY) and the Association of Research-Based Pharmaceutical Companies (VFA). Prior to the start of the observational cohort study, the underlying methods and intended performance received a positive opinion by the Ethics Committee Münster. Furthermore, there is written documentation of the patients’ information and consent.
Tab.1: Clinical findings documented by the physicians (mean values) (scale 1 =”non/not“ to 5 =”strong”)
Fig. 1: Patients‘ judgement 4,0
. screening examination . intermediate examination . final examination
no. of patients with symptom
mean mean symptomasymptomatology tology (screening (intermediate examination) examination)
value
2,5 2,0
general unrest
105
3,4
2,8 (25%)
2,1 (53%)
concentration disorders
90
2,9
2,4 (28%)
2,1 (42%)
depressiveness
74
3,6
3,0 (24%)
2,4 (47%)
103
3,2
2,6 (27%)
1,8 (66%)
96
2,9
2,4 (27%)
1,9 (52%)
1,5
pronounced tiredness
1,0
impaired general state of health
even sleep
relaxed sleep
Fig. 1a: Symptoms relating to sleep quality (scale 5 = never to 1 = very often) 100
. intermediate examination . final examination
80
60
40
20
0
balanced
motivated/fresh
start-up time
Fig. 1b: Improvement of symptoms relating to day-time well-being (in the morning) 4,0
mean symptomatology (final examination)
(% improvement vs. screening visit)
3,0
53.4%) as documented by the physicians (Tab. 1). The parameter sleep quality inquired from the patients changed only sligthly (5.2%) during the first two weeks. Marked improvement (by 31.4%) was seen only after subsequent single-agent therapy with Kytta-Sedativum® Dragees (Fig. 1a). 67.9% of the patients felt that their sleep quality had improved by the end of treatment (compared to the screening visit). The “start-up” time in the morning until feeling wide awake and full of energy shortened (Fig. 1b). The overall judgement regarding efficacy of the triple herbal combination was documented as “good” to “very good” by 80.4% of the physicians. Patients’ judgement of “good” to “very good” was slightly lower at 74.5%. No ADR occurred in any patient. The physicians and patients rated the tolerability in more than 96% as “very good“ or “good” (Fig. 2).
. screening examination . intermediate examination . final examination
Conclusion:
3,0
2,0
1,0
0,0
depressive
unbalanced
restless/nervous
Fig. 1c: Symptoms relating to day-time well-being (during the day), (scale 5 = strong to 1 = non/not)
Physicians‘ judgement
Patients‘ judgement
0,9% 5,6%
93,5%
Results:
At all examination visits, all clinical symptoms presented marked improvement over the initial findings. Particular improvement was recognisable for the clinical symptoms ”pronounced tiredness“ (by 65.8%) and “general unrest“ (by
symptom
3,5
Improvement of symptoms %
Benzodiazepines (BZD) are frequently prescribed hypnotics, but under long-term therapy against sleep disorders patients may be affected by adverse reactions such as day-time tiredness, dizziness and muscle weakness (with resultant risk of falls) as well as reduced memory performance and unempathy. The regular intake of BZD may also lead to the development of tolerance and dependency. Abrupt discontinuation of intake may cause rebound phaenomena. BZDs should therefore be gradually tapered in a controlled manner under medical supervision. During and after BZD withdrawal it may be helpful to offer patients an effective and well tolerated alternative. Observational cohort studies carried out with the phytopharmaceutical drug Kytta-Sedativum® Dragees (by Merck Selbstmedikation GmbH) have shown that symptoms such as general unrest and nervousness were markedly attenuated and quality of sleep clearly improved. The triple herbal combination is composed of standardised extracts from valerian root, hops strobiles and passionflower herb. Due to the known tolerability problems of BZDs, the presented study investigated under everyday conditions whether KyttaSedativum® Dragees is an effective alternative to BZD.
value
Aim:
. very good . good . satisfactory
Fig. 2: Tolerability
3,8% 10,4%
85,8%
The presented observational cohort study once more confirmed the positive benefit-risk-ratio of Kytta-Sedativum® Dragees. The study demonstrated that patients under BZD withdrawal benefited from accompanying and subsequent therapy with the triple herbal combination (valerian root, hops strobiles, passionflower herb). In summary, all symptoms improved during the observation phase. Some symptoms regarding sleep quality showed only slight improvement during the first two weeks of treatment (equivalent to BZD withdrawal phase), but improved markedly after BZD withdrawal under single-agent therapy with Kytta-Sedativum® Dragees. This delayed improvement can be explained on the grounds of BZD withdrawal and its associated problems. The symptoms relating to day-time well-being demonstrated continuous improvement. Regarding the problems of dependency and tolerability of BZDs, the presented observations indicate that Kytta-Sedativum® Dragees is an effective alternative.
References:
Wähling C, Wegener T, Tschaikin M. Pflanzliche 3er-Kombination: Wirksame Alternative zu Benzodiazepinen. Z Phytother 2009; 30: 69-72
