Wähling C, Wegener T, Tschaikin M. Triple herbal combination: An effective alternative to benzodiazepines.Zeitschrift fur Phytotherapie. 2009;30:69-72.

Benzodiazepines are prescribed as a sedative or tranquilizer. Chronic use leads to dependency and tolerance. When benzodiazepines are discontinued, the dose should be tapered down to avoid rebound (or withdrawal) phenomena (return of symptoms that are more severe than the original symptoms).

Herbs that help with sleep are popular to take during the benzodiazepine withdrawal phase. Kytta-Sedativum_®Dragees (Merck Selbstmedikation GmbH; Darmstadt, Germany) is a triple herbal combination composed of standardized extracts from valerian (Valeriana officinalis, Valerianaceae; 3-6:1, extractant: ethanol 70% v/v) root, hops (Humulus lupulus, Cannabaceae; 4-8:1, extractant: ethanol 40% v/v) strobiles, and passionflower (Passiflora incarnata, Passifloraceae; 4-7:1, extractant: ethanol 50% v/v) whole herb. The purpose of this study was to assess the safety, tolerability, and efficacy of Kytta-Sedativum Dragees (sugar coated tablet) during and after benzodiazepine withdrawal.

Patients (59 women, 48 men; ages 19-80 years) with moderate sleep disorders on average (not associated with mental or neurologic disorders) who needed to discontinue benzodiazepine use participated in this prospective, multicenter, observational study. The study was planned and conducted according to the regulations of the German Drug law for such studies and followed recommendations of recognized societies, e.g., the German Society of Phytotherapy.

A 2-week withdrawal phase was followed by a 4-week phase of treatment with Kytta-Sedativum tablets. During the 2-week withdrawal period the benzodiazepine dose was tapered-down. Kytta-Sedativum was prescribed to 86% of the patients starting at the beginning of the withdrawal period; 97% of the patients were taking Kytta-Sedativum during the second week, and 100% of the patients took it from the third week. In the majority of cases, 1 coated tablet per day was prescribed in the first week, and 2 coated tablets from the second week until week 6. Physicians and patients rated their symptoms.

The mean duration of benzodiazepine treatment had been 6.8 months. Benzodiazepine therapy was switched for 1 or more reasons: in 89% of cases on the physician’s recommendation, in 51% upon the patient’s request, and in 70% due to poor tolerability. After 2 and 6 weeks, all clinical symptoms improved from the screening visit. At 6 weeks, general unrest had improved in 71% of patients, concentration disorders had improved in 51% of patients, “depressive symptoms” had improved in 51% of patients, and impaired general state of health had improved in 71% of patients. Most of the patients (96%) rated tolerability as “very good” or “good,” compared to 99% as rated by physicians. The number of patients suffering from difficulty in falling asleep increased during the withdrawal phase from 66% to 79%, but decreased again to 49% after single-agent treatment with Kytta-Sedativum. Compared with the screening visit, 68% of the patients thought that their sleep quality improved by the end of the 6-week treatment with Kytta-Sedativum. At the end of the observation period, 74% of patients indicated having more motivation and drive than at the beginning. Day-time tiredness also improved; 83% of patients were affected by this at the screening visit, 56% were affected after withdrawal, and only 27% were affected after 6-weeks of treatment. Eighty percent of the physicians judged Kytta-Sedativum to be “good” or “very good,” and 74% of the patients judged it to be “good” or “very good.” At the end of the study, 64% of the patients said that they would continue therapy with Kytta-Sedativum, while 34% improved sufficiently to discontinue therapy.

The authors state that the “study once more confirmed the positive benefit-risk-ratio” of the herbal combination. Furthermore, they considered it a success that one-third of the patients terminated Kytta-Sedativum therapy at the time of the final visit due to improvement of their symptoms, while the vast majority of the rest continued with it.

The authors’ overall conclusion was: “Regarding the problems of dependency and tolerability of benzodiazepines, the presented observations indicate that Kytta-Sedativum Dragees is an effective alternative.”

The limitations of an open study should be taken into consideration when making definitive conclusions. As the study was observational and not blinded or placebo-controlled, it cannot be considered as a proof of efficacy in such a clinical situation according to the standards of evidence-based medicine. However, the benefits of this trial can be viewed as a reflection of the daily reality in prescribing practice. Such daily practice is difficult to replicate in a controlled clinical trial. Further, it may be constructive to compare results of this trial with those of others, although one of the study’s authors has indicted that, to his knowledge, such studies are not yet available. Although this trial shows patient improvement, there is no way to know to what extent the benefit was an herbal effect, a placebo effect, and/or a further natural reduction of withdrawal symptoms. Due to the overall good tolerability and lack of adverse events, more rigorous studies should be performed to provide greater evidence of Kytta-Sedativum’s ability to replace or reduce daily dosages of benzodiazepines.

—Heather S. Oliff, PhD

HerbalGram. 2010;85:26-27 American Botanical Council