Therapeutische Äquivalenz eines hochdosierten Phytopharmakons mit Amitriptylin bei ängstlich-depressiven Verstimmungen-Reanalyse einer randomisierten Studie unter besonderer Beachtung biometrischer und klinischer Aspekte

Author(s): Rahlfs, V.

Journal/Book: Forschende Komplementärmedizin. 1995; 2: 123-132.

Abstract: Objective: Examination of the antidepressive/anxiolytic efficacy of a combination of Valerian root and St.-John's-wort extract compared to amitriptyline. Proof of therapeutic equivalence by recently developed statistical tests of equivalence; descriptive analysis of depressive principal and additional symptoms.Design: Randomized, controlled double-blind study over 6 weeks.Patients: 153 outpatients between 20 and 65 years diagnosed with dysthymia, short or longer lasting depressive reactions, neurasthenia or neurotic depression.Intervention: Patients were treated either with 150-300 mg Valerian root/St.-John's-wort concentrate (BJK) 3 times daily (equivalent to 0.45-0.9 mg total hypericin) or with 25-50 mg amitriptyline 3 times daily in capsules.Main Outcome Measures: Hamilton depression scale (HAMD), a general well being scale (Bf-S) and a self rating scale for depression (SDS).Results: 147 patients completed the study with 82% treatment responders in the phytomedicine group and 77% responders in the amitriptyline group. The initial total Hamilton depression score was reduced from 24.2 to 8.4 after 6 weeks with ´Sedariston®-Konzentrat' and from 24.3 to 8.9 after amitriptyline. With the Mann-Whitney statistic as an effect size measure, equivalence could be derived an the 5% level for all 3 main outcome measures as well as for the pooled criteria (95% confidence interval, one-sided, lower boundary: 0.46; combined directional test). The improvement of symptoms in the phytomedicine group showed a highly parallel pattern compared to the amitriptyline group.Conclusion: The equivalence of the phytocombination medicine from Valerian root and St.-John's-wort is providing strong evidence for the usefulness of standardized phytomedicines in the treatment of patients with depressive mood disorders. This applies particularly in terms of tolerability profile which is much in favor of the phytocombination and therefore results in a good patient compliance.

Keyword(s): Klinische Studie

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