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Treatment of Somatoform Disorders With St. John’s Wort: A Randomized, Double-Blind and Placebo-Controlled Trial

From the Department of Neurology, Ruhr-University Bochum, Germany (T.M.); Ad libitum Medical Services, Berlin, Germany (M.M.); Lichtwer Pharma GmbH, Berlin, Germany (H.M.); and idv – Datenanalyse und Versuchsplanung, Gauting, Germany (V.W.R).

View larger version (52K): [in a new window]   Figure 1. Flow diagram of subject progress through the trial and allocation to analysis populations. Primary efficacy analysis was performed with the ITT population, comprising all patients randomized with at least baseline efficacy ratings. A supportive efficacy analysis was carried out with the PP population, consisting of all patients lacking major protocol violations and with a compliance rate 80%.

View larger version (36K): [in a new window]   Figure 2. Somatoform Disorders Screening Questionnaire - 7 days (SOMS-7), Hamilton Anxiety Scale, somatic subfactor (HAMA-SOM), and Symptom Check List 90 Revised, somatic subfactor (SCL-90-R-SOM) rating scores by week and treatment (ITT population, LVCF). Bars represent means ± standard deviation.

View larger version (39K): [in a new window]   Figure 3. Patients’ global judgments of efficacy prove superiority of SJW over placebo (ITT population, LVCF; p = .0001, one-sided Wilcoxon Mann-Whitney test). Bars show groupwise percentages of ratings.