Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2005; 10: 28
We investigated the efficacy of Hypericum perforatum extract WS 5570 in relapse prevention during continuation treatment following recovery from a recurrent episode of unipolar depression.
A randomised, placebo-controlled multicentre trial was performed in adult outpatients with a recurrent episode of mild or moderate major depression (ICD-10 F33.0, F33.1; DSM-IV 296.3), Hamilton Depression Rating Scale (HAM-D) total score (17 item version) ≥20 and ≥3, previous episodes in the past 5 years. After 6 weeks of single-blind treatment with 3 × 300mg/day WS 5570 patients with a score ≤2 on item ‘Improvement’ of the Clinical Global Impressions (CGI) scale and a HAM-D total score decrease ≥ 50% vs. baseline were randomised to 3 × 300mg/day WS 5570 or placebo for 26 weeks double-blind. The primary outcome measure was the time to relapse during continuation treatment (HAM-D ≥ 16, clinical diagnosis of depression or premature treatment termination for inefficacy). Secondary measures included the CGI and the Beck Depression Inventory (BDI).
Of the 703 patients included 570 responded to acute treatment and were randomised; 426 were evaluated according to ITT. Relapse rates were 51/282 (18.1%) for WS 5570 and 37/144 (25.7%) for placebo. Average time to relapse was 177 ± 2.8 and 163 ± 4.4 days for WS 5570 and placebo, respectively (P = 0.07). Patients treated with WS 5570 showed more favourable HAM-D and BDI time courses and greater overall improvement (CGI) than those randomised to placebo. During continuation treatment 176/376 patients in the WS 5570 group (46.8%) and 97/194 (50.0%) in the placebo group reported adverse events (0.005 and 0.006 events/day exposed). In both groups less than 5% of the patients had attributable adverse effects.
Hypericum extract WS 5570 showed a beneficial effect in preventing relapse after recovery from acute depression. Tolerability in maintenance treatment was excellent.
The trial was funded by Dr Willmar Schwabe Pharmaceuticals, manufacturer of Hypericum perforatum extract WS 5570.
