Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2004; 9: 18–9
To establish the equivalent clinical efficacy of Hypericum perforatum extract WS 5570 and paroxetine.
In a double-blind, randomised, 6-week trial in outpatients with moderate or severe depression (DSM-IV; 17-item HAMD total ≥ 22) the non-inferiority of H. perforatum extract WS 5570 to paroxetine was investigated. An adaptive interim analysis included 101 adults who received 900 mg/day WS 5570 (n = 50) or 20 mg/day paroxetine (n = 51). After 2 weeks the dose of patients with insufficient response was increased to 1800 mg/day WS 5570 (n = 38) or 40 mg/day paroxetine (n = 21).
The average HAMD total score (primary outcome measure) decreased from 25.1 ± 2.2 to 12.7 ± 9.1 for WS 5570 and from 25.3 ± 2.6 to 13.0 ± 8.3 for paroxetine. The mean treatment group difference was 0.0 (95% CI: –3.7 to 3.6; P = 0.084 for test for non-inferiority). Sixty per cent of the patients randomised to WS 5570 and 63.3% treated with paroxetine showed HAMD total score reductions ≥ 50% (P = 0.74). Remission (HAMD endpoint total score < 10) occurred in 46.6% of patients for WS 5570 and in 42.9% for paroxetine (P = 0.91). There were 0.039 adverse events per day of exposure for WS 5570 and 0.056 for paroxetine.
The results of the interim analysis indicate that in patients with moderate to severe depression, the anti-depressant effect of WS 5570 is comparable to that of paroxetine after 6 weeks of acute treatment.
