Efficacy and Tolerability of Hypericum Extract STW3 in Long-term Treatment with a Once-daily Dosage in Comparison with Sertraline

• DOI: 10.1055/s-2005-837807
• Publication Date: 2005-03-02T15:38:08Z
• Authors: M. Gastpar; A. Singer; K. Zeller
• Keywords: Sertraline; Hypericum; Tolerability

Objective: The objective of this double-blind, multi-center clinical study was to demonstrate the non-inferiority hypericum extract versus sertraline in treatment moderate depression. Methods: A total 241 patients with a diagnosis depressive disorder (according ICD-10 criteria) were randomized either 50 mg or 612 (hypericum group n = 123; 118). According protocol, 200 treated for at least 12 weeks (n 102 extract; 98 sertraline); 81 and 80 after week an additional weeks. Thus, most period 6 months. primary efficacy variable 17-item HAMD score end first 12-week double-blind period. Results: After period, decreased from almost identical initial values (22.0 ± 1.1 22.1 points sertraline) 8.3 5.5 (hypericum) 8.1 5.6 (sertraline) (mean SD) per-protocol (PP) population. statistical test (boundary δ 3) revealed that is not inferior (P < 0.0001). mean difference between treatments 0.1995 points, corresponding one-sided 97.5 % confidence interval (-∞, 1.3772). In who continued follow-up phase, 5.7 4.8 group) 7.1 6.3 (sertraline group). Comparable improvement also found von Zerssen's Adjective Mood Scale (BfS) CGI during second both groups. With 68.6 70.4 group, percentage rated as responders did differ significantly groups (12 weeks). adverse events (9.8 %) 16 (13.6 possibly related medication. No basic differences observed no interaction concomitant medication documented. cases, investigators assessed tolerability "good" "very good." Conclusions: results indicate STW 3 it well-tolerated drug These favorable effects achieved once-daily dose given up 24