RESUMEN
BACKGROUND: Mild to moderate depression is frequently treated by general practitioners in Germany, quite often with St. John's Wort preparations. In contrast, controlled clinical trials were usually performed in psychiatric specialist centers or hospitals. METHODS: In this one-armed, prospective non-interventional study 408 general practitioners documented 1300 patients with mild or moderate depression, which received 600 mg St. John's Wort extract WS 5570 once daily. The observation period was 8 to 10 weeks. Therapeuticeffectand tolerabilityof WS 5570 were investigated. Additionally, doctors were asked for their experienceswith and attitudes to depression therapy and complementary medicine, reasons for administration of St. Johns Wort and its contribution totreatmentsuccess. RESULTS: 807 patients, who were included in the analysis corresponding to the protocol, had rates for successful treatment (> 50% decrease of the Hamilton 17-item depression scale [HAMD]) 79,3%, respectively for remission 68,4%. Six patients (0.46%) dropped out for adverse drug reactions. For comparison with the results of an earlier controlled clinical study (WS 5570 600 mg/d vs. 1200 mg/d vs. placebo), which was conducted mainly by medical specialists, 257 patients complying with the inclusion criteria of the controlled study were analysed. HAMD-scores at entry (22.9) and improvement after 2 (-6.6) and 6 weeks (-10.8) were very similar to those reported in the controlled clinical trial. 202 evaluable questionnaires completed by 408 doctors were available. Doctors regarded self-healing and placebo effects as important therapeuticfactors; however, in 75% of the cases they assigned at least 50% of treatment success to the St. John's Wort preparation, and in 19% it was regarded as the only reason for improvement. CONCLUSIONS: General practitioners consider St. John's Wort extract WS 5570 a well tolerable therapeutic instrument contributing more than 50% to total treatment effect. Causal conclusions to the efficacy of WS 5570 cannot be drawn in this study because of the non-interventional design. Efficacy of treatment of mild to moderate depression in primary care is comparable to findings in specialist-based controlled clinical studies.
