Musselmann B, Rychlik R, Burkart M
Abteilung Allgemeinmedizin und Versorgungsforschung, Universitätsklinikum Heidelberg.
MMW Fortschr Med. 2011 Dec 15;153 Suppl 4:119-27.
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.
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.
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.
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.
在德国，轻度至中度抑郁症常由全科医生治疗，且常用圣约翰草制剂。相比之下，对照临床试验通常在精神科专科中心或医院进行。
在这项单臂、前瞻性非干预性研究中，408名全科医生记录了1300例轻度或中度抑郁症患者，这些患者每日服用一次600毫克圣约翰草提取物WS 5570。观察期为8至10周。对WS 5570的治疗效果和耐受性进行了研究。此外，还询问了医生他们在抑郁症治疗和补充医学方面的经验和态度、使用圣约翰草的原因及其对治疗成功的贡献。
符合方案纳入分析的807例患者中，成功治疗率（汉密尔顿17项抑郁量表[HAMD]降低>50%）分别为79.3%，缓解率为68.4%。6例患者（0.46%）因药物不良反应退出。为了与一项早期对照临床研究（WS 5570 600毫克/天与1200毫克/天与安慰剂对比）的结果进行比较，该研究主要由医学专家进行，对符合对照研究纳入标准的257例患者进行了分析。入组时的HAMD评分（22.9）以及2周（-6.6）和6周（-10.8）后的改善情况与对照临床试验报告的非常相似。408名医生完成了202份可评估问卷。医生认为自愈和安慰剂效应是重要的治疗因素；然而，在75%的病例中，他们将至少50%的治疗成功归因于圣约翰草制剂，19%的病例认为这是病情改善的唯一原因。
全科医生认为圣约翰草提取物WS 5570耐受性良好，对总治疗效果的贡献超过50%。由于本研究的非干预设计，无法得出关于WS 5570疗效的因果结论。初级保健中轻度至中度抑郁症的治疗效果与专科对照临床研究的结果相当。
