Melzer Jörg, Brignoli Reto, Keck Martin E, Saller Reinhard
Dept. of Internal Medicine, Institute of Complementary Medicine, University Hospital Zurich, Zurich, Switzerland.
Forsch Komplementmed. 2010 Mar;17(1):7-14. doi: 10.1159/000277628. Epub 2010 Feb 4.
Extracts of Hypericum perforatum have demonstrated in randomized trials (RCTs) to be effective in mild to moderate depressive episodes. However, as their use in daily practice may differ from that in RCTs we have conducted a study to achieve a better estimate of the range and frequency of adverse drug reactions (ADR) and the efficacy.
In an observational study in Germany, adult outpatients with depressive syndrome were treated with an extract of St. John's Wort. Study duration was 12 weeks, with control visits every 4 weeks. Besides anamnestic data, the variables assessed were: evolution of ICD-10 derived symptom score, Global Clinical Impression scale (GCI), and tolerability.
1,778 patients from 304 centers participated in the study (mean duration of disorder 7.3 +/- 18.9 months), and 1,541 patients completed it. At the last control visit the ICD-10 sum score had dropped by 63.1% and the proportion of patients described as 'normal to mildly ill' (GCI-s) had increased from 21.6% at admission to 72.4%. Regarding the GCI-i, 77% of the patients had improved 'very much' or 'much' at the last visit. This was consistent with their self-assessment (76%). Lower age and shorter duration of the disorder were associated with significantly better outcomes. The incidence of ADRs was 3.54% and had been decreasing continuously from the first control visit onwards; serious ADRs did not occur.
The herbal drug was well tolerated, and no new or serious ADR were identified. In view of the limitations inherent to the study design, it can be concluded that extracts of St. John's Wort are effective as an antidepressant in the management of depression in daily practice.
随机试验（RCTs）已证明贯叶连翘提取物对轻至中度抑郁发作有效。然而，由于其在日常实践中的使用情况可能与随机试验不同，我们开展了一项研究，以更好地评估药物不良反应（ADR）的范围和频率以及疗效。
在德国进行的一项观察性研究中，成年门诊抑郁综合征患者接受圣约翰草提取物治疗。研究持续时间为12周，每4周进行一次对照访视。除既往病史数据外，评估的变量包括：国际疾病分类第10版（ICD - 10）衍生症状评分的变化、整体临床印象量表（GCI）以及耐受性。
来自304个中心的1778名患者参与了该研究（疾病平均持续时间为7.3±18.9个月），1541名患者完成了研究。在最后一次对照访视时，ICD - 10总分下降了63.1%，被描述为“正常至轻度患病”（GCI - s）的患者比例从入院时的21.6%增至72.4%。关于GCI - i，77%的患者在最后一次访视时“非常显著”或“显著”改善。这与他们的自我评估结果（76%）一致。年龄较小和疾病持续时间较短与显著更好的结果相关。药物不良反应的发生率为3.54%，从第一次对照访视起持续下降；未发生严重药物不良反应。
该草药耐受性良好，未发现新的或严重的药物不良反应。鉴于研究设计固有的局限性，可以得出结论，在日常实践中，圣约翰草提取物作为抗抑郁药对抑郁症的治疗有效。
