Effect of Hypericum perforatum (St John's wort) in major depressive disorder -: A randomized controlled trial
Effect of Hypericum perforatum (St John's wort) in major depressive disorder -: A randomized controlled trial
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DOI：
10.1001/jama.287.14.1807
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发表时间：
2002-04-10
影响因子：
120.7
通讯作者：
Weisler, RH
中科院分区：
文献类型：
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作者：
Davidson, JRT;Gadde, KM;Weisler, RH
贯叶连翘提取物（圣约翰草）被广泛用于治疗不同严重程度的抑郁症。然而，它们在重度抑郁症中的疗效尚未得到最终证实。目的测试一种特征良好的穿孔草提取物（L1-160）在重度抑郁症中的疗效和安全性。安慰剂对照试验在美国12个学术和社区精神病研究诊所进行。参与者成人门诊患者（n=340）在1998年12月至2000年6月期间招募的患者，患有重度抑郁症，并且汉密尔顿抑郁量表（HAM-D）的基线总分至少为20分。干预患者被随机分配接受穿孔素、安慰剂或舍曲林（作为活性对照）治疗8周。根据临床反应，穿孔素的日剂量范围为900 - 1500 mg，舍曲林的日剂量范围为50 - 100 mg。第8周的应答者可以继续盲法治疗另外18 weeks.Main Outcome Measures在HAM-D总分从基线到8周的变化;完全应答率，由HAM-D和临床总体无症状性（CGI）scores.Results确定的2个主要结局指标，舍曲林和H perforatum与安慰剂无显著差异。HAM-D总分从基线至第8周的平均（SE）变化的随机回归参数估计值（下降幅度越大，表明改善越多）为-9.20（0.67）（95%置信区间[CI]，-10.51至-7.89），安慰剂vs -8.68（0.68）（95%CI，-10.01至-7.35）（P=.59），舍曲林为-10.53（0.72）（95%CI，-11.94至-9.12）（P=.18）。31.9%的安慰剂治疗患者出现完全缓解，23.9%的H穿孔治疗患者（P= 0.21）和24.8%的舍曲林治疗患者（P= 0.26）出现完全缓解。舍曲林在CGI改善量表上优于安慰剂（P= 0.02），这是本研究的次要指标。Hperforatum和舍曲林的副作用曲线与安慰剂不同。结论本研究不支持Hperforatum治疗中重度抑郁症的疗效。该结果可能是由于试验的检测灵敏度较低，但值得注意的是，完全没有提示穿孔血吸虫有效性的趋势。
Context Extracts of Hypericum perforatum (St John's wort) are widely used for the treatment of depression of varying severity. Their efficacy in major depressive disorder, however, has not been conclusively demonstrated.Objective To test the efficacy and safety of a well-characterized H perforatum extract (L1-160) in major depressive disorder.Design and Setting Double-blind, randomized, placebo-controlled trial conducted in 12 academic and community psychiatric research clinics in the United States.Participants Adult outpatients (n=340) recruited between December 1998 and June 2000 with major depression and a baseline total score on the Hamilton Depression Scale (HAM-D) of at least 20.Interventions Patients were randomly assigned to receive H perforatum, placebo, or sertraline (as an active comparator) for 8 weeks. Based on clinical response, the daily dose of H perforatum could range from 900 to 1500 mg and that of sertraline from 50 to 100 mg. Responders at week 8 could continue blinded treatment for another 18 weeks.Main Outcome Measures Change in the HAM-D total score from baseline to 8 weeks; rates of full response, determined by the HAM-D and Clinical Global Impressions (CGI) scores.Results On the 2 primary outcome measures, neither sertraline nor H perforatum was significantly different from placebo. The random regression parameter estimate for mean (SE) change in HAM-D total score from baseline to week 8 (with a greater decline indicating more improvement) was-9.20 (0.67) (95% confidence interval [CI], -10.51 to -7.89) for placebo vs -8.68 (0.68) (95% CI, -10.01 to -7.35) for H perforatum (P=.59) and -10.53 (0.72) (95% CI, -11.94 to -9.12) for sertraline (P=.18). Full response occurred in 31.9% of the placebo-treated patients vs 23.9% of the H perforatum-treated patients (P=.21) and 24.8% of sertraline-treated patients (P=.26). Sertraline was better than placebo on the CGI improvement scale (P=.02), which was a secondary measure in this study. Adverse-effect profiles for H perforatum and sertraline differed relative to placebo.Conclusion This study fails to support the efficacy of H perforatum in moderately severe major depression. The result may be due to low assay sensitivity of the trial, but the complete absence of trends suggestive of efficacy for H perforatum is noteworthy.