Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.
Rhodiola rosea versus sertraline for major depressive disorder: A randomized placebo-controlled trial.
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DOI：
10.1016/j.phymed.2015.01.010
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发表时间：
2015-03-15
期刊：
影响因子：
7.9
通讯作者：
Amsterdam, Jay D.
中科院分区：
文献类型：
--
作者：
Mao, Jun J.;Xie, Sharon X.;Zee, Jarcy;Soeller, Irene;Li, Qing S.;Rockwell, Kenneth;Amsterdam, Jay D.
关键词：
我们进行了一项概念验证试验，以评估红景天与舍曲林治疗轻中度抑郁症的相对安全性和有效性。我们假设罗斯罗西具有与舍曲林相似的治疗效果，但不良反应较少。第二阶段随机安慰剂对照临床试验57名受试者被随机分成三组，分别服用标准玫瑰花提取物、舍曲林或安慰剂12周。使用混合效应模型检验不同组间汉密尔顿抑郁量表(HAM-D)、贝克抑郁量表(BDI)和临床总体印象改变(CGI/C)评分随时间的变化。在所有治疗条件下，Ham-D、BDI和CGI/C评分都有轻微的下降，但在统计学上没有显著差异(分别为p=0.79、p=0.28和p=0.17)。舍曲林(−8.2，95%可信区间[CI]，−12.7至−3.6)与罗西(−5.1，95%CI：−8.8至−1.3)和安慰剂(−4.6，95%CI：−8.6至−0.6)相比，HAM-D得分的下降幅度更大。尽管舍曲林改善的几率(与安慰剂相比)大于罗西(1.39[0.38-5.04])，但服用舍曲林的受试者报告的不良事件(63.2%)多于罗西(30.0%)或安慰剂(16.7%)(p=0.012)。尽管玫瑰花与舍曲林相比产生的抗抑郁作用较小，但它的不良反应也明显减少，耐受性更好。这些发现表明，罗西虽然不如舍曲林有效，但对于轻度到中度抑郁的患者来说，可能具有更有利的风险收益比。
We performed a proof of concept trial to evaluate relative safety and efficacy of Rhodiola rosea (R. rosea) versus sertraline for mild to moderate major depressive disorder. We hypothesize that R. rosea would have similar therapeutic effects as sertraline but with less adverse events. Phase II randomized placebo controlled clinical trial 57 subjects were randomized to 12 weeks of standardized R. rosea extract, sertraline, or placebo. Changes over time in Hamilton Depression Rating (HAM-D), Beck Depression Inventory (BDI), and Clinical Global Impression Change (CGI/C) scores among groups were examined using mixed-effects models. Modest, albeit statistically non-significant, reductions were observed for HAM-D, BDI, and CGI/C scores for all treatment conditions with no significant difference between groups (p=0.79, p=0.28, and p=0.17, respectively). The decline in HAM-D scores was greater for sertraline (−8.2, 95% confidence interval [CI], −12.7 to −3.6) versus R. rosea (−5.1, 95% CI: −8.8 to −1.3) and placebo (−4.6, 95% CI: −8.6 to −0.6). While the odds of improving (versus placebo) were greater for sertraline (1.90 [0.44–8.20]; odds ratio [95% CI]) than R. rosea (1.39 [0.38–5.04]), more subjects on sertraline reported adverse events (63.2%) than R. rosea (30.0%) or placebo (16.7%) (p=0.012). Although R. rosea produced less antidepressant effect versus sertraline, it also resulted in significantly fewer adverse events and was better tolerated. These findings suggest that R. rosea, although less effective than sertraline, may possess a more favorable risk to benefit ratio for individuals with mild to moderate depression.
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DOI：
10.1023/b:bebm.0000020211.24779.15
发表时间：
2003-12-01
影响因子：
0.7
作者：
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通讯作者：
Ziegenfuss, T
影响因子：
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作者：
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通讯作者：
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影响因子：
1.9
作者：
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通讯作者：
WARE, JH
影响因子：
17.7
作者：
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通讯作者：
Fava, Maurizio
影响因子：
2.6
作者：
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通讯作者：
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