Yeung Wing-Fai, Chung Ka-Fai, Ng Ka-Yan, Yu Yee-Man, Ziea Eric Tat-Chi, Ng Bacon Fung-Leung
Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.
Department of Psychiatry, University of Hong Kong, Hong Kong SAR, China.
J Ethnopharmacol. 2014 Apr 28;153(2):309-17. doi: 10.1016/j.jep.2014.02.046. Epub 2014 Mar 12.
ETHNOPHARMACOLOGICAL RELEVANCE: Ganmai Dazao (GMDZ) decoction is a traditional Chinese herbal formula commonly used for the treatment of depression. The objective of this study was to assess the efficacy and safety of GMDZ, either alone or as co-therapy, for depression. MATERIALS AND METHODS: We systematically searched key databases (9 Chinese and 7 English) up until May 2013 for randomized controlled trials (RCTs). The primary outcomes were effective rate and self-rated or clinician-rated severity of depression. The secondary outcome was the occurrence of adverse events. Methodological quality of the RCTs was assessed by the Cochrane׳s risk of bias assessment. RESULTS: Ten RCTs were included. All were written in Chinese and the methodological quality was generally low. Pooled analysis of 5 studies which compared GMDZ with antidepressants showed that GMDZ was significantly more efficacious than antidepressants in effective rate (risk ratio: 1.14, 95% CI: 1.02 to 1.27, P=0.02, I(2)=0%), but comparable in Hamilton Depression Rating Scale (HDRS) score (mean difference: -2.10, 95% CI: -4.62 to -0.41, P=0.10, I(2)=92%). With regard to the other 5 studies which compared GMDZ plus antidepressants with antidepressants alone, there was no significant difference in effective rate (risk ratio: 1.24, 95% CI: 0.99 to 1.55, P=0.07, I(2)=93%), but the end-point HDRS score was significantly lower in GMDZ antidepressants combination (mean difference: -4.25, 95% CI: -6.50 to -2.00, P=0.0002, I(2)=96%). Adverse events were more common with antidepressants than GMDZ (rate ratio: 0.52, 95% CI: 0.32 to 0.82, P=0.005, I(2)=37%) and in antidepressants alone compared to GMDZ antidepressants combination (rate ratio: 0.23, 95% CI: 0.08 to 0.68, P=0.08, I(2)=0%). CONCLUSION: The overall results suggest that GMDZ has few side effects and the potential as an antidepressant. Adding GMDZ to antidepressants reduces side effects and enhances efficacy of antidepressants. However, due to the small number of studies and their limitations, further studies with better methodological quality and more comprehensive safety assessment are needed to determine the benefits and risks of GMDZ in the treatment of depression.
民族药理学相关性：甘麦大枣汤是一种常用于治疗抑郁症的传统中药配方。本研究的目的是评估甘麦大枣汤单独使用或作为联合治疗药物治疗抑郁症的疗效和安全性。 材料与方法：我们系统检索了截至2013年5月的关键数据库（9个中文数据库和7个英文数据库），以查找随机对照试验（RCT）。主要结局指标为有效率以及自评或临床医生评定的抑郁严重程度。次要结局指标为不良事件的发生情况。通过Cochrane偏倚风险评估对RCT的方法学质量进行评估。 结果：纳入了10项RCT。所有研究均为中文撰写，方法学质量总体较低。对5项比较甘麦大枣汤与抗抑郁药的研究进行的汇总分析表明，甘麦大枣汤在有效率方面显著优于抗抑郁药（风险比：1.14，95%置信区间：1.02至1.27，P = 0.02，I² = 0%），但在汉密尔顿抑郁量表（HDRS）评分方面相当（平均差：-2.10，95%置信区间：-4.62至-0.41，P = 0.10，I² = 92%）。对于另外5项比较甘麦大枣汤加抗抑郁药与单纯抗抑郁药的研究，有效率无显著差异（风险比：1.24，95%置信区间：0.99至1.55，P = 0.07，I² = 93%），但甘麦大枣汤与抗抑郁药联合使用时的终点HDRS评分显著更低（平均差：-4.25，95%置信区间：-6.50至-2.00，P = 0.0002，I² = 96%）。抗抑郁药组的不良事件比甘麦大枣汤组更常见（发生率比：0.52，95%置信区间：0.32至0.82，P = 0.005，I² = 37%），且单纯抗抑郁药组与甘麦大枣汤加抗抑郁药联合使用组相比不良事件更常见（发生率比：0.23，95%置信区间：0.08至0.68，P = 0.08，I² = 0%）。 结论：总体结果表明，甘麦大枣汤副作用少，具有作为抗抑郁药的潜力。在抗抑郁药中添加甘麦大枣汤可减少副作用并提高抗抑郁药的疗效。然而，由于研究数量较少及其局限性, 需要开展方法学质量更高、安全性评估更全面的进一步研究，以确定甘麦大枣汤治疗抑郁症的益处和风险。
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