Zhang Xin, Kang Deying, Zhang Lan, Peng Le
a Evidence-based Medicine and Clinical Epidemiology Department, West China Hospital , Sichuan University , Chengdu , China.
Aging Ment Health. 2014;18(8):941-53. doi: 10.1080/13607863.2014.899975. Epub 2014 Apr 4.
Shuganjieyu capsule is a pure herbal pharmaceutical product for depression. Our objective was to explore the effectiveness and safety of Shuganjieyu capsule for the treatment of major depressive disorder in adults.
Eight computerized databases were searched. In addition, randomized controlled trials (RCTs) on Shuganjieyu capsule were hand-searched on seven key Chinese journals. Data were extracted and evaluated by two reviewers independently. Analysis was performed by intention-to-treat where possible. Prespecified subgroup analyses were different-dose regimens, patient spectrum, publication status, and treatment duration.
Seven RCTs with 595 participants were included. Shuganjieyu capsule was superior than placebo in terms of response rate (RR = 2.42, 95% CI: 1.55-3.79; P = 0.0001), remission rate (RR = 4.29, 95% CI: 1.61-11.45; P = 0.004), the scores of the mean change from baseline of the HAM-D17 (MD = -4.17, 95% CI: -5.61 to -2.73; P < 0.00001) and from baseline of traditional Chinese medicine (TCM) syndrome score scale scores (MD = -6.00, 95% CI: -8.25 to -3.75; P < 0.00001). In addition, Shuganjieyu plus venlafaxine had a significantly higher response rate (RR = 1.56, 95% CI: 1.29-1.88; P < 0.00001) and was superior in terms of the scores of the mean change from baseline of the treatment emergent symptoms scale scores (MD = -0.74, 95% CI:-1.12 to -0.35; P = 0.0002) than venlafaxine alone.
Shuganjieyu capsule is superior to placebo in terms of overall treatment effectiveness and safety. Both response rate and remission rate among patients treated with the combination of Shuganjieyu plus venlafaxine were significantly higher than those treated with venlafaxine alone. Due to the considerable risk of bias in majority of trials, recommendations for practice should be cautious, and additional, well-designed RCTs are needed in next step.
舒肝解郁胶囊是一种用于治疗抑郁症的纯中药制剂。我们的目的是探讨舒肝解郁胶囊治疗成人重度抑郁症的有效性和安全性。
检索了八个计算机化数据库。此外，还在七种主要中文期刊上手工检索了关于舒肝解郁胶囊的随机对照试验（RCT）。由两名评价者独立提取和评估数据。尽可能采用意向性分析。预先设定的亚组分析包括不同剂量方案、患者范围、发表状态和治疗持续时间。
纳入了7项随机对照试验，共595名参与者。舒肝解郁胶囊在缓解率（RR = 2.42，95%CI：1.55 - 3.79；P = 0.0001）、治愈率（RR = 4.29，95%CI：1.61 - 11.45；P = 0.004）、汉密尔顿抑郁量表17项（HAM - D17）从基线的平均变化得分（MD = -4.17，95%CI：-5.61至-2.73；P < 0.00001）以及中医证候量表从基线的得分变化（MD = -6.00，95%CI：-8.25至-3.75；P < 0.00001）方面均优于安慰剂。此外，舒肝解郁胶囊联合文拉法辛的缓解率显著更高（RR = 1.56，95%CI：1.29 - 1.88；P < 0.00001），且在治疗中出现的症状量表从基线的平均变化得分方面（MD = -0.74，95%CI：-1.12至-0.35；P = 0.0002）优于单用文拉法辛。
舒肝解郁胶囊在总体治疗有效性和安全性方面优于安慰剂。舒肝解郁胶囊联合文拉法辛治疗患者的缓解率和治愈率均显著高于单用文拉法辛。由于大多数试验存在相当大的偏倚风险，临床实践建议应谨慎，下一步需要更多设计良好的随机对照试验。
