Department of Neurology, the Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou 325000, China.
J Ethnopharmacol. 2019 Apr 24;234:8-20. doi: 10.1016/j.jep.2019.01.010. Epub 2019 Jan 15.
Erxian decoction (EXD), a famous Chinese herbal prescription, consists of Rhizoma Curculiginis, Herba Epimedii, Radix Morindae Officinalis, Radix Angelicae Sinensis, Cortex Phellodendri, Rhizoma Anemarrhenae, all of which are recorded in the Chinese Pharmacopoeia.
To conduct an updated systematic and meta-analysis investigating efficacy and safety of EXD for menopausal syndrome.
An electronic search was conducted in eight databases from inception until July 2018. Randomized controlled trials with risk-of-bias score ≥ 7 according to the Cochrane Back Review Group were included for analyses. All participants with a diagnosis of menopausal syndrome met the established criteria. The treatment group was EXD monotherapy or adjunct therapy. Comparators were placebo, hormone replace therapy, hormone plus nonhormonal agents, nonhormonal agents and no treatment. The primary outcome measurements were the Kupperman index, total hot flush scores, total menopause rating scale (MRS) scores and total menopause-specific quality of life (MENQOL) scores. The secondary outcomes were total clinical effective rate, traditional Chinese medicine (TCM) syndrome scores, Hamilton depression (HAMD) scale scores, self-rating depression scale (SDS) scores, self-Rating Anxiety Scale (SAS) scores, athens insomnia scale (AIS) scores, serological indicators, blood pressure, and adverse events. RevMan 5.3 Software was used for data analyses. GRADE system was used to assess the level of evidence.
Sixteen eligible studies with 1594 subjects were identified. Five studies showed EXD was contradictory results according to Kupperman index of menopausal syndrome compared with hormone. One study showed EXD significantly improved total hot flush scores, total MRS scores and total MENQOL scores compared with placebo (P < 0.05). Meta-analysis of 10 EXD monotherapy or 2 paratherapy studies showed that both can significantly improve total effective rate compared with hormone (P < 0.05); 3 studies showed that EXD plus hormone significantly reduces the TCM syndrome scores, HAMD scale scores, SDS scores and SAS scores compared with hormone (P < 0.05). One study showed a significant effect of EXD for reducing AIS scores compared with hormone (P < 0.05); 7 studies showed contradictory effects for improving serological indicators compared with hormone. Two studies reported adverse effects, whereas the other studies did not mention. The quality of the evidence of primary outcomes was moderate to high according to the GRADE profiler.
The present findings do not allow an assessment of the evidence because the low-quality studies included cannot be reproduced. However, we identified an area, which is worthy of further research. Rigorous RCTs are still needed in the future.
二仙汤（EXD）是一种著名的中草药方剂，由仙灵脾、淫羊藿、巴戟天、当归、黄柏、知母组成，均收录于《中国药典》。
对二仙汤治疗更年期综合征的疗效和安全性进行更新的系统评价和荟萃分析。
从建库到 2018 年 7 月，在 8 个数据库中进行电子检索。对符合 Cochrane 偏倚风险评估工具≥7 分的随机对照试验进行分析。所有符合更年期综合征诊断标准的参与者均纳入研究。治疗组为二仙汤单药或辅助治疗。对照组为安慰剂、激素替代疗法、激素加非激素药物、非激素药物和无治疗。主要结局指标为 Kupperman 指数、总热潮红评分、总更年期评定量表（MRS）评分和总更年期特定生活质量（MENQOL）评分。次要结局指标为总临床有效率、中医证候评分、汉密尔顿抑郁量表（HAMD）评分、自评抑郁量表（SDS）评分、自评焦虑量表（SAS）评分、雅典失眠量表（AIS）评分、血清学指标、血压和不良事件。采用 RevMan 5.3 软件进行数据分析。采用 GRADE 系统评估证据水平。
共纳入 16 项符合条件的研究，涉及 1594 例患者。五项研究显示，与激素相比，二仙汤对更年期综合征的 Kupperman 指数无明显改善。一项研究显示，与安慰剂相比，二仙汤可显著改善总热潮红评分、总 MRS 评分和总 MENQOL 评分（P<0.05）。对 10 项二仙汤单药或 2 项辅助治疗研究的荟萃分析显示，二仙汤联合激素治疗与激素治疗相比，均能显著提高总有效率（P<0.05）；3 项研究显示，二仙汤加激素治疗与激素治疗相比，能显著降低中医证候评分、HAMD 评分、SDS 评分和 SAS 评分（P<0.05）。一项研究显示，二仙汤对降低 AIS 评分的效果优于激素（P<0.05）；7 项研究显示，与激素相比，二仙汤对改善血清学指标的效果存在争议。两项研究报告了不良反应，而其他研究未提及。根据 GRADE 概况图，主要结局指标的证据质量为中至高。
由于纳入的低质量研究无法重现，目前的研究结果不能对证据进行评估。然而，我们发现了一个值得进一步研究的领域。未来仍需要严格的 RCT 研究。
