Center for Evidence-based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China.
BMC Complement Altern Med. 2013 Nov 18;13:320. doi: 10.1186/1472-6882-13-320.
Traditional Chinese medicine has been widely used for the treatment of recurrent miscarriage in China and other Asian countries for long time. We conducted this review to systematically summarize the evidences of Chinese herbal medicine (CHM) for the prevention and treatment of recurrent miscarriage in randomized trials, and evaluate the effectiveness and safety of CHM compared with placebo or conventional medicine.
We searched studies in PubMed, ClinicalTrials, the Cochrane Library, CNKI, SinoMed and VIP databases until December, 2012. Randomized trials on CHM alone or in combination with conventional medicine for recurrent miscarriage compared with placebo or conventional medicine were included. We evaluated the methodological quality of each included trials using the Cochrane risk of bias tool.
A total of 41 RCTs (3660 participants) were included. The majority of trials had a high or unclear risk of bias. CHM used alone or plus progesterone-based treatment showed superior effect over progesterone-based treatment in improving live birth rate and embryonic developmental state (measured by B ultrasound). However, there is substantial heterogeneity within each subgroup analysis (I2 ranging from 35% to 71%). CHM plus progesterone and hCG-based treatment was superior to progesterone and hCG-based treatment in improving the embryonic developmental state, but not live birth rate. No severe adverse events were reported in relation to CHM.
Some Chinese herbal medicines or in combination with progesterone-based treatment demonstrated potentially beneficial effect in improving live birth rate and embryonic developmental state for women with recurrent miscarriage. However, due to the substantial heterogeneity among the herbal interventions and limitations of methodological quality of the included trials, it is not possible to recommend any specific CHMs for recurrent miscarriage. Further rigorous clinical trials are warranted to evaluate the efficacy and safety of CHM.
传统中医在治疗复发性流产方面在中国和其他亚洲国家已应用多年。我们进行这项综述,旨在系统地总结中药(CHM)治疗复发性流产的随机试验证据,并评估 CHM 与安慰剂或常规药物相比的有效性和安全性。
我们检索了 PubMed、ClinicalTrials、Cochrane 图书馆、CNKI、SinoMed 和 VIP 数据库中截至 2012 年 12 月的研究。纳入了 CHM 单独或与常规药物联合治疗复发性流产与安慰剂或常规药物比较的随机试验。我们使用 Cochrane 偏倚风险工具评估每个纳入试验的方法学质量。
共纳入 41 项 RCT(3660 名参与者)。大多数试验的偏倚风险较高或不明确。CHM 单独使用或加用孕激素治疗在提高活产率和胚胎发育状态(通过 B 超测量)方面优于孕激素治疗。然而,每个亚组分析内存在显著的异质性(I2 范围为 35%至 71%)。CHM 加用孕激素和 hCG 治疗在改善胚胎发育状态方面优于孕激素和 hCG 治疗,但对活产率无影响。未报告与 CHM 相关的严重不良事件。
一些中药或与孕激素联合治疗在提高复发性流产妇女的活产率和胚胎发育状态方面显示出潜在的有益作用。然而,由于草药干预的显著异质性和纳入试验的方法学质量限制,目前无法推荐任何特定的 CHM 用于复发性流产。需要进一步进行严格的临床试验来评估 CHM 的疗效和安全性。