Feng Xianjie, Cheng Shaomin, Xu Sheng, Chen Xin, Zhou Xu
College of Acupuncture and Tuina, Jiangxi University of Chinese Medicine, Nanchang, 330004, China.
School of Chinese Medicine, Jiangxi University of Chinese Medicine, Nanchang, 330004, China.
Heliyon. 2024 Aug 28;10(17):e36959. doi: 10.1016/j.heliyon.2024.e36959. eCollection 2024 Sep 15.
Cangfu Daotan decoction is a classic traditional Chinese medicine formula that has been found to be beneficial for treating polycystic ovarian syndrome (PCOS) in animal models. This systematic review aimed to assess the efficacy and safety of Cangfu Daotan decoction as an adjuvant treatment to Diane-35 for PCOS in humans.
Seven electronic databases were searched up to June 22, 2024, to identify randomized controlled trials (RCTs) that evaluated Cangfu Daotan decoction combined with Diane-35 versus Diane-35 alone for the treatment of PCOS. The effects of individual RCTs were combined via meta-analysis and were measured as relative risks (RRs) or weighted mean differences (WMDs).
Twenty-five RCTs with a moderate to high risk of bias were included, involving 1845 patients with PCOS. Meta-analyses indicated that compared with Diane-35 alone, the combination of Diane-35 and Cangfu Daotan decoction significantly improved the response rate (RR 1.19, 95 % confidence interval [CI] 1.14 to 1.24), pregnancy rate (RR 1.57, 95 % CI 1.18 to 2.09), ovulation rate (RR 1.22, 95 % CI 1.11 to 1.35), and ovarian volume (WMD -1.43 cm, 95 % CI -2.46 to -0.39). Cangfu Daotan decoction also significantly reduced the luteinizing hormone (LH) level, LH:FSH ratio, testosterone level, prolactin level, body mass index (BMI) and hirsutism and acne scores but had no significant effect on the follicle-stimulating hormone (FSH) level. All adverse events were mild and not related to Cangfu Daotan decoction treatment.
The findings suggest that Cangfu Daotan decoction, as an adjuvant therapy to Diane-35 for the treatment of PCOS, can reduce multiple sex hormone levels and BMI, relieve hyperandrogenism signs, and ultimately improve pregnancy outcomes, with good safety. The effect of Cangfu Daotan decoction on FSH remains uncertain. Due to limitations of risk of bias and heterogeneity, the quality of evidence was rated as moderate to very low.
苍附导痰汤是一种经典的中药方剂，已发现在动物模型中对治疗多囊卵巢综合征（PCOS）有益。本系统评价旨在评估苍附导痰汤作为达英-35辅助治疗PCOS在人体中的疗效和安全性。
检索截至2024年6月22日的七个电子数据库，以识别评估苍附导痰汤联合达英-35与单用达英-35治疗PCOS的随机对照试验（RCT）。通过荟萃分析合并各个RCT的效应，并以相对风险（RR）或加权平均差（WMD）衡量。
纳入了25项偏倚风险为中度至高度的RCT，涉及1845例PCOS患者。荟萃分析表明，与单用达英-35相比，达英-35与苍附导痰汤联合使用显著提高了有效率（RR 1.19，95%置信区间[CI] 1.14至1.24）、妊娠率（RR 1.57，95% CI 1.18至2.09）、排卵率（RR 1.22，95% CI 1.11至1.35）和卵巢体积（WMD -1.43 cm，95% CI -2.46至-0.39）。苍附导痰汤还显著降低了黄体生成素（LH）水平、LH:FSH比值、睾酮水平、催乳素水平、体重指数（BMI）以及多毛症和痤疮评分，但对促卵泡生成素（FSH）水平无显著影响。所有不良事件均为轻度，且与苍附导痰汤治疗无关。
研究结果表明，苍附导痰汤作为达英-35治疗PCOS的辅助疗法，可降低多种性激素水平和BMI，缓解高雄激素血症体征，并最终改善妊娠结局，安全性良好。苍附导痰汤对FSH的影响仍不确定。由于存在偏倚风险和异质性的局限性，证据质量被评为中度至极低。
