Table1_Exploring the role of Chinese herbal medicine in the long-term management of postoperative ovarian endometriotic cysts: a systematic review and meta-analysis.docx

BackgroundOvarian endometriotic cysts (OEC) represent the primary manifestation of endometriosis, constituting a hormonally dependent inflammatory disorder in gynecology. It significantly affects the quality of life and reproductive health of women. It is worth noting that traditional Chinese medicine (TCM), especially Chinese herbal medicine (CHM), has been widely applied in mainland China due to its unique therapeutic system and commendable clinical efficacy, bringing new hope for preventing and managing OEC.
ObjectiveThis study aims to evaluate the efficacy and safety of CHM in the management of postoperative OEC. Simultaneously, it seeks to explore the medication laws, therapeutic principles, and specific treatment mechanisms of CHM.
MethodsEight electronic databases were searched from their inception to 01 November 2023. Randomized controlled trials (RCTs) assessing the therapeutic effects and safety of CHM for postoperative OEC were included. The risk of bias for each trial was assessed using the Cochrane Collaboration’s tool. The certainty of the evidence was evaluated using the GRADE profiler 3.2. Additionally, we extracted formulation from the included studies, conducting a thorough analysis.
Results(ⅰ) Twenty-two RCTs involving 1938 patients were included. In terms of the primary efficacy outcome, the CHM group demonstrated a potentially lower recurrence rate compared to both control (odds ratio (OR) = 0.25; 95% confidence intervals (CI): 0.10–0.64) and conventional western medicine (CWM) (OR = 0.26; 95% CI: 0.11–0.65) groups. Furthermore, the joint application of CHM and CWM resulted in a significant reduction in the recurrence rate (OR = 0.26; 95% CI: 0.17–0.40). (ⅱ) Regarding secondary efficacy outcomes, (a) Total clinical efficacy rate: CHM showcased an augmentation in clinical effectiveness compared to both the control (OR = 4.23; 95% CI: 1.12–15.99) and CWM (OR = 2.94; 95% CI: 1.34–6.43) groups. The combined administration of CHM and CWM substantially enhanced overall clinical effectiveness (OR = 3.44; 95% CI: 2.37–5.00). (b) VAS Score: CHM exhibited the capacity to diminish the VAS score in comparison to surgery alone (Mean difference (MD) = −0.86; 95% CI: -1.01 to −0.71). Nevertheless, no substantial advantage was observed compared to CWM alone (MD = −0.16; 95% CI: -0.49 to 0.17). The integration of CHM with CWM effectively ameliorated pain symptoms (MD = −0.87; 95% CI: -1.10 to −0.65). (c) Serum Level of Cancer antigen 125 (CA125): the CHM group potentially exhibited lower CA125 levels in comparison to CWM alone (MD = −11.08; 95% CI: -21.75 to −0.42). The combined intervention of CHM and CWM significantly decreased CA125 levels (MD = −5.31; 95% CI: -7.27 to −3.36). (d) Pregnancy Rate: CHM exhibited superiority in enhancing the pregnancy rate compared to surgery (OR = 3.95; 95% CI: 1.60–9.74) or CWM alone (OR = 3.31; 95% CI: 1.40–7.83). The combined utilization of CHM and CWM demonstrated the potential to enhance pregnancy rates compared to CWM (OR = 2.99; 95% CI: 1.28–6.98). Concerning safety outcome indicators, CHM effectively decreased the overall incidence of adverse events and, to a certain extent, alleviated perimenopausal symptoms as well as liver function impairment. (ⅲ) Most of CHMs were originated from classical Chinese herbal formulas. Prunus persica (L.) Batsch (Taoren), Angelica sinensis (Oliv.) Diels (Danggui), Salvia miltiorrhiza Bunge (Danshen), Paeonia lactiflora Pall. (Chishao), and Corydalis yanhusuo W.T.Wang (Yanhusuo) were most frequently used CHM.
ConclusionCHM may be a viable choice in the long-term management of postoperative OEC, with the potential to enhance clinical efficacy while decreasing recurrence and adverse effects.

【背景】卵巢子宫内膜异位囊肿（Ovarian endometriotic cysts, OEC）是子宫内膜异位症的主要表现形式，属于妇科中激素依赖性炎症性疾病，可严重影响女性的生活质量与生殖健康。值得关注的是，由于独特的诊疗体系与优异的临床疗效，中医药（Traditional Chinese Medicine, TCM）尤其是中草药（Chinese herbal medicine, CHM）在中国大陆地区应用广泛，为卵巢子宫内膜异位囊肿的预防与管理带来了新的希望。
【目的】本研究旨在评估中草药（CHM）用于术后卵巢子宫内膜异位囊肿管理的疗效与安全性，同时探讨中草药的用药规律、治疗原则及具体作用机制。
【方法】本研究检索了8个电子数据库自建库至2023年11月1日的文献，纳入评估中草药用于术后卵巢子宫内膜异位囊肿疗效与安全性的随机对照试验（Randomized controlled trials, RCTs）。采用Cochrane协作网偏倚风险评估工具对每项试验的偏倚风险进行评价，使用GRADE profiler 3.2评估证据质量。此外，本研究从纳入的研究中提取方剂信息并开展深入分析。
【结果】(ⅰ) 共纳入22项随机对照试验，涉及1938例患者。在主要疗效结局方面，中草药组的复发率较对照组（比值比（odds ratio, OR）=0.25；95%置信区间（confidence intervals, CI）：0.10~0.64）与常规西医（conventional western medicine, CWM）组（OR=0.26；95% CI：0.11~0.65）均更低。此外，中草药联合常规西医治疗可显著降低复发率（OR=0.26；95% CI：0.17~0.40）。(ⅱ) 针对次要疗效结局：(a) 总临床有效率：相较于对照组（OR=4.23；95% CI：1.12~15.99）与常规西医组（OR=2.94；95% CI：1.34~6.43），中草药可提升临床疗效；中草药联合常规西医治疗可显著增强整体临床疗效（OR=3.44；95% CI：2.37~5.00）。(b) 视觉模拟评分（VAS Score）：相较于单纯手术治疗，中草药可降低VAS评分（均差（Mean difference, MD）=-0.86；95% CI：-1.01~-0.71）；但与单纯常规西医治疗相比无显著优势（MD=-0.16；95% CI：-0.49~0.17）。中草药联合常规西医治疗可有效改善疼痛症状（MD=-0.87；95% CI：-1.10~-0.65）。(c) 血清癌抗原125（Cancer antigen 125, CA125）水平：相较于单纯常规西医治疗，中草药组的CA125水平可能更低（MD=-11.08；95% CI：-21.75~-0.42）；中草药联合常规西医干预可显著降低CA125水平（MD=-5.31；95% CI：-7.27~-3.36）。(d) 妊娠率：相较于单纯手术（OR=3.95；95% CI：1.60~9.74）或单纯常规西医治疗（OR=3.31；95% CI：1.40~7.83），中草药可提升妊娠率；与单纯常规西医治疗相比，中草药联合常规西医治疗可潜在提高妊娠率（OR=2.99；95% CI：1.28~6.98）。在安全性结局指标方面，中草药可有效降低不良事件总发生率，并在一定程度上缓解围绝经期症状与肝功能损伤。(ⅲ) 所用中草药多源自经典方剂，其中桃仁（Prunus persica (L.) Batsch, Taoren）、当归（Angelica sinensis (Oliv.) Diels, Danggui）、丹参（Salvia miltiorrhiza Bunge, Danshen）、赤芍（Paeonia lactiflora Pall., Chishao）及延胡索（Corydalis yanhusuo W.T.Wang, Yanhusuo）为最常用的中草药。
【结论】中草药可作为术后卵巢子宫内膜异位囊肿长期管理的可行选择，有望在提升临床疗效的同时降低复发率与不良反应发生率。