Efficacy and safety of Chinese patent medicines combined with conventional therapies for endometriosis: A systematic review and bayesian network meta-analysis

IF 5.4 2区 医学 Q1 CHEMISTRY, MEDICINAL Journal of ethnopharmacology Pub Date : 2025-02-08 DOI:10.1016/j.jep.2025.119465
Wenrui Huang , Tianyun Liu , Yue yu , Xingyan Ou , Lei Chen , Xiaoxuan Tang , Xingzi Fang , Jing Ling , XueLian Du
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Abstract

Ethnopharmacological relevance

Conventional hormonal treatments for endometriosis (EMs) are often associated with significant side effects. In recent years, many clinical trials and studies have highlighted the remarkable efficacy of Chinese patent medicines (CPMs) in alleviating endometriosis-related pain, reducing CA125 markers, regulating hormone levels, and preventing symptom recurrence. Numerous randomized controlled trials (RCTs) have been conducted on CPMs such as Shaofu Zhuyu Decoction (SZD), Dan'e Fukang Plaster (DFP), Sanjie Zhentong Capsule (SZC), Guizhi Fuling Capsule (GFC), Xiaojin Capsule (XC), Gongliu Xiao Capsule (GLXC), Xuefu Zhuyu Capsule (XZC), Jingtong Yushu Granule (JYG), Zhitong Huazheng Capsule (ZHC), and Kuntai Capsule (KTC) for the treatment of endometriosis. However, these studies have yet to be evaluated through a network meta-analysis (NMA) compliant with PRISMA standards.

Aim of the study

This study aimed to compare the efficacy and safety of ten CPMs for treating EMs through a NMA on RCTs.

Materials and methods

PubMed, Cochrane, Embase, Web of Science, China National Knowledge Infrastructure, VIP Information, WanFang, and China Biomedicine databases were searched up to October 2024 for studies on the efficacy and safety of CPMs in treating EMs. Two researchers independently screened the studies, extracted data, and assessed quality using the Cochrane Risk of Bias 2.0 tool and the Confidence in Network Meta-Analysis framework. The NMA was conducted using Bayesian methods with StataSE and Rstudio, generating network diagrams, league tables, and Surface Under the Cumulative Ranking (SUCRA) line charts. This study was registered with PROSPERO (CRD42023477523).

Results

148 eligible trials involving 10 CPMs and 16198 participants were included in this NMA; all subsequent estimates refer to the comparison with conventional therapies. All 10 CPMs effectively improved the total effective rate and VAS pain scores. SZC induced the most significant improvement in total effective rate(compared to hormone therapy: risk ratio 5.51, 95% confidence interval 4.21 to 7.2, SUCRA 86.3%, moderate confidence of evidence; compared to GnRH-a: 4.74, (3.18–7), moderate confidence of evidence). DFP proved to be the most effective CPM for lowering the VAS pain scores. (compared to hormone therapy: mean difference −2.1, (−2.94 to −1.29), 78.8%, moderate confidence of evidence; and GnRH-a (−2.07, (−2.73 to −1.41), low confidence of evidence). Moreover, this study demonstrated the safety of CPMs, particularly in reducing hormonal and liver-related side effects. Specific CPMs like XZC, SZC, DFP, KTC, and GFC showed markedly lower relative risks of adverse events when compared to conventional therapies.

Conclusion

Chinese patent medicine may effectively treat EMs, excelling in total effective rate, pain relief, CA125 reduction, and safety. Nevertheless, these findings are preliminary and require validation through high-quality studies.

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中成药联合常规疗法治疗子宫内膜异位症的疗效和安全性:系统评价和贝叶斯网络meta分析。
民族药理学相关性:子宫内膜异位症(EMs)的常规激素治疗通常伴有显著的副作用。近年来,许多临床试验和研究都强调了中成药在缓解子宫内膜异位症相关疼痛、降低CA125标志物、调节激素水平、预防症状复发等方面的显著疗效。大量的随机对照试验(RCTs)对中药如少腑祛瘀汤(SZD)、丹阿复康膏(DFP)、三节祛瘀胶囊(SZC)、桂芝茯苓胶囊(GFC)、消金胶囊(XC)、宫流消胶囊(GLXC)、血腑祛瘀胶囊(XZC)、经通祛瘀颗粒(JYG)、止通化正胶囊(ZHC)、昆泰胶囊(KTC)治疗子宫内膜异位症进行了研究。然而,这些研究尚未通过符合PRISMA标准的网络元分析(NMA)进行评估。研究目的:本研究旨在通过随机对照试验比较10种cpm治疗EMs的疗效和安全性。材料和方法:检索PubMed、Cochrane、Embase、Web of Science、中国知网、VIP信息、万方、中国生物医学数据库,检索截至2024年10月的cpm治疗EMs的有效性和安全性研究。两名研究人员独立筛选研究,提取数据,并使用Cochrane风险偏倚2.0工具和网络信心元分析框架评估质量。NMA使用贝叶斯方法与StataSE和Rstudio进行,生成网络图、排名表和表面下累积排名(SUCRA)折线图。本研究已在PROSPERO注册(CRD42023477523)。结果:本NMA共纳入148个符合条件的试验,涉及10个cpm,被试16198人;所有后续估计都是指与常规疗法的比较。10种cpm均能有效提高总有效率和VAS疼痛评分。SZC对总有效率的改善最为显著(与激素治疗相比:风险比5.51,95%可信区间4.21 ~ 7.2,SUCRA 86.3%,证据置信度中等;与GnRH-a相比:4.74,(3.18 ~ 7),证据置信度中等)。DFP被证明是降低VAS疼痛评分最有效的CPM。(与激素治疗相比:平均差异为-2.1,(-2.94 ~ -1.29),78.8%,证据置信度中等;GnRH-a(-2.07,(-2.73 ~ -1.41),证据置信度低)。此外,本研究证明了cpm的安全性,特别是在减少激素和肝脏相关副作用方面。特异性cpm如XZC、SZC、DFP、KTC和GFC与常规治疗相比,不良事件的相对风险明显降低。结论:;中成药可有效治疗多发性硬化症,在总有效率、疼痛缓解、降低CA125、安全性等方面均有优势。然而,这些发现是初步的,需要通过高质量的研究来验证。
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来源期刊
Journal of ethnopharmacology
Journal of ethnopharmacology 医学-全科医学与补充医学
CiteScore
10.30
自引率
5.60%
发文量
967
审稿时长
77 days
期刊介绍: The Journal of Ethnopharmacology is dedicated to the exchange of information and understandings about people''s use of plants, fungi, animals, microorganisms and minerals and their biological and pharmacological effects based on the principles established through international conventions. Early people confronted with illness and disease, discovered a wealth of useful therapeutic agents in the plant and animal kingdoms. The empirical knowledge of these medicinal substances and their toxic potential was passed on by oral tradition and sometimes recorded in herbals and other texts on materia medica. Many valuable drugs of today (e.g., atropine, ephedrine, tubocurarine, digoxin, reserpine) came into use through the study of indigenous remedies. Chemists continue to use plant-derived drugs (e.g., morphine, taxol, physostigmine, quinidine, emetine) as prototypes in their attempts to develop more effective and less toxic medicinals.
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