Wei Xiuxiu, Wen Yongtian, Wei Yuchen, Liang Xu, Ma Xiangxue, Zhang Beihua, Tang Xudong
Graduate College, Beijing University of Traditional Chinese Medicine, Beijing, China.
Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China.
Front Med (Lausanne). 2022 Aug 9;9:940328. doi: 10.3389/fmed.2022.940328. eCollection 2022.
Irritable bowel syndrome with diarrhea (IBS-D) is a chronic functional gastrointestinal disorder that has a significant impact on quality of life, work productivity, and healthcare resources. External therapy of traditional Chinese medicine (TCM) has positive effects on IBS-D and is simple, convenient, and low-cost. This study aimed to systematically evaluate the efficacy and safety of external therapy of TCM for IBS-D.
This study was conducted according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), Chinese Scientific Journals (VIP), Wan Fang, and Chinese Biomedical (CBM) databases were electronically searched to collect randomized controlled trials comparing external therapy of TCM with Western medicine for IBS-D from inception to 31 December 2021. Two authors independently screened, extracted, and assessed the selected studies. The Jadad scale and Cochrane Collaboration Risk of Bias tool were used to evaluate study quality. The certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). The meta-analysis was performed using the Review Manager software (version 5.3).
Twenty-one studies involving 1,862 subjects were included. Acupuncture and moxibustion were the most commonly used external therapies. The meta-analysis showed that based on total effective rate with moderate certainty of evidence ( = 21 studies, = 1,862 participants, RR = 1.25, 95% CI [1.2, 1.31], I = 0%, < 0.00001), clinical cure rate with low certainty of evidence ( = 17 studies, = 1,502 participants, RR = 1.66, 95% CI [1.4, 1.96], I = 1%, < 0.00001), recurrence rate with very low certainty of evidence ( = 5 studies, = 260 participants, RR = 0.44, 95% CI [0.34, 0.58], I = 0%, < 0.00001), total symptom score (MD = -4.9, 95% CI [-7.34, -2.47]), and IBS severity scoring system score (IBS-SSS) with moderate certainty of evidence (MD = -52.72, 95% CI [-63.9, -41.53]), the experimental group had significant advantages compared with the control group. The sensitivity analysis further confirmed the robustness of the primary outcomes. The improvement in quality of life associated with IBS (IBS-QOL) was superior in the experimental group compared to the control group, and the difference was statistically significant; however, the clinical heterogeneity was strong. The inverted funnel plot of the included studies indicated a potential publication bias.
External therapy of TCM for IBS-D alleviated abdominal symptoms, improved clinical effectiveness, and reduced recurrence with great safety. However, because of the limitations of publication bias in trials, more rigorous studies with a clinical design are necessary for further verification of the outcomes.
[https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42020222993].
腹泻型肠易激综合征（IBS-D）是一种慢性功能性胃肠疾病，对生活质量、工作效率和医疗资源有重大影响。中医外治法对IBS-D有积极作用，且简便、价廉。本研究旨在系统评价中医外治法治疗IBS-D的疗效和安全性。
本研究按照系统评价和Meta分析的首选报告项目（PRISMA）指南进行。通过电子检索PubMed、Embase、Cochrane图书馆、Web of Science、中国知网（CNKI）、维普中文科技期刊数据库（VIP）、万方数据库和中国生物医学文献数据库（CBM），收集从创刊至2021年12月31日比较中医外治法与西医治疗IBS-D的随机对照试验。两名作者独立筛选、提取和评估入选研究。采用Jadad量表和Cochrane协作网偏倚风险工具评估研究质量。使用推荐分级的评估、制定与评价（GRADE）方法评估证据的确定性。采用Review Manager软件（5.3版）进行Meta分析。
纳入21项研究，共1862例受试者。针灸是最常用的外治法。Meta分析显示，基于证据中度确定性的总有效率（n = 21项研究，n = 1862例参与者，RR = 1.25，95%CI[1.2, 1.31]，I² = 0%，P < 0.00001）、证据低度确定性的临床治愈率（n = 17项研究，n = 1502例参与者，RR = 1.66，95%CI[1.4, 1.96]，I² = 1%，P < 0.00001）、证据极低确定性的复发率（n = 5项研究，n = 260例参与者，RR = 0.44，95%CI[0.34, 0.58]，I² = 0%，P < 0.00001）、总症状评分（MD = -4.9，95%CI[-7.34, -2.47]）以及证据中度确定性的IBS严重程度评分系统评分（IBS-SSS）（MD = -52.72，95%CI[-63.9, -41.53]），试验组与对照组相比具有显著优势。敏感性分析进一步证实了主要结局的稳健性。试验组IBS相关生活质量（IBS-QOL）的改善优于对照组，差异有统计学意义；然而，临床异质性较强。纳入研究的倒漏斗图显示存在潜在的发表偏倚。
中医外治法治疗IBS-D可缓解腹部症状，提高临床疗效，降低复发率，安全性高。然而，由于试验中存在发表偏倚的局限性，需要更严格的临床设计研究进一步验证结果。
