Table2_Systematic review and meta-analysis of Chinese herbal formula Tongxie Yaofang for diarrhea-predominant irritable bowel syndrome: Evidence for clinical practice and future trials.docx

Introduction: Diarrhea-predominant irritable bowel syndrome (IBS-D) significantly decreases the quality of life of patients and their families, and affects patients’ mental health. No specific western medications are available. Ancient classical Chinese medical texts have recognized Tongxie Yaofang (TXYF) as a therapy for diarrhea which is widely used in clinical practice. Standard TXYF prescription (S-TXYF) is composed of four herbal medicines: Atractylodes macrocephala Koidz. [Asteraceae; Rhizoma Atractylodis Macrocephalae.], Paeonia lactiflora Pall. [Ranunculaceae; Paeoniae Radix Alba], Citrus × aurantium L. [Rutaceae; Citri Reticulatae Pericarpium] and Saposhnikovia divaricata (Turcz. ex Ledeb.) Schischk. [Umbelliferae; Saposhnikoviae Radix]. This review aimed to evaluate the therapeutic effects and safety of S-TXYF for IBS-D.
Methods: Eight English and Chinese electronic databases were searched from their inception to 25 December 2021 for randomized controlled trials (RCTs) comparing S-TXYF with placebo, western medications or no treatment for IBS-D. The primary outcome was the global improvement of IBS-D symptoms. Data were analyzed using Cochrane’s Revman 5.4 software. Evidence certainty was assessed using the online GRADEpro tool for the primary outcome.
Results: Eleven RCTs involving 985 adults with IBS-D were included. For global improvement of symptoms, S-TXYF was superior to western medication and placebo (moderate evidence by GRADE). Regarding the improvement of stool consistency, stool frequency and abdominal pain, S-TXYF was significantly effective than placebo. In addition, S-TXYF was superior to western medication on improving the quality of life and relieving anxiety. Six trials reported adverse events: five of them reported (non-serious) adverse events occurred in both groups, and one trial reported that 3 cases with adverse events (constipation, elevation in liver-enzyme, nausea) occurred in S-TXYF group and 3 cases with adverse events (abdominal distension, nausea) occurred in placebo group.
Conclusion: Although current results showed that S-TXYF may have potential to treat IBS-D and its use appears to be safe, no a clear and confirmed conclusion can be drawn from our review as the overall inadequate design of the included trials reviewed. So more rigorous trials are warranted to establish confirmed evidence on its benefits and safety.

引言：腹泻型肠易激综合征（IBS-D）会显著降低患者及其家属的生活质量，同时损害患者的心理健康，目前尚无特效西医治疗药物。中医古典医籍早已将痛泻要方（Tongxie Yaofang, TXYF）列为腹泻的治疗方剂，且该方在临床中应用广泛。标准痛泻要方（Standard Tongxie Yaofang, S-TXYF）由四味中药组成：白术（Atractylodes macrocephala Koidz.，菊科Asteraceae；白术Rhizoma Atractylodis Macrocephalae）、白芍（Paeonia lactiflora Pall.，毛茛科Ranunculaceae；白芍Paeoniae Radix Alba）、陈皮（Citrus × aurantium L.，芸香科Rutaceae；陈皮Citri Reticulatae Pericarpium）、防风（Saposhnikovia divaricata (Turcz. ex Ledeb.) Schischk.，伞形科Umbelliferae；防风Saposhnikoviae Radix）。本系统评价旨在评估标准痛泻要方治疗IBS-D的疗效与安全性。
方法：本研究检索了建库至2021年12月25日的8个中英文电子数据库，纳入对比标准痛泻要方与安慰剂、西药或空白治疗用于IBS-D的随机对照试验（randomized controlled trials, RCTs）。本研究的主要结局指标为IBS-D症状的整体改善情况。采用Cochrane RevMan 5.4软件对数据进行分析，并通过在线GRADEpro工具对主要结局指标的证据质量进行评估。
结果：本研究共纳入11项随机对照试验，涉及985名IBS-D成人患者。在症状整体改善方面，标准痛泻要方优于西药与安慰剂（GRADE证据等级为中等）。在粪便性状、排便频率及腹痛改善方面，标准痛泻要方的疗效显著优于安慰剂。此外，标准痛泻要方在改善患者生活质量及缓解焦虑情绪方面也优于西药。共有6项试验报告了不良事件：其中5项试验显示两组均出现了（非严重）不良事件；1项试验显示标准痛泻要方组出现3例不良事件（便秘、肝酶升高、恶心），安慰剂组出现3例不良事件（腹胀、恶心）。
结论：尽管现有研究结果显示标准痛泻要方在治疗IBS-D方面具有潜在价值，且用药安全性良好，但由于纳入试验的整体设计存在不足，本系统评价无法得出明确且确凿的结论。因此，未来仍需开展设计更为严谨的临床试验，以明确标准痛泻要方治疗IBS-D的获益与安全性证据。