<br>针灸治疗腹泻型肠易激综合征：试点随机对照试验的研究方案,Trials

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针灸治疗腹泻型肠易激综合征：试点随机对照试验的研究方案
Trials ( IF 2.0 ) Pub Date : 2021-04-07 , DOI: 10.1186/s13063-021-05211-x
Ling-Yu Qi ₁ , Yu Wang ₁ , Li-Qiong Wang ₁ , Yan-Fen She ₂ , Guang-Xia Shi ₁ , Ying Li ₃ , Li-Li Chi ₄ , Bang-Qi Wu ₅ , Jian-Feng Tu ₁ , Ying Lin ₁ , Fang-Ting Yu ₁ , Jing-Wen Yang ₁ , Cun-Zhi Liu ₁

Affiliation

肠易激综合征（IBS）是最常见的功能性胃肠病之一。尽管针灸已成为 IBS 的常见替代疗法，但没有足够的证据证明其有效性。本研究旨在评估针灸治疗IBS的有效性和可行性。这是一项多中心随机对照临床试验。按照1：1：1的比例，将90例肠易激综合征患者随机分为特定腧穴（SA）组、非特定腧穴（NSA）组、非腧穴（NA）组。所有患者均在4周内接受针灸治疗12次，并随访8周。主要结局是缓解率，即随机分组后第 4 周最严重腹痛平均值比基线好 30%、稀便天数比基线少 50% 的患者百分比。次要结局包括其他时间点的缓解率、IBS 症状严重程度量表 (IBS-SSS)、患者健康问卷 9 抑郁量表 (PHQ-9)、IBS 生活质量量表 (IBS-QOL)、IBS 充分缓解(IBS-AR)、腹痛评分、腹胀评分、布里斯托大便评分 (BBS)、盲法评估和可信度评估。试验期间将监测和记录不良事件。 Chictr.org.cn ChiCTR2000030670。注册于2020年3月9日。

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Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial

Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effectiveness. This study was designed to assess the efficacy and feasibility of acupuncture in the treatment of IBS. This is a multicenter randomized controlled clinical trial. According to the ratio of 1:1:1, 90 patients with irritable bowel syndrome will be randomly divided into specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA) group. All patients will be treated with acupuncture 12 times within 4 weeks and followed up for 8 weeks. The primary outcome is the response rate, the percentage of patients whose average value of worst abdominal pain is 30% better and the days of loose stool is 50% less than the baseline, at week 4 after randomization. The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation. Adverse events will be monitored and recorded during the trial. Chictr.org.cn ChiCTR2000030670. Registered on 9 March 2020.

更新日期：2021-04-08

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