长安Ⅰ号方（Ⅰ）治疗腹泻型肠易激综合征的疗效：一项多中心随机双盲安慰剂对照临床试验
Therapeutic Effect of Chang'an I Recipe ( I ) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial.
作者信息
Tang Xu-Dong, Lu Bin, Li Zhen-Hua, Wei Wei, Meng Li-Na, Li Bao-Shuang, Tang Zhi-Peng, Gao Rui, Wang Feng-Yun, Lu Fang, Bian Li-Qun, Zhao Ying-Pan, Wang Ping, Zhang Yin-Qiang
机构信息
Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
Department of Gastroenterology, Zhejiang Provincial Hospital of Traditional Chinese Medicine, Hangzhou, 310000, China.
出版信息
Chin J Integr Med. 2018 Sep;24(9):645-652. doi: 10.1007/s11655-016-2596-9. Epub 2016 Aug 3.
OBJECTIVE
To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang'an I Recipe ( I ) in the treatment of irritable bowel syndrome with diarrhea (IBS-D).
METHOD
A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang'an I Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score (IBS-SSS) and the differences in adequate relief (AR) responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life (IBS-QOL) and Hospital Anxiety and Depression (HAD) scales. The safety indices included adverse events and related laboratory tests.
RESULTS
A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set (FAS), 191 were included in the per protocol set (PPS). In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval (CI) for difference in the effective rates between the two groups of 14.4%-40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively (95% CI 16.6%-43.4%). The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group (FAS: 59.6% vs. 35.5%; PPS: 62.8% vs. 38.1%). As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups (P>0.05). Both anxiety and depression scales of HAD were not significantly different between the two groups (P>0.05). No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant.
CONCLUSION
Chang'an I Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. (No.ChiCTR-TRC-09000328).
目的
评价中药肠安Ⅰ号方治疗腹泻型肠易激综合征（IBS-D）的疗效及安全性。
方法
设计一项多中心、随机、双盲、安慰剂对照的临床试验。根据纳入顺序，将IBS-D患者随机分为治疗组或安慰剂对照组，分别给予肠安Ⅰ号方或安慰剂，150 mL/袋，每日3次，共8周。主要疗效指标包括IBS症状严重程度评分（IBS-SSS）有效率及充分缓解（AR）应答者差异；次要疗效指标包括IBS生活质量（IBS-QOL）及医院焦虑抑郁（HAD）量表评分变化。安全性指标包括不良事件及相关实验室检查。
结果
共纳入216例患者，治疗组109例，对照组107例，最终206例纳入全分析集（FAS），191例纳入符合方案集（PPS）。在FAS中，治疗组和对照组的总有效率分别为67.6%和40.2%，两组有效率差异的95%置信区间（CI）为14.4%-40.2%；而在PPS中，治疗组和对照组的总有效率分别为71.3%和41.2%（95%CI 16.6%-43.4%）。FAS和PPS的一致结论显示治疗组疗效更佳。FAS和PPS均显示治疗组的AR应答者更高（FAS：59.6%对35.5%；PPS：62.8%对38.1%）。关于IBS-QOL，两组IBS-QOL总分及各维度得分差异无统计学意义（P>0.05）。两组HAD焦虑和抑郁量表得分差异均无统计学意义（P>0.05）。未发现明显与受试药物相关或具有临床意义的不良事件或实验室异常。
结论
肠安Ⅰ号方治疗IBS-D比安慰剂更有效，且无明显不良反应。（注册号：ChiCTR-TRC-09000328）
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