Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Xu-dong Tang; Bin Lu; Zhen-hua Li; Wei Wei; Li-na Meng; Bao-shuang Li; Zhi-peng Tang; Rui Gao; Feng-yun Wang; Fang Lu; Li-qun Bian; Ying-pan Zhao; Ping Wang; Yin-qiang Zhang

doi:10.1007/s11655-016-2596-9

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Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

OriginalPaper | Updated：2021-08-27

- Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
- Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
- 中国结合医学杂志（英文版） 2018年24卷第9期页码：645-652
- Affiliations：
  
  1. Department of Gastroenterology, Xiyuan Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  2. Department of Gastroenterology, Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou,China
  3. Department of Gastroenterology, Wangjing Hospital, China Academy of Chinese Medical Sciences,Beijing,China
  4. Department of Gastroenterology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine,Shanghai,China
- Author bio：
- Funds：
  
  Supported by China International Sciences and Technology Cooperation Program (No. 2007DFA30560)
- DOI：10.1007/s11655-016-2596-9
  中图分类号：
- 纸质出版日期：2018，
  
  网络出版日期：2016-8-3，
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Tang, Xd., Lu, B., Li, Zh. et al. Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial., Chin. J. Integr. Med. 24, 645–652 (2018). https://doi.org/10.1007/s11655-016-2596-9

Xu-dong Tang, Bin Lu, Zhen-hua Li, et al. Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(9):645-652.
Tang, Xd., Lu, B., Li, Zh. et al. Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial., Chin. J. Integr. Med. 24, 645–652 (2018). https://doi.org/10.1007/s11655-016-2596-9 DOI：

Xu-dong Tang, Bin Lu, Zhen-hua Li, et al. Therapeutic Effect of Chang’an I Recipe (肠安 I 号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial[J]. Chinese Journal of Integrative Medicine, 2018,24(9):645-652. DOI： 10.1007/s11655-016-2596-9.

摘要

To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang’an I Recipe (肠安 I 号方) in the treatment of irritable bowel syndrome with diarrhea (IBS-D). 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. 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. Chang’an I Recipe was more effective than placebo in the treatment of IBS-D

with no obvious adverse reactions. (No.ChiCTR-TRC-09000328)

Abstract

To evaluate the efficacy and safety of Chinese medicine (CM) decoction Chang’an I Recipe (肠安 I 号方) in the treatment of irritable bowel syndrome with diarrhea (IBS-D). 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

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

with no obvious adverse reactions. (No.ChiCTR-TRC-09000328)

关键词

irritable bowel syndrome with diarrheaChinese MedicineChang’an I RecipePlaceborandomized controlled trial

Keywords

irritable bowel syndrome with diarrheaChinese MedicineChang’an I RecipePlaceborandomized controlled trial

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