Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial

Xu-dong TANG; Sheng-sheng ZHANG; Xiao-hua HOU; Zhen-hua LI; Su-ning CHEN; Pei-min FENG; Xiao-nan YANG; Hui-zhen LI; Jie-qiong WU; Pei-jun XIA; Xiao-jun YANG; Heng-jun ZHOU; Hai-yan WANG; Yao-wei AI; Kang LI

doi:10.1007/s11655-019-3030-x

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Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial

Original Article | Updated：2021-08-27

- Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial
- Chinese Journal of Integrative Medicine Vol. 25, Issue 12, Pages: 887-894(2019)
- Affiliations：
  
  1.Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100091), China
  2.Department of Gastroenterology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing (100010), China
  3.Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan (430022), China
  4.Department of Traditional Chinese Medicine, Shengjing Hospital, China Medical University, Shenyang (110004), China
  5.Department of Gastroenterology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu (610075), China
  6.Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu (610041), China
  7.Department of Gastroenterology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin (300250), China
  8.Department of Gastroenterology, the Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine, Xianyang (712000), Shaanxi Province, China
  9.Department of Gastroenterology, the Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, Jinan (250001), China
  10.Department of Gastroenterology, Chongqing Traditional Chinese Medicine Hospital, Chongqing (400021), China
  11.Department of Gastroenterology, Harbin Traditional Chinese Medicine Hospital, Harbin (150076), China
  12.Department of Gastroenterology, Yuncheng Central Hospital, Yuncheng (044031) Shanxi Province, China
  13.Department of Gastroenterology, The First Hospital of Yichang, Yichang (443000), Hubei Province, China
  14.Harbin Concise Pharmaceutical Technology Development Co., Ltd., Harbin (150001), China
- Author bio：
  
  Correspondence to: Prof. TANG Xu-dong, Tel: 86-10-62835011, E-mail: txdly@sina.com
- Funds：
- DOI：10.1007/s11655-019-3030-x
  CLC：
- Published：01 December 2019，
  
  Published Online：10 July 2019，
  
  Accepted：02 November 2018
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Xu-dong TANG, Sheng-sheng ZHANG, Xiao-hua HOU, et al. Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial. [J]. Chinese Journal of Integrative Medicine 25(12):887-894(2019)
DOI：

Xu-dong TANG, Sheng-sheng ZHANG, Xiao-hua HOU, et al. Post-marketing Re-evaluation of Tongxiening Granules (痛泻宁颗粒) in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial. [J]. Chinese Journal of Integrative Medicine 25(12):887-894(2019) DOI： 10.1007/s11655-019-3030-x.

摘要

Abstract

Objective:

To evaluate the efficacy and safety of Tongxiening Granules (痛泻宁颗粒

TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea (IBS-D).

Methods:

A randomized

double-blind

double-dummy

and positive parallel controlled clinical trial was conducted from October 2014 to March 2016. Totally 342 patients from 13 clinical centers were enrolled and randomly assigned (at the ratio of 1:1) to a treatment group (171 cases) and a control group (171 cases) by a random coding table. The patients in the treatment group were administered orally with TXNG (5 g per time) combined with pinaverium bromide Tablet simulator (50 mg per time)

3 times per day. The patients in the control group were given TXNG simulator (5 g per time) combined with pinaverium bromide Tablets (50 mg per time)

3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief (AR) rate

Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL)

Hamilton Anxiety Scale (HAMA)

Hamilton Depression Scale (HAMD)

and the recurrence rate at follow-ups. Safety indices including the adverse events (AEs) and related laboratory tests were evaluated.

Results:

Primary outcome: IBS-SSS at baseline

weeks 2

6 showed no statistical significance in both full analysis set (FAS) and per protocol set (PPS

0.05). After 6 weeks of treatment

the total effective rate of IBS-SSS scores in the treatment group (147/171

86.0%) was higher than the control group (143/171

83.6%) by FAS (

0.05). In regard to secondary outcomes

after 6-week treatment

there was no significant difference in AR rate

total score of IBS-QOL

improvement of HAMD and HAMA total scores between the two groups (

0.05). The recurrence rate at 8-week follow-up was 12.35% (10/18) in treatment group and 15.79% (12/76) in control group

respectivery (

0.05). A total of 21 AEs occurred in 15 cases

of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups (

0.05).

Conclusion:

Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide. (No. ChiCTR-IPR-15006415)

关键词

Keywords

Tongxiening Granulesirritable bowel syndrome with predominant diarrheapost-marketing evaluationrandomized controlled trial

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