Post-marketing Re-evaluation of Tongxiening Granules () 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

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

Author: Xu-Dong TANG ¹ ; Sheng-Sheng ZHANG ² ; Xiao-Hua HOU ³ ; Zhen-Hua LI ⁴ ; Su-Ning CHEN ⁵ ; Pei-Min FENG ⁶ ; Xiao-Nan YANG ⁷ ; Hui-Zhen LI ⁸ ; Jie-Qiong WU ⁹ ; Pei-Jun XIA ¹⁰ ; Xiao-Jun YANG ¹¹ ; Heng-Jun ZHOU ¹² ; Hai-Yan WANG ¹³ ; Yao-Wei AI ¹⁴ ; Kang LI ¹⁵
Author Information

1. Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. txdly@sina.com.
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. Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China.
5. Department of Traditional Chinese Medicine, Shengjing Hospital, China Medical University, Shenyang, 110004, China.
6. Department of Gastroenterology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China.
7. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu, 610041, China.
8. Department of Gastroenterology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China.
9. Department of Gastroenterology, the Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine, Xianyang, 712000, Shaanxi Province, China.
10. Department of Gastroenterology, the Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, Jinan, 250001, China.
11. Department of Gastroenterology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400021, China.
12. Department of Gastroenterology, Harbin Traditional Chinese Medicine Hospital, Harbin, 150076, China.
13. Department of Gastroenterology, Yuncheng Central Hospital, Yuncheng, 044031, Shanxi Province, China.
14. Department of Gastroenterology, The First Hospital of Yichang, Yichang, 443000, Hubei Province, China.
15. Harbin Concise Pharmaceutical Technology Development Co., Ltd., Harbin, 150001, China.
Publication Type:Journal Article
Keywords: Tongxiening Granules; irritable bowel syndrome with predominant diarrhea; post-marketing evaluation; randomized controlled trial
From: Chinese journal of integrative medicine 2019;25(12):887-894
CountryChina
Language:English
Abstract: OBJECTIVE:To evaluate the efficacy and safety of Tongxiening Granules (, 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, 4, 6 showed no statistical significance in both full analysis set (FAS) and per protocol set (PPS, P>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 (P>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 (P>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, respectively (P>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 (P>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).