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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

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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, 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)

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Authors and Affiliations

  1. Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China

    Xu-dong Tang & Zhen-hua Li

  2. Department of Gastroenterology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China

    Sheng-sheng Zhang

  3. Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China

    Xiao-hua Hou

  4. Department of Traditional Chinese Medicine, Shengjing Hospital, China Medical University, Shenyang, 110004, China

    Su-ning Chen

  5. Department of Gastroenterology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China

    Pei-min Feng

  6. Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu, 610041, China

    Xiao-nan Yang

  7. Department of Gastroenterology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China

    Hui-zhen Li

  8. Department of Gastroenterology, the Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine, Xianyang, 712000, Shaanxi Province, China

    Jie-qiong Wu

  9. Department of Gastroenterology, the Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, Jinan, 250001, China

    Pei-jun Xia

  10. Department of Gastroenterology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400021, China

    Xiao-jun Yang

  11. Department of Gastroenterology, Harbin Traditional Chinese Medicine Hospital, Harbin, 150076, China

    Heng-jun Zhou

  12. Department of Gastroenterology, Yuncheng Central Hospital, Yuncheng, 044031, Shanxi Province, China

    Hai-yan Wang

  13. Department of Gastroenterology, The First Hospital of Yichang, Yichang, 443000, Hubei Province, China

    Yao-wei Ai

  14. Harbin Concise Pharmaceutical Technology Development Co., Ltd., Harbin, 150001, China

    Kang Li

Authors
  1. Xu-dong Tang
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  2. Sheng-sheng Zhang
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  3. Xiao-hua Hou
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  4. Zhen-hua Li
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  5. Su-ning Chen
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  6. Pei-min Feng
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  7. Xiao-nan Yang
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  8. Hui-zhen Li
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  9. Jie-qiong Wu
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  13. Hai-yan Wang
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  14. Yao-wei Ai
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  15. Kang Li
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Contributions

Tang XD and Li ZH designed the study; Zhang SS, Hou XH, Chen S, Feng PM, Yang XN, Li HZ, Wu JQ, Xia PJ, Yang XJ, Zhou HJ, Wang HY and Ai YW carried out the trial; Li K performed the statistical analysis; Tang XD designed and wrote the manuscript.

Corresponding author

Correspondence to Xu-dong Tang.

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Conflict of Interest

The authors declare no conflict of interest with respect to the research, authorship, and/or publication of this article. This study was funded by Chongqing Pharscin Pharmaceutical Co., Ltd.

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Tang, Xd., Zhang, Ss., Hou, Xh. 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. Chin. J. Integr. Med. 25, 887–894 (2019). https://doi.org/10.1007/s11655-019-3030-x

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