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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

  • Xu-dong TangEmail author
  • 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
Original Article
  • 18 Downloads

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)

Keywords

Tongxiening Granules irritable bowel syndrome with predominant diarrhea post-marketing evaluation randomized controlled trial 

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Supplementary material

11655_2019_3030_MOESM1_ESM.pdf (97 kb)
Appendix 1 Patients Recruited in Each Clinical Center

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Copyright information

© The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag GmbH Germany, part of Springer Nature 2019

Authors and Affiliations

  • Xu-dong Tang
    • 1
    Email author
  • Sheng-sheng Zhang
    • 2
  • Xiao-hua Hou
    • 3
  • Zhen-hua Li
    • 1
  • Su-ning Chen
    • 4
  • Pei-min Feng
    • 5
  • Xiao-nan Yang
    • 6
  • Hui-zhen Li
    • 7
  • Jie-qiong Wu
    • 8
  • Pei-jun Xia
    • 9
  • Xiao-jun Yang
    • 10
  • Heng-jun Zhou
    • 11
  • Hai-yan Wang
    • 12
  • Yao-wei Ai
    • 13
  • Kang Li
    • 14
  1. 1.Institute of Spleen-Stomach Diseases, Xiyuan HospitalChina Academy of Chinese Medical SciencesBeijingChina
  2. 2.Department of Gastroenterology, Beijing Hospital of Traditional Chinese MedicineCapital Medical UniversityBeijingChina
  3. 3.Department of Gastroenterology, Union Hospital, Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanChina
  4. 4.Department of Traditional Chinese Medicine, Shengjing HospitalChina Medical UniversityShenyangChina
  5. 5.Department of GastroenterologyAffiliated Hospital of Chengdu University of Traditional Chinese MedicineChengduChina
  6. 6.Department of Integrated Traditional Chinese and Western MedicineWest China Hospital of Sichuan UniversityChengduChina
  7. 7.Department of Gastroenterologythe Second Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjinChina
  8. 8.Department of Gastroenterologythe Second Affiliated Hospital of Shaanxi College of Traditional Chinese MedicineXianyangChina
  9. 9.Department of Gastroenterologythe Second Affiliated Hospital of Shandong Traditional Chinese Medicine UniversityJinanChina
  10. 10.Department of GastroenterologyChongqing Traditional Chinese Medicine HospitalChongqingChina
  11. 11.Department of GastroenterologyHarbin Traditional Chinese Medicine HospitalHarbinChina
  12. 12.Department of GastroenterologyYuncheng Central HospitalYunchengChina
  13. 13.Department of GastroenterologyThe First Hospital of YichangYichangChina
  14. 14.Harbin Concise Pharmaceutical Technology Development Co. Ltd.HarbinChina

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