PMID- 31292845 OWN - NLM STAT- MEDLINE DCOM- 20200424 LR - 20200424 IS - 1993-0402 (Electronic) IS - 1672-0415 (Linking) VI - 25 IP - 12 DP - 2019 Dec TI - 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. PG - 887-894 LID - 10.1007/s11655-019-3030-x [doi] AB - 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). FAU - Tang, Xu-Dong AU - Tang XD AD - Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. txdly@sina.com. FAU - Zhang, Sheng-Sheng AU - Zhang SS AD - Department of Gastroenterology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, 100010, China. FAU - Hou, Xiao-Hua AU - Hou XH AD - Department of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China. FAU - Li, Zhen-Hua AU - Li ZH AD - Institute of Spleen-Stomach Diseases, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, China. FAU - Chen, Su-Ning AU - Chen SN AD - Department of Traditional Chinese Medicine, Shengjing Hospital, China Medical University, Shenyang, 110004, China. FAU - Feng, Pei-Min AU - Feng PM AD - Department of Gastroenterology, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, 610075, China. FAU - Yang, Xiao-Nan AU - Yang XN AD - Department of Integrated Traditional Chinese and Western Medicine, West China Hospital of Sichuan University, Chengdu, 610041, China. FAU - Li, Hui-Zhen AU - Li HZ AD - Department of Gastroenterology, the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, 300250, China. FAU - Wu, Jie-Qiong AU - Wu JQ AD - Department of Gastroenterology, the Second Affiliated Hospital of Shaanxi College of Traditional Chinese Medicine, Xianyang, 712000, Shaanxi Province, China. FAU - Xia, Pei-Jun AU - Xia PJ AD - Department of Gastroenterology, the Second Affiliated Hospital of Shandong Traditional Chinese Medicine University, Jinan, 250001, China. FAU - Yang, Xiao-Jun AU - Yang XJ AD - Department of Gastroenterology, Chongqing Traditional Chinese Medicine Hospital, Chongqing, 400021, China. FAU - Zhou, Heng-Jun AU - Zhou HJ AD - Department of Gastroenterology, Harbin Traditional Chinese Medicine Hospital, Harbin, 150076, China. FAU - Wang, Hai-Yan AU - Wang HY AD - Department of Gastroenterology, Yuncheng Central Hospital, Yuncheng, 044031, Shanxi Province, China. FAU - Ai, Yao-Wei AU - Ai YW AD - Department of Gastroenterology, The First Hospital of Yichang, Yichang, 443000, Hubei Province, China. FAU - Li, Kang AU - Li K AD - Harbin Concise Pharmaceutical Technology Development Co., Ltd., Harbin, 150001, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20190710 PL - China TA - Chin J Integr Med JT - Chinese journal of integrative medicine JID - 101181180 RN - 0 (Drugs, Chinese Herbal) RN - 0 (Morpholines) RN - U2368VVE7O (pinaverium) SB - IM MH - Adult MH - Diarrhea/*drug therapy MH - Double-Blind Method MH - Drug Therapy, Combination MH - Drugs, Chinese Herbal/*therapeutic use MH - Female MH - Humans MH - Irritable Bowel Syndrome/*drug therapy MH - Male MH - Middle Aged MH - Morpholines/*therapeutic use MH - *Product Surveillance, Postmarketing MH - Quality of Life MH - Surveys and Questionnaires OTO - NOTNLM OT - Tongxiening Granules OT - irritable bowel syndrome with predominant diarrhea OT - post-marketing evaluation OT - randomized controlled trial EDAT- 2019/07/12 06:00 MHDA- 2020/04/25 06:00 CRDT- 2019/07/12 06:00 PHST- 2018/11/02 00:00 [accepted] PHST- 2019/07/12 06:00 [pubmed] PHST- 2020/04/25 06:00 [medline] PHST- 2019/07/12 06:00 [entrez] AID - 10.1007/s11655-019-3030-x [pii] AID - 10.1007/s11655-019-3030-x [doi] PST - ppublish SO - Chin J Integr Med. 2019 Dec;25(12):887-894. doi: 10.1007/s11655-019-3030-x. Epub 2019 Jul 10.