Liang Zheng1, Yaoliang Lai2, Weimin Lu3, Baiwen Li4, Heng Fan5, Zhixiang Yan6, Changzhen Gong7, Xinjian Wan8, Jing Wu3, Dawei Huang2, Yuanyuan Wang1, Yumei Mei1, Zhen Li1, Zhengyan Jiang1, Xingxing Liu5, Jingyi Ye9, Yongqiang Yang9, Huisuo Huang9, Jun Xiao10. 1. Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China. 2. Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine, Beijing, China. 3. Department of Gastroenterology, Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China. 4. Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, Hongkou, Shanghai, China. Electronic address: libaiwen@163.com. 5. Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. 6. The Institute of Chinese Medical Sciences, the University of Macau, Taipa, Macao, Special Administrative Region, China. 7. American Academy of Acupuncture and Oriental Medicine, Roseville, Minnesota. 8. Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, Hongkou, Shanghai, China. 9. The Macrohard Institute of Health, Roseville, Minnesota. 10. The Macrohard Institute of Health, Roseville, Minnesota. Electronic address: xiaox102@umn.edu.
Abstract
BACKGROUND & AIMS:Pinaverium bromide (pinaverium) is an antispasmodic commonly used to treat irritable bowel syndrome (IBS), but there has been no convincing evidence for its effectiveness and safety. We evaluated these in a prospective, double-blind, placebo-controlled trial. METHODS:Patients with IBS, based on Rome III criteria, were assigned randomly to groups given pinaverium (50 mg, 3 times/day; n = 218) or placebo (3 times/day; n = 209) at 4 hospitals in China, from August 2012 through December 2013. The primary end points were reductions in abdominal pain and Bristol stool score. Secondary end points were reductions in pain and stool frequencies and abdominal discomfort and its frequency. We also evaluated changes in IBS global symptom scores and the number of adverse effects. RESULTS: Based on an intention-to-treat analysis, a significantly larger proportion of patients receiving pinaverium met either of the primary end points (50.0% met an end point at week 2, and 77.5% met an end point at week 4), compared with placebo (P < .001). Pinaverium reduced at least 1 secondary end point in significantly more patients receiving pinaverium (76.1% had a reduction at week 2, and 91.7% had a reduction at week 4) than placebo (P < .001). Based on symptom scores, significantly higher percentages of patients receiving pinaverium believed that their IBS symptoms improved (60%) than in the placebo group (34%; P < .001); 29% of patients in the pinaverium group believed that their IBS symptoms stayed the same (29%) and 11% said they worsened. Pinaverium was not associated with severe adverse effects; common side effects included nausea (3.7%), dizziness (3.2%), increased blood pressure (2.3%), and abdominal discomfort (2.3%). CONCLUSIONS: Based on a controlled trial, pinaverium reduces symptoms of IBS. It can be considered a first-line treatment for IBS. TRIAL REGISTRATION: NCT01641224 (www.ClinicalTrials.gov).
RCT Entities:
BACKGROUND & AIMS:Pinaverium bromide (pinaverium) is an antispasmodic commonly used to treat irritable bowel syndrome (IBS), but there has been no convincing evidence for its effectiveness and safety. We evaluated these in a prospective, double-blind, placebo-controlled trial. METHODS:Patients with IBS, based on Rome III criteria, were assigned randomly to groups given pinaverium (50 mg, 3 times/day; n = 218) or placebo (3 times/day; n = 209) at 4 hospitals in China, from August 2012 through December 2013. The primary end points were reductions in abdominal pain and Bristol stool score. Secondary end points were reductions in pain and stool frequencies and abdominal discomfort and its frequency. We also evaluated changes in IBS global symptom scores and the number of adverse effects. RESULTS: Based on an intention-to-treat analysis, a significantly larger proportion of patients receiving pinaverium met either of the primary end points (50.0% met an end point at week 2, and 77.5% met an end point at week 4), compared with placebo (P < .001). Pinaverium reduced at least 1 secondary end point in significantly more patients receiving pinaverium (76.1% had a reduction at week 2, and 91.7% had a reduction at week 4) than placebo (P < .001). Based on symptom scores, significantly higher percentages of patients receiving pinaverium believed that their IBS symptoms improved (60%) than in the placebo group (34%; P < .001); 29% of patients in the pinaverium group believed that their IBS symptoms stayed the same (29%) and 11% said they worsened. Pinaverium was not associated with severe adverse effects; common side effects included nausea (3.7%), dizziness (3.2%), increased blood pressure (2.3%), and abdominal discomfort (2.3%). CONCLUSIONS: Based on a controlled trial, pinaverium reduces symptoms of IBS. It can be considered a first-line treatment for IBS. TRIAL REGISTRATION: NCT01641224 (www.ClinicalTrials.gov).
Authors: Edoardo Savarino; Fabiana Zingone; Brigida Barberio; Giovanni Marasco; Filiz Akyuz; Hale Akpinar; Oana Barboi; Giorgia Bodini; Serhat Bor; Giuseppe Chiarioni; Gheorghe Cristian; Maura Corsetti; Antonio Di Sabatino; Anca Mirela Dimitriu; Vasile Drug; Dan L Dumitrascu; Alexander C Ford; Goran Hauser; Radislav Nakov; Nisha Patel; Daniel Pohl; Cătălin Sfarti; Jordi Serra; Magnus Simrén; Alina Suciu; Jan Tack; Murat Toruner; Julian Walters; Cesare Cremon; Giovanni Barbara Journal: United European Gastroenterol J Date: 2022-06-13 Impact factor: 6.866
Authors: Paul Moayyedi; Christopher N Andrews; Glenda MacQueen; Christina Korownyk; Megan Marsiglio; Lesley Graff; Brent Kvern; Adriana Lazarescu; Louis Liu; William G Paterson; Sacha Sidani; Stephen Vanner Journal: J Can Assoc Gastroenterol Date: 2019-01-17