title: Pinaverium Reduces Symptoms of Irritable Bowel Syndrome in a Multicenter, Randomized, Controlled Trial.
abstract: OBJECTIVE
  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.
  
  
  BACKGROUND
  NCT01641224 (www.ClinicalTrials.gov).
authors: Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Liang
authors: L
authors: Zheng
authors: Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine, Beijing, China.
authors: Yaoliang
authors: Y
authors: Lai
authors: Department of Gastroenterology, Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Weimin
authors: W
authors: Lu
authors: Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, Hongkou, Shanghai, China. Electronic address: libaiwen@163.com.
authors: Baiwen
authors: B
authors: Li
authors: Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors: Heng
authors: H
authors: Fan
authors: The Institute of Chinese Medical Sciences, the University of Macau, Taipa, Macao, Special Administrative Region, China.
authors: Zhixiang
authors: Z
authors: Yan
authors: American Academy of Acupuncture and Oriental Medicine, Roseville, Minnesota.
authors: Changzhen
authors: C
authors: Gong
authors: Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, Hongkou, Shanghai, China.
authors: Xinjian
authors: X
authors: Wan
authors: Department of Gastroenterology, Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Jing
authors: J
authors: Wu
authors: Department of Gastroenterology, Beijing Xuanwu Hospital of Chinese Medicine, Beijing, China.
authors: Dawei
authors: D
authors: Huang
authors: Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Yuanyuan
authors: Y
authors: Wang
authors: Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Yumei
authors: Y
authors: Mei
authors: Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Zhen
authors: Z
authors: Li
authors: Department of Gastroenterology, The Second Jiangsu Provincial Hospital of Chinese Medicine, Nanjing University of Chinese Medicine, Nanjing, China.
authors: Zhengyan
authors: Z
authors: Jiang
authors: Department of Integrated Chinese Medicine and Western Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors: Xingxing
authors: X
authors: Liu
authors: The Macrohard Institute of Health, Roseville, Minnesota.
authors: Jingyi
authors: J
authors: Ye
authors: The Macrohard Institute of Health, Roseville, Minnesota.
authors: Yongqiang
authors: Y
authors: Yang
authors: The Macrohard Institute of Health, Roseville, Minnesota.
authors: Huisuo
authors: H
authors: Huang
authors: The Macrohard Institute of Health, Roseville, Minnesota. Electronic address: xiaox102@umn.edu.
authors: Jun
authors: J
authors: Xiao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000009:adverse effects; D002681:China; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D010919:Placebos / Q000008:administration & dosage; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D002121:Calcium Channel Blockers; D009025:Morpholines; D010919:Placebos; C013199:pinaverium
keywords: Clinical Trial; Functional Bowel Disorder; IBS; Pinaverium