Saudi Journal of Gastroenterology
Home About us Instructions Submission Subscribe Advertise Contact Login    Print this page  Email this page Small font sizeDefault font sizeIncrease font size 
Users Online: 2094 
Year : 2014  |  Volume : 20  |  Issue : 6  |  Page : 378-382

Efficacy and safety of drotaverine hydrochloride in irritable bowel syndrome: A randomized double-blind placebo-controlled study

1 Department of Gastroenterology, Fortis-Escorts Hospital, Jaipur, Rajasthan, India
2 Department of Gastroenterolgy, M.L.N. Medical College, Allahabad, Uttar Pradesh, India
3 Department of Gastroenterolgy, Sri Balaji Action Medical Institute, New Delhi, India

Correspondence Address:
Ramesh R Rai
H-6, Janpath, Shyam Nagar, Jaipur - 302 019, Rajasthan
Login to access the Email id

Source of Support: Sponsored by Walter Bushnell, New Delhi, Conflict of Interest: None

DOI: 10.4103/1319-3767.145331

Rights and Permissions

Backgrounds/Aims: To study the efficacy and safety of drotaverine hydrochloride (HCl) 80 mg tablet given thrice a day in the symptomatic relief of patients with irritable bowel syndrome (IBS). Patients and Methods: The study was a multicentric, randomized, double-blind, placebo-controlled parallel group study performed at three centers. The patients who fulfilled Rome II Criteria of IBS were included in the study. A total of 180 patients with IBS were randomized to drotaverine and placebo treatment groups. Abdominal pain and stool frequency were measured every week in both the groups for all the 4 weeks of treatment duration. Subject Global Assessment of Relief (SGA) of IBS symptoms was assessed at the end of the study. Appropriate statistical analysis was done using SPSS software. Statistical Analysis Used: Mann-Whitney U-test (two-tailed), Wilcoxon signed ranks test, and McNemar tests. Results: Pain frequency decreased significantly (P < 0.01) in 22 (25.9%), 51 (60%), and 66 (77.7%) patients in the drotaverine group, at the end of 2 nd , 3 rd , and 4 th weeks, respectively, as compared with 8 (9.4%), 18 (21.2%), and 26 (30.6%) in the placebo group. Pain severity scores also decreased significantly in the drotaverine group 66 (77.7%) as compared with placebo 26 (30.6%) after 4 weeks. Drotaverine HCl was shown to provide significant improvement (P < 0.01) in global relief in abdominal pain as perceived by the patient (85.9% vs 39.5%) and the clinician (82.4% vs 36.5%) in the drotaverine group as compared with placebo. There is significant (P < 0.01) improvement in stool frequency in drotaverine HCl treatment group as compared with placebo. The drug is well tolerated without any major side effects. Conclusions: A 4-week treatment with drotaverine significantly improves abdominal symptoms in patients with IBS.

Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
 Related articles
 Citation Manager
 Access Statistics
 Reader Comments
 Email Alert *
 Add to My List *
 * Requires registration (Free)

 Article Access Statistics
    PDF Downloaded639    
    Comments [Add]    

Recommend this journal