A randomised double blind placebo controlled trial to assess the efficacy and tolerability of short course of ornidazole in diarrhoea predominant irritable bowel syndrome

摘要

Background: Irritable bowel syndrome is a common disorder affecting the general population. At present the treatment is mainly symptomatic as the pathophysiology is not clear. Abnormal flora especially small bowel bacterial over growth is considered as one of the causes. A short course of ornidazole is compared with placebo to assess its efficacy and tolerability in diarrhoea predominant irritable bowel syndrome. Methods: This was a randomised double-blind placebo controlled trial done in the Departments of Gastroenterology and Pharmacology at Government Medical College, Calicut. Patients were randomly assigned to two groups to receive either ornidazole or Placebo. The baseline symptoms were recorded and graded to get a global symptom score. Patients assigned to ornidazole group received 500mg twice daily orally for 5 days and the control group received identical looking placebo tablets. The patients were reassessed every week for four weeks. The patients subjective global assessment of relief and global symptom score was recorded. Statistical analysis was done using Wilcoxon signed Rank test and Mann Whitney U test. Results: This study was done in twenty patients with a mean age of 30 with comparable baseline characteristics and symptom scores (p=0.969). Ornidazole produced a highly significant reduction in the global symptom score (p0.001) compared to placebo. It was maintained through the four weeks follow up. No serious adverse effects were reported. Two patients reported burning sensation in the stomach which was self limited. Conclusions: Ornidazole is efficacious than placebo in controlling the symptoms of diarrhoea predominant irritable bowel syndrome and is well tolerated.