A randomised double blind trial to compare the efficacy and tolerability of itopride hydrochloride versus domperidone in patients with non-ulcer dyspepsia: bloating predominant type

Background: Non-ulcer dyspepsia is a treatment challenge due to multiple pathophysiological mechanisms and different symptoms. Several prokinetic drugs are tried without any unanimity regarding safety and efficacy. The objective of the study was to compare the efficacy and safety of Itopride and Domperidone in bloating predominant non ulcer dyspepsia patients.Methods: Patients were randomly assigned to two groups (20 each) to receive either 50mg of Itopride three times daily or 10mg of Domperidone three times daily. Only patients with predominant bloating were considered and their baseline symptoms recorded. The symptoms were graded on a 4-point scale - the Global Symptom Score scale and the patients were reassessed at the end of 2 and 4 weeks. The relief of symptoms was also assessed at the end of 2 and 4 weeks on a 5-point scale - The Patients’ Subjective Global Assessment of Relief scale.Results: Both the drugs significantly produced symptomatic relief. Though Domperidone is marginally beneficial compared to Itopride after 4 weeks treatment in terms of improvement in symptom scores, the Subjective Global Assessment of relief did not show any significant improvement between the two drugs.Conclusions: Treatment with Itopride was safe, well tolerated, resulted in good symptomatic relief, and was comparable in efficacy to Domperidone in relieving the symptoms of NUD. Hence it can be considered a good alternative for the treatment of non-ulcer dyspepsia