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

Gopesh Valoth; Sabeena Kizhedath

doi:10.18203/2319-2003.ijbcp20174773

Authors

Gopesh Valoth Department of Pharmacology, Govt. Medical College, Thrissur, Thrissur, Kerala, India
Sabeena Kizhedath Department of Pharmacology, Govt. Medical College, Thrissur, Thrissur, Kerala, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20174773

Keywords:

Itopride, Non-ulcer dyspepsia, Prokinetic drugs

Abstract

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.

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Author Biography

Gopesh Valoth, Department of Pharmacology, Govt. Medical College, Thrissur, Thrissur, Kerala, India

References

Tack J, Bisschops R, Sarnelli G. Pathophysiology and treatment of functional dyspepsia. Gastroenterology 2004;127(4):1239-55.

Lin C. The Rome III criteria for the functional GI disorders ,2006. Available at: http://www.medscape.com.View Article/533460.Accessed 21August 2007.

Talley NJ, Stanghellini V, Heading RC. Functional gastroduodenal disorders. GUT. 1999;45(2):1137-42.

McQuaid KR. Dyspepsia. In: Feldman M, Friedman LS, Sleisenger MH, eds.Sleisenger and Fordtran’s Gastrointestinal and Liver Diseases: Pathophysiology, Diagnosis, Management. 8th Ed. Philadelphia, Pa: Saunders; 2002:121-138.

Pasricha PJ. Prokinetic agents, antiemetics and agents used in irritable bowel syndrome. In: Hardman JG, Limbird LE,eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th Ed, New York, McGraw -Hill; 2001:1021-1036.

Wysowski DK, Corken A, Gallo-Torres H. Postmarketing reports of QT prolongation and ventricular arrhythmia in association with Cisapride and Food and Drug Administration regulatory actions. American Journal of Gastroenterology. 2001;96:1698-70.

Iwanga Y, Miyashita N, Mizutani F. Stimulatory effect ofN- [4-[2-(dimethylamino) ethoxy] benzyl]-3-4-dimethoxybenzamide hydrochloride (HSR-803) on normal and delayed gastrointestinal propulsion. Jpn J Pharmacol. 1991;56:261-9.

Iwanga Y, Miyashita N, Morikawa K. Novel water soluble dopamine-2-antagonist with anticholinesterase activity in gastrointestinal propulsion. Gastroenterol. 1993;99:401-8.

Iwanga Y, Miyashita N, Saito T. Gastroprokinetic effect of a new benzamide derivative Itopride and its action mechanism in conscious dogs. Jpn J Pharmacol. 1996;71:129-37.

Kakiuchi M, Saito T, Ohara N. Pharmacological evaluation of Itopride hydrochloride with drug-induced arrhythmias. Jpn Pharmacol Ther. 1997;25:811-7.

Mushiroda T, Douya R, Takahara E. The involvement of flavin containing monooxygenase but not CYP3A4 in metabolism of Itopride hydrochloride, a gastro prokinetic agent: comparison with Cisapride and Mosapride citrate. Drug Meta Dispos. 2000;28:1231-7.

Banka NH. Role of prokinetics in dyspepsia. Gastroenterology Today. 2003;7:1-4.

Thomson AB, Barkun AN, Armstrong D. The prevalence of clinically significant endoscopic findings in patients with uninvestigated dyspepsia: The Canadian Adult Dyspepsia Empirical treatment – Prompt Endoscopy (CADET-PE) study. Aliment Pharmacol Ther. 2003;17:1481.

The Danish Dyspepsia Study group: Value of the unaided clinical diagnosis in dyspeptic patients in primary care. American Journal of Gastroenterology. 2001;96:1417.

Talley N, Silverstein MD, Agreus L. AGA technical review: Evaluation of dyspepsia. Gastroenterology. 1998;114:582.

Sawant P, Das HS, Desai H. A Comparative evaluation of efficacy and tolerability of Itopride hydrochloride and Domperidone in patients with non-ulcer dyspepsia. J Assoc Physicians India. 2004;52:626-8.