Effect of Acotiamide and Esomeprazole combination therapy on Functional Dyspepsia symptoms in comparison with Acotiamide or Esomeprazole Monotherapy: A Prospective Observational Study

Abstract

Aim: The aim of this study was to assess the effect of acotiamide and esomeprazole combination therapy in improving Functional Dyspepsia (FD) - related symptoms in comparison with acotiamide or esomeprazole monotherapy. Materials and Methods: This was a prospective observational study conducted in patients attending outpatient department of Gastroenterology, M S Ramaiah Hospitals and diagnosed to have functional dyspepsia based on Rome IV criteria. Group 1 received acotiamide, group 2 received esomeprazole and group 3 received acotiamide plus esomeprazole combination therapy for a period of 6 weeks. The efficacy of treatment was assessed using symptom assessment scale. We also assessed the responder rate, resolution rate and treatment emergent adverse events. Results: In this study a total of 52 patients completed the study in each group. There was a statistically significant improvement in symptom assessment scale - Epigastric pain syndrome (EPS), Postprandial distress syndrome (PDS), Total Abdominal Symptom (TAS) scores from baseline to 6 weeks in all the 3 treatment groups (p <0.001). Combination therapy (group 3) showed maximum reduction from baseline to week 6 (mean differences of 11.07, 3.53 and 5.65 in TAS, EPS, PDS scores respectively). The common adverse events reported were fever, headache, diarrhoea and nasopharyngitis. Conclusion: Combination therapy of acotiamide with esomeprazole was effective in reducing symptom scores at the end of 6 weeks in patients with FD as compared to monotherapy with either of the drugs.