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

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.

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.

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.

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.