Gastroesophageal Reflux Disease Associated With Anxiety: Efficacy and Safety of Fixed Dose Combination of Amitriptyline and Pantoprazole

Background The aim of the study was to evaluate the efficacy and tolerability of fixed dose combination of amitriptyline and pantoprazole in gastroesophageal reflux disease (GERD) associated with anxiety. Methods A non-randomized, open-labeled, non-comparative, multi-center study was conducted in a total of 99 patients (77 men and 22 women, mean age 44.16 ± 11.53 years). Each patient was administered a fixed dose combination of amitriptyline 10 mg and pantoprazole 40 mg once a day, for 4 weeks. GERD questionnaire, hospital anxiety and depression score (HADS) and SF-8 questionnaire (short-form health survey) were performed at baseline and at the end of study as assessment tools. Results At the end of study, data were extractable only in 96 patients because three patients were dropped out due to loss of follow-up at week 4. GERD symptoms and anxiety score reduced significantly (P < 0.0001) at week 4 compared to baseline. SF-8 score also improved significantly (P < 0.0001) at week 4. There were no adverse events reported. Conclusion Amitriptyline and pantoprazole combination was found to be effective and safe for management in GERD patients with coexisting anxiety.