Randomized trial of the effect of esomeprazole on functional dyspepsia during Ramadan fasting

Dyspeptic symptoms are frequently encountered during Ramadan and may be exacerbated by changes in eating habits. We assessed the efficacy of esomeprazole in patients with functional dyspepsia (FD) who fasted during Ramadan. In this randomized, double-blind controlled study, 245 patients diagnosed with FD who completed Ramadan fasting were randomly assigned (1:1 ratio) to receive either esomeprazole (n = 122) or placebo (n = 123) for 30 days. Dyspepsia was assessed using the Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) at baseline (pre-Ramadan), day7, day 14, and at end of Ramadan (End-Ramadan). The primary endpoint was the rate of responders defined as a > 50% reduction from baseline in SF-LDQ score at End-Ramadan. Secondary endpoints were changes in SF-LDQ scores over time, improvement in quality of life assessed by the general health and physical function components of SF-12 score, and safety. At End-Ramadan, 95% of the patients receiving placebo and 98% receiving esomeprazole were responders (p = 0.5). The SF-LDQ score improved more significantly with esomeprazole than with placebo at day7 [(mean difference 0.71 (95% CI - 1.64 to 1.18)], and at day 14 [(mean difference 0.77 (95% CI - 1.7 to 4.7)]. Both treatments significantly improved quality of life from baseline. All adverse events were minor and similar in both groups. Our results showed that, in patients with FD fasting during Ramadan, esomeprazole was effective. Our findings also suggest that fasting itself may contribute to significant improvement in FD symptoms. The potential synergistic effects of fasting combined with PPIs warrant further investigation.Trial registration: The protocol was registered at www.clinicaltrials.gov in 09/10/2020 under the number NCT05287633.