Famotidine in the treatment of functional dyspepsia: a randomized double-blind, placebo-controlled trial.

AIM: In the present study, we aimed to investigate patients with a documented diagnosis of functional dyspepsia (FD) who had been admitted to our outpatient Gastroenterology Clinic and provided consent to participate in this randomized, double-blind, placebo-controlled trial of the therapeutic impact of famotidine on the symptoms and quality of life of FD patients.

PARTICIPANTS AND

METHODS

A total of 160 patients attending our outpatient clinic with a diagnosis of FD according to Rome III criteria were enrolled in this double-blind study. They were randomized into case (famotidine treatment) and placebo groups; patients were asked to refill the Honk Kong dyspepsia index (a self global assessment tool) before the start of the study as well as after 3 months of treatment.

RESULTS

Both famotidine and placebo led to significant improvements in dyspepsia symptoms, except for vomiting in both groups and loss of appetite in the placebo control group. However, the extent of these improvements was not different between the two study groups for most of the study parameters, whereas belching, feeling of acid regurgitation, heartburn, and the total score for the Hong Kong dyspepsia index were significantly more responsive to famotidine than placebo. No significant effectiveness of famotidine therapy was found regarding quality of life.

CONCLUSION AND RECOMMENDATIONS: This study showed a significant improvement in the total dyspepsia scores of FD, with a marked effect on belching, heartburn, and the feeling of acid regurgitation. These findings suggest that famotidine may be administered in certain FD patients who have significantly more symptoms of belching, heartburn, and acid regurgitation.