Buccal Buspirone as add-on Therapy to Omeprazole Versus Omeprazole in Treatment of Gastroesophageal Reflux Diseases (GERD).

Abstract

Proton pump inhibitors (PPIs) are recommended as first line treatments for gastroesophageal reflux disease (GERD). Failure to PPIs has been mentioned as a problem in pharmacotherapy of GERD. The present study compared the symptom relief, quality of life (QoL) and adverse drug reactions (ADRs) of omeprazole plus buccal buspirone with that of omeprazole alone.This was a prospective, randomized trial between buccal buspirone (10 mg/d) plus omeprazole (20 mg/d) and omeprazole (20 mg/d) plus placebo administered for 4 weeks to patients with GERD symptoms. Patients who had GERD symptoms enrolled in this study. 67 patients were randomly assigned to either the buspirone plus omeprazole group (n = 33) or the placebo plus omeprazole group (n = 34). Finally, 58 patients completed the study (29 in each group). Treatment response rates in each drug group were evaluated according to the Frequency Scale for the Symptoms of GERD (FFSG). The QoL and ADRs have been also evaluated too.The treatment score rates for symptom relief according to the FFSG were 7.13 ± 5.13 in the buspirone group and 15.34 ± 8.17 in the placebo group. Regarding FFSG score, there is a significant difference between the groups (p < 0.0001). QoL were 6.86 ± 6.65 and 27.2 ± 20.95 in placebo and buspirone group, respectively after four weeks and there is a significant difference in two groups ( p < 0.0001).The total incidence of ADRs were similar in the buspirone and placebo groups (p = 0.36).A combination of buccal buspirone plus omeprazole may be a more effective treatment for GERD than omeprazole alone.