Efficacy and safety of pinaverium bromide as an add-on therapy in refractory dyspepsia: A randomized controlled trial

Background and AimFunctional dyspepsia (FD) remains a therapeutic challenge, and the efficacy of antispasmodic agents as adjunctive therapy is not well established. This study aimed to evaluate the efficacy and safety of pinaverium bromide added to omeprazole in treating refractory FD.MethodsWe conducted a randomized, placebo-controlled trial in patients with refractory dyspepsia. Participants were randomly assigned to receive pinaverium (50 mg, 3 times/day, n = 36) or placebo (n = 36) in addition to omeprazole for 8 weeks. The primary endpoint was the responder rate for adequate relief. Secondary outcomes included the Global Overall Symptom Scale (GOSS), quality of life, and safety profile.ResultsNo statistically significant differences were observed in the adequate relief response rate between the pinaverium bromide and control group at week 2 (58.3% vs. 62.9%, P = 0.697), week 4 (62.9% vs. 78.1%, P = 0.173), week 6 (64.7% vs. 75.0%, P = 0.363), and week 8 (64.7% vs. 75.0%, P = 0.363). Additionally, there were no significant differences observed in the decline of symptom score between the two groups at week 4 (8.4 +/- 7.6 vs. 7.7 +/- 7.1, P = 0.702) and week 8 (10.9 +/- 8.2 vs. 8.4 +/- 7.2, P = 0.196). Similarly, there were no significant differences in terms of quality of life between the two groups. Adverse event rates were also comparable between the two groups.ConclusionPinaverium bromide was found to be safe in the treatment of refractory dyspepsia, but it did not demonstrate a significant benefit in improving symptoms. This randomized, placebo-controlled study investigated the addition of pinaverium bromide to omeprazole for treating refractory functional dyspepsia (FD). Results showed no significant difference between pinaverium bromide and placebo in terms of achieving adequate symptom relief, overall symptom scores, or quality of life improvements. While pinaverium bromide was well-tolerated, the study suggests it provides no additional benefit for managing refractory FD when combined with omeprazole. image