Lansoprazole plus levosulpiride versus esomeprazole in participants with gastroesophageal reflux disease and erosive esophagitis: a double blinded randomized control trial.

Abstract

AIM: The aim was to compare the efficacy and safety of lansoprazole plus levosulpiride over esomeprazole. METHODOLOGY: This randomized control trial recruited 1000 participants having symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis and they were blindly randomized into two groups in a 1:1 ratio with appropriate concealment. Group 1 was given lansoprazole plus levosulpiride combination twice daily whereas group 2 was prescribed only esomeprazole twice daily. The primary efficacy endpoint was the healing of erosive esophagitis and GERD at week 49. Secondary assessments included improvement in quality of life. Participants' quality of life was assessed before starting the treatment and post-treatment using a short-form health survey questionnaire (SF-36). RESULTS: The lansoprazole plus levosulpiride group had significantly lower rates of positive postintervention GERD and erosive esophagitis status, and higher rates of sustained resolution of heartburn compared to the esomeprazole alone group. However, the lansoprazole plus levosulpiride group also had a higher risk of nausea. CONCLUSION: Lansoprazole plus levosulpiride is a more effective and safe treatment for GERD than esomeprazole alone. Participants in the lansoprazole plus levosulpiride group showed a significantly higher rate of sustained resolution of GERD, lower rates of postintervention GERD and erosive esophagitis status, and a higher incidence of nausea compared to the esomeprazole alone group. Although quality of life worsened in both groups, adverse effects did not significantly differ. These findings strongly support the use of lansoprazole plus levosulpiride as a preferred treatment option for GERD and erosive esophagitis, which could have significant clinical implications for managing this common condition.