Comparison between Proton Pump Inhibitor and H2 Receptor Antagonist in Relieving Cyclosporine-Associated Adverse Gastrointestinal Events: A Single Center, Randomized Controlled Trial

Abstract

Background: Cyclosporine (CS) has been effectively used in various skin diseases, but gastrointestinal (GI) adverse events are so common. However, there is no standardized treatment for managing CS-induced GI adverse events. Objective: To analyze the effectiveness of two empirical GI medications, an H2 receptor antagonist (H2RA) and proton pump inhibitor (PPI), in relieving CS-induced GI adverse events. Methods: This is a prospective, randomized clinical trial conducted at Ajou University Hospital. The patients completed a gastrointestinal symptom rating scale (GSRS) questionnaire to assess GI symptoms before and after taking the drugs. Results: A total of 60 patients, divided into a PPI group (n=30) and an H2RA group (n=30), were analyzed. The onset of GI events occurred in 6.04 days on average. GSRS scores improved significantly in both groups (p < 0.01). While abdominal pain, reflux syndrome, and indigestion syndrome consistently improved, changes in diarrhea syndrome and constipation syndrome were not statistically significant. The overall change in GSRS scores was higher in the PPI group, but the difference was not significant (p=0.76). Conclusion: Both PPI and H2RA significantly improved CS-induced GI side effects, with PPI showing a slight advantage over H2RA, but the cost of PPIs should be considered when deciding on first-line therapy. GI side effects typically appeared within 6.04 days of starting CS therapy, highlighting the importance of close monitoring and personalized intervention for improving patient compliance.