A Randomized Controlled Trial Comparing Vonoprazan and Proton Pump Inhibitors for Symptom Relief and Mucosal Healing in Scleroderma-Associated GERD

Abstract

Background: Gastroesophageal reflux disease (GERD) is a frequent and debilitating complication of systemic sclerosis (SSc), primarily due to esophageal dysmotility and smooth muscle atrophy. Standard treatment with proton pump inhibitors (PPIs) often provides suboptimal symptom relief. Vonoprazan, a potassium-competitive acid blocker (P-CAB), offers more potent and sustained acid suppression. This study aimed to compare the efficacy and safety of vonoprazan versus standard-dose PPIs in the treatment of SSc-associated GERD.

Methods: In a randomized controlled trial, 30 patients with SSc and symptomatic GERD were assigned to receive either vonoprazan 20 mg once daily or a standard-dose PPI for 8 weeks. Primary outcomes included changes in symptom severity scores and endoscopic mucosal healing. Secondary outcomes assessed quality-of-life (QoL) improvements and adverse events. Data were analyzed using independent t-tests and chi-square tests, with a significance threshold of p < 0.05.

Results: Patients in the vonoprazan group experienced a significantly greater reduction in GERD symptom scores compared to those receiving PPIs (mean difference: 3.1; p = 0.02). Mucosal healing occurred in 80% of vonoprazan-treated patients versus 53% in the PPI group (OR: 3.5; 95% CI: 0.8–14.9; p = 0.09). QoL improvements were noted in both groups, with a significantly greater effect observed in the vonoprazan group (p = 0.04). Adverse events were mild and similar in both arms

Conclusions: Vonoprazan provided superior symptom control and showed a favorable trend toward improved mucosal healing in patients with SSc-associated GERD compared to standard PPIs. These findings suggest vonoprazan may represent a more effective first-line treatment option in this challenging clinical population