Efficacy and safety of a fixed-dose papain and alpha-amylase combination in patients with functional dyspepsia: a real-world study

Background Functional dyspepsia (FD) is highly prevalent and often inadequately managed because conventional therapies may have limited efficacy or tolerability. Enzyme-based therapies offer a physiologically relevant alternative by supporting digestion. This study evaluated the real-world effectiveness and safety of a fixed-dose combination (FDC) of papain and alpha-amylase in patients with FD. Methodology This prospective, multicenter, single-arm intervention study enrolled adults with FD (Rome IV criteria) across four Indian centers. Patients received the FDC for 12 days. The primary endpoint was a ≥50% reduction in composite symptom score. Secondary endpoints included symptom resolution, time to relief, safety, and subgroup outcomes. Assessments were conducted at baseline, Day 7, and Day 12. Results Of 160 enrolled patients, 144 (90%) completed the study. Mean symptom scores declined significantly from 9.35 ± 1.42 (baseline) to 0.15 ± 0.35 (Day 12; p < 0.0001), indicating 98.4% improvement. Clinical response was achieved in all patients by Day 7 and sustained on Day 12, with 85.4% achieving excellent response. The arithmetic mean (unweighted) of domain-specific resolution percentages reached 98.7% by Day 12. Median time to initial relief was approximately 4 hours. Adverse events were mild and reported in 12.5% of patients. Conclusion The FDC demonstrated short-term rapid, substantial, and consistent symptom relief with favorable tolerability in patients with FD.