Digestive Enzyme Combination Eased Functional Dyspepsia Symptoms in 12-Day Indian Study

A fixed-dose combination of the digestive enzymes papain and alpha-amylase produced rapid and substantial symptom relief in patients with functional dyspepsia, according to a prospective, multicenter, single-arm intervention study conducted across four centers in India. The findings, published in Frontiers in Gastroenterology, report that mean composite symptom scores fell from 9.35 ± 1.42 at baseline to 0.15 ± 0.35 by Day 12, a 98.4% improvement that reached statistical significance at p < 0.0001.

Functional dyspepsia is a highly prevalent condition that is often inadequately managed because conventional therapies may have limited efficacy or tolerability. Enzyme-based therapies have been proposed as a physiologically relevant alternative by supporting digestion directly. The study enrolled adults who met the Rome IV criteria for functional dyspepsia and treated them with the fixed-dose combination for 12 days, with assessments at baseline, Day 7, and Day 12.

The primary endpoint was a reduction of at least 50% in the composite symptom score. Of the 160 patients enrolled, 144, or 90%, completed the study. Clinical response, as defined by the primary endpoint, was achieved in all patients by Day 7 and was sustained on Day 12, with 85.4% of patients achieving an excellent response.

Secondary outcomes reinforced the pattern seen in the primary measure. The arithmetic mean, unweighted, of domain-specific symptom resolution percentages reached 98.7% by Day 12. The median time to initial relief was approximately 4 hours, suggesting that patients perceived benefit early in the treatment course rather than only after days of dosing.

Safety findings were favorable. Adverse events were mild and were reported in 12.5% of patients over the short treatment period. The authors conclude that the fixed-dose papain and alpha-amylase combination demonstrated short-term rapid, substantial, and consistent symptom relief with favorable tolerability in patients with functional dyspepsia.

Subject of Research: A real-world single-arm study of a papain and alpha-amylase fixed-dose combination for functional dyspepsia symptom relief

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

Article References: Deepak, S. K., Jain, A., Dutta, S., Jain, A., Kshirsagar, S., Joshi, R., & Toppo, A. (2026). Efficacy and safety of a fixed-dose papain and alpha-amylase combination in patients with functional dyspepsia: a real-world study. Frontiers in Gastroenterology, 5, Article 1954358. https://doi.org/10.3389/fgstr.2026.1954358

Image Credits: AI Generated

DOI: 10.3389/fgstr.2026.1954358

Keywords: functional dyspepsia, papain, alpha-amylase, fixed-dose combination, digestive enzymes, single-arm study, symptom relief, Rome IV criteria, gastroenterology, India, drug safety, clinical study