(P09-010-23) Evaluation of the Effectiveness and Safety of Digestive Enzyme on the Improvement of Functional Dyspepsia

Objectives: Functional dyspepsia (FD), a common digestive disorder affecting about 12% of people in the US with symptoms such as abdominal pain, heartburn, and early satiety, is often treated with antioxidants and H2 receptor antagonists. Although these treatments may provide temporary relief, symptoms may recur and long-term use may cause side effects. This study aims to evaluate the potential of digestive enzyme supplements as a safe and effective alternative for managing functional dyspepsia, as there have been limited studies to prove their efficacy and safety.

Methods: We included 50 participants who received digestive enzyme 1 capsule/day for 10 days at home. The effectiveness of the treatment was assessed based on changes in the severity and frequency of symptoms such as bloating, early satiety, abdominal pain, heartburn, nausea, vomiting, regurgitation, and burping. Participants filled out self-reported questionnaires before and after the trial, and the data was analyzed using the Shapiro-Wilk test and Wilcoxon signed-rank test in R Studio 4.1.2.

Results: A total of 40 participants aged 19 to 43 years with FD were included, excluding those who did not complete the trial. Moderate bloating was experienced by 72.5% of participants at the beginning, decreasing to 12.5% (P=2.886e-07) by the end. Those who bloated more than 2 to 3 times a week decreased from 62.5% to 25% (P=1.991e-06). Initially, 50% of participants reported moderate abdominal pain, declining to 2.5% by trial end (p=2.534e-07). The incidence of moderate to severe heartburn decreased, with a notable improvement from 15% to 70% among participants whose symptoms disappeared (P=2.246e-08). Vomiting and regurgitation frequency showed no significant difference. Some participants reported increased gas and stomach pain after taking the capsules.

Conclusions: Digestive enzymes exhibit safety and efficacy in alleviating the majority of FD symptoms, but show limited efficacy in reducing regurgitation and vomiting.

Funding Sources: This work was supported by NUTRIPACKS LLC.