Evaluation of the safety and efficacy of a multienzyme complex in patients with functional dyspepsia: A randomized, double-blind, placebo-controlled study

Functional dyspepsia is characterized by a constellation of symptoms that can include bloating, fullness, nausea, heartburn, or burping—with no structural lesion. Lifestyle changes are recommended to minimize the symptoms of functional dyspepsia, including avoidance of nonsteroidal anti-inflammatory drugs (NSAIDs), coffee, high-fat foods, and coffee. Medications that are prescribed for dyspepsia range from antacids to prokinetics, proton-pump inhibitors (PPIs), and antidepressants. Despite these interventions, many patients continue to struggle with dyspeptic symptoms.

Although the etiology of functional dyspepsia is multifactorial, one contributing factor is thought to be a deficiency of digestive enzymes. Some studies have found digestive enzymes to improve symptoms of flatulence, bloating, belching, fullness, and postprandial distress.

In a randomized controlled trial in India, researchers evaluated the effects of a multi-enzyme formula in patients with functional dyspepsia.

Woman in sunlit room holding her stomach in pain

Methods

Forty patients who met the Rome III Diagnostic Criteria for functional dyspepsia (aged 18-75) were randomized to take a multi-enzyme combination (50 mg 3x/day) or a placebo for 60 days. The multi-enzyme contained alpha-amylase, protease, cellulase, lactase, and lipase (DigeZyme®, by Sabinsa Corporation, NJ, USA). The enzymes were from bacterial and fungal origin and produced via a fermentation process. Efficacy was measured with a battery of questionnaires and rating scales.

Results

Results found all efficacy measures to be statistically significant at day 30 and maintained until day 60. The questionnaires and rating scales indicated that the group taking the enzyme supplement experienced improvements in epigastric pain, postprandial distention, indigestion, heartburn, nausea, belching after meals, and overall severity of illness. There were no adverse events related to the enzyme supplement.

Conclusions

The results of this study support the use of digestive enzymes in patients with functional dyspepsia.

Majeed, M., Majeed, S., Nagabhushanam, K., Arumugam, S., Pande, A., Paschapur, M., & Ali, F. (2018). Evaluation of the safety and efficacy of a multienzyme complex in patients with functional dyspepsia: A randomized, double-blind, placebo-controlled study. Journal of Medicinal Food, 21(11), 1120-1128.