A randomized, double-blind, placebo-controlled study published in the peer reviewed Journal of Medicinal Foods* provided clinical evidence supporting the safety and efficacy of Sabinsa's multi-enzyme complex DigeZyme®, a proprietary blend of non-animal sourced enzymes, in the management of dyspeptic symptoms in patients with functional dyspepsia.
Functional dyspepsia is referred to as “non-ulcer dyspepsia” that causes an upset stomach or pain or discomfort, bloating, early satiety, postprandial fullness, nausea, heartburn, regurgitation, and burping and usually affects young adults, with women being affected more often than men. Although the cause of functional dyspepsia is unclear, it could be associated with poor eating habits, diet influences, food allergies, westernized lifestyles, medication side effects, psychological factors or excessive acid secretion, all of which can lead to inflammation.
The safety and efficacy of DigeZyme® was evaluated in a randomized, double-blind, placebo-controlled, parallel-group trial with 40 patients who were randomly assigned (1:1 ratio) to receive either DigeZyme® (50 mg, TID; n = 20) or placebo (n = 20) for 60 days. Supplementation with DigeZyme® to the patients suffering from functional dyspepsia demonstrated significant improvements in the severity of illness, dyspepsia and GI symptoms like epigastric pain and discomfort, postprandial distention, indigestion, heartburn, and nausea, fullness, early satiety, bloating, belching after meals, and vomiting, whereas the placebo group showed no such improvement at the end of study.
This study also reported that the DigeZyme® was safe and well-tolerated during the trial with no reported Adverse Events, no clinically significant changes in vital signs, and no abnormal lab values (biochemistry and haematology), in patients who received the DigeZyme® supplementation.
“We’re pleased to see additional research on our carefully designed digestive enzyme formula confirm health benefits that improve quality of life,” Dr. Muhammed Majeed, Founder & Chairman of the Sami-Sabinsa Group said. “Good digestion plays an important role in overall health and now we can clinically say that DigeZyme is part of that foundation.”
DigeZyme® has been available worldwide for more than a decade as a powdered blend, in a combination of five digestive enzymes (α-amylase, protease, cellulase, lactase, and lipase) that help break down carbohydrates, complex proteins, cellulosic fibers, lactose, and fats.
A 2017 study on DigeZyme®, published in Sports Nutrition and Therapy: Multi−Enzyme Complex for the Management of Delayed Onset Muscle Soreness after Eccentric Exercise: A Randomized, Double Blind, Placebo Controlled Study, identified DigeZyme’s potential for more rapid recovery from Delayed Onset Muscle Soreness (DOMS).
*Original Research: Full open access research for “Evaluation of the Safety and Efficacy of a Multi-enzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study” by Muhammed Majeed, Shaheen Majeed, Kalyanam Nagabhushanam, Sivakumar Arumugam, Anurag Pande, Mahesh Paschapur, and Furqan Ali in the “Journal of Medicinal Food” (2018). http://doi.org/10.1089/jmf.2017.4172; Published Online: 29 August 2018.