A randomised, double-blind, placebo-controlled study published in the Journal of Medicinal Foods provides 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, westernised 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 randomised, 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 a 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 such as 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 and 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 (alpha-amylase, protease, cellulase, lactase, and lipase) that help break down carbohydrates, complex proteins, cellulosic fibres, lactose and fats.