Enzyme therapy for management of coeliac disease.

OBJECTIVE: Enzyme therapy based on animal digestive extracts was investigated as a means of completely digesting toxic residues from gluten in the small intestine, thus providing a means of protection of the mucosa.
MATERIAL AND METHODS: A randomized, placebo-controlled, clinical trial of an encapsulated enzyme extract was conducted in 21 coeliac patients in remission who were challenged with a modest amount of gluten daily over 2 weeks. Enzyme extract (900 mg) in three divided doses was administered during this challenge to half the group and a placebo to the other half in a double-blind, crossover design. Symptoms were recorded in daily diaries; blood was taken for tissue transglutaminase antibodies (anti-tTG) at the start and at intervals up to 12 weeks. Duodenal biopsies were performed for histological assessment at the start and end of each challenge period for 6 patients chosen at random from volunteers. After a further 10 weeks, the groups were changed over, and the same assessments carried out.
RESULTS: Only 8 of the 21 patients (38%) had more than 5 episodes of moderate to severe symptoms during either of the gluten challenge periods, and in these, symptoms scores were ameliorated during enzyme therapy compared with the placebo period (p<0.02). Rises of 5 U/ml or more in anti-tTG occurred in only 5 patients at about 6-8 weeks after challenge, but were not correlated with symptoms.
CONCLUSIONS: Only 1 of the 6 patients had normal histology at entry, thus focusing attention on the need for better management of the disease. By histological criteria, enzyme therapy offered better protection than placebo during the gluten challenges. The study supports the use of enzyme supplementation as a safeguard for patients with coeliac disease because of the difficulty of ensuring a strictly gluten-free diet.

RCT Entities:   Population Interventions Outcomes