title: Enzyme therapy for management of coeliac disease.
abstract: 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.
  
  
  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.
authors.affiliation: School of Applied Sciences, RMIT University, Melbourne, Victoria, Australia.
authors.forename: Hugh J
authors.initials: HJ
authors.lastname: Cornell
authors.forename: Finlay A
authors.initials: FA
authors.lastname: Macrae
authors.forename: Joy
authors.initials: J
authors.lastname: Melny
authors.forename: Catherine J
authors.initials: CJ
authors.lastname: Pizzey
authors.forename: Fiona
authors.initials: F
authors.lastname: Cook
authors.forename: Sandra
authors.initials: S
authors.lastname: Mason
authors.forename: Prithi S
authors.initials: PS
authors.lastname: Bhathal
authors.forename: Teodor
authors.initials: T
authors.lastname: Stelmasiak
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002446:Celiac Disease / Q000175:diagnosis* / Q000188:drug therapy*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004798:Enzymes / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004798:Enzymes