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QUESTION: In patients with colorectal adenomas, does supplementation with ispaghula husk or calcium prevent adenoma recurrence?
Design
Randomised (allocation concealed*), blinded (patients, clinical staff, and investigators),* placebo controlled trial with 3 years follow up.
Setting
21 centres in 10 countries (Belgium, Denmark, France, Germany, Ireland, Israel, Italy, Portugal, Spain, and the UK).
Patients
665 patients who were 35–75 years of age, had a complete index colonoscopy showing ≥2 adenomas or 1 adenoma of >5 mm in diameter, and did not have a debilitating or life threatening disease. Exclusion criteria were history of large bowel disease, contraindications to calcium or fibre, or inability or unwillingness to stop current fibre or calcium supplementation. 552 patients (83%, mean age 59 y, 64% men) …
Footnotes
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Sources of funding: Europe Against Cancer Programme; Association Centre le Cancer; Association Luxembourgeoise Centre le Cancer; INSERM; French Ministry of Health; Deutsches Krebsforschungzentrum; Danish Cancer Society; FISS; Hospital supplies (Ireland); University of Coimbra; Istituto Tumori Genova.
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For correspondence: Professor J Faivre, Registre Bourguignon des Tumeurs Digestives, Faculté de Médecine de Dijon, BP 87900, 21079 Dijon, France. Fax + 33 380 66 8251.
↵† p Value calculated from data in article.