Clinical–Alimentary TractAspirin and Folic Acid for the Prevention of Recurrent Colorectal Adenomas
Section snippets
Study Design
The ukCAP study was a double-blind, randomized, placebo-controlled trial performed in 10 study centers (9 in the UK and 1 in Denmark, see list in Appendix). A 2 × 2 factorial design was used to allow separate assessments of both aspirin and folic acid in preventing the recurrence of colorectal adenomas. Recruitment for this study occurred between December 1997 and November 2001; the last patient completed the study in July 2005. Ethical approval for the study was gained independently for each
Results
A summary of recruitment is provided in Figure 1. A total of 945 patients were recruited into the trial (307 recruited from East Midlands, 82 from Birmingham, 103 from Bristol, 77 from Liverpool, 43 from Manchester, 33 from Blackpool, 79 from Belfast, 59 from South Yorkshire, 112 from South Wales, and 50 from Denmark). Six patients were classified as having been recruited in error. This included 1 patient for whom consent was withdrawn after 2 months of medication. In the remaining cases,
Discussion
In this randomized, double-blind trial the ukCAP investigators set out to determine whether aspirin (300 mg/day) or folate (0.5 mg/day) were effective in reducing the recurrence of colorectal adenomas in patients who had previous adenomas removed at colonoscopy. We found this dose of aspirin to have an effect, reducing the recurrence rate of adenomas of any size by 21%, and of advanced adenomas by 37%. Folate supplementation had no significant effect on adenoma recurrence.
In interpreting the
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Supported by a grant from Cancer Research UK (formerly the Cancer Research Campaign).