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Aspirin, resistant starch had no effect on incidences of colorectal adenoma or carcinoma
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Carriers of Lynch syndrome assigned to aspirin, resistant starch or both for up to four years had no decrease in the likelihood of developing colorectal adenoma or carcinoma.
The researchers used a two-by-two design and randomly assigned patients to 600-mg daily aspirin (n=350) or placebo (n=343), or to 30-g daily resistant starch (Novelose, National Starch and Chemical; n=358) or to placebo (n=369). The study was designed by members of the international Colorectal Adenoma/Carcinoma Prevention Programme 2 (CAPP2).
All patients were proven carriers of a pathologic mismatch-repair mutation or members of a family that met the Amsterdam diagnostic criteria and had been cured of a Lynch syndrome neoplasm without colectomy.
Sixty-six of 349 patients assigned to aspirin (18.9%) developed at least one neoplastic lesion compared with 65 of 342 (19%) of those assigned to placebo (RR=1.0; 95% CI, 0.7-1.4). After adjusting for various factors, the investigators concluded there was no statistical difference between the two groups.
The incidence of advanced adenoma or colorectal cancer in the aspirin group was 8.4% compared with 10.9% for those assigned to placebo (P=.03).
For the 727 patients receiving resistant starch or placebo, 67 patients (18.7%) assigned to resistant starch developed neoplasia compared with 68 (18.4%) in the placebo group (OR=1.0; 95% CI, 0.7-1.4). Adenomas and colorectal cancers were evenly distributed, but seven patients assigned to resistant starch developed a Lynch syndrome cancer compared with 17 assigned to placebo (P=.05).
N Engl J Med. 2008;359:2567-2578.