Abstract
The present double-blind, randomized, placebocontrolled clinical study was performed to evaluate the influence of low-dose aspirin enteric-coated tablets （100 mg/day for 6–10 months） in a total of thirty-four patients with familial adenomatous polyposis （17 each in the aspirin and placebo groups）. The sizes of colonic polyps tended to be higher in the placebo as compared to the aspirin group with an response ratio of 2.33（95% confidence interval 0.72–7.55） and subgroup analysis revealed patients with a mean baseline polyp size of ＜ 2 mm to show significant reduction of mean polyp sizes （diameter and height） in the aspirin group. Stratified analysis further revealed tendencies for greater polyp size reduction by aspirin in the subgroups who were women, aged ＜ 41 years, non-smokers, non-drinkers, with an APC gene mutation, positive for beta-catenin and for intraepithelial COX-2 staining. Adverse events occurred in 3 patients, all in the aspirin group, and in one case this required discontinuation of the drug. The results thus indicated a potential for aspirin to reduce colonic adenoma development in patients with familial adenomatous polyposis, but careful follow-up is needed to avoid or rapidly counter adverse events.
