Open AccessPreventive effects of low‐dose aspirin on colorectal adenoma growth in patients with familial adenomatous polyposis: double‐blind, randomized clinical trial
Author(s) -
Ishikawa Hideki,
Wakabayashi Keiji,
Suzuki Sadao,
Mutoh Michihiro,
Hirata Keiji,
Nakamura Tomiyo,
Takeyama Ikuko,
Kawano Atsuko,
Gondo Nobuhisa,
Abe Takashi,
Tokudome Shinkan,
Goto Chiho,
Matsuura Nariaki,
Sakai Toshiyuki
Publication year - 2013
Publication title -
cancer medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.403
H-Index - 53
ISSN - 2045-7634
DOI - 10.1002/cam4.46
Subject(s) - aspirin , medicine , placebo , gastroenterology , colorectal adenoma , colorectal cancer , adverse effect , randomized controlled trial , adenoma , familial adenomatous polyposis , clinical trial , colonoscopy , rectum , cancer , pathology , alternative medicine
Abstract There are several reports of clinical trials of aspirin in sporadic colon cancer. However, only one double‐blind trial of aspirin in patients with familial adenomatous polyposis ( FAP ) has been reported to date. This double‐blind, randomized, placebo‐controlled clinical trial was therefore performed to evaluate the influence of low‐dose aspirin enteric‐coated tablets (100 mg/day for 6–10 months) in 34 subjects with FAP (17 each in the aspirin and placebo groups). The increase in mean diameter of colorectal polyps tended to be greater in the placebo group compared with the aspirin group, which showed a response ratio, that is, aspirin response rate (number of subjects with reduced polyps/total)/placebo response rate (number of subjects with reduced polyps/total), of 2.33 (95% confidence interval: 0.72–7.55). Subgroup analysis revealed that the number of subjects with a mean baseline polyp diameter of ≤2 mm, and the diameter and number of polyps after intervention showed a significant reduction in the aspirin group. Adverse effects of aspirin, such as anastomotic ulcer, aphtha in the large intestine, and progression of anemia, occurred in three subjects. Moreover, none of the subjects developed colorectal cancer. The results thus indicated a potential for aspirin to reduce colorectal adenoma development in patients with FAP , but careful follow‐up is needed to avoid or rapidly counter severe adverse effects.