Preventive effects of low-dose aspirin on colorectal adenoma growth in patients with familial adenomatous polyposis: double-blind, randomized clinical trial

Cancer Med. 2013 Feb;2(1):50-6. doi: 10.1002/cam4.46. Epub 2013 Feb 3.


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.

Keywords: Adenoma; FAP; chemoprevention; colorectum; low-dose aspirin.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenoma / prevention & control*
  • Adenomatous Polyposis Coli / drug therapy*
  • Adenomatous Polyposis Coli / pathology
  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Anticarcinogenic Agents / administration & dosage
  • Anticarcinogenic Agents / adverse effects
  • Anticarcinogenic Agents / therapeutic use
  • Aspirin / administration & dosage*
  • Aspirin / adverse effects
  • Aspirin / therapeutic use
  • Colonoscopy
  • Colorectal Neoplasms / prevention & control*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Selection
  • Tablets, Enteric-Coated
  • Treatment Outcome


  • Anti-Inflammatory Agents, Non-Steroidal
  • Anticarcinogenic Agents
  • Tablets, Enteric-Coated
  • Aspirin