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Therapeutics
Chemoprophylaxis with aspirin (81 mg daily) reduced the incidence of colorectal adenomas in people at risk

https://doi.org/10.1136/ebm.8.6.178

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    (2003) N Engl J Med 348, 891. Baron JA, Cole BF, Sandler RS, et al.. A randomized trial of aspirin to prevent colorectal adenomas.. ;. :. –9.
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 QUESTION: In persons at risk (recent history of histologically documented adenomas), is chemoprophylaxis with aspirin more effective than placebo for reducing the incidence of colorectal adenomas?

    Design

    Randomised {allocation concealed*}†, blinded (clinicians and patients),* placebo controlled trial with a mean follow up of 33 months.

    Setting

    9 clinical centres in Canada and the US.

    Patients

    1121 patients (mean age 57 y, 64% men) who had ≥1 of the following: ≥1 histologically confirmed colorectal adenoma removed <3 months before recruitment; ≥1 histologically confirmed adenoma removed ≤16 months before recruitment and a lifetime history of ≥2 confirmed adenomas; or a histologically confirmed adenoma ≥1 cm in diameter removed <16 months before recruitment. Exclusion criteria included a history of a familial colorectal cancer syndrome, invasive colorectal cancer, and malabsorption syndromes. Follow up was 97%.

    Intervention

    Patients were allocated to aspirin, 325 mg/day (n=372) or 81 mg/day (n=377), or placebo (n=372).

    Main outcome measure

    Number of patients in whom ≥1 colorectal adenoma was detected at ≥1 year of follow up.

    Main results

    At ≥1 year, ≥1 colorectal adenoma was detected in fewer patients who received aspirin, 81 mg, …

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    Footnotes

    • Abstract and commentary also appear in ACP Journal Club.

    • Source of funding: National Institutes of Health and aspirin and placebo tablets provided by Bayer.

    • For correspondence: Dr J A Baron, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA. john.a.baron{at}dartmouth.edu

    • ↵* See glossary.

    • ↵† Information provided by author.