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Previous Volume 359:2567-2578 December 11, 2008 Number 24 Next

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ABSTRACT

Background Observational and epidemiologic data indicate that the use of aspirin reduces the risk of colorectal neoplasia; however, the effects of aspirin in the Lynch syndrome (hereditary nonpolyposis colon cancer) are not known. Resistant starch has been associated with an antineoplastic effect on the colon.

Methods In a randomized, placebo-controlled trial, we used a two-by-two design to investigate the effects of aspirin, at a dose of 600 mg per day, and resistant starch (Novelose), at a dose of 30 g per day, in reducing the risk of adenoma and carcinoma among persons with the Lynch syndrome.

Results Among 1071 persons in 43 centers, 62 were ineligible to participate in the study, 72 did not enter the study, and 191 withdrew from the study. These three categories were equally distributed across the study groups. Over a mean period of 29 months (range, 7 to 74), colonic adenoma or carcinoma developed in 141 participants. Of 693 participants randomly assigned to receive aspirin or placebo, neoplasia developed in 66 participants receiving aspirin (18.9%), as compared with 65 receiving placebo (19.0%) (relative risk, 1.0; 95% confidence interval [CI], 0.7 to 1.4). There were no significant differences between the two groups with respect to the development of advanced neoplasia (7.4% and 9.9%, respectively; P=0.33). Among the 727 participants receiving resistant starch or placebo, neoplasia developed in 67 participants receiving starch (18.7%), as compared with 68 receiving placebo (18.4%) (relative risk, 1.0; 95% CI, 0.7 to 1.4). Advanced adenomas and colorectal cancers were evenly distributed in the two groups. The prevalence of serious adverse events was low, and the events were evenly distributed.

Conclusions The use of aspirin, resistant starch, or both for up to 4 years has no effect on the incidence of colorectal adenoma or carcinoma among carriers of the Lynch syndrome. (Current Controlled Trials number, ISRCTN59521990 [controlled-trials.com] .)

Source Information

The affiliations of the authors are listed in the Appendix.

Address reprint requests to Dr. Burn at the Institute of Human Genetics, Newcastle University, International Centre for Life, Central Pkwy., Newcastle upon Tyne NE1 3BZ, United Kingdom, or at john.burn{at}ncl.ac.uk.

Full Text of this Article

Related Letters:

Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome
Yang F., Jin C., Fu D., Topping D. L., Bird A. R., Young G. P., Bishop D. T., Burn J., Mathers J. C.
Extract | Full Text | PDF  
N Engl J Med 2009; 360:1461-1463, Apr 2, 2009. Correspondence

This article has been cited by other articles:

• Jarvinen, H. J., Renkonen-Sinisalo, L., Aktan-Collan, K., Peltomaki, P., Aaltonen, L. A., Mecklin, J.-P. (2009). Ten Years After Mutation Testing for Lynch Syndrome: Cancer Incidence and Outcome in Mutation-Positive and Mutation-Negative Family Members. JCO 27: 4793-4797 [Abstract] [Full Text]  
• Yang, F., Jin, C., Fu, D., Topping, D. L., Bird, A. R., Young, G. P., Bishop, D. T., Burn, J., Mathers, J. C. (2009). Effect of Aspirin or Resistant Starch on Colorectal Neoplasia in the Lynch Syndrome. NEJM 360: 1461-1463 [Full Text]