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Volume 331:141-147 July 21, 1994 Number 3 Next

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ABSTRACT

Background People who consume a diet high in vegetables and fruits have a lower risk of cancer of the large bowel. Antioxidant vitamins, which are present in vegetables and fruits, have been associated with a diminished risk of cancers at various anatomical sites. We conducted a randomized, controlled clinical trial to test the efficacy of beta carotene and vitamins C and E in preventing colorectal adenoma, a precursor of invasive cancer.

Methods We randomly assigned 864 patients, using a two-by-two factorial design, to four treatment groups, which received placebo, beta carotene (25 mg daily), vitamin C (1 g daily) and vitamin E (400 mg daily), or beta carotene plus vitamins C and E. In order to identify new adenomas, we performed complete colonoscopic examinations in the patients one year and four years after they entered the study. The primary end points for analyses were new adenomas identified after the first of these two follow-up examinations.

Results Patients adhered well to the prescribed regimen, and 751 completed the four-year clinical trial. There was no evidence that either beta carotene or vitamins C and E reduced the incidence of adenomas; the relative risk for beta carotene was 1.01 (95 percent confidence interval, 0.85 to 1.20); for vitamins C and E, it was 1.08 (95 percent confidence interval, 0.91 to 1.29). Neither treatment appeared to be effective in any subgroup of patients or in the prevention of any subtype of polyp defined by size or location.

Conclusions The lack of efficacy of these vitamins argues against the use of supplemental beta carotene and vitamins C and E to prevent colorectal cancer. Although our data do not prove definitively that these antioxidants have no anticancer effect, other dietary factors may make more important contributions to the reduction in the risk of cancer associated with a diet high in vegetables and fruits.

Source Information

From Dartmouth-Hitchcock Medical Center and the Norris Cotton Cancer Center, Lebanon, N.H. (E.R.G., J.A.B., T.D.T., D.H.F., T.A.C., D.W.N., R.R., M.M.S.); the Cleveland Clinic Foundation, Cleveland (G.J.B., R.U.S.); the University of Minnesota, Minneapolis (J.H.B., J.S.M., D.C.S.); the Lahey Clinic, Burlington, Mass. (J.A.C.); Kaiser Permanente Medical Center-Sunset, Los Angeles (H.D.F.); UCLA, Los Angeles (R.W.H.); and the University of Iowa, Iowa City (R.W.S.). The members of the Polyp Prevention Study Group are listed in the Appendix.

Address reprint requests to Dr. Greenberg at Dartmouth Medical School, Hanover, NH 03755-3861.

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Antioxidant Vitamins and Colorectal Adenoma
Burke H. B., Ponz de Leon M., Roncucci L., Wroth T. H., Greenberg E. R., Baron J. A., Tosteson T. D.
Extract | Full Text  
N Engl J Med 1994; 331:1720-1721, Dec 22, 1994. Correspondence

Aspirin and the Risk of Colorectal Cancer in Women
Johnson K. A., Prindiville S. A., Morgan G., Roychowdhury D. F., van Bodegraven A.A., Lourens J., Sindram J.W., Kaufmann H. J., Schuler M., Giovannucci E., Speizer F. E., Egan K., Marcus A. J.
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N Engl J Med 1996; 334:119-122, Jan 11, 1996. Correspondence

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