A clinical trial of antioxidant vitamins to prevent colorectal adenoma. Polyp Prevention Study Group - PubMed (original) (raw)
Clinical Trial
. 1994 Jul 21;331(3):141-7.
doi: 10.1056/NEJM199407213310301.
Affiliations
- PMID: 8008027
- DOI: 10.1056/NEJM199407213310301
Free article
Clinical Trial
A clinical trial of antioxidant vitamins to prevent colorectal adenoma. Polyp Prevention Study Group
E R Greenberg et al. N Engl J Med. 1994.
Free article
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 the 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.
Comment in
- ACP J Club. 1994 Nov-Dec;121(3):75
- Antioxidant vitamins and colorectal adenoma.
Burke HB. Burke HB. N Engl J Med. 1994 Dec 22;331(25):1720; author reply 1721. doi: 10.1056/NEJM199412223312515. N Engl J Med. 1994. PMID: 7969373 No abstract available. - Antioxidant vitamins and colorectal adenoma.
Ponz de Leon M, Roncucci L. Ponz de Leon M, et al. N Engl J Med. 1994 Dec 22;331(25):1720; author reply 1721. N Engl J Med. 1994. PMID: 7969374 No abstract available. - Antioxidant vitamins and colorectal adenoma.
Wroth TH. Wroth TH. N Engl J Med. 1994 Dec 22;331(25):1720-1. N Engl J Med. 1994. PMID: 7969375 No abstract available. - Clinical research--what should the public believe?
Angell M, Kassirer JP. Angell M, et al. N Engl J Med. 1994 Jul 21;331(3):189-90. doi: 10.1056/NEJM199407213310309. N Engl J Med. 1994. PMID: 8008033 No abstract available.
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