Abstract | BACKGROUND:
Familial adenomatous polyposis is an autosomal dominant disorder characterized by the formation of hundreds of colorectal adenomas and eventual colorectal cancer. Administration of the nonsteroidal antiinflammatory drug sulindac has been followed by regression of polyps in patients with this disorder, but no controlled trial of this drug in patients who have not had surgery has been reported. METHODS: We conducted a randomized, double-blind, placebo-controlled study of 22 patients with familial adenomatous polyposis, including 18 who had not undergone colectomy. The patients received sulindac at a dose of 150 mg orally twice a day for nine months or identical-appearing placebo tablets. The number and size of the polyps were evaluated every three months for one year. RESULTS: A statistically significant decrease in the mean number of polyps and their mean diameter occurred in patients treated with sulindac, as compared with those given placebo. When treatment was stopped at nine months, the number of polyps had decreased to 44 percent of base-line values and the diameter of the polyps to 35 percent of base-line values (P = 0.014 and P < 0.001, respectively, for the comparison with the changes in the group given placebo). No patient had complete resolution of polyps. Three months after treatment with sulindac was stopped, both the number and the size of the polyps increased in sulindac-treated patients but remained significantly lower than the values at base line. No side effects from sulindac were noted. CONCLUSIONS:
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Authors | F M Giardiello, S R Hamilton, A J Krush, S Piantadosi, L M Hylind, P Celano, S V Booker, C R Robinson, G J Offerhaus |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 328
Issue 18
Pg. 1313-6
(May 06 1993)
ISSN: 0028-4793 [Print] United States |
PMID | 8385741
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
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Topics |
- Adenomatous Polyposis Coli
(drug therapy, pathology)
- Adult
- Double-Blind Method
- Female
- Humans
- Intestinal Polyps
(drug therapy, pathology)
- Male
- Rectal Neoplasms
(drug therapy, pathology)
- Sulindac
(therapeutic use)
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