TREATMENT OF COLONIC AND RECTAL ADENOMAS WITH SULINDAC IN FAMILIAL ADENOMATOUS POLYPOSIS

Background. Familial adenomatous polyposis is an autosomal dominant di sorder characterized by the formation of hundreds of colorectal adenom as and eventual colorectal cancer. Administration of the nonsteroidal antiinflammatory drug sulindac has been followed by regression of poly ps in patients with this disorder, but no controlled trial of this dru g in patients who have not had surgery has been reported. Methods. We conducted a randomized, double-blind, placebo-controlled study of 22 p atients with familial adenomatous polyposis, including 18 who had not undergone colectomy. The patients received sulindac at a dose of 150 m g orally twice a day for nine months or identical-appearing placebo ta blets. The number and size of the polyps were evaluated every three mo nths for one year. Results. A statistically significant decrease in th e mean number of polyps and their mean diameter occurred in patients t reated with sulindac, as compared with those given placebo. When treat ment 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 p ercent of base-line values (P = 0.014 and P<0.001, respectively, for t he 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 incre ased in sulindac-treated patients but remained significantly lower tha n the values at base line. No side effects from sulindac were noted. C onclusions. Sulindac reduces the number and size of colorectal adenoma s in patients with familial adenomatous polyposis, but its effect is i ncomplete, and it is unlikely to replace colectomy as primary therapy.