EFFECT OF SULINDAC ON SPORADIC COLONIC POLYPS

Background/Aims: We sought to determine in a double-blinded, placebo-c ontrolled study if the nonsteroidal anti-inflammatory drug sulindac ca uses regression of sporadic colonic polyps. The impetus for this study is the profound regressive effect of sulindac on polyps in familial a denomatous polyposis. Methods: Asymptomatic patients undergoing routin e screening flexible sigmoidoscopy were enrolled if they had polyps of less than or equal to 1 cm in size. Of 162 patients screened, 22 pati ents were randomly enrolled to take 150 mg of sulindac twice daily, an d 22 patients took a placebo. Treatment duration was 4 months and was followed by colonoscopy with removal of all polyps. Results: Four pati ents were dropped from the study (sulindac group) due to urosepsis (1 patient), heartburn (2 patients), and anemia (1 patient). Compliance ( determined by monthly pill counting), mean age, and the effect of suli ndac vs. placebo on polyp regression or size were not statistically di fferent in the two treatment groups. Analysis of our data indicated th at there is only a 0.8% chance that the probability of polyp regressio n with sulindac is as large as 50%. Conclusions: Four months of treatm ent with sulindac does not result in a clinically significant regressi on of sporadic colonic polyps, although a small effect may not have be en detected by the size of our study. Our data suggest that the biolog ical response of sporadic and familial polyposis polyps to sulindac is different.