BACKGROUND/AIMS: We sought to determine in a double-blinded, placebo-controlled study if the nonsteroidal anti-inflammatory drug sulindac causes regression of sporadic colonic polyps. The impetus for this study is the profound regressive effect of sulindac on polyps in familial adenomatous polyposis. METHODS:Asymptomatic patients undergoing routine screening flexible sigmoidoscopy were enrolled if they had polyps of < or = 1 cm in size. Of 162 patients screened, 22 patients were randomly enrolled to take 150 mg of sulindac twice daily, and 22 patients took a placebo. Treatment duration was 4 months and was followed by colonoscopy with removal of all polyps. RESULTS:Four patients 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 sulindac vs. placebo on polyp regression or size were not statistically different in the two treatment groups. Analysis of our data indicated that there is only a 0.8% chance that the probability of polyp regression with sulindac is as large as 50%. CONCLUSIONS: Four months of treatment with sulindac does not result in a clinically significant regression of sporadic colonic polyps, although a small effect may not have been detected by the size of our study. Our data suggest that the biological response of sporadic and familial polyposis polyps to sulindac is different.
RCT Entities:
BACKGROUND/AIMS: We sought to determine in a double-blinded, placebo-controlled study if the nonsteroidal anti-inflammatory drug sulindac causes regression of sporadic colonic polyps. The impetus for this study is the profound regressive effect of sulindac on polyps in familial adenomatous polyposis. METHODS: Asymptomatic patients undergoing routine screening flexible sigmoidoscopy were enrolled if they had polyps of < or = 1 cm in size. Of 162 patients screened, 22 patients were randomly enrolled to take 150 mg of sulindac twice daily, and 22 patients took a placebo. Treatment duration was 4 months and was followed by colonoscopy with removal of all polyps. RESULTS: Four patients 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 sulindac vs. placebo on polyp regression or size were not statistically different in the two treatment groups. Analysis of our data indicated that there is only a 0.8% chance that the probability of polyp regression with sulindac is as large as 50%. CONCLUSIONS: Four months of treatment with sulindac does not result in a clinically significant regression of sporadic colonic polyps, although a small effect may not have been detected by the size of our study. Our data suggest that the biological response of sporadic and familial polyposis polyps to sulindac is different.
Authors: Marlies S Reimers; Charla C Engels; Peter J K Kuppen; Cornelis J H van de Velde; Gerrit J Liefers Journal: Nat Rev Clin Oncol Date: 2014-06-24 Impact factor: 66.675
Authors: Paul J Limburg; Michelle R Mahoney; Katie L Allen Ziegler; Stephen J Sontag; Robert E Schoen; Richard Benya; Michael J Lawson; David S Weinberg; Elena Stoffel; Michael Chiorean; Russell Heigh; Joel Levine; Gary Della'Zanna; Luz Rodriguez; Ellen Richmond; Christopher Gostout; Sumithra J Mandrekar; Thomas C Smyrk Journal: Cancer Prev Res (Phila) Date: 2011-01-05
Authors: Karen Colbert Maresso; Kenneth Y Tsai; Powel H Brown; Eva Szabo; Scott Lippman; Ernest T Hawk Journal: CA Cancer J Clin Date: 2015-08-18 Impact factor: 508.702