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- Title
Chemoprevention of colonic polyps with balsalazide: an exploratory, double-blind, placebo-controlled study.
- Authors
Terdiman, Jonathan P.; Johnson, Lorin K.; Kim, Young S.; Sleisenger, Marvin H.; Gum, James R.; Hayes, Ann; Weinberg, Vivian K.; McQuaid, Kenneth R.
- Abstract
<bold>Background: </bold>A number of agents, including aspirin, nonsteroidal antiinflammatory drugs, cyclooxygenase-2 inhibitors, folic acid, calcium, and vitamins, have been evaluated for their potential in chemoprevention of sporadic colorectal adenomas or cancer. Preclinical data suggest that 5-aminosalicylates also may have a chemopreventive effect.<bold>Aim: </bold>To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug.<bold>Methods: </bold>In this randomized, double-blind, placebo-controlled study, adults diagnosed with small polyps in the rectosigmoid colon were treated with either balsalazide 3 g/d or placebo for 6 months. Follow-up lower endoscopy was performed, and all polyps were measured and analyzed histologically. The primary endpoint was reduction in mean size of the largest polyp per subject.<bold>Results: </bold>Among 241 participants screened, 86 were randomized to treatment, with 75 subjects evaluable. Balsalazide 3 g/d (n = 38) did not significantly reduce the mean size of the largest colonic polyp or the number of polyps compared with placebo (n = 37). Although not significant, post-hoc analysis revealed that total adenoma burden per subject, calculated as the sum of the volumes of all adenomas in mm3, increased by 55% in the balsalazide group compared with 95% in the placebo group.<bold>Conclusions: </bold>Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies.
- Subjects
CHEMOPREVENTION; ADENOMA; POLYPS; PLACEBOS; ENDOSCOPY; ADENOMA prevention; COLON tumor prevention; COLON tumors; RESEARCH; COLON polyps; COLON (Anatomy); RESEARCH methodology; ORGANIC compounds; APOPTOSIS; MEDICAL cooperation; EVALUATION research; COMPARATIVE studies; RANDOMIZED controlled trials; BLIND experiment; GASTROINTESTINAL agents; MESALAMINE; LONGITUDINAL method; PHARMACODYNAMICS
- Publication
Digestive Diseases & Sciences, 2009, Vol 54, Issue 11, p2488
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-009-0966-2