Chemoprevention of Colonic Polyps with Balsalazide: An Exploratory, Double-Blind, Placebo-Controlled Study. Digestive diseases and sciences [Dig Dis Sci] Journal article | | Title | Chemoprevention of Colonic Polyps with Balsalazide: An Exploratory, Double-Blind, Placebo-Controlled Study. | | Author(s) | Terdiman JP, Johnson LK, Kim YS, Sleisenger MH, Gum JR, Hayes A, Weinberg VK, McQuaid KR | | Institution | Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA, Jonathan.Terdiman@ucsf.edu. | | Source | Dig Dis Sci 2009 Sep 11. | | Abstract | BACKGROUD: 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.
AIM: To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug.
METHODS: 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.
RESULTS: 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 mm(3), increased by 55% in the balsalazide group compared with 95% in the placebo group.
CONCLUSIONS: Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19757048 |
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