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Dig Dis Sci. 2009 Nov;54(11):2488-96. doi: 10.1007/s10620-009-0966-2.

Chemoprevention of colonic polyps with balsalazide: an exploratory, double-blind, placebo-controlled study.

Author information

  • 1Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143, USA. Jonathan.Terdiman@ucsf.edu

Abstract

BACKGROUND:

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 mm3, 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.

PMID:
19757048
[PubMed - indexed for MEDLINE]
PMCID:
PMC2762046
Free PMC Article

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