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

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.

• Authors: Jonathan P Terdiman, Lorin K Johnson, Young S Kim, Marvin H Sleisenger, James R Gum, Ann Hayes, Vivian K Weinberg, Kenneth R McQuaid
• Journal: Digestive diseases and sciences (Dig Dis Sci) Vol. 54 Issue 11 Pg. 2488-96 (Nov 2009) ISSN: 1573-2568 [Electronic] United States
• PMID: 19757048 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gastrointestinal Agents
• Phenylhydrazines
• Mesalamine
• balsalazide

Topics

• Adenoma (pathology, prevention & control)
• Aged
• Apoptosis (drug effects)
• Colon, Sigmoid (pathology)
• Colonic Neoplasms (pathology, prevention & control)
• Colonic Polyps (pathology, prevention & control)
• Double-Blind Method
• Gastrointestinal Agents (pharmacology, therapeutic use)
• Humans
• Male
• Mesalamine (pharmacology, therapeutic use)
• Middle Aged
• Phenylhydrazines (pharmacology, therapeutic use)
• Prospective Studies