Chemoprevention of Colonic Polyps with Balsalazide: An Exploratory, Double-Blind, Placebo-Controlled Study
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.
To investigate chemoprevention of colonic polyps with balsalazide, a 5-aminosalicylate prodrug.
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.
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.
Although balsalazide did not have significant chemopreventive effects on established colonic polyps, these results can aid in designing future prospective studies.
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- Chemoprevention of Colonic Polyps with Balsalazide: An Exploratory, Double-Blind, Placebo-Controlled Study
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Digestive Diseases and Sciences
Volume 54, Issue 11 , pp 2488-2496
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
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- 5-Aminosalicylic acid
- Colonic adenoma
- Colonic polyp
- Colorectal cancer
- Industry Sectors
- Author Affiliations
- 1. Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, CA, USA
- 2. Salix Pharmaceuticals, Inc, Morrisville, NC, USA
- 3. Department of Veterans Affairs Medical Center, San Francisco, CA, USA
- 4. Helen Diller Family Cancer Center Biostatistics Core, University of California, San Francisco, Box 1623, San Francisco, CA, 94143, USA