Researchers from England and the USA assessed the effect of celecoxib, a selective cyclooxygenase (COX)-2 inhibitor, on duodenal polyposis in familial adenomatous polyposis (FAP).
Non-selective COX inhibitors are known to inhibit large bowel carcinogenesis in patients with FAP. However, their role in the duodenum of these patients is less certain.
FAP patients were randomized to either celecoxib (100 mg twice daily [n = 34] or 400 mg twice daily [n = 32]) or placebo (n = 17) given orally twice daily for 6 months.
Efficacy was assessed qualitatively by blinded review by 5 independent observers of shuffled endoscopy videotapes. They compared the extent of duodenal polyposis at entry and at 6 months.
|Reduction in duodenal polyposis:|
Celecoxib, 400 mg: 15%
In addition, efficacy was also evaluated quantitatively by measurement of the percentage change in duodenal area covered by discrete and plaque-like adenomas from photographs of high and low density polyposis.
Shuffled and blinded video review showed a statistically significant effect of 400 mg twice daily celecoxib, compared with placebo treatment. All observers scored a beneficial effect.
Overall, patients taking celecoxib 400 mg twice daily showed a 14.5% reduction in involved areas, compared with a 1.4% for placebo.
However, patients with clinically significant disease at baseline (greater than 5% covered by polyps) showed a 31% reduction in involved areas with celecoxib 400 mg twice daily, compared with 8% on placebo.
Professor R. K. S. Phillips, of St. Mark's Hospital, Harrow, England, concluded on behalf of the group, "A panel of 5 endoscopists found a significant reduction in duodenal polyposis after 6 months of treatment with celecoxib 400 mg twice daily.
"COX-2 inhibition may help this otherwise untreatable condition."