Table 4.

Clinical trials of duodenal polyposis chemoprevention in FAP patients

Ref. #	First author	Type of study	Patients	Study drug	Duration	Outcome	Side effects
[19]	Nugent	Randomized, double-blind, placebo-controlled	24	Sulindac 200 mg twice a day	6 months	Qualitative polyp status improved in five patients, worsened in one and was unchanged in five (p = 0.12 compared to placebo)	One patient stopped sulindac within 6 weeks due to indigestion without endoscopic evidence of duodenal ulcer or erosion.
[102]	Seow-Cheon	Randomized crossover, double-blind	18	Calcium carbonate 380 mg/calciferol 500 mg daily or sulindac 300 mg daily	6 months	No significant difference in gastric or duodenal polyposis noted in either treatment group.	Not reported
[103]	Richard	Prospective	8	Sulindac 150 mg twice a day	Mean 8.75 months	No significant benefit seen. One patient progressed to invasive duodenal adenocarcinoma. Another patient showed recurrence of polyp with severe dysplasia requiring a pancreaticoduodenectomy.	Two patients discontinued sulindac due to abdominal cramps. Another stopped due to documented gastritis, duodenal ulcer, and progression of polyps to villous changes.
[104]	Phillips	Randomized, double-blind, placebo-controlled	83	Celecoxib 100 mg or 400 mg twice a day	6 months	When reviewed by five endoscopists, celecoxib 400 mg twice daily showed qualitative improvement in duodenal polyposis (p = 0.033). No quantitative improvement seen.	One patient had an allergic reaction to celecoxib. Second patient withdrew from study with symptoms of dyspepsia without evidence of peptic ulcer. Another with psychiatric history committed suicide.
[105]	Wallace	Randomized, placebo-controlled	26	Ranitidine 300 mg daily	6 months	No difference seen in duodenal polyp number compared to placebo (p = 0.9).	None reported