In this study, our objective was to determine whether 6 months of open
-label therapy with sulindac 400 mg/daily or piroxicam 20 mg/daily pro
mote regression of adenomatous colonic polyps left in situ. Left-sided
colonic polyps (size 3-12 mm) detected at colonoscopy were measured a
nd left without being biopsied. The bowel wall opposite to the polyps
was marked with India ink submucosally. Patients were assigned to drug
therapy, and compliance was determined by pill count. Polyps were mea
sured during sigmoidoscopy after 3 and 6 months of treatment; polyps w
ere removed at the 6-month examination. Examiners were not blinded to
drug therapy or previous polyp measurements. Seven patients completed
6 months of therapy (five sulindac and two piroxicam). Two additional
patients treated with piroxicam were withdrawn secondary to adverse ev
ents (bleeding gastric ulcer and rash). In one patient treated with su
lindac, a 6-mm polyp disappeared, and two other polyps seemed to regre
ss partially. One polyp regressed partially in a piroxicam-treated pat
ient. All other polyps remained unchanged. Conclusions: We did not obs
erve dramatic regression of sporadic colon adenomatous polyps to eithe
r sulindac or piroxicam after 6 months of therapy in this small uncont
rolled pilot study.