Allopurinol as prophylaxis against pouchitis following heal pouch-anal anastomosis for ulcerative colitis - A randomized placebo-controlled double-blind study

Pouchitis is the major long-term complication of restorative proctocolectom y for ulcerative colitis (UC), Allopurinol is a scavenger of oxygen-derived free radicals. which it is suggested play a role in the development of UC and pouchitis. The first aim was to test the hypothesis that the incidence of pouchitis can be reduced by prophylactic Allopurinol, and secondly to ev aluate if Allopurinol influences the overall pouch function. Methods: 273 p atients with UC who were planned for proctocolectomy and ileal pouch-anal a nastomosis at 12 centres in Sweden between October 1994 and June 1997 were offered the opportunity to participate. 184 patients (67%) were randomized to receive postoperative prophylactic Allopurinol 100 mg twice daily or pla cebo. All 273 patients had clinical and endoscopic follow-up at 1, 3, 6, 12 , 18, 24 months after surgery. Results: Of the 184 randomized patients, 94 were randomized to Allopurinol and 90 to placebo; 116 patients (63%) comple ted follow-up and the crude incidence of pouchitis among those patients ful lfilling the protocol was 31% in the Allopurinol group and 28% in the place bo group (ns). The cumulative risk for a first attack of pouchitis was 30% and 26% after 24 months (ns). The overall pouch function improved over time and did not differ significantly between the two groups. Conclusions: Prop hylactic Allopurinol did not reduce the risk of a first attack of pouchitis .