BACKGROUND:Bismuth carbomer liquid enemas are equivalent to mesalamine enemas for active distal ulcerative colitis. AIMS: In this study, the efficacy and safety of bismuth carbomer foam enemas for active chronic pouchitis was determined in a placebo-controlled trial. PATIENTS: Forty adult patients with active chronic pouchitis were randomly assigned into either concurrent therapy for pouchitis or no concurrent therapy. Topical corticosteroids and mesalamine were withdrawn prior to the study. METHODS: Patients received either bismuth carbomer (270 mg elemental bismuth) (n = 20) or placebo (n = 20) foam enemas for 3 weeks. Clinical assessment was performed at baseline and at 3 weeks using the pouchitis disease activity index score which incorporates symptoms, endoscopy and histology. Serum bismuth concentrations were determined by atomic absorption spectrophotometry. RESULTS: At 3 weeks nine of 20 patients (45%) in both the bismuth and placebo groups had improved. Ten patients discontinued prematurely because of worse diarrhoea (three in each group) or abdominal cramping after enema use (one from the bismuth group and three from the placebo group). No other side-effects were noted. Serum bismuth concentrations were negligible in all patients. CONCLUSIONS:Bismuth carbomer foam enemas (270 mg bismuth) nightly for 3 weeks are safe but not efficacious for active chronic pouchitis.
RCT Entities:
BACKGROUND:Bismuth carbomer liquid enemas are equivalent to mesalamine enemas for active distal ulcerative colitis. AIMS: In this study, the efficacy and safety of bismuth carbomer foam enemas for active chronic pouchitis was determined in a placebo-controlled trial. PATIENTS: Forty adult patients with active chronic pouchitis were randomly assigned into either concurrent therapy for pouchitis or no concurrent therapy. Topical corticosteroids and mesalamine were withdrawn prior to the study. METHODS:Patients received either bismuth carbomer (270 mg elemental bismuth) (n = 20) or placebo (n = 20) foam enemas for 3 weeks. Clinical assessment was performed at baseline and at 3 weeks using the pouchitis disease activity index score which incorporates symptoms, endoscopy and histology. Serum bismuth concentrations were determined by atomic absorption spectrophotometry. RESULTS: At 3 weeks nine of 20 patients (45%) in both the bismuth and placebo groups had improved. Ten patients discontinued prematurely because of worse diarrhoea (three in each group) or abdominal cramping after enema use (one from the bismuth group and three from the placebo group). No other side-effects were noted. Serum bismuth concentrations were negligible in all patients. CONCLUSIONS:Bismuth carbomer foam enemas (270 mg bismuth) nightly for 3 weeks are safe but not efficacious for active chronic pouchitis.
Authors: T Mimura; F Rizzello; U Helwig; G Poggioli; S Schreiber; I C Talbot; R J Nicholls; P Gionchetti; M Campieri; M A Kamm Journal: Gut Date: 2004-01 Impact factor: 23.059