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P P Metzger - One of the best experts on this subject based on the ideXlab platform.

  • bismuth carbomer foam Enemas for active chronic pouchitis a randomized double blind placebo controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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 Topical corticosteroids and mesalamine were withdrawn prior to the study.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.

  • Bismuth carbomer foam Enemas for active chronic pouchitis: a randomized, double‐blind, placebo‐controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

William J Tremaine - One of the best experts on this subject based on the ideXlab platform.

  • bismuth carbomer foam Enemas for active chronic pouchitis a randomized double blind placebo controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

  • Bismuth carbomer foam Enemas for active chronic pouchitis: a randomized, double‐blind, placebo‐controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

Stephen B. Hanauer - One of the best experts on this subject based on the ideXlab platform.

  • budesonide Enema for the treatment of active distal ulcerative colitis and proctitis a dose ranging study
    Gastroenterology, 1998
    Co-Authors: Stephen B. Hanauer, M Robinson, R E Pruitt, Audrey J Lazenby, Tore Persson, L Nilsson, Karen Walton Bowen, Lloyd P Haskell, Jeffrey G Levine
    Abstract:

    Abstract Background & Aims: Budesonide is a highly potent topical glucocorticosteroid that is characterized by low systemic availability as a result of high first-pass hepatic metabolism. The aim of this study was to evaluate the efficacy and safety of three doses of an Enema preparation of budesonide in patients with active distal ulcerative colitis/proctitis. Methods: In a double-blind multicenter trial, 233 patients were randomized to receive either a placebo Enema or budesonide Enema at a dose of 0.5 mg/100 mL, 2.0 mg/100 mL, or 8.0 mg/100 mL. The primary efficacy variables were an improvement of sigmoidoscopic inflammation grade, total histopathology score, and remission rates. Effects on cortisol concentrations were also assessed. Results: After 6 weeks of treatment, there was significant improvement in sigmoidoscopy and histopathology scores in the budesonide 2.0-mg and 8.0-mg dose groups compared with placebo. Remission was achieved in 19% of patients in the 2.0-mg budesonide group ( P ≤ 0.050) and 27% of patients in the 8.0-mg budesonide group ( P ≤ 0.001) compared with 4% in the placebo group. More than 90% of all budesonide patients had a normal adrenocorticotropin (ACTH)-stimulated cortisol response at the last visit. The budesonide Enemas were well tolerated. Conclusions: Budesonide Enema is both effective and safe for the treatment of active distal ulcerative colitis/proctitis. A dose of 2.0 mg/100 mL budesonide is the lowest effective dose. GASTROENTEROLOGY 1998;115:525-532

  • Dose‐ranging study of mesalamine (PENTASA) Enemas in the treatment of acute ulcerative proctosigmoiditis: Results of a multicentered placebo‐controlled trial
    Inflammatory Bowel Diseases, 1998
    Co-Authors: Stephen B. Hanauer
    Abstract:

    The safety and efficacy of mesalamine Enemas were determined in a dose-ranging study enrolling 287 patients with ulcerative proctitis and proctosigmoiditis in a doubleblind, placebo-controlled, multicenter trial. Patients were randomized to receive placebo, 1, 2, or 4 g in 100 ml mesalamine (PENTASA) Enemas h.s. for 8 weeks. Efficacy was assessed by clinical, sigmoidoscopic, and histologic improvement, as well as by induction of remission. Sixty-seven percent, 65%, and 75% of patients receiving 1-, 2-, and 4-g Enemas were markedly improved according to the physician's global assessment compared with 27% of patients treated with placebo. The mean improvement in sigmoidoscopic index was 5.8, 5.9, and 6.4 points (on a 15-point scale) for the 1-, 2-, and 4-g Enema groups compared with a decrease of 1.8 points for the placebo group. Improvement in biopsy scores was observed in 47, 55, and 59% of 1-, 2-, and 4-g groups contrasted with 27% of the placebotreated patients. All three doses were significantly more effective than placebo in reducing symptoms and trips to the toilet compared with placebo. No dose-response relation was demonstrated. The safety profile was similar to that of placebo. In conclusion, mesalamine Enemas are effective as a single agent in the short-term treatment of distal ulcerative colitis without an apparent dose response between 1 and 4 g nightly.

Bruce G Wolff - One of the best experts on this subject based on the ideXlab platform.

  • bismuth carbomer foam Enemas for active chronic pouchitis a randomized double blind placebo controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

  • Bismuth carbomer foam Enemas for active chronic pouchitis: a randomized, double‐blind, placebo‐controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

Herschel A Carpenter - One of the best experts on this subject based on the ideXlab platform.

  • bismuth carbomer foam Enemas for active chronic pouchitis a randomized double blind placebo controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.

  • Bismuth carbomer foam Enemas for active chronic pouchitis: a randomized, double‐blind, placebo‐controlled trial
    Alimentary Pharmacology & Therapeutics, 1997
    Co-Authors: William J Tremaine, William J Sandborn, Bruce G Wolff, Herschel A Carpenter, Alan R Zinsmeister, P P Metzger
    Abstract:

    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.