Oral beclomethasone dipropionate versus oral 5-aminosalicylic acid in the treatment of active ulcerative colitis: A randomised, 4 week, controlled study

Rizzello, Fernando; Gionchetti, Paolo; Valpiani, D.; Andriulli, Angelo; Adamo, Salvatore; Casetti, T.; Colombo, E.; D’Arienzo, A.; Novelli, G.; d’Albasio, G; Campieri, Massimo

doi:10.1016/s1590-8658(01)80277-2

Cited by 2 publications

(6 citation statements)

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“…Even in combination with oral 5-ASA, the good safety profile of oral BDP shown in previous studies has been confirmed. 19,20 Although there was a significant reduction in serum cortisol levels at the end of treatment, the mean value remained within the normal range, and, even though four patients had serum cortisol levels below the lower reference limit, no clinical signs or adverse reactions related to adrenal depletion were recorded. Also the incidence of adverse events was low, with no serious side-effects recorded.…”

Section: Discussionmentioning

confidence: 90%

“…Previous studies have demonstrated that BDP administered as controlled-release tablets produces a positive response in patients with active mild to moderately severe ulcerative colitis 19 and is as effective as oral 5-ASA. 20 Many ulcerative colitis patients experience relapses not always successfully treated with oral 5-ASA alone. In these patients, in order to reduce the mucosal inflammation and to improve the quality of life, it is useful to add systemic or local corticosteroid therapy.…”

Section: Discussionmentioning

confidence: 99%

“…The therapeutic efficacy of oral BDP in the treatment of active ulcerative colitis appears to be comparable to that of 5‐ASA, as demonstrated in previous studies 19 ,. 20 …”

Section: Introductionmentioning

confidence: 99%

“…18 The therapeutic efficacy of oral BDP in the treatment of active ulcerative colitis appears to be comparable to that of 5-ASA, as demonstrated in previous studies. 19,20 The present study was performed to compare efficacy and safety of oral BDP with placebo as adjunctive therapy to oral 5-ASA in the treatment of active ulcerative colitis.…”

Section: Introductionmentioning

confidence: 99%

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Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Rizzello

Gionchetti

D’Arienzo³

et al. 2002

Aliment Pharmacol Ther

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121

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SUMMARYAim: To evaluate efficacy and safety of oral beclometasone dipropionate (BDP) when added to 5-ASA in the treatment of patients with active ulcerative colitis. Methods: In a 4-week, placebo-controlled, double-blind study, patients with extensive or left-sided mild to moderate active ulcerative colitis were randomized to receive oral 5-ASA (3.2 g ⁄ day) plus BDP (5 mg ⁄ day) or placebo. Clinical, endoscopic and histologic features, and haematochemical parameters were recorded at baseline and at the end of the study. Results: One hundred and nineteen patients were enrolled and randomly treated with BDP plus 5-ASA (n ¼ 58) or placebo plus 5-ASA (n ¼ 61). Both treatment groups showed a statistically significant decrease of disease activity index (DAI) and histology score at the end of treatment (P ¼ 0.001, each). DAI score was lower in the BDP group than in the placebo group (P ¼ 0.014), with more patients in clinical remission in the BDP group (58.6% vs. 34.4%, P ¼ 0.008). Serum cortisol levels significantly decreased in BDP group vs. baseline (P ¼ 0.002), but without signs of pituitary-adrenal function depletion. A low incidence of adverse events was observed in both groups. Conclusions: Oral BDP in combination with oral 5-ASA is significantly more effective than 5-ASA alone in the treatment of patients with extensive or left-sided active ulcerative colitis.

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Section: Discussionmentioning

confidence: 90%

Section: Discussionmentioning

confidence: 99%

“…The therapeutic efficacy of oral BDP in the treatment of active ulcerative colitis appears to be comparable to that of 5‐ASA, as demonstrated in previous studies 19 ,. 20 …”

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Rizzello

Gionchetti

D’Arienzo³

et al. 2002

Aliment Pharmacol Ther

Self Cite

121

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“…An oral preparation of BDP has recently been tested in two multicentre Italian trials at a dose of 5 mg/day for 4 weeks, it shows a similar efficacy to oral mesalazine (2.4 g/day) in mild to moderate attacks, 24 and is significantly superior to placebo in patients not responding after 4 weeks of treatment with 3.2 g/day oral mesalazine 25 …”

Section: Management Of Mild‐moderate Ulcerative Colitismentioning

confidence: 99%

Treatment of mild to moderate ulcerative colitis and pouchitis

Gionchetti

Amadini

Rizzello

et al. 2002

Aliment Pharmacol Ther

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SUMMARYThe meta-analyses of published trials have shown topical therapy with 5-aminosalicylic acid (5-ASA) to be the treatment of choice in active distal ulcerative colitis. Oral aminosalicylates are effective for both distal and extensive ulcerative colitis, but in distal colitis the rates of improvement and remission are usually lower than those reported for rectal 5-ASA therapy. An alternative to 5-ASA therapy is represented by the new steroids; budesonide and beclometasone dipropionate (BDP) enemas, the most extensively studied, have been shown to be as effective as conventional steroids but with a significantly lower inhibition of plasma

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Oral beclomethasone dipropionate versus oral 5-aminosalicylic acid in the treatment of active ulcerative colitis: A randomised, 4 week, controlled study

Cited by 2 publications

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Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Oral beclometasone dipropionate in the treatment of active ulcerative colitis: a double‐blind placebo‐controlled study

Treatment of mild to moderate ulcerative colitis and pouchitis

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