A Controlled Randomized Trial of Budesonide versus Prednisolone Retention Enemas in Active Distal Ulcerative Colitis

Å. Danielsson Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

G. Hellers Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

E. Lyrenäs Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

R. Löfberg Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

Å. Nilsson Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

O. Olsson Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

S-Å. Olsson Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

T. Persson Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

L. Salde Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

J. Naesdal Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

M. Stenstam Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

R. Willén Dept. of Medicine, Umeå Hospital, Umeå, Sweden; Dept. of Medicine, Karlskrona Hospital, Karlskrona, Sweden; Dept. of Medicine, Söder Hospital, Stockholm, Sweden; Dept. of Medicine, Lund Hospital, Lund, Sweden; Dept. of Medicine, Helsingborg Hospital, Helsingborg, Sweden; Dept. of Medicine, Eskilstuna Hospital, Eskilstuna, Sweden; Dept. of Surgery, Jönköping Hospital, Jöznköping, Sweden; Dept. of Surgery, Lund Hospital, Lund, Sweden; Dept. of Medicine, Linköping Hospital, Linköping, Sweden; Dept. of Pathology, University of Lund, Lund, Sweden; Dept. of Clinical Research, AB Draco/Tika, Lund, Sweden

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Abstract

Sixty-four patients with active distal ulcerative colitis participated in a multicentre, randomized, investigator-blind trial to compare the effect of budesonide enema, 2 mg/100 ml, with prednisolone disodium phosphate enema, 31.25 mg/100 ml. Budesonide is a new potent corticosteroid with a rapid first-pass elimination. The patients were treated for 4 weeks, and the efficacy of the drugs were evaluated by sigmoid-oscopy, histology, and subjective symptoms after 2 and 4 weeks. After 4 weeks of treatment 16 of 31 patients (52%) receiving budesonide enema had healed endo-scopically, compared with 8 of 33 (24%) (p = 0.045) receiving prednisolone enema. Budesonide was superior to prednisolone in terms of both significantly improved sigrnoidoscopic and histologic scores and subjective symptoms evaluated by visual analogue scales. The patients receiving prednisolone had a significant depression of endogenous cortisol levels during the treatment period, but not the patients receiving budesonide. Budesonide enema seems to be a promising therapy for active distal ulcerative colitis and causes no adverse reactions.

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A Controlled Randomized Trial of Budesonide versus Prednisolone Retention Enemas in Active Distal Ulcerative Colitis

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A Controlled Randomized Trial of Budesonide versus Prednisolone Retention Enemas in Active Distal Ulcerative Colitis

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