Two consecutive trials of out-patient treatment for mild cases of active ulcerative colitis are described. In the first trial oral prednisone gave significantly better results than a placebo. In the second trial "salazopyrin" gave final results approaching those of prednisone, although over a longer time and with a higher incidence of unpleasant side-effects, but topical hydrocortisone gave disappointing results, probably because the technique of administration was not suitable for ordinary out-patient use.
The efficacy of corticosteroids in the treatment of ulcerative colitis has been established (Truelove and Witts, 1955), but the optimum dose has been less thoroughly studied. In a comparative trial of different methods of treatment Truelove (1960) reported a remission rate of 35% in out-patients using prednisolone 20 mg. daily, and Watkinson (1961a, 1961b) observed remission in 12 out of 36 patients given the same dose of prednisone.However, using a larger dose of prednisone in two outpatient trials, a remission rate of 650% was obtained at this clinic (Lennard-Jones, Longmore, Newell, Wilson, and Avery Jones, 1-960). The present study was therefore undertaken to compare the results of using 60, 40, and 20 mg. of prednisone daily as treatment for active ulcerative colitis.Design of the Trial The observations were made during 60 courses of treatment in 58 patients with active ulcerative colitis seen at a special out-patient clinic. Patients who entered the trial were allocated randomly to one of three treatment groups and received oral prednisone in a dose of 20, 40, or 60 mg. daily; both the patient and the doctor knew which treatment was given.The activity of the colitis was judged by the patients' symptoms, especially bowel disturbance and rectal bleeding, and by the appearance of the colonic mucosa on sigmoidoscopy. Patients were accepted for the trial if they had already been treated for the present attack of colitis with drugs other than corticosteroids or with prednisone in a dose of less than 20 mg. daily and the treatment had proved ineffective. To be eligible for the trial a patient must have been judged suitable for treatment with any of the doses of prednisone used; those in whom corticosteroid treatment was contraindicated were thus excluded. Patients were not included if the disease was confined to the rectum or if the colitis appeared to be improving spontaneously. Since all were treated as out-patients, the trial was necessarily limited to those whose colitis was of mild or moderate severity.When a patient entered the trial the treatment was selected by drawing from a box a folded slip marked with the dose of prednisone to be used.
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