Controlled trial of sulphasalazine in the treatment of ulcerative colitis

Sulphasalazine (salicylazosulphapyridine, Salazopyrin, Asulfidine) was first used by Svartz (1942) in the treatment of rheumatoid arthritis. Later, patients with arthritis associated with ulcerative colitis were treated with sulphasalazine with clinical improvement of both conditions (Svartz, 1948). The drug has since been used extensively in Scandinavia and in America in the treatment of ulcerative colitis, and many reports have indicated favourable results, some three-quarters of the patients showing improvement in most series (Bargen, 1949, 1956; Moertel and Bargen, 1959; Morrison, 1952; Svartz, 1954, 1960). However, at the time the present investigation was started in 1959 no controlled studies had been reported. Lennard-Jones, Longmore, Newell, Wilson, and Avery Jones (1960) report the result of two consecutive trials. In the first prednisone was compared with an inert tablet and found to be effective in cases of left-sided colitis. Prednisone was then used as a standard with which to compare sulphasalazine and hydrocortisone hemisuccinate retention enemata. There was no doubt about the effectiveness of prednisone as compared with that of an inert tablet. The authors considered that sulphasalazine probably brought about remission almost as frequently as prednisone, although more slowly. Under the conditions of their trial, however, a statistically significant result for the effectiveness of sulphasalazine was not obtained. The dosage of sulphasalazine used was 4 g. daily and the patients were assessed at the end of a three-week period. Truelove, Watkinson, and Draper (1962) compared combined oral and topical corticosteroid therapy with sulphasalazine over a 14-day period using the sequential method of analysis. The combined