[Drug safety, acceptance and effectiveness of 5-aminosalicylic acid (mesalazine) in the treatment of ulcerative colitis and Crohn disease]

Abstract

In an open clinical trial 71 patients with ulcerative colitis and 27 patients with Crohn's disease were treated with mesalazine (5-ASA). After four to eight weeks of acute phase treatment, maintenance therapy was ensued by treatment over a period of maximal 48 weeks. The activity of both inflammatory bowel disease clearly decreased. Relapse was not observed during maintenance treatment in ulcerative colitis. Pathological changes of clinical findings were not observed during treatment. Pathologic changes before treatment, which were associated with the disease, returned to normal during treatment. All potential side effects during treatment were recorded. The rate of side effects was low and all normalized when therapy was continued. The study confirms that mesalazine was safe, efficient and almost well tolerable.