Clinical Efficacy of Oral Mesalazine in Crohn’s Disease

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Abstract
A randomized controlled trial was performed to evaluate in Crohn's disease the clinical efficacy and safety of a higher dose of a new slow-release preparation of mesalazine (500 mg tablets). Twenty-four patients created with 3 g mesalazine/day were compared with 26 patients treated with sulfasalazine (3 g/day) and methylprednisolone (initially 40 mg). All patients had active Crohn's disease diagnosed by endoscopy, sonography and radiology. Patients were characterized before entry into the study and at two, four, eight and 12 weeks of treatment by activity indices according to Best and van Hees, as well as by erythrocyte sedimentation rate, thrombocyte count, Broca index and serum albumin. All clinical and laboratory parameters were well matched for the two groups of patients. During treatment with mesalazine and sulfasalazine/ methylprednisolone, clinical remission could be observed in 20 of 24 patients (83%) and 23 of 26 patients (88%), respectively. There was no difference between the two groups except for a slightly higher increase of the Broca index in the combined treatment group. Side effects were reported in three (12.5%) and six (23%) patients treated with mesalazine and sulfasalazine/methylprednisolone, respectively. In conclusion, oral mesalazine at a dose of 3 g/day was effective in active Crohn's disease and was well tolerated by the patients.

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