Source: Ophthalmology  |  Posted 9 years ago

Higher doses of mesalazine have no clinically significant advantage over the lower standard doses in preventing post-operative endoscopic and clinical recurrence of Crohn's disease.

A multi-centre team noted that, although mesalazine had been shown to help prevent such recurrence, the relationship between dosage and response remained unclear.

To see if the higher dose had any therapeutic advantage, the investigators enrolled 206 patients into a double-blind, randomised, multi-centre, controlled clinical trial. The patients had first or second intestinal resection for Crohn's disease limited to the terminal ileum, with or without involvement of the caecum/ascending colon.

Of the 206 patients, 101 were randomly allocated to receive mesalazine 4.0 grams daily and of these, 84 were endoscopically evaluable. The other 105 patients, of whom 81 were endoscopically evaluable, received 2.4 grams daily. Both regimens were started two weeks after surgery.

The primary outcome was endoscopic recurrence a year later evaluated by scores of > 0, > 1 and > 2. The secondary outcome was clinical recurrence, defined as Crohn's disease activity index above 150 points or a rise of 100 points or more.

Endoscopic recurrence of > 0 was significantly higher in the 2.4 gram group (62%) than in the 4.0 gram group (46%).

The two groups did not differ either in clinical recurrence or in the > 1 and > 2 endoscopic outcomes.