OMEGA-3-FATTY-ACIDS AND LOW CARBOHYDRATE-DIET FOR MAINTENANCE OF REMISSION IN CROHNS-DISEASE - A RANDOMIZED CONTROLLED MULTICENTER TRIAL

Background: There is no established therapy for maintaining remission in patients with Crohn's disease. Following different suggestions from the literature, two potential interventions for maintaining remission were tested against placebo, using either 5 g/day of a highly concent rated omega-3 fatty acid compound or a carbohydrate-reduced diet (84 g /day). Methods: A total of 204 patients were recruited after they had had an acute relapse. After remission (CDAI less than or equal to 150) was attained with steroid therapy, patients were randomized to receiv e either omega-3 fatty acids (n = 70), placebo (n = 65), or diet (n = 69). Low-dose prednisolone was given to all patients for the first 8 w eeks of intervention, CDAI and an acute-phase protein (CRP) were used as criteria for a relapse. Results: The proportion of patients without relapse within a year were similar in the placebo and active treatmen t group (intention-to-treat analysis: placebo, 30%; active treatment, 30%; protocol-adhering patients, 29% versus 28%). Patients did gain be nefit (53%; p = 0.023) for as long as they maintained the diet. Howeve r, intention-to-treat analysis (diet group, 40%) did not show a notice able difference when compared with placebo. Conclusions: Omega-3 fatty acids did not show an effect on extending the remission in Crohn's di sease. For the diet patients the question remains whether the noncompl iant patients dropped out early because they sensed a relapse approach ing or whether their condition deteriorated because they failed to com ply with the diet.