A DOUBLE BLIND, PLACEBO-CONTROLLED, RANDOMIZED CLINICAL TRIAL ON THE EFFECT OF NUTRIENT SUPPLEMENTATION IN PATIENTS WITH RHEUMATOID ARTHRITIS

Background: Nutrient supplementation as add-on therapy in rheumatoid arthritis (RA) has increasingly been advocated in recent years as a result of growing clinical evidence. In particular, objective information has been accumulating about beneficial effects of both omega-3 fatty acids supplements and antioxidants in the treatment of rheumatoid arthritis.Objectives: Investigate in a double blind placebo-controlled study the effects of a nutrient supplement, containing omega-3 fatty acid eicosapentaenoic acid (EPA), omega-6 fatty acid gamma-linolenic acid (GLA) and anti-oxidants, as add-on therapy in patients with active rheumatoid arthritis (RA).Methods: Sixty six RA patients with active disease, were included and randomized to receive either the nutritional supplement provided in tetrapacks for daily use, or a placebo for a period of 4 months. The supplemental drink-feed contained a combination of both polyunsaturated fatty acids EPA, GLA and the anti-oxidants vitamin C, vitamin E, selenium, zinc. Statistics: Data were analyzed using the standard SPSS methods. Univariate Anova analysis was performed to test the influence of the supplement on the different outcome parameters.Results: Of the sixty-six subjects included a total of 11 patients did not complete the trial (7 patients receiving the nutritional supplement and 4 receiving placebo: 3 patients due to gastro-intestinal complaints, versus 1 placebo; 4 patients abandoned the study because of inefficacy of the supplement versus 2 patients in the placebo-group.). Although some variables as the visual analog scale for pain (Mean changes and t-test: -1.39 mm; p=0.42), grip strenght (-5.6 kPa; p= 0.453), number of swollen joints (- 0.2; p=0.655) improved, we found no significant difference as compared to placebo. Also, the inter groups differences as determined by Univariate Anova analysis, both clinical and biochemical, did not reach statistical significance.Conclusion: Daily use of a drink-feed with fatty acids and anti-oxidants was not superior to placebo with regard to clinical benefit in patients with active RA.Citation: , volume , supplement , year 2002, page Session: Rheumatoid arthritis – Treatment 2