Clinical Trial on the Effect of Nutrient Supplementation in Patients with Rheumatoid Arthritis

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A Double Blind, Placebo-controlled, Randomized Clinical Trial on the Effect

of Nutrient Supplementation in Patients with Rheumatoid Arthritis

Category: 17 RA—treatment

Philip H J Remans1, Lisette Wagenaar2, Atie Jongma1, Nivine Levahrt1, Jaap K

Sont3, Wendeline Wouters-Wesseling2, Ferdinand C Breedveld1, M van

Laar1

1Leiden University Medical Center, Leiden, Netherlands2Numico Research,

Wageningen, Netherlands3Leiden University Medical Center, Medical

Statistics, Leiden, Netherlands

Presentation Number: 1374

Poster Board Number: 329

Keywords: nutrient supplementation, antioxidant, rheumatoid arthritis

Background: Nutrient supplementation has been advocated as a potentially

useful add-on therapy in rheumatoid arthritis (RA). In particular,

beneficial effects of both omega-3 fatty acids supplements and antioxidants

have been reported in a few controlled studies, although in none

combinations were evaluated.

Objective: To 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 patients with active RA were randomized to receive either

the nutritional supplement provided in tetrapacks for daily use, or placebo

for 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 different variables such as age, concommitant medication and

the different outcome parameters of the components of the ACR core set of

disease activity measures.

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: 4 patients dropped out because of gastro-intestinal

complaints (3 verum, 1 placebo); 6 patients because of inefficacy (4 verum,

2 placebo). 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) tended to improve, 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.

Conclusions: 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.