A double-blind, randomized, placebo-controlled study to explore the efficacy of a dietary plant-derived polysaccharide supplement in patients with rheumatoid arthritis.
OBJECTIVE
There is increased interest in the potential benefits of complementary therapies, of which dietary plant-derived polysaccharides (dPPs) are an important component. We examined the impact of oral ingestion of a pre-biotic dPP supplement active compound (AC) on serum glycosylation and clinical variables associated with inflammation and general health in patients with RA.


METHODS
A double-blind, placebo-controlled, parallel-group clinical trial was used. Participants were randomly assigned to receive AC (n = 33) or placebo (n = 36) for 6 months. Serum protein N-glycosylation was determined by mass spectrometry. Patient outcomes were assessed by validated clinical trial health questionnaires. The primary clinical efficacy variable was DAS-28.


RESULTS
The groups had comparable baseline clinical characteristics. AC was well tolerated with low drop-out rates. Supplementation resulted in a 12% significant drop in the levels of the agalactosylated (G0F) glycans [8.10 (0.89) to 7.16 (0.60); P = 0.03], but had no significant overall effect on patient outcomes. The placebo-treated group showed no change in G0F but exhibited a reduction in the levels of fully digalactosylated (G2) glycans (11%; P = 0.03). Although not clinically significant, DAS scores were, however, marginally lower in the placebo group [difference = 0.63 (0.23) s.e.; 95% CI 0.17, 1.10; P = 0.009], as were two of the secondary variables.


CONCLUSIONS
Short-term dietary supplementation with AC resulted in a moderate, but significant, reduction in G0F levels, but did not result in any clinically significant improvement in disease activity when assessing the study group as a whole.
The Sir Joseph Hotung Centre for Musculoskeletal Disorders, Division of Cellular and Molecular Medicine, St George's University of London, London SW17 0RE, UK. aalavi@sgul.ac.uk
Azita
A
Alavi
Lucy
L
Goodfellow
Owen
O
Fraser
Edward
E
Tarelli
Martin
M
Bland
John
J
Axford
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D000529:Complementary Therapies; D016001:Confidence Intervals; D018592:Cross-Over Studies; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D010936:Plant Extracts / Q000008:administration & dosage*; D011134:Polysaccharides / Q000008:administration & dosage*; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D016896:Treatment Outcome
D010936:Plant Extracts; D011134:Polysaccharides