PubMed日本語 - 関節リウマチ患者で食事の植物から派生した多糖補助剤の効能を調査する二重盲検、無作為、プラセボ対照試験。―QLifePro医療翻訳医療翻訳 QLifePro


A double-blind, randomized, placebo-controlled study to explore the efficacy of a dietary plant-derived polysaccharide supplement in patients with rheumatoid arthritis.


Published date



Azita Alavi, Lucy Goodfellow, Owen Fraser, Edward Tarelli, Martin Bland, John Axford


The Sir Joseph Hotung Centre for Musculoskeletal Disorders, Division of Cellular and Molecular Medicine, St George's University of London, London SW17 0RE, UK.


OBJECTIVES: 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.



参加者を,6ヶ月間のAC(n = 33)あるいはプラセボ(n = 36)投与のいずれかに無作為に割付けた。

補給はagalactosylatedされた(G0F)グリカン[7.16 (0.60)に対する8.10 (0.89); P = 0.03]のレベルの12%の有意の低下に帰着したが、患者結果に有意の全体の影響を及ぼさなかった。
プラセボ治療をうけている群はG0Fの変化を示さなくて、完全にdigalactosylatedされた(G2)グリカン(11%; P = 0.03)のレベルの減少を示した。
臨床的に重要でないにもかかわらず、しかしながら、DASスコアはプラセボ群[差= 0.63の(0.23) s.e.; 95%CI 0.17、1.10; P = 0.009](第2の変数の2つであった)でわずかにより低かった。


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