Therapeutic efficacy of infused molecular hydrogen in saline on rheumatoid arthritis: A randomized, double-blind, placebo-controlled pilot study

The aim of this study was to demonstrate the safety and efficacy of H2-saline infusion for treatment of rheumatoid arthritis (RA). We conducted a randomized, double-blind, placebo-controlled investigation of the infusion of 1ppm H2-dissolved saline (H2-saline) in 24 RA patients. Patients were randomized 1:1 to receive 500ml of either H2-saline or placebo-saline, which was drop infused intravenously (DIV) daily for 5days. The disease activity score in 28 joints (DAS28) was measured at baseline, immediately post infusion, and after 4weeks. Therapeutic effects of H2-saline on joint inflammation were estimated by measuring serum biomarkers for RA, tumor necrosis factor-α (TNFα), interleukin-6 (IL-6), matrix metalloproteinase-3 (MMP-3), and urinary 8-hydroxydeoxyguanosine (8-OHdG). In the H2-infused group, average DAS28 decreased from 5.18±1.16 to 4.02±1.25 immediately post infusion and reached 3.74±1.22 after 4weeks. No significant decrease in DAS28 was observed in the placebo group throughout the study. IL-6 levels in the H2 group significantly decreased in 4 weeks by 37.3±62.0% compared to baseline, whereas it increased by 33.6±34.4% in the placebo group. TNFα levels did not change remarkably in the H2 or placebo groups in 4 weeks post-infusion compared to baseline. The relative ratio of 8-OHdG in the H2 group also significantly decreased by 4.7%. After 4weeks, MMP3 was significantly reduced by 19.2%±24.6% in the H2 group, and increased by 16.9%±50.2% in the placebo group. Drop infusion of H2 safely and effectively reduced RA disease activity. •Intravenous infusion of H2-saline reduced the disease activities of RA.•Serum IL-6, serum MMP-3 and urinary 8-OHdG decreased due to infusion of H2-saline.•5days infusion of H2-saline was effective after 3weeks washout period.