Hydrogen in Patients With Corticosteroid-Refractory/Dependent Chronic Graft-Versus-Host-Disease: A Single-Arm, Multicenter, Open-Label, Phase 2 Trial
Qian L, Liu M, Shen J, Cen J, Zhao D. · Frontiers in Immunology. 2020;11:598359.
Study at a glance
Human
People younger than 65 years with corticosteroid-refractory or corticosteroid-dependent chronic graft-versus-host disease after allogeneic stem-cell transplantation.
Hydrogen-rich water 4 mL/kg orally three times daily as the only new intervention. Background corticosteroids and other immunosuppressants continued and could be tapered under the protocol. · The water contained 0.8 ppm dissolved H₂.
Planned treatment for up to 12 months, with assessments every 3 months; survival follow-up extended to a median of 38.5 months.
At last evaluation, 18/24 participants had an objective response (8 complete and 10 partial); five progressed and one was stable. Eighteen completed 12 months, two were lost to follow-up and four died within 12 months. Among responders, median prednisone dose fell from 0.185 to 0 mg/kg/day (p=0.004). The estimated 4-year survival was 74.7%; the responder-versus-nonresponder survival comparison was post hoc and cannot establish treatment causality.
Small uncontrolled open-label study with continuing background immunosuppression, organ-specific denominators and responder-defined survival comparisons. It cannot distinguish H₂ effects from natural history, co-treatment, regression to the mean or selection. Beijing Huoliqingyuan Beverage Co. supplied the water; the study was funded by the National Natural Science Foundation of China (81800180), and authors declared no commercial or financial conflicts.
What kind of evidence is this?
Human
Prospective multicenter, open-label, single-arm phase 2 trial
Immune and inflammatory conditions
H₂-rich water
Information not yet classified
Some editorial classification fields are still pending. The source-reported outcomes and result are shown below; Hydrogenology does not infer a positive or negative signal from prose automatically.
Methods
People younger than 65 years with corticosteroid-refractory or corticosteroid-dependent chronic graft-versus-host disease after allogeneic stem-cell transplantation.
24 participants from four institutions; median age 27 years. Nineteen had severe cGVHD and 19 were receiving corticosteroids at entry.
Planned treatment for up to 12 months, with assessments every 3 months; survival follow-up extended to a median of 38.5 months.
Hydrogen-rich water 4 mL/kg orally three times daily as the only new intervention. Background corticosteroids and other immunosuppressants continued and could be tapered under the protocol.
H₂ dissolved in drinking water — H₂ only, not Brown's gas.
The water contained 0.8 ppm dissolved H₂.
No concurrent control group; the article discusses historical response rates only.
Outcomes and reported result
NIH organ response criteria, overall response, Karnofsky performance status, prednisone use, toxicity and survival.
At last evaluation, 18/24 participants had an objective response (8 complete and 10 partial); five progressed and one was stable. Eighteen completed 12 months, two were lost to follow-up and four died within 12 months. Among responders, median prednisone dose fell from 0.185 to 0 mg/kg/day (p=0.004). The estimated 4-year survival was 74.7%; the responder-versus-nonresponder survival comparison was post hoc and cannot establish treatment causality.
The complete publisher article, tables, protocol details, organ-level responses, deaths, toxicity, funding, product supply and conflict declaration were checked.
A reported association, difference or mechanism is not automatically a clinical benefit.
Limitations and applicability
Small uncontrolled open-label study with continuing background immunosuppression, organ-specific denominators and responder-defined survival comparisons. It cannot distinguish H₂ effects from natural history, co-treatment, regression to the mean or selection. Beijing Huoliqingyuan Beverage Co. supplied the water; the study was funded by the National Natural Science Foundation of China (81800180), and authors declared no commercial or financial conflicts.
Corticosteroid-refractory/dependent cGVHD under this protocol; confirmatory controlled trials are required.
No single-study GRADE certainty rating is assigned. Read how records and evidence assessments are prepared.
Sources and record status
PMID: 33324415 · DOI: 10.3389/fimmu.2020.598359
Open-access publisher full article and PubMed Central copy.
Frontiers publisher full article and PubMed Central copy; full-text extraction checked 8 August 2026.
10 August 2026
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