Hydrogenology
Hydrogenology editorial study record

Randomized double-blind placebo-controlled trial of hydrogen inhalation for Parkinson’s disease: a pilot study

Yoritaka A et al. · Neurol Sci. 2021;42(11):4767–4770.

HumanOther formsPublished 2021
Study record, not medical adviceThis page reports one source and Hydrogenology’s source-text extraction. It does not establish that molecular hydrogen is effective, safe or appropriate for any person. Human, animal and laboratory evidence must not be treated as equivalent.
Source and classification

What kind of evidence is this?

Evidence stream

Human

Reported design

Randomized double-blind placebo-controlled parallel pilot trial

Research topic

Parkinson’s disease

Administration classification

Other forms

Study result signal

Not reported in this record.

Outcome type

Not reported in this record.

Reported in the source

Methods at a glance

Population or model

Japanese adults with Parkinson’s disease receiving levodopa

Sample

20 enrolled; 15 included in the per-protocol analysis: H₂ n=7 and placebo n=8

Duration

1 hour twice daily for 16 weeks

Intervention

Mixed air containing H₂ at 2,000 mL/min for 1 hour twice daily

Hydrogen form

H₂ diluted in air — H₂ was the active added gas, not Brown’s gas.

H₂ specification

6.5 ± 0.1% H₂ in the 2 L/min source mixture.

H₂ flow

130 mL/min H₂, calculated as 2,000 mL/min source-gas flow × 6.5% H₂.

O₂ delivered with H₂

No supplemental O₂ was reported. Because the balance composition of the mixed air is not quantified, O₂ flow cannot be calculated.

Comparator

Placebo air at 2,000 mL/min from an indistinguishable modified machine

Reported, not endorsed

Outcomes and reported result

Outcomes measured

MDS-UPDRS, PDQ-39, oxidative-stress measures, adherence and adverse events

Reported result

No significant between-group difference was found in total MDS-UPDRS or its parts at week 16. No adverse events were reported.

Results-extraction completeness

The complete open-access article was checked for gas concentration, flow, allocation, adherence, all reported outcome tables, adverse events and competing interests.

A reported association, difference or mechanism is not automatically a clinical benefit. Null findings, outcome type, study design and precision all matter.

Interpretation limits

Cautions and applicability

Design and reporting cautions

Very small pilot; five of 20 participants were excluded for insufficient inhalation time, leaving an unbalanced per-protocol sample. Several authors disclosed pharmaceutical relationships and departmental commercial endowments.

Applies directly to

Adults with Parkinson’s disease receiving levodopa under the reported home-inhalation protocol.

Preliminary appraisal framework

Not reported in this record.

Preliminary risk-of-bias status

Not reported in this record.

Appraisal rationale

Not reported in this record.

No single-study GRADE certainty rating is assigned. Certainty is assessed by important outcome across a complete eligible evidence set, not by attaching a final grade to one source.

Provenance

Sources and record status

Identifiers

PMID: 34319514 · DOI: 10.1007/s10072-021-05489-4

Publisher access

Open-access full text is available through PMC.

Extraction basis

Open-access PMC full text, PubMed record and UMIN registration.

Record revision

2026-08-10