Beschreibung:
<jats:title>Abstract
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<jats:title>Background</jats:title>
<jats:p>Oxidative stress is involved in the progression of Parkinson’s disease (PD). Recent studies have confirmed that molecular hydrogen (H<jats:sub>2</jats:sub>) functions as a highly effective antioxidant in animal models of PD. A placebo-controlled, randomized, double-blind, parallel-group clinical pilot study was conducted to assess the efficacy of hydrogen gas inhalation in Japanese patients with PD on treatment with levodopa.</jats:p>
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<jats:title>Methods</jats:title>
<jats:p>Twenty participants fulfilling the Movement Disorder Society criteria were enrolled. Participants inhaled 6.5 (0.1) vol% hydrogen gas in 2 L/min of mixed air or placebo air for 16 weeks, twice a day for 1 h.</jats:p>
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<jats:title>Results</jats:title>
<jats:p>Five participants were excluded due to deviation from the protocol of the total duration of inhalation < 112 h. No significant differences were seen in the change in the total Movement Disorder Society Unified Parkinson’s Disease Rating Scale score from baseline to the 16<jats:sup>th</jats:sup> week between the group that inhaled hydrogen gas and the group that inhaled placebo air (Mann–Whitney <jats:italic>U</jats:italic> test, <jats:italic>p</jats:italic> > 0.05). No adverse events were seen. The compliance to the protocol-based duration of inhalation time in all participants decreased with the elderly participants, the higher daily dose of levodopa, and the higher PDQ-39 items on emotions (<jats:italic>n</jats:italic> = 20, <jats:italic>p</jats:italic> < 0.05).</jats:p>
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<jats:title>Conclusion</jats:title>
<jats:p>This pilot study revealed that the inhalation of molecular hydrogen gas was safe, but did not show any beneficial effects in patients with PD.</jats:p>
<jats:p><jats:bold>Trial registration:</jats:bold> UMIN ID: 000,039,217 (October 6, 2018)</jats:p>
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