In this article, I shared an email correspondence where I address the controversial human clinical trial on Parkinson’s and H2. This trial has been popularized online and has been featured on Pakinsonnewstoday.com. In this “Randomized, double‐blind, multicenter trial for hydrogen water on Parkinson’s disease,” it was concluded hydrogen water had no statistical improvement in the disease progression of PD in 72 weeks. This was a rather large trial enrolling 178 patients in 14 different hospitals across Japan. Unfortunately, there appear to be significant issues with the methodology of the study and the study remains inconclusive. I cover much of this in my email reply, which is featured below.
“Hello,
I am aware of this study and I should have addressed it in my previous email, which I meant to do, but I forgot to grab it as I was dealing with many sources from my database. There were several methodological issues with this clinical study and several leading scientists in the study of biomedical hydrogen therapy, such as Tyler LeBaron, have publicly addressed them. Thus, I would not hang the entirety of the preliminary data on one study. It’s better to assess the preliminary data as a whole, rather than basing it on a single study. I do not think the term “inconclusive” is an accurate term for the preliminary data on H2 and PD but it is an accurate term for that particular study due to its methodological issues.
For example, here are some critical points of consideration or quotations about the study from colleagues of mine and myself.
- The placebo water had H2 in it, in non-insignificant amounts.
- They tested the concentration using a Trustlex meter which can be flawed.
-Did they test it throughout the whole trial or just the beginning?
-If the dissolved H2 level in the placebo-prepared water was not properly measured and monitored, its levels could have been significantly higher.
Side Note (Tywon): I have attached at the bottom of this email my statement as to why the Trustlex meter can be flawed and is therefore not a suitable or ideal tool for measuring dissolved H2 levels.
- Both groups lost ~3 points in a timeframe; based on other studies they should have lost 9-10. The deterioration rate in both groups was 1/3 which is normally present in placebo groups for PD.
-The reasoning for high dose intermittent would be as a rush for altering gene signaling. Would a high dose taken at the same time every day, day after day for a year and a half, equate to no better than low dose continuous? Anecdotally, we have observed that changes in dosing protocol every few months yields the best results, with many even reporting symptoms coming back if they stay with the same dose and time of administration every day, with similar reversals after a wash out period and different dosage. Without more raw data it is hard to really comment further.”
From Tyler LeBaron, Founder of MHI, world authority on the biomedical research of H2, and scientific researcher of medicinal molecular hydrogen.
“We are still investigating this trial. The results were reported while I was in Japan last year. Firstly, as Alex Tarnava pointed out, both groups lost only ≈ points (3) instead of predicted ≈ points (9-10) based on other placebo studies.
Secondly, the H2 concentration in the placebo was at least 0.16 ppm (a typical water ionizer concentration, and many of you water ionizer enthusiasts report and notice benefits even with this low H2 concentration).
Thirdly, the H2 concentration in the placebo may actually have been greater than 0.16 ppm. It was measured incorrectly. The placebo preparation protocol was sent to me and two other researchers and we are evaluating the methodology. We had a meeting on this in Japan last month, and again last week in China. Next month we will discuss the details while in China and compare our results.”
From Tywon Hubbard:
Lastly, I would add, both groups (H2 and placebo) only losing 3 points in the duration time-frame of 72 weeks leads to the notion or plausibility that hydrogen therapy could have actually slowed disease progression, considering other placebo-controlled studies predict 9~10 points lost in similar time-frames using the Unified Parkinson’s Disease Rating Scale (UPDRS) and the placebo water contained hydrogen gas.
Due to the fact the placebo water was inaccurately measured for dissolved hydrogen gas, meaning its 0.16 mg/L reading could have been considerably higher, it’s hard to draw any real conclusions from this article. We (my organization) have actually tested the Trustlex meter against Technical Titration and discovered the meter can exhibit >70% change in dissolved hydrogen content depending on TDS and pH of the water. Technical Titration exhibited an 8% change in dissolved hydrogen content due to human error. That is only 0.09~0.13 mg/L (8%) if the dissolved hydrogen concentration is near saturation (1.57 mg/L). Thus, the placebo water could have had close to 0.5 mg/L of dissolved hydrogen gas, which is close to the suggested therapeutic minimum for humans. Now, this is based on our independent testing, but I do believe it is valid.
The previous 48-week study demonstrated statistical improvements in PD patients and corroborates well with the other preliminary data. As it stands currently, that article holds higher merit, as the 72-week study is under critical review and clearly has some methodological issues.
I have attached images of Tyler LeBaron’s public statement online about this study and this is not the only place I believe he has made these statements about this study. I don’t know the results from his and other researcher’s meeting in Japan, but I will reach out to him, as it was a couple of years ago. Nonetheless, I hope these statements provide some clarity about that article. It’s not just Tyler LeBaron either making claims about the H2 concentration; It’s actually published in research.
“Randomized, double-blind, multicenter trial of hydrogen water for Parkinson’s disease: LETTERS: NEW OBSERVATIONS”
“The mean change in total UPDRS score remained within 3 points in the 2 groups. This deterioration in total UPDRS score was lower than those in the placebo groups in other trials (DATATOP study: 24th month, 14.025 ; QE3 trial: 16th month, 6.926 ).”
“The concentration of H2 (measured via oxidation reduction potential method using ENH-1000 [Trustlex Inc., Osaka, Japan]) in the placebo water in the “Hydrogen 7.0” kits used previously was identical to that in the bottles containing H2 water (0.16 ± 0.16 ppm; n = 30).”
If nothing else, I just want you to have an accurate view of the data and the conclusions it draws about therapeutic potential. In my view of the data, hydrogen appears to have therapeutic promise or potential for PD and is being regarded as a novel therapeutic strategy. There are no other recently published articles that I have in my database. There have been a number of review articles published in 2020 that discuss hydrogen’s therapeutic potential for neurological disorders and its protective effects, such as this one:
Neuroprotective Effects of Molecular Hydrogen: A Critical Review
“Meanwhile, we review the effectiveness and safety of H2 in the treatment of various nervous system diseases based on preclinical and clinical studies, leading to the conclusion that H2 can be a simple and effective clinical therapy for CNS diseases such as ischemia-reperfusion brain injury, Parkinson’s disease, and diseases characterized by cognitive dysfunction. The potential mechanisms involved in the neuroprotective effect of H2 are also analyzed.”
https://link.springer.com/article/10.1007/s12264-020-00597-1
Thank you for allowing me to guide you in all this information.
I hope all this helps and helps you come to an informed decision.”