Since our review we found a new publication (Experimental and Therapeutic Medicine 2018;15:3203-3210). This describes a study in which 31 people with ALS were treated with Endotherapia and were said to have benefits on their ALSAQ40 compared to a “worldwide reference” population. This study has the same significant flaws as the previous 12 patient study we described in our review. These flaws include the fact that the ALSAQ40 is a measure of quality of life. This is not tightly linked to motor function. It cannot be used to estimate survival. It is not an appropriate primary measure of ALS progression. We are unaware of a worldwide reference population that can be used to universally estimate disease progression. Since ALS progression is dependent on demographics and disease characteristics, careful matching is necessary when using historical control groups. Again, this does not appear to have been done here. No systematic screening for or reporting on adverse events appears in this new paper. Our TOE grades and conclusions are unchanged. We cannot recommend the use of Endotherapia as an ALS treatment at this time.
Key Information
Endotherapia has a proposed mechanism that hinges on the ability of an isolated laboratory’s immunoblots to identify the cause and specific pathways that are driving ALS progression. In our opinion this ability has never been convincingly demonstrated. While there is a flawed animal study supporting the utility of Endotherapia in rats, such studies rarely translate into useful human treatments (29). The data on Endotherapia in PALS have so many problems that we believe they are uninterpretable. ALSUntangled does not recommend the use of Endotherapia for ALS at this time. A reasonable next step would be a study to validate the utility of the above-described immunoblots, ideally by a group without a potential conflict of interest.
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