ALS Untangled®

ALSUntangled® reviews alternative and off label treatments (AOTs), with the goal of helping people with ALS make more informed decisions about them.

Patient trials

Acuscope

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Acuscope appears reasonably safe, but it is not clear that it has a mechanism of action that would be useful to PALS. One person with PLS experienced slightly slower ALSFRS-R measurements while using Acuscope than she did before starting it, but a PALS had slightly faster ALSFRS-R progression during treatment. Since the natural history of motor neuron disease progression can vary spontaneously, it is not clear that either of these slight changes in progression were related to the treatment. Given these limitations, at this time we cannot endorse the use of Acuscope to slow, stop or reverse ALS progression.‌‌

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Accilion

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In our opinion, Accilion does not have a mechanism that is plausible for the treatment of ALS. There is one patient with a confirmed diagnosis of slowly progressive ALS who had modest objective improvements in motor function while using Accilion. However, improvements such as these have been described before, even in patients taking a placebo (32). We believe improvements in PALS are important to study, but they may have multiple explanations and thus are not proof of treatment efficacy (32). At this time we do not recommend the use of Accilion for ALS.‌‌‌‌

Declaration of interest: ALSUntangled is sponsored by the ALS Association and the Motor Neurone Disease Association.

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Precision Stem Cell

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At ALSUntangled our goal is to provide guidance on the mechanism, pre-clinical data, anecdotal evidence, trials and risks of various alternative treatment options. Our goal is not to challenge the rights of PALS to pursue these options. Along these lines, MSC transplants in general have a promising mechanism, good pre-clinical data in ALS models and appear reasonably safe when performed with approved standardized protocols, proper oversight, and monitoring. However, the specific protocols used at PSC for PALS are poorly detailed, appear variable in terms of the sources of MSCs being used, the ways these are being modified and the places where these are being inserted, have no provision for confirming the material being inserted, and have only subjective and usually brief improvements associated with them. ALSUntangled strongly supports further study of MSC in PALS, but only with transparent, reproducible protocols that include confirmation of transplanted material and objective outcome measures. At this time, it does not appear to us that PSC is meeting these criteria.

Gluten-Free Diet

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Theoretically, gluten-induced autoimmunity could trigger ALS. However, the data supporting this link are weak, consisting of two association studies and a single case-report. Further studies are needed to confirm the relationship between GRDs and ALS, and the utility of the GFD in patients with both conditions. In spite of the fact that GFD is reasonably safe, it is a complex undertaking and is more expensive than a standard diet. While we wait for better data, it would be reasonable to screen PALS who have GI symptoms, iron-deficiency anemia, or an abnormal brain MRI for the antibodies associated with GFDs. Those with elevated antibodies could be referred to a gastroenterologist for further work-up, and if this is consistent with a GRD, then GFD could be tried under the guidance and monitoring of a dietician.‌‌‌‌

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Protandim

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Protandim appears reasonably safe and inexpensive, has a promising mechanism by which it could help ALS, and there is a patient with a validated ALS diagnosis whose ALSFRS-R score improved on it. There are significant problems with the data described, including small study sample sizes, failure to demonstrate that Protandim increases Nrf2 in humans, failure to establish an optimal dose, and potential conflicts of interest among several of the key individuals involved. Nonetheless, in our opinion, further study of Protandim in ALS appears warranted.

Declaration of interest: ALSUntangled is sponsored by the ALS Association and the Motor Neurone Disease Association.‌

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Mito Q

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MitoQ has a promising mechanism, positive preclinical data from two different ALS models, and appears reasonably safe and inexpensive, especially at doses of 10 mg daily. Available anecdotal data are insufficient to determine how helpful this might be in PALS. A small open-label pilot trial with validated ALS diagnoses and outcomes appears warranted.

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Rife Machine and Retroviruses

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It is possible, although currently unsettled, that ALS in some individuals may be due to a retrovirus. Even if true, however, Rife’s microscope technology, his identification of specific frequencies for pathogens, and the ability of Rife radio frequency machines to kill pathogens, are all unproven and highly implausible. We have identified no verified cases of ALS improving on any objective outcome measure with the Rife Machine. At this time ALSUntangled does not support the use of the Rife Machine for ALS.

Propofol

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Propofol has mechanisms of action that may be relevant in treating ALS, although the short action of the drug makes it unlikely that a single infusion could influence ALS pathophysiology in a meaningful way. On ALS.net, six patients with ALS reported wide-ranging subjective benefits coincident with propofol use. Unfortunately, none of these benefits has been verified on validated ALS outcome measures. Only one of 235 patients with confirmed ALS who received propofol for PEG at an ALS center, or in the PRO-ACT database, or in a stem cell trial, improved objectively. The improvements in this patient were much slower to begin, and longer in duration, compared to those reported by the cohort on ALS.net, suggesting that they were more likely due to other longer-acting medications the patient received (such as immunosuppression), the stem cell treatment, or an unusual reversible form of ALS (27–30). While we cannot conclusively rule out a very brief benefit from propofol in rare patients with ALS, the risks and costs involved do not appear to justify its use. We strongly discourage the off label use of propofol in ALS patients at this time. Patients with ALS who are going to have propofol on label for a procedure or surgery may wish to have their ALS neurologist measure an ALSFRS-R and FVC before and in the first few days after propofol exposure and to send these results to ALSUntangled for a possible follow-up review.