In summary, luteolin is an interesting naturally occurring bioflavinoid that has been shown to have a myriad of functions in various models that could potentially be useful in slowing progression in patients with ALS. However, convincing data to support any positive effect on human ALS do not yet exist. Furthermore, there are legitimate reasons to be concerned about safety in patients with ALS including the need for a concomitant carbohydrate-deficient diet which might induce unwanted weight loss, and an anecdotal report of accelerated progression on this supplement. Until carefully controlled, well-designed human efficacy and safety studies are performed, ALSUntangled does not support the use of luteolin or any luteolin-containing products in patients with ALS.
Patient case reports
Low dose naltrexone for ALS
Additional pharmacologic studies of LDN are needed to clarify its mechanisms of action. Some of its proposed mechanisms such as immunomodulation and neuroprotection could potentially be useful in ALS. However, there are no convincing data thus far to suggest that this is the case, and some limited data even raise a theoretical potential for a harmful effect. The benefits reported by a small Patients Like Me cohort are not consistent across participants, nor are they objectively verifiable. A small pilot study of a drug with similar mechanisms found no objective benefits in patients with ALS. Although reported costs are not exorbitant, there are reported and potential side-effects including liver toxicity. ALSUntangled does not recommend LDN use by patients with ALS at this time.
Hyperimmune Goat Serum for ALS
The mechanism of Aimspro remains unproven; if it is an immunomodulator and/or a modulator of sodium channels, it theoretically could be useful in ALS. A single, detailed but significantly flawed case report documents slowing in decline of certain respiratory functions in a patient claiming to have ALS, who started Aimspro shortly after bipap. Based upon this limited information, ALSUntangled supports further study of Aimspro, either in ALS animal models or in a small phase 2 trial with clear and objective endpoints carried out by skilled trialists familiar with the problems inherent with ALS clinical studies. Until a trial is undertaken, however, we do not support further use of this product by PALS.
Marty Murray’s Method
In our opinion, there are many serious problems with MM’s approach. First, ALSUntangled is aware of no evidence to support MM’s theory on ALS pathogenesis. No case of ALS has ever been shown to be caused or exacerbated by emotional repression. Statements that patients may have somehow caused their own ALS by repressing their emotions are not only completely unfounded but potentially hurtful, as pointed out by the numerous angry patient and caregiver posts cited. MM’s statement that ALS development “is never really about genes” demonstrates that he has a shocking lack of awareness of more than a decade of ALS scientific literature. Despite his claim that he is not offering a treatment, rather merely “teaching or coaching”, it is clear that some of those he contacts see his program as a potential therapy. It is also clear that MM has implied to clients that his method can lead to dramatically effective results, potentially ‘solving’ their ALS problem. Reticence to call an intervention a ‘treatment’ is a strategy sometimes used to avoid laws that restrict the practice of medicine without a license. In our opinion, degrees in political science, economics, and finance are not qualifications to provide medical advice, medical teaching or medical treatment. In the future, we hope that MM will clarify his lack of medical training, and the fact that he is offering ‘teaching or coaching’ and not medical treatment, to prospective clients. We find no evidence that MM has ever ‘solved’ or cured ALS. Of his few reported ‘successes’ the two we could contact reported improved attitudes and motivations. It is not clear whether these had anything to do with his approach, or to one of the other alternative or off-label approaches being utilized, or (most likely) to the benign natural history of their unusual motor neuron diseases. We could confirm no definite motor improvements and Case 2’s neurologist documented worsened motor function over the past year. Thus, terms like ‘solved’ and ‘cured’ should not be used by MM in describing his offering to patients. Finally, MM’s practice of cold-calling patients with ALS and their families is morally and ethically questionable and is clearly disturbing to many. Patients and families who receive harassing phone calls should be aware that they can take action against the caller (5).
The XCell-Center
While we applaud the use of informed consent for portions of the XCell-Center protocol, and the presentation of pilot efficacy and safety data, in our opinion many worrisome questions and problems remain. From a rational standpoint, we feel it is unlikely that all the diverse diseases (some without a name at all) being treated at the XCell-Center would respond to the same type of treatment. Nothing useful can be concluded from the flawed ALS pilot data that are presented; the positive effects reported are very likely nothing more than a placebo effect as seen in the first of our patients above. Regardless of whether the XCell product results in new motor neurons or promotes sprouting of existing ones, patients with ALS would not be expected to have improved motor function just one or even a few months after treatment as is being claimed. In our opinion, these misleading pilot data should be removed from the website or at least qualified with appropriate disclaimers.
We hope the XCell group will present all their ALS data for peer review, including evidence that their cells are surviving, as well as objective clinical outcome measures over a reasonable length of follow-up. This would be a useful first step toward planning what is ultimately necessary to demonstrate the safety and efficacy of this protocol – a randomized, blinded, controlled trial. Until this is completed, we do not condone the XCell Center’s protocol for patients with ALS.
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