Key Information
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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Mechanistic plausibility
Mechanistic plausibility
Mechanistic plausibility - C
Mechanistic plausibility
Mechanistic plausibility
Mechanistic plausibility
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Grade A: Two or more peer-reviewed publications reporting benefits in well-designed studies.
Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Grade B: One peer-reviewed publication reporting benefits in a well-designed study.
Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Grade C: One or more peer-reviewed publication(s) reporting benefits in flawed studies.
Animal studies are assumed to be ‘well designed’ when they follow published guidelines. When they deviate from these they are considered ‘flawed’.
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Pre-clinical models (animal or cell models recognized by ALSUntangled reviewers to be relevant to ALS)
Patient case reports
Patient case reports
Patient case reports
Patient case reports
Patient case reports
Patient case reports
Patient trials
Patient trials
Patient trials
Grade D: One or more peer-reviewed publications reporting benefits in a flawed trial.
Flawed trials means those in which there are identifiable problems with patient selection, randomization, blinding, controls or follow-up. These have ‘high or unclear risk of bias’ according to published criteria. Well-designed trials are those that have ‘low risk of bias’.
Patient trials
Patient trials
Risks (harms that occurred on this treatment)
Risks (harms that occurred on this treatment)
Risks (harms that occurred on this treatment)
Grade B (oral): More than 0% but less than10% of exposed patients experienced harms (no hospitalizations or deaths)
Grade D (intravenous): More than 0% but less than 5% of exposed patients experienced death or hospitalizations
Risks (harms that occurred on this treatment)
Risks (harms that occurred on this treatment)
Risks (harms that occurred on this treatment)
Grade D: More than 0% but less than 5% of exposed patients experienced death or hospitalizations
Grade F: At least 5% of exposed patients experienced death or hospitalization