Updated November 22, 2021
Since our initial review, the ingredients in the Deanna Protocol (DP) appear to have changed. According to the product’s website (which now sells a one-month supply of it for $135.99 ), the current ingredients are Alpha Ketoglutaric Acid, L-arginine, and GABA. The rationale for this change is unclear. It does not change our Mechanisms grade. The mSOD1 mouse study we mentioned in our review has been published (PLoS One. 2014; 9(7): e103526). This study shows that treatment with some of the ingredients in a former version of the DP was associated with slowed progression and improved survival. Flaws in this study include lack of rater blinding and treatment initiation prior to symptom onset (not possible in patients). A newer publication (Int J Pharm Pharm Res. 2017 Dec; 11(1): 348–374) reported that one (but not another) version of DP could reduce a measure of stress in motor neurons from patients with familial ALS caused by SOD1 mutations and also in iPSC-derived-motor-neurons from patients with sporadic ALS that were treated with glutamate. It is not clear whether the raters in this study were blinded to treatment assignment. It is also unclear how relevant these cell models are to humans with ALS. Thus, neither of these new publications change our Pre-Clinical Grade of C. The DP website continues to report anecdotal evidence of benefit, but we have not been able to validate the diagnoses or reported benefits in any of these patients. Thus, our Cases grade remains D. We found no human trials of DP in patients with ALS so our trials grade is unchanged. We found no new reports of side effects, so our Risks grade remains B. Our conclusion remains unchanged: we cannot recommend DP as an ALS treatment. We hope to see a well-designed pilot trial in people living with ALS in the future.
Updated July 24, 2023
As of July 2023 we found no new information that would warrant any TOE grade changes
Key Information
Click on any letter grade below for more info:
Preclinical Trials Grade:
C
Published: May 2013
Mitochondrial dysfunction, glutamate excitotoxicity, and oxidative stress have all been implicated in ALS pathogenesis, and targeting these mechanisms individually or by a cocktail such as the Deanna Protocol could play a role in future ALS therapies. However, many of the preclinical and animal studies related to these pathways have not translated into successful treatments in patients with ALS. While there are anecdotal reports of improvements in patients with ALS on the Deanna Protocol, there is no convincing objective evidence of benefit yet. Thus, at this time, ALSUntangled does not recommend the Deanna Protocol to patients with ALS.
Before it can be recommended, a reproducible version of the Deanna Protocol should be shown to influence plausible physiologic mechanisms such as central nervous system ketone bodies, as well as clinically meaningful outcome measures such as ALSFRS-R and FVC in patients with ALS.
Grade A: Shown in a peer-reviewed publication to act on a relevant mechanism in humans
Grade B: Shown in a peer-reviewed publication to act on a relevant mechanism in pre-clinical model(s)
Grade C: Theoretically and plausibly acts on an ALS-relevant mechanism in humans
Grade D: Acts on a biological mechanism but it is not clear that this mechanism is relevant in ALS
Grade F: Implausible; would violate known principles or laws of biology
Grade U: No useful information was found for this category
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’.
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’.
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’.
Grade D: One or more non-peer reviewed studies reporting benefits (published on a website or in an abstract)
Grade F: The only studies available show no benefit
Grade U: No useful information was found for this category
Grade A: One or more peer-reviewed publications reporting benefits with validated diagnosis and benefits
Grade B: More than one unpublished report of benefit with validated diagnosis and benefits
Grade C: One unpublished report of benefit with validated diagnosis and benefits
Grade D: Subjective report(s) of benefit without validated diagnoses and/or benefits
Grade F: The only reports available show no benefit
Grade U: No useful information was found for this category
Two or more peer-reviewed publications describing benefits in well-designed randomized, blinded placebo-controlled phase III trials
Grade C: One or more peer-reviewed publications reporting benefits in a well-designed randomized, blinded, placebo-controlled phase I or II trial
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’.
Grade F: The only trials available show no benefit
Grade U: No useful information was found for this category
Grade A: No exposed patients appear to have experienced harms
Grade B: More than 0% but less than 10% of exposed patients experienced harms (no hospitalizations or deaths)
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
Grade C: At least 10% of exposed patients experienced harms (no hospitalizations or deaths)
Grade D: More than 0% but less than 5% of exposed patients experienced death or hospitalizations
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
Grade F: At least 5% of exposed patients experienced death or hospitalization
Grade U: No useful information was found for this category
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