Off label use of Aripiprazole shows promise as a treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Crosby et al. 2021

the list of side affects are really off putting for starters the fact that they do not understand how this drug actually works is another reason for not having anything to do with it . also i have an instinctive feeling that just masking symptoms will create a lot of long term harm .
 
alktipping said:
the list of side affects are really off putting for starters the fact that they do not understand how this drug actually works is another reason for not having anything to do with it . also i have an instinctive feeling that just masking symptoms will create a lot of long term harm .
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This has already been litigated ad nauseum in other threads, the list of side effects and negative information people always cite is for much higher antipsychotic dosages, not 2 mg/day or less.

As @Jaybee00 stated, in a subset of patients the drug seems to lose efficacy after ~4 months of use on average, but there has been at least one anecdotal report suggesting that when you take a break from it for a few months and cycle back it works again, and so on.
 
This is underwhelming, and I think it's premature to be suggesting that doctors should be prescribing it outside trials.

First, there are no controls, so we don't know if people who weren't treated with aripiprazole would have responded similarly. It's quite likely that patients have become better at managing their illness with time, and with advice from their doctors. So, I would expect things like frequency of PEM to decrease.

Second, there are placebo effects. If a doctor is prescribing the drug and there's a buzz around it, and patients want to get better, there is a lot of scope for seeing an improvement that isn't really there. The outcomes are subjective 'how do you feel' surveys. This is magnified by the selection bias - patients who have some hope that the drug will work are much more likely to agree to take it.

Third, the average effects are relatively subtle, around 2 units on 0 to 10 scales - entirely consistent with a placebo effect and a bit of natural improvement over time. (Edit - this was for responders only; non-responders showed even less change)

Fourth, an objective measure, body weight, does not support the idea of these patients feeling much better and so becoming more active. 'On average, patients gained 0.15 kg per month while taking aripiprazole'. The only other objective finding was that 6 people out of the 101 returned to work - this level of apparent recovery could easily be attributed to a natural improvement.
 
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To be fair, my weight change point was rather weak. When I'm in a good patch, my weight goes down because I can be more active (and vice versa when I'm not well). But I know that some people with ME/CFS struggle to take in enough calories for various reasons; so improvement in ME/CFS for them might result in weight gain. It would have been helpful if the authors had reported weight change towards or away from the ideal weight of each individual.

And weight changes might have been confounded by the other medications people were taking.
 
@leokitten but people do report side effects at lower doses too, including intrusive suicidal thoughts. People with ME are especially sensitive to medication, and if lower doses are potentially helping ME, then there is the possibility there can be significant side effects at that dose too. We don’t know enough.

I’m glad they’ve published the data they have, but given there are no controls and everything else @Hutan has pointed out, I don’t think this study tells us much. I don’t understand why there hasn’t even been a small placebo controlled trial at Stanford yet, given they’ve been prescribing it for a while to patients?
 
Hutan said:
This is underwhelming, and I think it's premature to be suggesting that doctors should be prescribing it outside trials.
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I believe the paper didn’t suggest this, and yes you are right a retro study like this has major flaws/limitations. But it’s a start and I believe the last two sentences of the paper are to me the gist of the intent of the paper:
Overall, these results suggest that aripiprazole may effectively reduce symptoms of ME/CFS and warrants further investigation in a randomized clinical trial. Exploring the mechanism of action for aripiprazole in neuroinflammatory conditions may also provide new insight into the pathogenesis of ME/CFS.
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lunarainbows said:
I’m glad they’ve published the data they have, but given there are no controls and everything else @Hutan has pointed out, I don’t think this study tells us much. I don’t understand why there hasn’t even been a small placebo controlled trial at Stanford yet, given they’ve been prescribing it for a while to patients?
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Because research is very incremental, single papers aren’t meant to be the end all be all. It was an initial step. Most single research papers don’t tell us much.

Look for example at the recent Hanson proteomics paper, I would say the exact same thing it doesn’t tell us much at all. Doesn’t mean it’s not worth publishing a paper and moving forward with the next steps.
 
leokitten said:
I believe the paper didn’t suggest this, and yes you are right a retro study like this has major flaws/limitations. But it’s a start and I believe the last two sentences of the paper are to me the gist of the intent of the paper:
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I'm not being critical of the paper, sorry if it came across like that.

I find the evidence for aripiprazole helping people with ME/CFS underwhelming, not the paper. I agree it's helpful that the authors published. What I don't find helpful is Janet Dafoe, who should know better, suggesting that this is sufficient evidence for aripiprazole to be prescribed outside of a trial. That's just setting patients up to come into conflict with their doctors, and we have enough problems with how we are viewed by our doctors already.
 
leokitten said:
Because research is very incremental, single papers aren’t meant to be the end all be all. It was an initial step. Most single research papers don’t tell us much.

Look for example at the recent Hanson proteomics paper, I would say the exact same thing it doesn’t tell us much at all. Doesn’t mean it’s not worth publishing a paper and moving forward with the next steps.
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Oh I agree it’s worth publishing what they have - which is why I said I’m glad they did that. But what I don’t understand is why they have been unable to also do a small placebo controlled study, when at the same time they seem happy to actually prescribe this medication to lots of patients over quite some time now. I don’t think they have a shortage of money either? It’s only now that the OMF (If I remember correctly) is funding something.
 
lunarainbows said:
But what I don’t understand is why they have been unable to also do a small placebo controlled study, when at the same time they seem happy to actually prescribe this medication to lots of patients over quite some time now.
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Hutan said:
I'm not being critical of the paper, sorry if it came across like that.
What I don't find helpful is Janet Dafoe, who should know better, suggesting that this is sufficient evidence for aripiprazole to be prescribed outside of a trial.
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Exactly. This tees up so easily for a dose-response study.

I don't get why people don't understand that, regardless of whether an intervention is beneficial, you benefit (or fail to harm) the most people in the shortest amount of time by taking a disciplined approach to producing reliable evidence. The CCI people have repeatedly chosen not to get this. Hopefully the OMF will figure it out.

Ultimately patients will not be helped by an insurgent approach to medicine.
 
lunarainbows said:
But what I don’t understand is why they have been unable to also do a small placebo controlled study, when at the same time they seem happy to actually prescribe this medication to lots of patients over quite some time now. I don’t think they have a shortage of money either? It’s only now that the OMF (If I remember correctly) is funding something.
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This is what the paper says about funding
Funding
No funding.
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Most of the authors in this retrospective study are on the clinical side of Stanford medicine not research. This is the clinic Montoya started and Bonilla is now running. One author Laurel Crosby is in Ron Davis's research team and helped Bonilla co-write this retrospective study. Bonilla is the one that has driven the use of Abilify in the clinic. As others have said the purpose of the write up seems to be to get the information from the clinical side out there. I imagine the next step for RCT is looking for funding and trying to figure out what to measure biologically and physically.

Bonilla asked about next steps at an internal Stanford presentation last year that is posted here (content of document has a lot of the same wording as the paper)
http://med.stanford.edu/content/dam/sm/dbds/documents/data-studio/abstract.20201118.pdf
(document originally posted on PR and then on s4me by @Jaybee00 https://www.s4me.info/threads/aripiprazole-abilify.16972/page-9#post-313741)

Abilify has a lot of warnings associated with it's use. Full details on the various drugs sites.
https://www.rxlist.com/abilify-drug.htm
Here are a few
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g., obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia during treatment with atypical antipsychotics should undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
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Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.
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In clinical trials and/or postmarketing experience, events of leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including ABILIFY. Agranulocytosis has also been reported.
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In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber
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This is not a drug to try without close monitoring by a doctor and regular safety lab testing especially at the start.
 
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