Aripiprazole - Abilify

[Jonathan Edwards]

however it is just another risk you have to take into consideration.

But vulnerable, sick, desperate people are not necessarily in a position to 'take into consideration'.

I would wait a while and try to tease out if it really was the treatment

And how would you find that out without a trial?

It is then up to the reader to decide whether the treatment was actually effective, placebo, random remission, etc.

But nobody is in a position to know.

Would I be right in saying this forum would prefer I not post it, should that be the case?

I am just expressing my opinion as a doctor and someone who has seen the harm that comes from enthusiastic use of unproven treatments in family life as well. I think it is all a matter of balance - and always thinking of how you may harm other people first. Doctors are taught to think that right from the start. They fail but they are taught. My own view is that 'first do no harm' applies to all of us whether or not we have an MD.

 

[shak8]

Tardive dyskinesia can happen at low doses and be hard to detect. There is also fatal malignant neuroleptic syndrome, and diabetes, of course.

See the website drugs.com professional section on warnings:

https://www.drugs.com/pro/abilify.html

Unless you are psychotic, I wouldn't go near this drug-- (retired RN for what that is worth).

 

[sb4]

But vulnerable, sick, desperate people are not necessarily in a position to 'take into consideration'.

Thats true for some, others are, or are willing to take the risk. If these anecdotes where to be discouraged, treatment that could lead to improvements in quality of life would be missed.

And how would you find that out without a trial?

You wouldn't. I should imagine a high quality long term trial on an unproven treatment would take decades if it even gets approval in the first place.

But nobody is in a position to know.

You can't know, you can only make your best guess and weigh up whether you think the cost and risk outweighs the chance of improvement.

I am just expressing my opinion as a doctor and someone who has seen the harm that comes from enthusiastic use of unproven treatments in family life as well. I think it is all a matter of balance - and always thinking of how you may harm other people first. Doctors are taught to think that right from the start. They fail but they are taught. My own view is that 'first do no harm' applies to all of us whether or not we have an MD.

That's fair enough. For me I look at it that a good treatment for ME with high quality studies to back it up is probably decades away. There is harm done if I spend from 20ys old to 50 ill before an okay treatment appears. If I can just find some treatments that improve my symptoms to mild such that I can live a somewhat normal life then it is worth experimenting with anecdotal treatments.

 

[Wyva]

If I were to try an experimental, unproven treatment tomorrow, and gain a large improvement in symptoms; first I would wait a while and try to tease out if it really was the treatment or if it will hold out. Then after a while I would post about it here, on PR, and maybe elsewhere. It is then up to the reader to decide whether the treatment was actually effective, placebo, random remission, etc.

Would I be right in saying this forum would prefer I not post it, should that be the case? The reasons being it is unproven and could encourage others to try it which then could make them worse.

Just as a sidenote, this is exactly how pwME who feel CBT has helped them a lot post about it in my ME/CFS Facebook group (without knowing anything about PACE etc). They feel it has worked for them well and take every opportunity to share their n=1 experience enthusiastically with the others in the group. (And they tend to ignore what I say about its efficacy being unproven.)

I'm not saying that sharing experiences with Abilify is exactly the same but these are still similarly n=1 experiences.

 

[Jonathan Edwards]

Thats true for some, others are, or are willing to take the risk.

That seems to miss the point. Vulnerable desperate people may be just the people to 'take the risk'. We have to consider the effects of our actions on everyone.

If these anecdotes where to be discouraged, treatment that could lead to improvements in quality of life would be missed.

That makes no sense to me. Posting anecdotes on forums is not a way to get treatments established - it has nothing to die with treatments not 'being missed'. The way to ensure that is to report back to a physician who is in a position to do a trial and show the treatment really works. Meaningful trials of aripiprazole could have been done by now by the physicians who have reported a meaningless retrospective survey. They should have been doing a trial in the first place. Trials of treatments already licensed for other things do not take decades. They can be done very quickly .I know because that is what I did with rituximab.

You wouldn't.

So what's the point in posting? If nobody knows whether to take any notice. There is no way that anyone other than an expert in the field can weigh up the risks and benefits. Even as the world expert on rituxiomab in autoimmune disease I was floundering around without enough information. It is totally unrealistic to think that people can weigh these things up. They might think they can but most of them will have no idea.

 

[Ariel]

Meaningful trials of aripiprazole could have been done by now by the physicians who have reported a meaningless retrospective survey. They should have been doing a trial in the first place.

To me, that is one of the most frustrating elements of this whole thing. Why has this not been done? At this rate it will take decades to get anywhere, as people are not approaching things in an effective, efficient way. All of these medicines they are trying with patients [at the clinic] should be part of trials. Is that really too much to ask?

 

[Hutan]

Would I be right in saying this forum would prefer I not post it, should that be the case? The reasons being it is unproven and could encourage others to try it which then could make them worse.

A response from the moderation team:
This forum was set up with different aims and values from some other social media spaces. Members may share their personal experiences with experimental treatments with the explicit aim of creating discussion from a scientific perspective and allowing evidence, or lack of it, to be examined openly.

The Guidance note on Rule 5 sets out the approach we would like members to take. Some of the relevant bits are copied below.

1. First do no harm

The purpose of the rule is to minimise the risk that misleading comments will influence people's health choices.

Ask yourself 'If my opinion on this is wrong may I be causing serious harm to another pwME or their child, even if only because they are desperate and may over interpret what I say?'

Some people with ME report being harmed by treatments they would not have sought without other patients talking in positive terms about them.

People may also be harmed from delaying seeking medical assistance as a result of well meant reassurance or suggestions of possible diagnoses or treatments.

If someone reports new, worsening or worrying symptoms, the only safe advice is that they seek medical help.

Occasionally moderators will judge that a treatment is so potentially harmful that individuals will not be allowed to share their experiences of experimenting with such treatments outside of clinical trials. Such treatments may be discussed in the context of scientific research and warnings of side effects and harms.

3. Sharing your own experiences

You may share your own experience of medically prescribed and self prescribed treatments including drugs, herbs, nutritional supplements, diets, physical therapies, psychological therapies, and alternative medicine treatments.

You may invite others to share their experiences of any of the above treatments.

6. Expect scientific discussion

If you share your experiences of a particular treatment, expect others to want to discuss the scientific evidence.

Remember that however convinced you are that a particular treatment is effective for you, it is not sensible to over-claim cause and effect based on one person’s anecdotal experience.

Expect discussions of treatments to include warnings of side effects and possible harms, and discussion of the strength, or lack, of scientific evidence for the treatment.

Skepticism is not a denial of your personal right to experiment or of your experienced outcomes, nor an attempt to shut down sharing experiences. Questioning of evidence is a natural part of open discussion and should be welcomed in that light.

If you express skepticism about any claim a member makes of effectiveness of a treatment they have tried, focus on discussing the treatment and its biological action, possible side effects, and any scientific claims of cause and effect, without questioning the reality of an individual's experiences.

 

[Hutan]

So what's the point in posting? If nobody knows whether to take any notice. There is no way that anyone other than an expert in the field can weigh up the risks and benefits. Even as the world expert on rituxiomab in autoimmune disease I was floundering around without enough information. It is totally unrealistic to think that people can weigh these things up. They might think they can but most of them will have no idea.

Speaking personally (not with my moderator hat on):

If doctors are prescribing unevidenced treatments, or unevidenced treatments are being promoted on social media, I think it's good that that is posted about here on the forum, including personal experiences with the treatment. I hope this forum can be a place where people can come for a useful discussion about treatments. Becoming aware of the risks, and the difficulties with anecdotal reports may help people make better informed decisions. Even if people choose to try an unevidenced treatment, after reading a discussion here they may do so with a better understanding of potential side effects, and so may possibly be in a better position to mitigate them.

Not many doctors are interested enough to do trials of ME/CFS treatments, even the ones routinely prescribing unevidenced treatments. If a number of members are reporting benefits, then perhaps that will attract the attention of 'experts in the field', who might then be interested enough to investigate further and arrange a trial, or it might prompt an investigation into a possible underlying cause. Members may be interested enough to lobby for a good trial.

I appreciate members sharing their experience with treatments that are being promoted as helpful to ME/CFS. I know it's not always comfortable to do that. I also appreciate members who apply their expertise to help further inform us about those treatments. I know that that is not always a walk in the park either.

But, we are getting away from the topic of this thread.

 

[Jaybee00]

Shockingly, I *actually* agree with the above post by by @Hutan Must be an unusual moon phase or something....

 

[James Morris-Lent]

@Jonathan Edwards

What doctors would be worth contacting in the event that somebody thinks they have found a helpful treatment worth properly testing?

 

[Jaybee00]

Re: Do no harm. I think in general, "people" underestimate the risk of untreated MECFS. Patients mostly experience this disease as a progressive one. Which means not treating the disease is not necessarily doing no harm, especially *if* there is a potential for an untested treatment to help treat the disease. Waiting a couple of years for a full blown RCT, may mean that someone who is housebound becomes fully bedbound in the mean-time and requires a full-time carer. Risk of suicide is very high in this disease, and the longer untreated people decline, the greater the risk for suicide. I say give people the info and let them decide--informed consent.

Unless you are psychotic, I wouldn't go near this drug

Abilify is widely prescribed as an adjunct therapy for major depressive disorder, so not only for schizophrenia.

All of these medicines they are trying with patients [at the clinic] should be part of trials. Is that really too much to ask?

Unfortunately, it doesn't matter whether it's too much to ask. Unfortunately, you have to deal with the reality of the situation as it exists. If you want to wait for a published RCT trial on Abilify, consider that you will be waiting until ~2025, God willing. If you want a treatment based on a mechanistic understanding of the disease, because you don't want to take a drug with psychiatric applications, maybe you're waiting until 2038, with luck.

 

[Wilhelmina Jenkins]

Risk of suicide is very high in this disease, and the longer untreated people decline, the greater the risk for suicide. I say give people the info and let them decide--informed consent.

Thinking about this, I believe that the risk of suicide may be higher among people who get their hopes up about treatment after treatment that turn out to be ineffective. Just the process of going through the treatments can leave patients despondent and in a far worse financial situation. I remember back in the early ’90s, one of the most respected experts also had one of the highest suicide rates among his patients.

I tend to believe that the best results come when patients have a good understanding of the scientific process and do not expect too much progress too quickly. There are a lot of very intelligent people with this disease who truly believe that they should be able to figure out how to be well again. They tend to jump at straws and are often disappointed. And, of course, we have all seen patients end up in much worse condition after experimental treatments.

My own feeling is that pushing for more and better research is essential - nothing will happen until lots of good work is done. But that has to be coupled with a realistic view of science. I see people all the time saying that if NIH had done it’s job earlier, we would all be well by now. Maybe, but maybe not. They must do the work, but there are lots of diseases out there without cures.

The people I know who seem to do the best with this disease, assuming that they have their basic needs met, are those who try to adjust and pace, keeping a balance between hope and realism, trying to find any joy they can in the life that they have. I think that chasing treatments that have not gone through clinical trials can destroy that balance and lead to despair and greater likelihood of suicide.

 

[JES]

We seem to all agree that RCTs are much needed. As I pointed out in the other thread, psychiatrists in Europe aren't keen on prescribing Abilify for other than psychosis and schizophrenia. Having said that, the same doctors are prescribing low-dose quetiapine for sleeping, it's widespread despite evidence for that ranking in the same category as evidence for Abilify in ME/CFS. I don't know if Seroquel carries the same risk for TD as Abilify, but since both are second generation antipsychotics one would think so.

 

[Andy]

"We received reports that a small number of people with ME/CFS in the UK and overseas are apparently being prescribed or are obtaining an antipsychotic drug called Aripiprazole (trade name = Abilify) and using it as a treatment for ME/CFS.

We issued a rapid statement of concern on social media last week and this was updated to take account of additional information and some of the comments and queries that were raised during the discussion that ensued most notably on MEA Facebook.

The ME Association does not recommend that anyone with ME/CFS attempts to obtain or to take this drug, even in small doses, until such time as more appropriate research – double-blind placebo controlled clinical trials – can better determine safety and efficacy.

Even with supportive trial evidence, the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) would need to approve its use before it can be prescribed to treat ME/CFS. To take this drug at this time poses a significant potential risk to health."

More at https://meassociation.org.uk/2021/05/me-association-statement-aripiprazole-abilify-me-cfs/

 

[Hutan]

Having said that, the same doctors are prescribing low-dose quetiapine for sleeping, it's widespread despite evidence for that ranking in the same category as evidence for Abilify in ME/CFS. I don't know if Seroquel carries the same risk for TD as Abilify, but since both are second generation antipsychotics one would think so.

That's a good point.

I thought this short article was good:
The Conversation: Explainer - What is Seroquel and should you take it for insomnia?

Despite the safety concerns associated with using quetiapine as an antipsychotic, the risks may be acceptable when treating patients with serious mental illness, given there are few alternatives.
But the evidence so far suggests prescribing quetiapine off-label for people who have problems sleeping places them at unnecessary risk of harm.

 

[Andy]

Unfortunately, it doesn't matter whether it's too much to ask. Unfortunately, you have to deal with the reality of the situation as it exists. If you want to wait for a published RCT trial on Abilify, consider that you will be waiting until ~2025, God willing. If you want a treatment based on a mechanistic understanding of the disease, because you don't want to take a drug with psychiatric applications, maybe you're waiting until 2038, with luck.

And the reality of the situation is that we don't know that Abilify is safe for any pwME to take, or actually effective. I personally am happy to live with the potential knowledge that I put someone off from trying Abilify, only for it to turn out safe, rather than not speak up to provide balance, for more pwME to try it and be harmed by it, and a trial to then confirm the likelihood of those harms.

 

[Jonathan Edwards]

If doctors are prescribing unevidenced treatments, or unevidenced treatments are being promoted on social media, I think it's good that that is posted about here on the forum, including personal experiences with the treatment.

Yes I agree. We learn. My original concern was not about posting experiences of this sort but more in terms of appearing to try to champion a drug in terms of comparing side effects with other drugs and so on. I suspect that people posting at the moment are just enthusiasts, but enthusiasm can cloud issues. False analogies with other situations don't help. Doing a decent trial does not take a decade - and so on.

 

[Jonathan Edwards]

@Jonathan Edwards

What doctors would be worth contacting in the event that somebody thinks they have found a helpful treatment worth properly testing?

Not an easy one to answer. There are some intelligent people working in closely related fields who might see the value in testing something. After all Fluge and Mella weren't even in the field but were motivated. When IiME wanted to set up a rituximab study in the UK I organised a team who could have done that, none of whom were primarily in the ME field. We didn't follow through because Norway got phase 3 organised and the background immunology was not giving us much to use as a lab tracer.

 

[Tia]

Thinking about this, I believe that the risk of suicide may be higher among people who get their hopes up about treatment after treatment that turn out to be ineffective. Just the process of going through the treatments can leave patients despondent and in a far worse financial situation. I remember back in the early ’90s, one of the most respected experts also had one of the highest suicide rates among his patients.

I tend to believe that the best results come when patients have a good understanding of the scientific process and do not expect too much progress too quickly. There are a lot of very intelligent people with this disease who truly believe that they should be able to figure out how to be well again. They tend to jump at straws and are often disappointed. And, of course, we have all seen patients end up in much worse condition after experimental treatments.

My own feeling is that pushing for more and better research is essential - nothing will happen until lots of good work is done. But that has to be coupled with a realistic view of science. I see people all the time saying that if NIH had done it’s job earlier, we would all be well by now. Maybe, but maybe not. They must do the work, but there are lots of diseases out there without cures.

The people I know who seem to do the best with this disease, assuming that they have their basic needs met, are those who try to adjust and pace, keeping a balance between hope and realism, trying to find any joy they can in the life that they have. I think that chasing treatments that have not gone through clinical trials can destroy that balance and lead to despair and greater likelihood of suicide.

I strongly agree with every bit of this.

 

[5vforest]

There is a lot to respond to but I'm not really up to going point by point, nor do I think I really have a chance of changing anyone's minds.

However, I just want to say that as it stands, I will probably not share any of my experiences with off-label medications on this forum due to not necessarily the rules, but the prevailing attitudes and "culture" around these topics.

I sharing this not out of self-importance but because I suspect that there are probably others who share these feelings, either implicitly or explicitly. (I know others have stated in the past that they opt to discuss certain topics here, and others elsewhere, for similar reasons.)

To me this is unfortunate, since I like and admire you folks, and I think this forum is a great medium for discussion, much better than some of the alternatives. (I particularly hate Facebook Groups where discussions are not categorized, topics are repetitive and impossible to find, amongst other reasons.) I also think that the moderation here does a great job of keeping threads organized and on-topic.

Like it or not, many pwME are going to seek symptomatic improvement through the use of unvalidated treatments and methodologies. If one of our goals as a forum is to provide peer support, I think we could consider how to approach these topics in a way that is more understanding and less antagonistic.

As it is, I suspect that many people will opt take these discussions elsewhere, where they are less likely to get a balanced, scientific response to their inquiries.