Low-dose naltrexone in the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), 2019, Polo et al.

[Evergreen]

This is a retrospective review of medical files of 201 people with ME/CFS who were prescribed LDN, continued to take it, and provided follow-up data.

Here's what they did:

In some of the initially evaluated patients, the ME/CFS diagnosis was based on the Fukuda CFS criteria [Citation12]; however, most patients were diagnosed using the Canadian criteria [Citation13].

Treatment. The patients were directed to introduce LDN in a morning dose of 1.5 mg for one week, and then continue with a daily dose of 3.0 mg (1.5 mg twice daily). After six weeks on LDN they were allowed to increase the daily dose to 4.5 mg. Patients were informed about the most common adverse symptoms (nausea, insomnia, worsening of pain) that may appear during the initiation of LDN therapy. They were also told that the efficacy and safety of LDN had not been assessed in systematic studies, and the medication might have adverse effects that have not been previously described. If no treatment effect was observed within the first 6 months, LDN was discontinued.

Treatment responses and adverse effects were registered on control visits or upon renewal of prescriptions. Detailed information about both treatment responses and adverse effects collected during LDN treatment was compiled from patient medical reports.

Serious adverse effects (SAEs) were not reported, although 7.3% of the patients discontinued treatment because of adverse symptoms. The most common reason for discontinuation was nausea (5 patients, 2.5%). Increased anxiety was the reason for early termination in two patients (1.0%).

 

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Here's what they reported as results, with any reported improvement from baseline regarded as a treatment response:



I wonder if there was a translation issue with "improved vigilance/alertness". Maybe some Finnish members could shed light?

There's nothing there that would make me think LDN is likely to be better than placebo. I would expect more than 16-20% of people to report a reduction in pain based on placebo alone, so that's concerning for a drug that's usually touted as a pain treatment.

 

[Evergreen]

And here's what they found on adverse symptoms:

 

[Evergreen]

A bit more detail on adverse symptoms:

The most common adverse symptoms from LDN treatment experienced by ME/CFS patients were consistent with adverse symptoms reported when treating other illnesses with LDN. However, in ME/CFS, adverse symptoms were more common than expected during the initial phase of treatment. On the other hand, long-term adverse symptoms were practically absent.

The most common adverse symptom that led to discontinuation was nausea (5 patients, 2.5%, Table 6). For the most part, adverse symptoms were mild and only rarely (15 patients, 7.5%) led to discontinuation of treatment. With the exception of one patient, the adverse symptoms disappeared within a few days/weeks or in a few months at the latest.

The most severely ill (bedbound) patients had the greatest likelihood and severity of adverse symptoms associated with LDN initiation. In those patients, LDN therapy should be introduced in markedly lower doses and the dose titrated slowly. In the most severely affected ME/CFS patients, the dose titration protocol as well as the efficacy and safety of LDN should be studied separately.

 

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I'm particularly uncomfortable with people with severe and very severe ME/CFS being encouraged to try a drug and work through side effects when there's no evidence of it being more effective than placebo in ME/CFS at this point, and no good quality evidence of it being more effective than placebo in other conditions like fibromyalgia, MS.

I think the sooner the Systrom and Nacul trials are published, the better.

 

[Yann04]

I'm particularly uncomfortable with people with severe and very severe ME/CFS being encouraged to try a drug and work through side effects when there's no evidence of it being more effective than placebo in ME/CFS at this point, and no good quality evidence of it being more effective than placebo in other conditions like fibromyalgia, MS.

This is basically my life. Now that I’ve found a doctor who doesn’t want to send me to rehabilitation, I’m getting pressured to try random problematic drugs every month… And my caregivers are in on it…

 

[Evergreen]

This is basically my life. Now that I’ve found a doctor who doesn’t want to send me to rehabilitation, I’m getting pressured to try random problematic drugs every month… And my caregivers are in on it…

I hear you. I got myself discharged early from hospital a few years ago, and did not attend the planned out-patient follow-up for the same reason. It was madness. I went to a pain specialist recently and am again fending off LDN. I actually thought it would be easier to humour them and just try it. I took one 1mg capsule and had a really bad reaction to it. My body seemed to think it was an opiate, and I am not able to tolerate opioids.

I'm really sorry that you're under pressure from caregivers too. Do you need the doctor for other aspects of your care?

 

[Utsikt]

This is basically my life. Now that I’ve found a doctor who doesn’t want to send me to rehabilitation, I’m getting pressured to try random problematic drugs every month… And my caregivers are in on it…

That’s horrible, I’m sorry you have to go through that and have to spend so much precious energy on it. I made the mistake of saying I wanted to try some of them before I knew any better, and that apparently means that I have to try everything now.

 

[Wyva]

Yes, we do need those trials, the sooner the better. Some people in my group believe it seriously helps people, based on anecdotes in social media and unscientific surveys and they are always looking for doctors who would prescribe it. And of course the doctor who does prescribe it here is an anti-vaxxer who knows very little about ME/CFS but spreads all kinds of pseudoscientific misinformation (about various diseases, including autism), pushes ivermectin etc etc. We need those trials yesterday.

 

[DHagen]

Agreed about the trials. My experience in the USA has been that the health care professionals I have seen either a. have little-to-no experience with or understanding of ME at all or b. use LDN as a first line treatment - I have not encountered a single clinician or doctor that falls in-between these extremes. LDN is also so widely accepted as a standard treatment by the patients with whom I have interacted that I had not idea there was reason to be skeptical of it until I discovered S4ME and began reading here.
Unfortunately, the profoundly cruel and fundamentally anti-human system in which I am trapped demands that most patients try every treatment recommended to them if they are to have a hope of qualifying for a meagre disability benefits, so I started LDN a few weeks back.
Skepticism aside, it'd still be amazing if anything positive comes of it, and, if I'm being honest with myself, I probably would have ended up trying it in my desperation anyhow... but the deceptive representation and lack of choice does leave one feeling pretty angry.

 

[Evergreen]

Thanks for merging, moderators. I did search before I posted, and it didn't come up.

Unfortunately, the profoundly cruel and fundamentally anti-human system in which I am trapped demands that most patients try every treatment recommended to them if they are to have a hope of qualifying for a meagre disability benefits, so I started LDN a few weeks back.
Skepticism aside, it'd still be amazing if anything positive comes of it, and, if I'm being honest with myself, I probably would have ended up trying it in my desperation anyhow... but the deceptive representation and lack of choice does leave one feeling pretty angry.

You describe the quandary so well. We'd all love nothing more than a positive outcome from a well-conducted trial, so let's see what happens.

I had the added annoyance of it being really expensive. Yes, it's always talked about as being low-cost. Not where I am. And since I only took one capsule, it cost about as much as that amount of gold bullion. Maybe not quite that much. But enough to make me really miffed.

 

[Evergreen]

Some interesting threads with respect to LDN side effects:







You get the idea. Some positive anecdotes in there too.

A concerning possibility is people who recover gradually and naturally from long covid (or any other trigger) but attribute that recovery to LDN and then needlessly stay on a drug that messes with brain chemistry.