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

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Low-dose naltrexone in the treatment of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

https://www.tandfonline.com/doi/full/10.1080/21641846.2019.1692770

Olli Polo, Pia Pesonen & Essi Tuominen

ABSTRACT

Background: Myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is a common medical condition that limits physical and cognitive functions, with no known effective medical treatment.

Methods: We report on the safety and effectiveness data accumulated in clinical practice when treating ME/CFS with low-dose naltrexone (LDN, 3.0 – 4.5 mg/day). The medical records from 218 patients who received ar diagnosis of ME/CFS and LDN treatment during 2010–2014 were retrospectively analyzed...
 
Scihub link, https://sci-hub.se/10.1080/21641846.2019.1692770

Full abstract
Background: Myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is a common medical condition that limits physical and cognitive functions, with no known effective medical treatment.

Methods: We report on the safety and effectiveness data accumulated in clinical practice when treating ME/CFS with low-dose naltrexone (LDN, 3.0 – 4.5 mg/day). The medical records from 218 patients who received ar diagnosis of ME/CFS and LDN treatment during 2010–2014 were retrospectively analyzed.

Results: Outcome data were available in 92.2% of patients with an average follow-up time of 1.7 years. A positive treatment response to LDN was reported by 73.9% of the patients. Most patients experienced improved vigilance/alertness and improved physical and cognitive performance. Some patients reported less pain and fever, while 18.3% of patients did not report any treatment response to LDN. Mild adverse effects (insomnia, nausea) were common at the beginning of the treatment. Neither severe adverse effects nor long-term adverse symptoms were reported.

Conclusions: The high frequency of treatment response and good safety profile observed in this retrospective open label study could prompt prospective controlled studies to confirm the feasibility of LDN in alleviating ME/CFS symptoms.
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Important to note, I think, that they say
Based on this uncontrolled study, it is not possible to distinguish among subjectively experienced treatment effects, placebo effects and the pharmacological effects of LDN. Also the validating diagnosis for patients’ ‘medically unexplained’ symptoms and feeling understood and accepted by the doctor likely had an impact on patients’ expectations of effectiveness of the prescribed treatment.
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The medical records from 218 patients who received ar diagnosis of ME/CFS and LDN treatment during 2010–2014 were retrospectively analyzed.
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I didn't know that was an acceptable practice within medical research, analysing retrospectively.
 
So, safety is confirmed. Moving on to efficacy in blinded trials?

Effect seems to be minimal, though. As in it relieves some but doesn't do much to elevate function. Still better than, woah, TAU, which is now CBT-GET. The thing about setting a standard that the lowest possible subjective "improvement" should be treated as wildly significant is the kind of thing that comes back and bite people in the ass.

The entire BPS worldview around CBT-GET is that it's the best we got because it's the only thing that has been tested to have this minimal effect (nevermind that many other treatments would have a much greater effect, not hard when you need a femtometer-scale measurement). So if we got something that actually has minimal improvement, unlike their crap, that places it above CBT-GET (since it does, you know, nothing) then the whole thing becomes invalidated since its whole reason to exist becomes obsolete.

Something tells me the goalposts are already oiled and ready to move at a moment's notice.
 
Based on this uncontrolled study, it is not possible to distinguish among subjectively experienced treatment effects, placebo effects and the pharmacological effects of LDN. Also the validating diagnosis for patients’ ‘medically unexplained’ symptoms and feeling understood and accepted by the doctor likely had an impact on patients’ expectations of effectiveness of the prescribed treatment.
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This should be sent to a certain group of psychiatrists
 
Trish said:
I agree no conclusions about efficacy can be drawn. I suspect this is more of a prelimary publication to justify a grant bid to carry out a proper double blind study.
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I think that may be optimistic. If I was sent a grant proposal that quoted this as a preliminary study I would have clear reason to turn the grant down on the basis that the applicant had no idea how to do things properly. It may have been produced in the vain hope that it would help defend off label prescribing over a long period. But I had a feeling that Polo was no longer allowed to see ME cases?
 
Retrospective study, medical record review. A hot mess. Who knew that LDN could reduce fevers??? And i would hate to see another clinical trials with prolonged time on the drug, like a year, to see whether the patient is better? All the while, we are still in limbo?

Please, use objective measurements to assess effectiveness. And could we please assess other drugs?
 
This wasn't a trial so they couldn't do any measurements, this is just based on Polo's own observations from seeing a couple of hundred Finnish patients, among which I was. Apparently Polo tried to get a real blinded trial for LDN started several times, but it failed for reasons I don't know. And as Edwards mentioned, Polo's private clinic is closed since 2017. This basically screwed his reputation, so I'm afraid there won't be any more trials coming out of this.
 
I tried this recently. It did not work for me at all. I felt even more fatigued and flu-like, and spaced out (emotionally detached).
Tried a couple of times. Very disappointing.
 
NelliePledge said:
Isn’t it more appropriate to simply give numbers rather than turn them into percentages 1 out of 2 gives 50% but one person who reckons they’ve improved is one person.
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If you prefer it in numbers of people, then out of 35 ME/CFS patients who tried LDN, only one reported a major improvement.
 
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