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evidence based medicine, pain

Low-dose naltrexone for fibromyalgia is not standard of care

This week I saw an interesting tweet about low-dose naltrexone for fibromyalgia purporting that this therapy is “standard of care.” I’m not that surprised since I’m asked about it now and then. Google “fibromyalgia and low-dose naltrexone” and the Internet is awash with efficacy claims. Even Medscape, a physician education portal, has a post from 2012 entitled, “Confirmation: Low-dose naltrexone eases fibromyalgia pain.”


That is not what the *cough* body of literature says. Not at all. Actually, to be honest there isn’t even analtrexone body of literature there are two clinical trials looking at low-dose naltrexone and fibromyalgia (both from the same researcher). One is a single-blind cross-over study comparing 4.5 mg of naltrexone with placebo completed by 10 patients and the other is a double-blinded cross-over trial of the same dose completed by 28 patients.

In both studies there was about a 32% response rate meaning about one-third of the patients taking low-dose naltrexone felt improved. Interestingly, in these studies the placebo response rates were 11% and 18%, which is much lower than expected. In a recent double-blinded study of pregabalin for fibromyalgia the placebo response rate was 27%, far more typical for fibromyalgia studies.

The 32% response rate of the two low-dose naltrexone studies does look less impressive when compared against a more typical placebo response rate of 27%.

What can we learn from this?

Two studies with a total of 38 patients does not make a therapy standard of care, it makes it highly experimental. Given the low placebo response rate in the studies there are definite questions regarding the methodology or the possibility that naltrexone has side effects that make blinding a challenge. Or both.

There are some potentially interesting ideas behind naltrexone for fibromyalgia, but there are lots of interesting ideas that simply don’t hold up to the scientific method. That is, of course, why we need more than 2 small studies with possible flaws to say that any treatment is worth while trying, never mind saying that is the standard of care. And sites like Medscape, that are read by physicians and patients alike, should be more careful about headlines that spout “proof” based on such a paucity of data.


4 thoughts on “Low-dose naltrexone for fibromyalgia is not standard of care

  1. People who feel that this therapy works are very insistent and authoritative. They are active in many online health groups and feel that this therapy is effective for rheumatoid arthritis as well. I don’t think that those paltry studies are good enough to delay effective treatment.
    It is good to see it addressed.

    Posted by anet37 | September 7, 2013, 10:10 pm
  2. The best thing I have ever done for my fibromyalgia is have gone completely gluten free and dairy free after 6 months my pain is down to a level 2 compared to a 8-10 This might not be the answer for all but along with my daily supplement routine big difference Aloha Devra

    From: “Dr. Jen Gunter” Reply-To: “Dr. Jen Gunter” Date: Saturday, September 7, 2013 7:19 AM To: Devra Wathen Subject: [New post] Low-dose naltrexone for fibromyalgia is not standard of care Dr. Jen Gunter posted: “This week I saw an interesting tweet about low-dose naltrexone for fibromyalgia purporting that this therapy is “standard of care.” I’m not that surprised since I’m asked about it now and then. Google “fibromyalgia and low-dose naltrexone” and the Interne”

    Posted by devrawathen | September 8, 2013, 9:14 am
  3. I have been living with Fibromyalgia for over 5 years. I was unable to continue working as a caseworker due to the pain & side effects of the multitudes of medications my specialists had put me on. Medication that sky rocketed my weight to boot. I finally gave up taking any meds & was miserable and unable to have any kind of life when my sister told me about about a friend who was on LDN for her fibromyalgia and was experiencing a great reduction in pain. I was extremely skeptical as I had heard this about all the other meds I had been put on by specialist in this area. So, I researched LDN and found the above mentioned studies. What I also found was the lack of serious side effects for users of LDN or high doses for other diagnosis’. I called my specialist and he would not work with me to try LDN because of the anecdotal findings . I then tried my primary doc and again the answer was “no.” I found a naturopathic doctor that would work with me to try the LDN treatment. I have had significant results. My muscles are still extremely tender and sore and I still carefully watch my diet, but, I no longer suffer from the constant. debilitating, pain signals firing around the clock and causing me to curl up in a ball of misery. Again, my muscles & tendons feel sore all the time and I still experience pain but not as I did b4. I am now able to work. Not in my stressful field of casework but at least I’m a contributing member of society. LDN will never receive the research that is needed because there is no money to be made from it. Professionals that are unwilling to try and work with people suffering from chronic pain with LDN could be doing them a disservice. It amazes me that my doctors were more than happy to prescribe powerful drugs to me with major side effects but were unable to try a LDN regime that offers know known serious side effects and that does not cause weight gain. In fact, in addition to experiencing less pain I have lost 15 lbs of the weight I gained on all those other drugs since I have been on LDN… With no dietary changes. I wonder how many other people have had good results with LDN and it is not tracked and is just considered anecdotal? Makes me sad.

    Posted by Michelle self | May 8, 2016, 11:01 pm


  1. Pingback: Low-dose naltrexone for fibromyalgia is not standard of care | Believe Half Of What You See - November 25, 2013

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