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Inexpensive drug naltrexone appears to relieve fibromyalgia pain in Stanford pilot study

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Naltrexone, used more than 30 years for opioid addiction, and tested in recent trials for alcohol & smoking addictions, would cost only about $40 a month and has limited side effects.

For Tara Campbell, the onset of her fibromyalgia began slowly with repeated sore throats, fevers and fatigue. By the time she was diagnosed, a year later, she had become so debilitated by flu-like symptoms and exhaustion that she often couldn’t get off the couch all day.

“Fall, a year ago, I hit my very, very worst,” said Campbell, 39, of Walnut Creek, California. “I felt overall pain to the point that even when my children or husband just touched me it hurt.”

Campbell’s symptoms still linger, but since taking part in a Stanford University School of Medicine clinical trial in the spring of 2008, she’s improved enough that she’s gone back to working again as an interior decorator and even headed up the fundraising auction at her daughters’ school.

“I am really, really good,” Campbell said. “Having said that, I’m still not 100 percent. I’m still not that person I was before.”

Campbell was one of 10 women with fibromyalgia to take part in a small pilot study at Stanford over a 14-week period to test the new use of a low dose of a drug called naltrexone for the treatment of chronic pain. The drug, which has been used clinically for more than 30 years to treat opioid addiction, was found to reduce symptoms of pain and fatigue an average of 30 percent over placebo, according to the results of the study, published online April 22 in the journal Pain Medicine. [See “Low-Dose Naltrexone Reduces the Symptoms of Fibromyalgia.”]

“Patients’ reactions were really quite profound,” said senior author Sean Mackey, MD, PhD, associate professor of anesthesia and chief of the pain management division at Stanford University Medical Center.

“Some people decided to come off other medications. Some people went back to work really improving their quality of life.”

Still, Mackey and his colleagues remain cautious about recommending the drug this early on in the research process. “People need to understand that while we’re excited about preliminary results, they are still preliminary, and we need to do longer studies with more patients. There is still a significant amount of work to be done.”

The researchers are moving ahead with a second, longer-term trial of 30 patients who will be tested during a 16-week period. [Additionally, the Stanford researchers have posted an upcoming trial of “Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome” in the ClinicalTrials.gov database.]

The drug is particularly promising, the study states, because of the few treatment options available for fibromyalgia patients, its low cost of about $40 a month, and its limited side effects. Vivid dreams were reported by a few participants.

Still considered a controversial diagnosis, fibromyalgia is a disorder classified by chronic widespread pain, debilitating fatigue, sleep disturbance and joint disorder. Advocates and doctors who treat the disorder estimate it affects as much as 4 percent of the population. “The symptoms of fibromyalgia are commonly seen in a number of other diseases, and there is no well-established and objective blood test to confirm the diagnosis,” said Jarred Younger, PhD, the study’s lead author and an instructor in anesthesia and pain management at Stanford. “In the meantime, new treatments that work particularly well for fibromyalgia go a long way toward validating the usefulness of the diagnosis.”

The idea to explore the use of a low-dose of naltrexone as a treatment for fibromyalgia began about two years ago when Younger began searching for relief for patients with the disorder.

“I was asking patients, ‘Does anything work for you?'” he recalled. “A lot of people in support groups were saying, ‘Yeah, I tried naltrexone and it works for me.’ It just kept coming up.”

The use of naltrexone to treat pain at first seems counterintuitive, Younger said, because at normal doses the drug actually blocks the body’s pain relief systems. However, naltrexone appears to have the opposite effect when given at a lower dose. Naltrexone, at these lower doses, is thought to work by modulating glial cells in the nervous system, Mackey said. Glial cells provide support and protection for neurons and act as a link between the neuronal and inflammatory systems.

“We’re learning more and more that maybe by modulating these glial cells we can impact the abnormal processing of pain in these patients,” Mackey said.

During the study, the women used a handheld electronic device to capture their symptoms on a daily basis. They took a placebo for two weeks and then the drug for eight weeks, but they weren’t told when they were taking the drug or the placebo.

Some of the women, including Campbell, have continued to take the drug after the end of the study because the results were so positive, Younger said.

“Even after the study, it just got better and better and better,” Campbell said. “I think my improvement was about 40 percent during the study. When you’re not capable of doing much of anything, that’s a lot. I still have localized pain, but I don’t have the overall body pain. I can live with that if I don’t have the fatigue and flulike symptoms. I’m much more back to normal.”

Source: Stanford University Medical Center, news release Apr 17, 2009

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5 thoughts on “Inexpensive drug naltrexone appears to relieve fibromyalgia pain in Stanford pilot study”

  1. outofstep says:

    Why the FM diagnosis? Has she been diagnosed with both?

  2. pearls says:

    I’m happy that someone is looking at a drug for fibromyalgia that doesn’t cost a bundle.

    I do have a question about it, however: if it is used for people with drug problems, won’t that present a problem for the fibromyalgia patient who goes into an emergency room? Might the personnel there think the patient is a drug addict?

    -P. S.

  3. franlea says:

    Who will be able to participate in your next trial?

    I have been suffering with FM for many years and so far the best thing I have used is Nuerontin and Darvocet. I take it twice a day. Morning and night.

    I participated in a study about five years ago at Stanford but never heard what happened . There were about twenty of us. I did however make a good Fibro Friend. We still email and it does help when we are depressed!

    Can my doctor prescribe naltrexone for my fibromyalgia?

  4. ftg says:

    When I tried Low Dose Naltrexone, I had a very severe reaction to an amount my doctor said could not have caused reactions. I had slurred speech, extreme fatigue, was unable to sit up and was so weak I couldn’t even call out for help.

    After years and years I am finally starting to get better. I did laser detox for mercury, am treating hidden borellia infections using some herbal products, finally found an acupuncturist I love, (tried many times in the past with no benefit to the cfids or lyme both of which I have). I also have taken some vibrational remedies. For me, it has not been one thing but a combination of things that is helping me. I did talk to one person who did very well on LDN. It did not get to the root problems for me, and I was extremely sensitive to it, but then I am extremely sensitive to about every pharmaceutical as well as herbs etc

  5. TomgirlDEL says:

    I Have Chronic Lyme Disease and was suggested to try Naltrexone to help with pain and to boost my immune system..So what the heck if it did all that Im willing to try..Well I ended up un responsive and taken my ambulance to nearest hospital..My sugar dropped down to deadly low..went into convulsions..What A Dream from Hell. What My Doctors Didn’t tell me is That you can be not taking any narcotics! Wow I take oxycodone and Fendl. 100mg patch….This will cause serious reactions…Not sure why my doctor or pharmacist did not catch this…For Now on I will take no new meds unless I find out for sure what they counter react with..I could Of Died Over a little mistake..

    Please Always check for yourself on the computer about any drug that is given to you..You really have to be your own doctor and pharmacist these days…

    Lisa Ray (Delaware)

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