A recent analysis of the chronic fatigue syndrome treatment citations produced over the past three years indicated that behavioral studies, in particular, cognitive behavioral therapy (CBT) studies, dominated the ME/CFS treatment field. Behavioral studies tended to be large, well-replicated and most emanated from two countries – the UK and the Netherlands. Non-behavioral ME/CFS studies, on the hand, tended to be smaller, were rarely replicated, and many emanated from countries with smaller research establishments.
What kind of treatment studies showed up in the past year for fibromyalgia?
Fibromyalgia is similar to ME/CFS in that it receives poor funding, is controversial in some circles and often overlaps with ME/CFS. Fibromyalgia is different in that it has a home in specialty (rheumatology); its main symptom – pain – is a hot item right now, the FDA has approved three drugs for it and drug companies are interested.
In an attempt to understand what types of treatments researchers are focusing on right now in FM, I surveyed all FM treatment citations ( e.g. studies, reviews) found in PubMed over the past year. As with the chronic fatigue syndrome survey, I categorized them according to whether they referred to behavioral/non-behavioral studies and noted the country of origin.
A three-year survey of PubMed yielded 78 treatment citations for ME/CFS. A one year FM survey on PubMed yielded 68 citations.
Non-Behavioral Studies Dominate
In contrast to chronic fatigue syndrome biological studies dominated FM treatment publications
Only one-third of FM citations over the past year referred behavioral citations while two-thirds referred to non-behavioral, e.g. biological studies. This finding contrasted strongly with that found in the ME/CFS survey which indicated that 70% of treatment citations referred to behavioral treatments.
Behavioral Studies
Exercise studies dominated the behavioral approach to FM with two-thirds of the behavioral citations last year referring to them. Few CBT studies were done. In contrast to the two countries (UK, Netherlands) that dominated the behavioral treatment portfolio in ME/CFS, no countries dominated the behavioral treatment portfolio.
Non-behavioral Studies
Balanced Portofolio
FM’s non-behavioral treatment portfolio showed balance with drug citations easily the most prevalent but with other treatment aspects showing balance – showing that interest in FM comes from all quarters.
- Drugs – 22
- Brain and other Stimulation – 7
- Musculoskeletal Manipulation – 7
- Supplements and Nutrition – 7
- Others – 3
Drug Interest High But Innovation Lacking
Interest in FM drugs appeared high but innovation was lacking – no new drugs were tested
The 22 citations referring to drugs suggested significant interest in drugs for FM is present. However, no new drugs were assessed; all the citations referred to already approved or otherwise well-known drugs. The continuing emphasis on FDA approved drugs suggests that getting FDA approval is a sure way to continued research.
With fibromyalgia’s home Institute, NIAMS, focusing almost exclusively on behavioral aspects FM’s next breakthrough in drug development is probably not going to come out research done at the NIH. Given the NIH’s prominence in research that’s a real concern.
Stimulating Therapies Provide Hope
With seven studies done on two types of brain stimulation and two other stimulation types, nervous system stimulation technologies are clearly getting interest. How this aspect of treatment will shake isn’t clear but the field is developing rapidly, and improvements in the technology should continue.
These technologies are mostly non-invasive but one group found that implanting electrodes in the cervical vertebrae of treatment-resistant FM patients was well tolerated and significantly improved quality of life. Another intriguing possibility involves external or subcutaneous stimulation of the trigeminal nerve in the head. Besides FM trigeminal nerve stimulation is being tested in epilepsy and depression.
Vagus nerve stimulation has been assessed in FM (but not this year). Whether the very promising results from the one small study will be followed up on is unclear. It and the other stimulatory techniques showing up suggest, however, that a rich field is emerging.
A Range of Musculoskeletal Trials
Musculoskeletal treatment trials incorporated a number of different methods. Neurodynamic mobilization and extracorporeal shockwave treatment, for instance, use two different approaches to the musculoskeletal pain found in FM. Neurodynamic mobilization is a bodywork approach that seeks to relieve constrictions in the muscles.
Extracorporeal shockwave treatments use shockwaves to induce tissue repair and regeneration. It has been FDA approved for use in treatment-resistant plantar fasciitis.
Alternative Therapies and Nutrition
Some alternative therapies showing up FM are being examined in other diseases as well
Adding a food product palmitoylethanolamide (PEA) to duloxetine significantly reduced pain levels over duloxetine alone in FM patients. This is the first PEA trial in FM but other studies suggest that PEA may be helpful with chronic pain. Be warned that it may take some time though. A recent Italian pelvic pain study found PEA’s results didn’t show up at three months but did at six. PEA is getting quite a bit of research – most of which is coming out of Italy.
Hyperbaric oxygen therapy is another unorthodox but possibly helpful treatment that showed up in treatment studies last year. It too is being tested in a variety of disorders.
Acetyl-l-carnitine was about as effective as duloxetine in reducing pain. Testosterone – a substance used by many alternative practitioners – showed up in two citations last year.
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One can’t characterize the FM treatment field as booming (no new drug possibilities showed up in the literature last year) – but it is fairly diverse and, in contrast to ME/CFS, shows balance.
The four FM drugs expected approved over the next couple of years are reformulations of past drugs. While each may improve increased relief none is expected to break new ground – a need in FM. (Two are reformulations of Lyrica, one is a sublingual form of Flexeril, and one is a new SNRI.) Pridgen’s antiviral regimen is an entirely new approach. The Phase II study didn’t make it into the study literature this year but will next year and a trial is expected in 2017.
The lack of research funding for FM at the NIH is a concern. Although the NIH devotes more dollars to FM than ME/CFS, ME/CFS researchers are engaged in more innovative studies.
- From Autoimmune Drugs to Tai Chi: the NIH’s Approach to Fibromyalgia
- How Fibromyalgia Got to Be the Worst Funded Disease at the NIH
Given the new emphasis on pain research in general, though, there is reason to hope that new types of treatments are on the way.
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Survey
Country Breakdown
Behavioral = 23
Exercise – 16
CBT /GET – 3
- Music listening
- Symptom Control
- Forgiveness
- Mind/Body
- Mindfulness Training
Behavioral = 23
- Spain – 7
- US – 6
- Turkey – 4
- Italy – 2
- Brazil – 2
- France – 1
- Sweden – 1
Non-behavioral = 43
- USA – 12
- Spain – 5
- Italy – 3
- France – 3
- Belgium, Turkey – 2
- Denmark, Canada, Norway, Germany, Japan, Lebannon
Non-behavioral Categories
Drugs = 22
- Milnacipran – 7
- Duloxetine – 4
- Pain Drug Effectiveness – 2
- Lyrica – 2
- Amitriptyline – 2
- Neurontin, Tramadol – 1
- Amytriptyline, Duloxetine, Gabapentin, Pregbalin – Health care utilization, SSRI – review, Pharmacotherapy Review
Brain and other Stimulation = 7
- High-Definition transcranial Direct Current Stimulation (HD-tDCS) – 3
- rTMS – 2
- C2 Nerve Field Stimulation for the Treatment of Fibromyalgia: A Prospective, Double-blind, Randomized, Controlled Cross-over Study.
- Trigeminal nerve stimulation (TNS) for fibromyalgia: A proof-of-concept trial.
Muscoskeletal = 7
- Extracorporeal shockwave treatment
- Whole body vibration
- Neurodynamic mobilization http://www.ncbi.nlm.nih.gov/pubmed/26143052
- Kinesiotherapy
- Laser/Kinesiotaping
- The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial.
- CPAP
Supplements and Nutrition – 7
- Transdermal magnesium chloride
- Palmitoylethanolamide – http://www.ncbi.nlm.nih.gov/pubmed/26334329
- Treatment of pain in fibromyalgia patients with testosterone gel: Pharmacokinetics and clinical response. – http://www.ncbi.nlm.nih.gov/pubmed
- A novel use for testosterone to treat central sensitization of chronic pain in fibromyalgia patients.
- Response to vitamin B12 and folic acid in myalgic encephalomyelitis and fibromyalgia. – Gluten free diet
Alternative Therapies – 4
- Overview – Germany
- Hyperbaric oxygen therapy can diminish fibromyalgia syndrome–prospective clinical trial.
- Mud Pack/ Hot Pool
- Hyperthermia
Cort, I have no doubt the amount of time you put in to collecting this data. Great job conveying your results too.
It is disheartening that so much is vetted around drug trials. We know why this is so I won’t beat an old horse.
I would like to see more on FM, chronic pain, ME/CFS and myofascial pain syndrome comorbidity.
I would like to see research validating the cost savings complimentary therapies, like therapeutic massage or body work, accupuncture, and physical therapy (currently Medicare restricts visits) if insurance companies would kick it up a notch. These treatments should be available to everyone.
I am thrilled to see we are looking at electrical stimulation. This could be pivotal in getting to the root cause. It is not a panacea as those with implanted neurostimulators for CRPS will tell you, but it could help at least a subgroup of FM patients significantly, especially since so many of us do not tolerate many of the medications available today. Funny how you didn’t find any follow up studies of these drugs being used on the long-term, we should be able to collect data on that by now.
I WISH there was more on small nerve fiber neuropathy.
It is my understanding that the follow up study on immune cells found in the FM/a blood test is in peer review for publication, but the wheels of science can turn very slowly.
But, you are right, they are turning for fibromyalgia compared to ME/CFS, both woefully behind the pack.
Thanks Celeste as always for your insightful comments. I’m hoping we get some medical marijuana and LDN trials and I think the electrical stimulation is sooo interesting. I think they are going to get better and better at that technology and who knows what will happen.
I don’t know what the heck is going with small fiber neuropathy. We had that spate of studies that then nothing for quite awhile.
Hi
Thanks for this information.
I am a Fibro sufferer and am due to take part in a research trial study in a couple of weeks.
I live in Manchester UK.
I’m praying firstly that i recieve the new drug (it has no name yet just a number) and not the placebo and secondly that it works and it is going to give myself and others a better quality of life if & when it becomes available on prescription.
I’m wondering if its a treatment youve already trialed?
Liz
How interesting Liz. If you can come up with the number of the drug I can look it up. Good luck with the trial. I hope you’re in the “active arm”…
Very glad something new is in clinical trials 🙂
A quick google search gave me a result for the name (which I found odd but there it was). You could also get Pregabalin. I almost signed up too but couldn’t face the chance of pregabalin again. I hope the trial works for you and that some answers come from it. Thanks for volunteering for it.
Thank you Cort, for once again you give us hope and something to think about. I just was diagnosed with antibodies to gluten, casein, and soy. I never expressed any symptoms, yet my naturopath sees this stuff often with ME/CFS. My interest in one of your last posts on autoantibodies showing up in research on POTS has now heightened my interest. This area, along with some others, seems to hold some hope for those of us with NMH, OI, POTS. Thanks
It is just too bad that research time is being spent on these areas of CBT and GET. It seems very clear to me that dysautonomia is the ‘umbrella’ that will begin to explain all of our symptoms – regardless of dx of CFS/ME/SEID/FM. Here are 2 good articles: Michael J. Reichgott, “Clinical Evidence of Dysautonomia.” Also, Graham Exelby at dysautonomia.com.au. Sorry I was unable to provide direct links, but a quick search should bring them up.
It is appreciated that Epstein- Barr virus can cause autonomic dysfunction, as well as certain chemicals, neck trauma. What about autoimmune dysautonomia? Please read on this topic. It took me 17 years following neck trauma to get a firm dx of dysautonomia – despite classic presentation. One of these authors ( mentioned) says that scoliosis is a risk factor. Yes. Finally.
By the way, anxiety is known to be ‘just’ another symptom of dysautonomia.
Do you know anything about this? I found it interesting, as I have CFS-ME and had Chiari Malformation.
http://yourmedicalguide.info/italian-doctor-may-have-found-surprisingly-simple-cure-for-multiple-sclerosis/
I’m interested in learning more about this “Palmitoylethanolamide” (PEA). I’ve never heard of it. I tried LDN and did very well until I was diagnosed with multiple herniated discs. The LDN worked on the Fibro pain but not the disc pain. IF PEA can reduce pain so that I can increase my daily function… or maybe even using it in conjunction with LDN, that would be great! I noticed 1 of the PubMed articles sites a study on PEA with duloxetine (Cymbalata) that had positive results. That I’m already on. I’ll talk to my doctor about this. But at best this would still only be treating one of the major symptoms of Fibro.
Someone else mentioned “anxiety” in comments. I personally do extremely well with taking L-Theanine. It’s a fantastic supplement that has a calming effect without making you tired and NO side effects. I’ve never heard a negative word on this supplement.
Was the dosage of the 2 drugs ever published anywhere?