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.
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
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.
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.
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
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
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.
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.
Behavioral = 23
Exercise – 16
CBT /GET – 3
- Music listening
- Symptom Control
- 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
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
- The addition of upper cervical manipulative therapy in the treatment of patients with fibromyalgia: a randomized controlled trial.
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