"evaluate the effects of exercise training including cardiorespiratory (aerobic), muscle strengthening, and/or flexibility exercise on global well-being, selected signs and symptoms, and physical function in individuals with FMS."

"There is 'gold' level evidence that supervised aerobic exercise training has beneficial effects on physical capacity and FMS symptoms. Strength training may also have benefits on some FMS symptoms. Further studies on muscle strengthening and flexibility are needed. Research on the long-term benefit of exercise for FMS is needed."

Researchers from the section of Physical Medicine and Rehabilitation at the University of Manitoba Rehabilitation Hospital (Canada) recently published an article on a trial conducted to determine the benefit of nabilone, a synthetic cannabinoid, in pain management and quality of life improvement in fibromyalgia patients. The article was e-published ahead of print in the Journal of Pain, on October 30th.

The randomized, double-blind, placebo-controlled trial was conducted to determine the benefit of nabilone in pain management and quality of life improvement in 40 patients with fibromyalgia. A visual analog scale (VAS) for pain was used as the primary measure, with secondary outcome measures being number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ). The 4 week trial found that there were significant decreases in the VAS and anxiety in the nabilone treated group, with no significant improvements in the placebo group.

The researchers said:

"To our knowledge, this is the first randomized, controlled trial to assess the benefit of nabilone, a synthetic cannabinoid, on pain reduction and quality of life improvement in patients with fibromyalgia. As nabilone improved symptoms and was well-tolerated, it may be a useful adjunct for pain management in fibromyalgia."

On October 1^st the BBC and ME Association reported on a pilot study where CFS patients found they had less fatigue when eating dark chocolate with a high cocoa content. Study leader Professor Steve Atkin, said the idea for the study came after a patient reported feeling much better after swapping her normal milk chocolate for dark chocolate with a high cocoa solid content. The trial involved 10 patients who received a daily dose - 45g - of dark chocolate or white chocolate dyed to look like dark chocolate for two months. The patients then had a month off before taking the other type of chocolate for two months. Those taking dark chocolate reported significantly less fatigue and reported feeling more fatigue when they stopped eating it.

"Although effective treatments are available no guidelines exist for management of FMS... The objectives were to ascertain the strength of the research evidence on effectiveness of treatment of FMS and develop recommendations for its management based on the best available evidence and expert opinion to inform healthcare professionals."

Of the 146 studies they found were eligible for review, 39 pharmacologic intervention studies and 59 nonpharmacologic studies were used to create the final recommendations, after those of lower quality or with insufficient data were excluded. Identified categories of treatment were antidepressants, analgesics and "other pharmacological," and exercise, cognitive behavioral therapy, education, dietary interventions, and "other nonpharmacological interventions."

The authors conclude:

"These recommendations are the first to be commissioned for FMS, although previous reviews have addressed the area. These recommendations should assist health care providers, with a secondary intention to incorporate information into materials for patients. The 9 recommendations included 8 management categories, 3 of which had strong evidence from the current literature, and 3 were based on expert opinion."

Specific recommendations in these guidelines regarding general considerations for management of FMS are as follows:

• Comprehensive evaluation of pain, function, and psychosocial context is needed to understand FMS completely, because it is a complex, heterogeneous condition involving abnormal pain processing and other secondary features (level of evidence, IV D).
• Optimal treatment of FMS mandates a multidisciplinary approach, which should include a combination of nonpharmacologic and pharmacologic interventions. After discussion with the patient, treatment modalities should be specifically tailored based on pain intensity, function, and associated features such as depression, fatigue, and sleep disturbance (level of evidence, IV D).

Specific recommendations on nonpharmacologic management of FMS are as follows:

• Heated pool treatment, with or without exercise, is effective (level of evidence, IIa B).
• For some patients with FMS, individually tailored exercise programs can be helpful. These may include aerobic exercise and strength training (level of evidence, IIb C).
• For certain patients with FMS, cognitive behavioral therapy may be beneficial (level of evidence,IV D).
• Based on the specific needs of the patient, relaxation, rehabilitation, physiotherapy, psychological support, and other modalities may be indicated (level of evidence, IIb C).

Specific recommendations on pharmacologic management are as follows:

• Tramadol is recommended for management of pain (level of evidence, Ib A). Although other treatment options may include simple analgesics (eg, paracetamol) and other weak opioids, corticosteroids and strong opioids are not recommended (level of evidence, IV D).
• Antidepressants are recommended for the treatment of FMS because they decrease pain and often improve function (level of evidence, Ib A). Appropriate options may include amitriptyline, fluoxetine, duloxetine, milnacipran, moclobemide, and pirlindole.
• Tropisetron, pramipexole, and pregabalin are recommended for the treatment of FMS because they reduce pain (level of evidence, Ib A).

This is a tremendous step forward for Fibromyalgia patients as previously you needed to refer to individual studies when asking about treatments to try with doctors who are not expert and up-to-date in Fibro. Now there is one article that summarises everything. The recommendations for general considerations for management are brilliant, the recommendations on nonpharmacologic management are strongly needed and the recommendations on pharmacologic management are more up to date than anything else I have read (I'm very happy to see pramipexole is mentioned by name!).

"...[Fibromyalgia has] historically been substantially underserved by both the medical profession and the pharmaceutical industry.

 

...

Given the high unmet need and large patient population, fibromyalgia is one of the most keenly anticipated new central nervous system (CNS) markets in the pharmaceutical industry."

Wow. the government isn't doing well with Fibro this month! This petition was asking to Government to fund research into FMS. The Government's reply is as follows (emphasis added by me):

 "As you may know, relatively little is known about the causes of fibromyalgia. Despite a great deal of commitment on the part of professionals and voluntary organisations, there are still considerable gaps in our knowledge about the diagnosis and treatment of this condition.

The Department of Health (new window) supports research and development of relevance to the NHS in hospitals, general practice and other health care settings. It also funds the NHS Research and Development Programme, which is managed on its behalf by the Medical Research Council (MRC)(new window). The MRC is the main Government agency for research, which receives its funding via the Department for Innovation, Universities and Skills.

Currently, the MRC has no specific research on fibromyalgia, although the basic research that the MRC supports in areas of pain and neurobiology is relevant to developing our understanding of the condition. There is now a Medical Advisory Board attached to the Fibromyalgia All Party Parliamentary Group, and one of its tasks will be to look into research on fibromyalgia.

The MRC does not directly commission research projects or earmark funds for particular research areas. Funds are allocated by a process that requires investigators to submit proposals for rigorous peer review. The MRC always welcomes high quality applications for support into any aspect of human health and these are judged in open competition with other demands on funding. The key factor in deciding whether a proposal is funded or not is the quality of the science and its potential contribution to human health. In addition, the MRC identifies priorities for medical research in a number of ways, including strategic reviews of specific areas of science and by responding to Department of Health priorities.

In August 2003, the Chief Medical Officer (CMO) issued a newsletter that was sent to all doctors in England, specifically addressing the problem of fibromyalgia information dissemination. The CMO acknowledges the condition and the extent to which it affects the population. He raises awareness of a leaflet about fibromyalgia, which has now been made available to all GP surgeries throughout the UK. The leaflet offers guidance on the main symptoms, diagnosis and treatment of fibromyalgia together with a brief summary of the current ideas for the underlying pathogenesis.

The Medical Advisory Board of Fibromyalgia Association UK produced the leaflet which is available from the Association's website at: www.fibromyalgia-associationuk.org (new window). The leaflet preceded a more comprehensive medical pack on the management of fibromyalgia for the multi-disciplinary team, which can also be requested on the website.

You may also be interested in the National Service Framework (NSF) for Long-term Conditions (new window), which was published in March 2005. The NSF has a particular focus on the needs of people with neurological conditions and brain and spinal injury. It tackles some of the generic issues affecting a wide range of people with long-term conditions. Although it does not cover fibromyalgia directly, it is hoped that work to establish standards of service for neurological conditions will have wider application and so benefit people with non-neurological conditions."

Well, starting at the bottom, can the Government please at least decide what kind of condition Fibro is and so which framework/guidelines applies? In response to the last petition they said the Musculoskeletal Framework applies - 1, it shouldn't, and 2, fibromyalgia is mentioned by name in it and that is all. Most treatments/therapies/etc for musculoskeletal conditions do not apply with FMS. The NSF for Long-term Conditions, neurological ones in particular, would be better for FMS - as this reply suggests - except that the Government STILL doesn't recognise FMS as being neurological and the NSF makes no mention of it.

Part of the problem with this is the leaflet mentioned in the reply. Although it is a very useful leaflet that I recommend to FMS members, I also tell them that the sections on causes of Fibro and treatments are out of date. It is this out of date information that the Government is absing it's guidelines on.

Research into Fibro isn't exactly encouraged by what I can make out. The FMAUK doesn't promote research projects like the American Assoc does and a lot of doctors are more interested in the biopsycological side of things, as with ME-CFS. At least 1.8million people in the UK have fibromyalgia (and that figure is likely to be much higher in reality, especially when you consider the amount of mis-diagnoses that go on). Someone should be doing something about this and the Government could be encouraging this!

"...key objections remain:
 

• The guidance still fails to accept the WHO classification of ME/CFS as a neurological disorder - a classification that is also accepted by the Department of Health.
• The section of diagnostic assessment continues to use a much looser and unvalidated definition for considering a diagnosis of ME/CFS but fails to explain how this should then be narrowed down to confirm the diagnosis.
• The advice on management continues to be dominated by the recommendation that everyone with mild to moderate ME/CFS would benefit from trying a course of CBT and GET - which may well be based on the psychosomatic model of ME/CFS where it is maintained by abnormal illness beliefs and behaviour.  
• There is still very little in the way of additional information on symptomatic relief - pain in particular.
• There is still a complete failure to address many key aspects of management.
• The key message in the BMJ review about management of a relapse: '...advise patients to maintain physical activity if possible'  is not evidence based and may well result in a further exacerbation of symptoms.
• The coverage of issues affecting the severely affected remains inadequate - in particular the provision of domiciliary services.

And the shortened version for patients, carers and families contains far too much repetitive waffle that is of little practical value.

NICE were presented with a unique opportunity to provide practical guidance that would help to ensure that people with ME/CFS were offered management advice covering all aspects of the illness that would be acceptable and beneficial.  They have failed the task that was set.

People with ME/CFS in England, Wales, Scotland and Northern Ireland urgently require a network of physician led multidisciplinary services based on a biomedical model of causation.  Where such services already exist they are much appreciated by patients - as was demonstrated at the July 2007 meeting of the ME All Party Parliamentary Group at Westminster. They do not want a network of services that offer little more than CBT and GET.

Overall, we must therefore conclude that the NICE guidance remains unfit for purpose.  We call for the guidance to be withdrawn and rewritten by a group of health professionals who unambiguously accept that they are dealing with a physical rather than a psychosomatic illness.
 
The ME Association
7 September 2007 "

To Hold a Public Awareness Event"

The West Berkshire ME Support Group has expanded to become West Berks ME & FM Group and is planning to hold a Public Awareness Event later this year.

The West Berks ME & FM Group Public Awareness Event

"NICE guideline on ME/CFS is unfit for purpose and too costly to implement
 
The National Institute for Health and Clinical Excellence (NICE) recommends that everyone with mild or moderate ME/CFS (myalgic encephalopathy/chronic fatigue syndrome) should be offered a course of either cognitive behaviour therapy (CBT) or graded exercise therapy (GET).
 
This is despite published evidence remaining weak (especially for group CBT) and inconsistent [1]. Patient evidence submitted to the Chief Medical Officer's report concluded that CBT produced "no change"in 67% of cases and made the condition "worse" in 26% of cases [2].  Around 50% of respondents reported that inappropriate exercise therapy had also made their condition "worse" [2].
 
Using the NICE estimate on prevalence, this controversial recommendation will affect around 200,000 people.  A one-to-one course of CBT covering 12 to 16 sessions will cost well over £1500.  The cost of a professionally supervised exercise therapy programme is also likely to be substantial.
 
So where is around £300 million of new money going to come from at a time when very limited funding for some of the newly established NHS clinical services for people with ME/CFS is now being cut? [3]
 
And where are all the therapists going to come from? Those already in post cannot even cope with the present workload.
 
These are important questions that I raised at a NICE implementation and planning meeting in October 2006 - but nobody from NICE could provide a convincing answer.
 
These recommendations are going to be of no value whatsoever to many people with ME/CFS.  They are also going to be impossible to implement due to a lack of both funding and human resources. 
 
REFERENCES
 
1: Shepherd C and Chaudhuri A.  ME/CFS/PVFS - An Exploration of the Key Clinical Issues.  ME Association, July 2007.
2: CFS/ME Working Group. A Report of the CFS/ME Working Group: report to the chief medical officer of an independent working group.  London: Department of Health, 2002.
3: ME Association.  Summary of key points to emerge from All Party Parliamentary Group meeting held in Committee Room 17 at the House of Commons on Thursday 12 July.  "

 

"Shirwan Mirza points out one of the many significant omissions in the NICE guideline - namely considering vitamin D deficiency, especially in those on restrictive diets and lack of access to sunlight.

Vitamin D deficiency often goes unrecognised and can cause bone or muscle pain and muscle weakness.

The 2007 edition of ME Association guidelines for health professionals - 'ME/CFS/PVFS: An Exploration of the Key Clinical Issues' - does stress this point, but it shouldn't be left to a medical charity to do so. "

The first letter was then the only letter on this subject selected for physical publication in the journal,

• "When managing setbacks, healthcare professionals should put strategies in place that:

  1. Include relaxation and breathing techniques.
  2. Maintain activity and exercise levels if possible, by alternating activities with breaks and pacing activities, as appropriate.
  3. Involve talking to families and carers, if appropriate.
  4. Recognise distressing thoughts about setbacks/relapses such as ‘this means I’ll never get better’, but encourage optimism.
  5. Involve reconsidering and revising the levels and types of symptom control. "

"Pharmacological interventions for symptom control

Consider referral to a pain management clinic if pain is a predominant feature.

Consider offering a low-dose tricyclic antidepressant (amitriptyline) for poor sleep or pain – but not if the person is already taking a selective serotonin reuptake inhibitor (SSRI) because of the potential for serious adverse interactions.

Melatonin may be considered for children and young people with CFS/ME who have sleep difficulties, but only under specialist supervision because it is not licensed in the UK."

"Fibromyalgia (FM) is still often viewed as a psychosomatic disorder. However, the increased pain sensitivity to stimuli in FM patients is not an "imagined" histrionic phenomena. Pain, which is consistently felt in the musculature, is related to specific abnormalities in the CNS pain matrix. Brain-derived neurotrophic factor (BDNF) is an endogenous protein involved in neuronal survival and synaptic plasticity of the central and peripheral nervous system (CNS and PNS). Several lines of evidence converged to indicate that BDNF also participates in structural and functional plasticity of nociceptive pathways in the CNS and within the dorsal root ganglia and spinal cord. In the latter, release of BDNF appears to modulate or even mediate nociceptive sensory inputs and pain hypersensitivity. We were interested, if BDNF serum concentration may be altered in FM"

"This pilot study was the first to assess BDNF serum concentrations in fibromyalgia patients. They studied 41 fibromyalgia patients and 45 age-matched healthy controls. They found that the mean serum levels of BDNF in fibromyalgia patients were significantly increased as compared to healthy controls. Fibromyalgia patients had a mean level of 19.6 ng/ml; SD 3.1. Health controls had a mean level of 16.8 ng/ml; SD 2.7; p<0.0001."

Yet another nail in the coffin of the Fibro-is-psych argument.  I wish the argument could be put to rest once and for all tho...

[Fibromyalgia] should not be considered as a rheumatologic condition but rather as part of a broader spectre of [functional somatic syndromes]. Patients with [functional somatic syndromes] should be considered and treated together across medical specialities by general physicians in primary health care.

"Functional somatic syndrome refers to several related syndromes characterized more by symptoms, suffering and disability than by disease-specific abnormalities of structure or function. Physicians frequently encounter patients with disabling, medically unexplained symptoms, many of whom have already given themselves a diagnostic label for their complaints. These patients resist information that contradicts attribution of their symptoms to a specific disease. The functional somatic syndromes include entities such as multiple chemical hypersensitivity, sick building syndrome, repetition stress injury, chronic whiplash, chronic Lyme disease, the side effects of silicone breast implants, candidiasis sensitivity, Gulf War syndrome, mitral valve prolapse and hypoglycemia."

I beg your pardon?  Resist information? What absolute bloody bullshit. Most people with Fibro would love to be told that a test has come back positive and they have something else. Having something that you can't prove (easily - PET scans are expensive!) to these doubting doctors is no fun. The number of times I wished for a blood tests to come back positive! They have nooooo bloody idea.  And what's with putting RSI (with multiple inflammed tendons), Lyme (a disease caught from ticks that you can get tested for, if you're not in the UK) and hypoglycaemia (low blood sugar is low blood sugar!) in there too? Grrrrr. I found the abstract of the article that the definition was based on and it says:

"The term functional somatic syndrome has been applied to several related syndromes characterized more by symptoms, suffering, and disability than by consistently demonstrable tissue abnormality."

So I guess all those studies showing the high P, low dopamine, reduced brain flow, etc in Fibromites were nothing compared to this one article with no evidence?

I might add here that this is an opinion agreed on by that charlatan Simon Wessely, the shrink who's had such a bad impact on the opinion of and research into ME-CFS in the UK.

Public Service Announcement: Facing Fibromyalgia, Finding Hope

For the past ten years the National Fibromyalgia Association’s (NFA) mission has been to increase awareness about fibromyalgia in order to improve the quality of life for millions of people who suffer from this chronic and often misunderstood pain disorder.

With the launch of its new awareness campaign "Facing Fibromyalgia, Finding Hope.", the NFA is expanding its efforts to generate an increased awareness and interest in fibromyalgia. It is our hope that these efforts will result in:

• Empowering patients and physicians to talk about this disorder and how best to manage its symptoms.
• Provide information that will meet the current unmet educational needs of physicians, patients and the general public about the diagnosis and optimal management of fibromyalgia.
• Provide information that will help the general consumer to better understand what it is like to live with fibromyalgia.

The NFA hopes that its outreach via a national print, radio, TV and online web site campaign will provide information and lend support to the millions of Americans suffering with this common chronic pain condition.

Each element of the campaign will contribute to people with fibromyalgia by:

• Helping patients to learn about the condition and find out where to go for help and support
• Providing the latest news on current treatments and research
• Helping patients to discover key questions to ask their physicians
• Sharing personal stories of people with FM so others will know that they are not alone

Results from a national consumer awareness survey will be made public, providing statistical facts on the general publics perceptions and beliefs about fibromyalgia. A nationally-renowned medical expert will provide the media with a medical perspective on fibromyalgia.

The website for the campaign, which has been advertised on US TV is fibrohope.org. It's pretty damn good,  though I have three issues with it:

1. it puts down the The American College of Rheumatology (ACR) diagnostic criteria, including the bit about the 11 out of 18 tender points with no further info, such as how most doctors do not know how to perform the tender point (TP) test properly or even the guidelines for performing the test which would be news to most doctors IME!  I've come across alot of people who have all the Fibro symptoms, but can't get a diagnosis because their doctor performed the TP test wrongly and said they didn't have enough TPs for a diagnosis.
2. neurological symptoms are waaaay down the list. I'm really hoping that at some stage the NFA will get on the case of getting fibro recognised as a neuro condition. The WHO still has it under "rheumatism, other" and as a rheumtological condition is one of either the joints or the connective tissues, FM isn't a rheumatological condition! Sure joints and soft tissues show symptoms, but they do so in many neuro diseases. There is no damage of either joints or connective tissue in fibro, unlike with arthritis, lupus, etc. The symptoms come from the nervous system.
3. the treatments bit is really really short and has no mention of the cutting edge stuff that the NFA reports on. I wonder if they're limited here either legally or because of Pfizer's sponsorship.

Anyway, despite that I am very impressed.  The contrast between the Americans, who raise money, get sponsorship and get things done, and the UK Association is depressing.  Imagine having adverts about FM awareness on national TV here!