Not a Minute Too Soon

Remember trying to get your diagnosis? During the process, you receive all kinds of comments from family, friends and even doctors: ‘It’s just you getting older,’ ‘it’s all in your head,’ ‘do you really think there is something wrong with you?’ Finally, a long time later (for most people)and an exorbitant amount of money, because a correct diagnosis involves at least 3 months of pain and the exclusion of everything else (that’s a lot of tests).

Wouldn’t you have loved to have circumvented that step?

study from the Journal of Evaluation in Clinical Practice was conducted to help primary-care physicians become more skilled at correctly identifying fibromyalgia. According to the study, half of all primary-care providers from the U.S., Asia, and Europe did NOT know how to diagnose fibromyalgia.

The purpose of this study was to evaluate the potential usefulness of a new screening method using simple measures (achilles tendon tenderness, BP cuff-evoked pain, in tandem with a single patient question).

Patients with FM showed significantly greater sensitivity to digital pressure and BP-evoked pressure pain compared to patients with chronic pain but no fibromyalgia. Further, the patients who had right Achilles tenderness and who endorsed the deep-aching question had an 11 times greater chance of having fibromyalgia.

These results suggest that 2 tests, taking less than 1 minute, can indicate a probable diagnosis of fibromyalgia in a chronic pain patient. In the case of a positive screen, a follow-up examination is required for confirmation or refutation.

 

 

Drugs for Fibro: How Good Are They?

by Dr. John Quintner from NationalPainReport.Com

john-quintner-300x300John Quintner, MD, is a rheumatologist and pain medicine specialist in Australia who recently retired from clinical practice.
He has published numerous articles on chronic pain in Pain Medicine, Clinical Journal of Pain, The Lancet and other medical journals.

Most fibromyalgia sufferers will at some stage be offered a prescription for one or more of the officially approved drugs – Lyrica, Cymbalta, and Savella.

Many will ask their doctors two important questions: How good are these drugs and what harm can they cause me?

Many would be surprised by the answers they get – if the doctor is willing and able to provide them.

bigstock-Out-of-focus-woman-extending--34477478The concepts of NNT/NNH

One way to assess the effectiveness of drugs for pain management is by looking at the Number Needed to Treat (NNT) value.

The NNT value for drugs used to treat specific painful conditions is derived from large clinical trials that record the number of patients who report 50% or more reduction in their pain, compared to results from a placebo. The lower the NNT, the better the drug.

For example, if 10 patients with a specific condition are prescribed a drug and only one of them reports relief of pain, the NNT value for that drug is 10. This means that the other 9 patients will find the drug to be ineffective.

Continuing on the same theme, the potential for drugs to cause harmful side effects is expressed by another value – the Number Needed to Harm (NNH).

The NNH values for the three fibromyalgia drugs gives us an indication of how many patients need to be treated before one of them will report a harmful side effect. The higher the NNH, the safer the drug is.

By the way, it is well known that people taking placebo drugs can report adverse events.

NNT for Fibromyalgia Drugs

For Fibromyalgia patients, the NNT for Lyrica is 10for Cymbalta it is 6; and for Savella it is around 8-10.

This means that only one out of 10 patients taking Lyrica (Preglabin) will have pain relief of 50% or more. Only one out of 6 taking Cymbalta (Duloxetine) will have relief of pain and only about one out of 8 taking Savella (Milnacipran).

NNH for Fibromyalgia Drugs

The overall values for side effects of each drug, when compared to placebo, and expressed as NNH are as follows: between 6 -18 for Cymbalta; between 7-14 for Savella 7-14; and around 6 for Lyrica.

This means for every 6 patients with fibromyalgia treated with Lyrica, one of them will report a harmful side effect. There is a wide range of NNH’s for both Cymbalta and Savella.

Some adverse effects are relatively minor and will not deter a person from taking an effective drug. Other adverse effects are more serious and can be a reason for discontinuing the drug.

In the case of Lyrica, randomized controlled trials have shown that doses of 600 mg daily produce drowsiness in 15-20% and dizziness in 27% to 46%.

Other side effects include dry mouth, weight gain, peripheral oedema (swelling). In another important review, it was found that treatment was discontinued due to adverse events in one out of 4 patients.

In summary, a minority of patients will report substantial benefit with Lyrica, and more will have moderate benefit. Many will have no or trivial benefit, or will discontinue the drug because of adverse events.

Is this the sort of information that patients would like to have given to them?

In my experience, the answer is a resounding YES. But as each person is a unique individual, it is impossible to accurately predict who will and who will not like a particular drug.

Doctors are men who prescribe medicines of which they know little, to cure diseases of which they know less, in human beings of whom they know nothing.”

These oft-quoted words by the French philosopher Voltaire [1694-1778] still have a ring of truth about them. We now know much more about the drugs we prescribe, and about the various diseases we have uncovered and classified. But we still have much to learn about the responses of individual human beings.

Those who have been awarded a diagnosis of fibromyalgia find themselves in a “double bind.”

On the one hand, the very diagnosis can arouse disbelief at all levels of society and, on the other hand, the available drugs afford most of them little, if any, relief of pain.

Fibromyalgia Blood Test Accurate

blood bank

New research results have upheld the validity of a blood test that can diagnose fibromyalgia, according to the chief executive of a Santa Monica-based company that began offering the test earlier this year.

“We’ve proven that fibromyalgia can be diagnosed unequivocally through this test, a test that remains highly sensitive and specific,” said Bruce Gillis, MD, founder and CEO of EpicGenetics.

blood-cellsThe FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to Gillis, and have weaker immune systems than healthy patients.

But critics said the blood test was unreliable because the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis.

The new research, which was conducted by EpicGenetics, involved nearly 500 people. The blood test was given to 160 fibromyalgia patients, 100 lupus patients, 98 patients with rheumatoid arthritis and 119 healthy people who served as a control group.

Over 93% of the patients who had fibromyalgia were correctly identified by the blood test, according to Gillis, and over 89% of those who did not have fibromyalgia were correctly identified.

108. mutation“What we found is that the biomarkers do not occur in other rheumatologic diseases, it’s only in fibromyalgia,” Gillis told National Pain Report. “I cannot tell you if these biomarkers are the cause of fibromyalgia or if it’s a by-product from fibromyalgia. We don’t know that yet. But these findings are the first objective methods to prove a patient has fibromyalgia.”

“The test does two things. It doesn’t merely give you the diagnosis of fibromyalgia, it legitimizes the diagnosis of fibromyalgia,” says Gillis. “It proves it’s a real disease. It’s not a bogus affliction of neurotic, crazy, hypochondriacally people. They really are sick. There’s something wrong in their immune system processing.”

Much of the new research was conducted Daniel Wallace, MD, a rheumatologist at the Cedars-Sinai Medical Center in Los Angeles and a professor of rheumatology at UCLA. Wallace, who has written a number of books on fibromyalgia and other autoimmune diseases, is on EpicGentics scientific advisory board.  He could not be reached for comment on this story.

Dr Gillis says the research results were well received when he presented them last month at the annual meeting of the American College of Rheumatology in San Diego.

“It now I think eliminates the last criticisms by any naysayers regarding the test. It says that we listened to their criticism and we approached it in a direct fashion to answer the question,” Gillis said.

But some critics remain.

“I wish Dr Gillis well in his quest to establish even a shred of scientific credibility for his test, which has been vitiated by what Sir William Osler referred to as ‘the corroding influence of mammon,’”  wrote John Quintner, MD, a prominent rheumatologist in Australia, in an email to National Pain Report.

Quintner has been skeptical of previous research conducted by EpicGentics. So has Fred Wolfe, MD, a rheumatologist who has called the fibromyalgia blood test “junk science.”

Critics are waiting for the new research to be published in a peer-reviewed medical journal. Gillis says a report on the new study is still being written and he hopes to get it published in the next few months in a “highly regarded, well-respected, peer-reviewed journal.”

The FM test kit costs $744 and is not covered by most insurance companies. Blood samples are shipped to an EpicGenetics laboratory for testing and results are usually available in about a week.

From NationalPainReport.com

 

Hidden Pain or Thick Fog?

Now, I get it.

When I was first diagnosed, my doctor put me on Lyrica immediately; and then, it was steadily increased. If you’ve been reading this blog, you’ll know that I’m weaning off it. (If you’re not up to date, check Whatever…Nothing!) Well, I’m up to Week 4: I’m pissed off, short-tempered and in pain.

doses

It has even ruined the best part of my week: my shiatsu massage.

Last week’s massage was fabulous. This week, however, was another story; and, as I said at the beginning, now I understand how some of you can’t stand a massage.

pain 1pain 2The same place (no idea what it’s called) was incredibly sensitive but it got to the stage where if Peter touched my shoulder, that spot hurt; if he touched my arm, that spot hurt; if he touched my knee, (you guessed it) that spot hurt.

pain 3pain 4In fact, by the time the hour was up, if Peter touched anything, that spot hurt!

pain 5

Why the hell am I doing this to myself?

Well, the good news is that the Fibro Fog has lifted. So tell me, which would you prefer: the pain or the fog?

FINALLY…

Canadian researchers have released the first set of guidelines to help doctors diagnose and manage Fibromyalgia.

The evidence-based guidelines are the first national set in the English-speaking western world, said Dr John Pereira, a co-author of the guidelines from the University of Calgary’s faculty of medicine and a physician at the Calgary Chronic Pain Centre.

“For many years health-care professionals dismissed fibromyalgia as a non-existent condition. And more recently, while people have accepted that perhaps it does exist, still patients were told there was nothing that could be done for them,” Pereira said.

“In these guidelines we have clearly listed how to diagnose this condition and how to treat it effectively. So while there’s no cure for fibromyalgia, there are now good treatments that patients can consider.”

Main-Picture-Licensed-With-CaptionBecause of the prevalence of the condition, the guidelines recommend that primary care physicians take over the diagnosis and management role that has often been left to specialists.

The guidelines suggest a multi-modal treatment such as exercise, cognitive-behavioural therapy, education, self-management and relaxation techniques as well as medications that target a patient’s most bothersome symptoms: pain being the most serious.

The goal of treatment is to improve symptoms and “optimize function,” according to the guidelines. There is no one ideal treatment, although the guidelines say management should be tailored to each patient’s symptoms.

“Currently, there is no cure for fibromyalgia, but the guidelines set out the most appropriate management strategy,” said rheumatologist Dr Mary-Ann Fitzcharles, a corresponding author from the Research Institute of the McGill University Health Centre.

So, wherever you are in the world, perhaps this is something you can show your doctor/s to help establish your treatment plan.

Got Fibro? Now What?

Ok, you have a diagnosis…now what’s going to happen?

ae78c7c2bc0e5642e361bf001c101af9Most likely, your doctor is going to give you medication. There are many different medications used to manage FM, including pain medicines, sleeping pills, and antidepressants.  Some help ease pain. Others boost mood and improve sleep. Working with your doctor will help you find the right medication to add to your multi-faceted comprehensive treatment regimen. That way, you can begin to manage your symptoms effectively…

The first medication doctors will often try is an anti-depressant (this does NOT mean you are necessarily suffering from depression!), which helps relieve pain, fatigue, and sleep problems. Nonetheless, depression is commonly seen in people with FM.

Older anti-depressants, called tricyclics (including Elavil (amitriptyline) and Pamelor (nortriptyline)), have been used for many years to treat FM. They work by raising the levels of chemicals (neurotransmitters) in the brain.

Tricyclic anti-depressants increase levels of serotonin and norepinephrine in the brain. People with chronic pain often have decreased levels of these calming neurotransmitters. Tricyclics can relax painful muscles and heighten the effects of endorphins – the body’s natural painkillers. While these medications are often very effective, the side effects can sometimes make them difficult to take as they may cause drowsiness, dizziness, dry mouth, dry eyes, and constipation.

There are numerous types of anti-depressants and several of them have been shown to help relieve the pain, fatigue, and sleep problems in people with FM.

pillsThe most well-studied anti-depressants for FM include Cymbalta (duloxetine), Savella (milnacipran), and Effexor (venlafaxine). Cymbalta and Savella are specifically FDA-approved to treat FM. There is less medical research to show that Effexor helps FM. Other anti-depressants that have also been studied for FM and may help include Prozac (fluoxetine), Paxil (paroxetine), and Celexa (citalopram).

That’s a lot of different choices to work through and yes, it’s all trial and error to see what works for you. What works for one person with FM may not work for someone else. Different anti-depressants work differently in the body. That’s why you may have to try more than one anti-depressant to find the one that best relieves the pain, fatigue, and sleep difficulties. Your doctor may even want you to try a combination of more than one anti-depressant at a time.

Then, there are different types of pain relievers, sometimes recommended to ease the deep muscle pain and trigger-point pain that comes with FM. The problem is these pain relievers don’t work the same for everyone, either.

article-new_ehow_images_a05_sc_bu_can-nexium_-800x800Non-steroidal anti-inflammatory drugs (NSAIDs), when taken alone, don’t typically work that well for FM. However, when combined with other medications, NSAIDs often do help. NSAIDs are available over the counter and include drugs such as aspirin, ibuprofen, and naproxen. Further, the over-the-counter pain reliever acetaminophen elevates the pain threshold so you perceive less pain. Acetaminophen is relatively free of side effects. But avoid this medication if you have liver disease.

You also need to be careful taking aspirin or other NSAIDs if you have stomach problems. These medications can lead to heartburn, nausea or vomiting, stomach ulcers, and stomach bleeding. Don’t ever take over-the-counter NSAIDs for more than 10 days without checking with your doctor. Taking them for a prolonged period increases the chance of serious side effects.

Sometimes, your doctor will prescribe the muscle relaxant cyclobenzaprine. has proved useful for the treatment of FM. It has proved to be helpful with easing muscle tension and improving sleep. Muscle relaxants work in the brain to relax muscles; but you may experience dry mouth, dizziness, drowsiness, blurred vision, clumsiness, unsteadiness, and change in the colour of your urine. These medications may increase the likelihood of seizures, confusion and hallucinations.

Most recently, Lyrica, originally used to treat seizures, is being used to treat FM. Lyrica affects chemicals in the brain that send pain signals across the nervous system. So it reduces pain and fatigue and improves sleep.

Neurontin (gabapentin) is another anti-seizure medication that has also been shown to improve FM symptoms.

SMFM-278Other medications include pain relievers such as Ultram (tramadol) which is a narcotic-like medication that acts in the brain to affect the sensation of pain. However, it is not as addictive as narcotics.

In addition, doctors may prescribe benzodiazepines such as Ativan (lorazepam), Klonopin (clonazepam), Valium (diazepam), and Xanax (alprazolam) to help relax painful muscles, improve sleep, and relieve symptoms of restless legs syndrome. Benzodiazepines are addictive and must be used with caution on a short-term basis. Taking more than recommended increases the risk of serious side effects, including death.

Powerful narcotic medications, such as Percocet and OxyContin (oxycodone) and Vicodin and Lortab (hydrocodone), should only be considered if all other drugs and alternative therapies have been exhausted and there is no relief.

All of this seems quite daunting which is why you need to surround yourself with a team you trust, which may include doctors, friends and/or family. The most consistent treatment advice that all the experts in FM try to promote is a multi-faceted approach. So, as well as all these medications, you will need to explore a whole range of complementary treatments.

FCKI don’t mean to scare you; in fact, I am trying to help by blogging about research and my experiences with different activities (please explore the site). There is also a directory of other FM bloggers that allows you to find people who are going through the same stuff as you.

There Ain’t No Magic Pill

“There’s no magic pill…to fix their fibromyalgia,” says Mark J. Pellegrino, MD, of Ohio Pain and Rehabilitation Specialists and author of 13 books on fibromyalgia. “A balanced approach is important.”

And many experts agree the best treatment for fibromyalgia is a multifaceted approach that combines medication with lifestyle changes and alternative treatments.

But what about if you’re new to all of this? Where do you even start?

A treatment plan gives structure to getting from here to there. Be realistic and (yes, you’re already probably sick of hearing this already) small steps! A treatment plan is different from devising goals because of its flexibility and internal exploration. In most clinical settings, a treatment plan review is done quarterly or even monthly. After each review, the plan is rewritten to meet current needs.

Start With a Diagnosis

There are no lab tests for fibromyalgia. Doctors diagnose it by considering criteria such as how long you’ve had pain and how widespread it is, and by ruling out other causes. This can be a long and complicated process because the symptoms associated with fibromyalgia can be caused by other conditions. So it’s best to see a doctor who is familiar with fibromyalgia – which can be easier said than done, sometimes!

Learn About Fibromyalgia Medications – You are YOUR Best Advocate!

Once you’ve been diagnosed with fibromyalgia, your doctor will talk to you about treatment options. Several types of medicines are used to help manage fibromyalgia symptoms such as pain and fatigue.

Three medications are FDA-approved to treat fibromyalgia:

  • Cymbalta (duloxetine): a type of antidepressant called a serotonin and norepinephrine reuptake inhibitor (SNRI). Researchers aren’t sure how Cymbalta works in fibromyalgia, but they think that increasing levels of serotonin and norepinephrine help control and reduce feelings of pain.
  • Lyrica (pregabalin): Lyrica is a nerve pain and epilepsy drug. In people with fibromyalgia, it may help calm down overly sensitive nerve cells that send pain signals throughout the body. It has been effective in treating fibro pain.
  • Savella (milnacipran): Savella is also an SNRI. While researchers aren’t exactly sure how it works, studies have shown that it helps relieve pain and reduce fatigue in people with fibromyalgia.

Antidepressants are also sometimes prescribed to help people manage fibromyalgia symptoms:

  • Tricyclic antidepressants. By helping increase levels of the brain chemicals serotonin and norepinephrine, these medications may help relax painful muscles and enhance the body’s natural painkillers.
  • Selective serotonin reuptake inhibitors (SSRIs). Your doctor may prescribe one of these types of antidepressants by itself or in combination with a tricyclic antidepressant. SSRIs prevent serotonin from being reabsorbed in the brain. This may help ease pain and fatigue.

These medications are also sometimes prescribed for fibromyalgia:

  • Local anesthetics. Injected into especially tender areas, anesthetics can provide some temporary relief, usually for no longer than three months.
  • Anticonvulsants or seizure medications such as Neurontin are effective for reducing pain and anxiety. It is unclear how these medications work to relieve the symptoms in fibromyalgia.
  • Muscle Relaxants are occasionally prescribed to help alleviate pain associate with muscle strain in those with fibromyalgia.

Stay Active

Exercise is an important part of managing fibromyalgia symptoms. Staying physically active can relieve pain, stress, and anxiety.

The key is to start slowly. Begin with stretching and low-impact activities, such as walking, swimming or other water exercises, or bicycling. Low-impact aerobic exercises such as yoga, tai chi, or Pilates can also be helpful. Prior to starting any exercise routine, or if you want to increase the intensity of your exercise, talk with your doctor.

Physical Therapy

Physical therapy can help you get control of your illness by focusing on what you can do to improve your situation, rather than on your chronic symptoms.

A physical therapist can show you how to get temporary relief from fibromyalgia pain and stiffness, get stronger, and improve your range of motion. And she can help you make little changes, such as practicing good posture, that help prevent painful flare-ups.

Alternative Therapies

A number of popular fibromyalgia treatments fall outside the realm of mainstream medicine. In general, there hasn’t been extensive research on complementary and alternative medicine (CAM), but anecdotal evidence suggests that some may work. Always talk with your doctor before starting any alternative treatment.

Popular alternative treatments include:

  • Acupuncture. This ancient healing practice aims to increase blood flow and production of natural painkillers with thin needles inserted into the skin at strategic points on the body. Some studies report that acupuncture may help ease pain, anxiety, and fatigue.
  • Massage therapy. This may help reduce muscle tension, ease pain in both muscles and soft tissue,improve range of motion, and boost production of natural painkillers.
  • Chiropractic treatment. Based on spinal adjustments to reduce pain, this popular therapy may help relieve fibromyalgia symptoms.
  • Supplements. A number of dietary and other supplements are touted as treatments aimed at relieving fibromyalgia symptoms. Some of the most popular for fibromyalgia include magnesium, melatonin, 5-HTP, and SAMe, which may affect serotonin levels. However, results of studies on these supplements are mixed. Be sure to talk with your doctor before taking any supplements. Some may have side effects and could react badly with medication you are taking.
  • Herbs. As with supplements, scientific evidence for the effectiveness of herbs is mixed. A few studies have shown that St. John’s wort can be as effective as certain prescription medication for treating mild depression.

This is just a start – and you will probably need to tweak your plan as you go along, throwing out activities and treatments that don’t work for you, while grasping the positives with both hands. Remember, it may take a while to get where you want to be – it is all about experimentation (and just because something works for me does not mean it will work for you).

If you’d like to see iHerb’s selection of supplements, click here. Use Coupon Code LHJ194 to get $10 off any first time order over $40 or $5 off any first time order under $40.

Extreme Ups and Downs…Bipolar Spectrum?

What is the first thought that jumps into your head when I mention the word BIPOLAR?

Now…why am I asking you this?

According to a recent study in Italy, FM is related to bipolar spectrum disorders, particularly the hypomania/overactivity component.

110 FM patients were assessed for bipolar spectrum disorders using both categorical and dimensional approaches. The first was based on a version of the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinical Version interview, modified to improve the detection of bipolar spectrum disorders, the second on the hypomania symptom checklist HCL-32, “which adopts a dimensional perspective of the manic/hypomanic component of mood by including sub-syndromal hypomania.”

Bipolar-Disorder-testSeventy per cent of patients were diagnosed with bipolar spectrum disorder based on DSM-IV, while 86.3 per cent of patients were diagnosed according to the Zürich classification.

The study showed “a higher-than-expected co-morbidity between fibromyalgia and bipolar spectrum disorders among patients with fibromyalgia as compared to the general population,” the researchers concluded. “The rate found … is higher than the top prevalence rate of bipolar spectrum disorders reported in the literature from community studies.”

The bipolar spectrum is a concept which observes that many people with depression and other conditions share many of bipolar disorder’s symptoms. Under this concept, such people’s conditions are within the “bipolar spectrum,” without qualifying as true bipolar disorder. Although many psychiatrists find the bipolar spectrum concept useful, it has not yet been adopted widely.

Bipolar disorder is commonly believed by psychiatrists to have two main forms:

  • In bipolar disorder I (bipolar I), a person has at least one manic episode lasting at least a week. He or she also has multiple episodes of major depression. Without treatment, the episodes of depression and mania usually repeat in erratic cycles, with depression outnumbering manic episodes about 3 to 1.
  • In bipolar disorder II (bipolar II), a person has a milder form of mania, called hypomania, lasting several days or longer. Episodes of depression outnumber hypomanic episodes more than 30 to 1, in most people with bipolar disorder II. Because hypomania can be mistaken for ordinary happiness, bipolar II may often be misdiagnosed as depression alone.

Although these people do not meet the diagnostic criteria for bipolar disorder, some psychiatrists believe they have something important in common with people with bipolar disorder. Symptoms that may overlap between bipolar spectrum conditions and bipolar disorder include:

  • Depression with rapid mood swings (seen in many mental conditions)
  • Prolonged irritability (possibly a form of mania)
  • Impulsivity (common during manic episodes)
  • Euphoria and high energy (common in substance abusers)

Major and minor bipolar spectrum disorders are not associated with differences in demographic or clinical characteristics, suggesting that FM, rather than being related to depression, is related to bipolar spectrum disorders and in particular to the hypomania/overactivity component.

bipolar2Personally, I find this really difficult to digest. To me, it is completely understandable and reasonable (and nothing like a mental disorder) to have extreme downs when we feel like crap (which, for most of us, is more often than not); and extreme ups when the pain subsides and we can actually do something that makes us happy. This would make most of us fit within the Bipolar II category

Take the online bipolar test (Goldberg Bipolar Screening Test). It can help determine whether you might have the symptoms of bipolar disorder (Bipolar I or II).

Remember, this is NOT a diagnosis. Only a doctor or qualified mental health professional can make a diagnosis of bipolar disorder or major depression and recommend treatments. You can use the results to decide if you need to see a health professional to further discuss diagnosis and treatment of adult bipolar disorder.

Dubious Diagnostics

There’s been a lot of chatting about a new a new diagnostic test for FM (eg: http://akemisheartmindsoul.blogspot.com.au/2013/03/coming-soonnew-diagnstic-for.html, http://www.foxnews.com/health/2013/02/26/questions-arise-over-new-diagnostic-test-for-fibromyalgia/, http://www.fibroandfabulous.com/2013/02/questions-arise-over-new-diagnostic.html).

The test, called the FM test, measures production levels of certain cytokines, which are proteins that play an important role in your immune system. The test was developed by Dr Bruce Gillis, and in December 2012 ‘Unique immunologic patterns in fibromyalgia’ was published as Behm et al., which found lower levels of these cytokines in individuals with FM compared to healthy individuals. The authors declared that ‘they have no competing interests.’

In April 2012 a privately owned biomedical company called EpicGenetics, Inc filed a patent for ‘A method of diagnosing and treating fibromyalgia.’ This company is the one who conducted the clinical trials and are the manufacturers of the FM/a test – no competing interests?

In March 2013, EpicGenetics started selling the ‘test’ for $744 to physicians and directly to patients at $US744.99 a pop.

Epic-Genetics_Logo_RGBAccording to the EpicGenetics website, people with significantly lower cytokine levels have FM. The FM/a Test uses a 1-100 point scoring system to determine diagnosis – the FM Test calculates a positive FM diagnosis if there is a score between 50 and 100 points.

Professor WolfeHowever, Professor Fred Wolfe refers to the test as an example of Junk Science and Junk Ethics, as cytokine levels are abnormal in many physical and mental conditions. The authors studied none of those conditions.

Further, EpicGenetics provided almost no information about patient selection or many other vital data for a comparison trial. The CONSORT statement on publishing trials offers guidelines on the reporting of data. They didn’t follow these guidelines. As a clinical study, it was very poorly planned and carried out. As a pathology report it might pass. But the data did not in any way address the validity and reliability of their ‘test’ to diagnose FM.

Dr Daniel Clauw, director of the Chronic Pain and Fatigue Research Center at the University of Michigan, said these results are not consistent with results from previous studies, and would need to be replicated in other studies.

The blood test is only available through your doctor or a licensed physician. The doctor will take your blood sample and send it to EpicGenetics.  They will send the results back to your doctor usually within 7 days, who then will discuss the findings with the patient.

Professor Wolfe states, ‘For such an ethical violation, BMC Pathology should withdraw the paper. Want to diagnose fibromyalgia? Talk to the patient. In less time than it takes to get the blood drawn you can have the diagnosis (free!).’  Makes sense to me, Professor Wolfe!