Monday, July 1, 2013

More FM drug trials of the same, really? 1990 vs 2010 Criteria, which is it? My comment by Celeste Cooper

Am I in a fibrofog? Is this new drug trial for pain or for cognitive dysfunction in FM or both? The news reports are confusing. Is one right and the other wrong? They can’t both be right, can they? I went on a search. You can find the answer at the bottom on this blog.

New Fibromyalgia (FM) Clinical Trial Now Enrolling at Avail Clinical Research in Central Florida; Accepting M/F Patients with Fibromyalgia Age 18-59. June 30, 2013 Digital Journal, read here

There was no place to leave a comment. I would have because cognitive deficit is a primary symptom of fibromyalgia. Its effects are more extensive, including complete word loss, sudden onset dyslexia, severe and alarming short term memory loss etc. When we compare these cognitive affects with those experienced by people with chronic pain in general, there is a difference. My thinking is that some of these symptoms can also be attributed to hypothyroidism, and non-restorative sleep evidenced by loss of slow wave progression in sleep studies of fibromyalgia patients. This leads to the next question, "Will these factors be considered in participant screening? (More to come later). 

I found some red flag words - “mood disorders,” which can include biological psychiatric conditions, such as "bi-polar disorder" or "major depressive disorder," neither to be confused with a normal situation reaction of temporary anxiety or depression. These are terms that should not be used flippantly. As a chronic pain advocate and fibromyalgia expert, why?  What fibromyalgia patients experience is not different that the situational depression or anxiety that others with chronic pain experience. I will compromise that catastrophic thinking can sustain symptoms, but I am perplexed as to why anyone thinks it is any different in fibromyalgia when resent research suggested overwhelmingly that FM is a biological disorder. Are we to think that because migraine, interstitial cystitis, periodic limb movement and bruxism in sleep, and many of the comorbid conditions to FM should also be considered as "mood disorders?" Really?

This particular article suggests the 1990 criteria will be used to screen participants; however, that is not the case, which leads to more confusion. I suspect it is because the reporter saw that comorbid conditions are recognized, unlike what is suggested in the 2010 criteria. 

Accurate reporting is necessary. Read on to understand why this is a concern to me.

The next article just released. I was able to leave a comment:

New Fibromyalgia (FM) Clinical Trial Now Enrolling at Achieve Clinical Research in Birmingham, Alabama; Accepting M/F Patients with Fibromyalgia Age 18-70. July 1st, 2013 WatchListNews Press Release, here.

I hope this drug trial is targeted at a defective immune system versus chronic pain in general. Results of the FM/a Test have been overwhelming post research, and the follow up study in progress is ruling out the immune blood protein findings in FM in other rheumatological conditions. Otherwise, this study is on chronic pain in general. 

The number of Americans with chronic pain was amended from 116 million to an estimated 100 million, and the 2010 Preliminary Proposed criteria for diagnosing fibromyalgia has met with a great deal of criticism. The tool is confusing and does not require a physical exam. Many are boycotting this criteria because it is confusing and misleading. Since there is a blood test now for diagnosing FM, would that be a better place to start? It would certainly rule out any psychological illness that might otherwise be inaccurately diagnosed as FM.  The Wolfe, et al. criteria was amended in 2011 as "modified," and does NOT look specifically at the comorbid disorders you discuss. Instead, it looks at polysymtomatic syndrome as defined in the American Psychiatric Association diagnosis manual the DSM-5.

Side note: See “Fibromyalgianess is ALL in Our Head? My Correspondence with Dr Frederick Wolfe.”  Here.

I am highly suspicious that this drug trial is more of the same. While antidepressants and anticonvulsants medications help with chronic pain, the evidence has been underwhelming. Treating an immunological disorder with an SNRI, SSIR, [oops should have been SSRI] or anti-seizure meditation or a similar drug in those classifications is not going to improve patient outcome. Look at the prevalence of hypothyroidism in FM, would such drugs help with these symptoms? I suggest a really good review of the recent research regarding immunological factors, A-V shunting in the hands of FM patients, and the presence of small fiber neuropathy.

Last, but certainly not least, I saw no mention that patients would be screened for comorbid myofascial pain syndrome?  There is plenty of research and evidence to suggest that myofascial trigger points and attachment trigger points are present in ALL patients with chronic pain. The difference is investigating why latent MTrPs are easily activated in fibromyalgia when compared to the usual aggravating factors, spinal misalignment, posture, joint deformity, etc. I suspect the immunological effect of FM plays a role.

I suggest they change their study cohorts to people with chronic pain in general.

From PRWeb visit:

The primary objective of the study is to assess the ability of a new drug to reduce Fibromyalgia pain. Specifically, this will be accomplished by evaluating the safety and efficacy of a 6-week treatment regimen with this new Fibro drug, to a maximum dose of either 5 mg or 20 mg, relative to placebo, in subjects with FM. Efficacy will be assessed on the basis of the baseline-adjusted weekly mean pain score obtained in the last week of treatment, as derived from subjects’ daily reports in an electronic diary. Daily pain scores will be reported on an 11-point numeric rating scale (Pain-NRS).

The secondary objective of the study is to assess overall improvement in fibromyalgia following treatment with a new Fibro drug relative to placebo. This will be assessed by:
•the Patient Global Impression of Change (PGI-C); and
•the Fibromyalgia Impact Questionnaire (FIQ) total score.

5. Diagnosis of primary fibromyalgia (FM) as defined by the 2010 American College of Rheumatology Preliminary Diagnostic Criteria for Fibromyalgia

All blog posts and answers are not to replace medical advice.

Learn more about Celeste and her endeavors as patient, RN, educator and advocate at


Clarissa Shepherd said...

I feel that there is too much emphasis being placed on the psychological aspect of Fibro. This issue comes as a result of having a chronic illness and not the cause of said illness. Also the confusion is getting worse and not being made clearer. I feel that the Trigger point test is still valid and should be used. I know well people that aren't sore in the tender points. Pain management isn't being taken seriously and that is also an issue which is becoming more difficult for the patients.

Anonymous said...

Well said Clarissa and the trigger points are always valid in diagnosis along with history etc. We must get away from the psychological beliefs behind FM or we will never get all of the newest proven knowledge A-Z put together which in time will for sure give us at least better medical care for starters. I believe the small nerve fibers are involved, and I'm happy that a blood test is available but until the insurance companies accept this test for us and pay for it not many of us can take advantage of it. I only wish the true test to date would be looked at closely in a central location so as to start working on better medical care and hopefully a cure. Instead we are having studies done that should not include the word FM. Unless some of the researchers suffer from FM themselves seems like some are going in circles...yet so many answers are already available..who's connecting the dots?

Anonymous said...

I wish our GP and other physicians would take our concerns and comments and research we do seriously. Yes I do suffer from clinical depression BUT that is only a drop in the bucket of the vast array of symptoms that we all suffer from. This new Fibro blood test SHOULD be covered by insurances and Docs should STILL do the trigger points but I feel like if they have come as far as creating a blood test to diagnose than somebody needs to take all this research and come up with a medication to effectively treat or cure this dreaded disease!!!

The Pained Ink Slayer said...

Absolutely, Clarissa

The Pained Ink Slayer said...

I think the blood test is around the corner, but I am not putting all my eggs in one basket. I think there are many complex things going on in FM, all most likely the result of a dysfunctions master system, the HPA axis. There are too many comorbid disorders that have similar footprints.

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