Breaking Down the Complexity of ME/CFS – Part 1

Clinical Intuition divide and conquer

In 2012 the Solve ME/CFS Initiative organized a meeting at the Banbury Center of Cold Spring Harbor Laboratory, “Decoding Clinical Trials to Improve Treatment of ME/CFS.” We invited many of the investigators that over the years have conducted clinical trials for myalgic encephalomyelitis, Chronic Fatigue Syndrome and related disease areas; Jose Montoya, Øystein Fluge, Katherine Rowe, Carl-Gerhard Gottfries, Nancy Klimas, Peter Rowe, Italo Biaggioni and about 30 others.

Our meeting objective was to understand the science behind the clinical trials – why some worked and others didn’t – and then to take these lessons learned and apply this knowledge to future clinical trials.  It was clear from the many presentations that the complexity of ME/CFS made clinical trials challenging.  Many of the trials were small, few went further than Phase II (there are 4 phases in clinical trials) and none were replicated by other clinical researchers.  It was interesting however, to see that despite the limitations of these clinical trials, there were hints of some beneficial effect to some of the treatments.

This gave Elizabeth Unger MD, PhD, a meeting participant, the idea that we should try to capture this clinical intuition (the sense that doctors have that helps them understand and treat ME/CFS patients.) Dr. Sandra Kweder of the FDA was thinking similarly when she was quoted as saying:

“… But the key is that a lot of the researchers in this to date have been out there on their own. They’re clinicians who are following a series of patients for decades. And no one’s really been able to tap into the kind of information that they have…”

–  ME and CFS Stakeholder Teleconference Participant List, September 13, 2012

We worked with Biovista, one of our 2011 funded investigators, to develop a platform in order to tap into and capture clinical intuition.  Together we developed a web-based survey tool that asked questions focused on three main areas:

  1. Efficacy of drugs currently used in the treatment of ME/CFS symptoms
  2. Alternative treatment options (nutritional supplements, fluids,)
  3. Treatment strategies: How are symptoms interrelated? Which symptoms are more important to treat first?

About 15 ME/CFS expert clinicians participated in the survey.  We are now preparing the results of the survey for publication.  Once published, this will be useful information for ME/CFS patients to bring to their physicians to see how the ME/CFS experts from around the world are managing and treating their patients.

The knowledge that expert ME/CFS clinicians have gained is invaluable to us as we work to break down the complexity of ME/CFS.  By understanding what treatments work and which don’t, we learn about the biology that underpins these treatment responses.  By capturing this information we are expanding our knowledge base and once again putting ME/CFS into the context of other medical and scientific knowledge.  As we strive for a world free of ME/CFS, this is just one of the many ways we are working to accelerate discovery of safe and effective treatments.


Look for Part 2 and Part 3 of this blog series, Breaking Down ME/CFS, coming soon

Tags: , , , , , July 2, 2014
  • Nita Dozer Thatcher

    I think this has been needed for a long time. Thank you so much for spearheading this effort. Your dedication is appreciated!

  • Nancy M. Henson

    This is wonderful. I hope once all the info is available that it will make its way into papers and into medical journals. There are far tooo many drs. that still don’t believe ME/CFS is real.

  • Very nice! This is going to be very interesting and like Nancy says I hope it makes it into print!

    • Leigh Reynolds

      Thank you!

  • Bottsie Hicks

    Very excited to see this series! Do you have target dates for Parts 2 and 3?

    • Leigh Reynolds

      Thank you! Part 2 was published earlier today and Part 3 will be published on Wednesday.

  • Beckie Cann

    Unfortunately, most docs I have met do not read. Not EVER. Ergo: Most docs I have met do not treat CFS because those docs have more than enough Medicare and PPO-derived patients who will heal on their own. Thanks to Medicare expansion of covered benefits, everybody – regardless of age – receives vaccines at these uninformed docs’ offices. Eventually, all patients – regardless of age – will acquire CFS through over-vaccination. Until forced to read by any State Med Board Examiner order and sanction, most docs I have met will never, ever read and / or never, ever treat. If you don’t believe me, read anything that neurosurgeon Russell Blaylock, M.D. has written or spoken.

    • Reverend G J Callen

      Becky. I couldn’t agree more with your statement. I support your conjecture 100%. I have researched for 10-year now all material that I could find on this topic. I had hoped to cure or minimize the impact of my disabling ME/CFS. Only to be told that I know more than my doctor on the subject.

      The means to the end on my journey is patient self advocacy and having a doctor that does not take the patients learned knowledge of subject as an insult or attack on his / her academic knowledge. With that said academic knowledge = medical school training. Thus when one doesn’t stay abreast of their field of acumen – they are self obsolescence artifact.

      If they funded research for ME/CFS equal to that of AIDS or CANCER – we would all be back to contributing members of society.