Scientists trade insults over myalgic encephalomyelitis (ME) study

Posted on 08/02/2017 by wames

Times article, by Tom Whipple, 1 Aug 2017: Scientists trade insults over myalgic encephalomyelitis (ME) study

An acrimonious scientific row has broken out after a £5 million publicly funded study investigating treatments for chronic fatigue syndrome was condemned as “deeply flawed” and a “textbook example of a poorly done trial”.

The dispute led to mass resignations and an exchange of insults so intense that in emails seen by The Times one scientist referred to another as a “disgusting old fart neoliberal hypocrite”.

An entire edition of a health journal was devoted yesterday to attacking a landmark study called the Pace trial, published in The Lancet in 2011. It claimed to show that people with chronic fatigue syndrome (CFS) could improve their condition with simple lifestyle changes.

This has formed the basis of treatment of the condition, also known as myalgic encephalomyelitis (ME), in Britain, but provoked a backlash among some sufferers who feared that it implied the illness had a psychological rather than physiological origin. Others said that exercise, far from helping, made them worse. Academics have criticised the trial too, particularly after a freedom of information request revealed all the patient data. Some have argued that it showed the statistical methods were flawed, and that the criteria for deeming the trial a success were changed midway through.

The editors of the Journal of Health Psychology said it was clear that “the results are, at best, unreliable, and at worst manipulated to produce a positive-looking outcome”. They did not justify the “extraordinary sum” charged to taxpayers.

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See also:

The Times article, by Oliver Moody, Tom Whipple, 1 Aug 2017: Behind the story – A battle of prescriptions

One lot of scientists is mocked as stooges of a free-market conspiracy to dismantle the welfare state. The other stands accused of marshalling a bloody-minded and ideologically driven “witch-hunt”.How did an argument about a clinical trial become so personal?

The first thing to understand is that chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME), is a very real and traumatic illness affecting about a quarter of a million Britons.

Mail online article, by Stephen Matthews, 1 Aug 2017: ‘Disgusting old fart, neoliberal hypocrite’: Angry scientists throw insults at each other over the results of a £5 million taxpayer-funded study into chronic fatigue syndrome

  • One journal dedicated its August edition to ripping apart the ‘unreliable’ trial
  • The PACE study was published in The Lancet in 2011 – but was ridiculed by many
  • It claimed to show those affected could improve with simple lifestyle changes
  • The Journal of Health Psychology launched a scathing attack on the British study
  • Three editors resigned before its ‘unacceptably one-sided’ issue was published
  • But a co-editor hit back and called one ‘disgusting’ and told him to f*** off

Science media centre blog post, 31 Jul 2017: expert reaction to Journal of Health Psychology’s Special Issue on The PACE Trial

Prof. Malcolm Macleod, Professor of Neurology and Translational Neuroscience, University of Edinburgh, said:

“The PACE trial, while not perfect, provides far and away the best evidence for the effectiveness of any intervention for chronic fatigue; and certainly is more robust than any of the other research cited. Reading the criticisms, I was struck by how little actual meat there is in them; and wondered where some of the authors came from. In fact, one of them lists as an institution a research centre (Soerabaja Research Center) which only seems to exist as an affiliation on papers he wrote criticising the PACE trial.

“Their main criticisms seem to revolve around the primary outcome was changed halfway through the trial: there are lots of reasons this can happen, some justifiable and others not; the main think is whether it was done without knowledge of the outcomes already accumulated in the trial and before data lock – which is what was done here.

“So I don’t think there is really a story here, apart from a group of authors, some of doubtful provenance, kicking up dust about a study which has a few minor wrinkles (as all do) but still provides information reliable enough to shape practice. If you substitute ‘CFS’ for ‘autism’ and ‘PACE trial’ for ‘vaccination’ you see a familiar pattern…”

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inews blog post, by Paul Gallagher, 1 Aug 2017: ‘You’re a disgusting old fart neoliberal hypocrite’ – scientists in furious row over ME study

A furious row has erupted between scientists after a medical journal dedicated its entire August edition to ripping apart a “deeply flawed” £5m taxpayer-funded study investigating treatments for chronic fatigue syndrome (CFS).

The dispute led to three editors at the Journal of Health Psychology (JHP), who are all scientists, resigning. Professor George Davey Smith resigned before this month’s issue of the journal, which criticised the “extraordinary sum” of the study, was published. It is unsure how long the clinical epidemiologist, based at Bristol University, had been on the board for before leaving his post.

He said the journal displayed “unacceptable one-sidedness”, but an upset co-editor of the journal hit back. James Coyne told Professor Davey Smith to “f*** off” for his “attempted bullying”, leaked emails obtained by The Times show.

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Researchers identify biomarkers associated with CFS severity

Posted on 08/02/2017 by wames

Stanford Medicine News Center press release, by Bruce Goldman, 31 July 2017: Researchers identify biomarkers associated with chronic fatigue syndrome severity

Stanford investigators used high-throughput analysis to link inflammation to chronic fatigue syndrome, a difficult-to-diagnose disease with no known cure.

Researchers at the Stanford University School of Medicine have linked chronic fatigue syndrome to variations in 17 immune-system signaling proteins, or cytokines, whose concentrations in the blood correlate with the disease’s severity.

The findings provide evidence that inflammation is a powerful driver of this mysterious condition, whose underpinnings have eluded researchers for 35 years.

The findings, described in a study published online July 31 in the Proceedings of the National Academy of Sciences, could lead to further understanding of this condition and be used to improve the diagnosis and treatment of the disorder, which has been notably difficult.

More than 1 million people in the United States suffer from chronic fatigue syndrome, also known as myalgic encephomyelitis and designated by the acronym ME/CFS. It is a disease with no known cure or even reliably effective treatments. Three of every four ME/CFS patients are women, for reasons that are not understood. It characteristically arises in two major waves: among adolescents between the ages of 15 and 20, and in adults between 30 and 35. The condition typically persists for decades.

“Chronic fatigue syndrome can turn a life of productive activity into one of dependency and desolation,” said Jose Montoya, MD, professor of infectious diseases, who is the study’s lead author. Some spontaneous recoveries occur during the first year, he said, but rarely after the condition has persisted more than five years.

The study’s senior author is Mark Davis, PhD, professor of immunology and microbiology and director of Stanford’s Institute for Immunity, Transplantation and Infection.

‘Solid basis for a diagnostic blood test’

“There’s been a great deal of controversy and confusion surrounding ME/CFS — even whether it is an actual disease,” said Davis. “Our findings show clearly that it’s an inflammatory disease and provide a solid basis for a diagnostic blood test.”

Many, but not all, ME/CFS patients experience flulike symptoms common in inflammation-driven diseases, Montoya said. But because its symptoms are so diffuse —sometimes manifesting as heart problems, sometimes as mental impairment nicknamed “brain fog,” other times as indigestion, diarrhea, constipation, muscle pain, tender lymph nodes and so forth — it often goes undiagnosed, even among patients who’ve visited a half-dozen or more different specialists in an effort to determine what’s wrong with them.

Montoya, who oversees the Stanford ME/CFS Initiative, came across his first ME/CFS patient in 2004, an experience he said he’s never forgotten.

 “I have seen the horrors of this disease, multiplied by hundreds of patients,” he said. “It’s been observed and talked about for 35 years now, sometimes with the onus of being described as a psychological condition. But chronic fatigue syndrome is by no means a figment of the imagination. This is real.”

Antivirals, anti-inflammatories and immune-modulating drugs have led to symptomatic improvement in some cases, Montoya said. But no single pathogenic agent that can be fingered as the ultimate ME/CFS trigger has yet been isolated, while previous efforts to identify immunological abnormalities behind the disease have met with conflicting and confusing results.

Still, the sporadic effectiveness of antiviral and anti-inflammatory drugs has spurred Montoya to undertake a systematic study to see if the inflammation that’s been a will-o’-the-wisp in those previous searches could be definitively pinned down.

To attack this problem, he called on Davis, who helped create the Human Immune Monitoring Center. Since its inception a decade ago, the center has served as an engine for large-scale, data-intensive immunological analysis of human blood and tissue samples. Directed by study co-author Holden Maecker, PhD, a professor of microbiology and immunology, the center is equipped to rapidly assess gene variations and activity levels, frequencies of numerous immune cell types, blood concentrations of scores of immune proteins, activation states of intercellular signaling models, and more on a massive scale.

Finding patterns
This approach is akin to being able to look for and find larger patterns — analogous to whole words or sentences — in order to locate a desired paragraph in a lengthy manuscript, rather than just try to locate it by counting the number of times in which the letter A appears in every paragraph.

The scientists analyzed blood samples from 192 of Montoya’s patients, as well as from 392 healthy control subjects. The average age of patients and controls was about 50. Patients’ average duration of symptoms was somewhat more than 10 years.

Importantly, the study design took into account patients’ disease severity and duration. The scientists found that some cytokine levels were lower in patients with mild forms of ME/CFS than in the control subjects, but elevated in ME/CFS patients with relatively severe manifestations. Averaging the results for patients versus controls with respect to these measures would have obscured this phenomenon, which Montoya said he thinks may reflect different genetic predispositions, among patients, to progress to mild versus severe disease.

When comparing patients versus control subjects, the researchers found that only two of the 51 cytokines they measured were different. Tumor growth factor beta was higher and resistin was lower in ME/CFS patients. However, the investigators found that the concentrations of 17 of the cytokines tracked disease severity. Thirteen of those 17 cytokines are pro-inflammatory.

TGF-beta is often thought of as an anti-inflammatory rather than a pro-inflammatory cytokine. But it’s known to take on a pro-inflammatory character in some cases, including certain cancers. ME/CFS patients have a higher than normal incidence of lymphoma, and Montoya speculated that TGF-beta’s elevation in ME/CFS patients could turn out to be a link.

One of the cytokines whose levels corresponded to disease severity, leptin, is secreted by fat tissue. Best known as a satiety reporter that tells the brain when somebody’s stomach is full, leptin is also an active pro-inflammatory substance. Generally, leptin is more abundant in women’s blood than in men’s, which could throw light on why more women than men have ME/CFS.

More generally speaking, the study’s results hold implications for the design of future studies of disease, including clinical trials testing immunomodulatory drugs’ potential as ME/CFS therapies.

“For decades, the ‘case vs. healthy controls’ study design has served well to advance our understanding of many diseases,” Montoya said. “However, it’s possible that for certain pathologies in humans, analysis by disease severity or duration would be likely to provide further insights.”

Other Stanford co-authors of the study are clinical research coordinator Jill Anderson; Tyson Holmes, PhD, senior research engineer at the Institute for Immunity, Transplantation and Infection; Yael Rosenberg-Hasson, PhD, immunoassay and technical director at the institute; Cristina Tato, PhD, MPH, research and science analyst at the institute; former study coordinator Ian Valencia; and Lily Chu, MSHS, a board member of the Stanford University ME/CFS Initiative.

The study was funded by the National Institutes of Health (grant U19AI057229), the Stanford ME/CFS Initiative Fund and an anonymous donor.

Stanford’s departments of Medicine and of Microbiology and Immunology also supported the work.

Reaction to the study:

The Telegraph: ‘Yuppie flu’ an inflammatory disease which blood test could easily diagnose, say scientists

New Scientist: Blood biomarkers may help diagnose chronic fatigue syndrome

Medscape: New Chronic Fatigue Syndrome Biomarkers in the Pipeline

Sciencemag: More clues link immune system imbalance with chronic fatigue syndrome

Shots, Health News From NPR, by Miriam E. Tucker, 31 Jul 2017: Scientists Edge Closer To Elusive Lab Test For ‘Chronic Fatigue Syndrome’

Science alert blog post, by Signe Dean, 1 Aug 2017: We’ve Found Even More Proof That Chronic Fatigue Syndrome Is a Real Disease

Reuters Health News, by Lisa Rapaport, 31 July 2017: Molecular profile hints at inflammatory processes in chronic fatigue

Science media centre: expert reaction to cytokines for Chronic Fatigue Syndrome

Science daily: Chronic fatigue syndrome: Biomarkers linked to severity identified

Smithsonian mag blog post, by Ben Panko: New Study Gives Hope to Victims of Chronic Fatigue Syndrome

Futurism blog post, by Karla Lant, 3 Aug 2017: We Might Be Closer to a Lab Test for Chronic Fatigue Syndrome

 

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Cytokine signature associated with disease severity in CFS patients

Posted on 08/02/2017 by wames

Cytokine signature associated with disease severity in chronic fatigue syndrome patients, by Jose G. Montoyaa, Tyson H. Holmes, Jill N. Anderson, Holden T. Maecker, Yael Rosenberg-Hasson, Ian J. Valencia, Lily Chu, Jarred W. Younger, Cristina M. Tato, and Mark M. Davis in PNAS July 31, 2017

Significance:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) devastates the lives of millions of people and has remained a mystery illness despite decades of research. It has long been suspected that inflammation is central to its pathogenesis.

Although only two cytokines were found to be different (TGF-β higher and resistin lower) in ME/CFS patients compared with controls, 17 cytokines correlated with ME/CFS severity. Thirteen of these cytokines are proinflammatory and may contribute to many of the symptoms these patients experience for several years. Only CXCL9 (MIG) inversely correlated with fatigue duration.

Research abstract:

Although some signs of inflammation have been reported previously in patients with myalgic encephalomyelitis or chronic fatigue syndrome (ME/CFS), the data are limited and contradictory. High-throughput methods now allow us to interrogate the human immune system for multiple markers of inflammation at a scale that was not previously possible. To determine whether a signature of serum cytokines could be associated with ME/CFS and correlated with disease severity and fatigue duration, cytokines of 192 ME/CFS patients and 392 healthy controls were measured using a 51-multiplex array on a Luminex system.

Each cytokine’s preprocessed data were regressed on ME/CFS severity plus covariates for age, sex, race, and an assay property of newly discovered importance: nonspecific binding. On average, TGF-β was elevated (P = 0.0052) and resistin was lower (P = 0.0052) in patients compared with controls. Seventeen cytokines had a statistically significant upward linear trend that correlated with ME/CFS severity:

CCL11 (Eotaxin-1), CXCL1 (GROα), CXCL10 (IP-10), IFN-γ, IL-4, IL-5, IL-7, IL-12p70, IL-13, IL-17F, leptin, G-CSF, GM-CSF, LIF, NGF, SCF, and TGF-α. Of the 17 cytokines that correlated with severity, 13 are proinflammatory, likely contributing to many of the symptoms experienced by patients and establishing a strong immune system component of the disease. Only CXCL9 (MIG) inversely correlated with fatigue duration.

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Muscle injections with lidocaine improve resting fatigue and pain in patients with CFS

Posted on 08/01/2017 by wames

Research abstract:

Muscle injections with lidocaine improve resting fatigue and pain in patients with chronic fatigue syndrome, by Roland Staud, Taylor Kizer, Michael E Robinson in Journal of Pain Research, Vol. 2017, #10, pp 1477-1486 [June 26, 2017]

Objective

Patients with chronic fatigue syndrome (CFS) complain of long-lasting fatigue and pain which are not relieved by rest and worsened by physical exertion. Previous research has implicated metaboreceptors of muscles to play an important role for chronic fatigue and pain.

Therefore, we hypothesized that blocking impulse input from deep tissues with intramuscular lidocaine injections would improve not only the pain but also fatigue of CFS patients.

Methods

In a double-blind, placebo-controlled study, 58 CFS patients received

20 mL of 1% lidocaine (200 mg) or normal saline once into both trapezius and gluteal muscles. Study outcomes included clinical fatigue and pain, depression, and anxiety. In addition, mechanical and heat hyperalgesia were assessed and serum levels of lidocaine were obtained after the injections.

Results

Fatigue ratings of CFS patients decreased significantly more after lidocaine compared to saline injections (p=0.03). In contrast, muscle injections reduced pain, depression, and anxiety (p<0.001), but these changes were not statistically different between lidocaine and saline (p>0.05). Lidocaine injections increased mechanical pain thresholds of CFS patients (p=0.04) but did not affect their heat hyperalgesia.

Importantly, mood changes or lidocaine serum levels did not significantly predict fatigue reductions.

Conclusion

These results demonstrate that lidocaine injections reduce clinical fatigue of CFS patients significantly more than placebo, suggesting an important role of peripheral tissues for chronic fatigue. Future investigations will be necessary to evaluate the clinical benefits of such interventions.

In the media:

Health day: How chronic fatigue syndrome wears patients out by Mary Elizabeth Dallas, 27 July 2017

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Special issue of the Journal of Health Psychology on PACE trial: the making of a medical scandal

Posted on 08/01/2017 by wames

Special issue on the PACE Trial, by David F Marks in The Journal of Health Psychology Vol 22 issue 9 2017 [published online 31 July 2017]

Download as pdf

Abstract:

We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It reveals an unwillingness of the co-principal investigators of the PACE trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.

Concept

The Journal of Health Psychology received a submission in the form of a critical review of one of the largest psychotherapy trials ever done, the PACE Trial. PACE was a trial of therapies for patients with myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS), a trial that has been associated with a great deal of controversy (Geraghty, 2016). Following publication of the critical paper by Keith Geraghty (2016), the PACE Trial investigators responded with an Open Peer Commentary paper (White et al., 2017). The review and response were sent to more than 40 experts on both sides of the debate for commentaries.

The resulting collection is rich and varied in the perspectives it offers from a neglected point of view. Many of the commentators should be applauded for their courage, resilience and ‘insider’ understanding of experience with ME/CFS.

The Editorial Board wants to go on record that the PACE Trial investigators and their supporters were given numerous opportunities to participate, even extending the possibility of appeals and re-reviews when they would not normally be offered. That they failed to respond appropriately is disappointing.

What transpired
Commentaries were invited from an equal number of individuals on both sides of the debate (about 20 from each side of the debate). Many more submissions arrived from the PACE Trial critics than from the pro-PACE side of the debate. All submissions were peer reviewed and judged on merit.

The PACE Trial investigators’ defence of the trial was in a template format that failed to engage with critics. Before submitting their reply, Professors Peter White, Trudie Chalder and Michael Sharpe wrote to me as co-principal investigators of the PACE trial to seek a retraction of sections of Geraghty’s paper, a declaration of conflicts of interest (COI) by Keith Geraghty on the grounds that he suffers from ME/CFS, and publication of their response without peer review (White et al., 4 November 2016, email to David F Marks). All three requests were refused.

On the question of COI, the PACE authors themselves appear to hold strong allegiances to cognitive behavioural therapy (CBT) and graded exercise therapy (GET) – treatments they developed for ME/CFS. Stark COI have been exposed by the commentaries including the PACE authors themselves who hold a double role as advisers to the UK Government Department of Work and Pensions (DWP), a sponsor of PACE, while at the same time working as advisers to large insurance companies who have gone on record about the potential financial losses from ME/CFS being deemed a long-term physical illness. In a further twist to the debate, undeclared COI of Petrie and Weinman (2017) were alleged by two of the commentators (Agardy, 2017; Lubet, 2017). Professors Weinman and Petrie adamantly deny that their work as advisers to Atlantis Healthcare represents a COI:

We are very clear that there is not a COI that we need to declare. We have had nothing to do with the PACE trial and neither of us work on CFS. Our Atlantis link does not provide any conflicts as Atlantis focuses on supporting patient adherence to medication for various long term conditions, and has not had any involvement with patients with CFS. (Weinman and Petrie, 9 May 2017, email to David F Marks)

After the online publication of several critical Commentaries, Professors White, Sharpe, Chalder and 16 co-authors were offered a further opportunity to respond to their critics in the round but they chose not to do so. They wrote: As always, we would refer interested readers to our original publications and trial website where most, if not all, the issues brought up by commentators are addressed (Chalder and Sharpe, 12 May 2017, email to David F Marks).

After peer review, authors were invited to revise their manuscripts in response to reviewer feedback and many made multiple drafts. The outcome is a set of robust papers that should stand the test of time and offer significant new light on what went wrong with the PACE Trial that has been of such high significance for the nature of treatment protocols. It is disappointing that what has been the more dominant other side refused to participate.

Unfortunately, across the pro-PACE group of authors there was a consistent pattern of resistance to the debate. After receiving critical reviews, the pro-PACE authors chose to make only cosmetic changes or not to revise their manuscripts in any way whatsoever. They appeared unwilling to enter into the spirit of scientific debate. They acted with a sense of entitlement not to have to respond to criticism. Two pro-PACE authors even showed disdain for ME/CFS patients, stating: We have no wish to get into debates with patients. In another instance, three pro-PACE authors attempted to subvert the journal’s policy on COI by recommending reviewers who were strongly conflicted, forcing rejection of their paper.

The dearth of pro-PACE manuscripts to start off with (five submissions), the poor quality, the intransigence of authors to revise and the unavoidable rejection of three pro-PACE manuscripts led to an imbalance in papers between the two sides. However, this editor was loathe to compromise standards by publishing unsound pieces in spite of the pressure to go ahead and publish from people who should know better.

What next?
We are proud that this issue marks a special contribution by the Journal of Health Psychology to the literature concerning interventions to manage adaptation to chronic health problems. The PACE Trial debate reveals deeply embedded differences between critics and investigators. It also reveals an unwillingness of the co-principal investigators of the PACE trial to engage in discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5 million) on what is a textbook example of a poorly done trial.

ME/CFS research has been poorly served by the PACE Trial and a fresh new approach to treatment is clearly warranted. On the basis of this Special Issue, readers can make up their own minds about the scientific merits and demerits of the PACE Trial. It is to be hoped that the debate will provide a more rational basis for evidence-based improvements to the care pathway for hundreds of thousands of patients.

David F Marks
Editor
editorjhp@gmail.com

References
Agardy S (2017) Chronic fatigue syndrome patients have no reason to accept the PACE trial results: Response to Keith J Petrie and John Weinman. Journal of Health Psychology 22(9): 1206–1208.  Abstract

Geraghty KJ (2016) ‘PACE-Gate’: When clinical trial evidence meets open data access. Journal of Health Psychology 22(9): 1106–1112.

Lubet S (2017) Defense of the PACE trial is based on argumentation fallacies. Journal of Health Psychology 22(9): 1201–1205.  Abstract

Petrie K, Weinman J (2017) The PACE trial: It’s time to broaden perceptions and move on. Journal of Health Psychology 22(9): 1198–1200. Abstract

White PD, Chalder T, Sharpe M, . (2017) Response to the editorial by Dr Geraghty. Journal of Health Psychology 22(9): 1113–1117.  Abstract

Press release, by David F Marks, 29 July 2017: The PACE trial: the making of a medical scandal [published on Prof Coyne’s blog]

The PACE trial debate illustrates what can happen when researchers become entrenched in a particular point of view, and fail to engage in constructive exchange with critics and stakeholders. It reveals an unwillingness of the Co-Principal Investigators of the trial to engage in authentic discussion and debate. It leads one to question the wisdom of such a large investment from the public purse (£5million) on what is a textbook example of a poorly done trial.

Quick thoughts blog post, Prof James C Coyne, 31 Jul 2017: What to look for in the Special Issue of Journal of Health Psychology concerning the PACE trial

 

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Even “minor” infections can cause ME/CFS

Posted on 07/31/2017 by wames

Simmaron Research blog post, by Cort Johnson, 5 July 2017: Even “Minor” Infections Can Cause Chronic Fatigue Syndrome (ME/CFS)

Giardia hasn’t historically ranked high as a potential cause of chronic fatigue syndrome (ME/CFS). Some anecdotal reports suggest that a Giardia outbreak may have occurred prior to the Incline Village ME/CFS outbreak in the 1980’s. More recently, Corinne Blandino’s severe, decades long case of ME/CFS – which originated with an exposure to Giardia at work – demonstrated how devastating a case of Giardia triggered ME/CFS can be.

It wasn’t until city in Norway got exposed to Giardia in 2004, however, that Giardia, a protozoa, became one of the pathogens definitively linked with chronic fatigue syndrome (ME/CFS). Large studies (n=1254) examining the aftermath of the outbreak in a public water system in Bergen found that five years later, almost 50% of those originally infected still had symptoms of irritable bowel syndrome and/or chronic fatigue (post-infectious chronic fatigue).

“Other patients suffer a severe, long lasting illness, for which treatment is ineffectual, and even after the parasite has finally been eliminated, some sequelae persist, affecting quality of life and continuing to cause the patient discomfort or pain” (LJ Robertson et al, 2010)

Five percent suffered from fatigue severe enough for them to lose employment or be unable to continue their education. Interestingly, all had taken anti-parasitic drugs and all had apparently cleared the pathogen from their systems.  Five years later, 30% were deemed to have an ME/CFS-like illness and almost 40% had irritable bowel syndrome  (IBS).

The Giardia ‘Syndrome’ Strikes: Norwegian Studies Suggest ‘Minor Bugs’ May Commonly Trigger Chronic Fatigue Syndrome As Well

“Minor” Infection – Sometimes Serious Results
By all accounts Giardia shouldn’t be doing this. Giardia is not normally considered a serious infection. Most people have some diarrhea and pass the bug quickly – and if they don’t, antibiotics are usually (but not always) effective. Giardia, seemingly, produces the kind of “minor” infection that our medical system doesn’t spend much time on.

The Mayo Clinic reports that Giardia infection (giardiasis) is one of the most common causes of waterborne illness in the United States. The parasites are found in backcountry streams and lakes throughout the U.S., but can also be found in municipal water supplies, swimming pools, whirlpool spas and wells. Giardia infection can be transmitted through food and person-to-person contact.

Research studies are slowly revealing that the effects of even vanquished Giardia infections can be long lasting for some. The Mayo Clinic reports that intestinal problems such as lactose intolerance  may be present long after the parasites are gone. (Even though half a dozen studies have been published on the Bergen outbreak, Mayo fails to note that long term issues with fatigue and pain (or ME/CFS) may result).

The Bergen studies indicate, however, that this rather common infection worldwide can cause long term and even at times debilitating fatigue as well. The takeaway lesson from the Bergen studies is that one doesn’t need to have mono, Ross-River virus or Valley fever or any of several serious infections to get seriously afflicted. As Dr. Chia has been saying about enteroviruses for years, any minor infection has the potential to cause ME/CFS in the right person.

Read more about the research into Giardia and ME/CFS 

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In memory of Dr Bruce Carruthers

Posted on 07/28/2017 by wames

Phoenix rising blog post: In memory of Dr Bruce Carruthers

Sherri Todd, has informed us of the passing of Dr. Bruce Carruthers. Dr. Carruthers is one of the two doctors who did the original drafts of the Canadian Clinical Definitions from which the medical panels worked to make the final definitions which became know as “The Canadian Definitions”.

Read the tributes

Obituary in Vancouver Sun, 29 July 2017
 

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WAMES challenges NICE’s reason not to update the CFS/ME guidelines

Posted on 07/26/2017 by wames

WAMES sent our response to the NICE consultation on Monday 24th July 2017.

NICE asked: Do you agree with the proposal not to update the guideline?

WAMES replied:

We believe the NICE Guidance CG53 on CFS/ME omits guidelines on key issues, includes guidance that is potentially harmful and is misleading to both patients and clinicians. It is in need of urgent revision.

The decision not to review the guidelines has been taken on the basis that evidence in other trials support the original PACE trial results. No consideration has been given to the flaws that are common to all these trials.

i) broad patient selection criteria, ignoring the possibility of subgroups requiring different management approaches and ignoring the wide range of severity experienced by patients, or the possible differences between children and adults or men and women – research has repeatedly been shown that different criteria identifies different groups of patients and reduces the usefulness of research results e.g. Baraniuk,  Johnston  Nacul & Jason;

ii)    measuring only subjective outcomes;

iii)  the lack of double-blind, randomised, placebo-controlled trials, especially as some trials have actively sought to influence the results by promoting their approach as ‘the most effective therapies’;

iv)   assumptions about the nature of the illness, the factors that sustain it and the suitability of exercise therapy which are contradicted by scientific research into the illness.

We go on to challenge the decision to overlook the failings of the PACE trial and to call for stricter assessment of it and similar trials, by the Cochrane review panel. They should also take into account patient experience, and growing research evidence into the nature of the illness, the effect of exercise on the body and the way the post exertional response affects multiple symptoms.

Topics we believe are missing from the guidelines include:

  • help for healthcare and social care professionals to give ongoing care and management advice to patients who do not improve, who remain ill over a long period and who are severely affected
  • the difference between CBT aimed at changing negative illness beliefs and CBT designed to help people adapt and cope better with the limitations of the illness
  • Pharmacological interventions e.g. the use of amitriptyline for pain

We fear that a failure to update the Guideline will simply drive a bigger wedge between the medical and the patient communities, who do not find it a valuable or believable resource.

Read our full response

Read more about the consultation and the NICE proposal

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Another ‘False Start’ in ME/CFS Clinical Trials: The GETSET Study

Posted on 07/25/2017 by wames

Another ‘False Start’ in ME/CFS Clinical Trials: The GETSET Study, by Todd E. Davenport, PT, DPT, MPH, OCS

I am a physical therapist, and movement is my medicine. Some people might need more movement, in the form of an exercise program, while some people might need less movement, in the form of a pacing program.

I rely on scientific studies to help me decide who might benefit from which kind of treatment. Science helps me assign probabilities to outcomes, which I can then use to work with my patients collaboratively to establish the best possible treatment program to help them meet their goals. Reliable data from valid scientific studies can help me be more confident as a clinician that the decisions I make together with my patients actually will help them.

After starting my research career conducting clinical studies related to other fatiguing health conditions, I’ve now worked in the field of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) for over 10 years.

During that time, I’ve been fortunate to work with a caring and dedicated group of scientists and advocates. To say that the body of intervention studies in ME/CFS has involved disappointingly (and sometimes breathtakingly!) poor science is an understatement. The trend of poorly designed intervention studies, most recently headlined by the PACE trial, has just led to reinforcement of erroneous perceptions about ME/CFS without providing the tools necessary for clinicians like me to help ameliorate the devastating impact of ME/CFS on real peoples’ lives. So, it was with great interest that I read the GETSET study, which was recently published in the Lancet.

All the things that made me uneasy as a physical therapist about the PACE trial are back, now in the form of a study involving a slick self-help guide. It’s the same confirmation bias of telling folks to move in the context of a graded exercise program, and then having them parrot back the study hypothesis on standardized questionnaires. It’s the same absence of objective activity measures that result in the same self-fulfilling prophecy of telling people to move more, and then declaring victory when some of them are actually able to do it. It’s the same disregard for foundational scientific evidence of aerobic system compromise, immune activation, and other forms of organic pathophysiology in favor of a behavioral approach to ‘tell the tired people to move more.’

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Todd Davenport is Associate Professor and Program Director: Department of Physical Therapy, University of the Pacific, Stockton, CA Clinical and Research Consultant: Workwell Foundation, Ripon, CA

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Further commentary on the PACE trial: Biased methods & unreliable outcomes

Posted on 07/25/2017 by wames

Article abstract:

Further commentary on the PACE trial: Biased methods and unreliable outcomes, by
Keith J Geraghty in Journal of Health Psychology [First Published June 14, 2017]

Geraghty in the year 2016, outlines a range of controversies surrounding publication of results from the PACE trial and discusses a freedom of information case brought by a patient refused access to data from the trial. The PACE authors offer a response, writing ‘Dr Geraghty’s views are based on misunderstandings and misrepresentations of the PACE trial’.

This article draws on expert commentaries to further detail the critical methodological failures and biases identified in the PACE trial, which undermine the reliability and credibility of the major findings to emerge from this trial.

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