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.’

Read more

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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CFS prevalence is grossly overestimated using Oxford criteria compared to CDC (Fukuda) criteria in a US population study

Posted on 07/24/2017 by wames

Research abstract:

Chronic fatigue syndrome prevalence is grossly overestimated using Oxford criteria compared to Centers for Disease Control (Fukuda) criteria in a U.S. population study, by James N. Baraniuk in Fatigue: Biomedicine, Health & Behavior [Published online: 21 Jul 2017]

Background:
Results from treatment studies using the low-threshold Oxford criteria for recruitment may have been overgeneralized to patients diagnosed by more stringent chronic fatigue syndrome (CFS) criteria.

Purpose:
To compare the selectivity of Oxford and Fukuda criteria in a U.S. population.

Methods
Fukuda (Center for Disease Control (CDC)) criteria, as operationalized with the CFS Severity Questionnaire (CFSQ), were included in the nationwide rc2004 HealthStyles survey mailed to 6175 participants who were representative of the U.S. 2003 Census population. The 9 questionnaire items (CFS symptoms) were crafted into proxies for Oxford criteria (mild fatigue, minimal exclusions) and Fukuda criteria (fatigue plus ≥4 of 8 ancillary criteria at moderate or severe levels with exclusions). The comparative prevalence estimates of CFS were then determined. Severity scores for fatigue were plotted against the sum of severities for the eight ancillary criteria. The four quadrants of scatter diagrams assessed putative healthy controls, CFS, chronic idiopathic fatigue (CIF), and CFS-like with insufficient fatigue subjects.

Results:
The Oxford criteria designated CFS in 25.5% of 2004 males and 19.9% of 1954 females. Based on quadrant analysis, 85% of Oxford-defined cases were inappropriately classified as CFS. Fukuda criteria identified CFS in 2.3% of males and 1.8% of females.

Discussion
CFS prevalence using Fukuda criteria and quadrant analysis was near the upper limits of previous epidemiology studies. The CFSQ may have utility for on-line and outpatient screening. The Oxford criteria were untenable because they inappropriately selected healthy subjects with mild fatigue and CIF and mislabeled them as CFS.

 

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Neuroendocrine disorder in CFS

Posted on 07/21/2017 by wames

Research abstract:

Neuroendocrine disorder in chronic fatigue syndrome, by Slavica TOMIC, Snezana BRKIC, Dajana LENDAK, Daniela MARIC, Milica MEDIC STOJANOSKA, Aleksandra NOVAKOV MIKIC in Turkish Journal of Medical Sciences (2017) 47: sag-1601-110  [Published Online: 17 Dec 2016]

Background/aim:

Neuroendocrine disorders are considered a possible pathogenetic mechanism in chronic fatigue syndrome (CFS). The aim of our study was to determine the function of the hypothalamic–pituitary–adrenal axis (HPA) and thyroid function in women of reproductive age suffering from CFS.

Materials and methods:

The study included 40 women suffering from CFS and 40 healthy women (15–45 years old). Serum levels of cortisol (0800 and 1800 hours), ACTH, total T4, total T3, and TSH were measured in all subjects. The Fibro Fatigue Scale was used for determination of fatigue level.

Results:

Cortisol serum levels were normal in both groups. The distinctively positive moderate correlation of morning and afternoon cortisol levels that was observed in healthy women was absent in the CFS group. This may indicate a disturbed physiological rhythm of cortisol secretion. Although basal serum T4, T3, and TSH levels were normal in all subjects, concentrations of T3 were significantly lower in the CFS group.

Conclusion:

One-time hormone measurement is not sufficient to detect hormonal imbalance in women suffering from CFS. Absence of a correlation between afternoon and morning cortisol level could be a more representative factor for detecting HPA axis disturbance.

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CBT & objective assessments in CFS

Posted on 07/21/2017 by wames

The Journal of Health Psychology has published a short analysis by Graham McPhee on the way that real/objective assessments show that CBT gives no boost to ME/CFS. This is a video to introduce it: Objective Evidence & CFS

Article abstract:

Cognitive behaviour therapy and objective assessments in chronic fatigue syndrome, by Graham McPhee in Journal of Health Psychology [First Published June 19, 2017]

Most evaluations of cognitive behavioural therapy to treat people with chronic fatigue syndrome/myalgic encephalomyelitis rely exclusively on subjective self-report outcomes to evaluate whether treatment is effective. Few studies have used measures appropriate to assessing whether cognitive behavioural therapy changes in more objective measures.

A review of studies incorporating objective measures suggests that there is a lack of evidence that cognitive behavioural therapy produces any improvement in a patient’s physical capabilities or other objective measures such as return to work.

Future studies of chronic fatigue syndrome/myalgic encephalomyelitis should include some objective assessments as primary outcomes. If this is to include activity monitors, we first need a sound baseline dataset.

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