The profile of circulating microRNAs in ME & their relation to symptom severity, & disease pathophysiology

Posted on 11/25/2020 by wames

Profile of circulating microRNAs in myalgic encephalomyelitis and their relation to symptom severity, and disease pathophysiology, by Evguenia Nepotchatykh, Wesam Elremaly, Iurie Caraus, Christian Godbout, Corinne Leveau, Lynda Chalder, Catherine Beaudin, Emi Kanamaru, Renata Kosovskaia, Shawn Lauzon, Yanick Maillet, Anita Franco, Viorica Lascau-Coman, Saadallah Bouhanik, Yaned Patricia Gaitan, Dawei Li & Alain Moreau in Scientific Reports volume 10, no. 19620 (2020) 12 Nov 2020

 

Abstract:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex chronic disease, rooted in multi-system dysfunctions characterized by unexplained debilitating fatigue. Post-exertional malaise (PEM), defined as the exacerbation of the patient’s symptoms following minimal physical or mental stress, is a hallmark of ME/CFS. While multiple case definitions exist, there is currently no well-established biomarkers or laboratory tests to diagnose ME/CFS.

Our study aimed to investigate circulating microRNA expression in severely ill ME/CFS patients before and after an innovative stress challenge that stimulates PEM.

Our findings highlight the differential expression of eleven microRNAs associated with a physiological response to PEM. The present study uncovers specific microRNA expression signatures associated with ME/CFS in response to PEM induction and reports microRNA expression patterns associated to specific symptom severities.

The identification of distinctive microRNA expression signatures for ME/CFS through a provocation challenge is essential for the elucidation of the ME/CFS pathophysiology, and lead to accurate diagnoses, prevention measures, and effective treatment options.

 

CTV News: Montreal researchers develop new test to diagnose chronic fatigue syndrome

“We based our test on the cardinal symptom of the disease, which is discomfort after exertion,” said Moreau. “This is really what is most specific to myalgic encephalomyelitis.”

The test could also allow patients to be grouped into subgroups, in order not only to better understand the molecular mechanisms involved in certain symptoms but also to better select patients who could benefit from certain treatments.

“It becomes more interesting for both trying to work with more homogeneous subgroups to understand the disease and see what explains the severity or all of the symptoms,” said Moreau. “It may speed up research to better understand the disease.”

Finally, the test could allow early detection of patients in whom ME is developing, so that they can start treating them as quickly as possible.

OMF: Montréal ME/CFS Research Center Paper Published in Scientific Reports

MicroRNAs can represent potential indicators for diseases such as ME/CFS, and changes in microRNA expression could indicate cellular dysfunction and degeneration. Using a test to induce mild-but-reproducible Post Exertional Malaise (PEM), our team has so far uncovered and validated 11 different microRNAs associated with ME/CFS that are capable of differentiating ME/CFS patients from healthy patients — with 90 percent accuracy! 

This post-exertional stress challenge provoking PEM in ME/CFS patients has helped us gain unprecedented insight into the pathophysiology of ME/CFS. Based on the 11 different microRNA signatures discovered in ME/CFS, machine learning algorithms have also led to the classification of ME/CFS patients into four clusters associated with symptom severity.

These exciting results could lead to the development of a new, non-invasive diagnostic test for ME/CFS, a prognostic tool used to predict future cases, and identification of effective treatment options.

The Scientist: Blood MicroRNA Patterns Linked to Chronic Fatigue Syndrome

To Williams, the major value of the study lies in an analysis Moreau’s team conducted with the microRNA data that untangles the molecular pathways the 11 sequences are involved in.

This revealed that 7 out of the 11 microRNAs were involved in regulating immune functions, which “certainly fits with one arm of the research that suggests that immune activation is very important in leading to chronic fatigue,” she says.

An additional network analysis flagged the key genes each microRNA is associated with and other diseases they’ve been linked to, which included viral infection, sleep disorders, and cognitive impairments. “Using a network approach, you can start to shed light on which cellular processes are important. And then if that ties in with what we know already about the cellular processes in ME/CFS, then that all begins to paint a bit of a picture.”

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Video: Activity & energy management – Pacing

Posted on 11/25/2020 by wames

Dialogues for a neglected illness: Activity and energy management – Pacing

 

The Dialogues for ME/CFS project (also known as Dialogues for a neglected illness) has produced a new video explaining pacing for health professionals.

“Pacing is an individualized approach to managing physical, cognitive, and emotional energy within a patient’s specific limits by carefully planning where and how to spend their available energy. It is a critical tool to prevent and/or reduce PEM”  [Diagnosing and treating ME/CFS – ME/CFS Clinician Coalition USA July 2020]

“Striking the right balance between activity and rest is one of the most difficult aspects of coming to terms with M.E. On one hand is the need to take an appropriate amount of rest and relaxation, especially during the very early stages, as well as during periods of relapse or an exacerbation of symptoms. On the other is a natural desire to want to increase physical and mental activity when you’re starting to feel that some improvement is, at last, being made.

Achieving the right balance also has to take into account the fact that exceeding your limitations by sometimes only a very small amount can easily cause an exacerbation of symptoms…”        [ME Association website]


Watch video (15 mins) & read transcript 

The video features:

  • Dr Charles Shepherd (GP)
  • Dr Luis Nacul (biobank & researcher)
  • Dr Chris Snell (expert in exercise physiology)
  • Prof Mark VanNess (expert in exercise physiology)
  • Prof Todd Davenport (expert in exercise physiology)
  • 2 patients

From the Dialogues website:

Pacing has sometimes veered towards encouraging incremental increases in activity based on the idea that deconditioning contributes to ME/CFS. However, studies using cardiopulmonary exercise testing (CPET) have demonstrated an impairment in aerobic metabolism in ME/CFS that is not seen in people who are deconditioned.  The use of incremental increases in activity aiming to reduce deconditioning and increase tolerance, is therefore NOT recommended by the exercise scientists in this video. Their repeated CPET shows that when people with ME/CFS ‘push’ themselves or unknowingly keep trying to do too much, their symptoms increase and functional capacity decreases.

For decades, patients have been stigmatised and subjected to pressure to ‘do more’, or ‘try harder’, by society and the medical profession. Media headlines disseminated poor quality research, medical education for ME/CFS has been inaccurate or virtually non-existent and the old (2007) NICE Guideline advised graded exercise therapy (GET) as treatment. These circumstances have been harmful for patients and led to deteriorations in health, prolonged severe disability and social isolation.

In a very welcome turnaround in attitude, the new NICE guideline draft (2020) recognises that GET and treatments that exacerbate symptoms are harmful.

 

Other films from the project:

  • Introduction to ME/CFS
  • Post-Exertional Malaise
  • Severe & Very Severe ME / CFS
  • Graded Exercise Therapy
  • Patients’ Accounts – Symptoms
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Deep phenotyping of ME/CFS in Japanese population

Posted on 11/23/2020 by wames

Deep phenotyping of myalgic encephalomyelitis/chronic fatigue syndrome in Japanese population, by Toshimori Kitami, Sanae Fukuda, Tamotsu Kato, Kouzi Yamaguti, Yasuhito Nakatomi, Emi Yamano, Yosky Kataoka, Kei Mizuno, Yuuri Tsuboi, Yasushi Kogo, Harukazu Suzuki, Masayoshi Itoh, Masaki Suimye Morioka, Hideya Kawaji, Haruhiko Koseki, Jun Kikuchi, Yoshihide Hayashizaki, Hiroshi Ohno, Hirohiko Kuratsune & Yasuyoshi Watanabe in Scientific Reports vol 10, no: 19933 (2020) 16 Nov 2020

 

Research abstract:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a complex and debilitating disease with no molecular diagnostics and no treatment options.

To identify potential markers of this illness, we profiled 48 patients and 52 controls for standard laboratory tests, plasma metabolomics, blood immuno-phenotyping and transcriptomics, and fecal microbiome analysis. Here, we identified a set of 26 potential molecular markers that distinguished ME/CFS patients from healthy controls. Monocyte number, microbiome abundance, and lipoprotein profiles appeared to be the most informative markers.

When we correlated these molecular changes to sleep and cognitive measurements of fatigue, we found that lipoprotein and microbiome profiles most closely correlated with sleep disruption while a different set of markers correlated with a cognitive parameter.

Sleep, lipoprotein, and microbiome changes occur early during the course of illness suggesting that these markers can be examined in a larger cohort for potential biomarker application. Our study points to a cluster of sleep-related molecular changes as a prominent feature of ME/CFS in our Japanese cohort.

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Accurate & objective determination of ME/CFS disease severity with a wearable sensor

Posted on 11/20/2020 by wames

Accurate and objective determination of myalgic encephalomyelitis/chronic fatigue syndrome disease severity with a wearable sensor, by Turner Palombo, Andrea Campos, Suzanne D Vernon, Shad Roundy in J Transl Med. 2020 Nov 10;18(1):423 [doi: 10.1186/s12967-020-02583-7]

 

Research abstract:

Background:

Approximately 2.5 million people in the U.S. suffer from myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS). This disease negatively impacts patients’ ability to function, often resulting in difficulty maintaining employment, sustaining financial independence, engaging socially with others, and in particularly severe cases, consistently and adequately performing activities of daily living. The focus of this research was to develop a sensor-based method to measure upright activity defined as time with feet on the floor and referred to as UpTime, as an indicator of ME/CFS disease severity.

Methods:

A commercially available inertial measurement unit (IMU), the Shimmer, was selected for this research. A Kalman filter was used to convert IMU data collected by the Shimmer to angle estimates. Angle estimate accuracy was confirmed by comparison to a motion capture system. Leg angle estimates were then converted to personalized daily UpTime scores using a critical angle of 39º from vertical to differentiate between upright (feet on the floor) and not upright. A 6-day, case-control study with 15 subjects (five healthy controls, five moderate-level ME/CFS, and five severe-level ME/CFS) was conducted to determine the utility of UpTime for assessing disease severity.

Results:

UpTime was found to be a significant measure of ME/CFS disease severity. Severely ill ME/CFS patients spend less than 20% of each day with feet on the floor. Moderately ill ME/CFS patients spend between 20-30% of each day with feet on the floor. Healthy controls have greater than 30% UpTime. IMU-measured UpTime was more precise than self-reported hours of upright activity which were over-estimated by patients.

The angle of each lower leg is compared to the critical angle (θc) to determine uprightness. Accelerometer measurements (ax, ay, and az) and gyroscope (i.e. angular rate) measurements (p, q, and r) are in the local coordinate frame—x, y, and z. Roll (ϕ) and pitch (θ) are measured using the fixed global coordinate frame—X, Y, and Z

Conclusions:

UpTime is an accurate and objective measure of upright activity, a measure that can be used to assess disease severity in ME/CFS patients. Due to its ability to accurately monitor upright activity, UpTime can also be used as a reliable endpoint for evaluating ME/CFS treatment efficacy. Future studies with larger samples and extended data collection periods are required to fully confirm the use of UpTime as a measure of disease severity in ME/CFS.

With the added perspective of large-scale studies, this sensor-based platform could provide a recovery path for individuals struggling with ME/CFS.

 

Bateman Horne Center: Turning a Self-Report Questionnaire into a Wearable Device, by Suzanne D Vernon

Solve ME/CFS: Defining the Postural Contributors to Post-Exertional Malaise (PEM) in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)

If the proposed measure successfully detects changes in the amount of time in an upright posture, it will then be submitted to the FDA’s biomarker qualification program to qualify it for use in ME/CFS clinical trials. The existence of an FDA qualified biomarker and clinical outcome measure will be an important inducement to researchers and pharmaceutical companies to develop effective treatments.

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Raise funds for WAMES during Black Friday Week with Amazon Smile

Posted on 11/20/2020 by wames

Shopping during Black Friday Week? Use Amazon Smile

Amazon Black Friday Week    20th – 30th November 2020

Fundraise for WAMES when you shop online with Amazon during Black Friday Week.

Discover great deals and when you shop at smile.amazon.co.uk/ch/1144534-0 or via AmazonSmile in the Amazon Shopping app.

AmazonSmile will also donate to WAMES at no extra cost!

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Long Covid: overlap emerges with ME – including debate over treatment

Posted on 11/19/2020 by wames

Guardian article: Long Covid: overlap emerges with ME – including debate over treatment

by Linda Geddes, Science correspondent, Thu 19 Nov 2020

 

This article features people with long Covid, and looks at the similarities in symptoms of ME and the controversy over Graded Exercise Therapy for both.

…Based on current estimates, about 10% of Covid-19 patients develop lasting symptoms, one of the most common being fatigue. The underlying mechanism is still unclear, but possible explanations include reduced oxygen supply to tissues caused by heart or lung damage, or muscle weakness from prolonged bed rest.

However, some doctors are increasingly concerned about the overlap between long Covid and another largely virus-triggered illness:

“It’s extraordinary how many people have a postviral syndrome that’s very strikingly similar to myalgic encephalomyelitis/chronic fatigue syndrome,” said the US’s top public health official, Dr Anthony Fauci, in July. “They just don’t get back to normal energy or normal feeling of good health.”

Like people with ME/CFS, many long-Covid patients report headaches, brain fog, sleep problems, a racing heart, joint and muscle pain and fatigue. Some also experience a relapse of fever, muscle pain and exhaustion, known as “post-exertional malaise”, if they exercise beyond their capabilities.

“There are so many similarities between long Covid and ME/CFS it leads me to believe the underlying pathology is probably the same – except that long Covid is presenting as an epidemic, whereas ME/CFS has presented in a very sporadic way, and by no means in such large numbers in such a short space of time,” said Dr William Weir, a consultant in infectious diseases with a special interest in ME.

Another thing the conditions have in common is medical disagreement over how best to treat the fatigue they cause. Last week, the National Institute for Health and Care Excellence (NICE) dropped a longstanding recommendation that patients with ME/CFS be prescribed graded exercise therapy (GET), which involves incremental increases in physical activity to gradually build up tolerance. Patient advocates have long argued that GET can cause lasting damage to people’s health.

The new draft guidelines don’t cover Covid-related fatigue. This may be covered by separate “long Covid” guidelines that are expected next month. Yet patient advocates are concerned that GET might result in similar harm for people with long Covid.

“Although NICE has already issued a statement that GET may not be appropriate for people with post Covid illness, we are concerned that several of the new NHS England clinics for Covid rehabilitation are recommending graded exercise or its equivalent to patients,” said Sian Leary of the patient advocacy group #MEAction.

…

“It is crucial to acknowledge that not all long-Covid patients will behave like CFS,” said Dr Manoj Sivan, an associate clinical professor and consultant in rehabilitation medicine at the University of Leeds, who runs a long-Covid clinic in the city. He also sits on the BSRM’s executive committee. “Fatigue is multifactorial, and there are some patients with deconditioning and weakness who might benefit from GET,” he said.

However, he added that GET could be counterproductive in those patients presenting with a “boom and bust” pattern of symptoms consistent with postviral fatigue. Individualised patient assessment is therefore essential. “We know long Covid has different patterns of presentation and future research will look into targeting specific rehabilitation approaches to specific subgroups,” he said.

Until this happens, ME/CFS patient advocates are urging people with long Covid to learn from their experiences of dealing with postviral fatigue, stressing the importance of “pacing”. This means listening to your body and balancing physical and mental activity with rest, rather than pushing yourself to boost stamina. “It doesn’t mean you don’t do anything, but if you feel you need to rest, you should stop what you are doing and rest,” said Dr Amy Small, who credits the approach with her ongoing recovery.

Read the full article

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The impact of a structured exercise programme upon cognitive function in CFS patients

Posted on 11/18/2020 by wames

The impact of a structured exercise programme upon Cognitive Function in Chronic Fatigue Syndrome patients, by Paweł Zalewski, Sławomir Kujawski, Malwina Tudorowska, Karl Morten, Małgorzata Tafil-Klawe, Jacek J Klawe, James Strong, Fernando Estévez-López , Modra Murovska, Julia L Newton and the European Network on ME/CFS (EUROMENE) in Brain Sci. 2020, 10(1), 4 [doi.org/10.3390/brainsci10010004]

 

Research abstract: 

Background:

Cognitive function disturbance is a frequently described symptom of myalgic encephalomyelitis/ chronic fatigue syndrome (ME/CFS). In this study, the effects of a structured exercise programme (SEP) upon cognitive function in ME/CFS patients was examined.

Methods:

Out of the 53 ME/CFS patients initiating SEP 34 (64%) completed the 16 week programme. Cognitive function was assessed using a computerized battery test consisting of a Simple Reaction Time (SRT) (repeated three times) and Choice Reaction Time (CRT) measurements, a Visual Attention Test (VAT) and a Delayed Matching to Sample (DMS) assessment.

Results:

Statistically significant improvement was noted in the third attempt to SRT in reaction time for correct answers, p = 0.045, r = 0.24. Moreover, significant improvement was noted in VAT reaction time, number of correct answers and errors committed, p = 0.02, omega = 0.03, p = 0.007, r = 0.34 and p = 0.004, r = 0.35, respectively. Non-significant changes were noted in other cognitive tests.

Conclusions:

A substantial number of participants were unwilling or unable to complete the exercise programme. ME/CFS patients able to complete the SEP showed improved visual attention both in terms of reaction time and correctness of responses and processing speed of simple visual stimuli.

 

Health rising: Whoops! Did a GET Study Just Explain Why It Doesn’t Work in Chronic Fatigue Syndrome (ME/CFS)?

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NICE draft ME/CFS guideline says NO to graded exercise therapy (GET) cure!

Posted on 11/10/2020 by wames

NICE draft ME/CFS guideline now out for consultation

 

The draft of the revised NICE guideline has been published on November 10th 2020. It will be open for consultation until December 22nd.

As a stakeholder WAMES will be responding to this consultation and we invite Welsh residents to let us know what you think so we can include your thoughts in our response. Contact the helpline or use the contact form on this website

You can read the draft guideline here

Read excerpts from the guideline here on our blog. We will take our time to consider the implications of this important document.

Exercise

Exercise therapy  (GET) was the most controversial recommendation of the previous guideline so WAMES joins all people with ME in welcoming a change to this advice:

 

Physical activity (page 27)

Do not advise people with ME/CFS to undertake unstructured exercise that is not part of a supervised programme, such as telling them to go to the gym or exercise more, because this may worsen their symptoms.

Do not offer people with ME/CFS:

  • any therapy based on physical activity or exercise as a treatment or cure for ME/CFS
  • generalised physical activity or exercise programmes – this includes programmes developed for healthy people or people with other illnesses
  • any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy
  • structured activity or exercise programmes that are based on deconditioning as the cause of ME/CFS
  • therapies derived from osteopathy, life coaching and neurolinguistic programming (for example the Lightning Process).

Only consider a physical activity programme for people with ME/CFS who are ready to progress their physical activity beyond their current activities of daily living, or would like to incorporate physical activity into the management of their ME/CFS.

A physical activity programme, if offered, should only be delivered or overseen by a physiotherapist or occupational therapist with training and expertise in ME/CFS.

Tell people about the risks and benefits of a physical activity programme. Explain that some people with ME/CFS have found that physical activity programmes can make their symptoms worsen, for some people it makes no difference and others find them helpful.

If a physical activity programme is agreed with the person with ME/CFS, it should be personalised and should:

  • establish their physical activity baseline at a level that does not worsen their symptoms
  • start by reducing the person’s activity to within their energy envelope
    be possible to maintain it successfully before attempting to increase physical ability
  • use flexible increments for people who want to focus on improving their physical abilities while remaining within their energy envelope
  • recognise a flare or relapse early and outline how to manage it (see recommendations 1.11.21 and 1.11.22)
  • incorporate regular reviews.

Agree with the person how to adjust their physical activity after a flare or relapse. This should include:

  • providing access to support from the specialist ME/CFS physiotherapy service
    reducing physical activity within the person’s current energy envelope to stabilise their symptoms
  • only once symptoms stabilise and the person feels able to resume physical activity, establishing a new physical activity baseline.
  • Advise people with ME/CFS after a flare that the time it takes to return to the level of physical activity they had before the flare varies from person to person.

Reasons NICE give for this advice (p62):

  • because of the harms reported
  • because of the effects when people exceed the limits of their energy envelope
  • no therapy based on physical activity or exercise is effective as a treatment or cure for ME/CFS
  • people with ME/CFS have had varying results from physical activity programmes
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Effect of disease duration in a randomized phase III trial of rintatolimod, an immune modulator for ME/CFS

Posted on 11/04/2020 by wames

Effect of disease duration in a randomized Phase III trial of rintatolimod, an immune modulator for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, by David R Strayer, Diane Young, William M Mitchell in  PLoS ONE 15(10): e0240403, Oct 29 2020 [doi.org/10.1371/journal.pone.0240403]

 

Research abstract:

Background:
Rintatolimod is a selective TLR3 agonist, which has demonstrated clinical activity for ME/CFS in Phase II and Phase III double-blind, placebo-controlled, randomized, multi-site clinical trials.  [Also known as Ampligen]

Methods and findings:
A hypothesis-based post-hoc analysis of the Intent to Treat (ITT) population diagnosed with ME/CFS from 12 independent clinical sites of a Phase III trial was performed to evaluate the effect of rintatolimod therapy based on disease duration.

The clinical activity of rintatolimod was evaluated by exercise treadmill tolerance (ETT) using a modified Bruce protocol. The ITT population (n = 208) was divided into two subsets of symptom duration. Patients with symptom duration of 2–8 years were identified as the Target Subset (n = 75); the remainder (<2 year plus >8 year) were identified as the Non-Target Subset (n = 133).

Placebo-adjusted percentage improvements in exercise duration and the vertical rise for the Target Subset (n = 75) were more than twice that of the ITT population. The Non-Target Subset (n = 133) failed to show any clinically significant ETT response to rintatolimod when compared to placebo. Within the Target Subset, 51.2% of rintatolimod-treated patients improved their exercise duration by ≥25% (p = 0.003) despite reduced statistical power from division of the original ITT population into two subsets.

Conclusion/significance:
Analysis of ETT from a Phase III trial has identified within the ITT population, a subset of ME/CFS patients with ≥2 fold increased exercise response to rintatolimod. Substantial improvement in physical performance was seen for the majority (51.2%) of these severely debilitated patients who improved exercise duration by ≥25%. This magnitude of exercise improvement was associated with clinically significant enhancements in quality of life.

The data indicate that ME/CFS patients have a relatively short disease duration window (<8 years) to expect a significant response to rintatolimod under the dosing conditions utilized in this Phase III clinical trial. These results may have direct relevance to the cognitive impairment and fatigue being experienced by patients clinically recovered from COVID-19 and free of detectable SARS-CoV-2.

Trial registration
ClinicalTrials.gov: NCT00215800.

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Early growth response gene upregulation in Epstein-Barr Virus (EBV)- associated ME/CFS

Posted on 11/03/2020 by wames

Early growth response gene upregulation in Epstein-Barr Virus (EBV)- associated Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), by Jonathan Kerr in Biomolecules Vol 10, #11, p 1484,  Oct 26, 2020 [doi.org/10.3390/biom10111484]

 

Research abstract:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a chronic multisystem disease exhibiting a variety of symptoms and affecting multiple systems. Psychological stress and virus infection are important. Virus infection may trigger the onset, and psychological stress may reactivate latent viruses, for example, Epstein-Barr virus (EBV).

It has recently been reported that EBV induced gene 2 (EBI2) was upregulated in blood in a subset of ME/CFS patients. The purpose of this study was to determine whether the pattern of expression of early growth response (EGR) genes, important in EBV infection and which have also been found to be upregulated in blood of ME/CFS patients, paralleled
that of EBI2.

EGR gene upregulation was found to be closely associated with that of EBI2 in ME/CFS, providing further evidence in support of ongoing EBV reactivation in a subset of ME/CFS patients. EGR1, EGR2, and EGR3 are part of the cellular immediate early gene response and are important in EBV transcription, reactivation, and B lymphocyte transformation.

EGR1 is a regulator of immune function, and is important in vascular homeostasis, psychological stress, connective tissue disease, mitochondrial function, all of which are relevant to ME/CFS.

EGR2 and EGR3 are negative regulators of T lymphocytes and are important
in systemic autoimmunity.

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