ME/CFS & Covid-19: information for you & your doctor

COVID-19 Information and Resources – Bateman Horne Center, March 2020

 

Dr Lucinda Bateman

The Bateman Horne Center works for the medical advancement and treatment of  Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)and Fibromyalgia in Salt Lake City, Utah, USA.

In addition to the resources for patients and doctors on ME/CFS they have produced some briefing papers on Covid-19 and ME/CFS, many of which are helpful people from anywhere in the world.

Dr Suzanne Vernon

 

 

Medical Director: Dr Lucinda Bateman

Researcher: Dr Suzanne Vernon

 

 

Medical Considerations Letter — In the event you become acutely ill, the Medical Care Considerations Letter serves as a guiding resource for outside medical care intervention. The intent of this letter is to provide care professionals with further information about your illness of ME/CFS and/or severe FM to assist them with their medical intervention decisions.

“you should assume they have a serious, chronic, multisystem illness that may negatively impact their prognosis”

“Based on current evidence the underlying pathology of ME/CFS involves energy metabolism, the nervous system, and the immune system.”

COVID-19 and ME/CFS/FM Frequently Asked Questions: Drs. Bateman and Yellman answer specific questions about COVID-19 as it relates to ME/CFS/FM.

e.g. Are people with ME/CFS/FM at a higher risk than the general public of dying from COVID-19 if contracted? … The immune dysregulation of ME/CFS/FM may reduce ability to fight viral infections. Additionally, the presence of chronic inflammation, allergies, asthma, mast-cell activation may pose additional risks.

Suzanne D. Vernon, PhD, addresses: SARS, CoV-2, and COVID-19: A scientific overview of COVID-19, infection/transmission, testing, and treatments on the horizon.

Advance Care Planning: The Advance Care Planning document provides guidance for establishing advanced-care-directives and POLST documents.

Personal Guidance and Decision Making

e.g. Advance Directives: Everyone, not just those with ME/CFS, should document end-of-life wishes on paper regarding aggressive medical care in a life-threatening situation. Discuss with family and medical professionals as needed.

Videos

 

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ME, Covid-19 & self-isolating

What do people with ME need to know about Covid-19 and self-isolating?              updated 10 April 2020

 

The Health Minister for Wales has confirmed that people over 70 and people with a range of health conditions, including  neurological conditions, should self-isolate. People with a cough and/or high temperature are asked to self isolate for 7 days. Those who have had contact with someone with confirmed Covid-19 should self-isolate for 14 days. Everybody should stay at home except for essential shopping, short daily exercise a day, essential medical needs, travelling to and from essential work, but only where this cannot be done from home. Social distancing is required by all people when outside the home.

Many people with ME have been self-isolating to some extent for years, because they have been too ill to mix with others. They will be practised in ensuring they have enough food, cleaning products, personal care items, ‘distractions’ and medications, but the coronavirus Covid-19 poses some extra problems and questions.

Much is still not known about this new virus, but some clues are emerging from US research and from the badly affected countries of China and Italy.

People don’t have to have symptoms to be infectious

  • symptoms appear 2-14 days after infection
  • infection can last weeks, up to 37 days (China)
  • people can be infectious before & after symptoms are apparent, or without symptoms
  • it is uncertain how many have no obvious symptoms and are spreading the virus
  • no symptoms doesn’t necessarily mean less able to spread the virus

Infected people without symptoms might be driving the spread of coronavirus more than we realized

 

What are the symptoms?

Regular flu has similar symptoms to COVID-19. However, COVID-19 is more likely to cause shortness of breath and other respiratory symptoms. Some people have only mild symptoms while others are very ill and struggle to breathe.

Coronavirus symptoms            Check your symptoms

 

How does the virus spread?

  • it might be airborne to a small extent
  • it definitely remains on surfaces
  • it probably doesn’t survive in water
  • it survives to some extent in faeces
  • they are unsure if it survives in sewerage systems
  • it enters the body via the eyes, nose, mouth, not through the skin
  • cats can catch it but it is uncertain if they can infect humans

Coronavirus can stay infectious for days on surfaces. But it’s still okay to check your mail

 

Who is most at risk?

Early indications in China and Italy was that the majority of people who died were over 60 with certain underlying health conditions, (but anyone can catch and pass on the virus):

  • heart disease
  • diabetes
  • hypertension – high blood pressure
  • chronic lung disease
  • some cancers

It has now become clear that younger people with no known health conditions can also be at risk.

It is unknown to what extent people with ME are at greater risk but Dr Nancy Klimas believes we could be, as ‘one of the underlying problems is that the cells protecting you against viruses are less functional because overworked.’  Dr Charles Shepherd says: ‘an infection such as this will almost certainly cause a relapse, or significant exacerbation of symptoms’.

Public health England’s updated list of those at risk & requiring social distancing,  which includes Neurological Conditions, the obese and pregnant women.

 

What distance is safe when social distancing?

It may not be possible to avoid close contact with people giving you care, or for whom you care, but all sources say where possible stay 2 metres or 6 feet away from other people. If people are moving (cyclists or runners) it may be wise to stay up to 10m away. Face masks won’t stop you catching the virus, but they may reduce the likelihood of passing it on to others.

Prof Hugh Pennington adds: “This virus needs 15 minutes of close contact with someone carrying it for you to have a reasonable chance of contracting it…But if someone who is infected coughs or sneezes on you directly then the droplets can infect you — that will be a much higher risk.”

 

How long does it last on surfaces?

When self isolating we will need to receive post, groceries etc. Are they safe? US researchers measured how long the virus stays active on various surfaces:

  • up to 24 hours on cardboard
  • up to 2 or 3 days on plastic and stainless steel.
  • it remained viable in aerosols—attached to particles that stay aloft in the air—for up to 3 hours.

Accept goods from outside, then put away perishables without contaminating other items. Either thoroughly wash the outside of the items or leave them until they are safe to touch.  Wash your hands and don’t touch your face!!

 

Can you become re-infected?

  • it is uncertain if or how long immunity lasts
  • it appears to be possible to relapse, though numbers are small
  • there are 2 variations of the virus and potentially it could mutate, though probably unlikely
  • in some countries testing for the presence of the virus may not be reliable so people only think they have recovered
  • most people recover but some experience reduced lung function following recovery, which will require some rehab
  • some concerns have been expressed that the virus may trigger an ME-like reaction as happened with SARS.

Coronavirus: can you get covid-19 twice or does it cause immunity

 

What kills the virus?

  • soap & water – dried by single use paper or warm air
  • alcohol based sprays on surfaces – leave 5 mins before wiping
  • hand sanitisers
  • chlorine
  • cooking removes any danger from food
  • bleach – disinfects, but pollutes- 5 tbsp (1/3 cup) of bleach per gallon of water

BBC: How long does the coronavirus last on surfaces?

 

When to get tested?

The UK is stepping up testing of frontline workers but still only wants to test those whose symptoms become serious due to shortage of tests – if experiencing severe symptoms ring 111 anywhere in Wales.  (Don’t press any numbers, just hold to be connected to NHS Wales, rather than NHS England)

 

How should it be treated?

Treatment for Coronavirus Disease (COVID-19)

 

How can I self-isolate?

Information on what it means to self-isolate in your home, or in a room within your home can be found on the UK Government website.  Increasingly local support schemes are being set up by concerned citizens to make it possible for people to self-isolate, even when they don’t have friends or family nearby, or access to online deliveries.

For info about how to get or give support, find your COVID-19 Facebook support group here Some Council & AVO websites list local sources of help and delivery services. Age Cymru and RVS provide support.

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DNA Methylation & BDNF expression account for symptoms & widespread hyperalgesia in patients with CFS & FM

DNA Methylation and BDNF Expression account for symptoms and widespread hyperalgesia in patients with Chronic Fatigue Syndrome and Fibromyalgia, by Andrea Polli, Manosij Ghosh, Jelena Bakusic, Kelly Ickmans, Dora Monteyne, Brigitte Velkeniers, Bram Bekaert, Lode Godderis, Jo Nijs in Arthritis Rheumatol. 2020 Jun 20 [doi: 10.1002/art.41405]

 

Research abstract:

Background:

Epigenetics of neurotrophic factors holds the potential to unravel the mechanisms underlying the pathophysiology of complex conditions such as chronic fatigue syndrome (CFS). This study explored the role of brain-derived neurotrophic factor (BDNF) genetics, epigenetics, and protein expression in patients with both CFS and comorbid fibromyalgia (CFS/FM).

Methods:

A repeated-measures study in 54 participants (28 patients with CFS/FM and 26 matched healthy controls) was conducted.

Representation of a DNA molecule that is methylated.

Participants underwent a comprehensive assessment, including questionnaires, sensory testing, and blood withdrawal. BDNF protein level was measured in serum (sBDNF) using ELISA, while polymorphism and DNA methylation were measured in blood, using pyrosequencing technology. To assess temporal stability of the measures, participants underwent the same assessment twice within four days.

Results:

Repeated-measures mixed linear models were performed for between-group analysis. sBNDF was higher in patients with CFS/FM (F=15.703; mean difference: 3.31 ng/ml, 95% C.I. 1.65 to 4.96; p=.001), whereas BDNF DNA methylation was lower in Exon IX (F=9.312; mean difference -2.38%, C.I. -3.93 to -0.83; p=.003). BDNF DNA methylation was mediated by the Val66Met (rs6265) polymorphism. Lower methylation in the same region predicted higher sBDNF (F=4.910, t= -2.216, p=.029, 95% C.I. = -.712 to -.039) which in turn predicted participants’ symptoms (F=14.410, t= 3.796, 95% C.I.= 1.79 to 5.71, p=.001) and widespread hyperalgesia (F=4.147, t= 2.036, 95% C.I.= .01 to .08, p=.044).

Discussion:

sBDNF is higher in patients with CFS/FM and BDNF methylation in exon IX accounts for regulating protein expression. Altered BDNF might represent a key mechanism explaining CFS/FM pathophysiology.

Read full paper

 

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Protective effect of hemin against experimental CFS in mice: possible role of neurotransmitters

Protective effect of hemin against experimental Chronic Fatigue Syndrome in mice: possible role of neurotransmitters, by Vandana Thakur, Sumit Jamwal, Mandeep Kumar, Vikrant Rahi & Puneet Kumar  in Neurotoxicity Research (2020) [doi.org/10.1007/s12640-020-00231-y]

 

Research abstract:

Chronic fatigue syndrome (CFS) is a disorder characterized by persistent and relapsing fatigue along with long-lasting and debilitating fatigue, myalgia, cognitive impairment, and many other common symptoms.

The present study was conducted to explore the protective effect of hemin on CFS in experimental mice. Male albino mice were subjected to stress-induced CFS in a forced swimming test apparatus for 21 days. After animals had been subjected to the forced swimming test, hemin (5 and 10 mg/kg; i.p.) and hemin (10 mg/kg) + tin(IV) protoporphyrin (SnPP), a hemeoxygenase-1 (HO-1) enzyme inhibitor, were administered daily for 21 days.

Various behavioral tests (immobility period, locomotor activity, grip strength, and anxiety) and estimations of biochemical parameters (lipid peroxidation, nitrite, and GSH), mitochondrial complex dysfunctions (complexes I and II), and neurotransmitters (dopamine, serotonin, and norepinephrine and their metabolites) were subsequently assessed.

Animals exposed to 10 min of forced swimming session for 21 days showed a fatigue-like behavior (as increase in immobility period, decreased grip strength, and anxiety) and biochemical alteration observed by increased oxidative stress, mitochondrial dysfunction, and neurotransmitter level alteration.

Treatment with hemin (5 and 10 mg/kg) for 21 days significantly improved the decreased immobility period, increased locomotor activity, and improved anxiety-like behavior, oxidative defense, mitochondrial complex dysfunction, and neurotransmitter level in the brain.

Further, these observations were reversed by SnPP, suggesting that the antifatigue effect of hemin is HO-1 dependent. The present study highlights the protective role of hemin against experimental CFS-induced behavioral, biochemical, and neurotransmitter alterations.

Read full article

ME Research UK: Hemin protects against CFS-like symptoms in mice

Key findings

  • A CFS-like condition was induced in experimental mice, resulting in decreased activity, increased immobility and raised anxiety levels.
  • Treatment with hemin for 21 days improved all these symptoms, and also reduced oxidative stress, mitochondrial dysfunction and changes in the levels of several neurotransmitters.
  • It remains to be seen whether hemin has any effect in humans with ME/CFS, and might therefore be used as a therapy to alleviate symptoms.
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Post-viral fatigue and COVID-19: lessons from past epidemics

Post-viral fatigue and COVID-19: lessons from past epidemics, by Mohammed F Islam, Joseph Cotler,  & Leonard A Jason in Fatigue: Biomedicine, Health & Behavior 25 Jun 2020 [doi.org/10.1080/21641846.2020.1778227]

 

Review Abstract:

The COVID-19 pandemic, resulting from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), has severely impacted the population worldwide with a great mortality rate.

The current article reviews the literature on short- and long-term health consequences of prior epidemics and infections to assess potential health complications that may be associated with post-COVID-19 recovery.

Past research on post-epidemic and post-infection recovery has suggested that such complications include the development of severe fatigue. Certain factors, such as the severity of infection, in addition to the ‘cytokine storm’ experienced by many COVID-19 patients, may contribute to the development of later health problems.

We suggest that the patterns observed in past epidemics and infections may re-occur in the current COVID-19 pandemic.

Excerpts from Concluding remarks:

Past research has shown that elevated levels of post-infectious fatigue are common for some survivors of epidemics such as SARS and Ebolavirus. Chronic widespread musculoskeletal pain, fatigue, depression and disorder sleep in chronic post-SARS syndrome; a case-controlled study.  Post-Ebola syndrome among Ebola virus disease survivors in Monsterraro county, Liberia 2016. Moreover, fatigue has been associated with infections, such as infectious mononucleosis, that occur frequently outside of an epidemic or pandemic scale. Chronic fatigue syndrome following infections in adolescents.

These types of outcomes are not limited to just viral infections, but also bacterial infections. Post-infective and chronic fatigue syndromes precipitated by viral and non-viral pathogens: prospective cohort study. Given such evidence, we expect that some survivors of COVID-19 will develop post-infectious fatigue and other complications.

… Since the start of the epidemic, enough time has not elapsed to study the long-term trajectory of COVID-19, but reports are emerging about the occurrence of serious potentially longer-term health consequences. For example, several patients in Italy have developed Guillain-Barré.  There are reports of children developing Kawasaki disease, and other reports of COVID-19 causing lung scarring, blood clots, renal failure, and neurological complications.  Shi et al. found 19% of 416 hospitalized COVID-19 patients showed signs of heart damage. These types of findings of COVID-19 reinforce our contention that a portion of survivors will experience a variety of longer-term health complications including post-infectious fatigue.

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Preliminary ICF core set for patients with ME/CFS in rehabilitation medicine

Preliminary ICF core set for patients with myalgic encephalomyelitis/chronic fatigue syndrome in rehabilitation medicine, by Indre Bileviciute-Ljungar, Marie-Louise Schult, Kristian Borg, Jan Ekholm in J Rehabil Med 2020; 52: jrm0000X [DOI:10.2340/16501977-2697]

 

Lay Abstract:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a disabling condition with no diagnostic or prognostic markers. The patient group is heterogeneous, and impairments in functioning and disability vary between patients. The International Classification of Functioning, Disability and Health (ICF) is a well-established method to assess patient’s functioning and disability. This study sets out a preliminary Brief ICF Core Set for ME/CFS in rehabilitation medicine. However, this requires improvement, and approval by research society and clinicians working with ME/CFS. The introduction of post-exertional malaise as a new category in the ICF should also be considered.

Research abstract:

Objective:  To create and evaluate a preliminary ICF Core Set for myalgic encephalomyelitis/chronic fatigue syndrome using a team-based approach.

Design: Observational study.
Subjects/patients: A total of 100 consecutive patients (mean age 45 years, standard deviation (SD) 9 years) were assessed by a rehabilitation team and included in the study.

Methods: A preliminary International Classification of Functioning, Disability and Health (ICF) Core Set was created, based on literature studies, and on discussion forums between the team and the researchers. Patients were assessed by a rehabilitation medicine team regarding impairments in body function, activity limitations, and restrictions in participation.

Results: Clinical assessments of the component Body Functions found impairments in energy, fatigue, physical endurance, fatigability, sleep and pain in 82–100% of patients. At least half of the patients had impairments in higher cognitive functions, attention, and emotions, as well as sound and light hypersensitivity, general hyper-reactivity and thermoregulatory functions.

For the component Activity/Participation, the most frequent limitations and restrictions were in doing housework (93%), assisting others (92%), acquisition of goods and services (90%), remunerative employment (87%), handling stressful situations (83%), preparing food (83%), recreation and leisure (82%), informal socializing (78%) and carrying out daily activities (77%).

The most frequent degrees of impairments/limitations/restrictions assessed were light and moderate, except for remunerative employment, for which restrictions were severe.

Conclusion: Using unconventional methods, this study sets out a preliminary ICF Core Set list for patients with myalgic encephalomyelitis/chronic fatigue syndrome. Further studies are required to improve and test this Core Set in myalgic encephalomyelitis/ chronic fatigue syndrome populations.

Read full paper

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Clinical history segment extraction from CFS assessments to model disease trajectories

Clinical history segment extraction from Chronic Fatigue Syndrome assessments to model disease trajectories by Sonia Priou, Natalia Viani, Veshalee Vernugopan, Chloe Tytherleigh, Faduma Abdalla Hassan, Rina Dutta, Trudie Chalder, Sumithra Velupillai in Digital Personalized Health and Medicine, Vol 270, pp 98-102, 2020

 

Research abstract:

Chronic fatigue syndrome (CFS) is a long-term illness with a wide range of symptoms and condition trajectories. To improve the understanding of these, automated analysis of large amounts of patient data holds promise. Routinely documented assessments are useful for large-scale analysis, however relevant information is mainly in free text.

As a first step to extract symptom and condition trajectories, natural language processing (NLP) methods are useful to identify important textual content and relevant information.

In this paper, we propose an agnostic NLP method of extracting segments of patients’ clinical histories in CFS assessments. Moreover, we present initial results on the advantage of using these segments to quantify and analyse the presence of certain clinically relevant concepts.

Excerpt from Discussion:

When searching for pre-defined clinically relevant CFS concepts, most documents had at least one (94%), and most concepts were found inside the extracted segments (90%). Concepts only found outside of segments were either mentioned in a different context than clinical history (e.g. the concept anxiety was used to describe the patient’s current state) or used in the first sentence of the document (mainly for ‘virus/viral’).

We plan to extend this analysis by looking at additional concept mapping techniques such as word embeddings, clustering and topic modelling approaches.

Our main contributions in this study are:

an agnostic method of extracting segments of EHR text that convey history information, and an initial experiment of the benefit of using these segments to analyse the presence of certain clinically relevant concepts in a CFS cohort. This is a first step towards large-scale studies on CFS disease trajectories.

Download full book chapter

WAMES’ Comment

Analysing clinical histories to gather useful information on the nature and course of ME or CFS is dependant on the clinical histories being an accurate account of the patient experience. Many people with ME have been unhappy with the way their illness has been perceived and recorded by medical professionals, often due to an overemphasis on possible psychological factors and lack of a commonly used vocabulary.

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NICE ME/CFS Guideline to be published April 2021

NICE ME/CFS Guideline to be published April 2021

 

WAMES has received notification from NICE about the dates the stakeholder meetings will reconvene, and the proposed publication date of the revised ME/CFS clinical guideline.

 

24/6/20

Dear Stakeholder,

As you will be aware, because of the need to prioritise work on COVID-19 guidance and to avoid drawing frontline staff away from their clinical work, NICE cancelled all guideline committee meetings. This included meetings for the ME/CFS guideline. We have now rescheduled the remaining committee meetings for this guideline and agreed a revised timeline. This means that the consultation on the draft guideline will now start on 10 November, and the guideline will now publish on 21 April 2021.

 

Kind regards,

Katie Stafford, Senior Guideline Coordinator

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Economic burden of ME/CFS to patients: comparative study

Economic burden of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) to patients: comparative study, by D Araja, E Brenna, RM Hunter, D Pheby, U Berkis, A Lunga, M Murovska in Value in Health, Vol 22, Supp 3, Nov 2019, Page S909 [https://doi.org/10.1016/j.jval.2019.09.2671] ABSTRACT ONLY

 

Abstract:

Objectives:

Research is performed in framework of COST (European Cooperation inScience and Technology) Action 15111 EUROMENE (European Myalgic Encephalo-myelitis/Chronic Fatigue Syndrome (ME/CFS) Research Network) to investigate the opportunities for evaluation of economic impact of ME/CFS to patients.

Methods:

To achieve the objectives of this research, a study based on patient-reported survey has been carried out in Latvia, Italy and the United Kingdom (UK). The survey included questions concerning the socio-economic consequences of the disease, particularly regarding the health care costs. For data processing and analysis, the methods of economic analysis and statistical analysis are embraced.

Results:

In Latvia the survey has been launched with coverage of 100 patients (with dominance income of €500 per household member monthly). The results show that 1% of respondents spend more than €100 as an out-pocket payment for medicines and health care services monthly, 1.8% spend €51-100 for medicines, health care services and food supplements monthly, 17.2% spend €21-50, and 80% of respondents spend until €20 monthly to reduce the ME/CFS consequences.

The study performed in Italy with 87 participants suffered by ME/CFS found that 23% were unemployed and 55% had an income less than €15.000 annually. Patients spend average €210 monthly on medication and therapy.

A study conducted in the UK covered 262 patients with ME/CFS and healthy controls. The analysis shows marked lower economic well-being of people with ME/CFS in comparison with healthy controls. Average adjusted income for participants with CFS/ME was £12.242, but for healthy controls -£23.126. Considering the prevalence of ME/CFS in the UK population, the total cost of illness was estimated at £1.713 million per year.

Conclusions:

The patient-reported outcomes is a significant tool to collect the data for evaluation of socio-economic impact of ME/CFS, but for comparative studies the purchasing power parities should be taken into account.

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Characterization of cortisol dysregulation in FM & CFS: a state-space approach

Characterization of Cortisol Dysregulation in Fibromyalgia and Chronic Fatigue Syndromes: A State-Space Approach, by Divesh Deepak Pednekar, Md. Rafiul Amin, Hamid Fekri Azgomi, Kirstin Aschbacher, Leslie J Crofford, Rose T Faghih in Published in: IEEE Transactions on Biomedical Engineering PP(99):1-1 · March 2020 [DOI: 10.1109/TBME.2020.2978801]

 

Research abstract:

Objective:

Cortisol secretion & regulation model

Fibromyalgia syndrome (FMS) and chronic fatigue syndrome (CFS) are complicated medical disorders, with little known etiologies.

The purpose of this research is to characterize FMS and CFS by studying the variations in cortisol secretion patterns, timings, amplitudes, the number of underlying pulses, as well as infusion and clearance rates of cortisol.

Methods:

Using a physiological state-space model with plausible constraints, we estimate the hormonal secretory events and the physiological system parameters (i.e., infusion and clearance rates).

Results:

Our results show that the clearance rate of cortisol is lower in FMS patients as compared to their matched healthy individuals based on a simplified cortisol secretion model. Moreover, the number, magnitude, and energy of hormonal secretory events are lower in FMS patients. During early morning hours, the magnitude and energy of the hormonal secretory events are higher in CFS patients.

Conclusion:

Due to lower cortisol clearance rate, there is a higher accumulation of cortisol in FMS patients as compared to their matched healthy subjects. As the FMS patient accumulates higher cortisol residues, internal inhibitory feedback regulates the hormonal secretory events. Therefore, the FMS patients show a lower number, magnitude, and energy of hormonal secretory events. Though CFS patients have the same number of secretory events, they secrete lower quantities during early morning hours. When we compare the results for CFS patients against FMS patients, we observe different cortisol alteration patterns.

Significance:

Characterizing CFS and FMS based on the cortisol alteration will help us to develop novel methods for treating these disorders.

Read full paper

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Epidemiological and clinical factors associated with post-exertional malaise severity in patients with ME/CFS

Epidemiological and clinical factors associated with post-exertional malaise severity in patients with myalgic encephalomyelitis/chronic fatigue syndrome, by Alaa Ghali, Paul Richa, Carole Lacout, Aline Gury, Anne-Berengere Beucher, Chadi Homedan, Christian Lavigne & Geoffrey Urbanski in Journal of Translational Medicine vol 18, no. 246 (2020) Published: 22 June 2020

 

Research abstract:

Background

Post-exertional malaise (PEM), the cardinal feature of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), occurs generally after exposure to a stressor. It is characterized by the worsening of ME/CFS symptoms and results in aggravating the course of the disease and the quality of life of patients. Due to its unpredictable onset, severity, and recovery time, identifying patients with higher risk for severe PEM would allow preventing or reducing its occurrence. We thus aimed at defining possible factors that could be associated with PEM severity.

Methods

Adult patients fulfilling ME international consensus criteria who attended the internal medicine department of University hospital Angers-France between October 2011 and December 2019 were included retrospectively. All patients were systematically hospitalized for an etiological workup and overall assessment. We reviewed their medical records for data related to the assessment: epidemiological data, fatigue features, clinical manifestations, and ME/CFS precipitants.

PEM severity was appreciated by the Center for Disease Control self-reported questionnaire. The study population was classified into quartiles according to PEM severity scores. Analyses were performed with ordinal logistic regression to compare quartile groups.

The two-way link between recurrent infections and PEM in ME/CFS patients. An infectious precipitant results in impaired immune function leading to susceptibility to recurrent viral infections and some of ME/CFS manifestations such as fatigue and flu-like symptoms. Stress and mood changes can also impact the immune system. PEM will occur after a stressor (physical, cognitive, emotional and/or infectious) leading to a worsening of ME/CFS baseline symptoms, including immune/inflammatory-related symptoms and psychological disturbances. This will perpetuate the immune dysfunction with aggravation of ME/CFS symptoms, and more frequent viral infections. aME/CFS: myalgic encephalitis/chronic fatigue syndrome. bPEM: post-exertional malaise

Results

197 patients were included. PEM severity was found to be positively associated with age at disease onset ≥ 32 years (OR 1.8 [95% CI 1.1–3.0] (p = 0.03)), recurrent infections during the course of the disease (OR 2.1 [95% CI 1.2–3.7] (p = 0.009)), and when ME/CFS was elicited by a gastrointestinal infectious precipitant (OR 5.7 [1.7–19.3] (p = 0.006)).

Conclusion

We identified some epidemiological and clinical features, which were positively associated with PEM severity in subsets of ME/CFS patients. This could help improving disease management and patients’ quality of life.

Excerpt from conclusion:

Given the non-homogeneity of the ME/CFS population, and knowing that PEM is associated with disability and poorer outcome, we attempted to identify patients with higher risk for severe PEM on epidemiological and clinical features. To the best of our knowledge, our study is the first to identify factors that may influence PEM severity in ME/CFS patients.

We observed more severe PEM in older patients at disease onset, and among those who were suffering from recurrent infections during their disease course. More severe PEM was also observed in patients in whom ME/CFS onset was preceded by GI infectious precipitants.

Accordingly, this will allow adapting and individualizing the disease management, especially in the absence of curative treatment. Hence older patients should be advised to adhere more strictly to pacing strategies, and specific measures against infections together with pacing should be recommended for those who display recurrent and/or persistent infections. The aim is to prevent PEM occurrence, or at least reducing its severity, to help improving disease course and patients’ quality of life.

 

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A qualitative exploration of treatment preference in paediatric randomised control trials

A qualitative exploration of treatment preference in paediatric randomised controlled trials, by Lucy Beasant PhD thesis, University of Bristol, [Bristol Medical School (PHS), Bristol Population Health Science Institute] November 28, 2019. Supervisors: Esther M Crawley, Nicola J Mills & Bridget Young

 

Research abstract:

Randomised controlled trials (RCTs) rely on effective recruitment and retention for successful completion. Potential trial participants’ preference for a treatment (trial intervention) can affect recruitment, post randomisation drop-out and adherence to intervention groups in adult RCTs, but little is known about how they may affect paediatric
trials.

Communication of trial information in paediatric trial settings is complex as it needs to accommodate the parent’s as well as young person’s perspective, whilst at the same time maintaining high standards of trial conduct. This PhD explored how treatment preferences influenced recruitment and participation in paediatric RCTs by undertaking a systematic review of the literature and embedding qualitative research in four paediatric trials.

The systematic literature review focused on paediatric RCTs and qualitative studies that reported the treatment preferences of children and young people aged 0-17 years, and their parents. Fifty-two papers were identified, twelve of which contained qualitative data.

CONSORT figures reporting decline or withdrawal from trials due to treatment preference were tabulated and discussed descriptively. Techniques of meta-ethnography were drawn on to evaluate qualitative data. The systematic review showed treatment preferences acting as a barrier to recruitment to paediatric RCTs, particularly from a parental perspective. Parents’ understanding of trial processes and perceptions of the benefits and risks associated with treatments promoted discussion of preference. Few RCT papers reported the views of young people in relation to preference for treatment.

Qualitative methods were embedded in three chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) trials, and one surgical trial for acute, uncomplicated appendicitis. The QuinteT Recruitment Intervention (QRI) has been embedded successfully in adult RCTs to identify and address recruitment difficulties with the intention to optimise informed decision-making and recruitment.

Methods and approaches from the QRI (audio-recorded recruitment consultations,
interviews, recruiter training) were employed in the present research to explore the treatment preferences of young people, their parents, and to discuss issues of equipoise with recruiting health professionals. Data analyses drew on techniques of constant comparison, content and thematic analysis. All four RCTs were able to successfully recruit paediatric participants, but preference for treatment was a consistent reason for trial decline, post randomisation drop-out and discontinued treatment in the four trials under investigation.

Young people and their parents expressed treatment preferences when considering RCT participation in all four trials. However, young people were less likely to express preferences than their parents.

The views and equipoise of those recruiting and treating patients influenced families at all stages of recruitment, and during trial participation. Providing training for recruiters and wider clinical teams that promoted communicating equipoise, and the exploration of preference during discussions with families, had a positive effect on observed recruitment practices. More efforts are now needed to understand preference for treatment in paediatric RCT settings, particularly in relation to the impact on trial retention and the treatment outcomes under investigation.

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