NICE sets out steps NHS must take to implement ME/CFS guidelines

Abstract:

The National Institute for Health and Care Excellence has issued an unprecedented implementation statement setting out the practical steps needed for its updated guideline on the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS) to be implemented by the NHS.

Such statements are only issued when a guideline is expected to have a “substantial” impact on NHS resources, and this is thought to be the first. It outlines the additional infrastructure and training that will be needed in both secondary and primary care to ensure that the updated ME/CFS guideline, published in October 2021, can be implemented.

The statement is necessary because the 2021 guideline completely reversed the original 2007 guideline recommendations that people with mild or moderate ME/CFS be treated with cognitive behavioural therapy (CBT) and graded exercise therapy (GET). Instead, the 2021 guideline says that CBT should be only offered to support patients to manage their symptoms and that any exercise programme should be overseen by an ME/CFS specialist team.

Many areas have no or very limited specialist ME/CFS services, meaning that services must be commissioned, specialist health professionals need to be trained to deliver these services, and GPs need training in how to care for their patients. “With no nationally commissioned service for ME/CFS in either primary or secondary care, it will be for local systems to determine how to structure their services to achieve the aims of the guideline,” said Paul Chrisp, director of the Centre for Guidelines at NICE.

The 2007 recommendations were overturned during a long and difficult guideline development process. Patient groups had long argued that the recommendations were inappropriate, ineffective, and potentially harmful, and hindered research into the disease. But health professionals raised concerns about the proposed guidelines and the process that underpinned them. Just weeks before the final guideline was due to be published three members of the development committee resigned, royal colleges and other professional bodies signalled that they would not support it, and NICE had to delay publication. The guideline was finally published after a meeting was arranged with stakeholders to iron out differences, but concerns among medical leaders persisted.

When the 2021 guideline was published, Charles Shepherd, honorary medical adviser of the ME Association, told The BMJ that the recommendations were “something that currently cannot be coped with.” After publication of the implementation statement, he said, “I think NICE have gone as far as they can. It is now up to individual clinical services to reposition what they do in order to comply with the recommendations and for commissioners to start setting up new clinical services where none currently exist—especially in Wales and Northern Ireland.

“A lot of people with ME/CFS are clearly not getting the medical care and support that they need in both primary care and secondary care, especially those who are severely affected and do not have access to any form of domiciliary service or a dedicated inpatient facility.” He added: “It would obviously be helpful if the royal colleges could also express their support for implementation of the changes, as it’s not clear whether they remain unhappy with the recommendations downgrading CBT and the removal of GET.”

The same day NICE published its implementation statement, Sajid Javid, health and social care secretary, announced the publication of research priorities for ME/CFS by Action for ME, a charity that supports people with ME.  “We are committed to funding research into this important area,” he said. Javid and his chief scientific adviser, Lucy Chappell, will co-chair an advisory board of experts on ME/CFS, including patients, to discuss what needs to happen next and liaise with the devolved nations.

“We will be developing our own delivery plan later this year and will be working with stakeholders to understand how we can improve experiences and outcomes for people with these debilitating conditions,” he said. “At the heart of the delivery plan will be two core principles. Firstly, that we do not know enough about ME/CFS, which must change if we are to improve experiences and outcomes. Secondly, we must trust and listen to those with lived experience of ME/CFS.”

The BMJ asked three royal colleges for a response to the implementation statement, but none responded before publication.

Source: Ingrid Torjesen. NICE sets out steps NHS must take to implement ME/CFS guidelines. BMJ 2022;377:o1221. https://www.bmj.com/content/377/bmj.o1221

The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS

Abstract:

The British National Institute for Health and Care Excellence (NICE) recently published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). NICE concluded, after an extensive review of the literature, that graded exercise therapy (GET) is harmful and should not be used, and that cognitive behavioural therapy (CBT) is only an adjunctive and not a curative treatment. Leading proponents of the cognitive behavioural model (CBmodel) find it difficult to accept this paradigm shift.
In, for example, an article in The Lancet, they try to argue that the new NICE guideline is based on ideology instead of science. In this article we reviewed the evidence they used to support their claims. Our analysis shows that the trials they used in support suffered from serious flaws which included badly designed control groups, relying on subjective primary outcomes in non-blinded studies, including patients in their trials who didn’t have the disease under investigation or had a self-limiting disease, selective reporting, outcome switching and making extensive endpoint changes, which created an overlap in entry and recovery criteria, using a post-hoc definition of recovery which included the severely ill, not publishing results that contradict their own conclusion, ignoring their own (objective) null effect, etc.
The flaws in these trials all created a bias in favour of the interventions. Despite all these flaws, treatments that are said to lead to recovery in reality do not lead to objective improvement. Therefore, these studies do not support the claim that CBT and GET are effective treatments. Moreover, the arguments that are used to claim that NICE was wrong, in reality, highlight the absence of evidence for the safety and efficacy of CBT and GET and strengthen the decision by NICE to drop CBT and GET as curative treatments for ME/CFS.
Source: Vink M, Vink-Niese A. The Updated NICE Guidance Exposed the Serious Flaws in CBT and Graded Exercise Therapy Trials for ME/CFS. Healthcare. 2022; 10(5):898. https://doi.org/10.3390/healthcare10050898 https://www.mdpi.com/2227-9032/10/5/898/htm (Full text)

Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Who Have Already Visited Some Medical Institutions: The Points of Diagnosis and Treatment

Abstract:

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a syndrome primarily presenting fatigue-based symptoms; however, the challenge is this syndrome has no diagnostic biomarkers. The diagnosis and treatment of ME/CFS require highly specialized knowledge and skills. There is no definitive therapy for ME/CFS, including Chinese herbal medicine, vitamins, and/or L-carnitine. We recognised ME/CFS-like symptom in some patients infected COVID-19 . This directed our attention towards the research progress on the new research on the mechanisms and treatment of ME/CFS.

Source: Shimomura T. [Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Who Have Already Visited Some Medical Institutions: The Points of Diagnosis and Treatment]. Brain Nerve. 2022 May;74(5):660-667. Japanese. doi: 10.11477/mf.1416202094. PMID: 35589661. https://pubmed.ncbi.nlm.nih.gov/35589661/ [Article in Japanese]

Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Who Have Already Visited Some Medical Institutions: Diagnosis, Treatment and Research

Abstract:

Myalgic encephalitis/chronic fatigue syndrome (ME/CFS) is an acquired intractable disease characterized by profound fatigue, post-exertional malaise, sleep disturbance, cognitive impairment, and orthostatic intolerance, among other features. The onset often follows an infectious episode. Importantly, the various types of autonomic dysfunctions, pain, and intolerance to various stimuli in ME/CFS patients are intrinsically different from the “fatigue” of healthy individuals. In this short essay, I summarize the current diagnostic and therapeutic strategies for ME/CFS, as well as the progress in the immunological and imaging research on this intractable disease.

Source: Sato W. [Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) Who Have Already Visited Some Medical Institutions: Diagnosis, Treatment and Research]. Brain Nerve. 2022 May;74(5):652-659. Japanese. doi: 10.11477/mf.1416202093. PMID: 35589660. https://pubmed.ncbi.nlm.nih.gov/35589660/ [Article in Japanese]

The impact of Micro RNA-320a serum level on severity of symptoms and cerebral processing of pain in patients with fibromyalgia

Abstract:

Objectives: The aim of this work was to explore the expression of miR-320a level in fibromyalgia patients in comparison to healthy controls, and to clarify its impact on the severity of symptoms and the cerebral processing of pain assessed by middle latency somatosensory evoked potentials (SSEPs).

Design: Case-control study.

Setting: Rheumatology and Neurology outpatient clinics.

Subjects: Seventy-four fibromyalgia patients and seventy-four normal healthy controls.

Methods: The included patients were subjected to detailed history taking, assessment of severity of fibromyalgia symptoms using the Fibromyalgia Impact Questionnaire Revised (FIQR), assessment of pain intensity using the Neuropathic Pain Symptom Inventory (NPSI), measurement of the serum level of miR-320a in addition to of measurement peak latencies and amplitudes of middle latency SSEPs.

Results: Fibromyalgia patients had significantly higher micro-RNA-320a levels (0.907 ± 0.022) in comparison to controls (0.874 ± 0.015) (P-value < 0.001). The mean values of micro-RNA-320a levels were significantly higher in fibromyalgia patients with insomnia, chronic fatigue syndrome, persistent depressive disorder, and primary headache disorder than those without (P-value = 0.024, <0.001, 0.006, 0.036 respectively). There were statistically significant positive correlations between micro-RNA-320a levels, and disease duration, FIQR and NPSI total scores (P-value <0.001, 0.003, 0.002 respectively). There were no statistically significant correlations between micro-RNA-320a levels and middle latency SSEPs.

Discussion: Micro-RNA-320a level is significantly upregulated in fibromyalgia patient. It has a crucial impact on the severity of symptoms but not related to the cerebral processing of pain.

Source: Hussein M, Fathy W, Abdelaleem EA, Nasser M, Yehia A, Elanwar R. The impact of Micro RNA-320a serum level on severity of symptoms and cerebral processing of pain in patients with fibromyalgia. Pain Med. 2022 May 19:pnac076. doi: 10.1093/pm/pnac076. Epub ahead of print. PMID: 35587745. https://pubmed.ncbi.nlm.nih.gov/35587745/

Intimate partner violence and women living with episodic disabilities: a scoping review protocol

Abstract:

Background: Violence towards women with disabilities is most commonly perpetrated by current or former intimate partners and more than half of disabled women experience intimate partner violence in their lifetime. Disabilities differ by presence, type, and complexity, yet are commonly researched collectively. A more nuanced understanding of the relationship between intimate partner violence and episodic disability is required to better support women living with these concurrent challenges. The objective of this scoping review is to investigate and synthesize the literature reporting on intimate partner violence for women living with an episodic disability to identify key concepts and knowledge gaps on this topic. Ultimately, this review aims to improve health services for this stigmatized group of women with episodic disabilities.

Methods: This scoping review will consider all studies that focus on women (18 years of age or older) who have experienced intimate partner violence and have an episodic disability. Episodic disabilities will include multiple sclerosis, chronic fatigue syndrome, fibromyalgia, lupus, or rheumatoid arthritis. The broad review question is what is known about intimate partner violence within the context of women living with an episodic disability? Databases to be searched include MEDLINE (OVID), CINAHL, Embase, PsychInfo, and Scopus with no limits on language or time frame. Joanna Briggs Institute methodology will guide this scoping review to address the review questions outlined in the protocol. For papers that meet the inclusion criteria, data will be extracted, and findings will be presented in tables and narrative form. A PRISMA table will be included to enhance the transparency of the process. A descriptive qualitative approach to analysis will be conducted following Braun and Clarke’s reflexive thematic analysis. The findings of the scoping review will be presented through a thematic narrative.

Discussion: Findings from this review will be used to identify important priorities for future research based on knowledge gaps and inform both health care practices and health and social interventions for women living with intimate partner violence and episodic disabilities.

Source: Campbell KA, Ford-Gilboe M, Stanley M, MacKinnon K. Intimate partner violence and women living with episodic disabilities: a scoping review protocol. Syst Rev. 2022 May 18;11(1):97. doi: 10.1186/s13643-022-01972-x. PMID: 35585642. https://systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-022-01972-x  (Full text)

Unexplained post-acute infection syndromes

Abstract:

SARS-CoV-2 is not unique in its ability to cause post-acute sequelae; certain acute infections have long been associated with an unexplained chronic disability in a minority of patients. These post-acute infection syndromes (PAISs) represent a substantial healthcare burden, but there is a lack of understanding of the underlying mechanisms, representing a significant blind spot in the field of medicine.

The relatively similar symptom profiles of individual PAISs, irrespective of the infectious agent, as well as the overlap of clinical features with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), suggest the potential involvement of a common etiopathogenesis.

In this Review, we summarize what is known about unexplained PAISs, provide context for post-acute sequelae of SARS-CoV-2 infection (PASC), and delineate the need for basic biomedical research into the underlying mechanisms behind this group of enigmatic chronic illnesses.

Source: Choutka J, Jansari V, Hornig M, Iwasaki A. Unexplained post-acute infection syndromes. Nat Med. 2022 May;28(5):911-923. doi: 10.1038/s41591-022-01810-6. Epub 2022 May 18. PMID: 35585196. https://www.nature.com/articles/s41591-022-01810-6 (Full text)

Autonomic dysfunction in long-COVID syndrome: a neurophysiological and neurosonology study

Dear Sirs,

A significant proportion of patients infected from SARS-CoV-2 experience new, recurring, or ongoing symptoms usually 3 months after infection that may last for weeks or months and comprise the so-called Long-COVID Syndrome (LCS). Most frequent neurological symptoms include fatigue, memory/attention deficits, sleep disorders, myalgias and hyposmia []. The occurrence of LCS is not associated with the severity of foregoing acute COVID-19 nor have specific predisposing factors been identified so far. LCS shares common features with two other diseases, Fibromyalgia (FM) and Chronic Fatigue Syndrome (CFS): young women are predominantly affected, the etiology is unknown, although a previous viral infection is suspected, and both conditions have symptoms similar to those of LCS. Autonomic Nervous System (ANS) maladaptation has been proposed as a possible pathogenetic underlying mechanism. [, ]

Hence, a case–control study was conducted to investigate if ANS dysfunction may contribute to LCS. Consecutive, adult patients, with history of laboratory-confirmed COVID-19 without hospitalization, presenting with persistent LCS symptoms for > 3 months from COVID-19 onset, including fatigue, cognitive impairment (brain fog), orthostatic dizziness, palpitations, breathlessness or gastrointestinal symptoms, were evaluated at a referral center in Athens, Greece (“Attikon” University Hospital) between September 2021 and December 2021. LCS patients with cardiovascular complications or diabetes were excluded. Controls included colleagues, nursing staff and volunteers without history of SARS-COV-2 infection, cardiovascular diseases, diabetes and ANS disorders. Evaluation of ANS function was performed by Sympathetic Skin Response (SSR) to investigate the Sympathetic Nervous System (SNS), and the cross-sectional area (CSA) of the Vagus Nerve (VN) was assessed by ultrasound to investigate the Parasympathetic Nervous System (PNS) []. A detailed description of the methods is available in the online-only supplement. The study was approved by the Institutional Research Bioethics. Informed consent was obtained by all participants. Statistical analysis was performed using the Statistical Package for Social Science (SPSS Inc., version 24.0 for Windows; IBM, Armonk, NY, USA). Descriptive statistics are given as the mean and standard deviation, frequency, and percentage. Statistical comparisons between different groups were performed using the chi-square test (or exact test) for binary outcomes, and Student’s t test or Mann–Whitney U test for continuous variables as appropriate.

Read the full article HERE.

Source: Papadopoulou M, Bakola E, Papapostolou A, Stefanou MI, Gaga M, Zouvelou V, Michopoulos I, Tsivgoulis G. Autonomic dysfunction in long-COVID syndrome: a neurophysiological and neurosonology study. J Neurol. 2022 May 10:1–2. doi: 10.1007/s00415-022-11172-1. Epub ahead of print. PMID: 35536408; PMCID: PMC9086662. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9086662/ (Full text)

Exploring trajectory recovery curves of post-COVID cognitive symptoms in previously hospitalized COVID-19 survivors: the LONG-COVID-EXP-CM multicenter study

Dear Sirs,

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus, responsible of causing coronavirus disease 2019 (COVID-19), primary affects the respiratory system; however, neurological symptoms (e.g., ageusia, anosmia, headache) and also other severe complication are commonly experienced at the acute phase [, ]. Neurological symptoms presented at the acute COVID-19 phase such as headache [] or anosmia [] are likely present at a post-COVID phase; however, other neurological symptoms, e.g., cognitive disorders, are “de novo” developed in up to 22% of COVID-19 survivors []. A recent meta-analysis reported prevalence rates of 32%, 27% and 22% for post-COVID brain fog, memory loss, and attention/concentration problems the six months after respectively []. However, the presence of post-COVID cognitive symptoms are questioned by others [].

Interestingly, the recent definition of post-COVID includes cognitive dysfunction as one of the most common symptoms, after fatigue or dyspnoea []. The presence of post-COVID symptoms is overall associated with worse quality of life []. In fact, the presence of post-COVID cognitive symptoms represents a challenge for affected individuals since these symptoms affect daily life []. Although the presence of post-COVID cognitive symptoms is associated with nervous system changes [], it seems that these symptoms generally improve over time []. However, most studies investigating these symptoms have used cross-sectional designs. Therefore, understanding the longitudinal pattern of post-COVID cognitive symptoms may have significant implications in diagnosis, triaging, and management of post-COVID individuals.

Read the rest of this article HERE.

Source: Fernández-de-Las-Peñas C, Martín-Guerrero JD, Cancela-Cilleruelo I, Rodríguez-Jiménez J, Moro-López-Menchero P, Pellicer-Valero OJ. Exploring trajectory recovery curves of post-COVID cognitive symptoms in previously hospitalized COVID-19 survivors: the LONG-COVID-EXP-CM multicenter study. J Neurol. 2022 May 10:1–5. doi: 10.1007/s00415-022-11176-x. Epub ahead of print. PMID: 35538169; PMCID: PMC9090121. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9090121/ (Full text)

Post-COVID Condition in Adults and Children Living in the Same Household in Italy: A Prospective Cohort Study Using the ISARIC Global Follow-Up Protocol

Abstract:

Background: Emerging evidence shows that both adults and children may develop post-acute sequelae of SARS-CoV-2 infection (PASC). The aim of this study is to characterise and compare long-term post-SARS-CoV-2 infection outcomes in adults and children in a defined region in Italy.

Methods: A prospective cohort study including children (≤18 years old) with PCR-confirmed SARS-CoV-2 infection and their household members. Participants were assessed via telephone and face-to-face visits up to 12 months post-SARS-CoV-2 diagnosis of household index case, using the ISARIC COVID-19 follow-up survey.

Results: Of 507 participants from 201 households, 56.4% (286/507) were children, 43.6% (221/507) adults. SARS-CoV-2 positivity was 87% (249/286) in children, and 78% (172/221) in adults. The mean age of PCR positive children was 10.4 (SD = 4.5) and of PCR positive adults was 44.5 years (SD = 9.5), similar to the PCR negative control groups [children 10.5 years (SD = 3.24), adults 42.3 years (SD = 9.06)]. Median follow-up post-SARS-CoV-2 diagnosis was 77 days (IQR 47-169). A significantly higher proportion of adults compared to children reported at least one persistent symptom (67%, 68/101 vs. 32%, 57/179, p < 0.001) at the first follow up. Adults had more frequently coexistence of several symptom categories at both follow-up time-points. Female gender was identified as a risk factor for PASC in adults (p 0.02 at 1-3 months and p 0.01 at 6-9 months follow up), but not in children. We found no significant correlation between adults and children symptoms. In the paediatric group, there was a significant difference in persisting symptoms between those with confirmed SARS-CoV-2 infection compared to controls at 1-3 months follow up, but not at 6-9 months. Conversely, positive adults had a higher frequency of persisting symptoms at both follow-up assessments.

Conclusion: Our data highlights that children can experience persistent multisystemic symptoms months after diagnosis of mild acute SARS-CoV-2 infection, although less frequently and less severely than co-habitant adults. There was no correlation between symptoms experienced by adults and children living in the same household. Our data highlights an urgent need for studies to characterise PASC in whole populations and the wider impact on families.

Source: Buonsenso D, Munblit D, Pazukhina E, Ricchiuto A, Sinatti D, Zona M, De Matteis A, D’Ilario F, Gentili C, Lanni R, Rongai T, Del Balzo P, Fonte MT, Valente M, Zampino G, De Rose C, Sigfrid L, Valentini P; FIMP-Roma. Post-COVID Condition in Adults and Children Living in the Same Household in Italy: A Prospective Cohort Study Using the ISARIC Global Follow-Up Protocol. Front Pediatr. 2022 Apr 21;10:834875. doi: 10.3389/fped.2022.834875. PMID: 35529336; PMCID: PMC9070551.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9070551/ (Full text)