Tag: NICE guidelines

Impact of the COVID-19 Pandemic and the 2021 National Institute for Health and Care Excellence Guidelines on Public Perspectives Toward Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Thematic and Sentiment Analysis on Twitter (Rebranded as X)

Abstract:

Background: Myalgic encephalomyelitis (ME), also referred to as chronic fatigue syndrome (CFS), is a complex illness that typically presents with disabling fatigue and cognitive and functional impairment. The etiology and management of ME/CFS remain contentious and patients often describe their experiences through social media.

Objective: We explored public discourse on Twitter (rebranded as X) to understand the concerns and priorities of individuals living with ME/CFS, with a focus on (1) the COVID-19 pandemic and (2) publication of the 2021 UK National Institute for Health and Care Excellence (NICE) guidelines on the diagnosis and management of ME/CFS.

Methods: We used the Twitter application programming interface to collect tweets related to ME/CFS posted between January 1, 2010, and January 30, 2024. Tweets were sorted into 3 chronological periods (pre-COVID-19 pandemic, post-COVID-19 pandemic, and post-UK 2021 NICE Guidelines publication). A Robustly Optimized Bidirectional Embedding Representations from Transformers Pretraining Approach (RoBERTa) language processing model was used to categorize the sentiment of tweets as positive, negative, or neutral. We identified tweets that mentioned COVID-19, the UK NICE guidelines, and key themes identified through latent Dirichlet allocation (ie, fibromyalgia, research, and treatment). We sampled 1000 random tweets from each theme to identify subthemes and representative quotes.

Results: We retrieved 906,404 tweets, of which 427,824 (47.2%) were neutral, 369,371 (40.75%) were negative, and 109,209 (12.05%) were positive. Over time, both the proportion of negative and positive tweets increased, and the proportion of neutral tweets decreased (P<.001 for all changes). Tweets mentioning fibromyalgia acknowledged similarities with ME/CFS, stigmatization associated with both disorders, and lack of effective treatments. Treatment-related tweets often described frustration with ME/CFS labeled as mental illness, dismissal of concerns by health care providers, and the need to seek out “good physicians” who viewed ME/CFS as a physical disorder. Tweets on research typically praised studies of biomarkers and biomedical therapies, called for greater investment in biomedical research, and expressed frustration with studies suggesting a biopsychosocial etiology for ME/CFS or supporting management with psychotherapy or graduated activity. Tweets about the UK NICE guidelines expressed frustration with the 2007 version that recommended cognitive behavioral therapy and graded exercise therapy, and a prolonged campaign by advocacy organizations to influence subsequent versions. Tweets showed high acceptance of the 2021 UK NICE guidelines, which were seen to validate ME/CFS as a biomedical disease and recommended against graded exercise therapy. Tweets about COVID-19 often noted overlaps between post-COVID-19 condition and ME/CFS, including claims of a common biological pathway, and advised there was no cure for either condition.

Conclusions: Our findings suggest research is needed to inform how best to support patients’ engagement with evidence-based care. Furthermore, while patient involvement with ME/CFS research is critical, unmanaged intellectual conflicts of interest may threaten the trustworthiness of research efforts.

Source: Khakban I, Jain S, Gallab J, Dharmaraj B, Zhou F, Lokker C, Abdelkader W, Zeraatkar D, Busse JW. Impact of the COVID-19 Pandemic and the 2021 National Institute for Health and Care Excellence Guidelines on Public Perspectives Toward Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Thematic and Sentiment Analysis on Twitter (Rebranded as X). J Med Internet Res. 2025 May 21;27:e65087. doi: 10.2196/65087. PMID: 40397934. https://www.jmir.org/2025/1/e65087 (Full text)

The PACE Trial’s GET Manual for Therapists Exposes the Fixed Incremental Nature of Graded Exercise Therapy for ME/CFS

Abstract:

The British National Institute for Health and Care Excellence (NICE) published its updated guidelines for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in October 2021. 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. An article by White et al., which is written by 51 researchers, claims that there are eight anomalies in the review process and the interpretation of the evidence by NICE. In this article, we reviewed the evidence they used to support their claims.

Their three most important claims are that NICE redefined the disease, that CBT and GET are effective, and that fixed incremental increases are not part of GET. However, our analysis shows that the disease was not redefined by NICE. Instead, it was redefined in the 1990s by a group of doctors, including a number of authors of White et al., when they erased the main characteristic of the disease (an abnormally delayed muscle recovery after trivial exertion, which, over the years, has evolved into post-exertional malaise) and replaced it with chronic disabling severe fatigue. Their own studies show that CBT and GET do not lead to a substantial improvement of the quality-of-life scores or a reduction in CFS symptom count, nor do they lead to objective improvement.

Also, both treatments have a negative instead of a positive effect on work and disability status. Moreover, a recent systematic review, which included one of the authors of White et al., showed that ME/CFS patients remain severely disabled after treatment with CBT. Our analysis of, for example, the PACE trial’s GET manual for therapists exposes the fixed incremental nature of GET.

Why the authors are not aware of that is unclear because eight of them were involved in the PACE trial. Three of them were centre leaders and its principal investigators, four others were also centre leaders, and another one was one of the three independent safety assessors of the trial. Moreover, many of these eight authors wrote, or were involved in writing, this manual.

In conclusion, our analysis shows that the arguments that are used to claim that there are eight anomalies in the review process and the interpretation of the evidence by NICE are anomalous and highlight the absence of evidence for the claims that are made. Furthermore, our analysis not only exposes the fixed incremental nature of GET, but also of CBT for ME/CFS.

Source:Vink M, Partyka-Vink K. The PACE Trial’s GET Manual for Therapists Exposes the Fixed Incremental Nature of Graded Exercise Therapy for ME/CFS. Life (Basel). 2025 Apr 2;15(4):584. doi: 10.3390/life15040584. PMID: 40283139. https://www.mdpi.com/2075-1729/15/4/584 (Full text)

Confirmed: The Conclusion by NICE that CBT is not an Effective Treatment for ME/CFS; Re-Analysis of a Systematic Review

Abstract:

In this article, we analyzed the systematic review by Kuut et al. into the efficacy of cognitive behavioral therapy (CBT) for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a disease that predominantly affects women, and the eight trials
in it. We found many issues with the studies in the review, but also with the review itself.

For example, the systematic review by Kuut et al. included a researcher who was involved in seven of the eight studies in their review, and another one who was involved in five of them. Moreover, at least one of them was involved in every study in the review. On top of that, the three professors who were involved in the systematic review, have all built their career on the CB model and the reversibility of ME/CFS through CBT and GET and two of the systematic reviewers have a potential financial conflict of interest. Yet they failed to inform the readers about these conflicts of interest. Conducting a review in this manner and not informing the readers, undermines the credibility of a systematic review and its conclusion.

Regarding outcome differences between treatment and control group, it’s highly likely that the combination of non-blinded
trials, subjective outcomes and poorly chosen control groups, alone or together with response shift bias and/or patients filling in questionnaires in a manner to please the investigators, allegiance bias, small study effect bias and other forms of bias,
produced the appearance of positive effects, despite the lack of any substantial benefit to the patients, leading to the erroneous inference of efficacy in its absence. That CBT is not an effective treatment is highlighted by the fact that patients remained
severely disabled after treatment with it.

The absence of objective improvement as shown by the actometer, employment status and objective cognitive measures, confirms the inefficacy of CBT for ME/CFS. The systematic review did not report on safety but research by the Oxford Brookes University shows that CBT, which contains an element of graded exercise therapy, is harmful for many patients. Finally, our reanalysis highlights the fact that researchers should not mark their own homework.

Source: Vink M, Vink-Niese A. Confirmed: The Conclusion by NICE that CBT is not an Effective Treatment for ME/CFS; Re-Analysis of a Systematic Review. SciBase Neurol. 2024; 2(3): 1022. https://www.scibasejournals.org/neurology/1022.pdf (Full text)

NICE guideline on ME/CFS: robust advice based on a thorough review of the evidence

Abstract:

In 2021, the National Institute for Health and Care Excellence produced an evidence-based guideline on the diagnosis and management of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), a disabling long-term condition of unknown cause. The guideline provides clear support for people living with ME/CFS, their families and carers, and for clinicians. A recent opinion piece published in the journal suggested that there were anomalies in the processing and interpretation of the evidence when developing the guideline and proposed eight areas where these anomalies were thought to have occurred. We outline how these opinions are based on a misreading or misunderstanding of the guideline process or the guideline, which provides a balanced and reasoned approach to the diagnosis and management of this challenging condition.

Source: Barry PW, Kelley K, Tan T, et al. NICE guideline on ME/CFS: robust advice based on a thorough review of the evidence. Journal of Neurology, Neurosurgery & Psychiatry Published Online First: 28 February 2024. doi: 10.1136/jnnp-2023-332731 https://jnnp.bmj.com/content/early/2024/02/28/jnnp-2023-332731 (Full text)

Re: What happens inside a long covid clinic?

Dear Editor

As a patient with severe long covid and myalgic encephalomyelitis (M.E.), I was pleased to see the article ‘What happens in a long covid clinic?’ [1] raising awareness of the scale and impact of long covid and the importance of long covid clinics. According to a recent estimate by Altmann et al, 1 in 10 people who contract COVID-19 will be affected by long covid, whilst the oncoming impact of long covid on health systems, populations and economies will be “so large as to be unfathomable”.[2]

Around 2-14% of patients with long covid develop orthostatic tachycardia six to eight months after COVID infection and as many as 60% show some symptoms of POTS. [3] Yet there remain no agreed guidelines for POTS in long covid, making the early diagnosis and management of the condition in primary care challenging. NICE guidance on long covid only mentions POTS in passing with no information on management.[4] The approach outlined by Espinosa-Gonzalez and colleagues to diagnose and manage POTS in primary care could greatly improve function and health for people with POTS.[5]

While I commend the excellent NHS services highlighted in the feature [1], as a patient with severe long covid I would question how prevalent this integrated medically-led care model is across the country despite it being in the ‘The NHS plan for improving long covid services’.[6] Many patients I speak to in long covid support groups report long waits, only to then be offered basic wellbeing classes or rehabilitation without any active treatment for symptoms.

Access to clinics for the most severely affected is variable with not all services offering remote consultations or home visits. It is imperative that long covid clinics are medically led, inter-disciplinary and able to prescribe medications. Additionally, we need the same standard of care for patients with ME/CFS, who are still waiting for NICE guidance from 2021[7] to be implemented. A recent survey noted there remain significant gaps in provision for patients with ME/CFS.[8]

Previously young fit and healthy patients with severe long covid and ME are being left bed-bound without adequate diagnosis, support, care or treatment as there is no specialty or service that is set up to provide this. I went from climbing mountains and working on-call to unable to stand or feed myself in the space of 8 weeks with long covid – I am still severely affected a year later. Given the multi-system complexity of long covid and ME/CFS it is time for an interdisciplinary patient-centred service for post-viral illnesses that recognises the biological nature of the disease and the unique challenges patients with severe long covid and ME have with safely accessing services given their limited energy available, severe cognitive effects, physical immobility and range of complications across bodily systems.

The Department of Health and Social Care are currently seeking views on the interim delivery plan for ME/CFS care in an online consultation [9], which is relevant to both patient groups and professionals and could lay the groundwork for more comprehensive care of post-viral illnesses in the UK.

Yours sincerely,

Dr Alexis Gilbert BSc MBBS MPH FFPH

Source: MJ 2023;382:p1791 https://www.bmj.com/content/382/bmj.p1791/rr (Full text)

Severe myalgic encephalomyelitis/chronic fatigue syndrome in children and young people: a British Paediatric Surveillance Unit study

Abstract:

Objectives: Primary objective: to determine the point prevalence and incidence rate of severe myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in children aged 5-16 years over 13 months.

Secondary objectives: to describe the demographic features, symptoms, impact on activities of daily living, school attendance and time to diagnosis.

Design: Prospective surveillance study conducted by the British Paediatric Surveillance Unit. Paediatricians was asked if they had assessed a child with severe ME/CFS (screening definition for prevalence and incidence: children (5-16 years) diagnosed with ME/CFS so severe that they are unable to attend school for more than 1 hour a week during the last 6 weeks of the school term).

Participants: Patients 5-16 years of age, seen by paediatricians and two large ME/CFS specialist services across the UK and Ireland.

Outcome measures: Paediatrician-completed questionnaires describing demographics, symptoms, function and treatment, (applying National Institute for Health and Care Excellence (NICE)-recommended criteria to assess severity of ME/CFS). Diagnosis of severe, probable severe or possible severe ME/CFS was made only with evidence of NICE-recommended screening blood tests.

Results: 285 cases were reported, of which of which 33 were severe, 4 probable severe and 55 possible severe. Estimated prevalence was 3.2 per million children (95% CI 2.2 to 4.5). Including possible/probable severe ME/CFS gave 8.9 per million children (95% CI 7.2 to 11). The incidence rate was 0.90 per million children-years (95% CI 0.43 to 1.65) (1.97 per million children-years (95% CI 1.24 to 2.99)). Median age was 13 years and 58% of cases were female. Median time to diagnosis was 0.47 years.

Conclusions: Although the incidence of children presenting with severe ME/CFS is low, all were very disabled. In addition, the majority receive little or no education. Paediatricians need to consider how to provide rehabilitation and education for these disabled young people.

Source: Royston AP, Rai M, Brigden A, Burge S, Segal TY, Crawley EM. Severe myalgic encephalomyelitis/chronic fatigue syndrome in children and young people: a British Paediatric Surveillance Unit study. Arch Dis Child. 2022 Dec 1:archdischild-2022-324319. doi: 10.1136/archdischild-2022-324319. Epub ahead of print. PMID: 36456114. https://adc.bmj.com/content/early/2022/11/30/archdischild-2022-324319 (Full text)

What Primary Care Practitioners Need to Know about the New NICE Guideline for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in Adults

Abstract:

The new NICE guideline for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), published in October 2021, makes significant changes in treatment recommendations. It acknowledges the complexity of this chronic medical condition, which always impacts quality of life and can be profoundly disabling, recognising the prejudice and stigma that people with ME/CFS often experience in the absence of any specific diagnostic test.

The guideline outlines steps for accurate diagnosis, recognising post-exertional malaise as a core symptom; importantly, ME/CFS can now be diagnosed after just 3 months in a bid to improve long-term health outcomes. It recommends the need for individual, tailored management by a multi-disciplinary team, ensuring that the wellbeing of the individual is paramount. The guideline makes clear that any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy (GET), should not be offered as a treatment for ME/CFS and emphasises that cognitive behavioural therapy (CBT) should only be offered as a supportive intervention.

Because of the rigorous methodology required by NICE Committee review and the inclusion of the testimony of people with lived experience as committee members, this guideline will influence the future diagnosis and management of ME/CFS in the UK and beyond.

Source:  Kingdon, C.C.; Lowe, A.; Shepherd, C.; Nacul, L. What Primary Care Practitioners Need to Know about the New NICE Guideline for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in Adults . Preprints 2022, 2022110016 (doi: 10.20944/preprints202211.0016.v1).  https://www.preprints.org/manuscript/202211.0016/v1 (Full text available as PDF file)

Unpaid carers are the missing piece in treatment guidelines and research priorities for ME/CFS

Dear Editor,

The recent publication of a new NICE Guideline1 , an All-Party Parliamentary Group Report (APPG)2, and new Research Priorities3 heralds a dramatic shift in approaches and attitudes to Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS) in the UK. Largely ignored in all three publications, however, are unpaid carers (known outside the UK as family carers or caregivers). The vast majority of people with ME/CFS rely on their families for care and many of those families have been the driving force behind the changes to research and treatment
that are now unfolding.

There has been limited research on unpaid care in the specific context of ME/CFS, but the few existing studies clearly show that the usual toll of caring for a sick or disabled family member is compounded by the historic prejudice surrounding ME/CFS and the absence of evidence-based treatments.g.4-7.

While we applaud the commitment of NICE, the APPG, and the Priority Setting Partnership, it may still be decades before biomedical breakthroughs are made or translated into effective, widely available treatments for ME/CFS8. In the meantime, families will continue to provide the majority of
care for people with ME/CFS and bear the physical, psychological, and economic scars of doing so.

The new NICE guideline does recommend support for carers, but the supports it recommends are generic. They will do little to address the unique needs of ME/CFS carers or their systemic mistreatment by health and social care professionals. A change in the UK’s approach to ME/CFS is long overdue, but without a focus on unpaid carers the puzzle will always be missing a piece. The wellbeing of carers must also be a priority in ME/CFS
research and effective strategies must be developed to address their needs, and recognise and respect their expertise, in clinical practice and social care.

Kind regards,

Dr Siobhan O’Dwyer, University of Exeter Medical School
Ms Sarah Boothby, Former Carer
Dr Georgia Smith, University of Exeter Medical School
Dr Lucy Biddle, Bristol Medical School
Dr Nina Muirhead, Buckinghamshire NHS Trust
Dr Sharmila Khot, Cardiff and Vale University Health Board

Source: O’Dwyer S, Boothby S, Smith G, Biddle L, Muirhead N, Khot S. Unpaid carers are the missing piece in treatment guidelines and research priorities for ME/CFS. BMJ. 2022 Jul 14;378:o1691. doi: 10.1136/bmj.o1691. PMID: 35835467.  https://ore.exeter.ac.uk/repository/bitstream/handle/10871/130699/BMJ_Letter_ODwyer.pdf?sequence=3 (Text available as PDF file)

Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis

Letter to the Editor:

Sharpe et al. suggest that “the available evidence from randomized trials supports the use of the rehabilitative therapies of CBT and GET for patients with CFS/ME”.1 However, the current NICE guideline on the diagnosis and management of ME/CFS (which replaced the out-of-date guideline CG53 cited by Sharpe et al.) recommends that CBT and GET should not be prescribed as treatments for ME/CFS, due to the lack of evidence of efficacy and concerns about safety.2 As part of the process of updating its guidance, NICE reviewed all the relevant evidence from trials of these therapies. It concluded that none was better than low quality and that most was very low quality.3

It is notable that such therapies were first promoted and prescribed for ME/CFS before any clinical trials had been conducted to assess their efficacy or safety. In 1989, Wessely et al. acknowledged that it “may be correct in some cases” that physical and mental exertion should be avoided by people with ME/CFS, but they went on to recommend behavioural and cognitive therapies which encouraged patients to ignore their symptoms and gradually increase exercise, as there was “as yet no way” to identify the cases where such approaches may be harmful. Furthermore, the authors suggested that “it is reasonable to expect a patient to cooperate with treatment before being labelled as chronically disabled” for the purposes of receiving sickness benefits.4

Sharpe et al. acknowledge that since then CBT and GET have been “the most researched approaches” to treating what they refer to as CFS/ME. However, despite this, they conclude that “more research is needed into these approaches” and that “it would be a disservice to our patients to tell them we have nothing to offer them”.

It is deeply regrettable that, as NICE has concluded, there are currently no proven effective treatments for ME/CFS. However, it would be a far greater disservice to patients to prescribe ineffective and potentially harmful therapies than to tell them the truth. Given the history of how these therapies have been promoted, prescribed and researched, it is perhaps not surprising if some are reluctant to accept the evidence that they do not work and may be harmful. However, as Wilshire et al. concluded in their 2018 reanalysis of the PACE trial data: “The time has come to look elsewhere for effective treatments.”5

Read this article HERE.

Source: Saunders R. Evidence-Based Care for People with Chronic Fatigue Syndrome and Myalgic Encephalomyelitis. J Gen Intern Med. 2022 Jul 5. doi: 10.1007/s11606-022-07715-x. Epub ahead of print. PMID: 35790668. https://link.springer.com/article/10.1007/s11606-022-07715-x (Full text)

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