CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.
‘PACE-Gate’: When clinical trial evidence meets open data access
Science is not always plain sailing and sometimes the voyage is across an angry sea. A recent clinical trial of treatments for chronic fatigue syndrome (the PACE trial) has whipped up a storm of controversy. Patients claim the lead authors overstated the effectiveness of cognitive behavioural therapy and graded exercise therapy by lowering the thresholds they used to determine improvement. In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.
Exercise therapy for chronic fatigue syndrome
Exercise as treatment for adults with chronic fatigue syndrome, What is the aim of this review?, People with chronic fatigue syndrome have long‐lasting fatigue, joint pain, headaches, sleep problems, poor concentration and short‐term memory. These symptoms cause significant disability and distress. We wanted to find out whether exercise therapy can help people with chronic fatigue syndrome (myalgic encephalomyelitis)., Key messages, People who have exercise therapy probably have less fatigue at the end of treatment than those who receive more passive therapies. We are uncertain if this improvement lasts in the long term. We are also uncertain about the risk of serious side effects from exercise therapy., What was studied in the review?, We explored whether exercise therapy can reduce chronic fatigue syndrome symptoms. We searched for studies comparing the effect of exercise therapy with treatment as usual or other therapies., What are the main results of the review?, We found eight studies with 1518 participants. The studies compared participants who received exercise therapy to participants who received treatment as usual or more active treatments such as cognitive behavioural therapy., Participants had exercise therapy for 12 weeks to 26 weeks. The studies measured the effect of the therapy at the end of the treatment and also long term, after 50 or 72 weeks. Participants exercised at different levels of intensity using variations of aerobic exercising such as walking, swimming or cycling., Exercise therapy compared to treatment as usual or relaxation, Participants who have exercise therapy probably have less fatigue at the end of treatment, and they may have moderately better physical functioning. We are uncertain if these improvements last long term because we are very uncertain about the evidence., Participants who have exercise therapy may have slightly better sleep, both at the end of treatment and long term., We are uncertain about the risk of serious side effects and the effects of exercise therapy on pain, quality of life, and depression. This is because we lack evidence or because we are very uncertain about the evidence., Exercise therapy compared to cognitive behavioural therapy, Exercise therapy may make little or no difference to participants’ fatigue at end of treatment or in the long term. Exercise therapy may make little or no difference to participants’ physical functioning at end of treatment, but the long‐term effect on physical functioning is uncertain., No studies looked at the effect of exercise therapy on depression at the end of treatment, but it probably has little or no long‐term effect., We are uncertain about the risk of side effects. We are also uncertain about the effects on pain, quality of life, or sleep. This is because we lack evidence or because we are very uncertain about the evidence., Exercise therapy compared to adaptive pacing (living within limits), Participants who have exercise therapy may have slightly less fatigue and depressive symptoms and slightly better physical functioning and sleep at the end of treatment and long term than participants who have adaptive pacing., We are uncertain about the risk of serious side effects. We are also uncertain about the effect on quality of life or pain. This is because we lack evidence or we are very uncertain about the evidence., Exercise therapy compared to antidepressants, We are uncertain if exercise therapy is better than antidepressants at reducing fatigue. We are also uncertain of its effect on depression, side effects, pain, physical functioning, quality of life or sleep. This is because we lack evidence or we are very uncertain about the evidence., Why is this review important?, Exercise therapy is recommended by treatment guidelines and often used as treatment for people with chronic fatigue syndrome. People with chronic fatigue syndrome should have the opportunity to make informed decisions about their care and treatment based on robust research evidence and whether exercise therapy is effective, either as a stand‐alone intervention or as part of a treatment plan., It is important to note that the evidence in this review is from people diagnosed with 1994 criteria of the Centers for Disease Control and Prevention or the Oxford criteria. People diagnosed using other criteria may experience different effects.
Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review
The analysis of the 2017 Cochrane review reveals flaws, which means that contrary to its findings, there is no evidence that graded exercise therapy is effective. Because of the failure to report harms adequately in the trials covered by the review, it cannot be said that graded exercise therapy is safe. The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.
The negative impact of the psychiatric model of chronic fatigue syndrome on doctors’ understanding and management of the illness
Background: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a disabling condition that greatly impacts the lives of sufferers. Many sufferers report problems getting a confirmatory d...
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Essentials of Diagnosis and Management
Despite myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) affecting millions of people worldwide, many clinicians lack the knowledge to appropriately diagnose or manage ME/CFS. Unfortunately, clinical guidance has been scarce, obsolete, or potentially harmful. Consequently, up to 91% of patients in the United States remain undiagnosed, and those diagnosed often receive inappropriate treatment. These problems are of increasing importance because after acute COVID-19, a significant percentage of people remain ill for many months with an illness similar to ME/CFS.
Patient-reported treatment outcomes in ME/CFS and long COVID
Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and long COVID are persistent multisystem illnesses affecting many patients. With no known effective FDA-approved treatments for either condition, patient-reported outcomes of treatments may prove helpful in identifying management strategies that can improve patient care and generate new avenues for research. Here, we present the results of an ME/CFS and long COVID treatment survey with responses from 3,925 patients. We assess the experiences of these patients with more than 150 treatments in conjunction with their demographics, symptoms, and comorbidities. Treatments with the greatest perceived benefits are identified. Patients with each condition who participated in the study shared similar symptom profiles, including all the core symptoms of ME/CFS, e.g., 89.7% of ME/CFS and 79.4% of long COVID reported postexertional malaise (PEM). Furthermore, treatment responses between these two patient groups were significantly correlated (R 2 = 0.68). Patient subgroups, characterized by distinct symptom profiles and comorbidities, exhibited increased responses to specific treatments, e.g., a POTS-dominant cluster benefiting from autonomic modulators and a cognitive-dysfunction cluster from CNS stimulants. This study underscores the symptomatic and therapeutic similarities between ME/CFS and long COVID and highlights the commonalities and nuanced complexities of infection-associated chronic diseases and related conditions. While this study does not provide recommendations for specific therapies, in the absence of approved treatments, insights from patient-reported experiences provide urgently needed real-world evidence for developing targeted patient care therapies and future clinical trials.
Research update: The relation between ME/CFS disease burden and research funding in the USA
BACKGROUND: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a debilitating, chronic, multisystem disease that affects an estimated 1 to 2.5 milli...
Medical Care Situation of People with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in Germany
Background and Objective: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) is a severe illness with the hallmark symptom of Post-Exertional Malaise (PEM). Currently, no biomarkers or established diagnostic tests for ME/CFS exist. In Germany, it is estimated that over 300,000 people are affected by ME/CFS. Research from the United States and the UK shows that patients with ME/CFS are medically underserved, as they face barriers to medical care access and are dissatisfied with medical care. The first aim of the current research was to investigate whether patients with ME/CFS are medically underserved in Germany in terms of access to and satisfaction with medical care. Second, we aimed at providing a German-language version of the DePaul Symptom Questionnaire Short Form (DSQ-SF) as a tool for ME/CFS diagnostics and research in German-speaking countries. Materials and Methods: The current research conducted an online questionnaire study in Germany investigating the medical care situation of patients with ME/CFS. The questionnaire was completed by 499 participants who fulfilled the Canadian Consensus Criteria and reported PEM of 14 h or longer. Results: Participants frequently reported geographic and financial reasons for not using the available medical services. Furthermore, they reported low satisfaction with medical care by the physician they most frequently visited due to ME/CFS. The German version of the DSQ-SF showed good reliability, a one-factorial structure and construct validity, demonstrated by correlations with the SF-36 as a measure of functional status. Conclusions: Findings provide evidence that patients with ME/CFS in Germany are medically underserved. The German-language translation of the DSQ-SF provides a brief, reliable and valid instrument to assess ME/CFS symptoms to be used for research and clinical practice in German-speaking countries. Pathways to improve the medical care of patients with ME/CFS are discussed.
Rethinking the Standard of Care for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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Dismissing chronic illness: A qualitative analysis of negative health care experiences
In the US, medical training is inadequate regarding the symptomatology, prognosis, and treatment for myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS). As a result, many physicians lack the appropriate level of knowledge about effective methods for ME and CFS symptom reduction and often suggest inappropriate treatments, such as increased exercise or psychiatric services. The authors’ purpose in this study was to analyze negative patient experiences with health care professionals. Patients with ME and CFS who reported experiencing a dismissive physician attitude were asked to detail the encounter via open-ended response on an international, online survey. Participant responses were thematically coded and analyzed using processes outlined by Patton. Emergent themes related to perceived physician attitudes and how they impact patient wellbeing are described and their implications discussed. Additionally, we highlight suggestions for how the health care system can effectively approach this often marginalized patient group.
Patterns of Utilization of Medical Care and Perceptions of the Relationship between Doctor and Patient with Chronic Illness Including Chronic Fatigue Syndrome
To what extent do personal constructs affect the relationship between doctor and patient when the ill patient does not readily recover with treatment? Questionnaires were returned anonymously by 609 patients with a self-reported diagnosis of chronic fatigue syndrome, who were considered chronically ill. Findings were compared with those of an earlier study of a population of 397 general medical patients. The chronically ill patients lost an average of 65 days of work per year due to illness compared to general medical patients who missed six or fewer days per year because they were ill. The chronically ill patients also reported a 66% higher frequency of iatrogenic illness, spent more money on health care, took more medication, saw more specialists, and were more litigious than the general medical population. Research suggested several patterns of relationships between doctors and patients, and attitudes to health and illness, which may alert doctors to patients' perceptions, beliefs, encoded constructs, and patterns of relating that affect responses to treatment. More attention by doctors to patients who are experiencing the stress of chronic illness is indicated.
Long-term maintenance treatment with 300 mg thiamine for fatigue in patients with inflammatory bowel disease: results from an open-label extension of the TARIF study
OBJECTIVE AND AIMS: Fatigue is common in inflammatory bowel disease (IBD). In a RCT we demonstrated reductions in fatigue after 4 weeks' treatment with high-dose oral thiamine. We aimed to investigate whether 300 mg thiamine daily for 12 weeks could maintain the achieved levels of fatigue in patients with IBD after a 4-week intervention with high-dose thiamine; and evaluate the effect of a 6-month period where patients were free to take oral thiamine. METHODS: A randomised, open-label, controlled trial, performed as a long-term extension (LTE) study of an initial randomised, high-dose thiamine trial. Patients were allocated 1:1 to 300 mg oral thiamine or no thiamine for 12 weeks. Subsequently, the patients were allowed to self-treat with over-the-counter (OTC) oral thiamine 6-month. RESULTS: Regardless of allocation in the LTE study fatigue severity increased in the study period. No significant effect of 300 mg oral thiamine were found, when stratifying for initial allocation in the high-dose study or fatigue level at entry in the LTE study. Patients who took OTC thiamine had lower level of fatigue 6 month later (7.8; 95% CI: 5.5-10.1) when compared to the remains (11.0; 95% CI: 9.2-12.8) (p = .02). After the 6-months follow-up without restrictions, 66% of patients had reached normal fatigue levels. CONCLUSIONS: We found no beneficial effect on fatigue from thiamine taken in doses of 300 mg per day for 12 weeks following high-dose treatment. After a 6-months follow-up without restrictions 66% had reached a normal level of fatigue. CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov under study identifier NCT03634735.
Shadow Burden of Undiagnosed Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) on Society: Retrospective and Prospective—In Light of COVID-19
Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a poorly understood, complex, multisystem disorder, with severe fatigue not alleviated by rest, and other symptoms, which lead to substantial reductions in functional activity and quality of life. Due to the unclear aetiology, treatment of patients is complicated, but one of the initial problems is the insufficient diagnostic process. The increase in the number of undiagnosed ME/CFS patients became specifically relevant in the light of the COVID-19 pandemic. The aim of this research was to investigate the issues of undiagnosed potential ME/CFS patients, with a hypothetical forecast of the expansion of post-viral CFS as a consequence of COVID-19 and its burden on society. Methods: The theoretical research was founded on the estimation of classic factors presumably affecting the diagnostic scope of ME/CFS and their ascription to Latvian circumstances, as well as a literature review to assess the potential interaction between ME/CFS and COVID-19 as a new contributing agent. The empirical study design consisted of two parts: The first part was dedicated to a comparison of the self-reported data of ME/CFS patients with those of persons experiencing symptoms similar to ME/CFS, but without a diagnosis. This part envisaged the creation of an assumption of the ME/CFS shadow burden “status quo”, not addressing the impact of COVID-19. The second part aimed to investigate data from former COVID-19 patients’ surveys on the presence of ME/CFS symptoms, 6 months after being affected by COVID-19. Descriptive and analytical statistical methods were used to analyse the obtained data. Results: The received data assumed that the previously obtained data on the ME/CFS prevalence of 0.8% in the Latvian population are appropriate, and the literature review reports a prevalence of 0.2–1.0% in developed countries. Regarding the reciprocity of ME/CFS and COVID-19, the literature review showed a lack of research in this field. The empirical results show quite similar self-esteem among ME/CFS patients and undiagnosed patients with longstanding disease experience, while former COVID-19 patients show a significantly lower severity of these problems. Notably, “psychological distress (anxiety)” and “episodic fatigue” are significantly predominant symptoms reported by former COVID-19 patients in comparison with ME/CFS patients and undiagnosed patients prior to the COVID-19 pandemic. The results of our analysis predict that the total amount of direct medical costs for undiagnosed patients (out-of-pocket payments) is more than EUR 15 million p.a. (in Latvia), and this may increase by at least 15% due to the consequences of COVID-19. Conclusions: ME/CFS creates a significant shadow burden on society, even considering only the direct medical costs of undiagnosed patients—the number of whom in Latvia is probably at least five times higher than the number of discerned patients. Simultaneously, COVID-19 can induce long-lasting complications and chronic conditions, such as post-viral CFS, and increase this burden. The Latvian research data assume that ME/CFS patients are not a high-risk group for COVID-19; however, COVID-19 causes ME/CFS-relevant symptoms in patients. This increases the need for monitoring of patients for even longer after recovering from COVID-19′s symptoms, in order to prevent complications and the progression of chronic diseases. In the context of further epidemiological uncertainty, and the possibility of severe post-viral consequences, preventive measures are becoming significantly more important; an integrated diagnostic approach and appropriate treatment could reduce this burden in the future.
Shadow Burden of Undiagnosed Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) on Society: Retrospective and Prospective—In Light of COVID-19
Background: Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a poorly understood, complex, multisystem disorder, with severe fatigue not alleviated by rest, and other symptoms, which lead to substantial reductions in functional activity and quality of life. Due to the unclear aetiology, treatment of patients is complicated, but one of the initial problems is the insufficient diagnostic process. The increase in the number of undiagnosed ME/CFS patients became specifically relevant in the light of the COVID-19 pandemic. The aim of this research was to investigate the issues of undiagnosed potential ME/CFS patients, with a hypothetical forecast of the expansion of post-viral CFS as a consequence of COVID-19 and its burden on society. Methods: The theoretical research was founded on the estimation of classic factors presumably affecting the diagnostic scope of ME/CFS and their ascription to Latvian circumstances, as well as a literature review to assess the potential interaction between ME/CFS and COVID-19 as a new contributing agent. The empirical study design consisted of two parts: The first part was dedicated to a comparison of the self-reported data of ME/CFS patients with those of persons experiencing symptoms similar to ME/CFS, but without a diagnosis. This part envisaged the creation of an assumption of the ME/CFS shadow burden “status quo”, not addressing the impact of COVID-19. The second part aimed to investigate data from former COVID-19 patients’ surveys on the presence of ME/CFS symptoms, 6 months after being affected by COVID-19. Descriptive and analytical statistical methods were used to analyse the obtained data. Results: The received data assumed that the previously obtained data on the ME/CFS prevalence of 0.8% in the Latvian population are appropriate, and the literature review reports a prevalence of 0.2–1.0% in developed countries. Regarding the reciprocity of ME/CFS and COVID-19, the literature review showed a lack of research in this field. The empirical results show quite similar self-esteem among ME/CFS patients and undiagnosed patients with longstanding disease experience, while former COVID-19 patients show a significantly lower severity of these problems. Notably, “psychological distress (anxiety)” and “episodic fatigue” are significantly predominant symptoms reported by former COVID-19 patients in comparison with ME/CFS patients and undiagnosed patients prior to the COVID-19 pandemic. The results of our analysis predict that the total amount of direct medical costs for undiagnosed patients (out-of-pocket payments) is more than EUR 15 million p.a. (in Latvia), and this may increase by at least 15% due to the consequences of COVID-19. Conclusions: ME/CFS creates a significant shadow burden on society, even considering only the direct medical costs of undiagnosed patients—the number of whom in Latvia is probably at least five times higher than the number of discerned patients. Simultaneously, COVID-19 can induce long-lasting complications and chronic conditions, such as post-viral CFS, and increase this burden. The Latvian research data assume that ME/CFS patients are not a high-risk group for COVID-19; however, COVID-19 causes ME/CFS-relevant symptoms in patients. This increases the need for monitoring of patients for even longer after recovering from COVID-19′s symptoms, in order to prevent complications and the progression of chronic diseases. In the context of further epidemiological uncertainty, and the possibility of severe post-viral consequences, preventive measures are becoming significantly more important; an integrated diagnostic approach and appropriate treatment could reduce this burden in the future.
New Treatment Guideline, Same Old Denialism
The science is clear. CBT and GET are not useful treatments for ME/CFS. But cognitive dissonance is a powerful force, and we can fully expect continued denials from the conspiratorial fringe
I couldn’t sleep, then I tried cognitive shuffling | Psyche Notes to Self
The usual advice didn’t help my sleep problems, but then I tried an exercise that kickstarts the sleep-onset control system
