The primary goals of management are to provide a supportive healthcare environment with a team of occupational therapists, physiotherapists, and other appropriate therapists who will manage symptoms and improve functional capacity.
Primary care clinicians play a key role in management of patients with ME/CFS, typically retaining responsibility for long-term care and monitoring, in partnership with the ME/CFS specialist team in secondary care. A key role of the primary care clinician is to liaise with other health, social care, and educational professionals in response to specific evolving patient needs, and to facilitate access to resources in the community (e.g., physiotherapy, occupational therapy, dietetic support, and district nursing staff visits) as guided by disease severity and individual need.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
The National Institute for Health and Care Excellence (NICE) recommends that adults with ME/CFS receive a review of their care and support plan in primary care at least once a year; review at least every 6 months is recommended for children and young people with ME/CFS. More frequent primary care reviews should be arranged as needed, with the interval dependent on the severity and complexity of symptoms, and the effectiveness of symptom management.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Referral to the person's named contact in the ME/CFS secondary care team is required if new or deteriorating aspects of their condition develop.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
A possible strategy may be to provide counsel to patients every 3 months and to reassess any other health issues and treatable diseases.
General considerations
The primary goals of treatment are to manage symptoms and improve functional capacity; with symptom-oriented support, patients may experience improvements over time, or they may learn to better manage the effects of illness.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
The evidence base for ME/CFS treatments is limited.[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
There are no curative medications or treatments for ME/CFS. No drug therapies have been licensed for ME/CFS, and there is no evidence showing that any single drug therapy regimen is more effective than another.[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
After infectious and medical causes have been excluded, a treatment plan can be developed with the patient. Initial treatment should be individualised based on the spectrum of most severe complaints. One approach is to focus on the most severe symptoms and address each one at a time through a series of scheduled visits.
Initial treatment begins with rehabilitation and supportive care. Treatments for ME/CFS are palliative and restorative; there are no curative treatments. Time and patience are required to assist the newly diagnosed patient in developing the skills needed to cope with this debilitating condition. A supportive family, medical team, and home environment will facilitate adaptation to a new diagnosis of ME/CFS and its management.
Some patients with ME/CFS may already be established on a complicated and extensive treatment regimen. A general treatment strategy may involve a stepwise process of simplifying the treatment regimen across time (e.g., gradually reducing the number of medications). Treatment interventions tend to be multidimensional and tailored to each person’s circumstances. The focus of treatment should be oriented towards symptom management and functional improvement, and away from repeated, extensive diagnostic procedures, or ongoing referrals to additional specialists.
The provision of reliable educational materials may be useful, and can help with empowering the patient for self-management.
NHS: ME/CFS
Opens in new window
Treatment controversies and uncertainties: graded exercise therapy (GET)
Historically, treatment has been complicated by strong differences in opinion between people with ME/CFS and their support groups compared with medical specialists, as well as differences in opinion among specialists.[184]White P, Abbey S, Angus B, et al. Anomalies in the review process and interpretation of the evidence in the NICE guideline for chronic fatigue syndrome and myalgic encephalomyelitis. J Neurol Neurosurg Psychiatry. 2023 Dec;94(12):1056-63.
http://www.ncbi.nlm.nih.gov/pubmed/37434321?tool=bestpractice.com
[185]Mallet M, King E, White PD. A UK based review of recommendations regarding the management of chronic fatigue syndrome. J Psychosom Res. 2016 Sep;88:33-5.
http://www.ncbi.nlm.nih.gov/pubmed/27521650?tool=bestpractice.com
Further complexity has arisen owing to a historical lack of consensus about ME/CFS diagnostic criteria and about treatment approaches across Europe and around the world.[186]Strand EB, Nacul L, Mengshoel AM, et al. Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS): investigating care practices pointed out to disparities in diagnosis and treatment across European Union. PLoS One. 2019 Dec 5;14(12):e0225995.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0225995
http://www.ncbi.nlm.nih.gov/pubmed/31805176?tool=bestpractice.com
Although previous randomised controlled trials (RCTs) have reported benefits to structured GET in the management of ME/CFS, a re-analysis by Cochrane in 2019 highlighted the presence of methodological flaws. Concerns about the potential for iatrogenic harm with GET have been noted, owing to inadequate reporting of harms within RCTs.[187]Larun L, Brurberg KG, Odgaard-Jensen J, et al. Exercise therapy for chronic fatigue syndrome. Cochrane Database Syst Rev. 2019 Oct 2;(10):CD003200.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD003200.pub8/full
http://www.ncbi.nlm.nih.gov/pubmed/31577366?tool=bestpractice.com
[188]Geraghty K, Hann M, Kurtev S. Myalgic encephalomyelitis/chronic fatigue syndrome patients' reports of symptom changes following cognitive behavioural therapy, graded exercise therapy and pacing treatments: analysis of a primary survey compared with secondary surveys. J Health Psychol. 2019 Sep;24(10):1318-33.
http://www.ncbi.nlm.nih.gov/pubmed/28847166?tool=bestpractice.com
[189]Marks DF. Special issue on the PACE Trial. J Health Psychol. 2017 Aug;22(9):1103-5.
https://journals.sagepub.com/doi/10.1177/1359105317722370
http://www.ncbi.nlm.nih.gov/pubmed/28805511?tool=bestpractice.com
The possibility of iatrogenic harm with GET is supported by results of 2-day maximal exercise stress tests, where ME/CFS patients do well on the first day, but have reduced cardiopulmonary function on the second day, followed by exacerbation of fatigue and other ME/CFS symptoms.[111]Keller BA, Pryor JL, Giloteaux L. Inability of myalgic encephalomyelitis/chronic fatigue syndrome patients to reproduce VO₂peak indicates functional impairment. J Transl Med. 2014 Apr 23;12:104.
https://translational-medicine.biomedcentral.com/articles/10.1186/1479-5876-12-104
http://www.ncbi.nlm.nih.gov/pubmed/24755065?tool=bestpractice.com
[164]Loy BD, O'Connor PJ, Dishman RK. Effect of acute exercise on fatigue in people with ME/CFS/SEID: a meta-analysis. Med Sci Sports Exerc. 2016 Oct;48(10):2003-12.
https://journals.lww.com/acsm-msse/Fulltext/2016/10000/Effect_of_Acute_Exercise_on_Fatigue_in_People_with.18.aspx
http://www.ncbi.nlm.nih.gov/pubmed/27187093?tool=bestpractice.com
Graded exercise may be particularly counter-productive in severe and/or bed-bound ME/CFS because the treatment may induce post-exertional malaise (PEM) and prolonged exercise-induced exacerbations.
Dissenting opinion about the safety and efficacy of GET has led to uncertainty among clinicians as to how best to support patients in safely managing their activity and exercise levels. Fundamental gaps in the evidence regarding GET in ME/CFS remain, and a full update of the Cochrane review is currently in progress.[190]Cochrane. News: publication of Cochrane review: 'Exercise therapy for chronic fatigue syndrome'. Oct 2019 [internet publication].
https://www.cochrane.org/news/publication-cochrane-review-exercise-therapy-chronic-fatigue-syndrome
Based on these concerns, GET is no longer recommended as a treatment for ME/CFS by the NICE guidelines, or by the US Centers for Disease Control and Prevention (CDC).[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
[191]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: treatment of ME/CFS. Jan 2021 [internet publication].
https://www.cdc.gov/me-cfs/treatment/index.html
With respect to this decision, the NICE guideline development committee cites reports of harm in the qualitative evidence, as well as the committee's experience of the effects when people exceed their energy limit.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Many patients and clinicians now favour an alternative approach to managing activity levels in ME/CFS, referred to as ‘energy management’ or ‘pacing’, which involves carefully planning activities and rest to avoid overexertion (PEM). Note that energy management is intended as a possible coping strategy for people with ME/CFS, rather than as a curative therapy. The evidence for energy management is largely anecdotal, based on patient experience and clinical observation. This approach is supported by NICE in the UK, as well as by the CDC and the National Institutes of Health (NIH) in the US, and the European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE).[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
[145]Green CR, Cowan P, Elk R, et al. National Institutes of Health Pathways to Prevention workshop: advancing the research on myalgic encephalomyelitis/chronic fatigue syndrome. Ann Intern Med. 2015 Jun 16;162(12):860-5.
https://www.acpjournals.org/doi/10.7326/M15-0338?articleid=2322804
http://www.ncbi.nlm.nih.gov/pubmed/26075757?tool=bestpractice.com
[192]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: treating the most disruptive symptoms first and preventing worsening of symptoms. Apr 2021 [internet publication].
https://www.cdc.gov/me-cfs/healthcare-providers/clinical-care-patients-mecfs/treating-most-disruptive-symptoms.html
NICE emphasises the importance in the absence of clinical consensus to provide clarity of information and clear guidance around energy management, physical activity, and exercise to people with ME/CFS; this topic aligns with this pragmatic approach.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Note: NICE defines graded exercise therapy as "establishing a baseline of achievable exercise or physical activity and then making fixed incremental increases in the time spent being physically active. It is a therapy based on the deconditioning and exercise avoidance theories of ME/CFS." In practice, some patients with ME/CFS may tolerate a carefully individualised activity plan developed in collaboration with knowledgeable and experienced professionals: for example, those who feel ready to progress their physical activity beyond their current levels, and/or those who would like to incorporate physical activity or exercise into managing their ME/CS.[23]International Association for Chronic Fatigue Syndrome/Myalgic Encephalomeyelitis. Chronic fatigue syndrome/myalgic encephalomeyelitis: primer for clinical practitioners. 2014 [internet publication].
https://growthzonesitesprod.azureedge.net/wp-content/uploads/sites/1869/2020/10/Primer_Post_2014_conference.pdf
The activity plan must aim to minimise the negative effects of exertion on impaired aerobic and cognitive function. See the section Multidisciplinary support.
Multidisciplinary support
NICE guidance suggests that good care for people with ME/CFS results from access to an integrated team of health and social care professionals trained and experienced in managing ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
According to the NICE guidelines, it is necessary to undertake a thorough assessment of the person with ME/CFS to inform a care and support plan to improve health outcomes. This may include support for activities of daily living, developing self-management strategies, guidance on managing potential relapse, and encouraging flexible work commitments. It is essential that service providers are proactive and recommend flexibility for those with severe or very severe ME/CFS: specifically, by offering home visits or online or phone consultations, and by supporting applications for disability aids and appliances.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
NICE recommends referring people with ME/CFS to a physiotherapist or occupational therapist working in an ME/CFS specialist team if they:[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
have difficulties caused by reduced physical activity or mobility, or
feel ready to progress their physical activity beyond their current activities of daily living, or
would like to incorporate a physical activity or exercise programme into managing their ME/CFS.
Mobility support
As the primary physician it is important to promptly encourage assessment and access to occupational therapy for home adaptation for people with moderate to very severe ME/CFS. These aids may include, but are not limited to:
Disability parking
Wheelchairs
Motorised scooters
Shower chairs
Stairlifts
In addition, physiotherapy may support physical symptoms of ME/CFS. Physiotherapy is offered as a management approach and is not a proven treatment option. Furthermore, physiotherapy is to be closely monitored and guided by a physiotherapist with interest or training in ME/CFS and tailored to the individual concerns of the patient.
Structured GET is not recommended, owing to the potential for iatrogenic harm.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
However, patients with ME/CFS may tolerate an individualised activity plan developed in collaboration with knowledgeable and experienced professionals.[23]International Association for Chronic Fatigue Syndrome/Myalgic Encephalomeyelitis. Chronic fatigue syndrome/myalgic encephalomeyelitis: primer for clinical practitioners. 2014 [internet publication].
https://growthzonesitesprod.azureedge.net/wp-content/uploads/sites/1869/2020/10/Primer_Post_2014_conference.pdf
The activity plan must aim to minimise the negative effects of exertion on impaired aerobic and cognitive function.
Energy management/pacing
The concept of an 'energy envelope', as outlined by NICE guidelines, provides people with ME/CFS with a strategy to manage their exertional tolerance.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
The energy envelope refers to the amount of energy that the patient has available to perform all of their daily activities.[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
The size of the energy envelope needs to be defined on a daily basis because resources and tolerance can vary from day to day and depending on other life stressors. Exceeding the energy envelope depletes these reserves and leads to post-exertional worsening of symptoms and of cognitive and physical functioning. The patient and practitioner can work together to recognise personal energy limits and set reasonable limits on activities.
'Pacing' refers to a self-management strategy whereby individuals divide activities into smaller parts with interspersed rest intervals in order to remain within the limits of the envelope.[23]International Association for Chronic Fatigue Syndrome/Myalgic Encephalomeyelitis. Chronic fatigue syndrome/myalgic encephalomeyelitis: primer for clinical practitioners. 2014 [internet publication].
https://growthzonesitesprod.azureedge.net/wp-content/uploads/sites/1869/2020/10/Primer_Post_2014_conference.pdf
[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
[193]Friedberg F, Sunnquist M, Nacul L. Rethinking the standard of care for myalgic encephalomyelitis/chronic fatigue syndrome. J Gen Intern Med. 2020 Mar;35(3):906-9.
https://link.springer.com/article/10.1007%2Fs11606-019-05375-y
http://www.ncbi.nlm.nih.gov/pubmed/31637650?tool=bestpractice.com
As a general guide, patients are encouraged to keep their heart rate at less than 70% of the age-predicted maximum. Planned organisation of efforts is important to avoid doing harm by exceeding the limitations of the energy envelope.[194]Jason LA, Brown M, Brown A, et al. Energy conservation/envelope theory interventions to help patients with myalgic encephalomyelitis/chronic fatigue syndrome. Fatigue. 2013 Jan 14;1(1-2):27-42.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3596172
http://www.ncbi.nlm.nih.gov/pubmed/23504301?tool=bestpractice.com
While pacing may introduce a coping strategy for some patients, this is not a therapy and may not improve or alleviate the symptoms of ME/CFS, and should be undertaken with the guidance of a physician or nurse practitioner. Successful pacing is believed to be the most beneficial management strategy for ME/CFS according to NICE, the CDC, and the NIH.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
[145]Green CR, Cowan P, Elk R, et al. National Institutes of Health Pathways to Prevention workshop: advancing the research on myalgic encephalomyelitis/chronic fatigue syndrome. Ann Intern Med. 2015 Jun 16;162(12):860-5.
https://www.acpjournals.org/doi/10.7326/M15-0338?articleid=2322804
http://www.ncbi.nlm.nih.gov/pubmed/26075757?tool=bestpractice.com
[192]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: treating the most disruptive symptoms first and preventing worsening of symptoms. Apr 2021 [internet publication].
https://www.cdc.gov/me-cfs/healthcare-providers/clinical-care-patients-mecfs/treating-most-disruptive-symptoms.html
The aim is to optimise the patient’s ability to maintain activities of daily living and community/society participation.
It is important to highlight that structured GET is not recommended to accompany pacing strategies.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
However, patients with ME/CFS may tolerate an individualised activity plan developed in collaboration with knowledgeable and experienced professionals.[23]International Association for Chronic Fatigue Syndrome/Myalgic Encephalomeyelitis. Chronic fatigue syndrome/myalgic encephalomeyelitis: primer for clinical practitioners. 2014 [internet publication].
https://growthzonesitesprod.azureedge.net/wp-content/uploads/sites/1869/2020/10/Primer_Post_2014_conference.pdf
The activity plan must aim to minimise the negative effects of exertion on impaired aerobic and cognitive function.
Environmental modifications
People with ME/CFS commonly report sensitivities to light, noise, and odours, and are often diagnosed with comorbid multiple chemical sensitivities. Therefore, it may be pertinent to discuss encouraging the following to limit impact of the environment on symptoms:
Psychosocial interventions
Cognitive behavioural therapy (CBT) may be offered to adults, children, and young people with ME/CFS who would like to use it to support them in managing their symptoms.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Mindfulness is an alternative psychosocial approach recommended for symptom relief in ME/CFS by European ME/CFS guidance.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
Protocols for techniques including CBT or a mindfulness approach are not standardised as there are significant differences in outcomes between different countries and different studies depending on their inclusion criteria. Studies of CBT in people with ME/CFS report significant improvements in mental health scores, fatigue scores, and 6-minute walking, but effect sizes were low and were not corrected for multiple comparisons.[195]O'Dowd H, Gladwell P, Rogers CA, et al Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme. Health Technol Assess. 2006 Oct;10(37):iii-iv, ix-x, 1-121.
http://www.ncbi.nlm.nih.gov/pubmed/17014748?tool=bestpractice.com
[196]Ingman T, Smakowski A, Goldsmith K, et al. A systematic literature review of randomized controlled trials evaluating prognosis following treatment for adults with chronic fatigue syndrome. Psychol Med. 2022 Oct;52(14):2917-29.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693680
http://www.ncbi.nlm.nih.gov/pubmed/36059125?tool=bestpractice.com
Internet-supported CBT is an emerging approach that has shown initially promising results, and that may help facilitate access for people with difficulties attending face-to-face appointments.[197]Andersson G, Rozental A, Shafran R, et al. Long-term effects of internet-supported cognitive behaviour therapy. Expert Rev Neurother. 2018 Jan;18(1):21-8.
http://www.ncbi.nlm.nih.gov/pubmed/29094622?tool=bestpractice.com
It is important to highlight that the offer of psychosocial interventions does not reflect the belief that ME/CFS is of psychological aetiology; psychosocial interventions should be offered with considerable care to avoid distress.[198]Geraghty KJ, Blease C. Cognitive behavioural therapy in the treatment of chronic fatigue syndrome: a narrative review on efficacy and informed consent. J Health Psychol. 2018 Jan;23(1):127-38.
http://www.ncbi.nlm.nih.gov/pubmed/27634687?tool=bestpractice.com
Rather, these techniques have been beneficial in people suffering other chronic diseases. For example, in patients who have been chronically ill, mindfulness skills have a positive effect on depression, mood, and activity level.[199]Merkes M. Mindfulness-based stress reduction for people with chronic diseases. Aust J Prim Health. 2010;16(3):200-10.
http://www.ncbi.nlm.nih.gov/pubmed/20815988?tool=bestpractice.com
This approach facilitates the person with ME/CFS to identify unhelpful negative emotion-provoking thoughts, dysfunctional behaviours, and cognitive patterns, and uses a goal-oriented, systematic procedure to enhance self-esteem. CBT may help in dealing with a new diagnosis of ME/CFS, improve coping strategies, and assist with rehabilitation. CBT should be offered not as a 'cure' for ME/CFS but to support people to manage their symptoms and to refine self-management strategies to improve functioning and quality of life.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
In routine medical practice CBT has not yielded clinically significant long-term benefits in ME/CFS.[196]Ingman T, Smakowski A, Goldsmith K, et al. A systematic literature review of randomized controlled trials evaluating prognosis following treatment for adults with chronic fatigue syndrome. Psychol Med. 2022 Oct;52(14):2917-29.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9693680
http://www.ncbi.nlm.nih.gov/pubmed/36059125?tool=bestpractice.com
Family sessions can help educate and inform spouses, children, parents, and other significant people about the disabling nature of ME/CFS.[200]Verspaandonk J, Coenders M, Bleijenberg G, et al. The role of the partner and relationship satisfaction on treatment outcome in patients with chronic fatigue syndrome. Psychol Med. 2015 Aug;45(11):2345-52.
http://www.ncbi.nlm.nih.gov/pubmed/25732090?tool=bestpractice.com
NICE stipulates that CBT should only be delivered by a healthcare professional with appropriate training and experience in CBT for ME/CFS, and under the clinical supervision of someone with expertise in CBT for ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Although referral to mental health services with expertise in CBT has been recommended regardless of ME/CFS severity, this is limited by a lack of availability in some settings of a qualified CBT psychologist, social worker, nurse, or other practitioner with ME/CFS training.
CBT may also be helpful in the treatment of comorbid depression and/or anxiety and insomnia. See the section Management of common symptoms/comorbidities below.
Further resources providing psychosocial support may be available through ME/CFS support groups. Successful support groups have effective leadership and positive programming that avoids simply exchanging complaints.
Management of common symptoms/comorbidities
Evidence regarding the management of common symptoms and comorbidities is limited, and there are few randomised double-blind placebo-controlled studies of treatments for ME/CFS to direct logical treatment.[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
Choice of drug should be based on the side-effect profile of the drug and the patient's initial response to treatment. Please note that drug treatments are sometimes used off-label and should be managed carefully to prevent synergistic or other adverse events; specialist advice (from a clinician experienced in managing ME/CFS) is recommended. Given that some patients with ME/CFS may have hypersensitivity to medication adverse effects, starting drug treatment at a low sub-therapeutic dose, and gradually increasing to therapeutic levels over time as tolerated, is usually recommended.[201]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: monitoring the use of all medicines and supplements. Jul 2018 [internet publication].
https://www.cdc.gov/me-cfs/healthcare-providers/clinical-care-patients-mecfs/monitoring-medication.html
The most recent update to the NICE guidelines for ME/CFS emphasises that no medicines or supplements are to be offered as a cure for ME/CFS; several pharmaceutical agents have been removed from the guideline compared with its previous iteration.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Fatigue, PEM, and cognitive disturbance
According to the CDC, NICE, and the Mayo Clinic, pacing provides the most beneficial approach to reducing the burden of fatigue and PEM in ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
[192]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: treating the most disruptive symptoms first and preventing worsening of symptoms. Apr 2021 [internet publication].
https://www.cdc.gov/me-cfs/healthcare-providers/clinical-care-patients-mecfs/treating-most-disruptive-symptoms.html
[202]Mayo Clinic. Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). May 2023 [internet publication].
https://www.mayoclinic.org/diseases-conditions/chronic-fatigue-syndrome/diagnosis-treatment/drc-20360510
Other supportive measures may include:
Sleep alteration
Sleep difficulties are a major problem, and initial management is to address sleep hygiene. NICE guidance recommends personalised sleep management advice for people with ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
If this is ineffective, evaluate for underlying causes of sleep problems. In the general adult population, CBT for insomnia (CBT-I) is typically recommended as the first-line management option for chronic insomnia.[203]Qaseem A, Kansagara D, Forciea MA, et al. Management of chronic insomnia disorder in adults: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2016 Jul 19;165(2):125-33.
https://www.acpjournals.org/doi/10.7326/M15-2175
http://www.ncbi.nlm.nih.gov/pubmed/27136449?tool=bestpractice.com
Normalisation of the sleep/wake rhythm begins by stopping daytime napping and proceeds to improving the quality of sleep through relaxation therapy. Instruction is provided to prevent relapse.
See Insomnia.
Pain
Rehabilitation and allied health services may provide non-pharmacotherapeutic approaches to pain including acupuncture and massage if touch is tolerated by the patient.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
NICE guidance for ME/CFS refers to the treatment of headache and neuropathic pain, detailing a choice of aspirin, paracetamol, or non-steroidal anti-inflammatory drugs (NSAIDs) (for headache), and amitriptyline, duloxetine, gabapentin, or pregabalin (for other pain in ME/CFS).[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
NICE made the recommendation not to recommend any pharmacological interventions specific to pain in ME/CFS, citing a lack of evidence. The options above referred to by NICE are consistent with those recommended for pain in ME/CFS in European guidance by EUROMENE.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
However, it is important to highlight that there is limited evidence for these pharmacotherapeutic agents for the treatment of pain in ME/CFS through RCTs. Note that pain medications improve pain but do not treat systemic hyperalgesia.
Referral to specialist pain services may be required if pain does not respond to initial management.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
If the initial treatment is not tolerated, pharmacological recommendations for the management of pain in fibromyalgia may be used to guide treatment, in conjunction with specialist pain/ME/CFS/fibromyalgia services.[204]Welsch P, Üçeyler N, Klose P, et al. Serotonin and noradrenaline reuptake inhibitors (SNRIs) for fibromyalgia. Cochrane Database Syst Rev. 2018 Feb 28;(2):CD010292.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD010292.pub2/full
http://www.ncbi.nlm.nih.gov/pubmed/29489029?tool=bestpractice.com
[205]Walitt B, Urrútia G, Nishishinya MB, et al. Selective serotonin reuptake inhibitors for fibromyalgia syndrome. Cochrane Database Syst Rev. 2015 Jun 5;(6):CD011735.
https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011735/full
http://www.ncbi.nlm.nih.gov/pubmed/26046493?tool=bestpractice.com
See Fibromyalgia.
The following should not be offered according to NICE guidelines: cannabis sativa extract, capsaicin transdermal patch, lacosamide, lamotrigine, levetiracetam, morphine, oxcarbazepine, topiramate, tramadol (long-term use), venlafaxine.[206]National Institute for Health and Care Excellence. Neuropathic pain in adults: pharmacological management in non-specialist settings. Sep 2020 [internet publication].
https://www.nice.org.uk/guidance/cg173
Orthostatic intolerance
Orthostatic intolerance even without postural orthostatic tachycardia is a major limiting condition that can be treated with compression stockings, positional changes, and salt loading.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
[207]Bou-Holaigah I, Rowe PC, Kan J, et al. The relationship between neurally mediated hypotension and the chronic fatigue syndrome. JAMA. 1995 Sep 27;274(12):961-7.
http://www.ncbi.nlm.nih.gov/pubmed/7674527?tool=bestpractice.com
Advice on diet, daily activities, and activity support should be tailored to the individual, taking into account their other ME/CFS symptoms.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
There may be a role for fludrocortisone, pyridostigmine, or other drugs used for orthostatic instability in ME/CFS.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
[208]Joseph P, Pari R, Miller S, et al. Neurovascular dysregulation and acute exercise intolerance in myalgic encephalomyelitis/chronic fatigue syndrome: a randomized, placebo-controlled trial of pyridostigmine. Chest. 2022 Nov;162(5):1116-26.
http://www.ncbi.nlm.nih.gov/pubmed/35526605?tool=bestpractice.com
NICE advises that pharmacotherapy for orthostatic intolerance in people with ME/CFS should only be prescribed or overseen by a clinician with expertise in orthostatic intolerance; this is because pharmacotherapy may worsen other symptoms in people with ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Referral to secondary care is warranted if symptoms are severe or worsening, or there are concerns that another condition may be the cause.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
See Postural orthostatic tachycardia syndrome.
Gastrointestinal symptoms
Symptoms akin to irritable bowel syndrome and food intolerances are commonly reported in ME/CFS.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
Monitor patients for malnutrition and unintentional weight loss or gain.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
Dietary modification and food avoidance practices may be recommended in specific circumstances with support from a dietician.[10]Nacul L, Authier FJ, Scheibenbogen C, et al. European Network on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (EUROMENE): expert consensus on the diagnosis, service provision, and care of people with ME/CFS in Europe. Medicina (Kaunas). 2021 May 19;57(5):510.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8161074
http://www.ncbi.nlm.nih.gov/pubmed/34069603?tool=bestpractice.com
However, it should be highlighted that RCTs examining the effects of dietary interventions in ME/CFS have yielded inconsistent results.[209]Campagnolo N, Johnston S, Collatz A, et al. Dietary and nutrition interventions for the therapeutic treatment of chronic fatigue syndrome/myalgic encephalomyelitis: a systematic review. J Hum Nutr Diet. 2017 Jun;30(3):247-59.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5434800
http://www.ncbi.nlm.nih.gov/pubmed/28111818?tool=bestpractice.com
Dietary management is not offered as a cure or treatment but rather as part of a management plan with the aim of minimising the effects of diet on gastrointestinal manifestations.
The NICE guidelines for ME/CFS encourage referring people with ME/CFS for a dietetic assessment and creation of a management plan by a dietitian with a special interest in ME/CFS, if they are:[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
In the event that food avoidance practices and dietary management is not successful, pharmacological interventions may be utilised to improve gastrointestinal symptoms.
See Irritable bowel syndrome.
Co-existing depression or anxiety
For comorbid anxiety or depression, CBT ± antidepressants may be helpful, in keeping with the management of depression and anxiety for the general population.[210]Karyotaki E, Smit Y, de Beurs DP, et al. The long-term efficacy of acute-phase psychotherapy for depression: a meta-analysis of randomized trials. Depress Anxiety. 2016 May;33(5):370-83.
http://www.ncbi.nlm.nih.gov/pubmed/27000501?tool=bestpractice.com
[211]Health Quality Ontario. Psychotherapy for major depressive disorder and generalized anxiety disorder: a health technology assessment. Ont Health Technol Assess Ser. 2017 Nov 13;17(15):1-167.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5709536
http://www.ncbi.nlm.nih.gov/pubmed/29213344?tool=bestpractice.com
There is no evidence to suggest that antidepressants help with PEM, cognitive dysfunction, orthostatic intolerance, or other cardinal features of ME/CFS. Choice of antidepressant drug for comorbid depression or anxiety should be based on the treatment history, the adverse-effect profile of the drug, and the patient's initial response to treatment.
A suicide evaluation is standard practice for all patients who appear to be clinically depressed or highly stressed. In one UK-based study, suicide-specific mortality was found to be significantly increased in patients with ME/CFS compared with the general population, indicating the need for physician awareness and compassionate care.[212]Roberts E, Wessely S, Chalder T, et al. Mortality of people with chronic fatigue syndrome: a retrospective cohort study in England and Wales from the South London and Maudsley NHS Foundation Trust Biomedical Research Centre (SLaM BRC) Clinical Record Interactive Search (CRIS) Register. Lancet. 2016 Apr 16;387(10028):1638-43.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2901223-4/fulltext
http://www.ncbi.nlm.nih.gov/pubmed/26873808?tool=bestpractice.com
Possible adverse effects of standard treatments for depression include sedation, orthostatic hypotension, and increased appetite and weight gain, which may worsen fatigue and autonomic lability in some patients. Based on clinical experience, difficulties in achieving necessary amounts of exercise mean that people with ME/CFS may experience exaggerated adverse effects such as weight gain that may promote iatrogenic type 2 diabetes and metabolic syndrome with associated long-term health consequences.
Improvements with drug therapy may take several weeks, but more severe levels of depression may predict a slower treatment response.[213]Wearden AJ, Dunn G, Dowrick C, et al. Depressive symptoms and pragmatic rehabilitation for chronic fatigue syndrome. Br J Psychiatry. 2012 Sep;201(3):227-32.
http://www.ncbi.nlm.nih.gov/pubmed/22844025?tool=bestpractice.com
See Depression in adults, Depression in children, Generalised anxiety disorder, and Suicide risk mitigation.
Further-line treatments
In the event that a person with ME/CFS desires pharmacological intervention when rehabilitation and support strategies have been unsuccessful, pharmacological interventions targeting fatigue and cognitive disturbances may be considered by a specialist in ME/CFS following risk-benefit analysis.
The NICE guidelines for ME/CFS highlight that the evidence for these agents is limited and of very low quality. Ultimately, NICE has recommended that many of these pharmaceuticals should not be used for the treatment of ME/CFS.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206
It is essential to highlight that no pharmacological interventions can be offered as a treatment or cure for ME/CFS; however, based on clinical experience, they may provide some relief.
Given that some patients with ME/CFS may have hypersensitivity to medication adverse effects, starting drug treatment at a low sub-therapeutic dose, and gradually increasing to therapeutic levels over time as tolerated, is usually recommended.[201]Centers for Disease Control and Prevention. Myalgic encephalomyelitis/chronic fatigue syndrome: monitoring the use of all medicines and supplements. Jul 2018 [internet publication].
https://www.cdc.gov/me-cfs/healthcare-providers/clinical-care-patients-mecfs/monitoring-medication.html
Further-line pharmaceutical agents that are sometimes prescribed in secondary care for cognitive disturbances and fatigue (based on very low-quality evidence) include modafinil, amantadine, and methylphenidate.[214]Garg H, Douglas M, Turkington GD, et al. Recovery from refractory chronic fatigue syndrome with CBT and modafinil. BMJ Case Rep. 2021 Mar 22;14(3):e240283.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986944
http://www.ncbi.nlm.nih.gov/pubmed/33753384?tool=bestpractice.com
[215]Randall DC, Cafferty FH, Shneerson JM, et al. Chronic treatment with modafinil may not be beneficial in patients with chronic fatigue syndrome. J Psychopharmacol. 2005 Nov;19(6):647-60.
http://www.ncbi.nlm.nih.gov/pubmed/16272188?tool=bestpractice.com
[216]Pliszka AG. Modafinil: a review and its potential use in the treatment of long COVID fatigue and neurocognitive deficits. Am J Psychiatry Resid J. 2022 Jun 28;17(4):5-7.
https://ajp.psychiatryonline.org/doi/10.1176/appi.ajp-rj.2022.170402
[217]Meirleir KD, McGregor N. Canadian chronic fatigue syndrome guidelines. J Chronic Fatigue Syndrome. 2003;11(1).
https://www.investinme.org/Documents/PDFdocuments/CanadianDefinitionME-CFS.pdf
[218]Blockmans D, Persoons P. Long-term methylphenidate intake in chronic fatigue syndrome. Acta Clin Belg. 2016 Dec;71(6):407-14.
http://www.ncbi.nlm.nih.gov/pubmed/27351244?tool=bestpractice.com
Note that amantadine in particular is associated with several adverse events, and may be poorly tolerated.[217]Meirleir KD, McGregor N. Canadian chronic fatigue syndrome guidelines. J Chronic Fatigue Syndrome. 2003;11(1).
https://www.investinme.org/Documents/PDFdocuments/CanadianDefinitionME-CFS.pdf
Further-line agents that are sometimes prescribed for sleep disturbance include trazodone, low-dose tricyclic antidepressants, and cyclobenzaprine. Evidence on these drugs specific to ME/CFS is lacking.[219]Morillas-Arques P, Rodriguez-Lopez CM, Molina-Barea R, et al. Trazodone for the treatment of fibromyalgia: an open-label, 12-week study. BMC Musculoskelet Disord. 2010 Sep 10;11:204.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2945951
http://www.ncbi.nlm.nih.gov/pubmed/20831796?tool=bestpractice.com
[220]Calandre EP, Morillas-Arques P, Molina-Barea R, et al. Trazodone plus pregabalin combination in the treatment of fibromyalgia: a two-phase, 24-week, open-label uncontrolled study. BMC Musculoskelet Disord. 2011 May 16;12:95.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3112435
http://www.ncbi.nlm.nih.gov/pubmed/21575194?tool=bestpractice.com
[221]Clemons A, Vasiadi M, Kempuraj D, et al. Amitriptyline and prochlorperazine inhibit proinflammatory mediator release from human mast cells: possible relevance to chronic fatigue syndrome. J Clin Psychopharmacol. 2011 Jun;31(3):385-7.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3498825
http://www.ncbi.nlm.nih.gov/pubmed/21532369?tool=bestpractice.com
[222]Tofferi JK, Jackson JL, O'Malley PG. Treatment of fibromyalgia with cyclobenzaprine: a meta-analysis. Arthritis Rheum. 2004 Feb 15;51(1):9-13.
https://onlinelibrary.wiley.com/doi/epdf/10.1002/art.20076
http://www.ncbi.nlm.nih.gov/pubmed/14872449?tool=bestpractice.com
Treatments of uncertain efficacy
Few medications have had beneficial effects on PEM, fatigue, cognitive dysfunction, or long-term sleep disruption in ME/CFS.[223]Collatz A, Johnston SC, Staines DR, et al. A systematic review of drug therapies for chronic fatigue syndrome/myalgic encephalomyelitis. Clin Ther. 2016 Jun;38(6):1263-71.
http://www.ncbi.nlm.nih.gov/pubmed/27229907?tool=bestpractice.com
Pain medications improve pain but do not treat systemic hyperalgesia. No drug therapies have been licensed for ME/CFS. Palliative treatments are instead directed at specific symptoms.
Systematic reviews have examined randomised clinical trials evaluating pharmacological and non-pharmacological treatments for ME/CFS, although in the absence of more definitive studies comparing participants meeting different case definitions, it is difficult to draw clear conclusions from this research.[183]Smith ME, Haney E, McDonagh M, et al. Treatment of myalgic encephalomyelitis/chronic fatigue syndrome: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50.
https://www.acpjournals.org/doi/10.7326/M15-0114
http://www.ncbi.nlm.nih.gov/pubmed/26075755?tool=bestpractice.com
[224]Kim DY, Lee JS, Park SY, et al. Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). J Transl Med. 2020 Jan 6;18(1):7.
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-019-02196-9
http://www.ncbi.nlm.nih.gov/pubmed/31906979?tool=bestpractice.com
RCTs assessing anticholinergics, corticosteroids, and hormones targeted against cardinal symptoms of ME/CFS have produced equivocal findings.[225]Bagnall AM, Whiting P, Richardson R, et al. Interventions for the treatment and management of chronic fatigue syndrome/myalgic encephalomyelitis. Qual Saf Health Care. 2002 Sep;11(3):284-8.
https://qualitysafety.bmj.com/content/11/3/284
http://www.ncbi.nlm.nih.gov/pubmed/12486997?tool=bestpractice.com
RCTs investigating other agents, including immunomodulators or anti-inflammatories, have demonstrated limited safety and efficacy in ME/CFS. Rituximab is a chimeric monoclonal antibody targeting the pan-B-cell antigen CD20.[226]Abdulla NE, Ninan MJ, Markowitz AB. Rituximab: current status as therapy for malignant and benign hematologic disorders. BioDrugs. 2012 Apr 1;26(2):71-82.
http://www.ncbi.nlm.nih.gov/pubmed/22339395?tool=bestpractice.com
Small randomised placebo-controlled and open studies showed improvement rates of 60% to 83% after 22-83 weeks of treatment compared with 7% to 10% in placebo groups.[31]Capelli E, Zola R, Lorusso L, et al. Chronic fatigue syndrome/myalgic encephalomyelitis: an update. Int J Immunopathol Pharmacol. 2010 Oct-Dec;23(4):981-9.
http://www.ncbi.nlm.nih.gov/pubmed/21244747?tool=bestpractice.com
[58]Fluge Ø, Bruland O, Risa K, et al. Benefit from B-lymphocyte depletion using the anti-CD20 antibody rituximab in chronic fatigue syndrome: a double-blind and placebo-controlled study. PLoS One. 2011;6(10):e26358.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0026358
http://www.ncbi.nlm.nih.gov/pubmed/22039471?tool=bestpractice.com
[97]Fluge Ø, Mella O, Bruland O, et al. Metabolic profiling indicates impaired pyruvate dehydrogenase function in myalgic encephalopathy/chronic fatigue syndrome. JCI Insight. 2016 Dec 22;1(21):e89376.
https://insight.jci.org/articles/view/89376
http://www.ncbi.nlm.nih.gov/pubmed/28018972?tool=bestpractice.com
[227]Fluge Ø, Risa K, Lunde S, et al. B-lymphocyte depletion in myalgic encephalopathy/chronic fatigue syndrome: an open-label phase II study with rituximab maintenance treatment. PLoS One. 2015 Jul 1;10(7):e0129898.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0129898
http://www.ncbi.nlm.nih.gov/pubmed/26132314?tool=bestpractice.com
However, one large randomised placebo-controlled study showed no significant treatment benefit and a large placebo effect.[228]ME Association. Negative phase III clinical trial result from Norway for rituximab in ME/CFS. Nov 2017 [internet publication].
https://www.meassociation.org.uk/2017/11/me-association-statement-negative-phase-iii-clinical-trial-result-from-norway-for-rituximab-in-mecfs-27-november-2017
[229]Fluge Ø, Rekeland IG, Lien K, et al. B-Lymphocyte depletion in patients with myalgic encephalomyelitis/chronic fatigue syndrome: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2019 May 7;170(9):585-93.
http://www.ncbi.nlm.nih.gov/pubmed/30934066?tool=bestpractice.com
Rituximab can cause serious adverse events including febrile neutropenia, infusion-related reactions, and other events requiring hospitalisation. Routine use of rituximab is contraindicated in ME/CFS.
The absence of effective therapies indicates a significant need for research to clarify that the emerging treatment aligns with the pathophysiology of ME/CFS. Randomised double-blind placebo-controlled studies will be needed to identify drugs that are beneficial in ME/CFS.
Addressing potential barriers to treatment
In the setting of treatment resistance, the diagnosis should be re-evaluated including the possibility of comorbid conditions.
Factors contributing to sub-optimal engagement with treatment recommendations may include severe fatigue, pain, difficulties in travelling to the physician, and severity of PEM following visits to the physician.
Family, financial, and other conflicts may interfere with the physician-patient relationship. Sleep disruption with reversal of day-night cycles may confound travel plans and appointments. Furthermore, concomitant problems such as irritable bowel syndrome with uncontrolled explosive diarrhoea can be an embarrassment that keeps the person housebound.
Social withdrawal with depression should be addressed, and all such patients asked about suicidal ideation. Management of depression as described above may be of value in these situations. Pain medications can help.
Patients with severe or very severe ME/CFS may be bed-bound and require home visits and in-home therapy sessions because severe pain and discomfort will prevent them from travelling. It is essential that service providers are proactive and recommend flexibility for those with severe or very severe ME/CFS: specifically, by offering home visits or online or phone consultations, and by supporting applications for disability aids and appliances.[8]National Institute for Health and Care Excellence. Myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome: diagnosis and management. Oct 2021 [internet publication].
https://www.nice.org.uk/guidance/ng206