dr charles shepherd isle of man september 2015 me/cfs: research, diagnosis and management
TRANSCRIPT
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Dr Charles ShepherdISLE OF MAN
September 2015ME/CFS: Research, Diagnosis and Management
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BioPersonal experience of PVFS++ following
chickenpox + cerebellar encephalitic component
PMH in hospital psychiatry
Medical Adviser, ME Association
MRC Expert Group on ME/CFS Research
>> UK CMRC
CMO Working Group
DWP Fluctuating Conditions Group
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Disagreements, uncertainty, consensus…
Background: WHO, DoH, DWP, NICE, MRC, Royal Colleges all accept this is a genuine and disabling illness BUT…
1 Nomenclature: ME, CFS, PVFS, SEID
2 Over 20 Clinical and Research definitions: Fukuda, Oxford, NICE, Canadian…..
3 Cause: Physical>>P+P> Psychological
4 Diagnosis: Often a long delay in making a diagnosis
5 Management: Rituximab >>> CBT and GET
Result: ME/CFS rather like calling any form of arthritis a chronic joint pain syndrome and assuming they all have the same cause/disease pathway and management
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What is ME/CFS? Often fit young adults; children and adolescents as well
Acute onset often following infection or immune system stressor - vaccination
Muscle: exercise-induced fatigue and…..
Post- exertional exacerbation of symptoms
CNS: cognitive dysfunction: memory concentration info processing word finding
Problems with balance, thermoregulation, alcohol intolerance
ANS dysfunction: O intolerance, O hypotension and POTS; Ryynaud’s
Immune system: sore throats and glands
Pain in approx 75%: muscles, joints, neuropathic
Non restorative sleep
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Epidemiology of ME/CFSPrevalence of 0.2 to 0.4% = ? 250,000 in UK,
?200 to 300 in IoM (pop 85,000)
Commonest cause of long term sickness absence from school
Adults onset: early 20s to mid 40s
All social classes
Strong female predominance
Spectrum of severity: 25% severe at some stage >> severely neglected by the NHS
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Royal Free disease 1955 >> Lancet editorial: ME
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Middlesex Hospital: McEvedy and Beard, BMJ 1970 >> mass hysteria
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Chickenpox
Working in hospital medicine………….
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Personal experienceExtremely fit young adult
Well motivated
Infection ‘pre spots’ >> 48 hours >> exercise induced muscle fatigue, brain (balance/OI and cognitive++) and flu-like: not deconditioning
Two years to get a diagnosis
Well meaning but very bad management++
Work >> off sick >> work
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1980s: ME >> CFSUS and UK decision to rename and redefine ME as CFS
>> Now over 20 diagnostic criteria for both clinical and research purposes
UK: Oxford research (>> 2014 NIH report recommended removal), NICE clinical guideline (2007)
US: 1994 Fukuda/CDC research
Canadian, London (ME), International, IoM (2015)……
>> Messy compromise of ME/CFS: represents a very heterogenous group of clinical presentations and disease pathways
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IoM Report: February 2015Lancet editorial: What’s in a name? (2015,
v385, p663)
Complex, serious multisystem DISEASE process
Rename CFS and ME – systemic exertion intolerance syndrome (SEID)
Mixed reaction from patient community
New clinical definition >>
3 No longer a diagnosis of exclusion
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What causes ME/CFS: A three stage illness?
Consensus: Predisposing factors
Genetic predisposition increases susceptibility >>
Consensus: Precipitating factors
Viral infections++ other immune system stressors, including vaccinations – hepatitis B+ >> abnormal host response
Gradual onset in up to 25%
Debate: Perpetuating factors>>
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Evidence for cytokine mediated fatigue??
Viral infection >> low level immune system activation
MRC at KCH: what happens to people with hepatitis C who are treated with interferon alpha and develop ME/CFS symptoms as a result?
Hornig/Lipkin: Science Advances, 1 February 2015. Early cases (< 3 years) had a prominent activation in both pro- and anti-inflammatory cytokines (IL17a+). Correlation of cytokine alterations with illness duration suggesting immunopathology of ME/CFS is not static.
Link to neuroinflammation through activated microglia?
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Is ME/CFS a Neuroimmune Disease??
>> Neuroendocrine dysfunction >> HPA downregulation and hypocortisolaemia
Neurotransmitter dysfunction >> ?serotonin
Autonomic NS dysfunction >> orthostatic intolerance and POTS/postural orthostatic tachycardia syndrome
Low level neuroinflammation
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Neuroinflammation: Japanese group
PET scans: neuroinflammation is higher in CFS/ME patients than in healthy people.
Inflammation in cingulate cortex, hippocampus, amygdala, thalamus, midbrain, and pons elevated in a way that correlates with symptoms >>
Impaired cognition>> amygdala
Pain >> thalamic.
Ref: Nakatomi et al. Journal of Nuclear Medicine, 2014, 55, 945 – 950.
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Ref: Nakatomi et al.JNM , 2014, 55, 945 - 950
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Dorsal root ganglionitis
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Is there a peripheral Mitochondrial component
to peripheral fatigue??
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Prof Anne McArdle, University of Liverpool
Arnold DL et al. Lancet, 1984, 1367 – 1369: Excessive intracellular acidosis of skeletal muscle on exercise in a patient with post viral fatigue syndrome (CS)
Defect in energy producing component leads to fatigue….
But does the presence of dysfunctional mitochondria then activate a process that leads to chronic low grade inflammation?
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Research Initiatives……MRC Expert Group on ME/CFS Research
Identified research priorities including immune dysfunction and neuroinflammation
>> 5 MRC funded studies costing £1.5m+
>>UK CFS/ME Research collaborative
2015 conference in Newcastle in October
£££ Charity funding: ME biobank
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Diagnosis
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Consensus: Early and accurate diagnosis
Timescale for diagnosis and management:
First three months of post viral fatigue >> PVFS, which is often self resolving but can >> ME/CFS
NICE and CMO WG: Working diagnosis of ME/CFS if symptoms persist beyond 3 to 4 months and no other explanation found. Don’t wait 6 months!
Referral to hospital based services >> CMO report >>postcode lottery
High rate of late diagnosis and misdiagnosis >>Newton et al, p23 MEA purple booklet
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Consensus: Routine investigations for TATT:
NAD ESR + CRP/C reactive protein
FBC +/- serum ferritin in adolescents
Biochemistry: urea, electrolytes, calcium, creatinine, random blood sugar
Liver function tests > ?PBC, ?hepatitis C ?NAFLD – raised transaminases, link to Gilbert’s syndrome
Creatine kinase – ?hypothyroid myopathy
Thyroid function tests and 9am cortisol
Screen for coeliac disease - tissue transglutaminase antibody >> arthralgia, fatigue, IBS, mouth ulcers
Urinalysis for protein, blood and glucose
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In some circumstances….
Pursue abnormal LFTSs: primary biliary cirrhosis (anti mitochondrial antibodies); Gilbert’s syndrome, NAFLD
Raised calcium: ? sarcoidosis
Joint pain+ Autoantibody screen for ? SLE (anti nuclear antibodies, anti DNA antibodies, complement)
Infectious diseases: hep C (blood transfusion), Lyme; HIV, Q fever (contact with sheep), toxoplasmosis
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In some circumstances….Dry eyes and dry mouth > ? Sjogren’s syndrome
(Schirmer’s test for dry eyes)
Low cortisol and suggestion of Addison’s (hypotension; low sodium; raised potassium) >> synacthen test
Autonomic function tests >> tilt table test for POTS
Muscle biopsy or MRS?
Serum 25-hydroxyvitamin D (25-OHD) if at risk: restrictive diet; lack of sunlight; severe condition
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Debate: How should we manage ME/CFS patients
Correct diagnosis > label > validation > uncertainties
Specialist referral +/-
2007 NICE guideline on ME/CFS
Activity management >> time and expertise
Symptomatic relief
Drugs aimed at underlying disease process
Help with education, employment
DWP benefits: ESA
Information and support: MEA Management Report
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2007 NICE GuidelineHeavily criticised by patients for ‘one size fits all’
recommendations re CBT and GET
Place on ‘static list’ in 2014
June 2014: Professor Mark Baker acknowledged that the guideline did need to be revised
>> decision rests with NHS England
NIH report 2015: ….behaviour therapy or graded exercise are not a primary treatment strategy and should only be used as a component of multimodal therapy
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Debate + Pacing vs GET Aim: balance rest with activity = Pacing
Depends on Stage, Severity, Variability and symptoms such as autonomic and cognitive dysfunction
Establish a comfortable baseline: physical and cognitive
May involve increase/decrease in overall activity
Gradual and flexible increases
[Rest] >>> [Activity] >> [Rest]
Accept progress may be slow and erratic
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Pacing vs GET – patient evidence
GRADED EXERCISE THERAPY > More structured and progressive increase
Clinical trial evidence +ve, including PACE trial
MEA Management Report: N = 906
22% improved; 22% no change; 56% worse
MEA: Abandon as a primary intervention
PACING
Clinical trial evidence –ve/not there
Patient evidence +++
N = 2137: 72% improved; 24% no change; 4% worse
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Cognitive behaviour therapy
Covers approaches based on abnormal illness beliefs/behaviours >> practical coping strategies
RCT evidence: some +ve
MEA Patient Evidence (N =998):
26% improved; 55% no benefit; 19% worse
MEA Report: Help people who are having difficulty coping with ME/CFS and/or mental health problems
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Consensus: Drugs for symptomatic relief
ANS dysfunction and POTS
IBS symptomatology
Nausea
Pain
Non restorative sleep
NOT for fatigue, cognitive dysfunction
Depression, Psychosocial distress….
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ANS dysfunctionOrthostatic intolerance very common
POTS may occur: rise in pulse to over 120/min or 30 bpm on supine to standing
Referral for tilt table testing?
Self-help measures >>
Increase hydration
Salt where low blood pressure
Drugs?? Midodrine??
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IBS and nauseaVery common overlap
Exclude other explanations of fatigue + IBS:– coeliac; ovarian malignancy
IBS-C; IBS-D and IBS mixed
Drug approaches depending on type
Dietary approaches
FODMAP diet:
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Pain management Spectrum of severity
Muscular, arthralgic and neuropathic
OTC analgesics often of limited value
Low dose sedating tricyclic >> ? liquid prep (25mg/5ml)
Duloxetine/Cymbalta >> fibromyalgic component
Anticonvulsants: Gabapentin and Pregabalin
Opiates? Tramadol
Non-drug options: acupuncture; TENS machine; relaxation
Referral to pain clinic?
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Non restorative sleepDifferent types of sleep disturbance
Sleep hygiene
Short-acting hypnotics
Low dose sedating tricyclic – eg amitriptyline 10mg to 30mg
Melatonin??
MRC clinical trial of sodium oxybate
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Mental health problemsCan co-exist
Depression > psychological approaches first
Drugs: commence with low dose and increase slowly
Tricyclics – limited role due to sedation/side-effects
SSRIs – with care as some very sensitive to low doses
No evidence from RCTs that antidepressants are an effective form of treatment for ME/CFS
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Some problems with RCTs in relation to ME/CFS
Not blinded
Often rely of self-reported outcome measures
Often fail to include objective outcome measures such as actographs, disability benefit and employment status
Specialist centre treatment is not the same as what happens out in the real world
Results do not match consistent patient evidence
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Can we treat underlying disease process? Not yet!
Antiviral medication: valganciclovir?
Immunotherapy: cytokine inhibition/Etanercept?
Neuroendocrine: cortisone? thyroxine NO!
Central fatigue: modafinil?
Recent clinical trials:
Ampligen – antiviral and immunomodulatory
Rituximab >>
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Rituximab
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RituximabAnti-CD20 antibody >> B cell depletion
Used to treat lymphoma
Significant response in 3 lymphoma cases with ME/CFS
MOA? removal autoantibodies or reactivated infection
Norwegian RCT 30 placebo/30 treated >> significant benefits
Expensive
Potential to cause serious++ side effects
Norwegian phase 3 trial underway but not yet replicated
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Other key aspects of management
DWP Benefits – ESA, PIP
Education
Employment and occupational health
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Key messages >>>Name that doctors and patients agree on
Practical simple clinical definition (?IoM)
Early and accurate diagnosis + proper investigation
Pragmatic management guidance that is not based on the ‘one size fits all’ hypothesis
NHS in patient and domiciliary services that cater for the severe end of the spectrum
Research definition that recognises the heterogeneity of disease pathways involved and facilitates sub-grouping
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