Table 1PICO characteristics of review question

PopulationAdults, children and young people who are diagnosed as having ME/CFS.
Intervention(s)These can include (but are not restricted to):
  • Antidepressants
    • Include all SSRIs / SNRIs and tricyclics
  • Immunomodulatory drugs. For example:
    • Rintatolimod (Ampligen)
    • Rituximab
  • Pro-inflammatory cytokines. For example:
    • Anakinra
  • Sleep medication. For example:
    • Melatonin
  • Pain relief. For example:
    • Pregabalin
    • Gabapentin
    • cannabinoids
  • Antiviral drugs
  • Oral corticosteroids
    • fludrocortisone / hydrocortisone / other steroids
  • Modafinil
  • Sodium Valproate
  • Low dose Naltrexone
Combinations of treatments (including combinations with non-pharmacological treatments) are allowed.
Comparison(s)
  • No treatment
  • Each other (both within and between drug classes)
  • Placebo/control/usual care
  • Non-pharmacological interventions
Outcomes

Longest follow up available:

CRITICAL OUTCOMES:

  • Mortality
  • Quality of life (any validated scales). For example:
    • SF36
    • EQ5D
  • General symptom scales (any validated scales). For example:
    • De Paul Symptom Questionnaire
    • Self-Rated Clinical Global Impression Change Score
  • Fatigue/fatiguability (any validated scales). For example:
    • Chalder fatigue Scale
    • Fatigue Severity Scale
    • Fatigue Impact scale
  • Physical functioning (any validated scales). For example:
    • SF36 physical function
    • SF36 PCS
  • Cognitive function (any validated scales). For example:
    • MMSE
  • Psychological status (any validated scales). For example:
    • Hospital Anxiety and Depression Scale
    • Becks Depression Inventory
  • Pain (VAS/NRS)
  • Sleep quality (any validated scales). For example:
    • Pittsburgh Sleep quality Index
    • Epworth Sleepiness Scale
    • Leeds Sleep Evaluation Questionnaire VAS
  • Treatment-related adverse effects
  • Activity levels – step counts
  • Return to school / work
  • Exercise performance measures. For example:
    • Hand grip
    • Maximal Cycle Exercise Capacity
    • 6 min walk
    • Timed Up and Go
    • 5 repetition sit to stand
    • 40m walk speed
    • Step test
IMPORTANT OUTCOMES:
  • Care needs
  • Impact on families and carers

Study design

  • Randomised controlled trials
  • Systematic review of randomised controlled trials. For a systematic review to be included it must be conducted to the same methodological standard as NICE guideline reviews. If sufficient details are not provided to include a relevant systematic review, the review will be used for citation searching.
Cross-over RCTs will be considered provided the wash-out period is considered adequate.

Non RCTs will not be considered.

From: Pharmacological interventions

Cover of Pharmacological interventions
Pharmacological interventions: Myalgic encephalomyelitis (or encephalopathy) / chronic fatigue syndrome: diagnosis and management: Evidence review F.
NICE Guideline, No. 206.
National Guideline Centre (UK).
Copyright © NICE 2021.

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