title: Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome.
abstract: OBJECTIVE
  Adverse events (AEs) are health related events, reported by participants in clinical trials. We describe AEs in the PACE trial of treatments for chronic fatigue syndrome (CFS) and baseline characteristics associated with them.
  
  
  METHODS
  AEs were recorded on three occasions over one year in 641 participants. We compared the numbers and nature of AEs between treatment arms of specialist medical care (SMC) alone, or SMC supplemented by adaptive pacing therapy (APT), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). We examined associations with baseline measures by binary logistic regression analyses, and compared the proportions of participants who deteriorated by clinically important amounts.
  
  
  RESULTS
  Serious adverse events and reactions were infrequent. Non-serious adverse events were common; the median (quartiles) number was 4 (2, 8) per participant, with no significant differences between treatments (P=.47). A greater number of NSAEs were associated with recruitment centre, and baseline physical symptom count, body mass index, and depressive disorder. Physical function deteriorated in 39 (25%) participants after APT, 15 (9%) after CBT, 18 (11%) after GET, and 28 (18%) after SMC (P<.001), with no significant differences in worsening fatigue.
  
  
  CONCLUSIONS
  The numbers of adverse events did not differ significantly between trial treatments, but physical deterioration occurred most often after APT. The reporting of non-serious adverse events may reflect the nature of the illness rather than the effect of treatments. Differences between centres suggest that both standardisation of ascertainment methods and training are important when collecting adverse event data.
authors.affiliation: East London Foundation NHS Trust, London, UK.
authors.forename: Dominic
authors.initials: D
authors.lastname: Dougall
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK.
authors.forename: Anthony
authors.initials: A
authors.lastname: Johnson
authors.affiliation: Biostatistics Department, Institute of Psychiatry, King's College London, UK.
authors.forename: Kimberley
authors.initials: K
authors.lastname: Goldsmith
authors.affiliation: Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.
authors.forename: Michael
authors.initials: M
authors.lastname: Sharpe
authors.affiliation: Nuffield Department of Medicine, University of Oxford, UK.
authors.forename: Brian
authors.initials: B
authors.lastname: Angus
authors.affiliation: Academic Department of Psychological Medicine, King's College London, UK.
authors.forename: Trudie
authors.initials: T
authors.lastname: Chalder
authors.affiliation: Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK. Electronic address: p.d.white@qmul.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: White
mesh_terms: D000328:Adult; D015928:Cognitive Behavioral Therapy; D005081:Exercise Therapy / Q000009:adverse effects*; D015673:Fatigue Syndrome, Chronic / Q000628:therapy*; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D017211:Treatment Failure
keywords: Adverse events; Body mass index; Chronic fatigue syndrome; Depression; Medically unexplained symptoms