Display Settings:

Format

Send to:

Choose Destination
See comment in PubMed Commons below
J Psychosom Res. 2014 Jul;77(1):20-6. doi: 10.1016/j.jpsychores.2014.04.002. Epub 2014 Apr 22.

Adverse events and deterioration reported by participants in the PACE trial of therapies for chronic fatigue syndrome.

Author information

  • 1East London Foundation NHS Trust, London, UK.
  • 2MRC Clinical Trials Unit at UCL, London, UK.
  • 3Biostatistics Department, Institute of Psychiatry, King's College London, UK.
  • 4Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.
  • 5Nuffield Department of Medicine, University of Oxford, UK.
  • 6Academic Department of Psychological Medicine, King's College London, UK.
  • 7Wolfson 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.

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.

Copyright © 2013. Published by Elsevier Inc.

KEYWORDS:

Adverse events; Body mass index; Chronic fatigue syndrome; Depression; Medically unexplained symptoms

PMID:
24913337
[PubMed - in process]
PMCID:
PMC4065570
Free PMC Article

Images from this publication.See all images (1)Free text

Fig. 1
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for PubMed Central
    Loading ...
    Write to the Help Desk