期刊
JOURNAL OF PSYCHOSOMATIC RESEARCH
卷 77, 期 1, 页码 20-26出版社
PERGAMON-ELSEVIER SCIENCE LTD
DOI: 10.1016/j.jpsychores.2014.04.002
关键词
Adverse events; Body mass index; Chronic fatigue syndrome; Depression; Medically unexplained symptoms
类别
资金
- Medical Research Council
- Department of Health for England
- Scottish Chief Scientist Office [G0200434]
- Department for Work and Pensions
- East London Foundation NHS Trust
- NIHR Biomedical Research Centre for Mental Health at the South London
- Maudsley NHS Foundation Trust
- Institute of Psychiatry, Kings College London
- MRC [G0200434] Funding Source: UKRI
- Medical Research Council [G0200434] Funding Source: researchfish
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 AFT. 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. (C) 2014 The Authors. Published by Elsevier Inc.
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