Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT
Abstract Background The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome. Reports concluded that both treatments were moderately effective, each leading to recovery in...
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| Format: | Article |
| Language: | English |
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BMC
2018-03-01
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| Series: | BMC Psychology |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s40359-018-0218-3 |
| _version_ | 1818294622716166144 |
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| author | Carolyn E. Wilshire Tom Kindlon Robert Courtney Alem Matthees David Tuller Keith Geraghty Bruce Levin |
| author_facet | Carolyn E. Wilshire Tom Kindlon Robert Courtney Alem Matthees David Tuller Keith Geraghty Bruce Levin |
| author_sort | Carolyn E. Wilshire |
| collection | DOAJ |
| description | Abstract Background The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome. Reports concluded that both treatments were moderately effective, each leading to recovery in over a fifth of patients. However, the reported analyses did not consistently follow the procedures set out in the published protocol, and it is unclear whether the conclusions are fully justified by the evidence. Methods Here, we present results based on the original protocol-specified procedures. Data from a recent Freedom of Information request enabled us to closely approximate these procedures. We also evaluate the conclusions from the trial as a whole. Results On the original protocol-specified primary outcome measure - overall improvement rates - there was a significant effect of treatment group. However, the groups receiving CBT or GET did not significantly outperform the Control group after correcting for the number of comparisons specified in the trial protocol. Also, rates of recovery were consistently low and not significantly different across treatment groups. Finally, on secondary measures, significant effects were almost entirely confined to self-report measures. These effects did not endure beyond two years. Conclusions These findings raise serious concerns about the robustness of the claims made about the efficacy of CBT and GET. The modest treatment effects obtained on self-report measures in the PACE trial do not exceed what could be reasonably accounted for by participant reporting biases. |
| first_indexed | 2024-12-13T03:34:41Z |
| format | Article |
| id | doaj.art-b98233e1c9eb499ea7cadf46ad650b6b |
| institution | Directory Open Access Journal |
| issn | 2050-7283 |
| language | English |
| last_indexed | 2024-12-13T03:34:41Z |
| publishDate | 2018-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychology |
| spelling | doaj.art-b98233e1c9eb499ea7cadf46ad650b6b2022-12-22T00:01:04ZengBMCBMC Psychology2050-72832018-03-016111210.1186/s40359-018-0218-3Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBTCarolyn E. Wilshire0Tom Kindlon1Robert CourtneyAlem MattheesDavid Tuller2Keith Geraghty3Bruce Levin4School of Psychology, Victoria University of Wellington, New ZealandIrish ME/CFS AssociationSchool of Public Health, University of CaliforniaSchool of Health Sciences, University of ManchesterDepartment of Biostatistics, Columbia UniversityAbstract Background The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome. Reports concluded that both treatments were moderately effective, each leading to recovery in over a fifth of patients. However, the reported analyses did not consistently follow the procedures set out in the published protocol, and it is unclear whether the conclusions are fully justified by the evidence. Methods Here, we present results based on the original protocol-specified procedures. Data from a recent Freedom of Information request enabled us to closely approximate these procedures. We also evaluate the conclusions from the trial as a whole. Results On the original protocol-specified primary outcome measure - overall improvement rates - there was a significant effect of treatment group. However, the groups receiving CBT or GET did not significantly outperform the Control group after correcting for the number of comparisons specified in the trial protocol. Also, rates of recovery were consistently low and not significantly different across treatment groups. Finally, on secondary measures, significant effects were almost entirely confined to self-report measures. These effects did not endure beyond two years. Conclusions These findings raise serious concerns about the robustness of the claims made about the efficacy of CBT and GET. The modest treatment effects obtained on self-report measures in the PACE trial do not exceed what could be reasonably accounted for by participant reporting biases.http://link.springer.com/article/10.1186/s40359-018-0218-3Chronic fatigue syndromeMyalgic encephalomyelitisGraded exercise therapyCognitive behavioral therapy |
| spellingShingle | Carolyn E. Wilshire Tom Kindlon Robert Courtney Alem Matthees David Tuller Keith Geraghty Bruce Levin Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT BMC Psychology Chronic fatigue syndrome Myalgic encephalomyelitis Graded exercise therapy Cognitive behavioral therapy |
| title | Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT |
| title_full | Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT |
| title_fullStr | Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT |
| title_full_unstemmed | Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT |
| title_short | Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT |
| title_sort | rethinking the treatment of chronic fatigue syndrome a reanalysis and evaluation of findings from a recent major trial of graded exercise and cbt |
| topic | Chronic fatigue syndrome Myalgic encephalomyelitis Graded exercise therapy Cognitive behavioral therapy |
| url | http://link.springer.com/article/10.1186/s40359-018-0218-3 |
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