PACE trial authors continue to ignore their own null effect

Vink, Mark

doi:10.1177/1359105317703785

Cited by 13 publications

(15 citation statements)

References 26 publications

(46 reference statements)

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“…The PACE (pacing, graded activity, and cognitive behaviour therapy: a randomised evaluation) trial of the effectiveness of cognitive behaviour therapy (CBT) and graded exercise for chronic fatigue syndrome came in for fierce criticism in this journal on the grounds that when objective measures of outcome were used the effectiveness of CBT disappeared ( Geraghty, 2017 ; Vink, 2017 ). The authors of the PACE trial relied on subjective self-report measures to ‘promote’ the cognitive behaviour therapy and graded exercise therapy protocols that they themselves had developed.…”

Section: Introductionmentioning

confidence: 99%

Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform

Scott¹

2018

J Health Psychol

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Improving Access to Psychological Therapies is a UK government-funded initiative to widen access to the psychological treatment of depression and anxiety disorders. The author has had the opportunity to independently assess 90 Improving Access to Psychological Therapies clients, using a standardised semi-structured interview, the Structured Clinical Diagnostic Interview for DSM Disorders (SCID) and to listen to their account of interaction with the service. The results suggest that only the tip of the iceberg fully recovers from their disorder (9.2%) whether or not they were treated before or after a personal injury claim. There is a pressing need to re-examine the modus operandi of the service.

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Section: Introductionmentioning

confidence: 99%

Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform

Scott¹

2018

J Health Psychol

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“…Only cognitive behavioral and exercise therapies have been recommended, although they only have partial benefits (Price et al, 2008; Larun et al, 2016). However, previous recommendations of these therapies that were based on a large-scale clinical study (called the “Pacing, graded activity, and cognitive behaviour therapy; a randomised evaluation” trial) were abandoned or revised in both the USA and UK due to serious criticism by both scientists and patients (Geraghty, 2017; Vink, 2017).…”

Section: Introductionmentioning

confidence: 99%

The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

et al. 2019

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Background: There is a strong demand for therapeutics to treat chronic fatigue syndrome (CFS), although there are limitations. Myelophil, which is a combination of extracts from Astragali Radix and Salviae Miltiorrhizae Radix, has been clinically used to treat fatigue-related disorders in South Korea. We conducted a randomized controlled clinical trial of Myelophil in patients with CFS and evaluated its efficacy and safety in two hospitals. Methods: We enrolled 98 participants (M: 38, F: 60) with CFS in a phase 2 trial of oral Myelophil (2 g daily) or placebo for 12 weeks. The primary end point was a change in the Chalder fatigue scale, as scored by a numeric rating scale (NRS). The secondary end points included changes in the visual analogue scale, fatigue severity scale (FSS), and 36-item short-form health survey (SF-36). Biomarkers of oxidative stress and cytokines were evaluated by blood tests. Results: Ninety-seven participants (48 in the Myelophil group and 49 in the placebo group) completed the trial. An analysis of all participants showed that Myelophil slightly improved fatigue symptoms compared with those of the placebo, but this effect was not statistically significant (p > 0.05 for the NRS, VAS, FSS, and SF-36). By contrast, an analysis of the subpopulation (53 participants, M: 24, F: 29) with severe symptoms (≥63, median NRS value of total participants) showed a statistically significant improvement in fatigue symptoms in the Myelophil group compared with the placebo (p < 0.05 for NRS, FSS, and SF-36). There were no significant changes in the biomarkers for oxidative stress and cytokines before or after the treatment. No Myelophil-related adverse response was observed during the trial. Conclusion: These results support the hypothesis that Myelophil can be a therapeutic candidate to manage CFS and provide the rationale for its progression to a phase 3 clinical trial. Clinical Trial Registration: , identifier KCT0002317.

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“…Participants with a score of 60 to 65 (inclusive) were thus considered ill enough to participate and to have an abnormal level of physical functioning, yet were also recovered and severely disabled. Three participants (0.45%) saw their physical functioning score go down from 65 to 60, reflecting deterioration, and three others (0.45%) had unchanged physical functioning scores, but all (0.9%) were still classed as recovered, according to the physical functioning recovery criterion (Vink, 2017b). Something similar happened to the fatigue scores.…”

Section: Analysis Of Trials That Were Still In Progressmentioning

confidence: 99%

Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

Vink¹,

Vink-Niese²

2019

Health Psychology Open

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Analysis of the 2008 Cochrane review of cognitive behavioural therapy for chronic fatigue syndrome shows that seven patients with mild chronic fatigue syndrome need to be treated for one to report a small, short-lived subjective improvement of fatigue. This is not matched by an objective improvement of physical fitness or employment and illness benefit status. Most studies in the Cochrane review failed to report on safety or adverse reactions. Patient evidence suggests adverse outcomes in 20 per cent of cases. If a trial of a drug or surgical procedure uncovered a similar high rate, it would be unlikely to be accepted as safe. It is time to downgrade cognitive behavioural therapy to an adjunct support-level therapy, rather than a treatment for chronic fatigue syndrome.

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PACE trial authors continue to ignore their own null effect

Cited by 13 publications

References 26 publications

Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform

Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform

The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

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