- Jul 2018
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europepmc.org europepmc.org
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On 2014 Jan 20, Tom Kindlon commented:
Things are not clear cut in the CFS field yet
I'm afraid I found the analysis in this paper to be somewhat superficial. In particular, it did not explore why positive statements might not predominate for GET and CBT.
Evidence-based medicine should not just be about efficacy measures but also adverse events. The reporting of harms in trials of CBT and GET for CFS has been recognised as being poor (2,3). As one systematic review pointed out: "There is limited evidence about adverse effects associated with behavioural interventions. Withdrawals from treatment in RCTs suggest that there may be an issue but the evidence is often difficult to interpret because of poor reporting."
A published survey of Norwegian ME/CFS patients found that of 620 who reported their experiences of graded exercise, 488 (78.7%) said that it had caused an overall deterioration (1). Surveys of patients in other countries have also found a high rate of adverse events associated with graded exercise regimes (2).
I am not that familiar with the Norwegian health system but in other countries central schemes to collate information on adverse events associated with interventions, such as the yellow card scheme, are not available for nonpharmacological interventions (such as CBT and GET), increasing the importance of survey data.
While some efficacy has been reported for CBT and GET, the measures used have generally been self-reported. Objective results are less impressive. For example, a review of three Dutch CBT studies found that no increase in activity levels, as measured by motion sensors, was recorded (above those in the control groups) despite improvements being reported in fatigue, as well as other subjective measures in the individual studies.
The recently published PACE Trial got a lot of positive media coverage. However, on the only measure that could be described as being an objective measure, the six-minute walking distance (6MWD), there was no difference between the CBT and control groups. The GET group did improve on the 6MWD. However, 379m is not a particularly impressive result at 12 months considering 644m is the distance reference equations would estimate for this cohort.
Anyone familiar with such evidence could justifiably be cautious in statements about CBT and GET.
A common threshold for interventions to be seen as evidence-based is at least two positive (high quality) RCTs. Most posited therapies in the field have not been subjected to two RCTs. Any comments on other therapies, including on the Lightning Process, should certainly be tempered in the meantime.
References:
[1]. Bjorkum T, Wang CE, Waterloo K. [Patients' experience with treatment of chronic fatigue syndrome.] Tidsskr Nor Laegeforen. 2009 Jun 11;129(12):1214-6
[2]. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Bulletin of the IACFS/ME. 2011;19(2):59-111. http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/ tabid/501/Default.aspx
[3]. Chambers D, Bagnall AM, Hempel S, Forbes C. Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. Review.
[4]. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7.
[5]. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011;377:823-36.
Conflict of Interest: I am the Assistant Chairperson and Information Officer of the Irish ME/CFS Association. All my work for the Association is unpaid
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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- Feb 2018
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europepmc.org europepmc.org
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On 2014 Jan 20, Tom Kindlon commented:
Things are not clear cut in the CFS field yet
I'm afraid I found the analysis in this paper to be somewhat superficial. In particular, it did not explore why positive statements might not predominate for GET and CBT.
Evidence-based medicine should not just be about efficacy measures but also adverse events. The reporting of harms in trials of CBT and GET for CFS has been recognised as being poor (2,3). As one systematic review pointed out: "There is limited evidence about adverse effects associated with behavioural interventions. Withdrawals from treatment in RCTs suggest that there may be an issue but the evidence is often difficult to interpret because of poor reporting."
A published survey of Norwegian ME/CFS patients found that of 620 who reported their experiences of graded exercise, 488 (78.7%) said that it had caused an overall deterioration (1). Surveys of patients in other countries have also found a high rate of adverse events associated with graded exercise regimes (2).
I am not that familiar with the Norwegian health system but in other countries central schemes to collate information on adverse events associated with interventions, such as the yellow card scheme, are not available for nonpharmacological interventions (such as CBT and GET), increasing the importance of survey data.
While some efficacy has been reported for CBT and GET, the measures used have generally been self-reported. Objective results are less impressive. For example, a review of three Dutch CBT studies found that no increase in activity levels, as measured by motion sensors, was recorded (above those in the control groups) despite improvements being reported in fatigue, as well as other subjective measures in the individual studies.
The recently published PACE Trial got a lot of positive media coverage. However, on the only measure that could be described as being an objective measure, the six-minute walking distance (6MWD), there was no difference between the CBT and control groups. The GET group did improve on the 6MWD. However, 379m is not a particularly impressive result at 12 months considering 644m is the distance reference equations would estimate for this cohort.
Anyone familiar with such evidence could justifiably be cautious in statements about CBT and GET.
A common threshold for interventions to be seen as evidence-based is at least two positive (high quality) RCTs. Most posited therapies in the field have not been subjected to two RCTs. Any comments on other therapies, including on the Lightning Process, should certainly be tempered in the meantime.
References:
[1]. Bjorkum T, Wang CE, Waterloo K. [Patients' experience with treatment of chronic fatigue syndrome.] Tidsskr Nor Laegeforen. 2009 Jun 11;129(12):1214-6
[2]. Kindlon T. Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Bulletin of the IACFS/ME. 2011;19(2):59-111. http://www.iacfsme.org/BULLETINFALL2011/Fall2011KindlonHarmsPaperABSTRACT/ tabid/501/Default.aspx
[3]. Chambers D, Bagnall AM, Hempel S, Forbes C. Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. Review.
[4]. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7.
[5]. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, et al. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet. 2011;377:823-36.
Conflict of Interest: I am the Assistant Chairperson and Information Officer of the Irish ME/CFS Association. All my work for the Association is unpaid
This comment, imported by Hypothesis from PubMed Commons, is licensed under CC BY.
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