Bewijs dat Nederland geld stopte in PACE trial
Geplaatst: 20 feb 2011, 16:23
Comment
www.thelancet.com
Published online February 18, 2011
Chronic fatigue syndrome: where to PACE from here?
*Gijs Bleijenberg, Hans Knoop
Expert Centre for Chronic Fatigue, Ra
dboud University Nijmegen
Medical Centre, 6500 HB Nijmegen, Netherlands G.Bleijenberg@nkcv.umcn.nl
In The Lancet, Peter White and colleagues1 report the four-group PACE randomised trial in adults with chronic fatigue syndrome. PACE stands for “Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation”. The investigators report the efficacy of three behaviour interventions and specialist medical care. The Article provides a useful panel to summarise the interventions.
PACE tested the safety of the interventions. Concerns about the safety of cognitive behaviour therapy and graded exercise therapy have been raised more than once by patients’ advocacy groups. Few patients receiving cognitive behaviour therapy or graded exercise therapy in the PACE trial had serious adverse reactions and no more than those receiving adaptive pacing therapy or standard medical care, which for cognitive behavioural therapy has already been shown.2 This finding is important and should be communicated to patients to dispel unnecessary concerns about the possible detrimental effects of cognitive behaviour therapy and graded exercise therapy, which will hopefully be a useful reminder of the potential positive effects of both interventions.
Another important aspect of PACE (the largest randomised trial of cognitive behaviour therapy and graded exercise therapy to date) is that the efficacy of both interventions was compared with another therapy and specialist medical care alone. Also, for the first time, adaptive pacing therapy was empirically tested. Both graded exercise therapy and cognitive behaviour therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients. Adaptive pacing therapy emphasises that chronic fatigue syndrome is a chronic condition, to which the patient has to adapt. Although PACE was not intended to compare cognitive behaviour therapy and graded exercise therapy with each other, there was actually no difference between the two. Both were more effective than adaptive pacing.
Graded exercise therapy and cognitive behaviour therapy might assume that recovery from chronic fatigue syndrome is possible, but have patients recovered after treatment? The answer depends on one’s definition of
recovery.3 PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%—although not very high, the rate is significantly higher than that with both other interventions.
Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy). Both interventions could be improved if more was known about the mechanisms of change. These mechanisms could differ between the interventions, but we think this is unlikely. The rationale behind graded exercise therapy is that increasing the level of physical activity and fitness will cause symptoms to be reduced. The basis of cognitive behaviour therapy is described in PACE as the fear-avoidance theory. There is little empirical support for these proposed mechanisms of change. Mediation analysis of a randomised trial4 which tested the efficacy of graded exercise therapy for chronic fatigue syndrome showed that a decrease in symptom focusing, rather than an increase in fitness, mediated the reduction in fatigue.
Wiborg and colleagues5 have shown that the effect of cognitive behaviour therapy on fatigue in chronic fatigue syndrome is not mediated by a persistent increase in physical activity. We noted that a decrease in focus on fatigue mediated the effect of cognitive behaviour therapy on fatigue and impairments in patients with the
syndrome.6 Similarly, we have shown that higher levels of perceived activity and an increased sense of control over symptoms contribute to the treatment effect.
The central role of cognition in relation to fatigue might explain why graded exercise therapy is effective and adaptive pacing therapy is not. Both treatments aim to increase activity, but the activity-related cognition is probably different in adaptive pacing therapy—“I have to focus on how fatigued I am in order to stop in time, I can’t do more, I have to stop”—from that in graded exercise therapy—“I am able to do more than I thought I could” (ie, less focused). Remarkably in this context, confidence in the treatment at the start is substantially lower with cognitive behaviour therapy than it is with adaptive pacing therapy. Despite lowered confidence in cognitive behaviour therapy, this therapy is more effective than is adaptive pacing therapy. Patient’s confidence in treatment can only change if a change in abilities is perceived, which generally seems to happen in cognitive behaviour therapy.
Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change.
*Gijs Bleijenberg, Hans Knoop
Expert Centre for Chronic Fatigue, Ra
dboud University Nijmegen
Medical Centre, 6500 HB Nijmegen, Netherlands G.Bleijenberg@nkcv.umcn.nl
We have received funding from The Netherlands Organisation for Health Research and Development, the Dutch Cancer Society, the Dutch MS Research fund, and the Princess Beatrix Foundation.
1 White PD, Goldsmith KA, Johnson AL, et al, on behalf of the PACE trial management group. 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; published online Feb 18. DOI:10.1016/S0140-6736(11)60096-2.
2 Heins M, Knoop H, Stulemeijer M, Prins JB, Van der Meer JWM, Bleijenberg G. Possible detrimental effects of cognitive behaviour therapy for chronic fatigue syndrome. Psychother Psychosom 2010; 79: 249–56.
3 Knoop H, Bleijenberg G, Gielissen MFM, van der Meer JWM, White PD.
Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome? Psychother Psychosom 2007; 76: 171–76.
4 Moss-Morris R, Sharon C, Tobin R, Baldi JC. A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change. J Health Psychol 2005; 10: 245–59.
5 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; 40: 1281–87.
6 Wiborg JF, Knoop H, Prins JB, Bleijenberg G. Does a decrease in avoidance behavior and focusing on fatigue mediate the effect of cognitive behaviour therapy for chronic fatigue syndrome? J Psychosom Res 2011; published online Feb 12.
ifte: 02/19/11
www.thelancet.com
Published online February 18, 2011
Chronic fatigue syndrome: where to PACE from here?
*Gijs Bleijenberg, Hans Knoop
Expert Centre for Chronic Fatigue, Ra
dboud University Nijmegen
Medical Centre, 6500 HB Nijmegen, Netherlands G.Bleijenberg@nkcv.umcn.nl
In The Lancet, Peter White and colleagues1 report the four-group PACE randomised trial in adults with chronic fatigue syndrome. PACE stands for “Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation”. The investigators report the efficacy of three behaviour interventions and specialist medical care. The Article provides a useful panel to summarise the interventions.
PACE tested the safety of the interventions. Concerns about the safety of cognitive behaviour therapy and graded exercise therapy have been raised more than once by patients’ advocacy groups. Few patients receiving cognitive behaviour therapy or graded exercise therapy in the PACE trial had serious adverse reactions and no more than those receiving adaptive pacing therapy or standard medical care, which for cognitive behavioural therapy has already been shown.2 This finding is important and should be communicated to patients to dispel unnecessary concerns about the possible detrimental effects of cognitive behaviour therapy and graded exercise therapy, which will hopefully be a useful reminder of the potential positive effects of both interventions.
Another important aspect of PACE (the largest randomised trial of cognitive behaviour therapy and graded exercise therapy to date) is that the efficacy of both interventions was compared with another therapy and specialist medical care alone. Also, for the first time, adaptive pacing therapy was empirically tested. Both graded exercise therapy and cognitive behaviour therapy assume that recovery from chronic fatigue syndrome is possible and convey this hope more or less explicitly to patients. Adaptive pacing therapy emphasises that chronic fatigue syndrome is a chronic condition, to which the patient has to adapt. Although PACE was not intended to compare cognitive behaviour therapy and graded exercise therapy with each other, there was actually no difference between the two. Both were more effective than adaptive pacing.
Graded exercise therapy and cognitive behaviour therapy might assume that recovery from chronic fatigue syndrome is possible, but have patients recovered after treatment? The answer depends on one’s definition of
recovery.3 PACE used a strict criterion for recovery: a score on both fatigue and physical function within the range of the mean plus (or minus) one standard deviation of a healthy person’s score. In accordance with this criterion, the recovery rate of cognitive behaviour therapy and graded exercise therapy was about 30%—although not very high, the rate is significantly higher than that with both other interventions.
Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy). Both interventions could be improved if more was known about the mechanisms of change. These mechanisms could differ between the interventions, but we think this is unlikely. The rationale behind graded exercise therapy is that increasing the level of physical activity and fitness will cause symptoms to be reduced. The basis of cognitive behaviour therapy is described in PACE as the fear-avoidance theory. There is little empirical support for these proposed mechanisms of change. Mediation analysis of a randomised trial4 which tested the efficacy of graded exercise therapy for chronic fatigue syndrome showed that a decrease in symptom focusing, rather than an increase in fitness, mediated the reduction in fatigue.
Wiborg and colleagues5 have shown that the effect of cognitive behaviour therapy on fatigue in chronic fatigue syndrome is not mediated by a persistent increase in physical activity. We noted that a decrease in focus on fatigue mediated the effect of cognitive behaviour therapy on fatigue and impairments in patients with the
syndrome.6 Similarly, we have shown that higher levels of perceived activity and an increased sense of control over symptoms contribute to the treatment effect.
The central role of cognition in relation to fatigue might explain why graded exercise therapy is effective and adaptive pacing therapy is not. Both treatments aim to increase activity, but the activity-related cognition is probably different in adaptive pacing therapy—“I have to focus on how fatigued I am in order to stop in time, I can’t do more, I have to stop”—from that in graded exercise therapy—“I am able to do more than I thought I could” (ie, less focused). Remarkably in this context, confidence in the treatment at the start is substantially lower with cognitive behaviour therapy than it is with adaptive pacing therapy. Despite lowered confidence in cognitive behaviour therapy, this therapy is more effective than is adaptive pacing therapy. Patient’s confidence in treatment can only change if a change in abilities is perceived, which generally seems to happen in cognitive behaviour therapy.
Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change.
*Gijs Bleijenberg, Hans Knoop
Expert Centre for Chronic Fatigue, Ra
dboud University Nijmegen
Medical Centre, 6500 HB Nijmegen, Netherlands G.Bleijenberg@nkcv.umcn.nl
We have received funding from The Netherlands Organisation for Health Research and Development, the Dutch Cancer Society, the Dutch MS Research fund, and the Princess Beatrix Foundation.
1 White PD, Goldsmith KA, Johnson AL, et al, on behalf of the PACE trial management group. 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; published online Feb 18. DOI:10.1016/S0140-6736(11)60096-2.
2 Heins M, Knoop H, Stulemeijer M, Prins JB, Van der Meer JWM, Bleijenberg G. Possible detrimental effects of cognitive behaviour therapy for chronic fatigue syndrome. Psychother Psychosom 2010; 79: 249–56.
3 Knoop H, Bleijenberg G, Gielissen MFM, van der Meer JWM, White PD.
Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome? Psychother Psychosom 2007; 76: 171–76.
4 Moss-Morris R, Sharon C, Tobin R, Baldi JC. A randomized controlled graded exercise trial for chronic fatigue syndrome: outcomes and mechanisms of change. J Health Psychol 2005; 10: 245–59.
5 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; 40: 1281–87.
6 Wiborg JF, Knoop H, Prins JB, Bleijenberg G. Does a decrease in avoidance behavior and focusing on fatigue mediate the effect of cognitive behaviour therapy for chronic fatigue syndrome? J Psychosom Res 2011; published online Feb 12.
ifte: 02/19/11
