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Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial

Summary Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed t... Full description

Journal Title: The Lancet (British edition) 2011, Vol.377 (9768), p.823-836
Main Author: White, PD, Prof
Other Authors: Goldsmith, KA, MPH , Johnson, AL, PhD , Potts, L, MSc , Walwyn, R, MSc , DeCesare, JC, BSc , Baber, HL, BSc , Burgess, M, PhD , Clark, LV, PhD , Cox, DL, PhD , Bavinton, J, BSc , Angus, BJ, MD , Murphy, G, MSc , Murphy, M, FRCP , O'Dowd, H, PhD , Wilks, D, FRCP[Ed] , McCrone, P, Prof , Chalder, T, Prof , Sharpe, M, Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: Kidlington: Elsevier Ltd
ID: ISSN: 0140-6736
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recordid: cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3065633
title: Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
format: Article
creator:
  • White, PD, Prof
  • Goldsmith, KA, MPH
  • Johnson, AL, PhD
  • Potts, L, MSc
  • Walwyn, R, MSc
  • DeCesare, JC, BSc
  • Baber, HL, BSc
  • Burgess, M, PhD
  • Clark, LV, PhD
  • Cox, DL, PhD
  • Bavinton, J, BSc
  • Angus, BJ, MD
  • Murphy, G, MSc
  • Murphy, M, FRCP
  • O'Dowd, H, PhD
  • Wilks, D, FRCP[Ed]
  • McCrone, P, Prof
  • Chalder, T, Prof
  • Sharpe, M, Prof
subjects:
  • Abridged Index Medicus
  • Activities of Daily Living
  • Adaptation, Physiological
  • Adult
  • Adverse events
  • Alliances
  • Anxieties
  • asjc
  • atira
  • Behavior modification
  • Behavior therapy
  • Behavior therapy. Cognitive therapy
  • Behavioral health care
  • Biological and medical sciences
  • Care and treatment
  • Chronic fatigue syndrome
  • Clinical trials
  • Clinics
  • Cognition & reasoning
  • Cognitive ability
  • Cognitive Therapy
  • Comparative analysis
  • Criteria
  • Data collection
  • Encephalomyelitis
  • Exercise
  • Exercise therapy
  • Exercise Therapy - adverse effects
  • Fast track
  • Fast track — Articles
  • Fatigue
  • Fatigue Syndrome, Chronic - physiopathology
  • Fatigue Syndrome, Chronic - therapy
  • Female
  • General aspects
  • Health care
  • Health services
  • Humans
  • Internal Medicine
  • Likert scale
  • Male
  • Medical research
  • Medical sciences
  • Medicine(all)
  • Mental disorders
  • Patient outcomes
  • Patients
  • Physicians
  • Psychology. Psychoanalysis. Psychiatry
  • Psychopathology. Psychiatry
  • pure
  • Questionnaires
  • Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
  • Randomization
  • Regression analysis
  • Regression models
  • Safety
  • Side effects
  • Specialization
  • Statistical analysis
  • Studies
  • Subgroups
  • subjectarea
  • Surveys and Questionnaires
  • Therapists
  • Therapy
  • Treatment Outcome
  • Treatments
  • Usage
ispartof: The Lancet (British edition), 2011, Vol.377 (9768), p.823-836
description: Summary Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org , number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not differ for APT (0·7 [−0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not differ for APT (3·4 [−1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
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creatorWhite, PD, Prof ; Goldsmith, KA, MPH ; Johnson, AL, PhD ; Potts, L, MSc ; Walwyn, R, MSc ; DeCesare, JC, BSc ; Baber, HL, BSc ; Burgess, M, PhD ; Clark, LV, PhD ; Cox, DL, PhD ; Bavinton, J, BSc ; Angus, BJ, MD ; Murphy, G, MSc ; Murphy, M, FRCP ; O'Dowd, H, PhD ; Wilks, D, FRCP[Ed] ; McCrone, P, Prof ; Chalder, T, Prof ; Sharpe, M, Prof
creatorcontribWhite, PD, Prof ; Goldsmith, KA, MPH ; Johnson, AL, PhD ; Potts, L, MSc ; Walwyn, R, MSc ; DeCesare, JC, BSc ; Baber, HL, BSc ; Burgess, M, PhD ; Clark, LV, PhD ; Cox, DL, PhD ; Bavinton, J, BSc ; Angus, BJ, MD ; Murphy, G, MSc ; Murphy, M, FRCP ; O'Dowd, H, PhD ; Wilks, D, FRCP[Ed] ; McCrone, P, Prof ; Chalder, T, Prof ; Sharpe, M, Prof ; on behalf of the PACE trial management group ; PACE trial management group
descriptionSummary Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org , number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not differ for APT (0·7 [−0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not differ for APT (3·4 [−1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group. Interpretation CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition. Funding UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.
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0ISSN: 0140-6736
1EISSN: 1474-547X
2DOI: 10.1016/S0140-6736(11)60096-2
3PMID: 21334061
4CODEN: LANCAO
languageeng
publisherKidlington: Elsevier Ltd
subjectAbridged Index Medicus ; Activities of Daily Living ; Adaptation, Physiological ; Adult ; Adverse events ; Alliances ; Anxieties ; asjc ; atira ; Behavior modification ; Behavior therapy ; Behavior therapy. Cognitive therapy ; Behavioral health care ; Biological and medical sciences ; Care and treatment ; Chronic fatigue syndrome ; Clinical trials ; Clinics ; Cognition & reasoning ; Cognitive ability ; Cognitive Therapy ; Comparative analysis ; Criteria ; Data collection ; Encephalomyelitis ; Exercise ; Exercise therapy ; Exercise Therapy - adverse effects ; Fast track ; Fast track — Articles ; Fatigue ; Fatigue Syndrome, Chronic - physiopathology ; Fatigue Syndrome, Chronic - therapy ; Female ; General aspects ; Health care ; Health services ; Humans ; Internal Medicine ; Likert scale ; Male ; Medical research ; Medical sciences ; Medicine(all) ; Mental disorders ; Patient outcomes ; Patients ; Physicians ; Psychology. Psychoanalysis. Psychiatry ; Psychopathology. Psychiatry ; pure ; Questionnaires ; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects) ; Randomization ; Regression analysis ; Regression models ; Safety ; Side effects ; Specialization ; Statistical analysis ; Studies ; Subgroups ; subjectarea ; Surveys and Questionnaires ; Therapists ; Therapy ; Treatment Outcome ; Treatments ; Usage
ispartofThe Lancet (British edition), 2011, Vol.377 (9768), p.823-836
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72011 Elsevier Ltd. All rights reserved. 2011 Elsevier Ltd
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0White, PD, Prof
1Goldsmith, KA, MPH
2Johnson, AL, PhD
3Potts, L, MSc
4Walwyn, R, MSc
5DeCesare, JC, BSc
6Baber, HL, BSc
7Burgess, M, PhD
8Clark, LV, PhD
9Cox, DL, PhD
10Bavinton, J, BSc
11Angus, BJ, MD
12Murphy, G, MSc
13Murphy, M, FRCP
14O'Dowd, H, PhD
15Wilks, D, FRCP[Ed]
16McCrone, P, Prof
17Chalder, T, Prof
18Sharpe, M, Prof
19on behalf of the PACE trial management group
20PACE trial management group
title
0Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
1The Lancet (British edition)
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descriptionSummary Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org , number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not differ for APT (0·7 [−0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not differ for APT (3·4 [−1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group. Interpretation CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition. Funding UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.
subject
0Abridged Index Medicus
1Activities of Daily Living
2Adaptation, Physiological
3Adult
4Adverse events
5Alliances
6Anxieties
7asjc
8atira
9Behavior modification
10Behavior therapy
11Behavior therapy. Cognitive therapy
12Behavioral health care
13Biological and medical sciences
14Care and treatment
15Chronic fatigue syndrome
16Clinical trials
17Clinics
18Cognition & reasoning
19Cognitive ability
20Cognitive Therapy
21Comparative analysis
22Criteria
23Data collection
24Encephalomyelitis
25Exercise
26Exercise therapy
27Exercise Therapy - adverse effects
28Fast track
29Fast track — Articles
30Fatigue
31Fatigue Syndrome, Chronic - physiopathology
32Fatigue Syndrome, Chronic - therapy
33Female
34General aspects
35Health care
36Health services
37Humans
38Internal Medicine
39Likert scale
40Male
41Medical research
42Medical sciences
43Medicine(all)
44Mental disorders
45Patient outcomes
46Patients
47Physicians
48Psychology. Psychoanalysis. Psychiatry
49Psychopathology. Psychiatry
50pure
51Questionnaires
52Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
53Randomization
54Regression analysis
55Regression models
56Safety
57Side effects
58Specialization
59Statistical analysis
60Studies
61Subgroups
62subjectarea
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64Therapists
65Therapy
66Treatment Outcome
67Treatments
68Usage
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titleComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
authorWhite, PD, Prof ; Goldsmith, KA, MPH ; Johnson, AL, PhD ; Potts, L, MSc ; Walwyn, R, MSc ; DeCesare, JC, BSc ; Baber, HL, BSc ; Burgess, M, PhD ; Clark, LV, PhD ; Cox, DL, PhD ; Bavinton, J, BSc ; Angus, BJ, MD ; Murphy, G, MSc ; Murphy, M, FRCP ; O'Dowd, H, PhD ; Wilks, D, FRCP[Ed] ; McCrone, P, Prof ; Chalder, T, Prof ; Sharpe, M, Prof
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0Abridged Index Medicus
1Activities of Daily Living
2Adaptation, Physiological
3Adult
4Adverse events
5Alliances
6Anxieties
7asjc
8atira
9Behavior modification
10Behavior therapy
11Behavior therapy. Cognitive therapy
12Behavioral health care
13Biological and medical sciences
14Care and treatment
15Chronic fatigue syndrome
16Clinical trials
17Clinics
18Cognition & reasoning
19Cognitive ability
20Cognitive Therapy
21Comparative analysis
22Criteria
23Data collection
24Encephalomyelitis
25Exercise
26Exercise therapy
27Exercise Therapy - adverse effects
28Fast track
29Fast track — Articles
30Fatigue
31Fatigue Syndrome, Chronic - physiopathology
32Fatigue Syndrome, Chronic - therapy
33Female
34General aspects
35Health care
36Health services
37Humans
38Internal Medicine
39Likert scale
40Male
41Medical research
42Medical sciences
43Medicine(all)
44Mental disorders
45Patient outcomes
46Patients
47Physicians
48Psychology. Psychoanalysis. Psychiatry
49Psychopathology. Psychiatry
50pure
51Questionnaires
52Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
53Randomization
54Regression analysis
55Regression models
56Safety
57Side effects
58Specialization
59Statistical analysis
60Studies
61Subgroups
62subjectarea
63Surveys and Questionnaires
64Therapists
65Therapy
66Treatment Outcome
67Treatments
68Usage
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0White, PD, Prof
1Goldsmith, KA, MPH
2Johnson, AL, PhD
3Potts, L, MSc
4Walwyn, R, MSc
5DeCesare, JC, BSc
6Baber, HL, BSc
7Burgess, M, PhD
8Clark, LV, PhD
9Cox, DL, PhD
10Bavinton, J, BSc
11Angus, BJ, MD
12Murphy, G, MSc
13Murphy, M, FRCP
14O'Dowd, H, PhD
15Wilks, D, FRCP[Ed]
16McCrone, P, Prof
17Chalder, T, Prof
18Sharpe, M, Prof
19on behalf of the PACE trial management group
20PACE trial management group
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jtitleThe Lancet (British edition)
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0White, PD, Prof
1Goldsmith, KA, MPH
2Johnson, AL, PhD
3Potts, L, MSc
4Walwyn, R, MSc
5DeCesare, JC, BSc
6Baber, HL, BSc
7Burgess, M, PhD
8Clark, LV, PhD
9Cox, DL, PhD
10Bavinton, J, BSc
11Angus, BJ, MD
12Murphy, G, MSc
13Murphy, M, FRCP
14O'Dowd, H, PhD
15Wilks, D, FRCP[Ed]
16McCrone, P, Prof
17Chalder, T, Prof
18Sharpe, M, Prof
aucorp
0on behalf of the PACE trial management group
1PACE trial management group
formatjournal
genrearticle
ristypeJOUR
atitleComparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
jtitleThe Lancet (British edition)
addtitleLancet
date2011
risdate2011
volume377
issue9768
spage823
epage836
pages823-836
issn0140-6736
eissn1474-547X
codenLANCAO
notes
0Authors contributed equally
1Members listed at end of paper
abstractSummary Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments. Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org , number ISRCTN54285094. Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p=0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p=0·0003), but did not differ for APT (0·7 [−0·9 to 2·3] points lower; p=0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p=0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p=0·0005), but did not differ for APT (3·4 [−1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p=0·0027; GET p=0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group. Interpretation CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition. Funding UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.
copKidlington
pubElsevier Ltd
pmid21334061
doi10.1016/S0140-6736(11)60096-2
oafree_for_read