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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 . 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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Intervention_Educational
cognitive behaviour therapy
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Intervention_Other
specialist medical care
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Intervention_Educational
adaptive pacing therapy ( APT )
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Intervention_Educational
APT
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Intervention_Psychological
CBT
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Intervention_Physical
SMC-alone
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Outcome_Other
effectiveness and safety
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Outcome_Physical
fatigue
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Outcome_Other
Chalder fatigue questionnaire score
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Outcome_Physical
physical function
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Outcome_Other
short form-36 subscale score
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Outcome_Adverse-effects
serious adverse events
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Outcome_Adverse-effects
serious adverse reactions
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Outcome_Physical
mean fatigue scores
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Participant_Condition
chronic fatigue syndrome
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Participant_Condition
chronic fatigue syndrome
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Participant_Condition
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