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Table 3 Included RCTs with diagnostic-inclusion criteria without PEM as a criterion (CF patients)

From: The evidence base for physiotherapy in myalgic encephalomyelitis/chronic fatigue syndrome when considering post-exertional malaise: a systematic review and narrative synthesis

Author,
Year
Country
Intervention (I) Comparison (C) Participants details (I/C)
Number allocated (N),
Mean age (year)
Gender (% female)
Diagnostic criteria Duration
Session duration
Frequency
No. of sessions (ss),
period (# weeks)
Outcome measure momentsa (weeks) Main outcome measures
1 Primary
2 Secondary
Adverse events
Treatment withdrawn
(I/C)
ITTb
Results (benefits), compared to controlc
Concl.—Authors own conclusion
“PACE-trial”
White et al. 2011, 2013 [58, 85] (2007 [86])
Bourke et al. 2014 [120]
Sharpe et al. 2015 [121]
Chalder et al. 2015 [122]
McCrone et al. 2012 [79]
UK
GET or APT, each in addition to SMC SMC
SMC + CBT (not evaluated here)
N = 641 (160,160/161)
Age: 38
76–80%
Oxford
(51% London criteriad, 67% empirical CDC)
GET: 14 ss, 23 weeks
APT: 14 ss, 23 weeks
SMC 3 ss, 52 weeks
12 rand (mid-therapy)
24 (= post)
52 rand
134 (104–230) rand
1: CFQ, SF-36-PF
2: WSAS, HADS, JSQ, PGIC, CFS symptoms, pain, fibromyalgia, PEM occurrence and poor concentration or memory, EQ-5D, 6-min walking ability, self-paced step test of fitness, lost employment
Yes [83]
24/15/17
No
Post: CFQ: GET signif, APT ns; SF-36-PF: GET signif, APT ns
Long-1 year: CFQ: GET p < 0.01, APT ns; SF-36-PF: GET p < 0.01, APT ns
WSAS/JSQ/HADS/PGIC: GET p < 0.05, APT ns; PGIC−/ + : GET 6/41%, APT: 7/31%. Concentration and memory: ns; PEM occurrence, pain, fibromyalgia: GET p < 0.05, ATP ns 6-min walking: GET p < .001/ns, APT ns; Fitness, lost employment, EQ-5D: GET, APT ns
Serious adverse events were infrequent, non-serious adverse events were common, physical deterioration occurred most often after APT, p < 0.001
Long-2 year CFQ: GET, APT ns, SF-36-PF: GET, APT ns
Concl: 1 year: GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition. GET was more effective in reducing the frequency of both muscle and joint pain than APT and SMC, but small effect sizes
2 year: There was little evidence on long-term differences between groups
“FINE-trial”
Wearden et al. 2010 [59]
UK
PR—Pragmatic rehabilitation (≈CBT + GET) GP-TAU
SL-Supportive listening, general treatment
N = 296 (95/101/100)
Age: 45
78%
Oxford
(London criteria: 30%/31%/33%)
10 ss
18 weeks
20 basel
70 basel
CFQ, SF-36-PF, HADS, JSQ Yes
18/17
Yes
Short: CFQ, HADS-depr, Jenkins, p < 0.05, SF-36-PF ns
Long: all variables ns, No adverse events
Concl: Pragmatic rehabilitation improved sleep, fatigue and depression in CFS patients, but has no long-term effect
Powell et al., 2001, 2004 [60, 123]
UK
Education to encourage GET
1. Minimum intervention
2. Min. + telephone
3. Min. + face to face treatment
TAU (medical assessment, information, advice booklet, encouraging activity and positive thinking)—delayed onset (1 year) N = 148 (37/39/38/34)
Age: 34/32/33/34
78%
Oxford 1: 3 h, 2 ss
2: + 30 min, 7 tel ss
3: + 1 h, 7 ss,
12 weeks
12 rand
26 rand
52 rand
104 rand
1: SF-36-PF, CFQ
2: HADS, JSQ, PGIC
No
5,7,7/2
Yes
Long-1 year: CFQ, SF-36, HADS, JSQ: p < 0.001, 56% fulfilled no longer CFS trial criteria. PGIC−/ + : –/78%
Long-2 year: benefit sustained, 56% fulfilled no longer CFS trial criteria
Difference between intervention groups ns
Intervention resulted in substantial improvement compared with TAU. Benefits sustained until 2 year follow-up. Delayed treatment was associated with lower efficacy
  1. Ss: sessions: ns non-significant, APT: Adaptive Pacing Therapy; CBT: Cognitive Behavioural Therapy; GET: Graded exercise therapy; TAU: Treatment As Usual; SMC: Specialist Medical Care, CFQ: Chalder Fatigue scale/Questionnaire; EQ-5D: Euroqol Questionnaire; HADS: Hospital Anxiety and Depression Scale; JSQ: 4-item Jenkins Sleep Questionnaire; PGIC: Patient Global Impression of Change; PGICdet/impr: PGIC (very) much worse/better; SF-36–PF: Short Form Health Survey - Physical Functioning; WSAS: Work and Social Adjustment Scale
  2. aRand: from randomisation moment, basel.: from baseline, post: (at) post-treatement
  3. bData for at least one key outcome was analyzed by ‘intention to treat’ analysis (ITT)
  4. cResults in favour of intervention. If results favours comparison intervention, ‘[C]’ is added. Post: post-treatment, Short-time follow-up, Long-longtime follow-up
  5. d‘Second-version’, with unknown modifications