Table 3 Included RCTs with diagnostic-inclusion criteria without PEM as a criterion (CF patients)
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(# weeks) | Outcome measure momentsa (weeks) | Main outcome measures 1 Primary 2 Secondary | Adverse events Treatment withdrawn (I/C) ITTb | Results (benefits), compared to controlc Concl.—Authors own conclusion |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 |