Zhou 2010.
Methods | Parallel design Method of randomisation: randomisation stated, methods unclear Method of concealment: interventions used in the 2 groups were visibly different, so participants and medical staff would be aware of what was being used Blinding: unclear Analysis: no loss to follow‐up | |
Participants | Location: China
Setting: both inpatients and outpatients Number of participants: 128 participants at randomisation and all completed the study (59% male, mean age 57 years) Treatment 1 group (electroacupuncture plus cupping): 64 (56% male, mean age 58 years) Treatment 2 group (medication): 64 (62% male. mean age 56 years) Stroke criteria: ischaemic stroke, criteria unclear Time since stroke onset at randomisation: within 3 years after stroke, mean 6 months Fatigue criteria: SSQOL‐energy < 12 Other entry criteria: within 3 years after stroke, < 70 years old Comparability of groups: unclear |
|
Interventions | Treatment 1 intervention (electroacupuncture plus cupping): electroacupuncture for 30 minutes daily, 10 days as 1 cycle, for 3 cycles with 2‐day intervals between cycles, plus cupping at back for 10 minutes, once every 2 days, for 5 weeks Treatment 2 intervention (medication): oral sertraline (50 mg, daily, for 5 weeks), plus oral compound aminobutyric acid and vitamin E capsules (2 capsules, 3 times per day, for 5 weeks) and oral magnesium gluconate solution (1000 mg/10 mL, containing magnesium 58.6 mg, 3 times per day, for 5 weeks) Treatment duration: 5 weeks Delivered by: rehabilitation therapists or physicians |
|
Outcomes | Time for fatigue assessment: baseline, at the end of 5‐week treatment, at 2‐month follow‐up Primary outcome: SSQOL‐energy at the end of treatment Secondary outcome: SSQOL‐energy at 2‐month follow‐up |
|
Notes | Only people with severe fatigue (SSQOL‐energy subscale < 12) were recruited Funding: no information available |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | High risk | Interventions used in the 2 groups were visibly different, so participants and medical staff would be aware of what was being used |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not enough information reported |
Intention‐to‐treat | Low risk | No loss to follow‐up reported |
CDSMP: Chronic Disease Self‐Management Programme CIS‐f: Checklist Individual Strength‐fatigue subscale CPAP: continuous positive airway pressure FSS: Fatigue Severity Scale ITT: intention‐to‐treat IQR: interquartile range MFI‐20: Multidimensional Fatigue Inventory‐20 MFS: Mental Fatigue Scale MRI: magnetic resonance imaging PSF: post stroke fatigue SAH: subarachnoid haemorrhage SD: standard deviation SF‐36‐vitality: Short Form‐36 vitality subscale SSQOL‐energy: Stroke‐specific Quality of Life‐energy subscale TIA: transient ischaemic attack VAS‐f: Visual Analogue Scale‐fatigue