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. 2016 Aug 26;2016(8):CD004131. doi: 10.1002/14651858.CD004131.pub3

Zhang 2013a.

Methods RCT
 Method of randomisation: closed envelopes
 Blinding: Investigators, participants, not blinded
 Adverse effects: not stated
ITT analysis: none
 Losses to FU: not stated
Participants Country: China
 Number of participants included: 90 (30/30/30)
 Demographics: 43‐75 years, 54% male
 Type of stroke: both ischaemic and haemorrhagic strokes
 Diagnosis: WHO definition and all confirmed by CT/MRI
 Severity on entry: not stated
 Time from stroke onset: 6‐19 months
 Setting: inpatient
 Comparability: no significant difference in age or time post onset
Interventions 3 arms:
  • acupuncture only

  • WM only

  • acupuncture + WM


Comparison eligible: acupuncture + WM versus WM
Acupuncture treatment
  • Acupuncture rationale: not stated

  • Needling details

    • Points used: scalp acupoints

    • Numbers of points used: 4 acupoints

    • Depths of insertion: 0.66‐1.05 inches

    • Deqi elicited: yes

    • Needle stimulation: manual and electrical

    • Needle retention time: 30 minutes

    • Needle type: hua tuo brand, length 0.98 inches

  • Treatment regimen

    • Number of treatment sessions: 30 sessions

    • Frequency of treatment: 5 sessions/week

    • Total course: 6 weeks

  • Practitioner background: not stated

  • Co‐intervention: WM


Control interventions: WM
Outcomes
  • Improvement of depression (Hamilton Depression Scale)

  • Improvement of sleep (Rhone Planck Sleepiness Scale)

  • Adverse event

  • FU: 6 weeks

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation by using closed envelopes
Allocation concealment (selection bias) Low risk Randomisation by using closed envelopes
Blinding (performance bias and detection bias) 
 All outcomes High risk Quote: "unable to blind to participants and operators"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "unable to blind to participants and operators"
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Details not given
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Information on attrition was not reported
Selective reporting (reporting bias) Unclear risk Some patient‐related outcomes were not reported, such as information on quality of life or all‐cause mortality
Other bias Unclear risk No information provided