Chen 2016a.
Methods | Computer‐generated random numbers by independent research staff Assessors blinded |
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Participants | Multi‐centre trial in China 250 participants; 148 male 100% stroke within 2 to 7 days Dysphagia identified by bedside swallowing assessment and videofluoroscopic swallowing study Baseline characteristics and prognostic values similar between both groups |
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Interventions | Rx: acupuncture and conventional stroke rehabilitation care C: conventional stroke rehabilitation care only Duration: 3 weeks Follow‐up: 7 weeks |
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Outcomes | Primary outcome: NIHSS index Secondary outcomes: FMA for motor function, rate of recovery based on BSA, VFSS, MMSE, and MoCA |
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Notes | Exclusions: serious heart, liver, and kidney‐related diseases; blood coagulation dysfunction; inability to complete the MMSE test or bedside swallowing assessment; congenital disabilities; posterior circulation infarcts; receiving thrombolytic; participated in other clinical trials within previous 3 months; pregnant or breastfeeding | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers provided by independent research staff |
Allocation concealment (selection bias) | Low risk | Random numbers placed into sequentially numbered, opaque, sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants and acupuncturist aware of treatment allocations. All allopathic medical staff and rehabilitation therapists blinded |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and acupuncturist not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 participants lost to follow‐up; 4 discontinued intervention. Not all participants given VFSS examination |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |