Perez 1997.
Methods | Computerised randomisation Triple‐blind trial; outcomes assessed by blinded therapist Analysis by ITT No cross‐overs or losses to follow‐up 1 participant withdrawn with heart failure (nifedipine group) Baseline prognostic factors balanced between treatment groups |
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Participants | 1 centre in UK 17 participants; 8 men Mean age 77 (SD 7) years All first ischaemic stroke 100% CT Enrolment 2 weeks after stroke |
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Interventions | Rx: nifedipine (30 mg orally daily, Bayer, UK) (n = 8) Pl: matching tablet; treatment for 4 weeks (n = 9) |
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Outcomes | Primary outcome: clinical improvement in swallowing Other outcomes: incidence of silent aspiration, pharyngeal transit time and response duration, swallowing delay (all assessed by videofluoroscopy), death |
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Notes | Exclusions: inability to sit, high clinical risk of aspiration, receptive dysphasia, cognitive impairment, pre‐stroke dysphagia, existing neurological or psychiatric disease, current treatment with calcium channel blockers or aminophylline Follow‐up: 4 weeks. 1 participant withdrawn with heart failure |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised randomisation |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | Low risk | Triple‐blind trial |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Triple‐blind trial |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcomes assessed by blinded therapist |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant withdrawn with heart failure (nifedipine group) No cross‐overs |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Other bias | Low risk | None identified |