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. 2018 Oct 30;2018(10):CD000323. doi: 10.1002/14651858.CD000323.pub3

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1 participant withdrawn with heart failure (nifedipine group)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
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
Interventions Rx: nifedipine (30 mg orally daily, Bayer, UK) (n = 8)
Pl: matching tablet; treatment for 4 weeks (n = 9)
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
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Follow‐up: 4 weeks. 1 participant withdrawn with heart failure
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 All outcomes Low risk 1 participant withdrawn with heart failure (nifedipine group)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