Neutel 2005.
Methods | multicenter, double‐blind, double‐dummy, randomized, blinded end point, crossover study. After 4 weeks single‐blind placebo run‐in period, patients received chronotherapeutic propranolol and propranolol each for 4 weeks
Sample size calculation: not reported carryover effects: not reported no washout period between treatment arms |
|
Participants | Country: not reported
Number randomised: 44
gender: 31 men, 13 women
mean age: 53.4±8.46 years Ethnicity: Caucasian 27, African American 5, Asian 3, Hispanic 5, Other 4 inclusion criteria: seated DBP of 95–114 mm Hg and a mean daytime ambulatory DBP (8 a.m.to 4 p.m.) of 90–114 mm Hg exclusion criteria: mean DBP ≥115 mm Hg and/or a mean SBP≥200 mm Hg |
|
Interventions | 120 mg od chronotherapeutic delayed‐release propranolol (Innopran XL) dosed at bedtime: N=44 120 mg od traditional propranolol (Inderal LA) dosed in the morning : N=44 |
|
Outcomes |
Mortality: not reported Morbidity: not reported Blood Pressure data:24h BP change, morning (6 am to noon) BP change by 34h ABPM, data was obtained from text. Adverse Events: not reported |
|
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | not reported |
Allocation concealment (selection bias) | Unclear risk | not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | double‐dummy |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants were reported. Three patients were excluded, one was excluded by the investigator for being uncooperative and noncompliant with study medication, one for being off study medication for a significant period of time, and one patient was removed for alcohol abuse. |
Selective reporting (reporting bias) | Low risk | all outcomes were reported. |
Other bias | Unclear risk | carryover effects were not reported |