Zanchetti 1993.
Methods | Multicenter study involving 2‐week placebo run‐in period, followed by double‐blind, placebo‐controlled treatment period of 4 weeks. ABPM was performed at the end of the placebo run‐in period and on the last day of treatment for a period of 24‐36 hours. Recordings were considered valid if had at least 1 valid BP measurement per hour and at least 24 hours of continuous BP recordings after removal of outlying values by an automatic procedure | |
Participants | Participants with mild‐to‐moderate essential hypertension defined as a sitting clinic DBP 95‐114 mmHg were randomized (126 participants). 81 had valid ABPM data and were included in the analysis | |
Interventions | Nifedipine GITS 30 mg (25 participants), nifedipine GITS 60 mg (28 participants), or placebo (28 participants), once daily for 4 weeks. Nifedipine 60 mg and placebo were used for this analysis | |
Outcomes | Antihypertensive efficacy | |
Notes | No information about time of dosing provided. Emailed first author with no response. Assumed 8 a.m. dosing; 'hour 0' | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No description of the process of randomization |
Allocation concealment (selection bias) | Unclear risk | No description of the process |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description of the process |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No description of the process |
Incomplete outcome data (attrition bias) All outcomes | High risk | Only participants with study defined "valid" BP measurements included in analysis |
Selective reporting (reporting bias) | Low risk | All outcomes in methods were reported |
Other bias | High risk | Bayer SpA, Milan involved in study group |
ABPM: ambulatory blood pressure monitoring; DBP: diastolic blood pressure; SBP: systolic blood pressure; SD: standard deviation.