Coope 1986.
Methods | Multicentre study Randomisation: participants were randomised on a 50:50 basis without stratification using random number tables. Opaque envelopes were supplied in sequence from the trial administrative centre that gave instructions for allocation to treatment or control group. Loss to follow‐up: not stated Mean duration of follow‐up: 4.4 years |
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Participants | Geographic region: England and Wales Study setting: primary care Number of participants: 884 (31% men) Age range: 60 to 79 years (mean: 65 years) Race: not stated Exclusion criteria: atrial fibrillation, A‐V heart block, ventricular failure, bronchial asthma, diabetes mellitus (needing pharmacological treatment) or any serious concomitant disease, and untreated hypertension with levels persistently > 280 mmHg for SBP or 120 mmHg for DBP or people already being treated for hypertension (within 3 months) Mean BP at entry: 196.4/98.8 mmHg BP entry criteria: not stated Comorbid conditions: smoking 215 (24%) |
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Interventions |
Beta‐blocker group: Step 1: atenolol 100 mg/day Step 2: bendrofluazide 5 mg/day Step 3: methyldopa 500 mg/day Step 4: any other recognised therapy such as nifedipine retard 20 mg twice daily Control group: No treatment Proportion on assigned treatment at end of study: beta‐blocker group: 70% |
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Outcomes | Total mortality CHD mortality: fatal MI, sudden death CHD morbidity: non‐fatal MI Cerebrovascular mortality: fatal stroke Cerebrovascular morbidity: non‐fatal stroke Cardiovascular mortality: fatal stroke, MI, sudden death, ventricular failure, ruptured aneurysm, hypertensive nephropathy Cardiovascular morbidity: non‐fatal stroke, MI, non‐fatal ventricular failure |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Used random number table |
Allocation concealment (selection bias) | Low risk | Used opaque sequentially numbered envelopes supplied by the trial administrative centre |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blind outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Not indicated whether reasons for missing outcome data were similar across treatment groups |
Selective reporting (reporting bias) | Unclear risk | No access to protocol |
Other bias | Unclear risk | Other antihypertensive drugs added to randomly allocated treatment to control BP. The observed effects may equally have resulted from the different additional drugs. |