VA COOP 1982.
Methods | Multicentre study
Randomisation: described as randomised controlled trial, but method of allocating participants to treatment not described Blinding: participants, providers, and assessors blinded Loss to follow‐up: 8% Mean duration of follow‐up: 12 months Participants withdrawn from the study for uncontrolled BP not included in the analysis |
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Participants | Geographic region: USA Study setting: hospital Number of participants: 683 (all men) Age range: 21 to 65 years (mean: 49.6 years) Race: 43% white and 57% black BP at entry: DBP 95 to 104 mmHg Comorbid conditions: not described |
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Interventions |
Beta‐blocker group: Propranolol 40 mg twice daily, increasing to 640 mg/day Diuretic group: Hydrochlorothiazide 25 mg twice daily, increasing to 200 mg/day Participants still on assigned baseline therapy at study end: beta‐blocker group, 39%, diuretic group: 52% |
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Outcomes | Total mortality Cerebrovascular disease CHD |
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Notes | Participants were withdrawn from the study if, on any follow‐up visit, DBP ≥ 120 mmHg | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants and providers blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "A total of 73 (10.7%) of the patients were dropped from the study after randomization. Of these, 42 (57.5%) were in the propranolol group and 31 were taking hydrochlorothiazide. The difference was not significant" Analyses by intention‐to‐treat |
Selective reporting (reporting bias) | Unclear risk | No access to study 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. |
ACE: angiotensin‐converting enzyme; BP: blood pressure; CHD: coronary heart disease; CHF: congestive heart failure; CVD: cardiovascular disease; DBP: diastolic blood pressure; LVH: left ventricular hypertrophy; MI: myocardial infarction; SBP: systolic blood pressure; SD: standard deviation; SR: sustained release; TIA: transient ischaemic attack.