Oslo 1986.
Methods | Open, randomized trial conducted in ambulatory young men randomized to treatment or no treatment in Norway. | |
Participants | 785 men, mean age 45.3 years, range 40‐49 years. Ethnicity not reported. Baseline mean SBP/DBP 156.2/97 mmHg, pulse pressure 59 mmHg. Inclusion criteria: SBP 150‐179 mmHg and DBP < 110 mmHg. Followed for 5‐6 years. Target BP < 140/90 mmHg. Exclusion criteria: new or previous CHD; cardiovascular disease; intermittent claudication; CHF or valvular heart disease; drug‐treated hypertension during the last year; diabetes mellitus (fasting blood sugar ≥ 8.3 mmol/L); retinopathy (Keith‐Wagener grade 3 and 4); renal disease (proteinuria, haematuria, creatinine ≥ 123.8 mmol/L, chronic nephritis); hepatic disease; psychosis; severe neurosis; people regularly treated with psychopharmacological drugs; malignant disease; chronic disease such as rheumatoid arthritis; endocrine disorders; obvious alcohol abuse and social maladjustment; secondary hypertension; electrocardiographic changes at rest: left bundle branch block, atrial fibrillation, S‐T segment depressions; marked left ventricular hypertrophy; Rmax + Smax in precordial leads ≥ 45 mm and simultaneous ST‐T changes (Minnesota code 4‐l) S‐T segment depression and T‐wave flattening or inversion. Mean follow‐up: 5 years. |
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Interventions |
Treatment: hydrochlorothiazide (95%), methyldopa, and propranolol (26%). At 5‐year follow‐up, 36.7% were taking hydrochlorothiazide alone, 26% were taking hydrochlorothiazide + propranolol, 20% were taking hydrochlorothiazide + methyldopa and 18% were taking other drugs. Control: no treatment. |
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Outcomes | Stroke, CHD, all‐cause mortality, CHF, SBP and DBP | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "During 1973, 785 men, aged 40 to 49, with mild, symptom‐free hypertension were randomly assigned for a five‐year controlled drug treatment study, 406 men in the treatment group and 379 in the control group." "The randomization was performed by a "random number table"." Comment: participants were randomly allocated using random number tables and the baseline characteristics were similar. |
Allocation concealment (selection bias) | Low risk | Method used for allocation concealment not mentioned. Participants and physicians aware of treatment given; however, baseline characteristics were similar. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Drug treatment was started with hydrochlorothiazide. If SBP remained above 140 mm Hg and/or DBP above 90 mm Hg, alpha methyldopa was added. If there were side effects, methyldopa was replaced with propranolol. The control group was not given a placebo." Comment: no mention of blinding, both participants and physicians aware of treatment provided. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Possible and definite coronary events and other cardiac complications were also evaluated by a "blind" diagnostic board of two independent cardiologists." Comment: blinding of outcome assessors probably done, though it was not clearly stated. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quotes: "In this study the patients have seen the same physicians and the same paramedical staff during 4 years and the drop‐out rate has been small, 0.6 per cent and the same in both groups." "Three men refused the drugs, and 13 (1.7%) dropped out of the study, three in the treatment group and 10 in the control group." "The mean observation time was 66 months (range: 60 to 76). Only 13 (1.7%) men failed to report for regular examinations. However, these men were followed for possible cardiovascular events at the end of the study." Comment: number of dropouts was low and participants were followed until end of study to account for all outcomes. |
Selective reporting (reporting bias) | Low risk | Quote: "Each patient with cardiovascular events has been counted once, i.e., the number of events is identical with the number of patients with events. If a patient had more than one event, the most serious was counted. Nobody had both coronary heart disease and a cerebrovascular event." Comment: all outcomes (coronary, cerebrovascular and other events) properly reported and accounted for in results section. |
Other bias | Unclear risk | Conflict of interest not reported. Source of funding not stated. |