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. 2017 Aug 16;2017(8):CD008276. doi: 10.1002/14651858.CD008276.pub2

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.
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.
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.