Carter 1970.
Methods | Randomised single‐site open‐label study conducted in UK Patients were stroke survivors admitted to the hospital and followed in clinics |
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Participants | 99 participants, of which 71 were aged 60 to 79 years; 54% men; age range 40 to 79; mean 69 years; race/ethnicity not reported; mean BP at entry not reported N = 71; age 60 to 79 Pre‐existing factors: stroke 100%; BP entry criteria: SBP > 160 mmHg and DBP < 110 mmHg, or DBP ≥ 110 mmHg irrespective of SBP Exclusion criteria: cerebral haemorrhage; embolism; tumour; accelerated hypertension; "those with an obvious need for hypotensive therapy"; left ventricular failure; congestive cardiac failure; gross radiological cardiac enlargement; various cardiac arrhythmias or evidence of renal failure Mean follow‐up: 4.0 years |
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Interventions | Treatment: first choice ‐ thiazide diuretic (dose or type of thiazide was not specified; assumed to be high‐dose thiazide); second choice ‐ methyldopa; third choice ‐ bethanidine, debrisoquine, or guanethidine Control: observation without placebo | |
Outcomes | Total mortality: death from all causes Stroke; coronary heart disease; congestive heart failure Dropouts due to side effects: not reported Quality of life or functional status outcomes: not reported |
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Notes | Percentage of patients not on assigned therapy at study end: not reported Difference in blood pressure at study end: not reported Data on mortality were available in 60‐ to 79‐year age group from the Mulrow 1998 review. Data on cardiovascular mortality and morbidity; cerebrovascular mortality and morbidity; and coronary heart disease mortality and morbidity, and withdrawals due to adverse effects were not available |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "placed at random into treated (50) or control (49) groups. The two groups matched reasonably closely with regard to numbers, age, sex, and severity of hypertension" Comment: method of randomisation was not described |
Allocation concealment (selection bias) | Unclear risk | Method for allocation concealment was not mentioned |
Blinding of participant and personnel (performance and detection bias) | High risk | Study does not state blinding of participants or personnel. Treating physicians were aware of the treatment prescribed |
Blinding of outcome assessment | High risk | Study does not mention blinding of the outcome assessor |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "2 out of 99 patients (2%) have been lost to follow‐up, a treated man aged 65 and untreated women of 70 ‐ so results are available for 49 treated and 48 untreated patients" Comment: the attrition rate is extremely low, and although reason for loss to follow‐up was not mentioned, it could not have affected the outcome analysis |
Selective reporting (reporting bias) | Unclear risk | Protocol is not available to confirm reporting bias. Mortality rate and recurrence rate of strokes mentioned, as study objectives were reported in the results section "Figures for minor strokes or transient cerebral ischaemic attacks are not available" |
Industry sponsorship bias | Unclear risk | "Part of the expenses of this research project was covered by a grant from the clinical research subcommittee of the North West Metropolitan Regional Hospital Board" |