Schnaper 1975, Study 2.
Methods | 2‐week screening/observation period; 2‐week placebo period; inclusion criteria=supine DBP 95‐115 mm Hg; 6‐week double‐blind treatment period, followed by 1‐week placebo period, followed by 4‐week double‐blind continuation of fixed dosage of medication to responding patients Responding patients included: 1) those whose mean arterial pressure (DBP plus 1/3 PP), either supine or standing, had dropped by ≥15 mm Hg since end of preceding placebo period; and 2) patients whose supine or standing DBP decreased to ≤90 mm Hg. Patients who did not respond were dropped from study and were started on a titration regimen of 1 of 2 active drugs. |
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Participants | Prazosin 3 mg: n=20; baseline SBP/DBP not reported Placebo: n=10; baseline SBP/DBP not reported |
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Interventions | Prazosin 3 mg once daily Placebo |
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Outcomes | Change from baseline in trough standing SBP/DBP using mercury sphygmomanometer Change from baseline in trough standing SBP/DBP using mercury sphygmomanometer |
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Notes | BP change reported; SD of change not reported; endpoint BP and SD not reported; baseline BP and SD not reported; imputed overall trial mean SD of change for SBP and DBP; BP data from Table 4, p. 85 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described. |
Allocation concealment (selection bias) | Low risk | Quote: "...and each patient was given an individually coded bottle. A sealed envelope containing the code was attached to the bottle so the investigator could selectively break the code in an emergency." |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Medication was dispensed in identical capsules..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "In two patients, pressure rose to an unacceptable level after six weeks and four weeks, respectively. The code was broken, and they were given active therapy with prazosin. These patients are clearly failures on placebo and as such are significant to this trial. For this reason, they were included in the efficacy analysis as placebo patients, with the last pressures recorded during the double‐blind phase as their final values." |
Selective reporting (reporting bias) | High risk | BP lowering efficacy was primary outcome. Safety/tolerability data not reported |
Other bias | Unclear risk | Funding source not reported. |