Mersey 1984.
Methods | Minimum 2‐week washout period; 3‐week single‐blind placebo lead‐in period; inclusion criteria=supine DBP 95‐114 mm Hg; 7‐week double‐blind treatment, consisting of 3‐week dose titration period (initial dose of 1 mg once daily, increased by steps to 20 mg once daily, regardless of BP) followed by 4‐week fixed dose period | |
Participants |
Reported in Mersey 1984: All patients: n=64(41 males, 23 females); 35 white, 29 other; age range 21‐72 years; Terazosin 20 mg: n=38; baseline supine SBP=149.7 mm Hg, DBP=100.4 mm Hg Placebo: n=26; baseline supine SBP=147.1 mm Hg, DBP=99.2 mm Hg Reported in Dauer 1986 (Study M81‐061): Terazosin 20 mg: n=38; baseline standing SBP=147.9(15.4) mm Hg, DBP=103.3(6.2) mm Hg; baseline supine SBP=152.2(13.6) mm Hg, DBP=101.0(3.7) mm Hg Placebo: n=26; baseline standing SBP=143.8(15.3) mm Hg, DBP=100.4(6.1) mm Hg; baseline supine SBP=147.1(13.8) mm Hg, DBP=99.2(3.6) mm Hg |
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Interventions | Terazosin 20 mg once daily Placebo |
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Outcomes |
Reported in Mersey 1984: Change from baseline in trough supine SBP/DBP using mercury sphygmomanometer Change from baseline in peak supine SBP/DBP using mercury sphygmomanometer Reported in Dauer 1986 (Study M81‐061): Change from baseline in trough standing SBP/DBP using mercury sphygmomanometer Change from baseline in trough supine SBP/DBP using mercury sphygmomanometer |
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Notes | Used BP data reported in Dauer 1986 instead of Mersey 1984 Reported in Mersey 1984: BP change reported, SD of change not reported, endpoint BP reported, endpoint SD not reported; baseline BP reported, baseline SD not reported Reported in Dauer 1986 (Study M81‐061): BP change and SE of change reported, endpoint BP and SD not reported; baseline BP and SE reported; calculated SD of change from N and SE of change; BP data from Table IV, p. 32 |
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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 (performance bias and detection bias) All outcomes | Unclear risk | Not described. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Losses to follow‐up and withdrawals not reported in Mersey 1984 or separately for M81‐061 in Dauer 1986. Unclear how dropouts were dealt with. |
Selective reporting (reporting bias) | High risk | BP lowering efficacy was primary outcome. Quote: "...pulse rate did not increase with P or T." Comment: Quantitative HR and safety/tolerability not reported in abstract or separately for Study M81‐059 in Dauer 1986. |
Other bias | High risk | Full trial data has not been published separately, only summarized in abstract and Dauer 1986 review article. Funding source not reported. |