Harder 1994.
Methods | 2‐week washout; 2‐week placebo run‐in period; inclusion criteria=sitting DBP 95‐115 mm Hg; 8‐week double‐blind treatment | |
Participants | All patients: n=16 (11 males, 5 females); all white; age range=42‐68 years; baseline SBP=163(23) mm Hg, DBP=103(8) mm Hg Bunazosin 3 mg: n=4; baseline supine SBP=155.3(23.9) mm Hg, DBP=100.0(7.1) mm Hg, HR=87.8(12.2) bpm Bunazosin 6 mg: n=4; baseline supine SBP=168.5(9.3) mm Hg, DBP=98.8(4.8) mm Hg; HR=76.0(13.5) bpm Bunazosin 12 mg: n=4; baseline supine SBP=180.3(28.4) mm Hg, DBP=110.0(8.6) mm Hg; HR=81.0(13.1) bpm Placebo: n=4; baseline supine SBP=149.0(21.0) mm Hg, DBP=102.5(6.5) mm Hg, HR=85.0(16.1) bpm |
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Interventions | Bunazosin 3 mg once daily Bunazosin 6 mg once daily Bunazosin 12 mg once daily Placebo |
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Outcomes | Trough supine SBP/DBP using mercury sphygmomanometer Trough supine HR WDAE |
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Notes | Individual patient BP and HR reported at baseline and endpoint; calculated BP change and SD of change for each group; BP and HR data from Table 1, p. 39 | |
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Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "One patient on 6 mg bunazosin was withdrawn from the study after the occurrence of nycturia due to mild heart failure." |
Selective reporting (reporting bias) | Low risk | BP lowering efficacy was primary outcome. HR and safety/tolerability data reported. |
Other bias | High risk | Quote: "The study was performed in one center as a part of a double‐blind, placebo controlled multicenter trial comparing the efficacy of three different dose levels of bunazosin and placebo in a parallel‐group design." Comment: Publication of the full trial results has not been identified. Risk of publication bias is high. Funding source not reported. |