Skip to main content
. 2012 Aug 15;2012(8):CD004643. doi: 10.1002/14651858.CD004643.pub3

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
Interventions Bunazosin 3 mg once daily
Bunazosin 6 mg once daily
Bunazosin 12 mg once daily
Placebo
Outcomes Trough supine SBP/DBP using mercury sphygmomanometer
Trough supine HR
WDAE
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 All outcomes Low risk Quote: "One patient on 6 mg bunazosin was withdrawn from the study after the occurrence of nycturia due to mild heart failure."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.