Schreiber 1998.

Methods	Single‐site study (Austria). Open label Method of randomization: NR Concealment of allocation: NR Duration of treatment: 6 hours Follow‐up:6 hours
Participants	133 patients* with pulmonary oedema and high blood pressure. * Note: not all randomized patients were included in the analysis of the original publication (please see below discussion) The total number of patients included in the original analysis was: n=112 45 patients from the urapidil group 67 patients from the nitroglycerin group This is because 20 (15%) patients withdrew or dropped out from the trial. However there is a discrepancy in the numbers as follows: Of those 20, 13 were reported according to the randomization group and 7 not according to the randomization group. "Withdrawals/dropouts reported according to randomization group: 13 Urapidil : 11 (3 due to AMI, 9 due to dose violation) Nitroglycerin : 2 ( due to AMI) "Withdrawals/dropouts reported NOT according to randomization group: 7 So, 112 + 20 = 132 patients. Thus, there is a discrepancy between the number of patients described in the text (total 132) with those described as total randomized patients (133). Therefore, total randomized (133) minus those included in the analysis (112) equals 21(16%) not included in the original analysis We tried to contact the authors to explain this discrepancy but they did not replied to our request. Inclusion Criteria: Patients with systolic blood pressure > 200 mmHg ,and diastolic blood pressure > 100 mm Hg in association with clinical evidence of pulmonary edema ( rales over both lungs) Exclusion Criteria: Allergic reactions Pregnancy, Myocardial infarction Respiratory insufficiency requiring intubation or coma at the time of the emergency physician arrived. * Baseline characteristics for the two randomized groups: Nitroglycerine (N): n= 67 Urapidil (U): n= 45 Mean age ± SD ( years) N:74 9 U: 73±11 BP: (mm Hg) N:216/116 U:218/118
Interventions	Nitroglycerine (N): n= 67 Urapidil (U): n= 45 Dose regimen: Sublingual Nitroglycerine : Initial dose of 0.8 mg and then 0.8 mg every 10 minutes. If after hospital admission SBP was > 180 mm Hg and/or DBP 100 mm Hg the drug was still continued but changed to IV infusion on a rate of 0.5‐ 5mg/ h to reach SBP < 160 mm Hg and DBP below 90 mmHg within 30 min after admission and no re‐elevation of BP for 6 h. IV Urapidil (peripheral alpha1 receptor blocker and central 5‐HT1A ‐receptor agonist): Initial dose 12.5 mg and then 12.5 mg every 15 minutes. If after hospital admission SBP was > 180 mm Hg and/or DBP 100 mm Hg the drug was still continued but changed to IV infusion on a rate of 5‐25mg/ h to reach SBP < 160 mm Hg and DBP below 90 mmHg within 30 min after admission and no re‐elevation of BP for 6 h.
Outcomes	Obtained from this trial for the two randomized groups: Nitroglycerine (N): n= 67 Urapidil (U): n= 45 Total SAE: not reported (NR) Mortality = nil Total non‐fatal cardiovascular events: NR Individual CVE: Left ventricular failure requiring intubation: Urapidil: 0 Nitroglycerin: 2 Blood pressure: Data was obtained from table 1 page 560 ( base‐line values) and from text on page 559 & 560. It was not possible to follow full ITT principles due to inconsistencies in the report. (see notes above) The calculated weigthed mean BP change was: Nitroglycerin: SBP ‐59.5 ±20; DBP‐33.5±11 Urapidil: SBP ‐73.5 ±21; DBP‐42±13 Standard deviation of change was not reported but imputed from end point. Heart rate: Data was obtained from table 1 page 560 ( base‐line values) and from text on page 559 & 560. It was not possible to follow full ITT principles due to inconsistencies in the report. (see notes above) The calculated weigthed mean HR change was: Nitroglycerin: ‐17.5±9 Urapidil: SBP ‐15±7 Standard deviation of change was not reported but imputed from end point.
Notes	Funding: Not reported
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear