Trübestein 1984.
| Methods | Study design: States randomized, double‐blinded. Method of randomization: Not stated. Blinding: Double‐blinded. Dropouts: 8 in the placebo group and 12 in the buflomedil group, leaving 93 for analysis (46 in placebo group, 47 in buflomedil group). |
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| Participants | Country: Germany. Setting: Clinic. No.: 113 patients. Age: 50 to 70 years old. Gender: Not stated. Inclusion criteria: Symptoms of intermittent claudication for 6 months to 5 years and PFWD of 50 to 400 m. After a four‐week run‐in period during which all patients received placebo and other vasoactive drugs were stopped, patients were checked to test whether their PFWD differed by not more than 30% from the value at the beginning of the run‐in period (mean of two consecutive measurements). Patients were then allocated randomly to treatment groups. Exclusion criteria: Special physical training for at least six months prior to study start; systolic blood pressure at the ankle of less than 70 mm Hg, diabetic microangiopathy or necrosis, inflammatory vascular disease such as endarteritis obliterans, coronary heart disease with angina pectoris, myocardial insufficiency, respiratory insufficiency, arthropathy, symptoms of severe liver or kidney disease, laboratory values of more than 10% outside normal range, pregnancy, beta‐blockers and any other vasoactive drugs. |
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| Interventions | All patients received placebo tablets (four daily ‐ 2 in the morning, one at midday and one in the evening) for four weeks run‐in. Treatment: Buflomedil 600 mg daily (2 x 150 mg in the morning, 1 x 150 mg at midday and 1 x 150mg in the evening.) Control: Matching placebo. Duration: 12 weeks treatment. (16 weeks in total including the 4 week run‐in period.) |
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| Outcomes | Primary: PFWD and MWD were measured by treadmill (5 km/h at 10° elevation). Ankle‐arm pressures were measured by Doppler at rest and after exercise and pressure differences (brachial artery‐posterior tibial artery) were calculated. Measurements were performed at days 28, 56, and 84. |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Unclear risk | B ‐ Unclear |
AMI: acute myocardial infarction ECG: electrocardiogram MWD: maximal walking distance PAOD: peripheral arterial occlusive disease PFWD: pain‐free walking distance SBP: systolic blood pressure