Hepp 1992.
Study characteristics | ||
Methods | Study design: double‐blind, randomised Country: Germany Setting: 9 centres Intention‐to‐treat: not mentioned |
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Participants | Number of participants randomly assigned: 195 (98 pentoxifylline, 97 PGE1) Number of participants analysed: 195 Exclusions postrandomisation: 0 Losses to follow‐up: 0 Age (mean): 65 years Sex: male:female: 2.8:1 Inclusion criteria: PFWD 50–200 m; stable stadium Fontaine IIb for 6 months; diagnosis of stenosis through digital subtraction angiography or conventional angiography of lower limbs; signing an informed consent form; variance of walking distance at beginning < 20% Exclusion criteria: pregnancy; present heart failure; kidney failure; prestenosis (e.g. stenosis of the aorta abdominalis or iliacal arteries); necrosis or rest pain; pulmonary insufficiency; arthrosis; MI within previous 6 months; orthostatic dysregulation and experiencing collapse; severe cardiac rhythm problems; epilepsy |
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Interventions | Treatment: IV pentoxifylline, 200 mg bid Control: IV PGE1, 40 µg bid Duration: 4 weeks |
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Outcomes | Primary: mean TWD and PFWD Secondary: side effects |
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Notes | Treadmill protocol: not specified Mean PFWD and TWD expressed in metres only |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomisation list." Comment: no other information provided. |
Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "blind." Comment: no other information provided. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No incomplete outcome data. |
Selective reporting (reporting bias) | Unclear risk | Protocol not available; insufficient information available to permit judgement. |
Other bias | Low risk | Study appeared free of other bias. |