Skip to main content
. 2020 Oct 16;2020(10):CD005262. doi: 10.1002/14651858.CD005262.pub4

Hepp 1992.

Study characteristics
Methods Study design: double‐blind, randomised
Country: Germany
Setting: 9 centres
Intention‐to‐treat: not mentioned
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
Interventions Treatment: IV pentoxifylline, 200 mg bid
Control: IV PGE1, 40 µg bid
Duration: 4 weeks
Outcomes Primary: mean TWD and PFWD
Secondary: side effects
Notes Treadmill protocol: not specified
Mean PFWD and TWD expressed in metres only
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.