Volker 1978.
| Study characteristics | ||
| Methods | Study design: double‐blind, randomised Country: Germany Setting: single centre Intention‐to‐treat: yes |
|
| Participants | Number of participants randomly assigned: 50 (25 in each group) Number of participants analysed: 50 Exclusions postrandomisation: 0 Losses to follow‐up: 0 Age: range 56–65 years Sex: pentoxifylline: 18 males, 7 females, placebo: 17 males, 8 females Inclusion criteria: Fontaine stage II, walking distance < 600 m; no vasoactive substances allowed Exclusion criteria: none reported |
|
| Interventions | Treatment: oral pentoxifylline, 400 mg tid Control: placebo Duration: 4 weeks |
|
| Outcomes | Primary: mean PFWD Secondary: QoL, side effects |
|
| Notes | Treadmill protocol: not specified Mean PFWD expressed in metres only |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Randomly assigned according to admission into the study; no other information provided. |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double‐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. |
ABI: ankle‐brachial pressure index; ACD: absolute claudication distance; bid: twice daily; COAD: chronic occlusive artery disease; GI: gastrointestinal; HCl: hydrochloride; IC: intermittent claudication; IDDM: insulin‐dependent diabetes mellitus; IV; intravenous; MI: myocardial infarction; mph: miles per hour; NYHA: New York Heart Association; PAD: peripheral arterial disease; PAVK: Peripheral Arterial Occlusive Disease 86 Questionnaire; PFWD: pain‐free walking distance; PGE1: prostaglandin E1; PAOD: peripheral arterial occlusive disease; QoL: quality of life; SD: standard deviation; SF‐36: 36‐item Short Form; SFA: superficial femoral artery; tid: 3 times daily; TWD: total walking distance; WHO: World Health Organization; WIQ: Walking Impairment Questionnaire.