Perhoniemi 1984.
| Study characteristics | ||
| Methods | Study design: double‐blind, randomised. Cross‐over after 3 months Country: Finland Setting: single centre Intention‐to‐treat: not mentioned |
|
| Participants | Number of participants randomly assigned: 35 Number of participants analysed: 31 (17 group 1, 14 group 2) Exclusions postrandomisation: 0 Losses to follow‐up: 4 Age (mean): 60 years (range 45–80 years) Sex: 25 males, 6 females Inclusion criteria: typical history and objective symptoms of IC; moderate claudication (IIb); maximum walking distance < 500 m Exclusion criteria: gangrene or ulcer of the legs; arterial reconstructive surgery within 6 months; symptomatic heart failure or symptomatic angina pectoris limiting exercise performance; severe hypertension WHO III |
|
| Interventions | Treatment: oral pentoxifylline, 400 mg tid Control: flunarizine, 5 mg tid Duration: 3 months, then cross‐over; no washout period (group 1: flunarizine followed by pentoxifylline; group 2: pentoxifylline followed by flunarizine) |
|
| Outcomes | Primary: median TWD, PFWD Secondary: ABI, side effects |
|
| Notes | Treadmill protocol: 3.6 km/h at 0% inclination; in 3 participants, the speed was increased to 5.4 km/h Median PFWD and TWD expressed in metres at baseline and as % change at follow‐up |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "patients were randomized into two groups according to the system of randomized blocks." |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participants received medication on a "double‐dummy basis"; 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. |