Greco 1992.
Study characteristics | ||
Methods | Randomized controlled double‐blind trial | |
Participants | 20 diabetic patients with intermittent claudication minimum 1 year, ABI < 0.75, MWD from 100 to 500 m, and < 20% variation in ACD during the washout period. 20 patients were randomized into 2 groups of 10 participants. 1 dropout from the placebo group was reported | |
Interventions | Intervention (n = 10): oral PLC 1.5 g/d for 6 months Control (n = 10): oral placebo 1.5 g/d for 6 months |
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Outcomes | Initial claudication distance (PFWD) on treadmill (slope 10%, speed 2.5 km/h) Absolute claudication distance (MWD) on treadmill Ankle brachial Index |
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Notes | Funding by Sigma Tau | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information about sequence generation of parallel groups |
Allocation concealment (selection bias) | Unclear risk | No description of method of allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "a controlled double‐blind trial versus placebo" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding of outcome assessment assumed, hence no influence on outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout data available; all results reported in absolute and relative numbers; P values reported |
Selective reporting (reporting bias) | Low risk | No selective reporting bias assumed |
Other bias | Unclear risk | Small number of participants (20); possible conflict of interest (funding by Sigma Tau) |