Burnand 1989.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: none |
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Participants | Country: UK Setting: hospital Number: 49 patients Age: mean 53 years Gender: 18 M:31 F Inclusion criteria: venous reflux by volumetry, with varicose veins and lipodermatosclerosis Exclusion criteria: patients with ankle‐to‐arm arterial Doppler pressure ratio < 1.0 (significant arterial disease) |
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Interventions | Treatment: oxerutin (Paroven) 500 mg per 12 hours Control: placebo Duration: 30 days Follow‐up: 30 days |
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Outcomes | Primary
Secondary
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A double‐blind controlled trial was undertaken.." and "the two groups of patients were balanced and randomized by trial number so that as far as possible an equal number in each group..." Comment: no details of randomisation method provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods of allocation concealment described |
Blinding (patients) | Low risk | Quote: "Were given Paroven 500 mg bd or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "Were given Paroven 500 mg bd or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "This code was not broken until the completion of the study" Comment: outcome assessors blinded |
Incomplete outcome data | Low risk | Comment: neither exclusions post randomisation nor losses to follow‐up described |
Selective reporting | Low risk | Comment: no published protocol identified, and no differences between outcomes reported in the methods section and those reported in the results section |
Other bias | Low risk | Comment: none detected |