Balmer 1980.
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: Switzerland Setting: not stated Number: 40 patients Age: mean 46.2 ± 14.1 years active group; mean 52.3 ± 14.1 years placebo group Gender: 4 M:36 F Inclusion criteria: CVI without venous ulcers Exclusion criteria: varicose ulcers |
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Interventions | Treatment: oxirutoside 900 mg per day Control: placebo Duration: 28 days Follow‐up: 28 days Compression therapy was allowed if participants were unwilling to abandon this support |
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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: "The trial was double‐blind, randomised, placebo controlled, between patients..." Comment: no information given about method of randomisation used |
Allocation concealment (selection bias) | Unclear risk | Comment: no information given about method of treatment allocation used |
Blinding (patients) | Low risk | Quote: "Patients receiving respectively the test drug or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "Patients receiving respectively the test drug or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "Patients receiving respectively the test drug or identical placebo" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Low risk | Comment: no exclusions post randomisation and no losses to follow‐up |
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 |