Bergqvist 1981.
Study characteristics | ||
Methods | Study design: randomised, cross‐over, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 6/149 (4%) |
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Participants | Country: Sweden Setting: outpatient clinic and local population Number: 149 patients Age: 'adults' Gender: 33 M:116 F Inclusion criteria: symptoms related to varicose veins and CVI Exclusion criteria: not stated |
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Interventions | Treatment: oxirutoside 1000 mg intravenous injection followed by 1 tablet of 500 mg per 8 hours Control: placebo Duration: 28 days Follow‐up: 28 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: "They were then randomly allocated to treatment with either HR or identical placebo" Comment: no details of randomisation method provided |
Allocation concealment (selection bias) | Unclear risk | Comment: no method of allocation concealment described |
Blinding (patients) | Low risk | Quote: "The placebo regime was identical" and "... or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "The placebo regime was identical" and "... or identical placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "The placebo regime was identical" and "... or identical placebo" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Low risk | Comment: number of participants in each group described. Loss to follow‐up described along with exclusions after randomisation, including reasons |
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 |