Prerovsky 1972.
Study characteristics | ||
Methods | Study design: 2 independent, randomised, double‐blind, cross‐over, placebo‐controlled trials
Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: none |
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Participants | Country: Czechoslovakia Setting: research centre Number: 50 patients Age: 'adults' Gender: not stated Inclusion criteria: signs (oedema, pigmentation, post‐thrombotic syndrome) and symptoms of CVI Exclusion criteria: not stated |
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Interventions | Treatment: oxirutoside 1200 mg per day Control: placebo Duration: 126 days Follow‐up: 126 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: "... after the administration of 3 capsules of HR (900 mg) or 3 capsules of placebo in a double blind cross‐over trial in a randomized‐order" Comment: method of randomisation not described |
Allocation concealment (selection bias) | Unclear risk | Comment: no method of allocation concealment described |
Blinding (patients) | Unclear risk | Comment: no information given about methods used for blinding |
Blinding (study researchers) | Unclear risk | Comment: no information given about methods used for blinding |
Blinding (outcome assessment) | Unclear risk | Comment: no information given about methods used for blinding |
Incomplete outcome data | Low risk | Comment: number of participants described in each group, along with the most important characteristics. However, inclusion and exclusion criteria were, apart from clinical features, not well described. Adverse events and drop‐outs were well described |
Selective reporting | Low risk | Comment: no 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 |