Nocker 1990.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: not stated Losses to follow‐up: not stated |
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Participants | Country: Germany Setting: university Number: 30 Age: 55 to 59 years Gender: menopausal females Inclusion criteria: stage II CVI with symptoms Exclusion criteria: venoactive drugs, anti‐inflammatories, corticosteroids or diuretics in the last 8 days before the start of the study; use of compression bandages or elastic stockings |
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Interventions | Treatment: oxirutoside 600 mg or 900 mg or 1200 mg or 1500 mg per day Control: placebo Duration: 90 days Follow‐up: 112 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) | Low risk | Quote: "Patients were randomized to one of the five groups, receiving oral solutions of HR in small bottles containing 600, 900, 1200, 1500 mg HR or simply distilled water (controls) with six patients in each group" Comment: no methods described for randomising participants |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods for 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 | Unclear risk | Comment: no data given about drop‐outs. Most important characteristics described with inclusion and exclusion criteria |
Selective reporting | Low risk | Comment: no protocol identified, but no differences between outcomes reported in the methods section and those reported in the results section |
Other bias | Low risk | Comment: none detected |