Chassignolle 1994.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 4/40 (10%) |
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Participants | Country: France Setting: hospital Number: 40 patients Age: 32.0 (1.3) years active group; 35.6 (1.1) years placebo group Gender: female Inclusion criteria: women with functional CVI Exclusion criteria: not stated |
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Interventions | Treatment: diosmine 1000 mg per day Control: placebo Duration: 60 days Follow‐up: 60 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: "Patients were randomly assigned to two parallel groups of 20" Comment: no randomisation methods stated |
Allocation concealment (selection bias) | Unclear risk | Comment: no methods of allocation concealment stated |
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 in each group described, number of participants who dropped out prematurely stated and reasons for dropping out 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 |