Cloarec 1994.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: 16/120 (13%) Losses to follow‐up: not stated |
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Participants | Country: France Setting: not stated Number: 120 patients Age: mean 50 years Gender: not stated Inclusion criteria: history of CVI for several years Exclusion criteria: not stated |
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Interventions | Treatment: O‐(beta‐hydroxyethyl)‐rutoside 2000 mg per day Control: placebo Duration: 56 days Follow‐up: 56 days |
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Outcomes | Primary
Secondary
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Notes | This clinical trial is published in abstract format; not possible to extract data showing results | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "A multicenter double blind randomized clinical trial was designed" Comment: no methods described for randomisation of participants |
Allocation concealment (selection bias) | Unclear risk | Comment: no information given about methods used for allocation concealment |
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: only 13% drop‐out rate (16/120) for violation of study protocol reported |
Selective reporting | High risk | Comment: no protocol identified. In the methods section, subjective symptoms identified that were not reported in the results section (pain, heaviness, swelling, restless leg, cramps, presence of pitting oedema) |
Other bias | Low risk | Comment: none detected |