Hachen 1982.
Study characteristics | ||
Methods | Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 2/50 (4%) |
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Participants | Country: Switzerland Setting: hospital Number: 50 females Age: 10 to 45 years Gender: 50 F Inclusion criteria: recent onset of CVI; no venous surgery, presence of symptoms (heaviness, fatigue, etc.) or aggravation during prolonged sitting or standing or during premenstrual periods Exclusion criteria: pregnancy, diabetes, polyneuropathy, osteo‐articular lesions in the legs, arterial peripheral insufficiency, oral contraceptives, poor co‐operation |
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Interventions | Treatment: calcium dobesilate 1000 mg per day 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: "Fifty female patients with recent onset of venous insufficiency were randomly allocated to two subgroups receiving either calcium dobesilate or a corresponding placebo" Comment: no method of randomisation of participants described |
Allocation concealment (selection bias) | Unclear risk | Comment: no method of allocation concealment described |
Blinding (patients) | Low risk | Quote: "Fifty female patients with recent onset of venous insufficiency were randomly allocated to two subgroups receiving either calcium dobesilate or a corresponding placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (study researchers) | Low risk | Quote: "Fifty female patients with recent onset of venous insufficiency were randomly allocated to two subgroups receiving either calcium dobesilate or a corresponding placebo" Comment: Identical placebo ensures double‐blinding |
Blinding (outcome assessment) | Low risk | Quote: "Fifty female patients with recent onset of venous insufficiency were randomly allocated to two subgroups receiving either calcium dobesilate or a corresponding placebo" Comment: Identical placebo ensures double‐blinding |
Incomplete outcome data | Low risk | Comment: number of participants in each group described. Participants who withdrew prematurely from the trial described, along with reasons for withdrawal. Four per cent of participants lost to follow‐up |
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 |