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. 2020 Nov 3;2020(11):CD003229. doi: 10.1002/14651858.CD003229.pub4

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%)
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
Interventions Treatment: calcium dobesilate 1000 mg per day
Control: placebo
Duration: 28 days
Follow‐up: 28 days
Outcomes Primary
  • Plethysmographic parameters

  • Symptoms ‐ pain, heaviness, swelling and paraesthesia measured by an ordinal scale scored from ‐3 (total relief) to +1 (deterioration)


Secondary
  • Global score of symptoms

  • Side effects

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