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

Bergqvist 1981.

Study characteristics
Methods Study design: randomised, cross‐over, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: 6/149 (4%)
Participants Country: Sweden
Setting: outpatient clinic and local population
Number: 149 patients
Age: 'adults'
Gender: 33 M:116 F
Inclusion criteria: symptoms related to varicose veins and CVI
Exclusion criteria: not stated
Interventions Treatment: oxirutoside 1000 mg intravenous injection followed by 1 tablet of 500 mg per 8 hours
Control: placebo
Duration: 28 days
Follow‐up: 28 days
Outcomes Primary
  • Symptoms ‐ pain, cramps, tired legs, pruritus, swelling, side effects

  • Signs ‐ plethysmographic values, calf circumference


Secondary
  • Not stated

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "They were then randomly allocated to treatment with either HR or identical placebo"
Comment: no details of randomisation method provided
Allocation concealment (selection bias) Unclear risk Comment: no method of allocation concealment described
Blinding (patients) Low risk Quote: "The placebo regime was identical" and "... or identical placebo"
Comment: Identical placebo ensures double‐blinding
Blinding (study researchers) Low risk Quote: "The placebo regime was identical" and "... or identical placebo"
Comment: Identical placebo ensures double‐blinding
Blinding (outcome assessment) Low risk Quote: "The placebo regime was identical" and "... or identical placebo"
Comment: Identical placebo ensures double‐blinding
Incomplete outcome data Low risk Comment: number of participants in each group described. Loss to follow‐up described along with exclusions after randomisation, including reasons
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