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

Balmer 1980.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: none
Participants Country: Switzerland
Setting: not stated
Number: 40 patients
Age: mean 46.2 ± 14.1 years active group; mean 52.3 ± 14.1 years placebo group
Gender: 4 M:36 F
Inclusion criteria: CVI without venous ulcers
Exclusion criteria: varicose ulcers
Interventions Treatment: oxirutoside 900 mg per day
Control: placebo
Duration: 28 days
Follow‐up: 28 days
Compression therapy was allowed if participants were unwilling to abandon this support
Outcomes Primary
  • Oedema as measured by circumference of ankle and calf (mm)


Secondary
  • Symptoms ‐ pain, cramps, tiredness, pins and needles, swelling, restless legs measured by an ordinal scale (0 to 4)

  • Clinician's assessment

  • Side effects

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The trial was double‐blind, randomised, placebo controlled, between patients..."
Comment: no information given about method of randomisation used
Allocation concealment (selection bias) Unclear risk Comment: no information given about method of treatment allocation used
Blinding (patients) Low risk Quote: "Patients receiving respectively the test drug or identical placebo"
Comment: Identical placebo ensures double‐blinding
Blinding (study researchers) Low risk Quote: "Patients receiving respectively the test drug or identical placebo"
Comment: Identical placebo ensures double‐blinding
Blinding (outcome assessment) Low risk Quote: "Patients receiving respectively the test drug or identical placebo"
Comment: Identical placebo ensures double‐blinding
Incomplete outcome data Low risk Comment: no exclusions post randomisation and no losses 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