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

Nocker 1990.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: not stated
Losses to follow‐up: not stated
Participants Country: Germany
Setting: university
Number: 30
Age: 55 to 59 years
Gender: menopausal females
Inclusion criteria: stage II CVI with symptoms
Exclusion criteria: venoactive drugs, anti‐inflammatories, corticosteroids or diuretics in the last 8 days before the start of the study; use of compression bandages or elastic stockings
Interventions Treatment: oxirutoside 600 mg or 900 mg or 1200 mg or 1500 mg per day
Control: placebo
Duration: 90 days
Follow‐up: 112 days
Outcomes Primary
  • Symptoms ‐ tired and heavy legs, tenseness, tingling measured by means of a visual analogue scale (VAS)

  • Signs ‐ oedema by volume of leg


Secondary
  • Side effects

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomized to one of the five groups, receiving oral solutions of HR in small bottles containing 600, 900, 1200, 1500 mg HR or simply distilled water (controls) with six patients in each group"
Comment: no methods described for randomising participants
Allocation concealment (selection bias) Unclear risk Comment: no methods for allocation concealment described
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 Unclear risk Comment: no data given about drop‐outs. Most important characteristics described with inclusion and exclusion criteria
Selective reporting Low risk Comment: no protocol identified, but no differences between outcomes reported in the methods section and those reported in the results section
Other bias Low risk Comment: none detected