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

Prerovsky 1972.

Study characteristics
Methods Study design: 2 independent, randomised, double‐blind, cross‐over, placebo‐controlled trials
  • In the first trial, outcomes are haemodynamic, so this trial was not included

  • The second trial is included


Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: none
Participants Country: Czechoslovakia
Setting: research centre
Number: 50 patients
Age: 'adults'
Gender: not stated
Inclusion criteria: signs (oedema, pigmentation, post‐thrombotic syndrome) and symptoms of CVI
Exclusion criteria: not stated
Interventions Treatment: oxirutoside 1200 mg per day
Control: placebo
Duration: 126 days
Follow‐up: 126 days
Outcomes Primary
  • Oedema, leg volume, pitting oedema, cellulitis

  • Symptoms ‐ heavy legs, fatigue, pain, cramps, swelling scored by a qualitative scale (improvement, without changes, deterioration)


Secondary
  • Not stated

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "... after the administration of 3 capsules of HR (900 mg) or 3 capsules of placebo in a double blind cross‐over trial in a randomized‐order"
Comment: method of randomisation not described
Allocation concealment (selection bias) Unclear risk Comment: no method of 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 Low risk Comment: number of participants described in each group, along with the most important characteristics. However, inclusion and exclusion criteria were, apart from clinical features, not well described. Adverse events and drop‐outs were well described
Selective reporting Low risk Comment: no 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