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

Cauwenberge 1978.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: not stated
Losses to follow‐up: 51/120 (42.5%)
Participants Country: Belgium
Setting: Liège
Number: 120 patients
Age: 'adults'
Gender: not stated
Inclusion criteria: varicose veins, postphlebitic syndrome
Exclusion criteria: symptoms not attributed to CVI
Interventions Treatment: O‐(beta‐hydroxyethyl)‐rutoside 1200 mg per day
Control: placebo
Duration: 90 days
Follow‐up: 90 days
Outcomes Primary

  • Oedema

  • Pain

  • Cramps

  • Tiredness

  • Swelling

  • Restless legs

  • Paraesthesia


Secondary

  • Not stated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The patients are divided into two series according to the degree of symptoms. Within these two series, patients were distributed randomly into two groups, receiving respectively the active ingredient or placebo"
Comment: no method of randomisation stated
Allocation concealment (selection bias) Unclear risk Comment: no method of allocation concealment stated
Blinding (patients) Low risk Quote: "We also used a placebo of identical presentation"
Comment: Identical placebo ensure double‐blinding
Blinding (study researchers) Low risk Quote: "We also used a placebo of identical presentation"
Comment: Identical placebo ensure double‐blinding
Blinding (outcome assessment) Low risk Quote: "We also used a placebo of identical presentation"
Comment: Identical placebo ensure double‐blinding
Incomplete outcome data High risk Comment: number of participants in each group described, but no information given on important characteristics of participants. Number of persons excluded after randomisation was important (51/120; 42.5%). Reasons for exclusion were given
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