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

Cloarec 1994.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: 16/120 (13%)
Losses to follow‐up: not stated
Participants Country: France
Setting: not stated
Number: 120 patients
Age: mean 50 years
Gender: not stated
Inclusion criteria: history of CVI for several years
Exclusion criteria: not stated
Interventions Treatment: O‐(beta‐hydroxyethyl)‐rutoside 2000 mg per day
Control: placebo
Duration: 56 days
Follow‐up: 56 days
Outcomes Primary
  • Reduction in calf and ankle circumference


Secondary
  • Pain

  • Cramps

  • Tiredness

  • Swelling

  • Restless legs

  • Pitting oedema measured by a scale (0 to 3)

  • Plethysmographic parameters

  • Transcutaneous oxygen tension

Notes This clinical trial is published in abstract format; not possible to extract data showing results
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A multicenter double blind randomized clinical trial was designed"
Comment: no methods described for randomisation of participants
Allocation concealment (selection bias) Unclear risk Comment: no information given about methods used for allocation concealment
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: only 13% drop‐out rate (16/120) for violation of study protocol reported
Selective reporting High risk Comment: no protocol identified. In the methods section, subjective symptoms identified that were not reported in the results section (pain, heaviness, swelling, restless leg, cramps, presence of pitting oedema)
Other bias Low risk Comment: none detected