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

Chassignolle 1994.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: 4/40 (10%)
Participants Country: France
Setting: hospital
Number: 40 patients
Age: 32.0 (1.3) years active group; 35.6 (1.1) years placebo group
Gender: female
Inclusion criteria: women with functional CVI
Exclusion criteria: not stated
Interventions Treatment: diosmine 1000 mg per day
Control: placebo
Duration: 60 days
Follow‐up: 60 days
Outcomes Primary
  • Plethysmographic parameters

  • CVI symptoms ‐ heaviness, pain, tiredness, itching, paraesthesias and cramps measured by an ordinal scale (0 to 4). Global evaluation of symptoms (score functional)

  • CVI signs ‐ oedema, cyanosis, redness, leg heat and induration measured by an ordinal scale (0 to 4). Global evaluation of signs (score objective)

  • Tolerance


Secondary
  • Not stated

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Patients were randomly assigned to two parallel groups of 20"
Comment: no randomisation methods stated
Allocation concealment (selection bias) Unclear risk Comment: no methods of allocation concealment stated
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 in each group described, number of participants who dropped out prematurely stated and reasons for dropping out described
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