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

Guilhou 1997.

Study characteristics
Methods Study design: randomised, multi‐centre, double‐blind, placebo‐controlled
Method of randomisation: not stated
Exclusions post randomisation: none
Losses to follow‐up: 6/107 (6%)
Participants Country: France
Setting: hospital
Number: 107 patients
Age: 'adults'
Gender: 30 M:77 F
Inclusion criteria: venous ulcers
Exclusion criteria: not stated
Randomisation of treatment stratified according to ulcer size: < 10 cm or ≥ 10 cm
Interventions Treatment: diosmine 450 mg plus hesperidin 50 mg per 12 hours plus compression stockings
Control: placebo and standard compression stockings
Duration: 60 days
Follow‐up: 60 days
Outcomes Primary
  • Percentage of participants with complete healing at 2 months


Secondary
  • Percentage of surface area healed

  • Aspect of ulcer and peri‐ulcerous skin of the reference ulcer

  • Total number of healed ulcers in cases of multiple ulcers

  • Evolution of symptoms of CVI

  • Socioeconomic incidence

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomisation of treatment was stratified according to the size of the ulcers"
Comment: no method of randomisation 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 in each group described. ITT analysis conducted. Information provided about participants who withdrew prematurely from the study, along with reasons for premature withdrawal
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