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
Secondary
|
|
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 |