Planchon 1990.

Study characteristics
Methods	Study design: randomised, double‐blind, placebo‐controlled Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 6/110 (5%)
Participants	Country: France Setting: hospital Number: 110 participants Age: mean 50 (range 22 to 79) years Gender: 18 M:92 F Inclusion criteria: symptoms of functional and organic (post‐thrombotic syndrome and varices) CVI Exclusion criteria: venous thrombosis; long‐term immobilisation; hepatic, renal and cardiac oedema; neurological, arterial and metabolic symptoms
Interventions	Treatment: diosmine 450 mg plus hesperidin 50 mg × 2 capsules per day Control: placebo Duration: 60 days Follow‐up: 60 days
Outcomes	Primary Symptoms of CVI and oedema Symptoms ‐ pain, cramps, heaviness, paraesthesias measured by an ordinal scale (0 to 3) Oedema ‐ circumference of ankle Cyanosis and redness measured by an ordinal scale (0 to 3) Secondary Side effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "The award of the therapeutic group membership made by draw lots was ignored until the complete end of the study by both the clinician and the patients" Comment: drawn seems a method of randomisation
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, as well as the inclusion and exclusion criteria and the most important characteristics. Numbers of participants who withdrew prematurely were described, including reasons for dropping out, information about compliance and adverse events
Selective reporting	Low risk	Comment: no 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