Unkauf 1996.

Study characteristics
Methods	Study design: randomised, double‐blind, parallel, placebo‐controlled trial Method of randomisation: not stated Exclusions post randomisation: none Losses to follow‐up: 23/133 (17%)
Participants	Country: Germany Setting: outpatients Number: 133 patients Age: mean 58.9 ± 8.6 years active group; mean 60.6 ± 10.0 years placebo group Gender: 133 F Inclusion criteria: CVI grade II (according to Widmer) Exclusion criteria: premenstrual syndrome oedema; acute phlebitis or thrombosis; cardiac insufficiency or peripheral arterial disease; other venotonic drugs, laxatives, theophylline, diuretics, cardiac glycosides, angiotensin‐converting enzyme or calcium antagonist within preceding 8 days; changes in postmenopausal hormone therapy within preceding 2 months
Interventions	Treatment: oxerutins 1000 mg per day Control: placebo Duration: 90 days Follow‐up: 90 days All participants received standard compression stockings
Outcomes	Primary Oedema ‐ leg volume Secondary Symptoms ‐ tension, tired, heavy legs, tingling measured by a visual analogue scale (cm) Side effects
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The study had a double‐blind, randomised, multi‐centered, paralel‐group design with two treatment groups" 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, along with the most important characteristics and inclusion and exclusion criteria. ITT analysis conducted. Information about adverse events, exclusion after randomisation and loss to follow‐up given
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