Vanscheidt 2002b.

Study characteristics
Methods	Study design: randomised, double‐blind, placebo‐controlled trial Method of randomisation: computer‐generated random number table Exclusions post randomisation: not stated Losses to follow‐up: 56/167 (34%)
Participants	Country: Germany Setting: university Number: 167 patients Age: mean 53.2 ± 13.3 years active group; mean 53 ± 10.9 years placebo group Gender: 166 F Inclusion criteria: stages I and II of Widmer or CEAP 3 to 4 Exclusion criteria: other diseases with oedema, compression therapy for the past 6 months before the study; support stockings; patients more than 30% overweight; any concomitant medication that may interfere with study treatment
Interventions	Treatment: Ruscus aculeatus 72 to 75 mg per day Control: placebo Duration: 90 days Follow‐up: 90 days
Outcomes	Primary Oedema ‐ leg volume change measured by water plethysmography Secondary Oedema ‐ circumference of lower leg and ankle Symptoms ‐ tiredness, heaviness, tension, tingling measured by VAS Quality questionnaire: Freiburg Life Quality Assessment (FLQA)
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "The study was designed as a multi‐center, double‐blind, randomized, placebo‐controlled trial with women suffering from chronic venous insufficiency..." 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	High risk	Comment: number of participants in each group described, along with important characteristics and inclusion and exclusion criteria. In addition, number of participants who withdrew prematurely described, but percentage was important (34%) and no ITT analysis performed
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