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. 2012 Nov 14;2012(11):CD003230. doi: 10.1002/14651858.CD003230.pub4

Pilz 1990.

Methods Study design: 2 parallel arms, randomised, 
 double‐blind.
Method of randomisation: block randomisation.
Exclusion post randomisation: two.
Losses to follow up: none.
Quality score = 4.
Participants Country: Germany.
Setting: GP practice.
No: 30 entered, 2 drop outs.
Age: (mean) 46 in total patient sample.
Sex: males 6; females 24.
Inclusion criteria: Symptoms of CVI with peripheral leg oedema.
Exclusion criteria: patients under 20 and over 70 years of age, less than 2 symptoms of CVI, leg ulcers, oedema or leg pain of other origin than CVI, rheumatic diseases, concomitant medication, compression treatment.
Interventions Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily.
Control: placebo.
Duration: 20 days.
Outcomes Primary: (not explicitly stated).
Secondary: (not explicitly stated).
Notes Standardised mean difference (95% CI):
Primary: circumference (mm). 
 a) ankle 0.70 (‐0.04 to 1.45) 
 b) calf 0.86 (0.11 to 1.61)
Secondary: (not explicitly stated) adverse events. 
 none.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Low risk Block randomisation and allocation of patients to treatment and control groups was performed centrally by Klinge Pharma. The random code was stored in sealed envelopes.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Verum and placebo were indistinguishable in terms of outer appearance and taste
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk It is unclear how incomplete outcome data were addressed
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Other bias Unclear risk No evidence of other biases