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

Rudofsky 1986.

Methods Study design: 2 parallel arms, randomised, 
 double‐blind.
Method of randomisation: random number generator.
Exclusion post randomisation: none.
Losses to follow up: 1.
Quality score = 5.
Participants Country: Germany.
Setting: hospital.
No: 40 entered, 1 drop out.
Age: (mean) 41 and 38 years in treatment and placebo groups, respectively.
Sex: males 14, females 25.
Inclusion criteria: clinical signs of CVI (e.g. varicosis, hyperpigmentation), symptoms (e.g. leg pain, pruritus), venous capacity of over 6 ml per 100 ml tissue, venous pressure (dorsum pedis) of at least 60 mmHg.
Exclusion criteria: CVI stage III, acute phlebitis, oedema of other origin than CVI, concomitant medication (e.g. diuretics, vasoactive drugs).
Interventions Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily.
Control: placebo.
Duration: 4 weeks.
Outcomes Primary: (not explicitly stated) 
 leg volume (ml)
Secondary: (not explicitly stated) 
 1) circumference 
 2) leg pain 
 3) pruritus
Notes Standardised mean difference (95% CI):
Primary: 
 0.46 (‐0.18 to 1.10)
Secondary:
Not enough data provided for effect size calculation.
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk Allocation concealment not reported
Blinding (performance bias and detection bias) 
 All outcomes Low risk Verum and placebo capsules were indistinguishable .... Thus it was impossible for physician and patient to determine whether they received the true or placebo medication
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 There is no evidence of other biases