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

Friederich 1978.

Methods Study design: crossover, randomised, 
 double‐blind.
Method of randomisation: not reported.
Exclusion post randomisation: not reported.
Losses to follow up: 23.
Quality score = 4.
Participants Country: Germany.
Setting: hospital.
No: 118 entered, 23 drop outs.
Age: (mean) 48 and 47 years in men and women, respectively.
Sex: males 11; females 107.
Inclusion criteria: oedema, leg pain, pruritus, feeling of tenseness and fatigue.
Exclusion criteria: not reported.
Interventions Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily.
Control: placebo.
Duration: 20 days.
Outcomes Primary: (not explicitly defined) symptoms 
 1) leg pain 
 2) oedema 
 3) pruritus
Secondary: (not explicitly defined) patients' impression of effectiveness.
Notes Standardised mean difference (95% CI):
Primary: 
 1), 2), 3) Not enough data provided for effect size calculation.
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 Treatment and placebo capsules were identical in terms of outer appearance
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 further biases