Skip to main content
. 2012 Nov 14;2012(11):CD003230. doi: 10.1002/14651858.CD003230.pub4

Diehm 1996a.

Methods Study design: 3 parallel arms, randomised, double‐blinded (for placebo and HCSE only).
Method of randomisation: not reported.
Exclusion post randomisation: none.
Losses to follow up: not reported.
Quality score = 2.
Participants Country: Germany.
Setting: hospital.
No: 240 entered, drop outs not reported.
Age: (mean) 52 years.
Sex: not reported.
Inclusion criteria: 
 oedema due to CVI (confirmed by medical history, clinical findings, venous Doppler and duplex sonography.
Exclusion criteria: venotherapeutic drugs within the last 6 weeks before run‐in.
Interventions Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily.
Control: placebo or compression stockings.
Duration: 12 weeks.
Outcomes Primary: (not explicitly stated) leg volume (ml).
Secondary: (not explicitly stated) circumference, symptoms .
Notes Standardised mean difference (95% CI):
Primary: 
 HCSE versus placebo 
 0.49 (0.14 to 0.85)
HCSE versus compression 
 ‐0.03 (‐0.31 to 0.25)
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 "Patients were treated over a period of 12 weeks in a randomised partially blinded placebo controlled paralles study"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk It is unclear how incomplete data were addressed
Selective reporting (reporting bias) Low risk No evidence of selective reporting
Other bias Unclear risk No evidence of other biases