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 |