Erler 1991.
Methods | Study design: 2 parallel arms, randomised, double‐blind. Method of randomisation: block randomisation. Exclusion post randomisation: not reported. Losses to follow up: not reported. Quality score = 3. |
|
Participants | Country: Germany. Setting: hospital. No: 40 entered, drop outs not reported. Age: (mean) 55.5 and 53.9 years in treatment and control group, respectively. Sex: males 10; females 20. Inclusion criteria: oedema due to CVI. Exclusion criteria: oedema due to other conditions than CVI, vasoactive medication, compression treatment, venous ulcers. |
|
Interventions | Treatment: 1 capsule HCSE (standardised to 75 mg escin) twice daily. Control: O‐beta‐hydroxyethyl rutosides (2 g daily). Duration: 8 weeks. |
|
Outcomes | Primary: circumference before and after oedema provocation. Secondary: (not explicitly defined) symptoms (leg pain, oedema, pruritus, fatigue). |
|
Notes | Standardised mean difference (95% CI): Primary: 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 | Neutrally coated capsules which were indistinguishable 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 |