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. |
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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). |
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Interventions | Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily. Control: placebo. Duration: 4 weeks. |
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Outcomes | Primary: (not explicitly stated)
leg volume (ml) Secondary: (not explicitly stated) 1) circumference 2) leg pain 3) pruritus |
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Notes | Standardised mean difference (95% CI): Primary: 0.46 (‐0.18 to 1.10) Secondary: Not enough data provided for effect size calculation. |
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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 |