Lohr 1986.
Methods | Study design: 2 parallel arms, randomised, double‐blind. Method of randomisation: not reported. Exclusion post randomisation: not reported. Losses to follow up: 6. Quality score = 3. |
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Participants | Country: Germany. Setting: GP practice. No: 80 entered, 6 drop outs. Age: (mean) 54 years in total patient sample. Sex: males 17; females 57. Inclusion criteria: CVI. Exclusion criteria: not reported. |
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Interventions | Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily. Control: placebo. Duration: 8 weeks. |
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Outcomes | Primary:
leg volume Secondary: 1) circumference 2) leg pain 3) oedema 4) pruritus |
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Notes | Primary and secondary outcomes: 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 | The study was conducted randomised and double blind |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is not clear how incomplete outcome data were addressed |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Unclear risk | No evidence of other biases |