Morales 1993.
Methods | Study design: 2 parallel arms, randomised,
double‐blind. Method of randomisation: not reported. Exclusion post randomisation: not reported. Losses to follow up: three. Quality score = 3. |
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Participants | Country: Brazil. Setting: hospital. No: 54 entered, 3 drop outs. Age: (mean) 40 years in total patient sample. Sex: males 2; females 52. Inclusion criteria: oedema, varicosis, venous ulcers. Exclusion criteria: diabetes mellitus, oedema of other origin, peripheral arterial disease, diuretic medication. |
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Interventions | Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily. Control: placebo. Duration: 20 days. |
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Outcomes | Primary: (not explicitly defined)
oedema Secondary: (not explicitly defined) 1) leg pain 2) 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 | "This is a double blind randomised placebo controlled parallel study of the ise of dried horse chestnut extract (Venostasin retard) in chronic venous insufficiency of the limbs:" |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | It is unclear how incomplete outcome data were addressed |
Selective reporting (reporting bias) | High risk | No evidence for selective reporting |
Other bias | Unclear risk | No evidence of further biases |