Pilz 1990.
Methods | Study design: 2 parallel arms, randomised,
double‐blind. Method of randomisation: block randomisation. Exclusion post randomisation: two. Losses to follow up: none. Quality score = 4. |
|
Participants | Country: Germany. Setting: GP practice. No: 30 entered, 2 drop outs. Age: (mean) 46 in total patient sample. Sex: males 6; females 24. Inclusion criteria: Symptoms of CVI with peripheral leg oedema. Exclusion criteria: patients under 20 and over 70 years of age, less than 2 symptoms of CVI, leg ulcers, oedema or leg pain of other origin than CVI, rheumatic diseases, concomitant medication, compression treatment. |
|
Interventions | Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily. Control: placebo. Duration: 20 days. |
|
Outcomes | Primary: (not explicitly stated). Secondary: (not explicitly stated). |
|
Notes | Standardised mean difference (95% CI): Primary: circumference (mm). a) ankle 0.70 (‐0.04 to 1.45) b) calf 0.86 (0.11 to 1.61) Secondary: (not explicitly stated) adverse events. none. |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Low risk | Block randomisation and allocation of patients to treatment and control groups was performed centrally by Klinge Pharma. The random code was stored in sealed envelopes. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Verum and placebo were indistinguishable in terms of outer appearance and taste |
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 other biases |