Friederich 1978.
Methods | Study design: crossover, randomised,
double‐blind. Method of randomisation: not reported. Exclusion post randomisation: not reported. Losses to follow up: 23. Quality score = 4. |
|
Participants | Country: Germany. Setting: hospital. No: 118 entered, 23 drop outs. Age: (mean) 48 and 47 years in men and women, respectively. Sex: males 11; females 107. Inclusion criteria: oedema, leg pain, pruritus, feeling of tenseness and fatigue. Exclusion criteria: not reported. |
|
Interventions | Treatment: 1 capsule HCSE (standardised to 50 mg escin) twice daily. Control: placebo. Duration: 20 days. |
|
Outcomes | Primary: (not explicitly defined) symptoms
1) leg pain
2) oedema
3) pruritus Secondary: (not explicitly defined) patients' impression of effectiveness. |
|
Notes | Standardised mean difference (95% CI): Primary: 1), 2), 3) 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 | Treatment and placebo capsules were identical 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 |