Natali 1985.
| Methods | Study design: double blind randomised clinical trial. Method of randomisation: not stated. |
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| Participants | Country: France. Setting: outpatient setting. Number randomised: 18, treatment group 9, control group 9. Age: treatment group 60.8, control group 66.2. Sex: treatment group 7 males and 2 females, control group 8 males and 1 female. Inclusion criteria: Patients with PAD (stage IIb according to Fontaine); age 30 to 75 years; occlusive lesions of deep femoral arteries verified by arteriography; stable condition. Exclusion criteria: non co‐operative patient; significant psychiatric disorder; physical condition that does not allow exercise tests to be performed; any other ailment that could influence the course of the PAD or interfere with the assessment of treatment effects (e.g. Parkinson's disease, tumours); treatment of the same type as the product studied; treatment that could interfere with the assessment of treatment effects. |
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| Interventions | Treatment: 160 mg Ginkgo biloba special extract EgB 761 daily. Control: placebo. Duration: 6 months. |
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| Outcomes | Walking distance: ACD and ICD by treadmill testing (3 km/h and 5% incline); adverse reactions. | |
| Notes | Conflicts of interests: Internal rapport of Dr. Wilmar Schwabe Arzneimittel/Pharmaceuticals, Karlsruhe, Germany | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Patients were randomised. |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
| Blinding (performance bias and detection bias) All outcomes | Unclear risk | The intervention and the placebo were presented the same way. |