Comparison of two dosages of ginkgo biloba extract EGb 761 in patients with peripheral arterial occlusive disease Fontaine's stage IIb. A randomised, double-blind, multicentric clinical trial.

摘要

BACKGROUND: Rheologically-active drugs are widely used in the therapy of peripheral arterial occlusive disease (pAOD) Fontaine's stage II. Several clinical trials have demonstrated the efficacy of Ginkgo biloba extract in the treatment of pAOD Fontaine's stage II. A pilot study indicated the superiority of 240 mg Ginkgo biloba extract daily compared with the standard dosage of 120 mg to 160 mg daily. This trial was conducted to confirm the superiority of the higher dosage of Ginkgo biloba extract in patients with pAOD Fontaine's stage IIb statistically. PATIENTS AND METHODS: 74 patients were analysed. Thirty-eight patients received the standard dosage (EGb 761 120 mg/d), and 36 patients received 240 mg EGb 761 daily. The primary efficacy criterion was the difference of the pain-free walking distance between the start of treatment and after 24 weeks measured on a treadmill under standardized conditions. RESULTS: The pain-free walking distance improved in both groups. There was a mean increase of 60.6 m in the group of patients who received 120 mg Ginkgo biloba extract daily and a statistically significant higher (p = 0.0253) mean increase of 107.0 m in the group of patients who were treated with the higher dosage. CONCLUSION: Both dosage regimens investigated in this trial led to a clinically relevant improvement of the pain-free walking distance after 24 weeks of treatment. The superiority of the higher dosage over the standard dosage was statistically significant. Both treatment variations were safe and well tolerated.