Number of pages: 7
Type of document: Journal Article
Related webpage or webdocument: www.ncbi.nlm.nih.gov/pubmed/22030896
More information on authors/freelancers connected to LBI :
Miek C. Jong Ph.D.
Language of document: English
Title in English: No significant effects of Ginkgo biloba special extract EGb761 in the treatment of primary Raynaud Phenomenon: a randomized controlled trial
Abstract / summary in English:
Medicinal treatment of vasospastic Raynaud phenomenon is limited to primarily vasodilator medicines.
OBJECTIVE: To explore the possible beneficial effects and tolerability of 120 mg two times a day of Ginkgo Biloba special extract EGb 761 in patients suffering from Raynaud disease (RD) (primary Raynaud phenomenon).
METHODS: In a placebo-controlled, double-blind, pilot study, 41 patients with RD were randomized to either the active treatment group (EGb 761, n = 21) or placebo group for 10 weeks, after an initial 2-week run-in phase. The primary efficacy variables were self-reported changes of the frequency, duration, and severity of vasospastic attacks between the placebo-controlled run-in phase and the end of the study.
RESULTS: Most of the patients were female, and both groups were perfectly matched with respect to demographic characteristics. The frequency of daily attacks reduced from 3.6 ± 2.3 to 2.4 ± 2.6 (-33%) in the EGb 761 group and from 2.9 ± 2.0 to 2.0 ± 1.8 (-31%) in the placebo group with no significant difference according to the ordinary least squares test (P = 0.3564). Furthermore, no significant differences were found with respect to the duration and severity of vasospastic attacks between the EGb 761 and placebo groups (P = 0.4392 and P = 0.7187, respectively). In all, 17 adverse events (AEs) were reported, 6 AEs from 5 patients in the EGb 761 group and 11 AEs from 8 patients in the placebo group. Serious AEs did not occur.
CONCLUSION: EGb 761 treatment showed an excellent safety profile in patients with RD but could not demonstrate a statistically significant reduction in clinically relevant symptoms compared with placebo.
Keywords in English: Ginkgo biloba, EGb 761, Raynaud phenomenon, placebo-controlled