No significant effect of ginkgo biloba special extract EGb 761 in the treatment of primary Raynaud phenomenon: a randomized controlled trial.
BACKGROUND
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.


CONCLUSIONS
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.
Department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. s.bredie@aig.umcn.nl
Sebastian J H
SJ
Bredie
Miek C
MC
Jong
D000328:Adult; D004311:Double-Blind Method; D005260:Female; D020441:Ginkgo biloba; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D010936:Plant Extracts / Q000009:adverse effects / Q000494:pharmacology*; D011928:Raynaud Disease / Q000188:drug therapy* / Q000503:physiopathology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014661:Vasoconstriction; D000096983:Ginkgo Extract
D010936:Plant Extracts; C063170:Ginkgo biloba extract; D000096983:Ginkgo Extract