PMID- 22030896 OWN - NLM STAT- MEDLINE DCOM- 20120702 LR - 20211203 IS - 1533-4023 (Electronic) IS - 0160-2446 (Linking) VI - 59 IP - 3 DP - 2012 Mar TI - No significant effect of ginkgo biloba special extract EGb 761 in the treatment of primary Raynaud phenomenon: a randomized controlled trial. PG - 215-21 LID - 10.1097/FJC.0b013e31823c0bed [doi] AB - 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. 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. FAU - Bredie, Sebastian J H AU - Bredie SJ AD - Department of General Internal Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. s.bredie@aig.umcn.nl FAU - Jong, Miek C AU - Jong MC LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - J Cardiovasc Pharmacol JT - Journal of cardiovascular pharmacology JID - 7902492 RN - 0 (Plant Extracts) RN - 19FUJ2C58T (Ginkgo biloba extract) SB - IM MH - Adult MH - Double-Blind Method MH - Female MH - Ginkgo biloba MH - Humans MH - Male MH - Middle Aged MH - Pilot Projects MH - Plant Extracts/adverse effects/*pharmacology MH - Raynaud Disease/*drug therapy/physiopathology MH - Severity of Illness Index MH - Time Factors MH - Treatment Outcome MH - *Vasoconstriction EDAT- 2011/10/28 06:00 MHDA- 2012/07/03 06:00 CRDT- 2011/10/28 06:00 PHST- 2011/10/28 06:00 [entrez] PHST- 2011/10/28 06:00 [pubmed] PHST- 2012/07/03 06:00 [medline] AID - 10.1097/FJC.0b013e31823c0bed [doi] PST - ppublish SO - J Cardiovasc Pharmacol. 2012 Mar;59(3):215-21. doi: 10.1097/FJC.0b013e31823c0bed.