Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial

Abstract

BackgroundVitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.Methods12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized G. biloba two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.ResultsAfter 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.ConclusionsThe criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of Ginkgo biloba BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.Trial RegistrationClinical trials.gov registration number NCT00907062

Complementary and Alternative Medicine for Vitiligo

“…Ginkgo biloba has antioxidant and immunomodulatory properties. Ginkgo biloba extracts given orally can prevent the active progression of vitiligo and induce repigmentation (Parsad et al, 2003;Szczurko et al, 2011). Considering the mechanism of action of Ginko biloba, combination with phototherapy would theoretically be more effective than Ginko biloba alone.…”

Assessment of Dietary Supplementation in the Treatment of Vitiligo

“…The results indicated that G. biloba supplements significantly arrested disease progression compared to placebo, and increased repigmentation with few side effects [23]. A more recent open-label pilot study by Szczurko et al showed significant improvement in Vitiligo Scoring Index (VASI) scores with 60 mg of G. biloba twice daily for 12 weeks in a total of 12 patients [24]. Additional studies are needed on a larger scale to replicate these findings and provide a better understanding of the mechanism and application of G. biloba in the treatment of vitiligo, although initial findings are promising.…”

Treatment of Generalised Vitiligo with Tacrolimus 0.1% Ointment vs. UVB Intense Pulsed Light Phototherapy: A Pilot Study

“…In addition, repigmentation was also assessed by the 0-3 VETF staging score as recommended (10). To the best of our knowledge, this score has been used so far only in one pilot clinical trial but did not show significant improvement (11). For statistical evaluation, the student t-test was used to calculate the difference between the means of 2 independent samples.…”