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

BMC Complement Altern Med. 2011 Mar 15;11:21. doi: 10.1186/1472-6882-11-21.

Abstract

Background: Vitiligo 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.

Methods: 12 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.

Results: After 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.

Conclusions: The 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 registration: Clinical trials.gov registration number NCT00907062.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Child
  • Dermatologic Agents / pharmacology
  • Dermatologic Agents / therapeutic use*
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Ginkgo biloba*
  • Humans
  • Male
  • Outcome Assessment, Health Care
  • Patient Selection
  • Phytotherapy*
  • Pilot Projects
  • Plant Extracts / pharmacology
  • Plant Extracts / therapeutic use*
  • Reference Values
  • Skin / drug effects*
  • Skin / pathology
  • Skin Pigmentation / drug effects*
  • Treatment Outcome
  • Vitiligo / drug therapy*
  • Vitiligo / pathology
  • Young Adult

Substances

  • Dermatologic Agents
  • Plant Extracts

Associated data

  • ClinicalTrials.gov/NCT00907062