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

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.

Authors+Show Affiliations

Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, 130 Dundas St East, Suite 305, Mississauga, ON L5A 3V8, Canada. orest@noumena.caNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21406109

Citation

Szczurko, Orest, et al. "Ginkgo Biloba for the Treatment of Vitilgo Vulgaris: an Open Label Pilot Clinical Trial." BMC Complementary and Alternative Medicine, vol. 11, 2011, p. 21.
Szczurko O, Shear N, Taddio A, et al. Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial. BMC Complement Altern Med. 2011;11:21.
Szczurko, O., Shear, N., Taddio, A., & Boon, H. (2011). Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial. BMC Complementary and Alternative Medicine, 11, p. 21. doi:10.1186/1472-6882-11-21.
Szczurko O, et al. Ginkgo Biloba for the Treatment of Vitilgo Vulgaris: an Open Label Pilot Clinical Trial. BMC Complement Altern Med. 2011 Mar 15;11:21. PubMed PMID: 21406109.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial. AU - Szczurko,Orest, AU - Shear,Neil, AU - Taddio,Anna, AU - Boon,Heather, Y1 - 2011/03/15/ PY - 2010/09/01/received PY - 2011/03/15/accepted PY - 2011/3/17/entrez PY - 2011/3/17/pubmed PY - 2011/8/27/medline SP - 21 EP - 21 JF - BMC complementary and alternative medicine JO - BMC Complement Altern Med VL - 11 N2 - 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. SN - 1472-6882 UR - https://www.unboundmedicine.com/medline/citation/21406109/Ginkgo_biloba_for_the_treatment_of_vitilgo_vulgaris:_an_open_label_pilot_clinical_trial_/ L2 - https://bmccomplementalternmed.biomedcentral.com/articles/10.1186/1472-6882-11-21 DB - PRIME DP - Unbound Medicine ER -