In order to evaluate the efficacy of a topical green tea extract, researchers conducted a randomized, double-blind, vehicle (placebo)-controlled trial involving 502 men and women aged 18 and older. Participants were clinically diagnosed with 2 to 30 external genital and perianal warts and were randomly assigned to receive sinecatechins ointment 15%, sinecatechins ointment 10% or vehicle (placebo). The duration of treatment was a maximum of 16 weeks or until there was complete clearance of all baseline and new warts, whichever occurred first, followed by a 12 week treatment free phase at which time wart recurrence was assessed.
Seven patients were excluded from analysis and the results were based on 495 patients (254 men and 241 women). Baseline warts were mainly on the vulva (41.2% of women), and penile shaft (36.9% men), followed by the perianal area (18.1% total), perineal area (15.3% total) and glans penis (11.8% men).
Complete clearance of all baseline and newly occurring warts occurred in 57.2% and 56.3% of patients treated with both 15% and 10% sinecatechins ointment compared with 33.7% for the vehicle (both P < .001). Significant results were observed at week 4 and 6 and all follow-up visits. Partial responses of at least 50% occurred in 78.4% of the 15% ointment group, 74.0% of the 10% ointment group, and 51.5% in the vehicle group. The recurrence on any wart occurred in 6.5% of the patients using the 15% ointment, 8.3% with the 10% ointment and 8.8% using the vehicle. There was also a very low rate of new warts at the end of the treatment in all groups.
Tatti S, Swinehart J, Thielert C, et al. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts. ObGyn 2008;111:1371-1379.
Commentary: External genital warts are one of the most common sexually transmitted infections, yet no single treatment has emerged as delivering the best outcomes. Options include herbal topical applications of thuja, licorice root and vitamin A, homeopathic medicines, and conventional treatments including podofilox solution or gels, imiquimod cream, trichloroacetic acid, cryotherapy, curettage, electrosurgery, excision, laser therapy, interferon and 5-fluorouracil gel.
This study is one of two independent phase III studies to establish efficacy and safety of sinecatechins ointment. Overall, patients in both the 15% and 10% ointment group had a significantly higher number of complete clearances of baseline warts and a lower number of recurrent lesions during the 12 week treatment free follow-up period. The results were better in women than in men, likely due to the greater keratinization of the skin on the penile shaft. Based on clearance rates of all warts, a 50% success was achieved in almost 80% of patients in both sinecatechins ointment strengths. Recurrence rates are higher in cryotherapy, imiquimod and podofilox. The results of the current study indicate that a green tea extract ointment standardized to 15% or 10% sinecatechins is a very effective topical treatment to clear warts, inhibit new external anogenital warts and keep patients wart free.