Tea Extract Vaginal Ovule for Intermediate Flora: Randomized Blinded Vehicle-Controlled Multicenter Pilot Clinical Trial with Microbiome Analysis

Abstract

Although tea contains antioxidant and antibacterial compounds, it has not yet been clinically tested in the context of abnormal vaginal flora. Our aim was to determine the safety and efficacy of vaginal ovule with 2 mg tea extract once-daily for 5-7 days for symptoms of intermediate vaginal flora. This was randomized blinded vehicle-controlled multicenter clinical trial with composite primary endpoint (drop in the Nugent score (NS), vaginal pH, or improvement of subjective symptoms) compared between the active and vehicle arm using Fisheŕs exact test at α=0.05. Wet mounts were taken from 274 participants from 14 centres, 97 + 95 participants fulfilled the inclusion criteria. In the active and vehicle arm, composite scores improved in 51.8 % (43/83) and 38.3 % (31/81) participants, respectively, representing an odds ratio = 1.73 (CI 0.93- 3.23, p=0.082). In all 274 participants, 7 mild adverse reactions were recorded of which 6 occurred in the passive arm. Intention-to-treat analysis showed more frequent improvement of subjective symptoms (p=0.047) and reduction in burning (p=0.006) in the active arm. The results suggest that as little as 2 mg of tea extract have the capacity to relieve subjective symptoms, notably the perception of genital burning. Tolerability of the tea ovule seems at least as good as that of the vehicle alone. Tea extract deserves further evaluation in larger doses.