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

• Authors: TUŽIL Jan; FILKOVÁ Barbora; JIRČÍKOVÁ Jitka; DOLEŽALOVÁ Helena; MALINA Jiří; DECKER Barbora; KERESTES Jan; GEMERLOVÁ Pavla; LÍBALOVÁ ČEPICKÁ Zuzana; DVOŘÁK Vladimír; KAČER Viktor; KOSOVÁ Hana; ADAMOVÁ Zuzana; DOLEŽAL Tomáš
• Year of publication: 2020
• Type: Article in Periodical
• Magazine / Source: Journal of Biologically Active Products from Nature
• MU Faculty or unit: Faculty of Medicine

Web

• https://www.researchgate.net/publication/346387638_Tea_Extract_Vaginal_Ovule_for_Intermediate_Flora_Randomized_Blinded_Vehicle-Controlled_Multicenter_Pilot_Clinical_Trial_with_Microbiome_Analysis
• https://www.tandfonline.com/doi/abs/10.1080/22311866.2020.1839557

• Doi: http://dx.doi.org/10.1080/22311866.2020.1839557
• Keywords: Antioxidant; vaginosis; catechin; Nugent score; vaginal pH; vaginal flora
• Description: Although tea contains antioxidant and antibacterial compounds, it has not yet been clinicallytested in the context of abnormal vaginal flora. Our aim was to determine the safety and efficacy of vaginalovule with 2 mg tea extract once-daily for 5-7 days for symptoms of intermediate vaginal flora. This wasrandomized blinded vehicle-controlled multicenter clinical trial with composite primary endpoint (drop in theNugent score (NS), vaginal pH, or improvement of subjective symptoms) compared between the active andvehicle arm using Fisher ´s exact test at?=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 improvedin 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 thepassive 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 extracthave the capacity to relieve subjective symptoms, notably the perception of genital burning. Tolerability of thetea ovule seems at least as good as that of the vehicle alone. Tea extract deserves further evaluation in largerdoses. (5) (PDF) Tea Extract Vaginal Ovule for Intermediate Flora: Randomized Blinded Vehicle-Controlled Multicenter Pilot Clinical Trial with Microbiome Analysis. Available from: https://www.researchgate.net/publication/346387638_Tea_Extract_Vaginal_Ovule_for_Intermediate_Flora_Randomized_Blinded_Vehicle-Controlled_Multicenter_Pilot_Clinical_Trial_with_Microbiome_Analysis.