Fatemeh Ahangari1, Azizeh Farshbaf-Khalili2, Yousef Javadzadeh3, Mohammad Adibpour4, Behnaz Sadeghzadeh Oskouei5. 1. Department of Midwifery, Students' Research Committee, Nursing and Midwifery Faculty, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Aging Research Institute, Physical Medicine and rehabilitation Research Center, Tabriz University of Medical Science, Tabriz, Iran. 3. Department of Pharmaceutics, Tabriz University of Medical Sciences, Faculty of Pharmacy, Tabriz, Iran. 4. Department of Parasitology, Tabriz University of Medical Sciences, Tabriz, Iran. 5. Department of Midwifery, Tabriz University of Medical Science, Tabriz, Iran.
Abstract
AIM: To determine the effect of vaginal tablet of Salvia officinalis, alone and in combination with Clotrimazole, on the recovery of Vulvovaginal candidiasis. METHODS: In this triple-blind randomized controlled trial, 111 participants were randomly assigned into three groups of 37 patients using block randomization with block sizes of 6 and 9, and allocation ratio of 1:1:1: 100 mg vaginal tablet of Clotrimazole and Placebo (CP), 400 mg vaginal tablet of S. officinalis and Placebo (SP), and vaginal tablet of S. officinalis and Clotrimazole (SC), once daily for 7 days. On the seventh day after the treatment was ended up, Vulvovaginal candidiasis were examined by vaginal symptoms and wet test, and if positive, they were examined by culture in chrome agar Candida medium. RESULTS:Socio-demographic characteristics was similar (P > 0.05). Thirty-six, 36 and 35 patients, respectively in CP, SC and SP groups recruited in the study. The frequency of a positive wet test confirmed by Sabrodextrose agar medium 7 days after treatment was significantly lower in SC group than the reference group of CP (adjusted odds ratio = 0.09, 95% confidence interval: 0.93-0.932, P = 0.043). There was no significant difference between SP and CP group (P = 0.071, 95% confidence interval: 0.032-1.151, adjusted odds ratio = 0.192). Also, there was no significant difference between the three groups in terms of vaginal symptoms at the baseline (P > 0.05), however the statistical differences were indicated after the intervention in cheesy discharge, pruritus and Vulvovaginal edema (P < 0.05.(. CONCLUSION: S. officinalis in the form of vaginal tablet, alone and when combined with Clotrimazole, can treat the Vulvovaginal Candidiasis.
RCT Entities:
AIM: To determine the effect of vaginal tablet of Salvia officinalis, alone and in combination with Clotrimazole, on the recovery of Vulvovaginal candidiasis. METHODS: In this triple-blind randomized controlled trial, 111 participants were randomly assigned into three groups of 37 patients using block randomization with block sizes of 6 and 9, and allocation ratio of 1:1:1: 100 mg vaginal tablet of Clotrimazole and Placebo (CP), 400 mg vaginal tablet of S. officinalis and Placebo (SP), and vaginal tablet of S. officinalis and Clotrimazole (SC), once daily for 7 days. On the seventh day after the treatment was ended up, Vulvovaginal candidiasis were examined by vaginal symptoms and wet test, and if positive, they were examined by culture in chrome agar Candida medium. RESULTS: Socio-demographic characteristics was similar (P > 0.05). Thirty-six, 36 and 35 patients, respectively in CP, SC and SP groups recruited in the study. The frequency of a positive wet test confirmed by Sabrodextroseagar medium 7 days after treatment was significantly lower in SC group than the reference group of CP (adjusted odds ratio = 0.09, 95% confidence interval: 0.93-0.932, P = 0.043). There was no significant difference between SP and CP group (P = 0.071, 95% confidence interval: 0.032-1.151, adjusted odds ratio = 0.192). Also, there was no significant difference between the three groups in terms of vaginal symptoms at the baseline (P > 0.05), however the statistical differences were indicated after the intervention in cheesy discharge, pruritus and Vulvovaginal edema (P < 0.05.(. CONCLUSION:S. officinalis in the form of vaginal tablet, alone and when combined with Clotrimazole, can treat the Vulvovaginal Candidiasis.
Authors: Alex Farr; Isaak Effendy; Brigitte Frey Tirri; Herbert Hof; Peter Mayser; Ljubomir Petricevic; Markus Ruhnke; Martin Schaller; Axel P A Schäfer; Birgit Willinger; Werner Mendling Journal: Geburtshilfe Frauenheilkd Date: 2021-04-14 Impact factor: 2.915