Comparing the effectiveness of Salvia officinalis, clotrimazole and their combination on vulvovaginal candidiasis: A randomized, controlled clinical trial

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.

Guideline: Vulvovaginal candidosis (AWMF 015/072, level S2k)

“…The antifungal effect of the plant Salvia officinalis is attributed to the presence of cis‐thujone and camphor. Treatment with salvia vaginal tablets, with or without clotrimazole, was shown to be effective against C albicans 222 …”

Utilizing Liposomal Quercetin and Gallic Acid in Localized Treatment of Vaginal Candida Infections

“…Although C. albicans is a commensal microorganism, the perturbation of vaginal homeostasis could facilitate the overgrowth of this opportunistic fungus and the onset of symptomatic candidiasis. Even if VVC is not a life-threatening problem, it can impair the quality of life of patients leading to several physical and sexual impediments, with economic costs estimated at one billion dollars per year [1][2][3]. Candidiasis clinically manifests mostly through Pharmaceutics 2020, 12, 9 2 of 21 itching, pruritus, irritation, burning, pain, white cheesy discharges, vulvar and vaginal erythema, and edema [4].…”

“…Therapeutic approaches for VVC comprise both local and oral administration of different azole drugs, such as fluconazole, ketoconazole and clotrimazole [6], that are able to reduce symptoms of an initial infection in a large number of patients [3]. Unfortunately, since all azoles have a similar fungistatic effect on Candida spp., the cells exposed repetitively to these antifungals may adapt to drug pressure and became resistant [7].…”

Vulvovaginal Candidosis (Excluding Mucocutaneous Candidosis): Guideline of the German (DGGG), Austrian (OEGGG) and Swiss (SGGG) Society of Gynecology and Obstetrics (S2k-Level, AWMF Registry Number 015/072, September 2020)

“…It has antimicrobial, anti-inflammatory, antiseptic, hepatoprotective, antitumoral, immunomodulatory, wound-healing, anesthetic and antioxidative properties [134,138]. Salvina officinalis is another alternative therapy option [139], as is therapy with progestogens [66,140].…”

“…[134,138]. Salvina officinalis ist eine weitere Therapiealternative [139], ebenso wie die Therapie mit Gestagenen [66,140].…”