Colloidal Nano Silver Gel effective and safe in treating bacterial vaginosis and vulvovaginal candidiasis: IJOGR
Vaginal infections, often termed "Infectious Vaginitis," are common concerns for women across the lifespan, with a higher prevalence among women of reproductive age. It is the most frequent reason for women to seek medical attention. Although these infections are not associated with significant mortality, they are often associated with high levels of anxiety and have a negative impact on sexual life, self-esteem, and quality of life. The more prevalent vaginal infections are caused by disturbances in the natural vaginal microbiome. The normal vagina flora is characterized by the dominance of lactic acid producing bacteria, especially Lactobacillus spp., which help to maintain an acidic pH of vaginal fluids within the range of 3.5-4.5. Along with lactobacilli, a healthy, acidic premenopausal vagina also contains a heterogeneous mixture of Gardnerella vaginalis, Escherichia coli, group B streptococcus (GBS), genital Mycoplasma species, Candida albicans, and other species.
The most commonly documented cause of vaginitis is bacterial vaginosis (BV). BV is characterized by a dramatic switch of vaginal bacterial flora from normal predominant Lactobacilli to a polymicrobial flora. Vulvovaginal candidiasis (VVC) is the second most common vaginal infection, while trichomoniasis, caused by Trichomonas vaginalis, is the most common non-viral sexually transmitted infection. True mixed infection rarely occurs in women with vaginitis, but coinfection occurs much more frequently. Coinfection with Candida species is observed in about 20%-30% of women with BV. The coinfection rates of BV pathogens and trichomoniasis are even more prevalent. Other etiologies of vaginitis include vulvar skin diseases, desquamative inflammatory vaginitis, and genitourinary syndrome of menopause.
Despite the availability of numerous oral, topical, and intravaginal medications for the treatment of vaginal infections, their management remains challenging. Associated side effects, development of resistance, lack of prevention and destruction of biofilms, and higher recurrences are the limitations of currently available conventional therapies. Ineffectiveness due to poor penetration and rapid removal from the vaginal canal are the major hurdles in achieving infection cure with local antimicrobial therapies. There is a need to develop newer therapeutic options for treating vaginal infections that overcomes the limitations of current therapies.
During the last decades, nanotechnologies-based formulations, such as nanoparticles, have been explored to overcome the limitations of current therapies for vaginal infections. These novel formulations can improve local drug delivery, biodistribution, retention, and uptake in vulvovaginal tissues. Other important benefits nanotechnology-based formulations offer are reduced toxicity, enhanced patient compliance, and improved treatment outcomes.
The study by Dani, Godbole and Mehta evaluated the efficacy and safety of colloidal nano silver gel (SilverSol® Vagigel) (A patented technology from American Biotech Labs, USA) in combination with 0.2% lactic acid in the female subjects for the treatment of vaginal infections.
This study was a multicenter, randomized, double-blind, placebo-controlled pilot study in which post-menarchal female subjects between 18 and 65 years of age clinically diagnosed with bacterial vaginosis and vulvovaginal candidiasis were enrolled. The participants were randomized to receive treatment with SilverSol® Vagigel or placebo (vehicle) gel (both treatments as one 4 gm application inserted into the vagina with an applicator device, once daily at bedtime for internal use and 2 gm gel for local application to the vulva and vagina for external use twice daily for a period of 14 days). The primary endpoint evaluated was the proportion of subjects achieving clinical cure. The secondary endpoint was the proportion of subjects achieving microbiological cure at the end of the study visit.
A total of 57 subjects were randomized in the study out of which 38 subjects were randomized in SilverSol® Vagigel arm and 19 subjects were randomized in placebo arm. SilverSol® Vagigel significantly improved cure rates of vaginal infections compared to placebo.
The proportion of subjects achieving clinical cure of vaginal infections was higher i.e., 33 (86.84%) subjects in SilverSol® Vagigel arm compared to 07 (41.18%) subjects in Placebo gel arm (p-value: 0.0009).
The clinical cure rate with SilverSol® Vagigel was 81.82% (P=0.1758) for bacterial vaginosis and 92.59% (P=0.0010) for vulvovaginal candidiasis patients at the end of the study.
Overall SilverSol® Vagigel treatment resulted in a significantly higher microbial cure of vaginal infections (P=0.0028) compared to placebo, with a microbial cure rate of 100% for bacterial vaginosis (P=0.0330) and 85.19% for vulvovaginal candidiasis (P=0.0097).
No adverse events were reported in subjects treated with SilverSol® Vagigel.
In this study, SilverSol® Vagigel was effective and safe in treating the most common vaginal infections i.e. bacterial vaginosis and vulvovaginal candidiasis. Overall, the findings of this study, combined with the existing body of evidence, indicate that SilverSol® Vagigel may represent a valuable addition to the armamentarium of available therapies for vaginal infections, offering potential benefits for patients in terms of improved outcomes and reduced side effects. Overall, SilverSol Vagigel represents an excellent advancement in women’s health, offering a highly effective and safe solution for treating vaginal infections. Leveraging the exceptional antibacterial, antiviral, antifungal, andimmune-enhancing properties of SilverSol®, SilverSol® Vagigel formulation can emerge as a promising therapeutic option for treating a wide range of vaginal infections and delivering unparalleled safety and efficacy in addressing diverse feminine health concerns.
Source: Dani, Godbole and Mehta / Indian Journal of Obstetrics and Gynecology Research 2024;11(1):83–89; https://doi.org/10.18231/j.ijogr.2024.015
