1. INTRODUCTION
Globally, bacterial vaginosis is the most frequent source of vaginal
infection among reproductive-aged women.1 Its
approximated worldwide prevalence is high ranging from 23% to
29%.1 Clinically, it is correlated with amplified
risks for adverse infectious and obstetric aftermaths, such as pelvic
inflammatory disease, human immunodeficiency virus infection, sexually
transmitted infections, abortion, preterm delivery, miscarriage and
postoperative endometritis.2-5
The standard of care for bacterial vaginosis includes oral or vaginal
antimicrobial therapies. Such therapies largely comprise clindamycin and
5-nitroimidazole derivatives (most commonly, metronidazole, tinidazole
and secnidazole).6 However, these available
conventional antimicrobial therapies are unsatisfactory for various
factors. Such factors include the unfavorable gastrointestinal adverse
events, high frequencies of vulvovaginal candidiasis, medication
interaction with alcohol, insufficient targeting of the pathogenic
bacterial vaginosis biofilms and high recurrence rates post
treatment.7-15 Probiotics have been shown to be
beneficial for bacterial vaginosis treatment when compared to
placebo.16 Nevertheless, no studies are available for
head-to-head comparison between probiotics and conventional
antimicrobial therapies to establish the tangible therapeutic impact of
probiotics for treatment of bacterial vaginosis.16 A
recent report demonstrates no substantial benefit of combination
metronidazole and probiotics versus monotherapy metronidazole for
treatment of bacterial vaginosis.17 All in all, there
is a pressing requirement to conceive alternative treatments for
bacterial vaginosis.
Astodrimer gel (also known as VivaGel® or SPL7013) is a novel
muco-adhesive gel that belongs to a unique class of dendrimers—highly
branched nanoparticles with microbicidal actions against bacteria and
viruses.18, 19 Astodrimer gel has been illustrated in
healthy women to be well-endured without systemic
absorption.20, 21 Thus, astodrimer gel is advantageous
over conventional antibiotics that give rise to drug-related systemic
adverse events. Four randomized controlled trials (RCTs) have
demonstrated favorable outcomes for astodrimer gel for treatment of
patients with bacterial vaginosis.22-24Mechanistically, astodrimer gel has been depicted to suppress
propagation of bacterial pathogens involved in bacterial vaginosis,
including Gardnerella vaginalis .22, 23 When
compared to conventional antibiotics, the novel mechanism of action of
astodrimer gel involves hindering bacterial attachment to vaginal
epithelial cells as well as interrupting and thwarting formation of
bacterial biofilms.22, 23 Thus, the potential for
development of therapy resistance or relapse is minimized with
astodrimer gel when compared to conventional antibiotics.
The aim of this systematic review and meta-analysis is to pool the
available evidence from RCTs that examined the efficacy and safety of
astodrimer gel for the treatment of patients with bacterial vaginosis.