aResearch Centre of Obstetrics and Gynaecology of Moscow Area, Moscow, Russia
bResearch Centre of Obstetrics, Gynaecology and Perinatology of Rosmedtechnologies, Moscow, Russia
cUniversity of Pavia – “Medicine and Surgery” School, Pavia, Italy
aResearch Centre of Obstetrics and Gynaecology of Moscow Area, Moscow, Russia
bResearch Centre of Obstetrics, Gynaecology and Perinatology of Rosmedtechnologies, Moscow, Russia
dScientific Division, Polichem SA, Lugano, Switzerland
dScientific Division, Polichem SA, Lugano, Switzerland
Summary
Introduction
Bacterial vaginosis (BV) is a standard situation that impacts virtually one-third of girls of childbearing age (29%) [1]. In Caucasian ladies, the prevalence is 5% to fifteen%; in African and black American ladies, it’s 45% to 55%; and in Asian ladies the prevalence is much less nicely studied, however generally it’s round 20% to 30% [2].
The aetiology of BV continues to be unclear however it’s at present thought-about to be a synergistic polymicrobial syndrome, characterised by depletion of Lactobacillus spp and an intense enhance (100- to 1,000-fold above regular ranges) in vaginal anaerobic micro organism, together with Gardnerella vaginalis, Prevotella spp, anaerobic gram-positive cocci, Mobiluncus spp, Mycoplasma hominis and Atopobium vaginalis [3, 4], resulting in a substitute of lactobacilli and a rise in vaginal pH.
BV can typically come up as a continual or recurrent illness and the rationale for recurrences will not be well-known. Based mostly on fluorescence in situ hybridisation of vaginal biopsy specimens, Mendling et al [4] have demonstrated that BV is related to the event of an adherent polymicrobial biofilm that’s extremely organised and accommodates ample Gardnerella vaginalis on the vaginal epithelium. Bacterial biofilms have not too long ago been related to a number of recalcitrant infections (involving Escherichia coli, Helicobacter pylori and Pseudomonas aeruginosa) [5]. The biofilm enhances bacterial attachment to epithelial surfaces, permits micro organism to achieve a lot greater concentrations than in luminal fluids, and prevents the medicine from reaching the micro organism, which reside within the movie in a quiescent, latent state [6]. This commentary may present a proof of the excessive charges of BV relapses [7, 8]. The presence of Atopobium vaginae strictly related to Gardnerella vaginalis within the persistent and adherent bacterial biofilm has been confirmed [4], and appears to be the primary motive for the failure of BV remedy [9]. Though some authors counsel that Atopobium vaginae might play a task in reducing the vaginal pH degree by way of lactic acid manufacturing [10], Marconi et al have discovered that Atopobium vaginae content material strongly will increase if the vaginal pH is 4.9 or greater [11]. Due to this fact, they counsel that strains of this bacterium might have completely different capacities of lactic acid manufacturing however to not a big degree to safeguard the vaginal microflora.
Vaginal vitamin C is out there as silicon-coated tablets containing 250 mg ascorbic acid. This formulation is ready to launch the vitamin over hours, permitting a statistically important vaginal pH-lowering impact [12]. The efficacy of vaginal vitamin C in relieving BV indicators and signs has been confirmed in two research by Petersen et al [13, 14]. Furthermore, Abbaspour et al have confirmed that the efficacy of vaginal vitamin C in BV remedy is non-inferior to that of normal native metronidazole gel remedy [15].
The principle objective of BV remedy and, particularly, of BV prevention is to maintain the vaginal pH at 4.5 or decrease, with a view to stop the overgrowth of pathogens till the conventional lactobacilli are re-established and capable of keep the pH themselves [16]. Anaerobes develop poorly at pH 4.5 or decrease; the optimum pH for Prevotella spp and Gardnerella vaginalis progress is 6 – 7. In vitro research present that the concentrations of those micro organism enhance with rising pH, however each are inclined to low pH. An excellent strategy to handle recurrent BV can be to take care of the vaginal pH at 4.5 with a prophylactic remedy that is ready to management the overgrowth of micro organism. On this context, a viable therapeutic agent might be ascorbic acid, as it could capable of assist re-establish and keep the vaginal ecosystem.
Based mostly on the above-mentioned concerns, the current examine aimed to guage the potential impact of vitamin C, well-known to have a vaginal pH-lowering impact, within the prophylaxis of BV relapses in sufferers who’ve been cured from a BV episode.
Supplies and Strategies
Outcomes
Dialogue – “vitamin c vs boric acid for bv”
A therapeutic strategy within the remedy of BV relapse is to re-establish and keep the physiological acidity of the vagina, as the expansion of anaerobes and different faecal micro organism is inhibited by low pH. Makes an attempt to attain this through re-colonisation with exogenous lactobacilli haven’t been profitable. One other, extra accepted strategy is to cut back vaginal pH, with a view to create a damaging atmosphere for pathogen progress and to attain long-lasting normalisation of vaginal flora utilizing intravaginal ascorbic acid (vitamin C). Using antibiotics might induce resistance within the pool of micro organism recognised to trigger BV and, conversely, may have an effect on the conventional flora of lactobacilli [9], favouring recurrence inside a number of weeks in over 70% of girls taking antibiotics for bacterial vaginosis [18]. Ascorbic acid (250 mg, in a silicone provider that ensures extended motion) performs a significant function in sustaining low vaginal pH values and enhances therapeutic processes within the vaginal ecosystem – recolonisation with lactic acid micro organism. The mechanism of motion is straightforward: by way of the reducing of vaginal pH to the physiological degree of three.8 – 4.5, anaerobic overgrowth is inhibited and the circumstances for the re-growth of physiological lactobacilli flora are re-established.
The outcomes of the current examine present that 250 mg ascorbic acid vaginal tablets taken 6 days per 30 days safely halves the chance of BV recurrence from 32.4% to 16.2% throughout a 6-month prophylactic remedy. The O.R. confirms that topics handled with placebo had a doubled threat of BV recurrence in contrast with the group of topics handled with vitamin C. Contemplating the time to the primary BV relapse, remedy of not less than 5 cycles is important with a view to cut back, at a big degree, the chance of BV recurrence. As this was a prophylaxis examine, in ladies who on the screening go to had been wholesome and who terminated the examine in case of relapse, a between-treatment distinction in scientific parameters was not anticipated. On the similar time, variations in pH weren’t anticipated however conversely, a discount in pH was famous for 3-month and 6-month remedy.
In conclusion, common use of silicon-coated vitamin C (250 mg) tablets, after the usual antibiotic remedy for BV, protects ladies by decreasing the chance of recurrence in all probability by re-establishing the conventional lactobacilli flora that is ready to keep vaginal pH.
Acknowledgments
Conflicts of Curiosity and Supply of Funding
Vladislav N. Krasnopolsky, Vera N. Prilepskaya, Franco Polatti, Nina V. Zarochentseva, and Guldana R. Bayramova acquired honoraria from Polichem S.A. as examine investigators. Maurizio Caserini and Renata Palmieri are workers of Polichem S.A.
Polichem S.A. sponsored all phases of the examine and equipped the trial product.