Abstract
Many non-prescription preparations intended to treat or alleviate symptoms of vaginal infection are available in American and European markets, but many have scant preclinical or clinical research underpinning. Respecta®Balance Gel (RBG) is marketed as an adjunct to probiotic treatment and its relevant antimicrobial properties were studied. Key findings with the manufacturer-supplied gel showed reduced turbidity in broth-dilution tests by 50% against Candida albicans and Candida glabrata at RBG concentrations 0.2–0.4% of neat product, respectively. A 50% reduction in turbidity of Escherichia coli, Streptococcus agalactiae, Enterococcus faecalis ranged from 1.6–2.2% and Gardnerella vaginalis was shown by flow cytometry counts to undergo a 50% reduction at 0.3% RBG. Propidium iodide staining indicated a rapid reduction of cell integrity of G. vaginalis almost immediately while after 4 h 45% of E. coli cells were stained. The lactic acid in BHI inhibited bacteria and yeast at concentrations ranging from 0.2–1.8% but inhibition was not solely due to pH since a 1:4 dilution of RBG resulted in a pH near neutral (6.75). Other findings showed biofilm accumulation assessed after 10-days exposure of Candida spp. to RBG and was reduced by an average of one-third (community strains) to one-half (drug-resistant strains). One excipient of the RBG, disodium EDTA, inhibited the growth of bacteria and yeast at concentrations below those present in RBG and may accentuate the activity of the host defense factor, lactoferrin. We conclude that RBG is a potent inhibitor of vaginal microorganisms relevant to vaginitis or intrapartum infections and contains excipients that may contribute to its antimicrobial activity.
Highlights
For decades infectious diseases have been addressed largely through the application of antibiotics to specific conditions
Since Respecta® Balance Gel (RBG) contains EDTA which may contribute to antimicrobial activity, we showed EDTA at concentrations present in RBG inhibited six test organisms (Table 1) and the ED50 values for EDTA alone ranged from 2.6% to 9.5% of the amount present in neat RBG
RBG is a formulation of components generally recognized as safe in the marketed formulation
Summary
For decades infectious diseases have been addressed largely through the application of antibiotics to specific conditions. In the case of gynecologic and obstetrical infections, antibiotics have served both for therapy and prophylaxis. This primary reliance on antibiotics engendered antibiotic guidelines and standards of care that inform medical practice worldwide [1,2,3]. Allowances are made for use of non-antibiotic modalities in some situations. While antibiotics will remain the mainstay of therapy, non-antibiotic treatment modalities could provide useful alternatives that circumvent selective pressure for antibiotic resistance and supply nonprescription treatments for infectious conditions that do not demand physician-directed intervention [8,9,10]
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