The supplement Ginesan L is based on the association of lyophilised L. acidophilus (a species of lactic acid-producing bacteria present in human vaginal microflora) and lactic acid, for the treatment of all kinds of vaginal disbiosys associated to the presence of an excess of pathogenic bacteria, or by colonization of Candida yeasts, independently of the underlying cause.
The product, under the form of 900 mg tablets containing 15 mg of 60% lactic acid and at least 5x108
CFU of L. acidophilus, is formulated for the direct intravaginal application once or twice a day.
MECHANISM OF ACTION:
Microbial vaginosis is one of the most frequent vaginal infections occurring in sexually active women of reproductive age:it has been estimated that one woman out of three will develop the condition at some point in its live.
These affections are caused by an unbalance of the vaginal flora,such as the intake of antibiotic drugs, or can be consequence of primary diseases which downregulate the immune system.
Also the use of intrauterine devices can predispose to vaginosis.
Yet the main agent that is responsible for many cases of vaginal infections is a yeast such as Candida albicans, normally resident in the human body, but which can become invasive in cases of alterations of the normal microflora.
The symptomatology more commonly associated with vaginosis is the presence of an abnormal, homogeneous,whitish malodorous vaginal discharge. More rarely, vaginosis is also associated to other symptoms, such as inflammation,pain or erythema.
Among the strains of Lactobacilli, L. acidophilus has been shown to be particularly able to coaggregate with G. vaginalis,blocking the adherence of this pathogen to vaginal epithelial cells, and⁄or displacing previously adherent strains.
For these reasons, the use of the probiotics could be important not only in women prone to urogenital infections, but also in healthy subjects, as it has been shown that the vaginal flora is often asymptomatically depleted of lactobacilli, thereby increasing the risk of subsequent outbreak of infections.
However, the most potent antimicrobial substance that is produced by Lactobacilli is lactic acid. This metabolic end-product is the main responsible for the low pH (around 4-4.5) of the healthy vaginal environment, which inhibits the growth of pathogen species such as Gardnerella, Prevotella, Bacteroides.
Thus, the addition in our topical formulation of exogenous lactic acid can synergistically help the probiotic microorganism to restore the normal environment in the vagina, and to stop the infection spread, more rapidly than using the probiotic or lactic acid alone.
Soy isoflavones are natural phytoestrogens, that contribute to the transformation of the L.acidophilus into lactic acid and by this lowering of pH and wellbeing the vaginal wall elasticity.
DIRECTIONS FOR USE:
The recommended posology is one tablet per day,at night and before sleep, to be taken until resolution of the symptoms of vaginosis.
Also can be taken two tablets for two times per day,depending the needs or as prescribed by doctor.
Before use, the tablets should get wet with a little water in order to melt (dissolves) easier into vaginal environment, and deeply inserted in the vagina.
The product can also be taken concomitantly to first-line antimicrobial drugs, as their mechanisms of action are completely different, and so their effects can be additive.
Differently from metronidazole or other antibiotic/antimycotic drugs, the occurrence of side effects of lactic acid or L. acidophilus in the gynaecological use has never been reported, at the doses required to achieve the therapeutic effects.
The substances are useful in pregnant women, where they can reduce the risk of premature birth, and also during menstruation.
However, if possible, in the latter case the normalization of the vaginal flora should be achieved before the onset of the subsequent menstrual period, since the transient changes occurring in the vaginal flora in the first part of the cycle may increase the probability of a relapse of the vaginosis.
CLINICAL EVIDENCE / CLINICAL STUDIES
The majority of the randomised clinical trials with placebo have reported that daily intra-vaginal administrationof 108-1010 CFU L. acidophilus for at least 6–12 days resulted in the substantial cure of bacterial vaginosis or
(in one study) of vaginal vulvo-candidiasis, reducing the recurrences, promoting the increase in vaginal lactobacilli, reducing the number pathogens microorganisms, and favouring the restoration of a normal vaginal microbiota. There are also evidences that the addition of 10-20 mg lactic acid can synergistically help the probiotic in the reestablishment of a healthy vaginal microflora. The administration of lactic acid, in some cases, gave results that were near to those achieved by using oral metronidazole or clindamycin, but without the side effects associated to the use of these synthetic drugs.
57 Women with BV receiving intra-vaginally, twice-daily for 6
days, suppositories containing L. acidophilus (5x108 to 2x109
CFU⁄mL), or placebo.
7–10 days after start of treatment, BV was present in 43% lactobacilli-treated vs. 100% placebo-treated (p < 0.005); Bacteroides were detected in 38.4% lactobacilli-treated vs. 96.4% placebo-treated (p < 0.005); vaginal lactobacilli were detected in 64% lactobacillitreated
vs. 38% placebo-treated (p < 0.005). Restoration of normal vaginal microbiota was established in 57% lactobacilli-treated vs. 0% placebo-treated (p < 0.0005).
Transm Dis 1992;
7-10 days after treatment :
*Decrease of BV (Bacterial vaginosis)
*Decrease of bacteroides detected
*High level of Lactobacilli
*Restoration of normal vaginal flora