SUMMARY: Incredulously, the latest 16S rRNA research now challenges what was thought for years to be a ‘protective,’ ‘normal,’ and healthy vaginal microbiome. Our many microbiomes ideally are “inherited” and originate from our passage through the vagina, and yet it seems a ‘healthy’ and ‘normal’ vaginal microbiome has been elusive; in fact, many women have a compromised vaginal microbiome and many are asymptomatic, or perhaps not…
16S rRNA now proves the notion of a Lactobacillus-dominated vaginal microbiome as ‘normal’ and ‘healthy’ is overly simplistic and is giving way to an appreciation of diverse and dynamic bacterial communities. Indeed, the composition and stability of the vaginal microbiome varies by race, age, even within an individual—and it’s quickly become clear that the formula for a “normal,” “healthy” microbial community cannot be computed by ratios of bacterial species. In fact, there is a racial difference in the vaginal environment and the microbial [community] in parallel. Thus, it is time to learn what a ‘normal‘ and ‘healthy’ vaginal microbiome looks like, and if you read this post, you’ll know more than your doctor at your next exam! This 16S rRNA study title says it all: “The vaginal microbiome: rethinking health and diseases.
Yep, we’re going there folks… and men pay attention, if not for yourself… your significant other, daughters, and future children will love you for this information!
The whole foods and lubricant take on vaginal health
I was surprised by the number of women I work with who report that a whole foods diet (such includes live probiotics) along with toxin eliminations (a big change relative to vaginal health I would imagine is ditching personal lubricants and instead use coconut oil), were actually resolving many vajayjay issues. I am talking all ages…. bacterial vaginosis (BV), yeast, discomfort during togetherness, vaginal atrophy, dry vagina… and I mean resolved to the point where prescription and estrogen based suppositories were no longer needed!
Granted, this is anecdotal, but the numbers don’t lie. Curiosity got the best of me, and I learned there is real science that supports my observations relative to vaginal microbiome. Also worth noting: one lubricant, K-Y®Jelly differs regionally in ingredient formulation and composition. Just to repeat: K-Y® Jelly ingredients differs worldwide — I find that incredibly odd, don’t you?!? That’s just one more reason to distrust and ditch such, just saying…
Defining a “healthy” vaginal microbiome is elusive as it can look like it is on the verge of chronic disease…“These findings challenge the common wisdom that the occurrence of high numbers of lactobacilli and a vaginal pH <4.5 is synonymous with ‘normal’ and ‘healthy’.”
What is a ‘healthy’ vaginal microbiome (or gut… or any other microbiome for that matter) is not really known:
In the third trimester, the vaginal microbiome changes and ends up looking like the microbiomes of people with metabolic syndrome, a condition characterized by obesity, high blood sugar and a higher risk of diabetes and heart disease. This microbiome community might indicate someone on the verge of chronic disease — or merely motherhood. But think about it… packing fat and building up blood sugar really does make perfect sense when nourishing a growing fetus [and I add, prepping for breast milk production]. -Of the bugs that shape us: maternal obesity, the gut microbiome, and long-term disease risk, and
Gut microbiota changed dramatically from first (T1) to third (T3) trimesters, with vast expansion of diversity between mothers, an overall increase in Proteobacteria and Actinobacteria, and reduced richness. When transferred to germ-free mice, T3 microbiota induced greater adiposity and insulin insensitivity compared to T1. Our findings indicate that host-microbial interactions impacting host metabolism can occur, and may be beneficial, in pregnancy. –Host remodeling of the gut microbiome and metabolic changes during pregnancy.
Relative to the non-pregnant, see the recent 16S rRNA findings, The vaginal microbiome: rethinking health and diseases, which challenges “the occurrence of high numbers of lactobacilli and a vaginal pH <4.5 [being] synonymous with ‘normal’ and ‘healthy.’ This study explains: One of four common Lactobacillus species (L. crispatus, L. iners, L. gasseri and L. jensenii) dominate vaginal microbiota in the majority of normal and healthy women. However, an appreciable proportion (more than a quarter of the women studied) were asymptomatic, otherwise healthy individuals, having vaginal microbiota that LACK significant numbers of Lactobacillus sp. and instead harbor a diverse array of facultative and strictly anaerobic microorganisms (86):
- 70 to 80% of women have healthy microbiomes that are Lactobacilli dominant. Lactobacilli strains present include L. iners, L. crispatus, L. gasseri, L. jenesenii, followed by L. acidophilus, L. fermentum, L. plantarum, L. brevis, L. casei, L. vaginalis, L. delbrueckii, L. salivarius, L. reuteri, and L. rhamnosus.
- Different L strains dominate based on ethnicity, and
- there was higher average pH in Black and Hispanic women, 4.7 and 5.0 respectively, compare to 4.4 and 4.2 for Asian and White women.
- 20 to 30% of women having healthy microbiomes lack appreciable numbers of Lactobacillus but include a diverse array of facultative or strictly anaerobic bacteria that are associated with a somewhat higher pH (5.3–5.5). This proportion reached 40% among Black and Hispanic women. These microbiota include of members of the genera Atopobium, Corynebacterium, Anaerococcus, Peptoniphilus, Prevotella, Gardnerella, Sneathia, Eggerthella, Mobiluncus and Finegoldia among others (52; 86; 115; 122–124). Further explanation for this quarter of women studied comes from, Characterizing the “Healthy” Vagina: “Their vaginas had fewer Lactobacillus and greater numbers of other anaerobic bacteria, although the bacterial communities always included members of genera known to produce lactic acid... the microbiome of these women resembled the bacterial communities of women suffering from BV and by looking at the microbial components, you’d say they have BV, but they have no clinical symptoms. These people are not unhealthy.”
- The below study slide shows the phylotypes for 32 healthy reproductive aged women sampled twice-weekly over a 16-week period. “These findings challenge the common wisdom that the occurrence of high numbers of lactobacilli and a vaginal pH <4.5 is synonymous with ‘normal’ and ‘healthy’.”
Rationalizing the non-Lactobacillus dominant microbiome
“Previous studies have hypothesized non-Lactobacillus dominant vaginal microbiota may be nonetheless able to maintain functional vaginal ecosystems, by preserving lactic acid production and possibly other important functions (36; 86; 122). Actually many underappreciated microorganisms, such as members from Atopobium, Streptococcus, Straphylococcus, Megasphaera, and Leptotrichia, are capable of homolactic or heterolactic acid fermentations (89; 122). The highly diversified microbial community may have accommodated functional redundancy, allowing for the function of the ecosystem to persist in the face of perturbations (117). In the absence of symptomology, these types of vaginal bacterial communities might be considered ‘normal’ and ‘healthy’, even though the composition of these communities closely resemble those associated with symptomatic bacterial vaginosis.“ The vaginal microbiome: rethinking health and diseases
So ‘Omics’ technology (who, what, and why) will ascertain the functional properties of the microbiome community as a whole. Recall the pearls of our first meeting, that the microbiome by definition, includes the collection of ALL of the genes contained in the human microbiota; in other words, it is the cumulative genes of bacteria, arachea, viruses, and eucarya, and that is on the order of 2 to 20,000 million microbial genes vs only 20,000 human genes. Big number magnitudes can be confusing; recall this from our discussions:
Not to be forgotten: Epigenetics and gene expression
Epigenetics and gene expression plays a huge role in BV (and all other health truth be told, but you already know that). Recall that for epigenetics, an environmental factor occurs and this turns on and off differing gene expression. This too goes back to our first encounter; recall the analogy of a rocket blast sending to a new orbit. An easy to understand epigenetic tutorial is within the post, THE SCIENCE BEHIND FOOD AND DISEASE (scroll to the section titled “Disease is rooted in our DNA expression,”) which you can read for a quick refresher. Most find it helpful after realizing the huge amount of gene expression occurring simply due to the introduction of one probiotic:
An example of epigenetics at work for BV: “In postmenopausal women, BV was associated with apparent reduced expression of host antimicrobial factors . When probiotic L. rhamnosus GR-1 was administered to the vagina of premenopausal women [this is the environmental change], it resulted in 3 536 gene expression changes [that is not a typo] and increased expression levels of some antimicrobial defenses .” –Vaginal Microbiota and the Use of Probiotics. Now that’s a lot of gene expression!
Past conventional wisdom of what is a ‘normal’ and ‘healthy’ vaginal microbiome follows:
Such may apply for those with lactobacillis dominant vaginal microbiomes, but all bets are off for more than a quarter of women whose “microbiomes lack appreciable numbers of Lactobacillus but include a diverse array of facultative or strictly anaerobic bacteria that are associated with a somewhat higher pH (5.3–5.5),” unless ‘omics’ shows microbiome functional equivalency.
- The pH of the normal healthy vagina is within 3.5–4.5… maintained by the production of lactic acid by the lactobacilli. Any compromise with the pH (due to pathophysiological conditions or physical activities such as insertion of contraceptive devices and intercourse) may result in the increase of the pH within the vaginal lumen, which in turn may result in the lactobacilli population and a subsequent increase in the growth of other microbe. As the lactobacilli count decreases, there is a decrease in the production of lactic acid. Lactic acid has a potent anti-microbial property which helps in preventing the growth of the pathogenic microbes.[21,22] Lactobacilli also produce antimicrobial products such as bacitracin and hydrogen peroxide which further help in the prevention of the proliferation of the pathogenic microorganisms.[23,24] Lactobacilli have the capability to excrete the substances, which hinders their multiplication, from the vaginal lumen. Bacterial vaginosis: Etiology and modalities of treatment—A brief note
- Through the metabolism of glycogen, lactobacilli are responsible for the physiological mild acidity (i.e. a vaginal pH of < 4.5) of the vaginal secretions. An acidic vaginal pH significantly increases the binding capacity of lactobacilli to the vaginal epithelium and reduces the activity of several pathogenic bacterial enzymes such as sialidase8., Vaginal Microbiota and the Use of Probiotics
- The menopausal vaginal microbiome differs from pre-menopausal… the menopausal microbiome fluctuates little over time, unlike that of pre-menopausal women, and there was an inverse correlation between Lactobacillus ratio and dryness, a condition commonly found after menopause, which shown here to be associated with changes in vaginal epithelial cell integrity and inflammation. –PLOS ONE paper, Vaginal Microbiome and Epithelial Gene Array in Post-Menopausal Women with Moderate to Severe Dryness
- In postmenopausal women, almost all subjects had vaginal mucosa populated with more than 1 organism, many of which had pathogenic potential such as Bacteroides, Prevotella, and Gardnerella, associated with BV, and E. coli and Enterococcus, associated with UTI , Vaginal Microbiota and the Use of Probiotics
- High pH and vaginal levels of IL-6 are detected during vaginal infections11 The vaginal pH is recognized as the most significant predictor of the status of the vaginal ecosystem. Interleukin 6 (IL-6), an inflammatory cytokine, is a major mediator of the host response to inflammation and infection10. Efficacy of an acidic vaginal gel on pH and interleukin-6 levels in low-risk pregnant women: a double-blind, randomized placebo-controlled trial
Consider the most common vaginal syndrome afflicting fertile, premenopausal and pregnant women: BV
“Conventional treatment is antibiotic vaginal creams or suppositories and oral antibiotics (metronidazole and clindamycin). This treatment is not designed to restore the lactobacill, thus, the recurrence rate remains high.” –Vaginal Microbiota and the Use of Probiotics. I applaud these researchers for their honesty. BV:
- Is the most common urogenital vaginal infection in premenopausal women aged 15-44 with an incidence rate ranging from 5% to 50%. A National Health and Nutrition Examination Survey (3700 vaginal swabs) found prevalence of BV was 29% in the general population aged 14 to 49 years of age but 50% in African Americans, which included symptomatic and asymptomatic infection.
- Is often asymptomatic, or perhaps instead we may find this microbiome to be “normal’ and ‘healthy’ for more than a quarter of women not having lactobacillus dominant microbiomes,
- Occurs in up to 20% of pregnant women and is linked to serious pregnancy complications placing the fetus at risk.
- BV increases risk of: Pelvic inflammatory disease, UTI, and increased susceptibility to sexually transmitted diseases, including HIV, syphilis, gonorrhea, and trichomoniasis. Bacterial vaginosis: Etiology and modalities of treatment—A brief note
- Pregnancy complications: “Pregnant women with BV are more likely to have babies who are born premature (early) or with low birth weight than women who do not have BV while pregnant. BV during pregnancy has been linked to serious pregnancy complications, including premature rupture of the membranes surrounding the baby in the uterus, preterm labor, premature birth, infection of the fluid that surrounds the baby, as well as infection of the mother’s uterus after delivery8.” –Bacterial Vaginosis – CDC Fact Sheet and STDs & Pregnancy – CDC Fact Sheet.
- Recurrence is ridiculously frequent: “BV recurs in up to 40% of women within 3 months after initiation of antibiotic therapy and in up to 50% of women after 6 months… side-effects and disadvantages associated with treatment, including superinfections by pathogenic microorganisms and susceptibility of lactobacilli to clindamycin... Moreover, vaginal pathogens, particularly G. vaginalis and anaerobic bacteria, are showing increasing drug resistance. The high recurrence rates resulting in repeated exposure to antibiotics and the emergence of drug-resistant strains suggest a need for alternative therapeutic tools based both on new antibacterial agents and probiotic products.”
The root cause of BV (one dysbiosis example):
- Vaginal communities continually experience various kinds of chronic and acute disturbances caused by human behaviors such as the use of antibiotics, hormonal contraceptives and other methods of birth control, sexual activity, vaginal lubricants, douching and so forth, in addition to many other intrinsic factors such as the innate and adaptive immune systems of hosts (64; 88; 110). Further, a disturbed state itself may constitute the clinical syndrome known as bacterial vaginosis (BV), which as a disruption of ecological equilibria is believed to increase the risk to invasion by infectious agents.-The vaginal microbiome: rethinking health and diseases
- “BV is a common vaginal infection and is associated with the loss of the lactobacilli colonies with a subsequent overgrowth of anaerobic polymicrobials within the vaginal lumen. Of late, its occurrence has increased many-fold and is one of the most widely studied obstetric/gynecologic infectious diseases.” –-Bacterial vaginosis: Etiology and modalities of treatment—A brief note
- “The anaerobic bacteria overgrows (Gardnerella vaginalis, Atopobium vaginae, Prevotella spp., Mobiluncus spp., Mycoplasma hominis) with a coincident reduction of lactobacilli particularly those producing hydrogen peroxide. 70% to 95% of lactobacilli present in the vaginal flora of healthy women produce hydrogen peroxide. This percentage drops to 5% in women affected by vaginal infections.” Bacterial vaginosis: a review on clinical trials with probiotics
- BV is a condition characterized by a depletion of lactobacilli population and the presence of Gram-negative anaerobes, or in some cases Gram-positive cocci, and aerobic pathogens… BV is associated with multiple species of bacteria that occur in 90% of the cases, and essentially consists of an elevated vaginal pH (>4.5) and depletion of lactobacilli. Vaginal Microbiota and the Use of Probiotics. A ‘healthy’ microbiome is dominated with Lactobacilli strains present including L. iners, L. crispatus, L. gasseri, L. jenesenii, followed by L. acidophilus, L. fermentum, L. plantarum, L. brevis, L. casei, L. vaginalis, L. delbrueckii, L. salivarius, L. reuteri, and L. rhamnosus.Vaginal Microbiota and the Use of Probiotics Note however the latest 16S rRNA findings that more than a quarter of women lack lactobacillis dominancy, –The vaginal microbiome: rethinking health and diseases, (32 healthy reproductive aged women sampled twice-weekly over a 16-week period, see below slide.)
- The BV microbiota typically contains a broader range of species than found under healthy conditions, with Atopobium vaginae, Bacteroides spp., Gardnerella vaginalis, Mobiluncus, Megasphera,Mycoplasma hominis, Peptostreptococcus, and Prevotella being particularly prevalent [3, 42–46]. –Vaginal Microbiota and the Use of Probiotics Note too, typically increased diversity means increased immunity… apparently such is not necessarily correct considering BV.
Lactobacilli role in the vagina:
- Lactobacilli have long been thought to be the keystone species of vaginal communities in reproductive-age women. These microorganisms benefit the host by producing lactic acid as a fermentation product that lowers the vaginal pH to ~3.5–4.5 (12). While a wide range of other species are known to be members of vaginal bacterial communities, their ecological functions and influence on the overall community dynamics and function are largely undetermined.-The vaginal microbiome: rethinking health and diseases
- Lactobacilli play an important role in the inhibition of growth, adhesion, and spread of pathogenic microbes. This has been accounted to its ability to form biofilms over the mucosal layer of the vagina and thereby compete for the nutrients and receptors with the pathogenic microbes. In addition to this, they secrete lactic acid, H2O2, bacteriocins, and biosurfactants which have good antimicrobial property. Apart from the antimicrobial property of lactic acid, they help in maintaining the pH of vagina within 3.5–4.5 thereby not allowing a conducive environment for the growth of the pathogenic microbes. Lactobacillus fermentum, Lactobacillus casai, L. acidophilus, and Lactobacillus iners are some of the species which have been found in vagina. Bacterial vaginosis: Etiology and modalities of treatment—A brief note
- Further, Bacterial vaginosis: a review on clinical trials with probiotics explains that: In BV, anaerobic bacteria overgrows (Gardnerella vaginalis, Atopobium vaginae, Prevotella spp., Mobiluncus spp., Mycoplasma hominis) with a coincident reduction of lactobacilli particularly those producing hydrogen peroxide. Lactobacilli exert their protective functions by:
- stimulation of the immune system;
- competition with other microorganisms for nutrients and for adherence to the vaginal epithelium;
- reduction of the vaginal pH by the production of organic acids, especially lactic acid;
- production of antimicrobial substances, such as bacteriocins, and hydrogen peroxide (Aroutcheva et al., 2001). The hydrogen peroxide microbial metabolite represents one of the most effective protective agents against pathogens. It has been observed that 70% to 95% of lactobacilli present in the vaginal flora of healthy women produce hydrogen peroxide. This percentage drops to 5% in women affected by vaginal infections (Eschenbach et al., 1989).
So here goes… time to share research that actually supports that whole foods (includes fermented foods) and switching personal lubricant to coconut oil) can actually modulate the vaginal microbiome from dysbiosis to healthy!
NOTE: The synergy of the multiple probiotics in fermented whole foods is a likely contributor to efficacy and therapeutic effect.
What’s in that SCD yogurt and sauerkraut anyway… bacteria wise???
Live bacteria in SCD yogurt includes: L.acidophilus, S.Thermophilus, L.Bulgaricus, and/or L.rhamnosus, see the post CLA GRASSFED SCD YOGURT & CYTOKINE STUDIES: ERIVAN & WHOLE FOODS 365.
Bacteria in live un-pasteurized sauerkraut includes:
- Lactic acid bacteria: Leuconostoc mesenteroides, Lactobacillus plantarum, Pediococcus pentosaceus, and Lactobacillus brevis, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, Lactobacillus coryniformis, and Weissellasp, Leuconostoc fallax. and unexpectedly, only two isolates of P. pentosaceus and 15 isolates of L. brevis were recovered during this study which used only one sauerkraut production facility in Wisconsin since there are currently very few commercial production facilities in the United States. DNA Fingerprinting of Lactic Acid Bacteria in Sauerkraut Fermentations.
- Lactobacillus plantarum appeared as the dominant species, [Lactic acid bacteria diversity in fermented cabbage estimated by culture-dependent and-independent methods].
- Culture-dependent methodologies have identified Leuconostoc, Lactobacillus, and Pediococcus as dominant bacterial genera in sauerkraut fermentation (34). The present study revealed Weisella (46.1%), Leuconostoc (26.6%), and Lactococcus (15.9%) were the most common dominant genera in sauerkraut. -Metagenomic Analysis of the Viral Communities in Fermented Foods
Worth mentioning… the viruses in fermented foods: You can read those found in kimchi, sauerkraut and fermented shrimp in Metagenomic Analysis of the Viral Communities in Fermented Foods, but the pearls are that they do exist, we know very little about them except they do impact health, and the microbiome by definition, does include the collection of all of the genes contained in the human microbiota; in other words, it is the cumulative genes of bacteria, arachea, viruses, and eucarya, and that is on the order of 2 to 20,000 million microbial genes vs only 20,000 human genes. Sorry again for the headache… just going back to our first encounter:
Summary Tables: antibiotics, probiotics and BV therapies
On a sidebar, the gynecologists I speak with are encouraged by these probiotic findings as increasing cases of antibiotic resistant pathogenic microorganisms is a growing concern and the conventional treatment (antibiotics) often fails with frequent recurrence. Thus, the use of probiotics for BV treatment is a natural and non-toxic option. I will note that the studies suggest that probiotic effectiveness and timeliness is individual. Some treatment protocols suggest probiotics in conjugation with anti-microbials… this approach can always be a Plan B, or C, or D… Trying the OTC femdophilus probiotic product, discussed below, may be a worthy Plan B consideration. Talk with your healthcare provider always.
Now you know, eating fermented foods is worth a try for modulating the vaginal microbiome which should be non-negotiable no matter what your age. Ditching OTC personal lubricants, as discussed below, must contribute too.
I will note that some women have success using the OTC femdophilus product which contains L.rhamnosus and L.reuteri. I always advocate whole foods over supplement but this product is worth a try if whole foods don’t work. It does have added ingredients that make it non-SCD legal for those adhering to SCD or similar.
Time now to talk personal lubricants and the vagina.
In summary, seems their ingredient composition can be toxic to the vagina and mucosa enhancing transmission of pathogens. Characterization of Commercially Available Vaginal Lubricants: A Safety Perspective, provides: The FDA and the European Medicine Agency… traditionally list lubricants as medical devices and relieve these products from extensive pre-clinical and clinical testing as otherwise required for drug products [10,11]. While there is a stringent lack of data on the safety of vaginal OTC lubricants, different in vitro and in vivo animal studies indicate that water-based lubricants may induce changes to the vaginal environment and mucosa that can lead to toxic effects and, eventually, enhancement of the transmission of sexually transmitted pathogens, such as HIV [12,13,14,15,16].
WHO in collaboration with the United Nations Population Fund (UNFPA) and Family Health International (FHI360), recently recognized these risks and issued an “Advisory Note” on the technical requirements of lubricants, namely when used in addition to condoms .
I advocate toxin elimination so of course I recommend ditch vaginal lubricants, and instead, use ordinary coconut oil, unrefined & cold pressed please, for a number of reasons:
- Some lubricants can impact fertility by changing vaginal pH.
- It’s unsettling that recent studies have indicated that vaginal lubricant products might be smoothing the way for toxicity concerns and disease transmission.
- How’s that coconut oil? Coconut oil simply works better than OTC personal lubricants. Most are amazed how incredibly wonderful this edible kitchen staple safely works as a personal lubricant for both men and women. Honestly, try it; I have yet to hear of anyone not loving this!
- Note however, never use an oil-based lube with latex condoms (this includes, baby oil, coconut oil, etc.) or you run the risk of condom breakage, see WHO/UNFPA/FHI360 Advisory note. However, it is concerning that lubricant condom compatibility and safety is not as thoroughly assessed and/or documented as commonly believed. Recommendations have been made for thorough and modern review of lubricants and their impact on latex condom integrity. –Condoms and condiments: compatibility and safety of personal lubricants and their use in Africa.
Coconut Oil is a safe lubricant relative to fertility
The Advanced Fertility Services Blog, Will Using Lubricants Affect My Fertility explains: Lubricants that change the pH balance in the vagina make the environment more hostile to sperm. Some lubricants can reduce sperm motility, which makes it harder for sperm to travel through the cervix, uterus, and fallopian tubes… there are a number of lubricants that do not adversely affect the pH balance of the vagina. Water-based lubricants are safe for conception, as are vegetable oil-based lubricants. Some oils, like coconut oil and olive oil, can even be used as lubricant on their own. -The Advanced Fertility Services Blog, Will Using Lubricants Affect My Fertility
Lubricants can damage cells lining the walls
This study notes that personal lubricants have been found to damage cells lining the vaginal epithelium potentially making the body more vulnerable to sexually transmitted infections (STIs). Jim Pickett, chair of the International Rectal Microbicide Advocates (IRMA) group, a global network pushing for safe and effective STI-preventing products, says, “Just because a lubricant causes cell damage in the lab, we don’t know whether that has anything to do with disease transmission in humans in the real world.” –Studies Raise Questions About Safety Of Personal Lubricants. Really?!?
♥Personal lubricants change the vaginal pH and they come with ingredient and health associated risks.
Most women and men are not aware that recent reports raise questions about personal lubricant safety: that there is toxicity concerns associated with personal lubricant use, and it likely is their ingredient composition (parabens, preservatives, phenoxyethanol..) behind their toxicity.Twelve commercially available vaginal lubricant gel products were studied for: pH value, pH buffering capacity, osmolality and cytotoxicity relevant to vaginal implications. The safety of vaginal lubricants was being analyzed in light of the recent Advisory Note by the World Health Organization (WHO) for personal lubricants to be concomitantly used with condoms.
In summary, Characterization of Commercially Available Vaginal Lubricants: A Safety Perspective, showed that most products do not comply with pH and osmolality recommended standards, thus posing a potential hazard.
- Four products presented values of osmolality around three-times higher than the maximum acceptable limit of 1200 mOsm/kg.
- In vitro cell testing further identified substantial cytotoxicity even at 1:100 dilutions for three products, contrasting with no significant effect of up to at least a 1:5 dilution of a Universal Placebo gel.
This study further explained: “the individual toxicity of specific lubrication formulation (ingredients or components) plays an important role in the toxicity outcome of a particular product.”
“Although further assessment is required, these results highlight potential safety issues related to the formulation of commercially available vaginal lubricants.”
“In vitro and in vivo animal studies indicate lubricants may induce changes to the vaginal environment and mucosa that can lead to toxic effects. These can also lead to enhancement of transmission of sexually transmitted pathogens.”
- Fillergyn® gel (BSDpharma, Lodi, Italy),
- Geliofil® Classic gel (Laboratoires Effik,
- Meudon-la-Forêt, France),
- GelSea® gel (LDPSA, Paris, France),
- Ginix® gel (ISUS, Lisbon, Portugal),
- Ginix® Plus gel (ISUS),
- Hyalo Gyn® gel (Fidia Farmaceutici, Abano Terme, Italy),
- K-Y® Jelly (Johnson & Johnson, Issy les Moulineaux, France), NOTE: K-Y® Jelly ingredients differs worldwide — I find that incredibly odd, don’t you???,
- Phyto Soya® gel (Arkopharma Laboratoires Pharmaceutiques, Carros, France),
- RepHresh® gel (Lil’ Drug Store Products, Cedar Rapids, IA, USA),
- Replens® gel (Lil’ Drug Store Products), Velastisa® Intim VG moisturizer gel cream (Isdin, Barcelona, Spain) and
- Vidermina® gel (Istituto Ganassini, Milano, Italy).
Copied below my signature is the study: conclusion, pH and osmolality value of the tested products, acid buffering, toxicity, toxicity also exists due to ingredients, and understanding osmolality and epithelial cell damage of the tested products; ditching such lubricants simply is a no brainer.
IN SUMMARY: Try daily consumption of fermented foods (a forkful a few times throughout the day) and use coconut oil (unrefined and cold pressed) instead of OTC lubricants for vaginal microbiome health, for all ages.
Details of the study, Characterization of Commercially Available Vaginal Lubricants: A Safety Perspective:
Conclusions: Concerns have been raised about the safety of OTC vaginal lubricants. Lack of data, however, limits proper judgment on commercially available products, either by women or their assisting clinicians. The present study detailed the characteristics of different lubricants linked to vaginal safety. Most of the studied lubricants presented pH and/or osmolality values outside the ranges recommended by the WHO. Furthermore, cytotoxicity studies were able to identify safety concerns, even if the true impact of these findings requires further assessment. No definite correlation between gel pH or osmolality and cytotoxicity were found. Individual composition for tested products [the ingredients], as well as regional formulation variability [Just to repeat: K-Y® Jelly ingredients differs worldwide — I find that incredibly odd, don’t you???], seems to be essential to undertake any specific cause-effect analysis. Further characterization is also deemed necessary in order to fully understand the potential hazard of the tested products, namely condom compatibility and safety to microbiota. In this last case, the ubiquitous presence of preservatives (parabens and others) in the composition of lubricants and the concentrations used may be of paramount importance. These and other excipients may interact differently with microbiota and trigger singular toxicity mechanisms, thus potentially leading to inconsistencies with cytotoxicity data obtained in the reported investigation for cells of epithelial origin. Thus, further specific toxicity testing using vaginal microbiota, namely Lactobacilli sp., is advisable. Overall, it seems highly recommended that regulatory agencies and manufacturers join efforts in the (re-)evaluation of commercial lubricants and, consequently, consider their eventual reformulation.
pH and osmolality value of the tested products: The maintenance of an acidic pH contributes to the normal vaginal physiology and microbiota, as well as to a balanced immune response. Vaginal products should present compatibility with vaginal pH and, ideally, maintain it or even help in its reestablishment (e.g., in cases of bacterial vaginitis or menopausal women) [25,26]. Most of the tested products presented pH values in the acidic range. K-Y® Jelly, curiously, has distinct compositions in different geographical regions, namely in Europe, the United States and South America, [I find that incredibly odd, don’t you???} making comparison impossible. Differences were notable (4.5–4.6) [15,16]. GelSea had high pH levels (not suitable for vaginal use) and low pH values below 3 are not acceptable for human use per animal studies . RepHresh and Replens begin with a very low pH (3.4 and 3.0 respectively). No data has been reported for some of the lubricants. The lubricant pH results are presented in Table 1:
Understanding osmolality and epithelial cell damage of the tested products:
This Chemical and Engineering News article, Studies Raise Questions About Safety Of Personal Lubricants explains: