Vestibulodynia is chronic pain and discomfort around the vagina’s opening, mainly inside the inner lips of the vulva (the vestibule). Postmenopausal dyspareunia (pain during sex) and vulvar pain are common complaints for postmenopausal women.
Researchers noted that Tibolone (TIB) “is the most effective and safe alternative for treating menopausal symptoms”. Lactobacilli and lactoferrin are also effective in treating vaginal microbiota dysbiosis.
In the latest study, after 90 days of taking Respecta, women experienced a “statistically significant” decrease in their Visual Analog Scale for vulvar burning/pain and reduction in pain evaluation test scores.
“This study provides evidence that the combination of TIB+ Respecta was effective in reducing symptoms related to vestibular pain and hypersensitivity in a postmenopausal setting,” the authors wrote in the journal Nutrients.
A common complaint
Dyspareunia and vulvodynia are genital pain disorders that can severely affect women’s quality of life. Unfortunately, many women don’t feel able to report genital pain, and many healthcare providers don’t ask.
Postmenopausal dyspareunia and vulvar pain are common complaints. They affect about 60% of women within a few years after their hormone levels start to drop.
Meanwhile, vulvodynia is a pathological condition that mainly affects the vulva and the tissues around the vaginal introitus. It was once thought of as an “invisible” condition dismissed as psychosomatic or psychogenic by healthcare providers.
Tibolone is a compound with estrogenic, progestogenic and androgenic activity. It is very quickly metabolized to 3α-hydroxy Tibolone and 3β-hydroxy Tibolone—two metabolites responsible for the estrogenic activity. Treatment with TIB is recognized as a hormone replacement therapy (HRT) for postmenopausal women.
There’s evidence of TIB’s positive action on postmenopausal dyspareunia and vulvovaginal dryness. These results could be explained by activation of androgen and estrogen receptors. TIB also has positive effects on the vaginal maturation index and alleviates atrophic vaginitis symptoms.
Assessing pain
Researchers recruited 35 postmenopausal women who had stopped menstruating for at least a year and who were affected by vulvar burning/pain and introital dyspareunia.
Their symptoms were evaluated on a Visual Analog Scale ranked from zero (no pain) to 10 (unbearable pain). The women then took part in a pain evaluation test to assess sensitivity at six points around the vestibule, identifying the sites of their pain.
All participants took open-label, oral TIB 2.5 mg and Lactobacilli mixture (5 × 109 CFU per capsule) including Lactobacillus acidophilus GLA-14 (BCCM/LMG Bacteria Collection, Ghent, Belgium, LMG S-29159) and Lactobacillus rhamnosus HN001 in combination with bovine LF RCX (50 mg) (Respecta). Each was taken once a day for 90 days before researchers analyzed the results.
After taking Respecta for three months, the women involved in the study reported decreased scores in both the Visual Analog Scale and the pain evaluation test. The authors maintain that more studies featuring more women are needed to confirm the findings.
“Our results are encouraging and should stimulate further research regarding this innovative pathophysiological neural mechanism of postmenopausal vulvar pain and vestibular hypersensitivity,” the researchers wrote.
For their study, they noted as limitation the lack of a control group and follow-up, as well as the small sample of women involved.
Source: Nutrients 2024, 16(14), 2378
doi: 10.3390/nu16142378
"Effectiveness of Combination of Tibolone and Lactobacilli Plus Lactoferrin in Postmenopausal Women with Vulvar Vestibular Pain: A Preliminary Report"
Authors: Vincenzo De Leo et al.