Vaginal hyaluronic acid matches up to oestrogen for relieving GSM

In the treatment of genitourinary syndrome of menopause (GSM), the nonhormone alternative vaginal hyaluronic acid is equally efficacious as the treatment standard vaginal oestrogen, while being well-tolerated, as shown in a pilot study.

After 12 weeks of treatment, the primary outcome of symptom severity, as assessed using the overall Vulvovaginal Symptom Questionnaire (VSQ) score, decreased by 3.3 points with vaginal hyaluronic acid and by 3.7 points with vaginal oestrogen, with no clinically meaningful difference between the treatment arms (mean difference, −0.4, 95 percent confidence interval [CI], −3.5 to 2.8; p=0.81). Similar improvements were observed across all subdomains of the VSQ. [Menopause 2024;doi:10.1097/GME.0000000000002390]

Results for the secondary objective and subjective measures were also largely comparable between the treatment arms, with improvements observed in the visual analogue scale (VAS) scores (dyspareunia: mean difference, –0.6; p=0.54; vaginal itching: mean difference, 0.8; p=0.45; vaginal dryness: mean difference, –0.7; p=0.51), total Vaginal Symptom Index (VSI) score (mean difference, 0.6; p=0.64), total Female Sexual Function Index (FSFI) score (mean difference, –3.9; p=0.06), and vaginal pH (mean difference, −0.2; p=0.24) at week 12.

Only two outcomes showed notably greater improvements with vaginal oestrogen than with hyaluronic acid, and these were the FSFI lubrication subscore (mean difference, –1.2; p=0.02) and the Vaginal Maturation Index (mean difference, 33.9; p<0.01).

Finally, the vast majority of participants in both treatment arms reported improved GSM symptoms based on the Patient Global Impression of Improvement (PGI-I; 96 percent in the oestrogen group vs 91 percent in the hyaluronic acid group; p=0.61).

In terms of safety, “both vaginal therapies were well tolerated by participants, with high medication compliance rates and no serious treatment-related adverse events in either arm,” the investigators said.

Adverse events reported in the two treatment arms were often mild vaginal symptoms that occurred at the onset of therapy and then self-resolved with continued use. One case of urinary tract infection in the vaginal oestrogen arm and one case of vulvovaginal candidiasis in the vaginal hyaluronic acid arm were deemed unlikely related to treatment and were both adequately treated with antimicrobial therapy.

“Our pilot study indicates that treatment with vaginal hyaluronic acid can not only improve subjective measures related to GSM, but also objective measures, like vaginal pH,” the investigators noted.

The finding that vaginal oestrogen demonstrated a superior effect on VMI compared with vaginal hyaluronic acid is worth noting, they added. While this aligns with previous research, it also underscores the challenge of relying solely on objective measures to assess GSM treatment efficacy, with an earlier study suggesting that VMI may not accurately reflect symptom severity. [Am J Obstet Gynecol 2003;188:382-388]

“Based on our own clinical experience with GSM and what we have learned from the pelvic organ prolapse literature, there is a shift toward patient-reported outcomes now because they correlate more with patient satisfaction, treatment adherence, and overall, patient-centred care,” the investigators said. [Int Urogynecol J 2022;33:2603-2631]

“Therefore, we chose a quality-of-life questionnaire, the VSQ, as the primary outcome for this study, because we thought that the change in their quality of life would be more meaningful and impactful to women in their decision-making about GSM treatment,” they added.

In the study, 49 postmenopausal women (average age 60 years) with symptoms consistent with a diagnosis of GSM were randomly assigned to receive treatment with vaginal suppositories that contained hyaluronic acid (n=23) or with vaginal oestrogen cream (n=26) for 12 weeks. Vaginal dryness was the predominant GSM symptom in both treatment arms, followed by dyspareunia.