OBJECTIVE: To compare the efficacy and safety of the vaginal mussel adhesive protein (MAP) hydrogel with the promestriene or the placebo hydrogel for treating moderate-to-severe postmenopausal vulvovaginal atrophy (VVA) symptoms.
METHODS: This 12-week randomised clinical trial enrolled postmenopausal women with moderate-to-severe VVA to receive treatment with MAP, promestriene or placebo hydrogel. The primary outcome was the decrease in severity of most bothersome symptom (MBS) between baseline and 12 weeks. Additional measures included a composite vaginal symptom index, vaginal health index, female sexual function index (FSFI) score, vaginal pH, vaginal maturation value, vaginal microecology, treatment satisfaction, meaningful benefit and treatment safety.
RESULTS: We recruited 105 participants, and 96 provided data for the study analysis. Three treatments had similar mean reductions in MBS severity over 12 weeks: MAP, -1.72 (95% CI, -1.91 to -1.53); promestriene, -1.55 (95% CI, -1.86 to -1.24) and placebo, -1.71 (95% CI, -1.95 to -1.48). Compared to the placebo, the MAP significantly improved the Satisfaction (P = .003) of the FSFI. In addition, the MAP and promestriene improved the vaginal microecology significantly. Adjusted for age and year after menopause, the mean reductions in MBS and the mean improvements in FSFI of MAP were comparable with promestriene (MBS, P = .410; FSFI, P = .233) but greater than the placebo (MBS, P = .028; FSFI, P = .046).
CONCLUSION: After adjusting for age and year after menopause, MAP demonstrates comparable efficacy to promestriene but superior effectiveness to placebo in alleviating postmenopausal vulvovaginal symptoms.
| Discipline Area | Score |
|---|---|
| Family Medicine (FM)/General Practice (GP) |  |
| General Internal Medicine-Primary Care(US) | |
| Gynecology | |
Could be another option.
This paper aimed to study whether a biological adhesive protein derived from a mussel would be effective therapy for reducing female vulvovaginal atrophy (VVA) related symptoms, ideally seeking to find alternatives to vaginal topical estrogen products. Using mussel-derived adhesive protein hydrogel (MAP), promestriene hydrogel (a topical estrogen not available in the US), and placebo hydrogel all worked similarly to decrease the "most bothersome symptoms (MBS)" after 12 weeks. MAP hydrogel did significantly improve the subjective "female sexual function index (FSFI)" more than placebo. This is not a topic commonly addressed in the medical literature and may be a promising way to treat VVA without using estrogen.
This study is very useful for gynecologists. This is the first RCT evaluating the short-term (12 weeks) efficacy and safety of moisturizer (MAP hydrogel), placebo of moisturizer (placebo hydrogel), and vaginal oestrogen (promestrien) treatment for postmenopausal vulvovaginal atrophy (VVA). For postmenopausal women, reductions in quality of life from moderate-to-severe VVA symptoms are comparable to those caused by other chronic conditions. Genitourinary syndrome of menopause (GSM) affects approximately 45%-77% of postmenopausal women and significantly impairs their health, sexual function, and quality of life. The results from this study pointed out that MAP hydrogel demonstrated efficacy comparable to promestriene and superior to placebo hydrogel, suggesting that MAP hydrogel is a promising non-hormonal treatment in postmenopausal women with VVA. Further investigation in this area should be continued.
