Genitourinary syndrome of menopause: Common problem, effective treatments
ABSTRACT
After menopause, about half of all women experience genital, sexual, and urinary symptoms associated with decreases in estrogen, termed genitourinary syndrome of menopause. First-line therapies are nonhormonal vaginal lubricants and moisturizers. For persistent symptoms, prescription estrogen in cream and ring formulations is effective.
KEY POINTS
- Practitioners can use the patient’s most bothersome symptom and her vaginal pH level to assess clinical responses to therapy.
- The diagnosis is based on clinical signs and symptoms from the medical history and physical examination.
- If the symptoms are not bothersome to the patient, the syndrome does not require treatment.
Selective estrogen-receptor modulator
In 2013, the FDA approved ospemifene for the treatment of dyspareunia caused by GSM. Ospemifene, an estrogen agonist in the vagina, is taken daily as a 60-mg oral dose. Long-term safety studies suggested no adverse effects on the endometrium or breast for at least 52 weeks.32
These studies also noted that ospemifene improved the vaginal maturation index (decreased parabasal cells and increased superficial cells) and decreased vaginal pH. It has further been shown to decrease severity of the self-identified most bothersome symptom—dyspareunia or vaginal dryness—compared with placebo.33
Potential increases in hot flashes, which may occur in up to 7% of patients, and the risk of blood clots should be considered. Additionally, the safety of ospemifene in women with a history of breast cancer has not been established. Although early studies suggest it either has no effect or possibly a protective effect on breast tissue, the FDA does not recommend its use in women at risk for breast cancer. Long-term effects on bone are unknown.
The labeling for ospemifene includes a boxed warning about the risk of stroke, blood clots, and cancer of the lining of the uterus. Patients should be counseled about worrisome signs or symptoms that require medical attention.
ALTERNATIVE THERAPIES
Treatments for GSM not approved by the FDA include laser and radiofrequency therapies, testosterone, isoflavones, and bioidentical hormones.
Laser and radiofrequency therapies
Both of these therapies aim to promote tissue remodeling with increased collagen and elastin production and increased vascularity. This, in turn, increases muscle support and tone.
Laser therapies act by ablating and coagulating vaginal tissues; radiofrequency therapies directly heat the tissue. Both treatments are office-based, require up to 3 initial treatments, and are followed by retreatment at approximately 1-year intervals.
Studies have reported high patient satisfaction rates (91% to 100%), improved sexual functioning, and decreased GSM symptoms of vaginal dryness, burning, itching, and dyspareunia.34–36 Data, however, are from observational studies, not placebo-controlled trials.
Although laser and radiofrequency therapies are FDA-approved for several indications, laser treatment for symptoms of vulvovaginal atrophy is not currently an approved indication. Patients should be advised of this.
Testosterone
Locally applied testosterone was shown in a small study to improve dyspareunia and vaginal dryness associated with aromatase inhibitor use in breast cancer patients.37 However, due to the lack of safety and efficacy data from larger, controlled trials, testosterone therapy is not currently recommended.
Isoflavones
Isoflavones are phytoestrogens found in soy. In a 12-week, double-blind placebo-controlled study of vaginally applied 4% soy isoflavone gel, improvements in vaginal atrophy symptoms, maturation values, and vaginal pH were found in 60 postmenopausal women.38 Additional data on efficacy and safety are needed before isoflavones should be considered as a treatment for GSM.
Bioidentical hormones
Bioidentical hormones are plant-derived hormones that are chemically similar or identical to those produced by the body. Although there are FDA-approved bioidentical hormones (eg, micronized progesterone, estradiol, DHEA), the term bioidentical usually refers to non-FDA-approved, commercially available hormones produced and compounded by specialty pharmacies.
Patients often view these substances as being better, safer, and more acceptable for use, and healthcare practitioners need to be prepared to address these beliefs. The FDA and the American College of Obstetricians and Gynecologists consider bioidentical hormones to be a marketing term and not an alternative treatment based on scientific evidence.39 Patients should be informed that bioidentical hormones have the same risks as any similar hormone preparation along with additional risks related to potential lack of purity and potency. Further, they have not been adequately studied in controlled clinical trials.
FOLLOW-UP CARE
Healthcare providers caring for women should assume a proactive role in diagnosing and treating the symptoms of GSM. And once diagnosis of GSM is established and treatment is under way, practitioners can use symptom questionnaires and vaginal pH testing as easy and reliable means of measuring clinical response to therapy.
