A double-blind, placebo controlled trial on the effects of a licorice extract on menopausal symptoms

Abstract

A licorice-extract (licogen) exhibits phytoestrogenic activity that may provide an alternative to traditional hormonal therapy. There is a paucity of data on its clinical effectiveness in treating symptoms associated with the menopausal transition. The objective of this study was to assess the effectiveness of a licorice extract (licogen) on menopausal symptomatology. Double-Blind, Placebo Controlled Trial. Symptomatic peri- and menopausal subjects were randomized to twelve months of placebo, licogen 50 mg, or licogen 100 mg. Fasting serum, ultrasound measurement of the endometrial thickness, vaginal pH and urinary assessment of N-telopeptide were obtained at these visits. Subjects completed daily diaries recording the number and severity of hot flushes, the number of nighttime awakenings and vaginal dryness. Generalized estimating equations used to compare differences between the groups. 51 subjects were randomly assigned to placebo (n = 10), licogen 50 mg (n = 21), or licogen 100 mg (n = 20). The mean age 50.8 yrs (SD 4.8 yrs), median FSH 53.0 mIU/ml (IQR, 19.7 - 66.5), median E2 12.8 pg/ml (IQR, 8.5 - 43.5). Endometrial thickness was not statistically different (P=0.90). Vaginal pH, urinary N-telopeptide, and vaginal dryness showed a statistically significant treatment effect, however this was not statistically significantly different from placebo. Both treatment groups showed a statistically significant reduction in moderate hot flushes over time however this was not statistically different from placebo (P=.17). These results indicate that use of licogen as an alternative to hormone therapy may help to improve moderate hot flushes and vaginal dryness and be a safe treatment for the endometrium. Further studies with a larger placebo group are indicated.