Efficacy and Safety of a Standardized Soy and Hop Extract on Menopausal Symptoms: A 12-Week,Multicenter,Randomized,Double-Blind,Placebo-Controlled Clinical Trial

Abstract

Objectives:

Soy and hop extracts have been investigated as alternatives for hormone replacement therapy. However, their combined efficacy is not known. We investigated the efficacy and safety of a combined soy and hop extract on postmenopausal symptoms.

Design:

Double-blinded, randomized controlled trial.

Settings/Location:

Gynecological outpatient clinic of tertiary hospital.

Subjects:

Seventy-eight women with moderate or severe menopausal symptoms assessed as modified Kupperman Menopoausal Index (KMI) scores >20.

Interventions:

They received either a combined soy and hop extract (n = 38) or placebo (n = 40).

Outcome measures:

Menopausal symptoms were evaluated through self-reporting of modified Kupperman Menopausal Index (KMI) scores at baseline and after 6 and 12 weeks. We assessed serum levels of bone metabolism biomarkers, ultrasonographic parameters, hormone profiles, compliance, and safety.

Results:

After 12 weeks of the treatment, treatment group scores decreased by 20.61 points compared with 14.80 points in the placebo group (p < 0.05). Fatigue, paresthesia, arthralgia, and myalgia, palpitation and vaginal dryness significantly improved more in the treatment group compared with the placebo group after 12 weeks (p < 0.05). Urine N-telopeptide in participants ≥50 years in the treatment group showed a reduced increase. Endometrial thickness and hormonal profiles did not show significant changes in either group. No serious adverse events were reported.

Conclusion:

The results suggest that 190 mg of combined soy and hop extract is safe and effective for improvement of menopausal symptoms.

CRIS No.: KCT0006019.