Reduced menopause symptoms with herbal supplement vs. hormone therapy
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Key takeaways:
- An herbal supplement was associated with reduced global, physical and psychosocial menopause symptom scores vs. estrogen plus progestogen.
- Hormone therapy was associated with reduced vasomotor symptoms.
An oral herbal supplement with glucosinolates, phytosterols and citrus flavonoids was associated with some improved menopausal symptoms short term compared with estrogen plus progestogen therapy, researchers reported in Menopause.
Researchers in Peru manufactured an herbal mixed complex based on glucosinolates, phytosterols and citrus flavonoids to help alleviate menopausal symptoms, Martha Villar-López, MD, from the social health insurance group at EsSalud and the Center for Clinical Research in Complementary Medicine at the National University of San Marcos in Lima, Peru, and colleagues wrote. A previous phase 1 clinical trial found that this oral herbal supplement was safe and tolerable for use by adult women, but no study has assessed its efficacy for menopausal symptoms, the researchers noted.
Villar-López and colleagues conducted a single-blind, three-armed phase 2 randomized clinical pilot trial with 54 postmenopausal women. All women were randomly assigned to an oral herbal supplement 1,500 mg per day containing glucosinolates, phytosterols and citrus flavonoids (n = 18), the supplement 3,000 mg per day (n = 18) or conjugated equine estrogens 0.625 mg per day plus medroxyprogesterone acetate 5 mg per day (n = 18) for 3 months.
The primary outcome was menopausal symptom intensity measured by the Menopause-Specific Quality of Life Questionnaire (MENQOL), which assesses how vasomotor, psychosocial, physical and sexual menopause symptoms impact quality of life with higher scores indicating worse severity. Secondary outcomes included hormonal, lipid and safety profiles of the oral herbal supplement.
At 3 months, researchers observed higher mean global MENQOL scores in the estrogen plus progestogen therapy group, whereas the herbal supplement groups had lower scores (difference, 24.4; P < .001). At 2 months, mean MENQOL global (difference, 13.7; P < .001) and physical (difference, 6.6; P = .002) scores for women in the herbal supplement groups were lower. In addition, the mean MENQOL psychosocial scores at 3 months were lower in the herbal supplement 1,500 mg per day and 3,000 mg per day groups compared with the estrogen plus progestogen therapy group (difference, 3.8; P < .001).
Women in the estrogen plus progestogen therapy group had better vasomotor symptom scores since month 1 compared with the herbal supplement groups (difference, –6.1; P < .001). The hormone therapy group also had higher mean levels of estradiol (difference, 34 pg/mL; P < .001) and lower follicle-stimulating hormone (difference, –34.7 mIU/mL; P < .001) and luteinizing hormone (difference, –24.3 mIU/mL; P < .001) compared with the herbal supplement groups since month 1.
Finally, women in the hormone therapy group had higher mean total cholesterol (difference, –7.9 mg/dL; P = .011), LDL cholesterol (difference, –7 mg/dL; P = .001) and HDL cholesterol (difference, 7.5 mg/dL; P < .001) levels compared with women in the herbal supplement 3,000 mg per day group.
“Although we recognize that estrogen plus progestogen therapy is the standard treatment, our herbal compound may be attractive for women with contraindications to estrogen plus progestogen therapy or those who simply do not want to take estrogen plus progestogen therapy,” the researchers wrote.
Perspective
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These particular herbal products are commonly used in Peru. Although this study is interesting, there are a number of shortcomings that make interpretation of the data difficult.
This study examines the results from 18 women in each of three groups: One group received a low dose of the herbal product; one received a higher dose; and one received medicinal hormone replacement therapy. The hormone group used a combination that is rarely used in the United States these days, namely a dose of 5 mg of medroxyprogesterone acetate with a 0.625 mg dose of conjugated equine estrogens. Most regimes these days use a 0.45 dose of conjugated equine estrogens with a dose of 2.5 mg of medroxyprogesterone acetate — medroxyprogesterone acetate particularly in the 5 mg dosing can have effects on mood.
There is no placebo group in this study. It is well-known that all studies of hormone replacement therapy can have a placebo effect of up to 35% or even 50%. There is no evaluation of endometrial safety; all studies for medications to be approved by the FDA for relief of menopausal symptomatology require a year of follow up for endometrial safety. This study only lasts for 3 months; again, a year of follow up would also be required to see maintenance of relief of menopausal symptoms.
So, although this study is interesting, more investigation would be needed to offer a prescription for this therapy to symptomatic women.
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