| Date: 08-14-2015 | HC# 071551-526 |
Re: Clinical Trial Finds Hops Beneficial in Treating Early Symptoms of Menopause
Aghamiri V, Mirghafourvand M, Mohammad-Alizadeh-Charandabi S, Nazemiyeh H. The effect of hop (Humulus lupulus L.) on early menopausal symptoms and hot flashes: A randomized placebo-controlled trial. Complement Ther Clin Pract. May 12, 2015; [epub ahead of print]. doi: 10.1016/j.ctcp.2015.05.001.
Hot flashes are the most common symptom of menopause, occurring in approximately 75% of perimenopausal women. Hormone therapy (HT) can be used to treat menopausal symptoms; however, HT is associated with increased risk of stroke, thromboembolic events, and breast cancer. Phytoestrogens are plant constituents with estrogenic activity. Hops (Humulus lupulus, Cannabaceae) are the inflorescence or flowering part of the hops plant; they contain prenylnaringenin, which is one of the most potent phytoestrogens. In 2006, a preliminary placebo-controlled study demonstrated the efficacy of hops in alleviating symptoms of menopause.1 The study concluded that further research was needed. To this end, the present randomized, double-blind, placebo-controlled study evaluated the effect of hops on early symptoms of menopause and hot flashes.
Women (n=120, aged 40-60 years) who were either postmenopausal (defined as ≥ 12 months to 5 years without menstrual bleeding) or premenopausal (defined as < 12 menstrual periods in the prior 12 months) and complaining of hot flashes participated in this study conducted at 20 health centers in Tabriz, Iran. Included women also had a Greene scale score of 15-42, indicating low to moderate symptom severity (the Greene scale measures menopause-related mental, physical, and vasomotor symptoms). Women were excluded if they did not have a cell phone for follow-up; consumed sulfonamides, methotrexate, triamterene, sulfasalazine, estrogen, phenytoin, anxiolytics, antidepressants, daily medicines, multivitamins, HT, herbal therapy to treat vasomotor symptoms during the last month, antithyroid drugs, or "flushing-causing" drugs; had contraindications to HT such as suspected or diagnosed breast or endometrial cancer; had abnormal and undiagnosed genital tract bleeding; had thromboembolic active disorders; had liver or gallbladder active disease; or were lactose intolerant. Women received either placebo or 1 hops tablet/day for 90 days. Each 650-mg hops tablet contained 500 mg of hops, which provided 100 µg of the "active ingredient" (presumably phytoestrogens). The authors do not indicate the brand of the hops tablet or the manufacturer. It is not clear if they made the tablet or obtained it from another source. The primary outcome measure was a change in symptoms of menopause according to the Greene scale and the secondary outcome measure was the change in the number of hot flashes recorded in a daily diary.
Both groups had similar baseline demographics. The mean duration of menopause was 36.5 months. At baseline, there was no significant difference between groups in the mean Greene total score or subgroup scores. Compared with the placebo group at 4, 8, and 12 weeks, the hops group had a significantly lower mean Greene total score, anxiety and depression subscores, physical symptoms subscore, vasomotor symptoms subscore, and loss of interest in sex subscore (P<0.001 for all). In particular, the hops group had a 38%, 69.5%, and 90% decrease in the mean Greene total score at weeks 4, 8, and 12, respectively. In comparison, the placebo group had a 1.2%, 2.6%, and 3.6% decrease in the mean Greene total score at weeks 4, 8, and 12, respectively. The number of hot flashes per week was significantly lower in the hops group (35.5%, 70.5%, and 94.5% decrease) than in the placebo group (1.1%, 0.4%, and 0.8% decrease) at weeks 4, 8, and 12, respectively (P<0.001 for all). No adverse events were reported.
The authors conclude that hops "dramatically reduced" symptoms of menopause. The authors' goal was to provide a minimum tolerable dose of hops, in oral form, with low daily frequency (once a day), that was convenient to use. They met this goal. The authors report that some people are sensitive to hops, and allergic reactions have occurred. Also, cough and bronchial inflammation occur in people constantly exposed to the dust or who work in hops fields. An important study limitation is that the specific hops product evaluated in this study was not reported. It is important for researchers to report product information so that clinical studies can be compared. Also, the purpose of clinical studies is to generate data to support the safety and efficacy of a specific formulation. Without knowing the specific product, physicians and consumers cannot glean information about what product produces the dramatic benefit observed in this study.
—Heather S. Oliff, PhD
Reference
1Heyerick A, Vervarcke S, Depypere H, Bracke M, De Keukeleire D. A first prospective, randomized, double-blind, placebo-controlled study on the use of a standardized hop extract to alleviate menopausal discomforts. Maturitas. 2006;54(2):164-175. 