Three new studies add further to our understanding of herbal medicines for management of menopausal symptoms.
Researchers at the First Hospital of Peking University, Beijing, recently published the first major trial looking at the effect of Black Cohosh (Cimicifuga racemosa) in Chinese women. They randomized 244 menopausal women aged 40–60 to daily treatment with 40 mg per day of Remifemin, an isopropanolic extract of Black Cohosh, or 2.5 mg Tibolone, a selective tissue estrogenic activity regulator (STEAR). This drug is not available in the US, but is widely used in Europe and Asia as an alternative to hormone replacement for menopause symptoms. Tibolone has estrogenic, progestogenic and androgenic activity.
After 12 weeks, both treatments effected large reductions in total scores on the Kupperman Menopause Index (KMI), measuring hot flashes, profuse sweating, insomnia, nervousness, depressive mood, vertigo, weakness and fatigue, joint pain, headaches and palpitations. Eighty-four percent of the Cohosh group and 85% of the Tibolone patients had significant changes in KMI.
Total KMI declined from a mean baseline of 24.7 (±6.1) to 11.2 (±6.2) after 4 weeks on Cohosh, and it dropped further to 7.7 (±5.8) after 12 weeks. Among the women on Tibolone, the KMI score dropped to 11.2 (±7.2) after 4 weeks, and down to 7.5 (±6.8) after 12 weeks (Bai W, Henneicke-von Zepelin H, Wang S, et al. Maturitas. 2007 Sep 20; 58(1): 31–41).
In terms of safety and side effects, Remifemin was the clear winner. Women taking the herbal product had fewer adverse events. None of the women in this group had vaginal bleeding, while 17 of those in the Tibolone group had abnormal bleeds. Breast and abdominal pain as well as leukorrhea were seen almost exclusively in the Tibolone-treated group. There were no serious adverse events in the Cohosh group, but there were two in the Tibolone group.
This study is particularly important in that it is the first study assessing Black Cohosh in an exclusively Asian population. There are inter-ethnic differences in menopausal symptom patterns; psychological and emotional symptoms seem to be particularly common among Chinese women as they enter menopause. The most common of these are nervousness, depressive mood swings, sleep problems and vertigo. In the current study, these types of symptoms were mild or moderate, at baseline and were significantly reduced at 12 weeks, both in the Cohosh group and in the Tibolone group.
The study is also notable because it is one of the few direct head-to-head comparisons between an herbal therapy and a pharmaceutical for menopause. In this instance, the two therapies were more or less equivalent in ameliorating symptoms, but the herbal therapy produced fewer side effects.
In Clover
Isoflavones from Soy and Red Clover are the other major players among the commonly used botanicals for menopause. Cancellieri and colleagues at the University of Messina, Italy, studied a product containing 72 mg of isoflavones, including 60 mg from Soy and 12 mg from Red Clover, in a cohort of 125 symptomatic postmenopausal women 45–65 years of age.
The patients were randomized to either placebo or the herbal combination, one tablet daily, which also included extracts of Valerian (250 mg), Chaste Tree (30 mg), and Black Cohosh (40 mg), as well as 121 mg vitamin E. As in Bai’s study, the outcomes were assessed in terms of Kupperman Index scores.
After 2 months, there were no differences between the two groups, but by the end of the fourth month, those on the herbal combination had significantly lower KMI scores, and this continued through the sixth month. The patients’ self-assessed symptom severity and the clinicians’ assessments both favored the herbal formula (Cancellieri F, De Leo V, Genazzani A, et al. Maturitas. 2007 Mar 20; 56(3): 249–256).
The investigators also measured lipids at each visit, and found that while there were no differences in terms of total cholesterol and HDL, there was a substantial decrease in LDL and triglycerides in the women on the herbal supplement.
Isoflavones for menopause, whether from Soy or Red Clover, have a mixed track record in past clinical trials; some studies show benefit, others do not. Isoflavone dosing often varies from trial to trial. This is especially true for Soy isoflavones; there are studies of doses as low as 20 mg all the way up to the more typical range of 100 mg/day.
A more promising area of the effects of Soy has been on lipids, with many studies showing a lowering of total cholesterol, LDL and triglycerides and an increase in HDL. In the current study, we only see a decrease in the LDL and triglycerides, most likely due to the Soy and Red Clover, not the other herbal constituents or vitamin E.
Interpretation of this new Italian study is difficult because the formula used contains many ingredients. It is impossible to assess which of the many constituents are responsible for the decrease in symptoms. Based on other research, like Bai’s study, one would have to guess that the Black Cohosh was the prime mover. If we just saw a decrease in hot flashes, one might conclude that it was the Soy or Red Clover. If it was just a reduction in insomnia, one might more likely suspect the Valerian.
We are at a disadvantage in more accurately interpreting the study because the authors did not publish the changes in each individual symptom included under the broad Kupperman Index. Overall, this specific isoflavone/herbal extract combination showed significant positive effect on the whole spectrum of menopausal symptoms, with some effect on lipids. But it is hard to glean much more than that from these data.
Pine Bark Takes a Bite Out of Perimenopause
Pycnogenol, a compound derived from the bark of French Maritime Pine trees that has many therapeutic properties, may have a role in reducing perimenopausal symptoms.
Pycnogenol is a powerful antioxidant, with strong antinflammatory and vasodilatory effects. It has been very well researched and proven effective in the management of deep vein thrombosis, hypertension, myocardial infarction, and also in improving glucose metabolism among diabetics, increasing skin elasticity, and reducing symptoms of osteoarthritis.
Taiwanese researchers studied a cohort of 230 perimenopausal women, aged 45–55, who were given either placebo (n = 75) or 100 mg of Pycnogenol (n = 155) twice daily for 6 months. The investigators used the 36-item Women’s Health Questionnaire to evaluate the climacteric symptoms at baseline, and at 1, 3 and 6 months after beginning treatment.
Perimenopausal symptoms of depression, vasomotor symptoms, memory, anxiety, sexual function, and sleep all improved significantly (P < 0.001) with Pycnogenol as soon as one month after starting the treatment. Severity and frequency of symptoms were markedly reduced. Most symptoms also improved with placebo, but not significantly.
Both groups showed decreases in blood pressure, but the women taking Pycnogenol showed increases in HDL with a concomitant lowering of LDL. Though the HDL difference between the Pycnogenol and placebo groups was not statistically significant, the LDL change—a difference of about 10%—was significant (Yang H-M, et al. Acta Obstetricia et Gynecologica. 2007; 86: 978–985).
I was surprised to see this study, as I have never thought to use Pycnogenol in the treatment of perimenopause/menopause symptoms. The most common symptoms of perimenopause/menopause that I see in my practice are hot flashes, sweating, heart palpitations, fatigue, depression, decreased sexual function, insomnia and cognitive impairment.
It’s imperative to have as many non-hormonal natural medicine options as possible. I’m pleased to be able to add Pycnogenol to my list of choices and will look forward to hopefully positive results.
