| Date: 03-13-2015 | HC# 101453-516 |
Re: Black Cohosh Reduces Severity of Vasomotor Symptoms and Hot Flash Frequency in Postmenopausal Women
Shahnazi
M, Nahaee J, Mohammad-Alizadeh-Charandabi S, Bayatipayan S. Effect of black cohosh
(Cimicifuga racemosa) on vasomotor symptoms in postmenopausal women: a randomized clinical trial. J Caring Sci. 2013;2(2):105-113.
The
onset of menopause is signaled by a decline in estrogen. Hormone therapy (HT)
is often used to treat menopausal symptoms. However, HT can increase the risk
of stroke, breast cancer, and cardiac disease. While black cohosh (Actaea racemosa, Ranunculaceae syn. Cimicifuga racemosa) is often used as an
alternative treatment for menopausal symptoms, the scientific evidence that
black cohosh significantly reduces hot flashes and vasomotor symptoms is
inconclusive. The purpose of this randomized, double-blind, placebo-controlled,
multi-center clinical trial was to evaluate the effect of black cohosh on the
severity of vasomotor symptoms and number of hot flashes in menopausal women.
Women
(n = 84, aged 45-60 years) with menopausal vasomotor symptoms were recruited at
4 health-care centers affiliated with the Shahid Beheshti University of Medical
Sciences; Tehran, Iran. Included patients met the following criteria: no
menstruation for ≥ 12 months; normal blood pressure (60/100 to 90/140); score
of ≥ 2 on the vasomotor symptom severity subscale; no history or existence of
breast cancer, cervical cancer, abnormal vaginal bleeding, hepatic disease,
depression, or hyperthyroidism; no use of hormones or herbs to treat menopausal
symptoms; no use of psychiatric medications during the previous 2 months or
during the study; no sensitivity to spices, seasonings, or oil-bearing
substances; no smoking or alcohol consumption; and literate.
Patients
received placebo or 6.5 mg/day black cohosh (CimifugolTM; Goldaru
Pharmaceutical Co; Shiraz, Iran) rhizome extract for 8 weeks. Each 6.5-mg coated
tablet contained 0.12-0.18 mg of 27-deoxyactein. [Note: No other product
information was provided. The authors state that this product is what is
available in Iran but did not specify this under materials or methods. Also,
there was no verification of the ingredients.] At baseline, 4 weeks, and 8
weeks, patients completed the Vasomotor Symptoms Severity Form (as defined by
the United States Food and Drug Administration) and the Greene Climacteric
Vasomotor Subscale tool, which includes hot flash and night sweat severity
scores. Also, before starting the study, the patients recorded daily hot
flashes for 1 week.
At
baseline, there were no significant differences between the groups. The
severity of vasomotor symptoms was significantly reduced for the black cohosh
group at 4 weeks (P = 0.002) and 8 weeks (P < 0.001) compared with placebo.
The mean number of hot flashes was significantly reduced for the black cohosh
group at 4 weeks (P < 0.001) and 8 weeks (P < 0.001) compared with
placebo. In the black cohosh group, hot flashes were reduced from a mean of
5.90/week at baseline to 1.07/week at 8 weeks. In contrast, in the placebo
group, hot flashes were reduced from a mean of 5.11/week at baseline to 3.92/week
at 8 weeks. No adverse effects were reported.
The
authors conclude that the black cohosh used in this study decreased vasomotor
symptom severity and the number of hot flashes compared with placebo. They
acknowledge that these findings corroborate with some reports, but not with
others. The authors hypothesize that other studies which did not show a
positive effect of black cohosh (1) used a different type of black cohosh
extract, (2) used a different dosage, (3) did not evaluate black cohosh for
long enough, or (4) evaluated a different population (race and body mass
index). Limitations of the study are that due to a shortage of research
funding, the patients were only followed for 8 weeks, and hormone levels were
not monitored.
Considering
the conflicting results reported in other trials, this promising study should
be reproduced using a better defined (chemically profiled) extract and a larger
study population.
—Heather S. Oliff,
PhD
