VAG Forte™ - Clinical Trials
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||I Clinical Trials
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60 tablets/30 days
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VAG Forte™ - Clinical Trials:
In 8 clinical trials the effect of black cohosh on reduction of menopause symptoms was analyzed in 2000 women. The clinical trials have demonstrated the effect similar to estrogen replacement therapy for treatment of neurovegetative menopause symptoms.
A number of clinical studies have been conducted on black cohosh extract, which is standardized to 1 mg triterpene glycosides per tablet. Overall, the studies show a clear reduction in menopausal symptoms (hot flashes, night sweats, headaches) and psychological parameters (depression, sleep disturbances, irritability) following 4-8 weeks of treatment. In some cases, subjects have been able to discontinue hormone replacement therapy while taking the black cohosh extract. (3)
A new study provides preliminary evidence that black cohosh used to help women cope with menopausal symptoms may reduce breast cancer risk.
However, much more research is needed before black cohosh can be recommended to prevent the disease, Dr. Timothy R. Rebbeck of the University of Pennsylvania School of Medicine in Philadelphia and colleagues caution. To examine how the use of these herbs might relate to breast cancer risk, the researchers compared 949 women with breast cancer to 1,524 healthy controls. Women who reported taking black cohosh were at 61 percent lower risk of breast cancer, the researchers found. Previous studies have shown that black cohosh can block cell growth, Rebbeck and colleagues note. The herb is also an antioxidant, and has been shown to have anti-estrogen effects as well. (4)
A randomized, double-blind, placebo-controlled trial in 80 menopausal women compared 8 mg/day of a black cohosh extract with placebo or conjugated estrogens (0.625 mg/day). At 12 weeks, scores on the Kupperman index and the Hamilton anxiety scale were significantly lower in the treated groups than in the placebo group; the scores of participants using black cohosh were somewhat better than the scores of those receiving the estrogen treatment. This is one of the few studies in which hot flashes were scored separately from other symptoms. Daily hot flashes decreased from 4.9 to 0.7 in the black cohosh group, 5.2 to 3.2 in the estrogen group, and 5.1 to 3.1 in the placebo group. (5)
Another clinical trial was studying the effect of black cohosh on bone and fat tissues. Therefore, osteoprotective effects of the black cohosh extract and an influence on fat tissue were studied in ovariectomized rats. Bone mineral density (BMD) of the tibia of ovariectomized rats was determined by computer-assisted tomography (CT). CT scans of fat depots were perimetrically quantified. Bone turnover and lipocyte activity were also determined. Treatment of the ovariectomized rats over a period of 3 months with the black cohosh extract showed osteoprotective effects; both significantly reduced the loss of BMD in tibia. CONCLUSION: The black cohosh extract exerted estrogenic effects in the bone (particularly in osteoblasts) and in fat tissue, but not in the uterus of ovariectomized rats. The extract appears to contain rat organ-specific selective estrogen receptor modulators (SERMs), and if these findings can be approved in human it may be an alternative to HRT. (6)
The anti-osteoporotic effect has yet to be discussed in the literature in terms of estrogen receptor-binding activity of black cohosh, although mention was made of a positive influence on osteoporotic states (Murray, 1997).
Li et al. (1996/97) reported a significant (approximately 10%) increase in spinal bone mineral density in ovariectomized rats fed a low calcium diet following administration of ethyl acetate-soluble fractions of Cimicifuga racemosa. The fractions prevented osteoporosis-like bone loss.
A steroidal triterpene derivative called actein, was found to lower blood pressure in rabbits and cats but not in dogs (Newall et al., 1996; Duke, 1985). It produced no hypotensive effects in either normal or hypertensive human beings, although some peripheral vasodilation was observed.