STUDY DESIGN

BENEFITS

DOSAGE

REFERENCE

1. Twelve-week, randomized, multicenter, double-blind clinical trial comparing the efficacy and tolerability of Remifemin® in the treatment of climacteric complaints compared with placebo.  The primary efficacy measure was the change from baseline on the Menopause rating Scale 1.

·          Remifemin® effectively relieved menopausal symptoms, particularly in women in the early stages of menopause*

·          Most significant reduction was in hot flash occurrence*

·          Other symptoms resulting in significant reduction include: psyche (irritability and memory), and atrophy (vaginal dryness)*

·          No significant adverse effects reported

40mg qd

Osmers R, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms.  Obstet Gynecol. 2005 May; 105(5):1074-83.

2. A review of 29 randomized controlled trials of complementary and alternative therapies for menopausal symptoms.

·          Black cohosh is one of the only herbal remedies shown to be effective for menopausal symptoms, especially hot flashes*

Kronenberg. F. Fugh-Berman A. Complementary and alternative medicine for menopausal symptoms: a review of randomized, controlled trials. Ann Intern Med. 2002 Nov 19;137(10:805-13.

3. Four-week, pilot study, open clinical trial of menopausal women with hot flashes, including women with a history of breast cancer.

·          Remifemin® reduced mean daily hot flash frequency by 50% after 4 weeks*

·          Overall, participants reported less trouble with sleeping, less fatigue, and fewer night sweats* 

·          No participants stopped therapy because of adverse effects

40mg qd

Pockaj BA, et al. Pilot evaluation of black cohosh for the treatment of hot flashes in women.  Cancer Invest. 2004;22(4):515-21

4. Double-blind study involving the use of Remifemin® in women ages 43 to 60 with menopausal complaints lasting 6 months.

·          Majority of woman saw a 70% reduction of physical and emotional symptoms after 12 weeks, including hot flashes, night sweats, mood swings, and irritability*

·          Significant improvement was noted after 4 weeks use*

·          Remifemin® works safely and effectively to treat menopause symptoms without affecting hormone levels or vaginal cytology (pap smear)*

40mg qd

Liske J, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizome): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med. 2002 Mar; 11(2): 163-74

5. Double-blind, 6 month study in hysterectomized women under 40 with at least one ovary.

·          As effective as estriol, conjugated estrogens, or hormone combinations at decreasing physical menopausal symptoms at 4, 8, 12, and 24 weeks*

4mg dry extract bid (equivalent to 2 tablets Remifemin® bid

Lehmann-Willebrock E, Riedel HH. Clinical and endocrinologic studies of the treatment of ovarian insufficiency manifestations following hysterectomy with intact adnexa. Zentralbl Gynakol. 1988; 110(10):611-8

6. Women aged 45 to 58 with menopausal complaints were studied in a double-blind, 12 week, placebo-controlled trial.

·          Remifemin® decreased physical symptoms of menopause by approximately 60% (Kupperman menopausal indeed)*

·          Daily hot flashes decreased by 86% in the Remifemin® group(from 4.9 to 0.7 per day)*

·          Emotional complaints were also dramatically reduced*

4mg dry extract bid (equivalent to 2 tablets Remifemin® bid

Stoll W. Phytopharmacon influences atrophic vaginal epithelium: Double Blind study – Cimicifuga vs. estrogenic substances. 1987.

STUDY DESIGN

BENEFITS

DOSAGE

REFERENCE

7. in vitro, MCF-7 cell culture model to determine estrogen-agopnist and antagonist activity of commercially available herbal menopause preparations containing red clover, soy black cohosh, or a combination of herbs.

·          Remifemin® had no effect on estrogen-sensitive cells in vitro.

·          Results suggest safety for women with a history of breast cancer who cannot take estrogen.

In Vitro(10^3-10^5 dilutions)

Bodinet C, Freudenstein J. Influence of marketed herbal menopause preparations on MCF-7 cell proliferation.  Menopause. 2004 May-Jun;11(3):281-9.

8. Six-week, in vivo investigation of Remifemin®’s ability to stimulate estrogen-receptor positive cells in an animal model

·          No estrogen stimulating effects were found.

·          Prolactin, follicle-stimulating hormone, and luteinizing hormone levels were unchanged.

0.714m 7.14 or 71.4mg/kg/day

Freudenstein J, et al. Lack of promotion of estrogen-dependent mammary gland tumors in vivo by an isopropanolic Cimicifuga racemosa extract. Cancer Res. 2002 Jun 15;62(12):3448-52.

9. Comprehensive review examining all published literature pertaining to pre-clinical and clinical safety of various forms of Cimicifuga racemosa, as well as FDA and World Health Organization (WHO) adverse event reporting systems, monographs, compendia, internal unpublished data from a major manufacturer, foreign literature, and historical, anecdotal report.

·          Uncontrolled reports, postmarketing surveillance, and human clinical trials of more than 2,800 patients demonstrate a low incidence of adverse events (5.4%).

·          Of the reported adverse events, 97% were minor and did not result in discontinuation of symptoms, and the only severe events were not attributed to Cimicifuga treatemtn.

·          Confirms the safety of specific Cimicifuga extracts, particularly isopropanolic preparations (Remifemin®), for use in women experiencing menopausal symptoms and as a safe alternative for women in whom estrogen therapy is contraindicated *.

Various

Low Dog T, et al. Critical evaluation of the safety of Cimicifuga racemosa in menopause symptom relief. Menopause: Journal of the North American Menopause society. 2003;10(4):299-313.

ORGANIZATION

PUBLICATION

EXCERPT OF KEY CONTENT

American Botanical Council

The ABC Clinical Guide to Herbs including a black cohosh monograph issues September 2002

“Of 10 clinical studies, including a total of 1,371 participants, nine of these studies demonstrated positive effects for menopausal symptoms.  Numerous clinical trials with varied methods and designs have been conducted on the standardized isopropanolic/ethanolic extract of black cohosh root, Remifemin®, from 1981 to the present.”

National Institute of Health

Questions and Answers About Black Cohosh and the Symptoms of Menopause issued October 2002

“Other preparations of black cohosh have been less well studied than Remifemin® …black cohosh is used primarily for hot flashes and other menopausal symptoms.  A number of studies using various designs have been conducted to determine whether black cohosh affects the menopausal symptoms… To provide more definitive evidence on the effects of black cohosh on menopausal symptoms, NCCAM is funding a 12-month, randomized placebo controlled study to determine whether treatment with black cohosh is effective in reducing the frequency and intensity of menopausal hot flashes.”

The North American Menopause Society

Alternatives to Hormone Replacement Therapy: Suggestions for the North American Menopause Siciety issued July 2002

“Reseach suggests that mild hot flashes can be relieved by consuming a serving of soy foods daily or taking a supplement of black cohosh.”