Remifemin Clinical Studies

Remifemin contains an exclusive standardized black cohosh extract which has been the subject of over 90 scientific papers including those based around efficacy, safety and the Restful Sleep Blend found in Remifemin GoodNight. It has been proven effective & is the most clinically studied natural intervention for menopause symptoms with over 50 years of use worldwide.

Remifemin and Symptom ReductionRemifemin vs. HRTRemifemin Goodnight and Sleep Improvement


  Study Design Benefits Dosage Reference
1. Randomized, double-blind, controlled 3-month study which enrolled 244 menopausal patients, aged 40-60 years. The primary endpoint was the Kupperman Menopause Index (KMI) and the frequency of adverse events at the end of treatment.
  • As effective as other HRT for menopausal symptoms
  • Confirms the safety of specific Cimicifuga extracts, particularly Remifemin®, for use in women with peri- and post-menopausal climacteric symptoms
40 mg qd Bai W, Henneicke-von Zepelin HH, Wang S, Zheng S, Liu J, Zhang Z, Geng L, Hu L, Jiao C, Liske E. Efficacy and tolerability of a medicinal product containing an isopropanolic black cohosh extract in Chinese women with menopausal symptoms: a randomized, double blind, parallel-controlled study versus tibolone. Maturitas. 2007 20;58:31-41.
2. A 12 week study in which subjective symptoms were evaluated in 2016 women with menopausal complaints. The primary efficacy measure was the change from baseline on the Kupperman index.
  • Remifemin demonstrated greatest efficacy in decreasing intensity of hot flashes
  • Other symptoms resulting in significant reduction include: night sweats, occasional sleeplessness, anxiety
  • Kupperman index scores decreased over duration of study, however, experienced greatest decrease during the first 4 weeks
40 mg qd Vermes G, Banhidy F, Acs N. The effects of remifemin on subjective symptoms of menopause. Adv Ther. 2005;22:148-54.
3. 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 I.
  • 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)
40 mg qd Osmers R, et al. Efficacy and safety of isopropanolic black cohosh extract for climacteric symptoms. Obstet Gynecol. 2005 May;105(5):1074-83.
4. 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
40 mg qd 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.
5. 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
40 mg 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.
6. Double-blind study involving the use of Remifemin® in women aged 43 to 60 with menopausal complaints lasting 6 months.
  • Majority of women saw up to a 70% reduction of hot flashes and effective relief for night sweats, irritability, mood swings and occasional sleeplessness and anxiety.†
  • Significant improvement was noted after 4 weeks use
  • Does not affect hormone levels or vaginal cytology (pap smear)
40 mg qd Liske J, et al. Physiological investigation of a unique extract of black cohosh (Cimicifugae racemosae rhizoma): a 6-month clinical study demonstrates no systemic estrogenic effect. J Womens Health Gend Based Med. 2002 Mar;11(2):163-74.
7. 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
4 mg dry extract bid (equivalent to 2 tablets Remifemin® bid) Lehmann-Willebrook E, Riedel HH. Clinical and endocrinologic studies of the treatment of ovarian insuffuciency manifestations following hysterectomy with intact adnexa. Zentralbl Gynakol 1988;110(10):611-8
8. Women aged 46 to 58 with menopausal complaints were studied in a double-blind, 12-week, placebo-controlled trial.
  • Remifemin® decreased the physical symptoms of menopause by approximately 60% (Kupperman Menopausal Index)
  • Daily hot flashes decreased by 86% (from 4.9 to 0.7 per day)
  • Emotional complaints were also dramatically reduced
4 mg dry extract bid (equivalent to 2 tablets Remifemin® bid) Stoll W. Phytopharmacon influences atrophic vaginal epithelium: Double blind study – cimicifuga vs. estrogenic substances. 1987.

9. Randomized, multi-center, double-blind and placebo controlled clinical trial.
  • Demonstrated that there is little supportive evidence for a significant hepatotoxic risk due to black cohosh use
  Naser B. Placebo-controlled trial shows no effects of an isopropanolic black cohosh extract on liver function. Presented at the American College of Obstetricians and Gynecologists Annual Clinical Meeting. Chicago, IL. 2009.
10. Prospective, open, uncontrolled drug safety study in which baseline status was compared with status after 6 months of treatment.
  • Study demonstrates that isopropranolic extract of black cohosh does not cause adverse effects on breast tissue
  • Data did not indicate any endometrial or general safety concerns during 6 months of treatment
40 mg daily Hirschberg AL, Edlund M, Svane G, Azavedo E, Skoog L, von Schoultz B. An isopropanolic extract of black cohosh does not increase mammographic breast density or breast cell proliferation in postmenopausal women. Menopause. 2007;14(1):89-96.
11. In vitro, MCF-7 cell culture model to determine estrogenagonist 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.
12. 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
0.714, 7.14, or 71.4 mg/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
13. 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 treatment.
  • Confirms the safety of specific Cimicifuga extracts, particularly 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.

14. Four-week multi-center observational cohort study involving 518 individuals with difficulties falling asleep or staying asleep (Average age: 51 years, 73% women)
  • At 2 weeks, 69% of participants experienced improvement in sleep quality
  • Supplementation reduced symptoms by an average of 88% after 4 weeks, including falling asleep, staying asleep and quality of sleep.
  • 27% of participants were symptom-free after 4 weeks
One-two tablets, bid-tid.
Each tablet contains:
75 mg V
23 mg H
45 mg LB
Friede M, et al. Herbal agents for the treatment of insomnia. Neurol Psych. 1997;11:697-700.
15. Eight-week, multi-center, non-interventional observational cohort trial with 830 individuals experiencing difficulties falling asleep or staying asleep (Average age: 53 years, 72% women)
  • After 4 weeks, symptoms of fatigue and occasional restlessness improved by more than 80%
One-two tablets, tid
Each tablet contains:
75 mg V
23 mg H
45 mg LB
Volk S, et al. Phytosedative for the treatment of nervous restlessness and insomnia. Zeitschrift für Phytotherapie. 1999;20(6):337-344.
16. Randomized, double-blind, placebo-controlled, crossover trial involving 19 healthy volunteers, ages 35-60 years
  • No influence on well-being or tolerability
  • No increase in adverse effects over placebo
Two tablets tid
Each tablet contains:
75 mg V
23 mg H
45 mg LB
Friede M. Everyday safety of a phytosedative from valerian roots, hops, and balm leaves. Nerveheilkunde. 1999;18:91-95.
17. German Commission E monograph, Fixed Combinations of Valerian Root, Hops, and Lemon Balm
  • Aids individuals who experience difficulty in falling asleep and staying asleep
  • No known contraindications, side effects, or interactions with other drugs
75 mg V
23 mg H
45 mg LB
Blumenthal M, ed. Fixed combinations of valerian root, hops, and lemon balm. In: The Complete German Commission E Monographs. Austin, Tex: American Botanical Council; Integrative Medicine Communications; 1998:304.

 
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