Woman with questions

Remifemin Quick Facts

Woman with questions

  • Black cohosh (known as cimicifuga racemosa or actaea racemosa) is a perennial plant that is native to North America.
  • The standardized extraction process and quality of black cohosh is what sets Remifemin apart from other black cohosh products.
    • The unique standardized iCR Black Cohosh active extract contained within Remifemin provides a guarantee and consistent potency with every table ensuring the same effectiveness with every dosage.
    • Only Remifemin has the active iCR Black Cohosh
  • Remifemin has a Grade of Recommendation A – which represents a seal of approval which is rarely achieved by herbal medicinal products and offers a profound basis for qualified counseling of climacteric patients.
  • There exists no official recommendation for the use of Cimicifuga racemosa crude drug. In contrast, exactly the 40% isopropanolic extract of Remifemin has been officially approved by the monographs of the WHO (2002), ESCOP (2011) and the HMPC of the European Medicines Agency (2011)
  • Over 50 years of usage by millions of women worldwide

 

How did Remifemin get it’s Grade A Seal of Approval?

Top-line summary of Review accepted for publication in eCAM:

 

** INTRODUCTION (page 2):

  • Effective and safe ways to treat climacteric complaints including vasometer symptoms (hot flashes, sweating) and vaginal dryness –have long been sought, especially as there are documented concerns associated with HRT
  • Different extracts of Cimicifuga racemosa are clinically used for climacteric complaints.
  • The extract production with a proven pharmaceutical quality under GMP conditions is a prerequisite for the Herbal Medicinal Product Committee (HMPC) of the European Medicines Agency (EMA) stipulating a clear therapeutic benefit for three specific extracts.
  • (The rhizome of Cimicifuga racemosa with attached roots is harvested in fall after the fruit has ripened and is used fresh or in dried form….)
  • This review differentiates between registered and standardized medicinal products and not registered/unspecified products.
  • It further differentiates and evaluates the safety and efficacy of phytopharmaceuticals from Cimicifuga racemosa for the treatment of climacteric complaints.

 

All clinical studies on Cimicifuga racemosa in English or German between 2000-2012 were sought via databases – MEDLINE, BIOSIS, EMBASE, EMBASE Alert and PubMed; as well as manual searches in library.

  • Selection criteria (inclusion, exclusion and stratification) for studies outlined on pages 4-5.

 

EFFICACY:

  • From 105 found studies, 19 were included on the clinical efficacy of cimicifuga racemosa in natural climacteric complaints
  • In total, 19 publications from 18 clinical studies have been identified, in which 10,284 patients were treated with Cimicifuga racemosa against natural climacteric complaints. Of these, in 15 clinical studies 10,121 patients (98.5%) were treated with a registered medicinal product, while in 3 studies a total of 163 patients (1.5%) was treated with Cimicifuga-products that had not been registered as medicinal products.
  • Concerning the special isopropanolic Cimicifuga racemosa extract (iCR), 9 original publications resulting from 9 clinical studies were found [18, 19, 20, 21, 22, 23, 24, 25, 26]. Two of these publications investigated the combination of iCR and St. John’s Wort in comparison to the mono-therapy with iCR [25] or placebo, respectively, [26]. Both preparations are medicinal products registered in several countries. In these 9 studies, a total of 9,391 patients were treated with iCR, 6,126 patients with the monotherapy and 3,265 patients with the combination preparation.
  • Thus more than 91% of all patients treated in clinical studies with Cimicifuga racemosa received the iCR-extract.
    • Among these were four randomized, controlled studies (Osmers 2005, Bal 2007, Nappi 2005, Ubelhack 2006) which provide confirmatory evidence of iCR’s efficacy.
    • Also among these were two controlled and three uncontrolled studies (Liske 2002, Vermes 2005, Schmidt 2005, Julia Molla 2009, Briese 2007) with proof of efficacy as primary end point.
    • The consistently positive evidence from high-quality randomized, controlled trials for an Oxford Level of Evidence 1b and the consistent Level-1-Data for a Grade of Recommendation A.

 

 

SAFETY:

  • Three Safety areas were reviewed:
    • General Safety, Liver Safety and safety on estrogen-sensitive organs

 

  • General safety – 28 publications selected from 134 identified
  • Safety on estrogen-sensitive organs – 14 publications selected from 83 found.

Under therapy, no adverse effects are to be expected on “critical” estrogen-sensitive organs such as breast or uterus. Based on the study results therefore, climacteric complaints in patients with breast cancer in their medical history can be treated with extracts of Cimicifuga racemosa. The most recent HPMC-monograph [8] confirms this assumption, provided that the cancer treating physician knows about the Cimicifuga therapy. (See page 25 for summary)

  • Liver safety – 8 selected from 125 found

Also within the context of all the studies, no liver damage was clinically observed as adverse event. Significant evidence is available for the isopropanolic extract in form of a meta-analysis of 5 randomized, controlled studies, in which liver safety parameters were recorded [37]. None of these revealed significant differences nor indications of a negative influence onto liver functions. (see page 26 for summary)

 

  • Concerning the safety of iCR –
  • one meta-analysis (Naser 2011) and 17 clinical trials (18 publications involving 11,054 patients –
  • Randomized/controlled: Jacobsen 2001, Liske 2002, Osmers 2005, Nappi 2005, Bai 2007, Ubelhack 2006;
  • Controlled: Garcia-Perez 2009, Briese 2007
  • Uncontrolled: Pockaj 2004, Schmidt 2005, Vermes 2005, Linden-Hirschberg 2007, Reame 2008, Rostock 2011, Lundstrom 2011
  • Case-controlled studies: Rebbeck 2007, Obi 2009;
  • Cohort study: Henneicke-von Zepelin (2007)
  • Consistent proof of safety by meta-analysis, randomized/controlled, controlled, uncontrolled, cohort and case-control studies qualify for an Oxford Level of Evidence 1a and Grade of Recommendation A.
  • All other Cimicifuga racemosa Herbal Medicinal Products marketed in the EU provide only one (generics) or few (Bionorica) studies with low case numbers and maximum exploratory evidence with an Oxford Level of Evidence 2b.

 

SUMMARY:

  • All clinical studies on Cimicifuga racemosa in English or German language from 2000-2012 demonstrate a good to very good tolerability of Cimicifuga racemosa: in general; at estrogen-sensitive tissues and at the liver.
  • However, among all Cimicifuga products only registered Medicinal Products were able to provide evidence for efficacy. Therefore, among the multitude of Cimicifuga products a positive benefit-risk-profile can only be stated for Herbal Medicinal Products of Cimicifuga racemosa.
  • Among all Herbal Medicinal Products the best evidence by far is provided by the special isopropanolic Cimicifuga racemosa (icR) – ie. by Remifemin.
  • A multitude of studies involving 11,000 patients demonstrated consistently confirmatory evidence of LOE 1b (LOE 1a for safety) leading to a GR A for iCR (Remifemin).

 

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