Soho Flordis International

Black cohosh (Actaea racemosa)

Proven relief from menopause symptoms

Ze 450 is a clinically proven extract of Actaea racemosa, that has been shown to significantly relieve a range of menopause symptoms 1-3

Actaea racemosa has been used for the relief of menopause symptoms for many years, providing an evidence-based option derived from nature for women going through this natural lifestage.

 

In the Femular range, a specific extract of Actaea racemosa (Black cohosh) is used, called Ze 450. Over the past decade, Femular has been extensively researched to provide relief of menopause symptoms and to ease the discomfort you may experience throughout menopause.

 

Discover more about the specific Ze 450 extract used in Femular and the key studies that support its benefits.

Actaea racemosa in history

Actaea racemosa, or Cimicifuga racemosa or Black cohosh as it is also called, is a perennial herb, native to North America. 1  

Traditionally, Actaea racemosa was used for the treatment of various concerns in  women’s reproductive and gynaecological health, and also the urinary and musculoskeletal systems.  

In the 1950s, it gained popularity among European women as a herbal medicine for menopausal complaints. 2-3

 

Today, there are different preparations and forms of Actaea racemosa widely used by women all around the world who are looking for a way to address hot flushes and other symptoms of menopause.

Actaea racemosa in history

The specific Ze 450 extract used in Femular

Ze 450 is the specific extract of Actaea racemosa used in the Femular range. The exclusive extract is manufactured according to strictly controlled production methods with careful consideration at every stage of growing, cultivation, extraction and production. This helps to ensure that each batch of Femular is consistent with the next and with the natural medicine tested in clinical research for menopausal symptom relief.  

The beneficial effect of Ze 450 is based on a number of clinical trials and studies in women throughout all stages of menopause. Results from these studies prove that Femular products can relieve menopausal symptoms including:1-3

 

  • Hot flushes
  • Night sweats
  • Sleep disturbances
  • Nervous tension
  • Irritability
  • Headache
  • Temporary feelings of sadness
  • Fatigue
  • Joint pain

Femular (1 tablet dose) is suitable for mild to moderate symptoms of menopause while Femular (2 tablet dose) is more suitable for those who have moderate to severe menopausal symptoms.

 

Always read the label. Use only as directed. If symptoms persist consult your healthcare professional. In very rare cases, Black cohosh has been associated with liver failure*.If you experience yellowing of the skin or whites of the eyes, dark urine, nausea, vomiting, unusual tiredness, weakness, stomach or abdominal pain, and/or loss of appetite, you should stop using Femular and see your doctor.

 

Each Femular tablet contains:

Extract equivalent to dry Actaea racemosa

42.25 mg = Ze 450 extract 6.5 mg

The specific Ze 450 extract used in Femular

How ZE 450 works

It is not fully understood how the Ze 450 extract of Actaea racemosa works, however evidence suggests that it may have effects on neurotransmitter receptors in the brain.

Several studies suggest that it may act on serotonin and opioid receptors which play a role in central nervous system processes that help govern body temperature(thermoregulation), and also feelings of stress, nervousness and mild anxiety. 3-5

 

The activity of Actaea racemosa in relation to oestrogen has also been investigated and the evidence suggests the Ze 450 extract in Femular is likely to be non-oestrogenic.4,6

 

The research in this area suggests that Actaea racemosa may work instead as a selective oestrogen receptor modulator (SERM) helping to modulate and mimic oestrogen and is not likely to have a direct oestrogenic effect. 4,6   

 

 

How ZE 450 works

Clinical studies on Ze 450 in Femular

Over 1000 women participated in clinical trials and studies, which demonstrated the beneficial effects of Ze 450 used exclusively in the Femular range. The research showed menopause symptom improvement as early as 1 month with increasing relief shown over 3 and 9 months. 8-10

Lopatka et al. 2007 8

541 women with menopausal complaints over 4 months*

Significant improvement

vs. baseline (symptoms prior to study) for:

  • Symptoms after 4 months including:
    Hot flushes and sweating,
    disturbed sleep,
    Irritability,
    fatigue,
    mlld anxiety,
    joint pain
    Symptoms showed trends of improvement as early as 1 month
    All complaints showed a steady improvement over the course of treatment
    76% of patients judged efficacy to be 'good' or 'very good'

*6.5 mg of Ze 450 (low dose, 1 tablet of Femular).  *6.5 mg of Ze 450 (low dose, 1 tablet of Femular).  

Schellenberg et al. 2012 2

180 women with menopausal complaints 12 weeks*

Significant improvement

vs. placebo for:

  • Menopausal symptoms at 3 months
    The greatest improvement was the reduction of hot flushes, sweating symptoms with high dose
    Self assessed quality of life
    A dose dependent effect of symptom relief was demonstrated
    A low dose* for mild symptoms and a high dose* for moderate to severe symptoms.
    For patients with severe symptoms, only the high dose provided relief.

*Placebo, 6.5 mg of Ze 450 (low dose, 1 tablet of Femular) or 13 mg of Ze 450 (high dose, 2 tablets of Femular)

Drewe et al. 2013 3

442 women with menopausal complaints over 9 months*

Significant improvement

vs. baseline (symptoms prior to study) for:

  • Relief of menopausal symptoms at 3 months, with high dose* including:
    Hot flushes, Sweating, Disturbed sleep, Nervous tesnsion, Temporary feelings of sadness, Joint & muscular pain, Headache
    Treatment with high dose* further improved symptoms beyond 3 months with significant relief seen at 9 months.
    Ze 450 was very well tolerated

*13 mg Ze 450 (high dose, 2 tablets of Femular or 1 tablet of Femular Forte) per day for 3 months, followed by a further 6 months treatment with either 13 mg Ze 450 (high dose)    or 6.5 mg Ze 450  per day (low dose, 1 tablet of Femular).

Flordis Difference

Femular with Ze 450 vs. Actaea racemosa  

 

There may be several products on the market labelled as containing a particular ingredient – such as Actaea racemosa. So what makes Femular with the specific Ze 450 extract of Actaea racemosa different?

 

Natural healthcare products containing Actaea racemosa can vary considerably depending on how they are produced. The specific Ze 450 extract used in the Femular range is produced using meticulous processes with careful consideration and control at every stage of growing, cultivation and production.

 

That means, you can be confident that the Femular product you are getting contains the same ingredient, processed in the precise way required that has demonstrated menopause symptom relief in clinical research. That’s the Flordis difference.

Femular with Ze 450: A Summary

Consistent quality

Rigorous processes, quality controls and extensive testing ensures that Femular with Ze 450 extract is the same as the medicine  tested in clinical trials to demonstrate menopause symptom relief.

Clinically Proven

Clinical research shows an improvement in symptoms after 1 month, with significant symptom relief at 3 months and at 9 months 8-10

Multiple menopause symptom relief

Including hot flushes, sweating, disturbed sleep, nervous tension & irritability 8-10

Well tolerated

Well-established tolerability based on worldwide surveillance reports. 

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Our source to patient philosophy

We make sure our natural medicines are consistent.

Not only do the clinical studies on our products demonstrate real health outcomes, they demonstrate the results you can expect from the same products you see on shelf. It’s all part of our Source to Patient philosophy.

See the steps taken to make our products
References
  1. Braun & Cohen, Herbs & Natural Supplements, 2005. Page 86
  2. Foster S. Black cohosh: Cimicifuga racemosa. A literature review. HerbalGram 1999;45:35–50
  3. Rhyu M-R et al. Agric Food Chem. 2006; 54(26):9852-9857
  4. Burdette JE, et al. J AgricFood Chem. 2003; 51: 5661-5670
  5. Naumenko et al., Neuropharmacology. 2011; 61 (8): 1360-136
  6. Garita-Hernandez, M. et al. PlantaMed. 2006; 72: 317-323
  7. Fritz et al., Integrated Cancer Therapies (2013); XX(X) 1-18
  8. Lopatka et al. Journal of Menopause. 2007; 2:16-21
  9. Schellenberg R, et al. Evidence-Based Complementary and Alternative Medicine. 2012:1-1
  10. Drewe et al. Phytomedicine 2013; 20:659-666
  11. Periodic Safety Update for Ze 450, 08/2018. Max Zeller Söhne AG.

 

#6.5 mg of Ze 450 (low dose, 1 tablet of Femular).  

^Placebo, 6.5 mg of Ze 450 (low dose, 1 tablet of Femular) or 13 mg of Ze 450 (high dose, 2 tablets of Femular) 

**13 mg Ze 450 (high dose, 2 tablets of Femular) per day for 3 months, followed by a further 6 months treatment with either 13 mg Ze 450 (high dose)    or 6.5 mg Ze 450  per day (low dose, 1 tablet of Femular).