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THE EVIDENCE FROM THE MEDICAL LITERATURE RELATED TO THE INGREDIENTS IN VIVACA®

Evidence from the medical literature related to the ingredients in VIVACA®. The following statements include suggestions and concerns raised by the scientific community related to studies that have been conducted in the past. How From The Earth Naturally Ltd (FTEN) has responded to these concerns is written in italics.

  • Although estrogen has been used for nearly 60 years to treat menopausal symptoms, concerns about the adverse effects of estrogen have led to increased interest in alternative therapies. Women with breast cancer in particular, cannot take estrogen and are looking for alternatives. (1)
  • Even for women who do chose some form of hormone replacement therapy, there is a growing body of scientific literature that suggests that incorporation of some form of alternative therapy could result in improved clinical outcomes (2,3)
  • The idea that therapies targeting non-estrogen components of the vasomotor response could influence symptoms is reasonable, however evidence of their efficacy and adverse effects is generally lacking or unclear.
  • Differences in findings across studies of the same botanical may be a function of less than optimal design, variation in product used, duration of treatment, inadequate dosing, and/or small or no comparable population samples.
  • When comparing products that differ in extraction technique, delivery system, ratio of ingredients and dose, the question of equivalency must be considered. (4)

With these considerations in mind, the formulation of VIVACA® has been extensively researched and tested using methods that would be considered to be comparable to other relevant and current clinical studies, using extraction procedures, delivery systems and doses of bioactive ingredients that are generally considered to be safe and effective.

  • The conclusions of many of the studies also fail to recognize that quality control issues such as growing conditions and processing (so called “seed to shelf”) Differences can make it difficult to compare results.

VIVACA® producers have first-hand knowledge of the botanical ingredients. Direct relationships with the growers allows information about the parts of the plants used, as well as the growing and harvest conditions to ensure that the active components are of best quality and highest levels. Processing details such as drying methods and precise extraction equipment to capture the plant essence are controlled and maintained for precise replication of results.

  • Development of analytical methods for identifying and verifying the quantity of active ingredients or marker compounds in botanical products must be a priority.

VIVACA® producers have employed the most modern and efficient methods of identifying and verifying the active ingredients and marker compounds used for quantifying doses. Quality control of ingredients will be monitored and maintained allowing replication and critical analysis of the scientific and clinical value of the product.

  • Of the botanicals previously studied for menopausal symptoms, Black Cohosh appears to be the most effective herb for relief of vasomotor symptoms. (5)
  • In addition to providing relief from depressive and anxiety symptoms of menopause, phytoestrogens which are substances included in the Red Clover extract have been shown to have a positive effect on plasma lipid concentrations and may reduce heart disease. (6,7)
  • In addition to being effective for climacteric symptoms when combined with Black Cohosh, St John’s Wort has been shown to improve mild to moderate depressive symptoms and appears to show efficacy for mood disorders related to menopausal transition. (8)
  • Rhodiola contains salidroside, which is thought to be responsible for increased capacity for mental work against a background of fatigue and stress. (9)

The development of the formulation of VIVACA® involved many levels of expertise, both in the scientific and nutritional regulatory community. Extensive experience in naturopathic medicine has determined that the combination of the four extracts leads to be the best treatment of symptoms. Current scientific data from well-designed randomized double-blind clinical trials have also shown evidence to support the combination of these extracts for synergistic effects. The doses of the extracts have been developed to adhere to strict regulatory requirements for effectiveness and safety.

References
  1. Geller, S.E. Sturdee, L. Botanical and Dietary Supplements for Menopausal Symptoms: What works, what doesn’t. J Women’s Health. 2005 Sept: 14(7): 634-649
  2. Gardner, C. Ease through menopause with homeopathic and herbal medicine. J Perianesth Nurs 1999 ; 14 : 139-143
  3. Gorden, JS. Manifesto for the new medicine; your guide to healing partnerships and he wise use of alternative therapies. Reading MA: Addison Wesley; 1996
  4. Low Dog, T. Menopause: a review of botanical dietary supplements. The American Journal of Medicine 2005 vol. 118 (12B): 985-1085
  5. Shams, T et al. Efficacy of black cohosh containing preparations on menopausal symptoms: a meta-analysis. Alternative Ther Health Med. 2010 Jan-Feb;16(1)L 36-44
  6. Lipovac, M. Et al. Improvement of postmenopausal depressive and anxiety symptoms after treatment with isoflavones derived from red clover extracts. Maturitas 2010 Mar;65(3):258-61
  7. Tice, J. Et al. Phytoestrogen Supplements for the treatment of hot flashes : the Isoflavone clover extract ( ICE) study. A Randomized controlled trial. JAMA, July 9 2003
    Vol 290, no.2: 201-214.
  8. Ubelhach, R. Et al. Black cohosh and St. Johns Wort for climacteric complaints: A randomized trial. Obstet Gynecol. 2006 Feb; 107 (2 pt 1) : 247-55
  9. Darbinyan V., et al. Rhodioloa rosea in stress induced fatigue – a double blind cross over study of a standardized extract . Phytomedicine 2000 Oct. 7(5): 365-371.