Natural Woman Clinical Monograph

Natural Woman Soy-Free Hormone Support
Natural Support for Menopausal Symptoms

Description:

Natural Woman Soy-Free Hormone Balance

Natural Woman offers advanced nutraceutical support for women in their peri- and post menopausal years. Unlike similar products that only provide high concentrations of phytoestrogens to help modulate hormone levels, Natural Woman also addresses problems with increased vascular sensitivity that can exacerbate vasomotor symptoms during menopause.

Natural Woman combines potent concentrates of black cohosh (Cimicifuga racemosa) and sage (Salvia officinalis) along with effective levels of hesperidin (as hesperidin methylchalcone), gamma-oryzanol, and the natural plant lignan, 7-hydroxymatairesinol (HMRlignan™).

These ingredients have been shown in preclinical and clinical studies to stabilize fluctuating hormone levels, improve vascular resistance, sustain lipid and bone metabolism, and significantly modulate hot flashes and other common menopausal complaints.

Natural Woman is an all-natural, vegetarian formulation that is free of soy phytoestrogens and can be used by women from their perimenopausal to their postmenopausal years.

Overview:

Menopause marks the time in a woman’s life when she transitions from her reproductive to non-reproductive years. This milestone may occur anytime between the ages of 40 and 61 with a median of 51.3 years and is confirmed when menstrual periods are absent for 12 consecutive months.

The time period leading up to menopause when physiological changes and accompanying symptoms may begin to occur is referred to as “perimenopause”, literally “around menopause.”

Perimenopause and menopause involve a natural reduction in ovarian activity ultimately leading to a permanent cessation of menstruation. Menopause can also be artificially induced by surgical removal of the ovaries or other conditions that cause a loss of ovarian function.

The primary biological changes that occur during menopause include declining numbers of ovarian oocytes and associated follicles, reduced production of ovarian steroid hormones such as estrogen, progesterone, and testosterone, and increased (or fluctuating) levels of follicle stimulating hormone (FSH) and luteinizing hormone (LH).

These changes typically produce a variety of symptoms including hot flashes, night sweats, mood alterations, menstrual irregularities, fatigue, atrophy of vaginal tissues, reduced libido, sleep disturbances, and changes in memory and cognitive function.

Declining ovarian hormone levels also increase the risk of a number of serious diseases including osteoporosis and cardiovascular disease.

While menopause is a natural process, the symptoms can be unpleasant, even debilitating. Over 70% of menopausal women report vasomotor symptoms such as flushing and night sweats, and 40-60% experience some form of sleep disturbance.

For many years, the conventional medical approach to managing climacteric symptoms was hormone replacement therapy (HRT). HRT is effective not only for alleviating menopausal discomforts, but for preventing postmenopausal bone loss.

In 2002, however, the large-scale, multicenter Women’s Health Initiative study revealed that significant health risks may be associated with use of synthetic estrogens derived from mares and/or synthetic progestin therapy.

The disturbing findings of the WHI ushered in a new era of interest in safer, non-hormonal approaches to health issues associated with menopause.  Since that time, a significant body of evidence has emerged supporting the use of certain natural agents in the treatment of menopausal symptoms.

Scientific studies indicate herbs such as black cohosh and sage and the nutrients hesperidin, gamma-oryzanol, and plant lignans exert a variety of physiological effects in women that promote hormonal, thermoregulatory, vascular, and neurochemical stability. These natural ingredients have been shown to not only effectively moderate hot flashes and other common climacteric complaints, but to beneficially modify risk factors associated with heart disease and osteoporosis.

Black Cohosh (Cimicifuga racemosa) 
Black cohosh is an herb indigenous to the Eastern United States and Canada. The herb contains a number of biologically active substances, primarily triterpene glycosides, flavonoids, phenolic acids, and tannins.

Native Americans and early settlers used the roots and rhizomes of black cohosh for a variety of ailments including malaria, rheumatism, kidney dysfunction, pain during  childbirth, and menstrual difficulties.

Today, black cohosh is approved by the German Commission E as a treatment for menstrual and menopausal complaints and is perhaps the most widely used natural remedy for menopausal symptoms.

Despite intensive study, black cohosh’s mechanism of action is still unclear. While some investigators believe it acts on specific tissue estrogen receptors, most studies indicate black cohosh has no estrogenic activity.

Data from animal and human studies indicate black cohosh may help stabilize fluctuating LH levels. Other research has found components of black cohosh bind to serotonin and/or dopamine receptors suggesting a means by which the herb can exert neuromodulatory and thermoregulatory effects.

Clinical trials utilizing black cohosh have yielded inconsistent results, most likely due to non-uniformity in preparations, methodological differences, use of black cohosh in combination with other botanicals, and variations in dosage and treatment times.

Nevertheless, the majority of research studies document clear benefits of black cohosh for alleviating perimenopausal symptoms.

One double-blind, placebo-controlled, multicenter trial reported in the journal Obstetrics & Gynecology examined the effects of 40 mg/day of standardized black cohosh extract in 145 postmenopausal women experiencing climacteric symptoms.

After 12 weeks, scores on a standardized, 10-point Menopause Rating Scale (MRS) were significantly reduced from baseline in women taking black cohosh compared to scores in the placebo group.

Subgroup analyses found women in their early menopausal years and those suffering from hot flashes were the most responsive to black cohosh treatment.

In another prospective trial, 48 menopausal women were administered 80 mg/day of black cohosh extract standardized to 2.5% triterpene glycosides.

After 12 weeks of treatment, mean symptom scores on the Kupperman Menopausal Index decreased significantly from 24.6 (indicative of moderate symptoms) to 12.8 (indicative of very mild symptoms).

During a subsequent 12-week washout period, Kupperman scores reverted back to near-baseline levels.

Importantly, this study evaluated the impact of black cohosh on breast tissue and found no significant changes in nipple aspirate fluid cytology or estrogenic markers over the 24-week intervention and follow-up periods.

A double-blind, placebo-controlled trial designed to compare the effect of standardized black cohosh extract with conjugated estrogens on postmenopausal bone metabolism found both treatments significantly improved serum markers of bone turnover. Researchers noted black cohosh elevated levels of bone-specific alkaline phosphatase, an indicator of increased osteoblastic bone formation, while estrogen therapy tended to reduce markers associated with osteoclastic bone degradation.

Finally, in a prospective, parallel-controlled trial, 64 symptomatic postmenopausal women were administered either 40 mg/day of standardized black cohosh or a combination of transdermal estradiol and an oral progestin.

After three months, both black cohosh and estrogen/progestin treatments were found to significantly reduce vasomotor symptoms, anxiety, and depression to an equivalent degree.

Serum LDL levels also significantly decreased in both treatment groups, but HDL increased only in women taking black cohosh.

At least a dozen other clinical trials conducted in research centers around the world have reported benefits for black cohosh in treating menopausal discomforts.

Hesperidin (as hesperidin methylchalcone)
Hesperidin is a flavanone polyphenol and one of the primary flavonoids found in citrus fruits.  Hesperidin is a glycoside consisting of the aglycone hesperetin and the disaccharide sugar rutinose.

Studies dating back to the 1930s report benefits of hesperidin in improving vascular strength and resistance despite the flavonoid’s poor solubility and absorption.

More recently, hesperidin derivatives such as hesperidin methylchalcone (HMC), which have a higher solubility and therefore greater bioavailability, have become available.  Preliminary studies indicate HMC’s supportive effects on the microvascular system may limit vasomotor instability caused by hormonal fluctuations during menopause.

In a blinded, controlled, crossover trial, 94 women who had undergone either physiological or surgical menopause received a preparation containing 300 mg of HMC, 900 mg of a hesperidin complex, and 1,200 mg of vitamin C for one month.  Comparator treatments were estrogen, salicylamide (as an antipyretic), and placebo.

At the end of the treatment periods, 88% of women receiving the HMC preparation reported complete relief or moderation in hot flashes compared to 66%, 43%, and 19% for estrogen, salicylamide, and placebo, respectively.

Gamma-Oryzanol
Gamma-oryzanol is a mixture of unsaponifiable components from rice bran oil. It consists primarily of triterpene alcohol and phytosterol esters of ferulic acid.

Gamma-oryzanol has been investigated for its antioxidant, neuroendocrine, anabolic, antiulcerogenic, antithrombotic, and antihyperlipidemic properties.

Studies conducted in Japan have found gamma-oryzanol to be an effective means of ameliorating menopausal symptoms.

According to published reports of an early, untranslated study, 300 mg/day of gamma-oryzanol provided substantial relief to a group of 21 women who had undergone either natural or surgically-induced menopause.

After 38 days, over 65% of the woman reported a 50% or greater improvement in menopausal symptoms, including hot flashes.

A larger, more recent trial examined the effects of 300 mg/day of gamma-oryzanol in 40 women with climacteric complaints.

After eight weeks, symptom scores on the Kupperman index had improved in 85% of the women.

A more detailed analysis revealed that 78.9% of women reporting vasomotor symptoms, 78.1% reporting headaches, 77.8% reporting weakness, 77.4% reporting nervousness, 77.3% reporting melancholia, 75.8% reporting arthralgia/myalgias, and 72.1% reporting sleep disturbances experienced “excellent” or “good” relief from their symptoms.

Studies indicate gamma-oryzanol may also beneficially modify cardiovascular risk profiles.

In animals, addition of gamma-oryzanol to the diet significantly lowers total cholesterol and non-HDL cholesterol fractions.

Human trials have found that supplementation with 300 mg/day of gammaoryzanol for periods ranging from 4-16 weeks significantly reduces blood levels of total cholesterol, LDL, triglycerides, apolipoprotein B, and lipid peroxides, while significantly elevating HDL.

Sage (Salvia officinalis)
Sage is a spice and medicinal herb that has been used throughout recorded history for a variety of health complaints.

According to botanical experts, sage possesses antioxidant, antimicrobial, and antispasmodic properties along with a capacity to relieve excessive perspiration.

Studies also indicate sage has anticholinesterase activity that can beneficially impact mood, memory and cognitive performance.

The active constituents of sage, including monoterpenes, alpha- and beta-thujone, camphor, and 1,8-cineole, are believed to be largely responsible for its medicinal effects.

Reports of sage’s antihidrotic and neuromodulatory benefits have led to two clinical trials evaluating its efficacy as a natural remedy for menopausal symptoms.

A pilot trial conducted in Italy found that an herbal combination of sage and alfalfa markedly reduces hot flashes and night sweats in postmenopausal women.

Of the 30 participating women, 20 reported complete symptom relief, while 10 experienced varying degrees of symptom reduction.

In a more recent multicenter trial, 69 symptomatic postmenopausal women were recruited to test the effects of 280 mg/day of sage extract.

After two months, mean numbers of mild, moderate, severe, and very severe hot flashes were reduced by 46%, 62%, 79%, and 100%, respectively.

Scores on the standardized Menopause Rating Scale (MRS) also diminished by an average of 46%.

Subscale analyses found hot flashes, sleep problems, physical/mental exhaustion, musculoskeletal discomforts, anxiety, depression, and irritability were the symptoms most improved by sage.

Lignans
Lignans are a type of phytoestrogen, chemically similar to isoflavones and naturally concentrated flaxseeds, whole grains, and certain trees like the Norway spruce.

Upon ingestion, most plant lignans are chemically modified by intestinal bacteria to the human lignans, enterolactone and enterodiol. These enterolignans are absorbed and can modulate estrogen activity by interacting with estrogen receptors (ERs).

Like most phytoestrogens, lignans are believed to exert a biphasic effect, antagonizing ERs in the presence of high estrogen levels and acting as weak ER agonists when estrogen levels are low.

In this way lignans have a normalizing effect on estrogen imbalances in the body.

Lignans also appear to influence estrogen by inhibiting aromatase activity and by shifting estrogen metabolism away from harmful 16-hydroxyestrone metabolites.

A number of studies document improvements in menopausal symptoms following consumption of lignans or high-lignan foods.

One randomized, double-blind trial found postmenopausal women who consumed a high-flaxseed diet for 12 weeks experienced a significant 41% reduction in hot flashes. This clinical benefit correlated with elevated urinary levels of enterolactone and enterodiol.

Another randomized, crossover trial compared the effects of 40 g/day of flaxseeds (equivalent to 21 mg/day of lignans) with HRT in a group of 25 menopausal women.

After 2 months, significant reductions in menopausal symptom scores (as measured by the Kupperman index) were noted in both treatment groups.

A third, blinded, controlled trial involving 28 postmenopausal women reported a significant reduction in hot flash severity along with a non-significant trend toward reduced hot flash frequency following 16 weeks of supplementation with 25 g/day of flaxseed.

Preliminary data indicate the novel lignan, 7-hydroxymatairesinol (HMRlignan™), holds particular promise for managing menopausal symptoms.  Derived from Norway spruce trees, HMRlignan™ is a direct enterolignan precursor.

Unlike dietary lignans, which exist as glycosides and must be cleaved within the intestinal tract, HMRlignan™ is delivered in its pure aglycone form for more rapid and efficient transformation into bioactive enterolactone.

A randomized, single-blind, pilot study tested the effects of 25 or 50 mg/day of HMRlignan™ in a group of 20 symptomatic postmenopausal women.

After eight weeks, mean numbers of daily hot flashes were reduced by 14% in the 25 mg group and by 53.5% in the 50 mg group. The results were significant for both groups, but demonstrate a superior effect for the higher dosage.

Similar to gamma-oryzanol, lignans also exert a favorable influence on lipid metabolism and cardiovascular risk markers.

A recent meta-analysis of 28 studies found supplementation with either whole flaxseed or flax lignans leads to significant reductions in both total and LDL cholesterol.

One study utilizing a postmenopausal cohort of the Framingham Offspring Study reported that women in the highest vs the lowest quartile of lignan consumption have higher HDL levels, reduced triglycerides, and significantly lower waist-to-hip ratios.

Data from animal and human studies also show intake of specific lignans can significantly lower markers of vascular inflammation and endothelial dysfunction.



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Indications:

Natural Woman provides natural relief for symptoms commonly associated with menopause.

This formula is especially recommended for women with vasomotor symptoms such as hot flashes and night sweats.

Women at higher risk of developing heart disease and/or osteoporosis may also benefit from regular use of Natural Woman.

Formula:

Supplement Facts
Serving Size: 1 Capsule
Servings per Container: 60

Amount Per Serving % Daily Value

Hesperidin Methylchalcone 150 mg *

Gamma-Oryzanol
(from rice bran oil)
150 mg *

Black Cohosh
(Cimicifuga racemosa)
root and rhizome,
dried extract, min. 2.5% triterpene glycosides,
calculated as 27-deoxyactein
20 mg *

Sage (Salvia officinalis) leaf 60 mg *

Norway Spruce (Picea abies)
dried lignan extract containing hydroxymatairesinol‡
25 mg *

* Daily value not established
Other Ingredients: Vegetarian capsule (hydroxypropyl methylcellulose, water), L-leucine, and silicon dioxide.

‡HMRlignan™ brand, a trademark of Linnea SA.

Suggested Use:

As a dietary supplement, take one (1) capsule twice daily, or as recommended by a healthcare professional.

Adverse Reactions:

While not clinically confirmed, black cohosh has a long history of use for induction of labor and may induce premature uterine contractions if taken during the first trimester of pregnancy.

Several case reports have linked black cohosh with possible hepatotoxicity; however, multiple, independent literature reviews conclude there is no credible evidence to indicate black cohosh has an adverse effect on liver function.

Drug Interactions:

In vitro, black cohosh constituents have been shown to augment the cytotoxicity of doxorubicin, docetaxel, paclitaxel, and 5-fluorouracil, but to decrease the cytotoxicity of cisplatin. These effects have not been demonstrated in animals or humans.

Contraindications:

Persons taking chemotherapeutic agents and pregnant women should consult with a healthcare professional before using Natural Woman. Do not use Natural Woman if you have known allergies or sensitivities to any of its ingredients.

How Supplied:

60 vegetarian capsules per bottle with full-bottle shrinkwrap. Packaged 12 bottles per case.

Storage:

Store in a cool, dry place (59°F-85°F) away from direct light. For long term storage up to two years, the product should be stored at a temperature between 36°F-46°F. Keep out of reach of children.



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