An integrative Chinese Herbal Formula for the Therapeutic Treatment of Menopausal Symptoms caused by Yin and Yang deficiency of Kidneys with liver fire

Dr. Sherman Lai, CMD., Dr. Ac., BSc.

Oriental Healing Arts Research Inc.

Guelph, ON, Canada

May 2006

Abstract: This article was designed to provide three different aspects of information about the ingredients of Fu-Ai™.  The first is to provide a scientific background of menopause from Western medical science.  The second is to provide a background of menopause according to traditional Chinese medicine (TCM).  Finally this paper provides a scientific literature review of the seven most important herbs in Fu-Ai™: Angelica Sinensis, Epimedium, Curculigo, Morindae, Leonurus, Moutan, and Anemmarhena.  The literature review provides scientific support of the efficacy of these herbs in therapeutic use and allows us to correlate their successful synergistic effects in Fu-Ai™. 

Keywords: Fu-Ai™, Menopause, Perimenopause, Hot Flashes, Night Sweats, Angelica Sinensis

It is inevitable that every woman will go through menopause at some point during her life.  Menopause is the point at which a woman stops ovulating and menstruation ceases, ultimately indicating the end of fertility.  It is a natural progression in life.  Menopause is different for every woman in that some may have a new sense of freedom and energy, while others suffer numerous symptoms for many years.

What is Menopause?

Menopause typically occurs in women that are between the ages of 42 and 56.  Menopause lasts for one full year, and begins after your last period. A full year without a period is needed before you can say you have been “through menopause.” However, the years surrounding menopause and encompassing the gradual change in ovarian function constitute an entire stage of a woman’s life, lasting anywhere from 6 to 13 years. The period prior to menopause is commonly known as perimenopause, while postmenopause follows menopause and lasts for the rest of a woman’s life.

Menopause does not usually begin until at least the age of 40.  However, some women may go through early menopause.  For example, women that have had a hysterectomy (removal of the uterus), an oophorectomy (removal of the ovaries), have gone under chemotherapy and/or radiation treatment, or have smoked for the majority of their lives, may end up going though menopause at an earlier age.

Many years before a woman stops ovulating, her ovaries slow the production of the following hormones: estrogen, progesterone and testosterone.  These hormones are typically referred to as the sex hormones; however, estrogen is also needed for many other organs and systems in the body.  Cells found in the vagina, bladder, breasts, skin, bones, arteries, heart, liver and brain all have estrogen receptors and require this hormone for normal function.  For example, estrogen is needed to maintain the body’s internal thermostat and is needed for proper bone formation.  Although estrogen levels drop drastically after menopause, trace amounts remain in the body.  The endocrine gland continues to secrete a small amount of estrogen; however, it is a weaker strain.

Progesterone, another hormone that is produced by the ovaries works as a counterpart to estrogen.  Its main function is to stimulate changes in the lining of the uterus which prepare it for implantation of a fertilized egg.  This hormone is also needed to maintain pregnancy, as well as promote development of the mammary glands.  Progesterone, like estrogen, also has effects beyond the reproductive system.  It has been shown to have a calming effect on the nervous system function.

Testosterone, the hormone that is widely known as a male hormone, is also produced in the female body, although in small amounts.  Testosterone has many functions in the female body, although its most important function is to maintain a healthy libido.

What Are the Signs of Menopause?

Many women experience little to no symptoms during perimenopause and/or menopause.  Although the majority of women may suffer from all or some of the following symptoms: fatigue, insomnia, night sweats, hot flashes, dry skin, anxiety, headaches, bloating, heart palpitations, irritability, decreased sex drive, mood swings, vaginal dryness and itchiness, reduced energy, urinary incontinence and weight gain.  Over the long term, the diminished supply of estrogen also increases the likelihood of cardiovascular disease, osteoporosis and vaginal atrophy.

With a proper diet, nutritional supplementation, exercise and supplementation with Fu-Ai™, women will find that most of the unpleasant side effects associated with menopause can be minimized, if not be completely eliminate.

TCM theory of Menopause

About one third of women in the perimenopausal period do not present any symptoms, leaving about two thirds of women suffering from menopausal symptoms.  In traditional Chinese medicine (TCM) there is no such term as perimenopausal or menopausal.  This state is referred to as the disharmony among four organs: the kidneys, liver, spleen and heart.  Clinical observational studies have shown that 80% of women in the pre-menopausal state exhibit signs of a decline in kidney Qi, therefore being diagnosed, according to TCM, with either kidney Yang or Yin deficiency or both Yin and Yang deficiency ; 20% of women may have a disharmony of the spleen and heart or liver Qi depression. These clinical studies have also shown kidney Yin and Yang deficiency with liver fire is the most prominent pattern of deficiency in western society. We believe that adrenal over-function and exhaustion due to a stressful and fast-pace life style is co-related with kidney Yin and Yang deficiency with liver fire. Symptoms of liver fire often are confused with a diagnosis of Yin-deficiency without Yang deficiency. The herbal ingredients in Fu-Ai™ were designed specifically to address this type of imbalance.  Individuals with disharmony among the heart, the spleen and the liver would benefit from a different formula; therefore, for the purpose of this literature review we are going to focus on kidney Yin and Yang deficiency with liver fire.

In cases displaying Yin deficiency of the kidney, the typical clinical manifestations are dizziness and tinnitus, flushed cheeks, blurry eyesight, hot flashes with perspiration, insomnia, mood swings (anxiety and irritation), dryness of skin, joint ache and weakness and irregular or very infrequent menses.  The tongue is red with a little coating and the pulse is rapid and thin.  Therapy should include replenishing the kidney by balancing the excessive Yang.

In cases displaying Yang deficiency of the kidney, the typical clinical manifestations are tiredness, mental fogginess, pale complexion, depression, chill sensation, poor appetite and heavy menses often metrorrhagia at times.  The tongue is pale with tooth-prints on each side and a white coloured thin coating; the pulse is deep and thin with weakness.  Therapy should include warming the kidney Yang, and  strengthening of the spleen.

Liver fire often exhibits symptoms of tension, irritation, anxiety, dizziness, and restless. The tongue is red and the pulse is thin and rapid.

In cases displaying both kidney Yin and Yang with liver fire, the clinical manifestations become somehow confusing to finalize a diagnosis because liver fire often produces symptoms similar to Yin deficiency, and the tongue tends to be red rather than pale; it tends to mislead a diagnosis of Yin deficiency; often patients express a combination of symptoms from both kidney Yin and Yang deficiency.

According to TCM Yin-Yang theory, balancing the Yin and Yang deficiency involves removing excessive Yang energy and raising Yin energy, but raising Yin energy will also require Yang energy. Therefore, seven main ingredients in Fu-Ai™ are formulated to address the deficiency of both Yin and Yang according to TCM:

 Angelica Sinensis, Epimedium, Curculicum, Morinda, Leonerus, Moutan, Anemmenhrea.

Table 1 provides a detailed explanation of each herb’s action in Fu-Ai™.

Table 1: Descriptive chart outlining the important action of the 7 major herbs found in Fu-Ai™.

 

Herb	Kidney Yin Function	Kidney Yang Function	Other Functions
Angelica Sinensis Dang Gui			Tonifies the blood and regulates menstrual patterns related to blood deficiency
Epimedium Yin Yang Huo	Tonifies kidney Yin	Tonifies kidneys and fortifies Yang for deficiency of kidney Yang leading to menstrual irregularities.	Expels wind-damp-cold such as spasms and cramps in hands and feet
Cuculigo Xian Mao		Tonifies kidneys and fortifies kidney Yang from deficiency of kidney Yang	Assists with urinary incontinence.  Expels cold and eliminates dampness relieving muscle spasms, joint and low back pain
Morinda Ba Ji Tian		Tonifies the kidney and fortifies the Yang for deficienct kidney Yang patterns	Assists with frequent urination, menstrual irregularities, coldness and low back pain.  Also strengthens bones in symptoms of low back pain and muscle atrophy
Leonurus Yi Mu Cao			Invigorates the blood and regulates the menstrual cycle.  Reduces blood stasis and acute swelling.
Moutan Mu Dan Pi	Clears fire from deficiency of Yin patterns such as sweating		Clears heat and cools the blood.  Also used for profuse menstruation due to heat in the blood.  Dispels blood stasis.  Clears ascending liver fire: headache, eye pain, and flushing
Anemarrhena Zhi Mu	Enriches Yin and moistens dry conditions: deficiency of lung and kidney Yin with such signs as night sweats, irritability and low grade fevers		Clears heat and drains fire: low grade fever, irritability, rapid pulse.

Certain herbs balance each aspect of the body.  Moutan and Anemarrhena help tonify and balance kidney Yin (help hot flashes and dryness) while Cuculigo and Morinda help to tonify kidney Yang (helps with tiredness and chillness). Epimedium helps to tonify the kidneys (and helps with adrenal exhaustion). Leonurus and Angelica Sinensis assist in regulating the menstrual hormones and invigorating the blood (and help with irregular bleeding, tiredness and hot flashes). 

The other 5 main ingredients: White peony, Atractylodes, Glycyrrhiza, Bupleurum and ligustrum serve the following functions: when combining with White Peony, Angelica nourishes the Yin in the blood that exerts an astringent effect to retain Yin energy (help joint aches, dryness, weakness and anemia). A combination of Glycyrrhiza and Atractylodes nourishes the upper warmer and regulate middle warmer (help digestive system); Bupleurum, when combined with White peony, calms the liver and ensures proper Qi flow in the liver (helps irritation, tension and mood swings). Ligustrum strengthens the Yin energy and nourishes the kidneys, enhances the liver function, which helps reduce grey hair). 

It can be demonstrated that Fu-Ai™ addresses these concerns by balancing both kidney Yin and Yang, making Fu-Ai™ a unique blend of integrative Chinese herbal formula that can therapeutically treat the symptoms associated with menopause.

The seven ingredients which have the most importance in Fu-Ai™ have also been sited in other scientific literature.  Table 2 outlines statistically significant findings from scientific studies that have researched the effects of each herb individually.

Table 2: Brief outline of the findings from 7 different studies researching the effects of Chinese herbs: Angelica Sinensisi, Epimedium, Curculigo, Morinda, Leonurus, Moutan, Anemarrhena

	Herb Researched	General Findings
Wang et al. (2003)	Angelica Sinensis	Research the possible antifibrotic effects of the herb.  Rats with chronic puromycin-induced nephrosis were treated with Astragalus and Angelica (3mL/d).  In the untreated rats, chronic renal injury progressed to marked fibrosis, however the treated group had marked reduction in renal deterioration.  Therefore concluding that the combination of Astragalaus and Angelica proved to be successful at retarding the progression of renal fibrosis.
Li et al. (2002)	Epimedium	To investigate the bone resorption caused by osteoclasts and modulating function of Epimedium.  Osteoclasts were separated from long limb bones of newborn rabbits and then exposed to different concentrations of Epimedium.  The results indicate that Epimedium can induce osteoclasts to commit apoptosis therefore inhibiting bone resorption.  Closer investigation revealed that this herb works in a dose dependant maner.
Lakshmi et al. (2003)	Curculigo	Studying the immunostimulant principles of the herb Curculigo prepared in a methanol solution.  In China the herb has been used in the treatment of decline in energy and wound healing.  Results showed that the methanol extract of Curculigo stimulated immune responses (increased phagocytic and macrophage activity, and increased blast cell transformation to lymphocytes) in mice.
Seo et al. (2005)	Morindae	To investigate the effects of Morindae on osteoporotic induced mice through sciatic neurectomization.  After having the right hind limb neuretcomized, mice were then fed Moridae Radix extract (varying levels of 50, 100 and 200mg/kg depending if they were in the therapeutic or prevention category) for 6-12 weeks.  In both categories it was noted that hind limb thickness, tibia failure load and Ca and P levels maintained the same.  It was also discovered that these results were dose dependant.  In conclusion it was said that Morindae Radix extract may act as both a suppressor of bone resorption and enhance bone formation in vivo.
Chinwala et al. (2003)	Leonurus	Investigate the anti-cancer effects of Leonurus.  The herb was extracted and treated in a saline solution, then tested against seven human cancer cell lines.  The herb’s apoptotic activity was then studied.
Satoh et al. (1997)	Moutan	* need better article than Na/K ATPase*
Iidthea et al. (1999)	Anemarrhena	Detection of anti-fungal properties in Anemarrhena.  The active fraction was isolated and found to be identical to nyasol (a compound that is known for its anti-fungal properties).  The herb was later discovered to be effective against 5 different strains of bacteria at concentrations of 12. 5-200µg mL.

Although these research articles do not address the main symptoms of menopause, they do address the activity of these herbs in a Western scientific point of view, which can be correlated to Eastern medical philosophies.  It is also important to remember that TCM evolves around the synergistic effect of herbal blends.  From this we can see the therapeutic benefits of the seven main ingredients of Fu-Ai™ for treating menopausal difficulties.

Appendix A: 

Ingredient List for 

Fu-Ai™ 

Angelica Sinensis Radix Angelicae Sinensis

Angelica Sinensis affects the heart, liver and the spleen.

This particular root has many functions including; tonifing, invigorating and harmonizing the blood, dispersing cold, moistening the intestines, decreasing swelling, expelling pus, generating flesh and alleviating pain, including the pain from tumors.  Clinically it has been shown to have an antibiotic effect and acts as a mild sedative.

Morinda Radix Morindae Officinalis

This herb is shown to effect the liver and the kidney.

Morinda has been shown to tonify the kidneys and fortify the yang and strengthen the sinew and bones.  Lastly, Morinda disperses wind and expels damp-cold.

Atractylodes (Alba) Rhizoma Atractylodis Macrocephalae

Atractylodes is used in Chinese medicine to treat the spleen and stomach.

It has been known to tonify and strengthen the spleen, augment the qi, dry dampness, stop spontaneous sweating due to qi deficiency and also calms the fetus.

Poria Poria cocos sclerotiumIn Chinese medicine, poria is used for a variety of functions.  Some actions of the herb include promoting urination, leaching out dampness, strengthening the spleen, and calming the spirit.

Traditionally, the herb is used as a diuretic, a cardiotonic, an antibacterial and anticancer agent, to increase immune responses, to lower blood sugar levels and to treat edema, chronic diarrhea and pelvic infections.

Moutan Cotex Moutan Radicis

Moutan affects the heart, liver and kidney channels. 

It has a wide range of effects, including clearing heat, cooling blood, clearing fire, invigorating blood, dispelling blood stasis, clearing ascending liver fire, draining pus and reducing swelling.  It has been shown to have strong antimicrobial effects.

Ligustrum Ligustrum lucidum

Ligustrum effectively nourishes and tonifies the liver and kidneys, clears heat, improves vision and tonifies yin.  In China, this herb is commonly used to brighten the eyes, strengthen the yin, quiet the five viscera, restore grey hair and if taken for a long time, to increase firmness of the flesh and youth in the body.

Curculigo Rhizoma Curculiginis

In Chinese medicine this particular herb is known to tonify the kidneys and fortify the yang.  It has been used for female and male infertility due to either a cold womb, or cold essence.  Curculigo also works to expel cold and eliminate dampness, especially useful for cold abdominal or lower back pain.  This herb is known to exerts its effects on the kidney ad liver channels.

Phellodrendron Bark  Cortex Phellondendri  

This bark exerts its affect on the kidneys and bladder.  Phellodrendon bark has been used as an antibiotic for many years.

Bupleurum Radix Bupleuri

Bupleurum exerts its affect on the gallbladder, liver, pericardium, triple burner.

Bupleurum has been shown in traditional uses to have an antibiotic affect, to regulate temperature as well as slightly lower ones blood pressure.  It has also been shown to have an antitussive effect through a study conducted on mice that produced a tranquilizing affect.  This is thought to be central in nature.  Its main mode of action is to resolve lesser yang disorders, to reduce fever, relieve constraint, spread liver qi and raise the yang qi in patterns of spleen and stomach deficiencies.

Epimedium Herba Epimedii

Epimedium exerts its effects on the kidney and liver channels.

Epimedium is for deficient kidney yang patterns with such symptoms as impotence and frequent urination.  It has also been shown to expel wind-damp-cold helping symptoms such as cramps, numbness and spasms in the hands and feet.  Lastly, Epimedium is known to tonify the yin and yang and harness ascendant liver yang for lower back pain, menstrual irregularity and dizziness.

Peony (White) Paeonia lactiflora

In China this herb is known to nourish the blood and regulate the menses.  It also calms and curves the liver yang and alleviates pain, while also preserving the yin and adjusting its nutritive and protective levels.  This herb will try and balance any disharmonies that exist between the liver and spleen.

Ligusticum Radix Ligustici Chuanxiong

In traditional Chinese medicine, Ligusticum has acrid and warm properties.  This herb is associated with the Liver, Gallbladder and Pericardium meridians. 

Ligusticum’s main functions are to promote the flow of blood and Qi, dispel wind, and relieve pain. In China, practitioners generally prescribe this herb to treat irregular menstrual periods, dysmenorrhea, and headaches. It is also given to patients with inflammation caused by injuries, carbuncles and boils.

Alisma  Rhizoma Alismatis Orientalitis

Alisma exerts its effects on the kidneys and bladder.

This herb has been shown to promote urination and leach out dampness as well as to drain kidney fire.

Eclipta Eclipta prostrata

Eclipta is known to nourish and tonify the liver and kidney, cool the blood, stop bleeding and tonify yin.

In China, the medicinal action of the plant is said to be astringent, checking hemorrhage and fluxes, and it is used to blacken the hair, tighten the teeth and relieve all sorts of eye troubles.

Anemarrhena Anemarrhena asphodeloides

Anemarrhena works on the lungs, stomach and kidneys.  The herbs main actions are to clear heat, drain fire, enrich yin, moisten dry conditions and generate fluids.

This particular herb has been shown to be useful in an antibiotic fashion and has demonstrated an inhibitory effect against numerous pathogenic bacteria.  There have also been clinical trials portraying Anemarrhena’s effect on temperature regulation.  Overall, this herb has been shown to inhibit the febrile response when one has been infected with Salmonella typhi.

Licorice Root Glycyrrhizae Uralensis, Radix

The Licorice Root is one of the most highly regarded herbs because of its ability to treat multiple functions.  Working on all 12 channels of the body, it tonifies the spleen, augments qi, moistens lungs, stops coughing, clears heat, relieves toxicity, alleviates pain and harmonizes characteristics of other herbs.

The Licorice has an extremely wide array of uses including anti-inflammatory effects, use for asthmatics, gastrointestinal uses and various forms of detoxification.

Leonurus Herba Leonuri Heterophylli

Leonurus exerts its effects on the heart, liver and bladder meridians.  Leonurus is traditionally used to; activate blood circulation and transform blood stasis, alleviate pain, regulate menstruation, promote urination and reduce swelling.

Gardenia Fructus Gardeniae Jasminoidis

In traditional Chinese medicine, Gardenia has bitter and cold properties.  This herb is associated with the heart, liver, lung, stomach and triple burner channels.

This herb has been shown to clear heat, drain fire, cool blood, resolve toxin, restrain bleeding, relieve irritability, and resolves blood stasis; the charred herb is especially useful for restraining blood.

Ginger (fresh) Rhizoma Zingiberis Officinalis Recens

Fresh ginger works on the Lung, Spleen and Stomach meridians.  

The herbs main actions are to warm the middle burner and alleviate vomiting, disperse cold and stop coughing, helps to reduce the toxicity of other herbs and lastly, it helps to adjust the nutritive and protective Qi.

Mint Menthae Herba

In China, this herb is known to dispel wind-heat; clear the head, eyes, and throat, alleviate itching and also enables constrained liver Qi to flow freely.  This herb will try to balance any disharmonies that exist between the lungs and liver.

Appendix B – 

Fu-Ai™ Case Studies

Case 1: 50 year-old professional woman with two children.

Menopausal Symptoms:

- Hair loss; drastic thinning

- Stiffness and aches of all joints; particularly knees, fingers and feet

- Frequent urination during sleep: up 7 to 9 times at night

- Irregular menstrual cycles: once every 2-4 months   

- Hot flashes at night (every 20 to 40 minutes some nights)

- Tired but anxious

Treatment with Fu-Ai™:

First month: 3.0 g (6 capsules) x 3 / day

Response: After completing the first month of treatment, her major improvements were:

- No more joint stiffness or aches

- Frequent urination during sleep reduced to once or twice per night

- Hot flashes at night reduced to one or two per night

No observable improvements in hair loss were noted at this time.

Second month: 3.5g(7capsules)x 2 / day

Response: After completing her second month of treatment, her major improvements were:

- No more joint stiffness or aches

- Frequent urination during sleep reduced to once every 3 to 4 nights

- No hot flashes at night

- No tiredness or feelings of anxiety 

- Hair loss greatly decreased

Third month: 3.0g (6 capsules) x 2 day

Response: After completing her third month of treatment, her major improvements were:

- No night urination

- No hot flashes

- No joint aches or stiffness

- No tiredness or feelings of anxiety

- Hair has definitely thickened

Due to her significant improvements she no longer needs to take Fu-Ai ™ on a daily basis, and can now use it only when needed. 

Case 2: 40 year-old, professional with one child. 

Menopausal Symptoms:

Has recently undergone a total hysterectomy due to an over sized fibroid causing excessive bleeding. After the hysterectomy, she began taking hormonal replacement therapy (HRT).

Within the first 2 weeks of taking HRT, she began to have the following symptoms:

- Unbearable hot flashes throughout the night

- Frequent, intense headaches

- Bloating

- Weight gain

- Lack of concentration

- Low libido

- Increased blood pressure

- Not feeling herself

Treatment with Fu-Ai™:

First 3 weeks: 3.0g (6capsules) x 3 / day

Response: At the end of her first three weeks, her major improvements were:

- Hot flashes had decreased in frequency and intensity (bearable).

- No more headaches

- No more bloating

- Improved concentration

- Blood pressure had returned to normal range

- Feeling more like herself.

- No change in her libido or weight gain

After 8 weeks: 3.0g(6 capsules)X 3/ day 

Response: At the end of her 8^th week of treatment, her major improvements were:

- No hot flashes

- No headaches

- No bloating

- Blood pressure stabilized in normal range

- Generally feeling good

- No change in low libido or weight gain.

After 12 weeks: 3.0g(6capsules)X2/ day 

Response: At the end of her 12^th week she maintained all of her previous improvements including:

- Slightly improved libido

- Weight loss (starting at the 11^th week)

Long term follow-up: 

Over the past 3 years, she occasionally took Fu-Ai™ only when needed.  She found that it worked exceptionally well when her stress and anxiety levels were elevated; providing immediate relief. 

Case 3: 47 year-old, professional with two children.

Menopausal Symptoms:

- Hot flashes throughout the night

- Depression (No sense of joy and happiness)

- Very tense and anxious

- Joint aches

- Constipation

Treatment with Fu-Ai™:

First 3 weeks: 3.5g (7 capsules) x 2/day

Response: At the end of her first 3 weeks of treatment, her major improvements were:

- 80% improvement on the symptoms of hot flashes, depression, tension/anxiety, and joint aches.

- 100% improvement in constipation.

After 8 weeks: 3.5g(7capsules) X 2/ day 

Response: At the end of her eighth week of treatment, her major improvements were:

- No constipation

- No joint aches

- No depression

- No feelings of tension or anxiety

- Occasional hot flashes at night (overall, since she felt emotionally better, it was much easier for her to deal with her mild hot flashes)

Long-term follow up:

She has found that taking a low dose of Fu-Ai™ on a daily basis (i.e.: 5 capsules in the morning before breakfast) has kept her feeling well over the past three years. She enjoys the preventative benefit of Fu-Ai™.

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