Dapagliflozin for the management of type 2 diabetes 21/8/2013 Decision Summary Date of DTG DTG Decision Date of LAPC Traffic Light List Date of funding Funding decision Commissioning Other considerations Application summary • Dapagliflozin is a sodium-glucose co-transporter-2 inhibitor, which blocks reabsorption of glucose by the kidneys, li
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Nutraceutical.comTHE SAFE ANSWER TO HORMONAL IMBALANCE, PMS, Note: This brief and easy to understand booklet explores the uses of natural prog-esterone for a myriad of symptoms women continually endure assuming thattheir only option is synthetic hormone therapy. Issues pertaining to menstrualdisorders, PMS, fibrocystic breasts, menopausal miseries, osteoporosis, and can-cer are discussed supporting the use of safe, natural forms of progesterone fromplant precursors. Natural progesterone may be the most valuable supplement awoman can take during the course of her life.
The information in this book is for educational purposes only and is not recommended asa means of diagnosing or treating an illness. All matters concerning physical and mentalhealth should be supervised by a health practitioner knowledgeable in treating that par-ticular illness. Neither the publisher nor author directly or indirectly dispense medicaladvice, nor do they prescribe any remedies or assume any responsibility for those whochoose to treat themselves.
PROGESTERONE: IGNORANCE IS NOT BLISS .
THE ROLE OF NATURALLY OCCURRINGPROGESTERONE IN THE BODY BOTANICAL PROGESTERONE: WHAT IS IT? .
NATURAL PROGESTERONE AND OTHERMENSTRUAL DISORDERS Has anyone ever asked you if you might be suffering from a proges- terone deficiency? Women ranging in age from 12 to 100 may be subjectto low progesterone levels and as a result, can suffer from a whole host ofmysterious ills related to a hormonal imbalance. While most women arefairly informed about birth control pills and estrogen replacement thera-py with all of its controversy, few of us understand the very profound roleprogesterone plays in determining our overall health. Moreover, the ther-apeutic effects of natural progesterone remain relatively unknown anduntapped. Of even more significance is that a growing number of women seem to be suffering from progesterone depletion and estrogen dominance. Ifyou’re like I was, this notion struck me as a completely new concept. I cansay now, in retrospect, that this bit of knowledge is clearly one of the mostimportant pieces of information I have had the opportunity to research. So many symptoms that women have to endure are readily branded as just part of inevitable PMS or worse yet, products of an overactive imag-ination or emerging psychosis. It is has been through my own personalexperience with terrible mood swings, horrendous periods and all sorts ofmiserable hormonal demons that I have come to write this booklet. Makeno mistake however, the information contained herein is based on scien-tific fact and is backed by the experience of medical doctors. More thanany other physician or scientist, Dr. John R. Lee, M.D. has pioneered anddocumented his remarkable results using natural progesterone from wildyam for his female patients. To say the very least, his findings have pro-found health implications for all women. Natural plant-based progesterone may well be the most important breakthrough therapy for women to come out of the latter twentieth cen-tury. Ironically, its use from botanical sources has a long tried and true his-tory. Like so many valuable natural treatments, the value of plant-basedprogesterones have been virtually ignored by modern medical practices. Unfortunately, most physicians focus on the use of synthetic estrogen or artificial progestins to manage female disorders such as osteoporosiswhen, in reality, progesterone may be the key hormone. Ironically, natur-al progesterone, unlike its pharmaceutical counterparts, offers an impres-sive array of therapeutic actions with complete safety and efficacy.
As previously mentioned, mainstream medicine continues to overlook the use of natural phytoestrogens which can offer practical treatment ofhormonally-related disorders without negative side effects. These simpleplant-based medicinals have been used for generations by women ofalmost every culture and for good reason. These botanicals have been ableto support the special health needs of both pre-and post-menopausalwomen with little or no side effects.
Progesterone plays a profoundly more critical role in the maintenance of female health than previously assumed. Too little of this vital femalehormone can lead to all kinds of menstrual disorders, infertility, miscar-riages, osteoporosis and even cancer. Progesterone deficiencies are muchmore common that most of us would assume, even in younger women. Replenishing progesterone in its natural form is a safe and effective way of relieving a whole host of female symptoms ranging from the mild-ly annoying to the seriously debilitating. Simply stated: there are viablealternatives to popping synthetic hormones for problems like PMS ormenopausal distress. In many cases, specific plant-based hormone creamscan achieve better results without the significant health risks associatedwith synthetic hormonal analogues.
Today, the use of natural progesterone is dramatically growing as women and health practitioners alike become disillusioned with synthet-ic hormonal therapies. Using pharmaceutical estrogen has proven to berather disappointing in treating osteoporosis.1 In addition, the controver-sy over the safety of birth control pills and estrogen replacement therapyfor post-menopause rages on. In the midst of much misinformation con-cerning artificial hormonal drugs, plants like wild yam are being recon-sidered and reevaluated for their intrinsic value. Ironically, modern technological manipulations of these natural phy- tochemicals has resulted in more potency and more risk to the humanbody which was not designed to cope with artificial compounds. It turnsout that ancient civilizations who turned to botanicals for female illsunderstood the value of natural therapies. In the face of high-tech phar-maceutical imitations, it turns out that Mother Nature knew what she wasdoing after all. The very delicate relationship between progesterone and estrogen lev- els is what creates hormonal balance. Today we frequently hear the phrase, “she’s suffering from a hormonal imbalance.” What exactly does a hor-monal imbalance imply, and why is it so prevalent among women of allages? The simple truth is that our twentieth-century life style creates agreat deal of health risks not previously experienced by earlier generations.
Many of these new, modern factors adversely effect our endocrine sys-tems, not to mention our overall health as well. Consequently, when weneed to synthesize certain levels of progesterone, we may be lacking theproper nutrients or, as may be the case with women who have used birthcontrol pills, our ovarian functions may be impaired. As a result, an excessof estrogen may develop predisposing us to a number of unpleasant symp-toms. Unprecedented degrees of mental stress combined with exposure to toxins, pollutants, preservatives, chemicals, and drugs can impair awoman’s ability to produce progesterone. In addition, the consumption ofsugary foods lacking in whole grains, overcooked, over processed, andfatty foods devoid of the raw enzymes we were meant to ingest can alsowreak havoc with our glandular health. The consumption of hormonallyfattened beef and poultry is certainly a concern, and may explain why pre-mature puberty occurs in some children who are exposed to unnaturalsources of animal estrogen. Why is there more infertility now that ever before? Why do seeming- ly healthy young women suffer from all sorts of menstrual disorders andunprecedented levels of PMS? Why is osteoporosis such a threat today,and why is breast cancer killing so many relatively young women? Whydo so many of us plow through perimenopause and postmenopause, per-plexed by a wide variety of ills that threaten our emotional and physicalwell-being? All of these questions are profoundly linked to hormonal factors and almost always reflect an estrogen dominance and a progesterone deficien-cy. I did not know that such a scenario even existed and like most women,did not understand that too much of certain kinds of estrogen can beextremely harmful. Furthermore, because I assumed that estrogen levelscontinued to decline as I got older, I never considered the possibility of apre-menopausal estrogen overload. It is crucial to remember that whenestrogen is unopposed by adequate levels of progesterone, a hormonalimbalance occurs. Unopposed estrogen is undesirable to say the least, andexplains why so many women suffer from estrogen-related ills even as theyapproach menopause. As mentioned, many women who suffer from a whole myriad of per- plexing and distressing symptoms can be unsuspecting victims of an estro-gen dominance. It is important to keep in mind that when estrogen is notbalanced out by adequate amounts of progesterone, a whole array ofdiverse symptoms may develop, many of which are easily misdiagnosedand subsequently, mistreated. In addition, we hear so much about keeping our estrogen levels up as we approach menopause, we rarely consider the fact that we may be suf-fering from an estrogen overload during pre-menopausal years. Mostphysicians neglect to discuss the very real effect of an estrogen dominance,but I can assure you that it is all too real. Enduring very heavy periods,developing sore and tender breasts, retaining water, bloating and seriousbouts with depression are more of a problem for many pre-menopausalwomen in their forties than one would assume.
In addition, most of us are unaware of the fact that a woman can have regular periods and not be ovulating. A continued lack of ovulation orimpaired ovulation can also create a progesterone deficiency leading to anabnormal buildup of the uterine lining which is never sufficiently shed.
The incomplete removal of the endometrium can lead to endometriosis,uterine fibroid cysts, fibrocystic breasts, bloating, depression, heavy orirregular periods and possible malignancies. Certainly, all estrogen is not bad; however, it would seem that most women suffer from a dominance of estrogen and a lack of progesterone.
Estrogen is the hormone that initiates female puberty, causing the devel-opment of the breast, uterus, fallopian tubes etc. It also contributes tofemale fat distribution. Prior to menopause, estrogen levels drop causingan eventual cessation of the menstrual period. Most conventional physicians will recommend estrogen replacement therapy to offset the risk of osteoporosis and to prevent cardiovascular dis-ease, two actions which are still questioned in many scientific circles. Thefocus on estrogen therapy may be misguided in many cases. More andmore evidence points to the fact that when progesterone levels are wherethey should be, conditions like PMS, osteoporosis, etc. dramatically improve. Unopposed or synthetic estrogen poses a number of health riskswhich most women will recognize immediately through their own per-sonal experience.
While estrogen balanced with progesterone is necessary for proper female development and reproduction, when is dominates, it can con-tribute to a number of unwanted reactions, including: • increases body fat stores, especially on upper thighs• promotes water and sodium retention in the cells• contribute to impaired blood sugar levels• increase the risk of endometrial (uterine) and breast cancer• increase blood clotting which raises the risk of stroke• contribute to mood swings• thickens the bile increasing the risk of gallbladder disease• cause headaches• promotes the loss of zinc• interferes with thyroid function• contribute to excess and irregular menstrual bleeding• decrease libido• reduce cellular oxygenation Aside from having your blood or saliva tested, it is relatively easy to assess whether or not you may be suffering from an estrogen dominance.
The following symptoms are typical of excess estrogen and progesteronedepletion: breast enlargement and tenderness, water retention, heavymenstrual flow or irregular periods, carbohydrate cravings, weight gain(fat on hips and thighs), fibrocystic breasts, uterine fibroids, loss of libido,PMS, mood swings/depression, and certain types of acne.
In light of the previous section, it is vital to keep in mind that when progesterone is produced and maintained, most of the negative sideeffects of estrogen are neutralized. Unfortunately, in far too many women,progesterone levels fail to do the job. Let’s discuss exactly what proges-terone is responsible for.
A woman’s ovaries produce two key hormones: estrogen and proges- terone during her ovulatory years. The corpus luteum makes progesteronejust before ovulation which rapidly escalates during the two week periodfollowing ovulation. The primary task of progesterone is to supportimplantation and sustain pregnancy. It does this by inhibiting uterinecontraction and by suppressing the immune system’s response to thedeveloping embryo as a foreign body.2 During the last two weeks of a woman’s menstrual cycle, progesterone is considered the dominant female hormone. During pregnancy, the pla-centa takes over the task of progesterone synthesis. Progesterone is alsomade in limited amounts in the adrenal glands of both men and womenand in the testes of the male.
The following breakdown gives general guidelines of amounts and time ofprogesterone secretion: • just before ovulation.2 to 3 mg per day• just after ovulation.20 to 25 mg per day• one week post ovulation.30 mg per day• during the 3rd trimester of pregnancy.300-400 mg per day Women who feel physically exhilarated and sometimes experience an unusual remission of diseases like bronchial asthma during pregnancymay be responding to elevated progesterone levels which help to boost theproduction of natural cortisone.
Approximately twelve days following ovulation, if fertilization has not occurred, progesterone levels decline rapidly, which initiates the sheddingof the uterine lining, also known as menstruation.
In time, progesterone is transported through the bloodstream to the liver where it is metabolized and excreted as waste through the kidneys(urine) and the bile. Typically, pregnancy tests are reacting to increased levels of HCG or of progesterone in the urine, indicating that pregnancyhas occurred. (Note: What is crucial to remember is that a woman’s cycle,regardless of her age, may not be characterized by the above scale. A num-ber of factors may cause estrogen to remain dominant, even after proges-terone is supposed to take over in the latter half of the cycle. Even youngwomen who suffer from nutritional deficiencies, stress, etc. may experi-ence an estrogen dominance, suggesting the need for natural progesteronesupplementation.) 1. It ensures the implantation and development of a fertilized egg and 2. It acts as a precursor to other steroid hormones such as cortisone which is produced in the adrenal glands and contributes to the production ofthe sex hormones including testosterone.
3. It exerts a number of desirable physiological actions.
Simply stated, certain plants exist in nature which contain both estro- gens and progesterone very similar to those produced in the human body.
These botanicals are referred to as “phytoestrogens” and number in thethousands. Some of these plants include soybeans and mistletoe, howev-er, one of the most abundant sources of progesterone is contained in dios-genin which is found in wild yam (dioscorea). Wild yam provides thesource of a cost effective and safe form of progesterone. Natural proges-terone is primarily produced from wild yam.
By contrast, synthetic progesterone preparations should technically be referred to as progestogens. Both Premarin and Provera are commonlyprescribed for hormonal imbalances, after a hysterectomy or duringmenopause. Premarin is actually an altered form of estrogen (conjugated)and Provera is not technically a progesterone but a synthetic analogue(progestin).
WILD YAM: NATURE’S ANSWER TOHORMONAL IMBALANCES In 1985 Rudolf Weiss wrote, “Wild yams contain diosgenin, a precur- sor in the synthesis of progesterone, and are the only known availablesource.”3 Mexican wild yam is the richest phytoestrogen available and pro-vides the human body with a natural and safe source of progesterone. Ithas an anti-spasmodic action which make is ideal for treating menstrualcramping and is an excellent contributor to achieving glandular balance.
Native Americans have used wild yam for generations for the treatment offemale disorders and as a supportive herbal for pregnancy.
In 1936, Japanese scientists discovered the glycoside saponins found in several wild yam species from which steroid saponins (diosgenin) could beextracted.4 Diosgenin is remarkably similar to progesterone it its chemicalconfiguration. Because of its steroidal saponins, wild yam has been usedfor hundreds of prescription drugs including some birth control pills;however, these forms of the plant have been chemically isolated andaltered resulting in variations of the plant’s natural compounds. Theseartificially manipulated chemicals can initiate abnormal responses in thehuman body, a fact which accounts for their long list of risks and sideeffects. Synthetic forms of progesterone whether derived from wild yamor not are not the same as an extract of the whole wild yam. It’s useful toknow that products listing wild yam as an ingredient may not includedthe saponin-rich portion of the yam root. Progesterone which is derived from wild yam is almost identical in its chemical structure to the natural progesterone synthesized by the humanbody. When wild yam is absorbed into the body it is easily converted intothe same molecule, a process which does not occur with synthetic vari-eties. The transition is easy and natural. Wild yam in and of itself does not contain simple progesterone or other steroids, but serves as a precursor to these compounds. The phytoe-strogen character of wild yam explains its traditional usage for menstrualcramping, dysmenorrhea, and afterbirth pains. Due to its mark e t a b i l i t y, pharmaceutical companies looked to patentable progesterone analogues which were chemically synthesized from the progesterone derived from the wild yam. This new class of drugswere called progestins or prestrogens and while they may have originatedfrom the wild yam, they differed profoundly in their overall biologicalaction as well as their toxicity. These enhanced and chemically synthesizedversions of wild yam progesterone did not offer the total and synergisticeffects wild yam provided in its natural state. Furthermore, they posed sig-nificant health risks which many women are not completely aware of.
While synthetic progestin drugs pose health hazards, natural progesteronedoes not.5 SIDE EFFECTS OF SYNTHETIC PROGESTIN DRUGS Premarin and Provera are two of the most commonly prescribed prog- estin drugs and come with a wide variety of side effects and health risks.
Over 30 negative side effects are listed for Provera alone. Taking Proveraduring early pregnancy may actually cause a miscarriage or deformity ofthe developing fetus. Premarin is comprised of two different types ofestrogen called estrone and estradiol, which have been linked with thedevelopment of certain kinds of cancer.
The risks involved with taking these synthetic progestins is due to their chemical structures. For the most part, the compound resembles naturalprogesterone, therefore it binds to the same receptor sites as to naturalprogesterone. The altered portions of the molecule, however, convey atotally different signal to the cells involved. It is this atomic manipulationwhich poses alarming health risks to the body. Health risks which are notassociated with natural hormonal precursors. A few of the side effectsassociated with synthetic progestins include: As is often the case, eventually the perils of synthetically derived plant analogues made health practitioners question their usage and the notion of using progesterone in its natural state has re-emerged. Unfortunately,its classification as a non-patentable simple substance relegates it to thestatus of an herbal supplement, which most doctors will not endorse.
Synthetic drugs are more potent, usually easier to take, have a longer phys-iologic action and are patentable. For all of these reasons, natural phy-tomedicines have been shelved as re l a t i vely worthless in comparison.
Chemically altered pro g e s t e rone is considered technically superior when inre a l i t y, natural forms of pro g e s t e rone may often be pre f e r a b l e .
OTHER BIOLOGIC BENEFITS OF NATURAL PROGESTERONE While natural progesterone has been referred to as a progestin because it maintains the lining of the uterus, it is technically separate and totallydifferent from synthetic progestins. In addition, natural progesterone pro-vides a number of biological actions which progestins do not. Some addi-tional benefits reported with the use of natural progesterone include: • reduction in joint pain and swelling• enhanced skin moisturization• fading of liver spots• faster healing of wounds• reduction of yeast infections• supports the immune system• protects against the side effects of unopposed estrogen• tranquilizing• sleep promotion THERAPEUTIC APPLICATIONS OF NATURAL PROGESTERONE • necessary for the survival and development of the fetus• helps to prevent osteoporosis• needed for the proper production of adrenal hormones• works to stabilize blood sugar• has a natural diuretic action• prevents salt retention• acts as an antidepressant• helps prevent the formation of fibrocystic breasts• enhances thermogenesis (the burning of fat) • contributes to regulating the thyroid gland• enhances libido• helps protect the uterus and breasts from malignancies• contributes to blood clotting mechanisms• precursor of corticosterones• helps to protect against breast cancer• normalizes zinc and copper levels• maintains the secretory endometrium Note: Using natural progesterone in cream, oil or other transdermal formis also very hydrating to the skin.
Natural progesterone is one of the safest supplements available. In contrast to synthetic progestins, this form of progesterone has little or noside effects. Some women may experience an initial reaction to introduc-ing progesterone, a phenomenon which involves an estrogen response. Inthese cases, estrogen-related symptoms may temporarily become worse. Ifthis occurs, natural progesterone should be continued or dosages adjust-ed until hormonal balance is achieved. Incidental spotting between peri-ods may occur but is usually resolved within three to five cycles. The useof natural progesterone has not been linked to any form of human can-cer.
Combining natural progesterone with other drugs has not resulted in any interference or alteration that is known of. No adverse effects of nat-ural progesterone have been reported on the developing fetus of pregnantwomen, unlike its synthetic counterparts. Using natural progesteronecreams during pregnancy appears to be perfectly safe and may even helpto counteract the post-partum depression which so many women experi-ence after their progesterone levels fall dramatically. (Note: When naturalprogesterone is first introduced into the body, an initial estrogen responsemay occur possibly making estrogen-related symptoms more intense. Thisreaction is perfectly normal and varies with each individual. It is a tem-porary phenomenon and continued use will eventually achieve hormonalbalance. Experiencing longer periods, heavier flows, more cramping, ten-der breasts etc. may indicate that natural progesterone dosages may needto be adjusted in order to achieve hormonal balance.) WHY TOPICAL APPLICATION OF NATURAL PROGESTERONE? Progesterone is a fat soluble compound which maintains its integrity much more readily when absorbed transdermally (through the skin) thanwhen taken my mouth. When progesterone is ingested orally, it is subjectto rapid breakdown (metabolism) in the liver, making it considerably lesseffective. Medical practitioners have used synthetic progesterone in a vari-ety of forms ranging from capsules to injections to vaginal and rectal sup-positories. Originally, orally administered progesterone or progestins were not efficiently absorbed through the intestinal wall and had to pass throughl i ver quently, much of the absorbed progestins were metabolized by the liverinto inactive compounds. Up to 80 percent of the effectiveness of proges-terone can be lost when taken orally.6 By contrast, progesterone is verynicely absorbed transdermally (through the skin) and much more of itsbiochemical activity is retained. I believe that natural progesterone cream derived from wild yam extractshould be used by almost every mature adult . . . I believe that progesteronecream could do more to preserve health and well-being in elderly people thanall the drugs in the world.7 Dr. Lee reiterates that “. . . natural progesterone is efficiently absorbed transdermally, a fact that enhances patient’s acceptance of its use andgreatly reduces the cost of therapy.”8 Salivary hormonal lab tests are becoming more common and have fur- ther supported the effectiveness of natural progesterone absorptionthrough the skin by monitoring levels.9 These tests have proven that prog-esterone levels rise when wild yam extracts are applied to the skin.
When a woman’s body experiences an imbalance of progesterone resulting in estrogen dominance, a variety of pre-menstrual symptoms canresult. Estrogen dominance can occur when a progesterone deficiency ispresent. PMS refers to a whole host of symptoms which can vary from woman to woman. Conventional therapies for PMS involves the use ofantidepressants, diuretics, counseling, nutritional regimens and synthetichormones. Interestingly, most symptoms which commonly characterizePMS are also typical of estrogen dominance. Due to this observation, Dr.
John R. Lee gave natural progesterone to his patients with PMS andobtained some impressive results. “The majority (but not all) of suchpatients reported remarkable improvement in their symptoms-complex,including the elimination of their premenstrual water retention andweight gain.”10 Let’s quickly review the hormonal flux which characterizes the men- strual cycle. During the week following the end of the menstrual period,estrogen is the dominating hormone which initiates the buildup of theuterine lining once again. At the same time, eggs in the ovary begin tomature. Estrogen levels also contribute to the secretion of more vaginalmucous at this time making the tissue environment more conducive tosperm survival and motility.
From ten to twelve days after the beginning of the last period, estro- gen levels will crest and then begin to taper just prior to ovulation andwhen the egg (corpus luteum) has matured enough to produce proges-terone. Consequently, progesterone will dominate during the second halfof the cycle. Increased levels of progesterone cause the body temperatureto rise, the continued development of the uterine blood-filled lining, andthe thinning of cervical secretions. All of these events occur in anticipa-tion of the presence of a fertilized egg. If pregnancy does not occur within 10 to 12 days after ovulation, both estrogen and progesterone levels rapidly fall, which initiates the sheddingof the uterine lining (menstruation) and a new cycle begins again. If awoman becomes pregnant, progesterone levels continue to rise and theuterine lining remains intact to receive and nourish the fertilized egg.
Eventually the placenta will produce much higher than normal amountsof progesterone throughout the remainder of the pregnancy.
It’s rather easy to see that a woman’s monthly cycle is regulated by the rise and fall of estrogen and progesterone. This perfectly natural fluctua-tion of hormones can wreak havoc with the health of a woman whenimbalances occur. More often than not, a hormonal imbalance consists ofa progesterone deficiency. Progesterone was designed by nature to inhibitmany of the negative effects of estrogen. If progesterone levels do not bal-ance out estrogen during the last two weeks of the cycle, PMS can become a problem. Dr. Lee illustrates this, saying: “A surplus of estrogen or a defi-ciency of progesterone during these two weeks allows for an abnormalmonth-long exposure to estrogen dominance, setting the stage for thesymptoms of estrogen side effects.”11 Clearly, natural progesterone may be one of the most, if not the most effective, therapies to deal with PMS miseries. Unfortunately, manywomen are completely unaware of its action or availability.
WHY DO SO MANY WOMEN SUFFER FROMHORMONE IMBALANCES? The question of why so many women, young and old, suffer from a hormonal imbalance persists. Today’s environment and life style are cer-tainly significant causal factors and explain, to a great degree why evenyoung, seemingly healthy women may experience a lack of progesterone.
Dr. Peter Elliston of the Harvard Anthropology Department foundthrough one of his studies of 18 women who all had regular menstrualcycles that seven of them did not experience a mid cycle increase in pro g-e s t e rone levels, suggesting that ovulation did not actually occur.1 2 Dr. Leecites this as yet another example of the widespread incidence of anov u l a-t o ry cycles occurring in young women throughout this country, a factwhich is undoubtedly linked to rising infertility rates in the United St a t e s .
Eating disorders, poor nutrition, widespread use of birth control pills, stress, pollution, etc., contribute to hormonally-related disorders andmost certainly affect progesterone production, the ability to conceive andmenopausal transitions.
• stress• environmental pollution• ingested toxins• nutritional deficiencies• birth control pills• synthetic hormones• menopause• xenoestrogens (substances which act like estrogen in the body such as • cer -tain pollutants) • hormonal residue in animal meats It’s relatively easy to determine if your hormones are out of balance and if you are lacking progesterone. One of the key symptoms of a prog-esterone deficiency is the presence of PMS. Even a young, relativelyhealthy woman can suffer from a lack of progesterone. In addition, we livein a world full of toxins, food additives and hormonally fattened meats.
Dr. Lee believes that widespread use of the birth control pill has causedthe ovaries to be compromised, possibly playing a role in the developmentof PMS that would normally not exist.13 Documented results from using natural progesterone have been impressive but remain relatively unknown by the majority of women.
Progesterone therapy can help relieve the following PMS symptoms:breast engorgement, breast tenderness, irritability, headaches, depression,moodiness, fatigue, anxiety, bloating, water retention, cramps, and irreg-ular periods. Dr. Joel T. Hargrove of Vanderbilt University Medical Center has had some very impressive results using natural progesterone to treat hispatients with PMS. He has had a 90 percent success rate using this formof progesterone.14 Interestingly, he used oral progesterone which had to beadministered in a much heavier dose to achieve the same results Dr. Leeobtained with transdermal progesterone.15 Natural progesterone can contribute to restoring normal menstrual cycling in certain cases. Many young women suffer from amenorrhea,which is the absence of the menstrual period due to an excess of strenu-ous exercise or a hormonal imbalance. Using natural progesterone canhelp to achieve the proper estrogen/progesterone ratios needed to initiatenormal cycling. Frequently, supplementation needs to occur over severalmonths before normal cycling will be achieved.
In addition, women who suffer from irregular periods or prolonged periods can benefit from the action of natural progesterone. Remember, that initially, cycles may become worse rather than better, but with con-tinued use, the prospect for normalizing the menstrual cycle is good if noother contributing factors exist. Natural progesterone supplementation may also be beneficial for infer- tility. Women who suffer from repeated miscarriages or have a difficulttime conceiving should be checked for a progesterone deficiency. It isadvisable to check your progesterone levels before taking potent fertilitydrugs or synthetic hormones. Using natural progesterone is suggested asan initial therapy.
Consider the following quote concerning mood elevation and depres- The domino effect of the inter-relationship between amino acids, vitaminsand neurotransmitters is further complicated by the presence of estrogen . . .
an estrogen overload can cause a number of distressing symptoms. Estrogenis a central nervous system stimulant while progesterone has the oppositeeffect. Maintaining the right balance between these two hormones is a com-plex and delicate process. Any imbalance can trigger a change in mood. Inorder to have enough serotonin, you need tryptophan which is necessary forits production. To have enough tryptophan, your body must have certainamounts of vitamin B6. This chemical chain can be broken by estrogen,which can block the action of vitamin B6 and force it to be eliminated fromthe body . . . consequently, you feel like the world is coming to an end.16 Ironically, synthetic forms of progesterone which are routinely pre- scribed to help with PMS related depression etc. can actually inhibit theabsorption of vitamin B6, thereby contributing to emotional instabilityand mood swings.
Clinical depression, anxiety attacks and mood swings can all respond to natural progesterone therapy. In addition to opposing estrogen, prog-esterone stimulates the adrenal glands which help to elevate mood andcreate energy. One of the most dramatic effects of using natural proges-terone is in creating emotional stability. In other words, fluctuating between euphoria and depression in response to hormonal flux is greatlyeased by increased progesterone. The short-tempered, anxious or nervousstates so typical of PMS are also tempered by keeping estrogen levels incheck. The developments of fibrocystic breasts is directly linked to an excess of e s t rogen. One of the most dramatic therapeutic effects of natural pro g e s-t e rone is the rapid clearing of these types of breast cysts. Dr. Lee’s experiencewith natural pro g e s t e rone treatment for this disorder is nothing less thanre m a rkable; he found that if natural pro g e s t e rone was applied in cream formfor two week prior to menstruation, fibrocystic breasts completely cleare dwithin 2 to 3 months.1 7 Fibroid tumors of the uterus can develop when estrogen remains unopposed by progesterone and can also result from repeated cycles whereovulation fails to occur. Typically women will suffer from these fibroidsapproximately ten years prior to the onset of menopause. Dr. Lee’s workwith treating uterine fibroids once again reiterates the need for naturalprogesterone supplementation. He writes, “If sufficient natural proges-terone is supplemented from day 12 to day 26 of the menstrual cycle, fur-ther growth of fibroids is usually prevented (and often the fibroidsregress).”18 An ovarian cyst usually forms when follicles in the ovary fail to nor- mally develop and subsequent release from the ovary is impaired in someway. As a result of this abnormality, hormonal balance is disrupted withtypical estrogen surges resulting in the formation of a growing cyst eitherfrom the follicle or from the corpus luteum. Consider the following quoteconcerning cysts: Natural progesterone, given from day 5 to day 26 of the menstrual month for2-3 cycles, will almost routinely cause the cyst to disappear by suppressingnormal FSH, LH and estrogen production, giving the ovary time to heal.19 During the thirties and forties of a woman’s lifetime, progesterone pro- duction can decrease resulting in shorter intervals between periods. Forexample, when the ovaries produce progesterone for only 9 days ratherthan the normal 14, menstruation may occur every 24 days rather thanthe usual 28 days. In addition, low levels of progesterone coupled with anestrogen dominance can cause the lining of the uterus to build up leadingto abnormally heavy menstrual flows or even spotting between periods. Many women who are in perimenopause (the years just prior to the onset of menopause) experience these symptoms in combination withintensified PMS. Weight gain, bloating, headaches, irritability, depres-sion, and anxiety are common complaints for women in their late thirtiesand throughout the forties. Frequently, these women had no cycle-relatedproblems in their earlier years and suddenly become all to aware of awhole host of troubling symptoms. More often than not, a drop in prog-esterone and an estrogen overload are to blame. Just because a woman no longer ovulates or has a menstrual cycle does not mean that she no longer needs to achieve a proper ratio of hormones.
On the contrary, it is during these years that the right kind of hormonalsupplementation needs to be implemented or menopausal symptoms anddiseases like osteoporosis may deve l o p. To d a y, estrogen replacement thera-py (ERT) is recommended for many postmenopausal women with theassumption that it can help pre vent heart disease, osteoporosis and possiblyA l z h e i m e r’s disease. Un f o rtunately much controversy surrounds the pre-scription of synthetic hormones due to their potentially dangerous sidee f f e c t s .
Ideally, a far better solution would be to supply the body with the proper natural biochemical building blocks to prompt the production ofnatural hormones. This is where phytoestrogens or plant-based com-pounds such as dioscorea (wild yam) can play a profoundly important rolein managing menopausal disorders such as osteoporosis. At this writing, evidence points to the fact that natural progesterone may be even more effective in treating osteoporosis than estrogen replace-ment therapy. While this evidence is still in its initial stages, it is signifi- cant and must be considered. In 1981, Dr. John Lee conducted a land-mark study evaluating the effectiveness of using natural progesterone forosteoporosis.20 His study indicated that it is the cessation of progesteroneproduction in postmenopausal women which causes the development ofosteoporosis. Contrary to current trends, progesterone replacement, notestrogen, in fact may be the answer to preventing and treating osteoporo-sis. Dr. Lee’s study has profound implications for all women. In his practice, Dr. Lee applied a natural progesterone cream on one hundred postmenopausal women and eliminated their usual dose of oralProvera (a synthetic progestin). The majority of these women were invarying stages of osteoporosis. Each participant used the natural proges-terone cream for several consecutive days each month over a period ofthree years. The results were dramatic, to say the least. In addition to pre-venting further height loss and eliminating aches and pains, the bonemineral density of the spine was preserved in 63 of the women. In otherwords, these women not only stopped the bone loss associated with osteo-porosis but actually experienced an increase in bone mass which, in manycases was more dramatic than had been seen with other therapies. In addi-tion, the incidence of bone fractures actually dropped to zero.
Dr Lee’s study found that estrogen was not the panacea for bone den- sity previously assumed. He discovered that the women who took estro-gen in combination with the progesterone were not better off than thosewho took progesterone alone. What was even more impressive was dis-covering that osteoporosis is a reversible condition with progesteronetherapy. Concerning the use of progesterone for osteoporosis, Dr. Leewrites: . . . when my 40 year old housewives had become 60-year olds with osteo-porosis and I learned of transdermal natural progesterone (being sold as askin moisturizer), I started adding it to my therapeutic regimen for osteo-porosis, at first only to those for whom estrogen was contraindicated. To mysurprise, serial bone mineral density tests showed a significant rise without ahint of side effects. With this obvious success, my use of natural progesteronespread to osteoporosis patients who were not doing all that well on estrogenalone. Again, it proved successful.21 Apparently, women who had the lowest bone densities experienced the greatest increases, implying that age and the progression of the diseasesdoes not affect the beneficial therapeutic action of natural progesterone.
This study is profoundly significant in that it strongly suggests that women who take estrogen to prevent or treat osteoporosis may be betteroff using natural progesterone. As a result of Lee’s findings, several physi-cians began to use natural progesterone cream for their pre- and post-menopausal patients. The most striking implication of Dr. Lee’s work with natural proges- terone is that contrary to current medical opinion, osteoporosis may bemore a manifestation of a progesterone deficiency than a lack of estrogen.
In addition, the disease may be initiated long before menopause whenestrogen levels are still high.22 Moreover, continued estrogen therapy forwomen with osteoporosis often caps out whereas progesterone therapycontinually promotes the production of new bone.23 Dr. C. NormanShealy, M.D. states: I believe that natural progesterone cream derived from wild yam extractshould be used by almost every mature adult . . . The most common cause ofdeath in elderly women is from the complications of fracture of the hip fromosteoporosis. Such fractures are also remarkably common in men. I believethat progesterone cream could do more to preserve health and well-being inelderly people than all the drugs in the world.24 The two types of cancer that are hormonally related include breast and uterine cancer due to the fact that the tissue which make up these areasare much more sensitive to hormone levels. It is a well known fact that anexcess of estrogen can increase the risk of developing uterine cancer andcertain types of estrogen have been linked to the formation of malignantbreast tumors.25 Any woman who continually suffers from insufficient progesterone can also increase her chances of developing certain types of cancer. A pro-longed lack of progesterone can cause uterine changes which eventuallyresult in the impaired shedding of the uterine lining. When this occurs month after month, endometrial hyperplasia can result, which is theabnormal thickening of the uterine lining. This buildup can lead to thedevelopment of uterine cancer. Progesterone can actually reduce the riskof developing uterine cancer which can develop from using estrogen ther-apy.26 In addition, for women who have survived uterine cancer and have undergone hysterectomies, natural pro g e s t e rone can be inva l u a b l e .
Because these women are advised to forgo hormonal treatments of anykind, they often suffer with osteoporosis or other symptoms typical ofmenopause. Taking natural progesterone poses no health risks and canhelp to prevent or treat these disorders. Concerning this group of womenDr. Lee writes: These are the women for whom I first began using natural progesterone ther-apy. Not only did progesterone reverse their osteoporosis and, in many, it cor-rected their vaginal atrophy, but none, to my knowledge, have ever developedcancer of any sort . . . The evidence is overwhelming that natural proges-terone is safe and only estradiol, estrone and the various synthetic estrogensand progestins are to be avoided to reduce the risk of endometrial cancer.27 In the case of breast cancer, studies strongly suggest that this type of malignancy is more likely to occur in premenopausal women who havenormal or high estrogen levels and low progesterone levels.28 Women over35 who continue to have periods but no longer ovulate and women whoare taking synthetic estrogen without progesterone during and aftermenopause may find themselves in this higher risk group.
One of the most interesting studies on progesterone was conducted at Johns Hopkins University in 1981, where physicians studied 1083women for between 13 to 33 years in assessing the incidence of breastcancer. They found that those women who had a progesterone deficiencywere over 5 times more at risk of developing breast cancer than thosewomen who had adequate progesterone levels.29 Moreover, the studyfound that women who suffered from a lack of progesterone also had tentimes more cancer-related death from all types of malignancies than thosewho did not.30 These statistics are dramatic, to say the least. Consider thefollowing quote: . . . the evidence is strong that unopposed estradiol and estrone [two formsof estrogen] are carcinogenic for the breasts, and both progesterone and estri- ol, the two major hormones throughout pregnancy, are protective againstbreast cancer. One is left to wonder why supplementation with these twobeneficial and safe hormones are not the ones used routinely for womenwhenever hormone supplementation seems indicated . . . both hormones areavailable and are relatively inexpensive. Why have these two hormones beenneglected by contemporary medical practice in favor of synthetic substi-tutes.31 THE CONNECTION OF PROGESTERONE TO WEIGHT LOSS Interestingly estrogen promotes the storing of fat and is responsible for the female contouring of the body, whereas progesterone enhances ther-mogenesis or fat burning. In addition, using natural progesterone to bal-ance out hormones can help to decrease carbohydrate cravings which arehormonally related. The hormonal flux typical of most female cycles usu-ally produces a premenstrual craving for sweets which is linked to fluctu-ating blood sugar and serotonin levels in the brain. Many women havefound that taking natural progesterone has resulted in a marked decreaseof “hormonal eating” which can result in unwanted weight gain. Thedesire to continually eat during periods of hormonal flux month aftermonth certainly plays a significant role in female obesity. Excessive hor-monal appetite stimulation is not normal, neither is it healthy.
Of additional interest is the fact that the more fat stores a woman car- ries, the more estrogen she makes, further compounding the problem. Fatcells contribute to estrogen dominance which in turn makes it harder toburn fat—a perfectly vicious little cycle. The estrogen factor for any over-weight woman must be considered, however, it is rarely addressed.
Clearing excess estrogen from the body is absolutely essential for effectiveweight loss. Again, supplementing the body with natural progesterone canhelp to accomplish this. While scientific documentation on the link between natural proges- terone therapy and fibromyalgia has yet to be researched, a significantnumber of women are finding that the pain associated with this disorderis alleviated when taking transdermal pro g e s t e rone. The cause offibromyalgia remains a mystery to medical doctors, although its connec-tion to hormonal factors or neurochemistry has been proposed. Taking natural progesterone has resulted in alleviating insomnia in some women,which may also be beneficial for those with fibromyalgia. The pain offibromyalgia is especially troublesome at night.
When is comes to the role of progesterone in males, a significant inequity exists. In other words, medical science has literally ignored therole of progesterone in the male menopause. Male menopause is alsocalled “andropause” and occurs when testosterone levels decrease. As aresult of this drop, bone weakness and prostate disorders can occur.
Testosterone acts very much like progesterone explaining why men can also develop brittle bones as testosterone levels decline. Men have proges-terone levels much the same as women do after the age of 50, and likewomen, men are subject to varying degrees of osteoporosis, although maleversions are much less severe. Men could very well benefit from using progesterone creams that have formulas designed to address testosterone imbalances which can lead toprostate disease. These formulas should contain the proper dosage ofprogesterone, which would be much less than the amount required for awoman. Dr. C. Norman Shealy M.D. writes, “Every male with DHEAlevels below 600 ng/dl should use natural progesterone cream, except menwith prostate cancer.”32 DHEA is the building block of the sex hormonesand is currently the subject of intense study due to its effect on aging anddegenerative disease. Natural progesterone is available in oils, capsule or cream form. The best delivery system for natural progesterone appears to be through theskin; therefore, creams, oils or other formulations designed for skinabsorption are recommended. The source of the natural progesteroneshould be wild yam extract and preparations using the whole wild yam arepreferable. Monthly costs for natural progesterone can vary according toits source, but usually average between $20 and $50 a month. To obtain maximum absorption, natural progesterone creams should be applied to the softer areas of the skin such as the neck, face, arm pits, thighs, breasts, etc. The soles of the feet or palms of the hands are alsoexcellent absorption sites and are recommended in individuals who arehighly allergic to topical creams or oils. A thin application over a larger area is recommended. Some women use the cream directly on their abdomens if they are experiencing men-strual cramping. Natural progesterone creams that have been combinedwith herbs such as saw palmetto can also be used by men and applieddirectly on the testicles.
Natural progesterone creams can be used every day, however, initial applications should be liberal (one half teaspoon) used both at morningand night. In time this quantity can be decreased. Using the cream every-day can lead to a decrease in sensitivity which may inhibit the action ofthe cream. For this reason, Dr. Lee has recommended that post-menopausal women use the cream for 2 to 3 week intervals with one weekoff. Women who are pre-menopausal or perimenopausal should use theprogesterone from day 12 to day 26 of their menstrual cycle. Application sites should be rotated for maximum efficacy. Leaving 3 to 5 days of the month without using the natural progesterone is also rec-ommended to prevent the development of a kind of “immunity” to thewild yam phytoestrogens. Each individual should determine whether theamount of cream used is effective and adjust accordingly. Most womenneed to use natural progesterone for an indefinite period of time. Natural progesterone in cream or other transdermal forms appears to be one of the most effective and safe supplements for the treatment of var-ious hormonally related disorders. It may well be superior to estrogenreplacement therapy in some cases and should be utilized and evaluatedfor its superior therapeutic actions. No longer the “forgotten hormone,”natural progesterone, especially in the form of wild yam extract, is noth-ing less than remarkable in its physiological actions. While so manywomen are turning to synthetic hormones, tranquilizers, and analgesics tomanage PMS and postmenopausal miseries, natural progesterone maywell be the best and safest alternative.
Getting the word out while scientific studies continue to support the credibility of using natural progesterone is currently underway. It wouldbe nothing less than tragic if an affordable and safe substance like wild yam extract remained unused due to a lack of knowledge. The word isspreading rapidly. Dr. Lee put it well when he stated: I must conclude with a tribute to what I call the women’s underground com-munication network, the vast informal woman-to-woman communicationnetwork that spreads hormone and health information with astonishingspeed and extent around the world. An informational and health revolutionis underway, thanks to the networking of intelligent, concerned women.33 I consider myself most fortunate to have become acquainted with nat- ural progesterone synthesized from wild yam. For me, the discovery ofthis safe and marvelous supplement has been nothing less than extraordi-nary. It has made what was once a life lived at the mercy of the hormon-al upheavals into one that is much more even-keeled, healthier and full ofoptimism. 1 John R. Lee, M.D., NATURAL PROGESTERONE: THE MULTIPLE ROLES OF A REMARKABLE HOR -MONE, Revised. (BLL Publishing, Sebastopol, California: 1993), 4. See also U.S. Barzel, “Estrogens in the pre-vention and treatment of postmenopausal osteoporosis: a review.” AM J MED, (1988), 85: 847-850 and D.R.
Felson, Y. Zhang, M.T. Hannan, et al., “The effect of postmenopausal estrogen therapy on bone density in elderlywomen.” THE NEW ENGLAND JOURNAL OF MEDICINE. (1993), 329: 1141-1146.
2 Darrell W. Brann, “Progesterone: The Forgotten Hormone?” PERSPECTIVES IN BIOLOGY AND MEDI-CINE. Summer, (1993), 34:4, 642. See also A.I. Csapo and B.A. Resch, “Induction of preterm labor in the rat bythe antiprogesterone.” AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY. (1979), 134:823-27.
3 Penelope Ody, THE COMPLETE MEDICINAL HERBAL. (Dorling Kindersley, New York: 1993), 52.
4 Daniel B. Mowrey, THE SCIENTIFIC VALIDATION OF HERBAL MEDICINE. (Keats Publishing, NewCanaan, Connecticut: 1986), 112.
5 Lee, 16.
6 Ibid., 52.
7 C. Norman Shealy, M.D., DHEA THE YOUTH AND HEALTH HORMONE. (Keats Publishing, NewCanaan, Connecticut: 1996), 34.
8 Lee, 4.
9 Ibid., 101.
10 Ibid., 50.
11 Ibid., 51.
12 Ibid., 101.
13 Ibid., 52.
14 Ibid., See also “Progesterone: Safe Antidote for PMS.” MCCALL’S MAGAZINE. October, (1990), 152-56 andLinda Carol Graham, “Do You Have a Hormone Shortage?” REDBOOK. Februar y, (1989), 16.
16 Rita Elkins, M.A., DEPRESSION AND NATURAL MEDICINE. (Woodland Publishing, Pleasant Grove,Utah: 1995), 129.
17 Lee, 84.
18 Ibid., 87.
20 Alan R. Gaby, M.D., PREVENTING AND REVERSING OSTEOPOROSIS. (Prima Publishing, Rocklin,California: 1994), 150. See also John, R. Lee, M.D. “Osteoporosis reversal: the role of progesterone.” INT CLINNUTR REV. (1990) 10:3, 384-91 and John R. Lee, M.D., “Osteoporosis reversal with transdermal progesterone.”LANCET. (1991), 336, 1327 and John R. Lee, M.D., “Is natural progesterone the missing link in osteoporosis pre-vention and treatment?” MED HYPOTHESES. 35, 316-18.
21 Lee, NATURAL PROGESTERONE, 4.
22 Ibid., 102.
24 Shealy, 34.
25 Lee, NATURAL PROGESTERONE, 71. See also R.A.Hiatt, R. Bawol, G.D. Friedman and R. Hoover,“Exogenous estrogen and breast cancer after bilateral oophorectomy.” CANCER. (1984), 54, 139-44.
26 Lee, 4. See alsoR.B. Gambrell, “The Menopause: Benefits and Risks of Estrogen-Progesterone ReplacementTherapy,” FERTIL STERIL, 1983, (37, 457-74).
27 Ibid., 7528 Ibid., 72. See also, L.D. Cowan, L.Gordis, J. A. Tonascia, and G.S. Jones. “Breast Cancer Incidence in Womenwith a History of Progesterone Deficiency. JOURNAL OF EPIDIMIOLOGY, 1981, (114) 209.17.
29 Schealy, 35.
31 Lee, 74.
32 Schealy, 35.
33 Lee, 102.
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