In recent years, there has been a dramatic increase in the variety of alternative medicine therapies in use by individuals, hospitals, physicians, and other health professionals in many fields. I am excited to see this changing trend and have been a long-standing advocate for integrating alternative approaches in Western (allopathic) medicine. I am such a proponent for the inclusion of these therapies in our usual medical approaches that I designed an annual continuing medical education course for physicians to learn more about complementary or alternative medicine and use these therapies with their patients. Although alternative medicine has been a term in general use, I prefer the term complementary medicine because I think these therapies are necessary for many patients and indeed do “complement” the techniques used in Western medicine. I have used many of the complementary medicine modalities for my own healing from various surgeries. I know with certainty that I would not have the mobility and range of motion I have today if I had not incorporated massage therapy, neuromuscular therapy, myofascial release, and hydrotherapy into my own rehabilitation. I have also personally used biofeedback, hypnotherapy, visualization-guided imagery, aromatherapy, therapeutic hot mud packs (prescribed by an Italian physician), physical therapy, chiropractic, acupuncture, and herbal therapies for reducing chronic pain and enhancing relaxation. I have also needed the best of Western medicine, involving complex imaging to diagnose my back and neck problems, precision neurosurgical approaches using high-tech operating microscopes to remove herniated cervical discs, and medications to reduce pain. I know at many levels, intellectually and from personal experience, how important it is for patients to have an integration of these therapies in order to get well and become healthy again.
As you read this book and hear me talk about the new scientific advances and hormone therapies in women’s health, remember this: First and foremost, my belief system emphasizes wellness and natural options as the foundation, with medical (surgery, medications, etc.) approaches to be added when needed. I know firsthand, however, how important both are to providing complete health care. I am convinced that the key to reducing future health care costs, maximizing patient recovery, and improving well-being will come from the blend of traditional Western and complementary therapeutic approaches.
In the best sense of the word, the blend of traditional Western and complementary therapeutic approaches used together in an integrated approach can be called “wholistic” medicine. The term holistic (wholistic) medicine as often used, however, tends to have a different meaning: “holistic” has come to refer primarily to therapies perceived as “natural,” and usually ends up meaning any “non-Western medical” approach to healing, such as herbal medicine, homeopathy, naturopathy, chiropractic, Chinese medicine, acupuncture, bodywork, energy-work, and others. In this common usage, Western scientific medicine is excluded, making a lopsided approach just like we see when traditional Western physicians ignore the complementary therapies available.
I would like share with you what wholistic medicine means to me as a practicing physician: To make “holistic” medicine truly whole or complete, it must mean “a combination of medical and complementary modalities for healing that takes into account the whole individual and the individual’s physical-emotional-spiritual-social needs in designing a plan for enhancing health, creating an environment for healing, and treating illness.”
Even though we have seen a surge in interest in complementary medicine, the above definition has been my philosophy and approach to health care since before I started medical school. I have continued to learn and grow in my own understanding of the many approaches that can help people in “dis-ease.” The way I view it, wholistic health care is not so much a technique as it is an attitude. It is an attitude of seeing each individual as a unique blend of physical, psychological, and social needs, then designing a tapestry of techniques and interventions that will best address the particular needs of that person. You may have a definition of wholistic medicine similar to mine and wish it were more available as a model of health care delivery. Consumers who use complementary therapies usually have to pay out of pocket, because these services are not as often covered by health insurance plans. I hope we will see a time in the near future when the benefits of complementary therapies are well established from the point of view of both clinical effectiveness and economically lower cost than is our present fragmented system. As a teacher for physicians and other health professionals, I strongly believe that we are making progress toward an integrated approach. I hear more and more physicians genuinely interested in learning about complementary therapies and incorporating these modalities for their patients and for themselves.
At the same time, it is distressing that I hear more condemnation of Western physicians among the alternative practitioners, who now appear as closed minded to Western approaches as allopathic physicians had previously been to the alternatives. “Holistic” medicine cannot be whole if its practitioners refuse to accept what allopathic Western medicine has to offer, anymore than we allopathic physicians can be whole in our approaches if we fail to include nutrition, exercise, bodywork, biofeedback, acupuncture, chiropractic, and a host of other complementary options. All of us, in the best interests of our patients and clients, need to stop the turf battles and start collaborating.
Women in particular seek a total approach to their health care, integrating techniques from traditional Western medicine with techniques from traditions of Eastern, Native American, and other ancient healing approaches. Women’s wisdom down through the ages provides us with an understanding of the ways women had an intuitive knowledge of the value of all these approaches to healing. In the Greek mythology, the two daughters of Aesculepius (god of healing), Panacea and Hygiea, were the goddesses of different realms of healing: Hygiea’s domain was health practices (now known as hygiene) and Panacea’s role was to apply the “healing balm” of kindness and compassion. The word panacea has now come to imply a relatively meaningless cure-all, something of little real value in technological medicine. But in its ancient meaning, you can see how crucial the healing balm of kindness and compassion is whenever there is suffering and a need for healing. In the ancient Greek view, the domains of both Hygiea and Panacea were important to the total healing process. This is the balance we again seek to achieve today.
Such ideas were important to early American women physicians. Elizabeth Blackwell, the first woman in the United States to earn a formal medical (M.D.) degree, had a profound influence on health care delivery for women in the nineteenth century. Dr. Blackwell was a strong proponent of proper use of the medicines available in her time (the late 1800s), along with healthy food, exercise such as walking, fresh air and sunshine, good hygiene, sanitary practices in hospitals and doctors’ offices, and other modalities we would today call wellness approaches. At the time she pushed for sanitary practices in hospitals, surgeons still did not know the value of hand washing between surgeries to cut down the infection rate. At Dr. Blackwell’s hospital for women, where she insisted upon such procedures of good hygiene and washing, the infection and death rates following childbirth were a minuscule percentage of the rates at the more prestigious New York hospitals run by her male medical colleagues who did not believe hand washing was necessary. Women physicians have often been in the forefront of encouraging the use of traditional therapies and wellness lifestyles, and women patients seem genuinely more responsive to and interested in these complementary approaches.
I have seen an ominous trend in the last several years as I speak to women’s groups around the country. I have seen an emerging antagonism toward Western medicine physicians and Western medications (pharmaceuticals). I hear women talk about the “good” alternative therapists and herbal remedies and how “bad” doctors and “drugs” are. Recent medical research has helped to clarify many of the health risks specifically threatening women’s well-being and longevity, and to develop effective therapies and medications with fewer side effects compared to those of the past. We have an enormous and exciting body of science to support the rationale and safety of the various medications available today to improve our health. At the same time, however, women are turning away from Western science and medicines in droves. I feel strongly that none of us can afford this “either/or” polarized model of thinking. I recognize all too well, and with sadness, just how much my own profession has failed to address the needs of women, but I believe women around the country are now in danger of throwing out the baby with the bath water when they reject what Western medicine has to offer. Women have rightly asked for more research into the health problems experienced by women. Yet, when that research shows that hormone therapy after menopause reduces the risks of certain diseases, many of the voices who cried out for more research now turn around and accuse physicians of medicalizing the natural menopause transition. I have been shocked and saddened by such views, and the anger with which they are spoken.
A mistaken idea often espoused by alternative therapists is that it is only medical drugs that are dangerous and cause unwanted side effects. Iatrogenic illness, meaning illness caused or aggravated by treatment procedures or medicines, has been with humankind ever since the first medicine man/woman gave someone an overdose of ground herbs. Curare is a plant-derived nerve toxin causing death by paralysis of the respiratory muscles if given in large enough amounts. You can become toxic on too many vitamin supplements, as well as by taking too much of a particular prescription drug. When I give a seminar, women tell me that herbal medicine is “more natural” and therefore safer. Herbs aren’t necessarily “gentler” or “safer” than pharmaceutical products. For example, I have seen quite a number of patients, as well as myself, who have had allergic reactions or toxicity symptoms to herbal products, contrary to the reassurances of herbalists who have said herbs are “balanced” and don’t cause allergic reactions. I also have patients who have had adverse reactions to Western pharmaceuticals. The street runs both ways. And if you are taking herbs to have a therapeutic effect, isn’t it just possible that they can also have side effects? Whenever you are taking “medicinals,” no matter what the source, there is the potential for benefit as well as the possibility of an undesirable reaction.
Yet many times, the same person who objects to taking a purified estrogen because it is made in a laboratory will take an herbal product with no ingredient list shown at all, or as a recent patient said to me, “Here is the list of herbs in this tonic, but I don’t have any idea what the words mean or what they do.” I have a hard time understanding the logic of this. I wouldn’t want to put something in my body unless I knew what I was taking, yet I see my patients doing this frequently when it comes to herbs and supplements. I find women often turning to alternative therapists as their primary or only provider of health services, and seek the road to wellness only through herbal remedies, vitamin supplements, colonics, and other practices that may or may not have appropriate application for a given person. The potential harm with this approach is that they may miss important and treatable medical problems. A common problem I see is the loss of energy and fatigue that occurs early in the course of thyroid decline, which may be missed if you just take extra vitamins and don’t have the appropriate thyroid tests done. Too often, particularly in women’s health care, both physicians and alternative therapists apply only their specialty, regardless of whether this resolves the problem. To put it another way, both groups get too involved with treating a symptom rather than the person and seeking the underlying cause(s) of the problem.
Keep this in mind as you design your health plan: Balance is the key. The body is an exquisitely sensitive, precision instrument, and it needs the proper balance in order to function optimally. That balance will be achieved in different ways, and with different techniques, for different individuals, using the tools of modern medicine along with the tools of complementary therapeutics. Each one of us is an individual with different needs. The key is to integrate and blend the therapeutic approaches right for you.
Perhaps several case vignettes of actual patients of mine will best illustrate these points and help to explain my philosophy of integrated approaches.
Ms. M. was a young woman in her early thirties who was referred to me by another physician, who said, “She is having significant problems with anxiety and mood swings, and I have her on these various medications, but she doesn’t seem to be getting better. She is having a hard time keeping her appointments with me, and I am really not sure what to do to help her. Would you see her and see what you think should be done?”
In doing a systematic medical and psychiatric evaluation of this young woman, I found an unrecognized medical problem (severe changes in her blood sugar levels and abnormally high levels of insulin production) that had a major impact on her mood swings. Her symptoms were much worse just prior to her menses because of the rise in progesterone that also affected her blood sugar regulation, and her symptoms were made worse by the high-dose progesterone suppositories her other physician had been using to treat PMS. She also had an unexpected “anxious agitation” reaction with the tranquilizers she had been receiving from several physicians. An additional factor causing her anxiety and agitation was the “withdrawal syndrome” each month that occurred when she stopped the large doses of natural progesterone she was using. I tapered her off these medications gradually over several months. I later suggested a small dose of a more appropriate anxiety-reducing medicine for her problem of adrenaline overactivity and treated her with a small amount of supplemental estrogen to correct her hormonal imbalance. Her meal plan was designed to increase protein and healthy types of fat to decrease the insulin surge, and I recommended more frequent small meals to stablize the blood glucose highs and lows. She was also started on a basic vitamin program with added calcium and magnesium. As a concert violinist, she had a great deal of stress, muscle tension, and performance anxiety aggravating her headaches and muscle pain. I used techniques of self-hypnosis, with relaxation-visualization training to help her with these problems and also referred her to a massage therapist and a chiropractor for regular bodywork to diminish the muscle tension and spasm. In addition, I recommended she seek training in the Alexander technique of muscle relaxation to improve her concert performance.
This woman also needed more intensive psychotherapy to help resolve problems from her childhood. It was rewarding to see that as she worked through these issues, she did not need the large doses of tranquilizers that had previously been prescribed. She is now doing very well, is taking far less medication, and taking estrogen has greatly improved her bone density as well as mood, sleep, memory, and concentration. She has made enormous strides on her road to well-being by understanding how she needs to eat, using effective relaxation techniques, working with various body therapies to address chronic neck and back problems, and having therapy sessions focused on her particular concerns for psychological health and spiritual growth. She has moved to New York and blossomed as a concert musician and music teacher, confident in her abilities as a soloist, as well as her roles as wife and mother.
What can we learn from this? The message is to listen carefully, look for patterns of symptoms (such as the premenstrual worsening of her mood changes, blood sugar swings, back and neck pain), and then systematically identify tools to improve overall health, comfort, and sense of control over life’s choices. Another lesson reinforced for me as I worked with this woman, is that women often need much less medication than the standard doses based on clinical drug studies done primarily on men. If you are not getting better with dose increases, talk to your physician about decreasing the dose of your medication to see if that will provide relief of troublesome symptoms. The gender differences in response to medication are quite striking and have not been addressed at all adequately in good research. I have addressed a number of these issues in earlier chapters.
Mrs. B. was sent to me by a psychic healer who intuitively “saw” a medical problem that doctors had not been able to diagnose. This woman had a back problem and had seen a chiropractor who recommended adjustment treatments and a long list of vitamin supplements. The manipulation helped ease the muscle spasm, but when this patient began on a lemon juice–maple syrup “cleansing fast” for a week or so (recommended by a naturopathic practitioner), the large doses of vitamins gradually began to create other problems. The imbalanced fasting formula, with such a high level of simple sugar carbohydrate and no protein, caused the excessive vitamins and minerals to become even more toxic.
Over the next three months, the patient developed bizarre “burning, electric shock-like sensations up and down my spine and body,” along with occasional numbness and tingling, marked mood changes, and generalized muscle weakness. She was seen then by a neurologist, but her unusual emotional expressions and behavior made him think she was “psychotic.” Since I worked in both internal medicine and psychiatry, I was asked to see her for a consultation. After getting the history I have just described, I asked her family to bring in all of the supplements she had been taking. It turned out to be a grocery bag full of various vitamins and herbal products. When I reviewed all of the overlap and duplication among the different products, and put the pieces of the puzzle together, it became clear that she had multiple vitamin and mineral toxicities from excess supplementation. These problems were then made worse by the syrup–lemon juice “cleansing” fasts that further upset body balance. She had not been on any allopathic or Western medications, and yet she clearly had toxicity symptoms. She was also a cigarette smoker, so of course the nicotine only aggravated her other problems. To regain normal nerve and muscle function, along with better mood stability, her body needed to be “detoxified” from these excesses. The situation for this woman was complicated enough that she required hospital admission in order to sort out the problems and do the necessary evaluations. The excessive supplements were stopped, and our dietitian worked with her on a healthy meal plan. Hypnotherapy was used to help with relaxation so she could stop the smoking that she thought was “calming my nerves.” Her neurological examination was abnormal, so I ordered a CAT scan of her lumbar spine and found that she had a partially ruptured lumbar disk that had intermittently caused some of the tingling sensations in her legs when she got into certain body positions. I prescribed physical therapy so she could learn good body posture, exercises to strengthen her back, and how to lift correctly. Since this woman’s only daughter was about to leave home for college, I felt that some of her mood symptoms were related to feelings of loss and could best be helped with supportive psychotherapy. I referred her to both physical and psychotherapists in her home town to continue this mind-body work.
What can we learn from what happened with this patient? One message is that multiple practitioners can unknowingly create problems by adding therapies that don’t blend well with something another therapist has recommended. I see this many times with my patients who may be starting hormone therapy with my guidance and then add herbal supplements from another practitioner at the same time. I also see women that have found a good stability on a hormone regimen and then another physician adds an antibiotic or other medication that alters the hormone metabolism, and the levels go haywire again. When you are seeing several health care providers, make sure that you tell each person what you are doing or taking under the care of someone else. For Mrs. B., the chiropractor had not recognized the toxicity from too much vitamin supplementation, or that his patient needed proper medical diagnosis about the unrecognized lumbar disk problem before she should start on a course of manipulation. Later, when she did see a neurologist, this physician did not take seriously her complaints of back pain because her behavior and emotionality, as well as the multiplicity of her unusual symptoms, made it difficult for him to see a neurological problem; he decided she was “psychotic.”
It does often happen that when a female patient (compared to a male patient) has symptoms that are unusual or puzzling, the female patient much more commonly will be told “there is really nothing wrong,” or she is written off as “neurotic” or “psychotic,” and the actual medical issues do not get promptly identified and treated appropriately. Neither Mrs. B. nor her family had communicated to anyone information about the juice-syrup fasting or the complete list of supplements she had been taking. Even the best physician cannot put a puzzle together if major pieces are missing. The subsequent integration of medicine, psychiatry, physical therapy, dietary therapy, hypnotherapy, and emotional support was crucial to provide the various modalities she needed for solving the puzzle of interconnected medical and behavioral problems. The point here is that vitamins, although natural, can be toxic in large amounts and can cause changes in mood and behavior along with unusual “nervous” symptoms that could be confused with a medical or psychiatric disorder.
The cases of Ms. M. and Ms. B. illustrate the success of an integrated mind-body comprehensive approach, with traditional medical care an important dimension of their initial assessment and treatment. Even though I am interested in many of the complementary therapies, one physician cannot provide all the therapeutic modalities that are needed to help solve all the problems. It requires the efforts of a team of people, each adding expertise to put together the pieces to create an integrated “whole.” These patient cases further illustrate the dangers of taking only one part of the continuum of available treatment approaches. On either end of the continuum, an imbalance may occur, causing the patient to become clinically worse. Modern medicine may take an “overkill” approach at times, but so may chiropractors, advocates of megavitamin supplementation, herbalists, and other alternative therapists who sell people on large numbers of supplements and encourage people to avoid what traditional Western medicine has to offer. At either extreme, such a stance is potentially dangerous. In like manner, physicians must be knowledgeable about and consider the value of complementary therapeutic modalities that may benefit patients, and seek to include these in medical therapeutic regimens.
You must always remember that health problems are highly individualized. Similar symptoms in two different people can mean entirely different things. A therapy of any kind that brings rapid relief to one person may be of no help to another and may cause serious side effects in a third. I think it is critically important that all health problems be initially evaluated by a competent, concerned physician, one who you feel listens to you, has your best interests at heart, and who encourages you to add other appropriate and compatible therapeutic approaches to your overall health plan. If you do not now have such a physician, you have every right as a patient to seek one. Such a physician should ideally work collaboratively with other therapists and therapeutic options as needed to assist the individual patient reach her optimum level of wellness. It is also important for YOU to tell your physician what supplements you are taking and what other therapies you are using. I think it is also very helpful when alternative medicine practitioners communicate with you and your physician when they see something unusual.
I remember one situation that really illustrates this latter point well. One of the massage therapists working with me in my medical practice told me she was worried about a woman who had just started bruising excessively during a massage session. I checked on the patient and discovered she was taking Coumadin (a blood thinner to help prevent clots); she had misunderstood her directions and was taking double the prescribed dose. She was now bleeding under the skin, which caused the bruises, and she needed immediate vitamin K injections as well as to decrease her Coumadin. Even though she did not know the cause of the bruising, the massage therapist’s astute observations that she promptly communicated to me helped prevent this patient from having a potentially serious hemorrhage.
This story also illustrates one of the very positive aspects of modern medicine: the ability, using various laboratory and other diagnostic means, to determine more precisely what is needed for a given patient, such as fine-tuning the amount of anticoagulant or measuring blood sugar levels to determine the amount of insulin to give a diabetic. This is a valuable aspect of modern health care that alternative practitioners would do well to recognize and utilize. On the other hand, there may be many herbal options for common ailments that are safer and more effective than taking repeated courses of antibiotics. For example, I am very concerned about the overuse of antibiotics, particularly in women, since this practice increases recurrent yeast infections and the problem of developing resistant bacteria, not to mention the enormous cost of these medications. Using natural approaches, such as acidophilus vaginal suppositories, helps to prevent both yeast and unwanted complications from antibiotic or antifungal medication overuse.
A good example of these principles is the recent surge of interest in alternative menopause therapies. Aging baby boomers have certainly made an impact. Our market share is being eagerly sought by makers of everything from acne preparations to portable devices to induce a state of “Zen.” Women have been heavily targeted with the exponential increase in marketing of “magic bullets” for menopause, PMS, and perimenopause. These include a wide array of soy supplements, progesterone, and wild yam creams, OTC forms of DHEA and melatonin. Unbeknownst to the consumer, who has been caught up with the labeling of all these as natural and therefore safe, all of these products have the potential to cause harmful effects if a woman already has a thyroid disorder or a decline in her ovarian hormone production. As one example, we have strong scientific data going back to the 1970s showing the soy isoflavones have marked antithyroid effects, yet that isn’t even mentioned in the current hype for taking soy supplements or adding soy foods to your diet. Even the ancient Chinese did not routinely eat soybeans until they had developed a fermentation process, hundreds of years after the discovery of soybeans, that eliminated some of these negative effects from eating unfermented soybeans. Fermented soy products include tempeh, miso, soybean paste, and tamari, and these are the forms more commonly eaten in Asian cultures.
There has been a great deal of emphasis on the Japanese high-soy diet being associated with a lower risk of breast cancer, with the result being an intensified sales pitch for soy supplements in pill form and protein powder drinks. But women are not given the balanced message that in Japan, there are many additional factors that also contribute to their lower risk of breast cancer: there is very little alcohol intake, especially among women, and alcohol is a known risk factor for development of breast cancer; Japanese women have far lower fat intake, particularly animal fats; and Japanese women are far more physically active with walking, Tai Chi, and other forms of exercise throughout their lives than are women in the United States. Alcohol, lack of exercise, and high-fat diets are well-known risk factors for breast cancers, as I reviewed in chapter 14. In addition, what you aren’t usually told is that the Japanese high-soy diet is comprised predominately of fermented soy foods, rather than the soy protein drinks and powders that are marketed in the United States. Why do our women’s health newspaper articles and magazines just focus on the observational, not causal, connection of high soy intake and lower breast cancer risk in Japan? Could it be related to the advertising dollars that makers of soy supplements spend to advertise their wares in those same magazines? Companies make more money getting us to buy their supplements than by teaching us to go out walking or do Tai Chi every day.
I am well aware of studies that have shown increased soy intake is associated with lower cholesterol, higher HDL cholesterol, and lower blood pressure. All of these factors in turn will help reduce risk of heart disease. But there is also newer research from three different countries that has shown clearly that the phytoestrogens, soy isoflavones, compete with our own body estradiol and progesterone at our body receptor sites. In fact, genistein, a soy isoflavone, even has differential binding affinities depending on which estradiol receptor (ER) is considered: It has a six-fold greater affinity for the ER-beta than for ER-alpha. An outgrowth of soy isoflavones binding at the body ERs is that high soy intake has been shown to suppress our own ovary production of estradiol and progesterone by 20–50 percent in several new cross-cultural studies of premenopausal women. If you are already having problems with your ovary hormones, what does the intake of soy do to make matters worse, not better? What about if you are trying to get pregnant, and having problems with infertility, but no one told you that your soy supplements could be interfering with having your ovaries work normally?
What if you have already lost significant bone? What does soy-induced ovarian suppression do to cause further bone loss? What if you are like many younger women I see in their thirties who are having frustrating problems with nightly insomnia, already being triggered by declining estradiol? What effect does soy intake have on your worsening sleep problems if it can further reduce your ovary estrogen production? Do you know the answers to these questions? Is anyone helping you sort this out? See what I mean about the importance of balanced information? Is it any wonder that consumers are confused? Could it be this information is left out in the desire to sell more products now that women’s economic clout has been “discovered”? If the books and materials you are reading are not discussing these issues, then you need to check other sources for your health planning. I am not against soy supplements per se, but I do think we should be careful about presenting all the facts, and about how we recommend using these products for different groups of women.
It isn’t just consumer magazines that are presenting only part of the picture. Just this summer I received two medical journals, one from the North American Menopause Society (U.S. publication) and one from the International Menopause Society. Coincidentally, they presented exactly the paradox I just described. The U.S. medical journal Menopause ran two-page, four-color ads for a red clover isoflavone supplement called Promensil, at the same time the international journal Climacteric published the first two placebo-controlled, prospective, randomized, double-blind studies showing that this same supplement had no effect greater than placebo on any of the menopausal symptoms measured, including objective measures of estrogen effect. Menopause Management, another U.S. medical journal that arrived at the same time and is sent to doctors all over the country, went a step further in promoting soy products—they actually packaged an ad and a sample soy protein drink package in the plastic wrap around a recent issue. Personally and professionally, I found this marketing ploy annoying in view of the very mixed results on soy’s effectiveness and its known potential problems for women with thyroid disorders and early ovarian decline. I was pleased to see that the editors of Climacteric took a higher road than the U.S. journals: their editors wrote a position statement explaining that they will not accept advertising for any health product that has not been proved to be effective on the problems for which it was advertised. And they certainly weren’t sending out sample soy products in shrink wrap.
The studies of the phytoestrogen Promensil, published in Climacteric in June 1999, were well designed and also had the important dimension of being placebo controlled. These were the first two such carefully done studies in the world. Prior to this, all we had were noncontrolled studies that did not use placebo comparisons. There has consistently been a very high positive response to placebo in studies assessing methods of controlling hot flashes; earlier studies that did not include placebo comparisons therefore tended to overestimate the value of phytoestrogen products such as soy on reducing hot flashes. These two studies were more comprehensive than earlier ones in that they also included several objective measures of estrogen effect as well as effects on standardized menopause symptom-rating scores. Women were defined as menopausal based on having had no periods for at least six months and an FSH greater than 40 IU/l, or based on having had their ovaries removed. Participants were excluded if they had been using any form of hormone therapy for the previous six weeks, if they were vegetarians or regular users of soy products, or were taking medications that induced liver enzymes. Promensil tablets contain 40 mg total isoflavones (genistein, daidzein, biochanin, and formononetin). The three study groups were (1) placebo tablets, (2) one Promensil tablet (40 mg), and (3) four Promensil tablets (160 mg), but all subjects consumed four identically appearing tablets daily. Pre- and post-trial measures included daily flushing frequency, Greene Menopause Scale of symptom severity, vaginal maturation index, vaginal pH, FSH, serum level of sex-hormone-binding globulin, complete blood count, liver function profiles, nonfasting lipid profile, and measures of twenty-four-hour urinary excretion of isoflavones.
The two study results were interesting in that the hot flash frequency decreased in all participants, but there was no difference in flushing frequency between placebo and isoflavone groups. There were no changes in biological measures of estrogen activity or in subjective symptom scores in isoflavone groups when compared to placebo. As you would expect to see in someone taking isoflavone supplements, there was a measurable dose-dependent increase in the urinary excretion of isoflavone metabolites between baseline and Week 12 in the group on Promensil. An 18.1 percent increase in HDL cholesterol occurred in the 40 mg isoflavone group, but no increase was found between placebo and the 160 mg isoflavone group.
Previous uncontrolled studies claiming a therapeutic effect of foods or supplements high in isoflavones appear to have been confounded by a large placebo response. These present studies confirm other studies showing no effect of isoflavones on FSH, SHBG, vaginal epithelium, or pH. Based on these findings in a well-designed, controlled study, my recommendation is that it appears premature to recommend isoflavone products as an appropriate therapy for menopausal symptoms, particularly if patients already have bone loss and/or other more serious consequences of estrogen decline.
In case you may be wondering whether the essentially negative findings might have occurred due to some bias of the physicians conducting the study, I want to point out that funding for both of these studies was provided by Novogen, Ltd., the company that manufactures Promensil, and one of the authors serves as a consultant to this company. So it is unlikely that there was a bias against the isoflavone product. The finding of a lack of effect for Promensil in these studies creates an ethical and commercial dilemma for a company that has already successfully marketed its product and has been advertising that use of Promensil leads to significant reduction in hot flashes. I was pleased to see that Novogen undertook proper scientific scrutiny of their product, in spite of the results showing Promensil was no better than placebo in reducing hot flashes.
An interesting finding was the 18 percent increase in HDL cholesterol in the 40 mg isoflavone group, but no increase compared to placebo in the 160 mg isoflavone group. The HDL findings may be confounded by the fact that the lipid specimens were not collected in the fasting state, but the dose-response difference seen here may represent a “therapeutic window” effect of isoflavones. Such a “window” effect has been shown in other studies of genistein effects at estradiol receptors, with one dose range having an agonist effect, and a different dose range having an antagonist effect. Such findings lend further caution to indiscriminate use of isoflavone products until we have a better understanding of the various dose-response relationships.
What does all this mean for you? In my view, it means before we can confidently recommend isoflavone and other dietary supplements for menopausal therapies, we have many issues to clarify in good studies. We need to know more about dose-response relationships for different target tissues, individual therapeutic variation, side-effect profiles based on dose, and effects on long-term disease risks that are known to be strongly linked with estrogen decline. Furthermore, we have to consider potential adverse interactions between dietary supplements and the prescription forms of hormone therapy our patients may also be using. I have been quite concerned by the types of problems I have seen occur in my own patients as a result of such interactions between OTC and prescription medications. For example, I described in chapter 15 the marked decrease in effectiveness of birth control pills when St. John’s Wort is added.
If you are using soy and other isoflavone products instead of estrogen in the belief that these plant extracts are more “natural” than estrogen, keep in mind that you may be missing an important window of opportunity to prevent long-term health problems. This is a practical point for you to discuss with your physician when you use OTC supplements instead of prescription medications. It is important to monitor objective measures of bone and lipid markers to be certain that silent disease risks are not going undetected.
Don’t be misled by the word natural when looking for remedies for PMS or menopausal changes. While there are many that may help briefly to alleviate minor symptoms, there is a variety of herbs that has been well documented to have toxic effects on the liver, and may cause a variety of other symptoms as well. Just because compounds are natural to plants does not necessarily mean they are natural for humans. Two recent reports in Archives of Internal Medicine and the Journal of the American Medical Association reviewed cases of both severe liver and kidney toxicity from herbal products. The patient who had severe liver damage encountered the problem many of us have been worried about: the product had been adulterated with chemicals that were not shown on the label, so the woman had no idea what she was getting until she developed serious medical problems and ultimately required a liver transplant. Since the FDA does not regulate the manufacture, safety, dosage recommendations, and effectiveness of these substances, you are dealing with two major problems when you use them: (1) the active ingredients simply are not known in many cases, and (2) the bottle may not contain what the label says it does. Even though I am at times frustrated with the slow process of FDA approval for new medications, the advantage is that at least when I prescribe a pharmaceutical-grade product, I know that its manufacture and labeling are closely scrutinized for safety, and there are standardized dosage forms and guidelines.
The primary disadvantage to herbal remedies, in my opinion, is that often you are not able to determine the actual amount of the active ingredients you are getting or what is actually in the preparation. Many of the mixed herbal products that are imported from China, for example, are not completely labeled, or have been found to contain adulterants that are not listed. And then there is the problem of determining the correct dose. If, for instance, an herbal prescription says to take six bay leaves every day, how much of the desired ingredient is in that leaf, and what size leaf is used? An advantage of Western pharmaceuticals is that one knows exactly how much 5 mg of a compound is. The dosage can be adjusted up or down with greater precision and accuracy than a random selection of six leaves or drops of a tincture. On the other hand, physicians may be too heavy handed in the amounts of Western pharmaceuticals they prescribe, especially for women patients. Doses of many medications for women often need to be started at much lower levels than are used for men. I have a number of women who have benefited from Prozac for premenstrual symptoms, but may need only 2 mg instead of the 20 mg dose recommended as the usual starting amount. If the differences in women’s body size and physiology are not taken into account, there is increased likelihood of adverse side effects. No matter what therapy is being prescribed, all of us involved in the health fields should keep in mind the important premise of all healing traditions: “DO NO HARM.”
Another overlooked safety issue with herbs is the problem of significant interactions with prescription medications. While herbs are often marketed as “completely safe, with no side effects,” people forget that these plant compounds have to be metabolized by the liver, in the same pathways that the body uses to metabolize prescription medications, foods and vitamins. That means it is possible to have very pronounced herb-drug-food interactions that may alter the chemical make-up and effects of each one. You have probably already heard about the serious problems that can occur when taking some medications and drinking grapefruit juice at the same time, or that coffee and fiber in your diet prevent proper absorption of thyroid medication.
Similar problems occur with herbs and prescription medications. One example is the risk of serious bleeding problems if you add Gingko biloba when you are taking Coumadin, a blood-thinner to prevent formation of blood clots, or if you are taking large doses of aspirin daily for arthritis. Low-dose, baby aspirin daily does not seem to cause bleeding problems when taken with gingko in moderate doses. There are other drug-herb interactions that may cause problems with bleeding, blood pressure regulation and sedation during surgery if you take the herbs too close to the time you are having a surgical or dental procedure. Some of these potentially dangerous interactions, in addition to gingko, include feverfew, garlic, ginseng and vitamin E. All of these decrease the effectiveness of platelets forming blood clots, so you may be more likely to have excessive bleeding if you take these within two weeks before your surgery. Kava, valerian, and St. John’s wort interact with sedative medications and anesthetics to intensify the effects of these drugs, possibly leading to prolonged sedation. Ginseng, black cohosh, and St. John’s wort can also adversely affect blood pressure, making it difficult to control during a surgery. To be safe, you should plan to stop taking any of the above herbs or supplements at least two weeks prior to your surgery. And be sure that you always let your physicians know what herbs, vitamins and supplements you are taking.
Another serious interaction between medications and herbs was reported recently based on studies at the National Institutes of Health. The commonly used herb, St. Johns’ wort, has been found to decrease the contraceptive effectiveness of the birth control pill up to 50 percent. With today’s low dose pills, there is no such margin for error if you want your pills to work to prevent pregnancy. Do not add St. John’s wort for depressive symptoms if you are taking birth control pills, or you could be in for a rude surprise with an unexpected pregnancy, no matter how many people may have found it helpful for relieving depression. In addition, since the herb appears to increase the liver’s metabolic break-down of the hormones and reduce their effectiveness, you are likely to find yourself back in the cranky, irritable, anxious, “perimenopausal panic” mood roller coaster. At this time, there is no such known drug interaction between birth control pills and antidepressants such as Prozac, Zoloft, Paxil, Celexa, Luvox, or Wellbutrin. Serzone, however, does diminish the effectiveness of oral estrogen or birth control pills. Both St. Johns’ wort and Serzone should be avoided as medications for depression if you are also taking prescription hormones. If you feel depressed on your current birth control pill, first talk with your physician about other types of birth control pill products to try that may have less progestin before you add other medicines or herbs for depression. Adding herbs on your own may give you more problems than you bargained for!
Another concern for menopausal women is that the amount of hormone effect may not be enough to provide levels needed to maintain bone density and to avoid increased heart disease risk if you are just using oral phytoestrogen and herbal supplements or from skin creams purportedly containing hormone-like substances. Although a number of natural remedies like black cohosh, evening primrose oil, red clover isoflavones, and soy isoflavones may alleviate milder symptoms such as hot flashes, the important question for you to evaluate is whether these remedies are having other desired effects in the body, such as bone preservation. So, deciding whether or not to use herbs depends upon your individual health needs and goals. If you know from testing that your bones and cholesterol levels are in desirable ranges, then you may decide to use an herbal remedy for reducing hot flashes. On the other hand, if your bone density is low, you really need to be sure that you are getting a reliable source of the right amount of estradiol to prevent further bone loss. I hope this approach provides a rational, commonsense way of deciding what is right for you. The following is a brief list of some commonly available herbs with potential for severe adverse effects. This is not a complete list. I encourage you to contact a reputable source (several listed in Appendix II) for additional information.
SOME POTENTIALLY DANGEROUS HERBS TO AVOID
• KNOWN TO CAUSE ACUTE LIVER INJURY, CHRONIC HEPATITIS, CIRRHOSIS, AND/OR LIVER FAILURE: chaparral, comfrey, coltsfoot, germander, margosa oil, mate tea, mistletoe and skullcap, Gordolobo yerba tea, pennyroyal (squawmint) oil, pyrrolizidine alkaloids, aflatoxins, Amanita phalloides, Jin Bu Huan (a Chinese herbal product), and others.
• KNOWN TO INCREASE HEART RATE, BLOOD PRESSURE (DANGEROUS IN PEOPLE WITH CVD): ephedra (Chinese name: mahuang), excessive amounts of caffeine (not generally shown on labels, but a common adulterant in tonics), and others.
• KNOWN TO CAUSE LIVER OR KIDNEY DAMAGE (ACUTE INTERSTITIAL NEPHRITIS AND/OR RENAL FAILURE): Tung Shueh pills (the culprit for the woman who developed liver failure) found to be adulterated with an anti-inflammatory agent, mefanamic acid, not shown on the label; aristolochic acid; products adulterated with phenylbutazone.
Always let your doctor know if you are taking any herbs or other supplements, so that if you develop problems, he or she has more information to use to help you prevent potentially serious interactions with prescription medications.
I think two overall keys to providing the best health care for women are the recognition of gender hormonal differences, and the recognition that each individual will have different needs and will benefit from a different blend of approaches. I think allopathic, osteopathic, homeopathic, and naturopathic physicians each have much to teach and to learn from the others. To provide optimal care for women of today, health professionals must use a variety of options, integrating the best of prescription hormones and medications when needed, along with healthy intake of vitamins, rational use of supplements, use of complementary herbs when appropriate, counseling and psychotherapy, stress management techniques such as hypnotherapy or biofeedback, as well as incorporating acupuncture, exercise prescriptions and the various types of body work and physical therapy. All of us in the health professions must also remember that prayer and ways of nourishing the soul are crucial elements of the healing process. As Ambrose Pare, a 16th century surgeon said, “God heals the wound, I merely dress it.”
There is a great deal of valuable, reliable, scientific information available today about safe and effective ways to blend these approaches and therapeutic options. I encourage you to always work with health professionals who are willing to help you find useful information and to sort out the “product sales” hype from the reputable scientific information now available. Our goal as health professionals should be to find the unique blend of physical, medical, herbal, psychological, and spiritual approaches for each of you as an individual to help you best regain your wellness balance and achieve harmony and good health.
We also need to take better advantage of developing a health partnership between the health professional and YOU, the patient, with your own capacity for self-healing. If we CHOOSE to use it, engaging our minds to activate the healing ability within us, is the most powerful medicine that exists for all of us. When we combine our internal healing power with the appropriate external modalities available to us, the integration enhances our ability to achieve the best state of health we can. Even if we have a disease, such as diabetes, we may still move to a greater state of wellness by eating healthy meals, exercising regularly, practicing relaxation skills, having massage therapy to improve circulation, and maintaining a positive outlook on life. It’s a different way of looking at things: Someone who has no disease or illness may still be unwell in mind, body or spirit, living a life full of unhealthy habits and feeling a sense of disease. Another person who, having a serious disease, yet practices the integration of internal and external healing options, may feel an inner calm, balance, and wellness even with significant disease still present. You choose which way you will live.
As a physician who is formally trained in medicine, I give you the best of my knowledge and wisdom, but you choose to use it or not. You are in control of your choices and options. Without YOU having an active commitment to and involvement in YOUR own health care, there can be no true healing process. YOU are the most crucial member of any health care team. My desire is to help you learn the information and skills to TAKE CHARGE of your own well-being, and then help you find the necessary resources to reach your goals. You have the power to be a well, educated woman.