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HORMONE Replacement Therapy in post-menopausal women ("HRT") A physician's long experience, and observations, concerning the very beneficial effects of "hormone replacement therapy" in women. Selected from the on-going INTERNET BOOK, "The Doctor's Terrific Tablets" ( http://www.terrific-tabs.com ) by John N. Todd III, M. D. (link)
SEE related subject, especially for MEDICAL DOCTORS: Potentially harmful effects of ALL medications (link) Originated 7/25/02; "doctored" 5/03; 6/03; 7/03; 8/8-20/03; 9/03; 3/04; 4/04; 6/04; 7/04; 1/05; 3/05; 4/15/05; 4/16/05; 4/17/05; 4/18/05; 4/20/05; 5/05; 1/29/06; 2/06; 1/3/07 CLICK HERE to go to the "FRONT PAGE" of "The Doctor's Terrific Tablets" CLICK HERE for ALPHABETICAL INDEX of this entire WEBSITE CLICK HERE to EMAIL your thoughts to the author It's a crying shame....indeed a pity.... that many post-menopausal women have been "scared-away" from treatment with correctly-prescribed "replacement" of normal, much-needed, physiological female hormones. As a physician, with a long history of treating many female patients with "hormone replacement", I am very distressed that many women (and many physicians) have been terrifed and intimidated by several recent articles in the medical literature, concerning possible harmful effects of taking "female hormones" (estrogen, and/or progesterone). I will refer additionally, below, to the articles in the medical journals.... and I will give my reasons for considering the reports to be faulty and erroneous in some of their methods and conclusions. According to an editorial in the Journal of the American Medical Association, dated 7/17/02, 38% of post-menopausal women in the United States were then (2002) taking "female hormones", prescribed by their personal physicians. That percentage has, no doubt, now been drastically reduced, because of initial reports from the "Womens Health Initiative" -- statistical reports which have undoubtedly scared many women away from treatment with very much-needed and very beneficial post-menopausal estrogen and/or progesterone supplements. (Concerning the "intimidation" of practicing physicians (the "real" doctors who are truly in medical practice, taking care of their own private patients) I want to mention, here, that many knowledgable and talented practicing doctors may now have become intimidated by some of the "conclusions" reported in certain recent medical-journal articles.... because the threat of "medical malpractice" will now increase, especially for those doctors who appropriately and correctly prescribe very beneficial "hormone replacement therapy" (HRT) for their female patients. This threat of "malpractice" has been magnified by sensationalized headlines and remarks, in newspapers and on television, concerning potential health-risks to women who receive "hormone replacement therapy". (See link, especially for doctors: There are no "safe" medications.) In the various news articles and reports about potential injurious side-effects of HRT, very little mention is made of the multiple benefits that accrue to post-menopausal women, with correctly-prescribed, long-term female-hormone replacement. Frequently, there is a suggestion that HRT is given solely for "hot flashes" and other manifestations of early menopause.... rather than emphasizing that HRT is, in reality, beneficial for a number of problems that may develop in the aging female. The first of the medical articles, to which I am referring.... ("Risks and Benefits of Estrogen and Progestin in Healthy Post-Menopausal Women" -- in the "Journal of the American Medical Association" [JAMA]; 7/17/02).... initiated a sequence of articles and editorial-comments.... damning the prescription of hormones for women, because of a potential increase in the "risk" of taking these hormones.... when compared with a comparable group of women who do not take hormones. The obvious and established benefits of taking female hormones.... when prescribed correctly, and in the proper dosages.... were given very little mention, in this same series of medical articles and editorials in the JAMA. The gist of the main medical research report -- assembled by "The Womens Health Initiative" ("The WHI Study"), and funded by the "National Heart, Lung, and Blood Institute" -- is that women should no longer take "hormone replacement therapy" (HRT).... because of potentially harmful effects.... manifested by a reported slight numerical increase in the incidence of heart attack, stroke, and cancer of the breast.... when compared with women who did not take these female hormones. This will be discussed additionally, below. My response to the conclusion of the "WHI Study".... based on my long experience in prescribing these hormonal-medications.... is that any potential risks from taking estrogen and/or progesterone "replacement" are FAR outweighed by very obvious long-term benefits to a woman's health. The conclusions of the authors of the July 2002 JAMA article are so far-fetched, that I have begun to wonder whether some "mysterious" and "ulterior" motive, or a pre-conceived conclusion, may have led these researchers to their decisions and recommendations. (I hate even to think it.... and I do not suggest it.... but is it conceivable that some individuals involved in designing this hormone-study began to realize that this long-term investigation was so heavly funded by our "National Heart, Lung and Blood Institute", that some type of dramatic conclusion had to be reported.... in order to "justify" this long and laborious and expensive research investigation -- and its extreme costs to the American taxpayers?) And, another point I want to mention -- I suspect that the research investigators and the authors of the medical report, are all "academic" physicians, and "PhD's", and "statisticians".... dwelling in university-medical-school "ivory towers".... physicians and "researchers" who are seldom-if-ever involved in real and genuine "hands-on", long-term observation, treatment, and follow-up of individualized "private" patients. I perceive several flaws in the WHI research study. I feel certain that my questions may have already been raised by a number of practicing, "real-doctors".... and the responses of the researchers may have been discussed, somewhere, in the medical literature.... but I choose, now, to document for myself, and for whoever-else may be interested, my thoughts and conclusions. (I must emphasize that I am now retired from medical practice. I do not now treat or advise any patients.... and I do not suggest that any of my comments and recommendations should be utilized in deciding about therapy for any individual patient.) One main "defect" in the "WHI Study" (in my opinion) is the selection of a "one-dose-fits-all" hormone tablet, for all of those participants who were assigned to take hormones. In "private" medical practice, where physicians actually see and evaluate and provide long-term care to patients, individualization of treatment and dose is a paramount consideration, dependent upon the patient's carefully-monitored response to a specific therapy. Never would a well-trained physician prescribe an arbitrary, pre-determined fixed-dose of two pre-selected powerful medications, for all of his female patients.... without consideration of the patients' ages, their physical activities, their size and weight, their intelligence and schooling.... and without consideration of their presenting-symptoms; and without awareness of the importance of an on-going frequent evaluation of obvious "human" individual variation in responses to any-and-all medications. Another major defect in the WHI study is the faulty protocol of investigating the concomitant pharmacological effects of two widely divergent hormones.... hormones that have greatly different effects in different patients, depending upon many individual characteristics of the recipients. (Compare that protocol with another theoretical "project".... who in this world, pray tell, would ever consider a "research" study on the cardiac effects of digoxin, by including a concomitant dose of quinidine as a part of the protocol?) Another MAJOR FLAW in the "protocol" of the WHI Study, is that the estrogen and progesterone were NOT "CYCLED", in such a way as to mimic the NORMAL physiological hormone cycle of all adult females. That is, "normally" and "physiologically", the production of the ovarian hormones (estrogen and progesterone) varies in amount during the different phases of the female "monthly" cycle.... based upon the "feedback" responses of the ovaries to the pituitary hormones (follicle-stimulating-hormone and luteinizing-hormone). These complex hormonal interactions prevail in ALL normal female animals, and vary greatly at different ages, and in different individuals .... and can easily get "out-of-balance", especially during and after the menopausal "change".... thus generating a wide array of individual symptoms, and "effects".... and potentially very serious complications. The wide variation of individual responses, in different human-animals.... to different medications.... cannot be over-emphasized. The WHI's protocol of a pre-conceived fixed dose of estrogen.... mixed-with a specified-in-advance, fixed dose of progestin.... seems to have neglected consideration of the well-known variation in absorption, excretion, break-down, and metabolic effects of specific medications, that individual patients invariably demonstate.... especially in regard to the "interplay" of very complex body-chemicals such as "hormones". The use of a one-dose-fits-all research-protocol could lead the "investigators" to the erroneous conclusion that a one-result and one-response will necessarily follow, for ALL patients. That concept is also faulty, and flawed.... and may have led the WHI-researchers to a one-recommendation for one-and-all female patients.... regardless of all other individual considerations. (To further consider the same emphasis.... No medical research-project would ever even think of doing a "study" of the effects of "thyroid-hormone-replacement", with the use of a one-dose-fits-all medication. Consider, also, a "study" evaluating "cortisone" therapy or "replacement". Would any researchers ever dream of suggesting a protocol utilizing a "same-dose-for-everybody" schedule.... realizing individual differences in response to all medications? Also, would any logical "researchers" ever consider the evaluation of the effects of thyroid therapy, by mixing the thyroid hormone with another hormone, such as "cortisone"? How absurd that would be! What about evaluation of the effects and risks of "anticoagulants".... would "researchers" give the same dose to all participants? OR.... can anyone imagine a research "study" of the treatment of diabetic patients, with the plan of a single pre-conceived dose of insulin or other hypoglycemic agent, for all patients? Neither would a single-dose-for-all trial be recommended for other "research" projects.... like, say, a blood-pressure treatment protocol.... or an investigation of cardiac effects of a certain digitalis preparation.... or a study of "tranquilizers", or antibiotics.... realizing, in all these examples, the wide variation of individual responses to medications.... in all patients.) NOW.... comparing medical research "doctors" with physicians in the "private" practice of medicine, consider this: all competent medical doctors, in private practice.... those "real doctors" who actually evaluate and treat personal and individual patients, on a long-term basis.... those real doctors realize the necessity of monitoring closely-and-frequently the differences in individual response to all medications.... and, all informed doctors understand the wide variation in absorption, metabolism, "enzyme polymorphism", excretion, and "idiosyncratic" effects of medications -- of any type.... and especially in regard to "hormone" therapy. Using hypothyroidism as an example again.... in treating "real" patients with a diagnosis of hypothyroidism, would a physician-in-private-practice ever consider treating all of his patients with the same dose of Synthroid.... without frequent close "hands-on" evaluation of the patient's response? And, as mentioned above, would a talented physician ever treat hypothyroidism with a mixed preparation of thyroid hormone, and a cortisone derivative? Is it not apparent that all patients -- male or female -- who have an obvious hormone insufficiency, should have treatment with "replacement" of that particular hormone, without mixing-in another medication? Using thyroid insufficiency as a simple example, still again.... a patient with hypothyroidism should have long-term treatment by "replacement" of the correct dose of a thyroid hormone.... and not thyroid hormone PLUS some other un-needed hormone such as testosterone. This same thesis applies to other hormone insufficiencies, such as estrogen deficiency.... where the goal is to return a patient to a normal "physiological" condition. It is obvious that all post-menopausal women, by definition, have varying degrees of estrogen-deficiency.... a "deficiency" that is slowly progressive, depending upon the age of the individual.... and dependent upon the multiple individual and unpredictable variations that exist.... from "animal" to "animal". But why, as in the WHI study, should all female patients be given the same dose of estrogen.... and why should all patients, even hysterectomized patients, be given progesterone in addition to the estrogen It is no wonder that a huge number of patients.... 42% of the patients on hormone-replacement.... dropped-out of this "Womens Health Initiative" hormone-study, because of various symptoms and undesirable responses.... after being required by the study's protocol to take a specified and fixed every-day dose of a combination estrogen-progesterone preparation. (A large number of "drop-outs" related to persistent heavy menstrual bleeding.) Is there any wonder that a great percentage of the patients "dropped-out" of the study when they detected that they had been made miserable by taking an inappropriate dose of mixed hormones.... on an un-physiological schedule? We can imagine that a large number of the volunteer-patients who "stuck-it-out", and continued the protocol.... also felt miserable because of the distorted "body chemistry" that had been imposed upon them by the protocol. Therefore, in "replacing" female hormones, it is logical and proper to reproduce (mimic) as closely as possible the "normal" sequential female hormone cycle. This becomes even more important, as progressive (and variable) decline occurs in ovarian function, as aging continues. (It is obvious that the responses to estrogen and progesterone therapy [for example] in a 54 year-old female, will not be the same as in a 68 year-old female.) In my own medical practice, when I recommended hormone "replacement", I routinely "cycled" the hormones, and I routinely "individuated" the dosages. Typically, a "hysterectomized" patient was started on a 21-day cycle of Premarin, alone (0.625 mg, or 1.25 mg), without progesterone.... followed by a 7-day rest-period. After this 28-day cycle of hormone replacement, the same cycle was begun again.... and closely monitored. If a patient tolerated this regimen, she was allowed to continue the same dose, indefinitely.... so long as she complied with periodic re-evaluation. In my private practice -- for those patients with intact uterus and ovaries, a typical regimen would be to take Premarin alone (0.625 mg. or 1.25 mg.) for the first 21 days of a 28-day cycle.... with Provera added, 10 mg. for 10 successive days, starting on the 15th day of the Premarin cycle. On this schedule, the Premarin would be completed on the 21st day of the 28 day cycle; and the Provera would be completed on the 24th day. The menstrual period would usually begin on the 24th or 25th day of the cycle.... related to estrogen "withdrawal", plus progesterone effect. After the 28th day of this combined estrogen-progestin therapy, the cycle was begun again. (On occasion, the full cycle would be lengthened by a day or two.... and the dosages of the hormones would be adjusted according to a patient's response.) I found this "hands-on", closely-monitored regimen to be well-tolerated and very beneficial to those patients who were intelligent enough to understand this logical "replacement" of much-needed normal physiological hormones.... and to report accurately and quickly their "feelings", and their responses to the hormone effects. Concerning the WHI study, it should be apparent to all informed researchers that the female-animal is not "designed" to stay under the CONSTANT metabolic effects of externally applied hormones. Just imagine.... leaving female breast tissue under the constant unremitting effect of estrogen stimulation. No wonder there was a relative increase (however slight) in the incidence of breast cancers, in the WHI Project. Similarly, look at the ill-conceived notion of leaving the female "patient" under the constant effect of progesterone. Again, there is no wonder that a relative increase in the incidence of heart-attack and stroke was detected, in the WHI Study. Another problem in the WHI Study.... the patients for this complex research study were "recruited" by what was called a "direct-mail campaign". The "follow-up" of the patients was by "self-administered questionnaire", every 6 months.... and the patients were "examined" (by whom, we do not know) at a clinic every ONE YEAR (gee whiz!).... hardly a fair and correct way to manage and treat human-patients.... especially with a combination of powerful hormones.... when a wide individual variation in response is predictable and expected. Still another "defect" in the WHI Study disturbs me greatly. I am distressed by the great emphasis, in the WHI Study report, that was placed on relatively small numerical differences in the occurrence of "side-effects", or injurious effects.... between the hormone-treated group, and the "placebo" group.... especially when one considers the great benefits that accrue to those women who take hormones correctly -- in the correct individualized dosages -- for extended periods (a lifetime.... and not for just a few months or years). This should be remembered.... There is no medication known that does not have some injurious effects for some patients. With all medications, a physician must evaluate and follow appropriately the "risk/benefit" ratio for each individual patient. (See important link The potentially harmful effects of any and all medications.) This, too, must be remembered: There is no other medication (other than "hormone replacement") that is truly beneficial for retarding or preventing osteoporosis -- and the numerous other symptoms and ailments that result from hormone insufficiency in women. Many therapeutic products and concoctions (various vitamines, calcium supplements, "herbal remedies", "nerve pills", sedatives, stimulants, anti-depressants, etc.) have been "thrown" onto the pharmaceutical market.... and many claims have been made.... but this fact remains -- if a woman's symptoms and abnormalities and physical "changes" result from a hormone insufficiency.... it is only logical that the cause of the problem be treated.... and that correct treatment should include "replacement" of the deficient hormones. There is no other treatment that rivals the success of correct hormone therapy. 2/17/06 -- A new study, also done by the "Women's Health Initiative", and reported in the New England Journal of Medicine (2/16/06).... concernng the effects of vitamine D and calcium supplements in reducing fractures in post-menopausal women.... concluded the following: "Conclusions: Among healthy postmenopausal women, calcium with vitamin D supplementation resulted in a small but significant improvement in hip bone density, did not significantly reduce hip fracture, and increased the risk of kidney stones." I consider the relative increase in injurious effects, reported in the WHI Study, to relate directly to (and possibly to have been CAUSED by) subjecting each of these "mail-order" females to the constant chemical (pharmacological) effect of these two powerful female hormones.... and to the dreadfully impersonal selection of the participants.... and to the totally inadequate professional follow-up of these women. I believe that it would be wise and proper to "re-constitute" the entire WHI study.... avoiding all the errors that I have postulated above.... so that women-of-the-world will not be deprived of appropriate and beneficial therapy for the manifestations of a universal malady that befalls almost all women who survive into their "senior" years. I do hope that all readers of this document will also read my thoughts on The potentially harmful effects of any and all medications (link).... so that all patients and all physicians will realize that no medication is totally-free from potential adverse side-effects. Notes for subsequent discussion by the author: 3/31/04; 6/17/04; 3/28/05; 4/15/05; 5/8/05; 1/29/06 My feeling.... after my personal "hands-on" selecting and treating and managing and following of many post-menopausal females.... is that my patients benefitted greatly from the appropriate "replacement" of female hormones.... when prescribed in proper and individualized dosages, for each individual patient. My observation, through my 30 years of treating many female patients, is that those women who took the prescribed female hormones correctly, as directed.... those who understood the goals of therapy, and who were followed and re-evaluated properly and regularly (by me)..... those women benefitted greatly -- and "safely".... for long periods of time. Obviously, one of the proven benefits to hormone replacement is in preventing or aborting osteoporosis. In addition, I feel certain that most post-menopausal women who take female hormones correctly, also benefit in several other ways.... they "look" better, and feel better, generally; they are more active, and energetic and enthusiastic; they have fewer aches and pains; their thought-processes are maintained; their psychological "outlook" is better; their skin "ages" more slowly; their sense-of-humor is brightenend; their "sexuality" and sexual "responses" are preserved; and on-and-on. 4/15/05.... The following is repeated from the main document, above: It must be remembered that there is no other medication that is truly beneficial for retarding or preventing osteoporosis.... and the numerous other symptoms and ailments that result from hormone insufficiency in women. Many therapeutic products and concoctions (various vitamines, calcium supplements, "herbal remedies", "nerve pills", sedatives, stimulants, anti-depressants, etc.) have been "thrown" onto the pharmaceutical market.... and many claims have been made.... but this fact remains -- if a woman's symptoms and abnormalities and physical "changes" result from a hormone insufficiency.... it is only logical that the cause of the problem be treated.... and that correct treatment should include "replacement" of the deficient hormones. There is no other treatment that rivals the success of correct hormone therapy. I realize that my strong impressions of the beneficial responses of women to hormone replacement, may be somewhat "anecdotal".... since I have no "controlled study" for comparison. However, I am convinced that I am correct in my own conclusions.... and I strongly feel that the WHI Study is flawed -- in its set-up.... and in its conclusions. I feel that women -- virtually ALL aging women -- have now been "scared-away" from considering an extremely important and effective therapy for many post-menopausal symptoms, and for various emotional problems, and degenerative disorders. I will have more to say, as time passes, concerning my impressions of the WHI Study. I will add later comments. For now, I simply want to express my initial thoughts.... my personal reflections. I will "doctor" this writing, from time to time.... and I will "upload" future thoughts to this same "tablet" of my website.... "The Doctor's Terrific Tablets". About the Author of this essay: The author of this expository is a Board-Certified medical specialist in Internal Medicine (now retired). As a part of his three-years of medical specialization, after medical school and internship, the author completed a one-year fellowship in "Metabolism and Endocrinology". The author practiced medicine for 32 years, after graduation from Medical School; and he spent the last 25 years of his professional career, in the private-practice of Internal Medicine.... diagnosing and "managing" and treating private patients, who chose to come to him for medical advice and therapy. I, the author of this opinion-piece, do not now treat or advise any patients. This essay is being written for my own satisfaction.... for I feel so very strongly that many women have been capriciously terrifed by several recent articles in the medical literature.... and that many women who would greatly benefit from the proper and physiological "replacement" of female hormones, have been "scared-away".... not only by articles in the medical literature.... but also by superficial and erroneous television and newspaper reporting ("sensational headline" remarks) -- concerning the medical facts. As a part of my medical training, and as a part of a personal concern for my many patients (male and female).... I have always been cognizant of possible "side-effects", or potentially injurious responses.... to any and every medication (drugs, vitamines, hormones) that I have ever prescribed. It is obviously a prominent part of the instruction and training of talented specialists, that they be aware of diagnostic and therapeutic pitfalls. (See link The potential harmful effects of any-and-all medications.) During my 25 years of treating "private" patients, I recommended and prescribed "female hormone" therapy for many women.... probably as many as 300 patients. I realize that my personal experience concerning the great benefits of hormone therapy, may be "anecdotal".... for there was no concomitant "statistical" comparison and analysis, with patients not on hormones. Of course, my long-standing opinion of "successful" and beneficial therapy was derived from my own close evaluation and medical judgement.... concerning the patients I treated. In addition, when I was active in medical practice, I had the benefit of evaluating many female patients who came to me, by their choice, at a late phase of their lives (50 years-old, and older)... many of whom who had not been treated with hormones, under the care of their prior physicians. Realizing all of these "variables" in my treating patients with "female hormones", I still want to express my thoughts and my experience concerning the use of these "replacement" hormones.... in carefully-selected women. In that regard, I need to mention that virtually all of my patients were intelligent and well-educated, and "white", and attentive to medical advice.... such as personal "preventive" care and protection of their own health.... and awareness of the importance of their diet, and weight; and exercise; and avoidance of alcohol and tobacco. I never chose to prescribe hormone-therapy to anyone who, in my judgment, would not follow proper medical directions.... including appropriate follow-up. More will be added, later. |