Tag Archives: HRT


update 10 Dec 2015  a reader in Germany  responds:  “ Excellent! I wonder when lawyers will start suing for withholding hormone replacement. 
I think you have made a very strong point by stating that government, medicine and industry are more interested in disease than health.”

its been a long time since this column last reviewed HRT for women (the KEEPS Trial) and for men, other than in the contexts of prevalent cancer phobiamongering.  Both our experience in practice, and longterm observational studies, are increasingly affirmative. Why should we be surprised?

Global pollution and overheating, antibiotic, alcohol and sugar abuse, and shortage of drinkable/arable water and therefore food are the dominant “natural” threats of the next decade let alone century. As a 2013 German-Chinese study says, Water-sustainability requires > 60% of arable land for soil water replenishment.
But thanks to worsening indoor living, sloth and food production policies, deficiency of antiinfection- anticancer antioxidant growth-promoting (not just rickets-and – goiter-preventing) microdose anabolic vitamin D3 and iodine have taken the lead , for the half of mankind who do not go hungry, in the essential needed mineral-vitamin microsupplements in life-and- lifequality-limiting micronutrient deficiencies for young and old. These micronutrient deficiencies are so easily and cheaply remedied for a few $ per person per year- but there is no incentive for high-tech profit-based government, medicine and industry to promote these since Only Disease Pays.

Now the recent October interview with leading Canadian andrologist Dr Alvaro Morales Testosterone Deficiency Focus of New Canadian Guidelines echoes what we have learned  the past 50 years over our career lifetimes about appropriate parenteral natural physiological HRT being as important for deficient aging men- testosterone replacement. This matches need for appropriate parenteral natural physiological HRT for postmenopausal women- for whom progesterone cream often suffices as the safe baseline, adding parenteral testosterone and parenteral estrogen only as selectively indicated.ie in both genders to conservatively restore physiological balanced baseline bloodlevels of healthy young adults. .
Its now 13 years since the USA hysterical banning (2002 then 2003) of all HRT after the badly designed and bad analyses and premature stopping of the Womens’ Health Initiative; which illogically tested unphysiological and long-discredited patent oral xeno- ie non-human hormones (premarin and medroxyprogestin) in mostly elderly women long past the Change- the midlife menopause and menopause symptom decade (ie late forties to late fifties).

Many of us in the International Menopause Society objected to this dangerous hysteria from 2002 onwards, but the Americans involved in the WHI refused to concede for a decade that they were wrong, since such admission would have opened them to culpable negligence claims.. . .

in 2013 co-editors Dr Nick Panay(UK) and Dr Ana Fenton (NZ) asked in the leading journal Climacteric about the Womens’ Health Initiative:WHI: have our worst fears come true? . This was based on ongoing analyses of studies eg by Drs Sarrell, Katz ea at Yale University that showed The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years who were denied HRT.

Ongoing studies over 60 years (Schleyer-Saunders, Lee, Dalton, Greenblatt, Gelfand, Gambrell, Schneider, Davey, Shapiro, Cheifitz, Burger & Davis, Nieschlag & Behre, Notelowitz, Lunenfeld, Utian, Harman, Bhasin, Zitzman, Hader, Saad ea) have clearly confirmed what was apparent from experience in the 1940s, and Masters and Grody’s initial landmark HRT studies in the1950s in both sexes, that appropriate human parenteral balanced HRT (testosterone/ progesterone, plus estrogen for women) retard all risks of aging degenerative diseases in sex-hormone deficient aging people; and also extend both healthspan and longevity ie are antiaging.

           Now we have come full circle with longterm followup of stable physiological parenteral testosterone replacement- patches, fortnightly depotTT – or quarterly Nebido TUndecanoate – in 100 000s of men globally to a mean testosterone level around 18nmol/L (let alone to appropriate testosterone  replacement in women):

ongoing followup from a European observer personal communication last week is borne out by already published studies below: “there is no evidence from various registries of increased incidence and/or severity of prostate cancer with testosterone treatment.

      Increasing signals are that adequate testosterone treatment is protective, for the prostate as well as the immune, cardiovascular, nervous, musculoskeletal and cognitive-mood systems. One registry follows both hypogonadal men who refused testosterone treatment, and those on replacement. In 8 years follow-up of 296 elective hypogonadal men , 26% had major cardio-/vascular medical endpoints (21 deaths -19 = 6% cardiovascular, 30 =10% strokes, and 26 = 9% myocardial infarction, in total 77 events) . The elective Nebido testosterone replacement group (360 men) reported NO cardio/vascular endpoints ie no medical deaths, strokes, or heart attacks.(1 traffic accident death, 1 postsurgical complication death), q.e.d. p<0.0000…

REFS- in italics :
Clin Interv Aging. 2014 Jul 23;9:1175-86.. Off-label use of hormones as an antiaging strategy: a review. Samaras N1ea Geneva University Switzerland. Given demographic evolution of the population in modern societies, one of the most important health care needs is successful aging with less frailty and dependency. During the last 20 years, a multitude of anti-aging practices have appeared worldwide, aiming at retarding or even stopping and reversing the effects of aging on the human body. One of the cornerstones of anti-aging is hormone replacement. At present, women live one third of their lives in a state of sex-hormone deficiency. Men are also subject to age-related testosterone decline, but andropause remains frequently under-diagnosed and under-treated. Due to the decline of hormone production from gonads in both sexes, the importance of dehydroepiandrosterone (DHEA) in steroid hormone production increases with age. However, DHEA levels also decrease with age. Also, growth hormone age-associated decrease may be so important that insulin growth factor-1 levels found in elderly individuals are sometimes as low as those encountered in adult patients with established deficiency. Skin aging as well as decreases in lean body mass, bone mineral density, sexual desire and erectile function, intellectual activity and mood have all been related to this decrease of hormone production with age. Great disparities exist between recommendations from scientific societies and actual use of hormone supplements in aging and elderly patients. In this article, we review actual data on the effects of age related hormone decline on the aging process and age-related diseases such as sarcopenia and falls, osteoporosis, cognitive decline, mood disorders, cardiovascular health and sexual activity. We also provide information on the efficiency and safety of hormone replacement protocols in aging patients. http://www.ncbi.nlm.nih.gov/pubmed/25092967

     WOMEN: The latest of many are the Danish studies of up to 16 yearsfollowup ;        2008 http://eurheartj.oxfordjournals.org/content/29/21/2660.abstract

2012 http://www.ncbi.nlm.nih.gov/pubmed/?term=BMJ+%28Schierbeck+et+al+2012%3B345%3Ae6409,

the USA KEEPS RCT of lower-dose premarin vs estradiol patch +- parenteral progesterone in perimenopausal women by Harman, Naftolin ea http://www.keepstudy.org/publications/index.cfm,

and again
Clin Endocrinol (Oxf). 2014 Oct;81(4):621-8. doi: 10.1111/cen.12459. Epub 2014 May 5. Transdermal testosterone improves verbal learning and memory in postmenopausal women not on oestrogen therapy. Davis ea . Monash University, Australia. Randomized, placebo-controlled trial in which participants were randomized (1:1) to transdermal testosterone gel 300 mcg/day, or identical placebo, for 26 weeks. 92 postmenopausal women aged 55-65 years, on no systemic sex hormone therapy. Eighty-nine women, median age 60 years, were included in the primary analysis. Testosterone treatment resulted in statistically significantly better performance for the ISLT (improved verbal learning and memory) compared with placebo, adjusted for age and baseline score (mean difference 1•57; 95%CI 0•13, 3•01) P = 0•03 At 26 weeks, the median total testosterone was 1•7 nm (interquartile range (IQR) 1•1, 2•4) in the testosterone group and 0•4 nm (IQR 0•3, 0•5) in the placebo group. The small but statistically significant effect of testosterone treatment on verbal learning and memory in postmenopausal women provides the basis for further clinical trials.
Testosterone in women-the clinical significance. Davis & Wahlin-Jacobsen .Lancet Diabetes Endocrinol. 2015 (12):980-92. http://www.ncbi.nlm.nih.gov/pubmed/26358173.      Testosterone is as much an essential hormone for women, with physiological actions mediated directly or via aromatisation to oestradiol throughout the body. Observational studies indicate that testosterone has favourable cardiovascular effects measured by surrogate outcomes. Adverse cardiovascular effects have not been seen in studies of transdermal testosterone therapy in women. http://www.ncbi.nlm.nih.gov/pubmed/24716847

BJU Int. 2014;114:125-30. Long-acting testosterone injections for treatment of testosterone deficiency after brachytherapy for prostate cancer. Balbontin, Morgentaler ea With a median of 31-months follow-up, long-acting testosterone injections in men mean 62yrs with prostate cancer treated with brachytherapy produced significant clinical benefits. There were no cases of rising serum PSA, prostate cancer progression or recurrence.
J Urol. 2015;193:80-6. Incidence of prostate cancer in hypogonadal men receiving testosterone therapy: observations from 5-year median followup of 3 registries. Haider A1, Zitzmann M Yassin ea Germany In 3 parallel, prospective, ongoing, cumulative registry studies 1,023 hypogonadal men received testosterone therapy since 1996. Patients were treated when total testosterone was 12.1 nmol/l or less (350 ng/dl) with symptoms of hypogonadism. Maximum followup 17 years (1996 to 2013), median followup was 5 years. Mean baseline patient age was 58 years and 41 years. Patients received testosterone undecanoate injections in 12-week intervals. Prostate monitoring/ biopsies were performed according to EAU guidelines. RESULTS: A total of 11 patients were diagnosed with prostate cancer in the 2 urology settings at proportions of 2.3% and 1.5%, respectively. The incidence per 10,000 patient-years was 54.4 and 30.7 , respectively, ie mean 0.42% pa – well below that in the general population. No prostate cancer was reported by the andrology center. CONCLUSIONS:Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer. If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men. http://www.ncbi.nlm.nih.gov/pubmed/?term=Incidence+of+Prostate+Cancer+in+Hypogonadal+Men+Receiving+Testosterone+Therapy%3A+Observations
Eur Heart J. 2015 Oct 21;36(40):2706-15. Normalization of testosterone level is associated with halved incidence of myocardial infarction and mortality in men. Sharma R1, ea University of Kansas retrospectively examined 83 010 male veterans with documented low TT levels http://www.ncbi.nlm.nih.gov/pubmed/26248567
Prostate Cancer Prostatic Dis. 2015 Dec;18(4):382-7. Preoperative low serum testosterone is associated with high-grade prostate cancer and an increased Gleason score upgrading.Pichon ea, France http://www.ncbi.nlm.nih.gov/pubmed/?term=Preoperative+low+serum+testosterone+is+associated+with+high-grade+prostate+cancer+and+an+increased+Gleason+score+upgrading+A+Pichon1%2C5%2C
Horm Mol Biol Clin Investig. 2015 Jun;22(3):101-9. Obesity and hypogonadism are associated with an increased risk of predominant Gleason 4 pattern on radical prostatectomy specimen. Neuzillet , ea France http://www.ncbi.nlm.nih.gov/pubmed/26047422
BJU Int. 2013;111:880-90. Prostate-specific antigen (PSA) concentrations in hypogonadal men during 6 years of transdermal testosterone treatment. Raynaud ea france http://www.ncbi.nlm.nih.gov/pubmed/23294726
Exp Clin Endocrinol Diabetes. 2015 Nov;123(10):608-13. The Effect of Metformin and Metformin-Testosterone Combination on Cardiometabolic Risk Factors in Men with Late-onset Hypogonadism and Impaired Glucose Tolerance.Krysiak ea Poland . No previous study has investigated the effect of metformin, administered alone or together with testosterone, on cardiometabolic risk factors in men with hypogonadism. The study included 30 men with late-onset hypogonadism (LOH) and impaired glucose tolerance (IGT) who had been complying with lifestyle intervention. After 12 weeks of metformin treatment (1.7 g daily), the participants were allocated to one of 2 groups treated for the following 12 weeks with oral testosterone undecanoate (120 mg daily, n=15) or not receiving androgen therapy (n=15). before and after 12 and 24 weeks of therapy with the final dose of metformin. Patients with LOH and IGT had higher levels of hsCRP, homocysteine and fibrinogen than subjects with only LOH (n=12) or only IGT (n=15). Metformin administered alone improved insulin sensitivity, as well as reduced 2-h postchallenge plasma glucose and triglycerides. Testosterone-metformin combination therapy decreased also total and LDL cholesterol, uric acid, hsCRP, homocysteine and fibrinogen, as well as increased plasma testosterone. The effect of this combination therapy on testosterone, insulin sensitivity, hsCRP, homocysteine and fibrinogen was stronger than that of metformin alone. The obtained results indicate that IGT men with LOH receiving metformin may gain extra benefits if they are concomitantly treated with oral testosterone. http://www.ncbi.nlm.nih.gov/pubmed/26600057
Swiss Med Wkly. 2015 Nov 24;145:w14216. Hypotestosteronaemia in the aging male: should we treat it? Christe N1, Meier CA1.Switzerland http://www.ncbi.nlm.nih.gov/pubmed/26599486 The term male hypogonadism is defined as the failure to maintain physiological concentrations of testosterone, a physiological quantity of sperm or the combination of both. Aetiologically, androgen deficiency can originate from the testes (primary hypogonadism) or from the hypothalamic-pituitary regulation of the testicular function (secondary hypogonadism). The causes of hypogonadism are very diverse .. But how about the aging male? It is known that there is a highly variable age-related decline in testosterone levels; whether this represents a variation of normality or has a true disease value requiring therapy has been disputed over more than a decade. The key questions surrounding this debate concern not only the age-dependent threshold for serum testosterone but, more importantly, the risks and benefits of testosterone replacement therapy in the aging male. randomised controlled trials of testosterone administration in aging males with a size of at least 100 patients and a follow-up of at least 6 months, identified eight studies. These studies mostly tried to evaluate the effect of testosterone on bone density, muscle strength and body composition, rather than clinically meaningful endpoints. Moreover, these trials have provided evidence for relevant cardiovascular adverse events in elderly men. This supports the need for further studies to define the treatment threshold for testosterone levels in the aging male, as well as with regard to the long-term risks and relevant benefits of testosterone therapy in this population. Until we have more solid data in aging males, testing for testosterone deficiency and testosterone replacement should remain reserved for patients with predisposing conditions, symptoms and signs of bona fide hypogonadism.
Rev Endocr Metab Disord. 2015 Nov 21. The complex and multifactorial relationship between testosterone deficiency (TD), obesity and vascular disease.Traish AM1, Zitzmann M2.Boston & Germany Univ. Testosterone deficiency (TD) is a well-established and recognized medical condition that contributes to several co-morbidities, including metabolic syndrome, visceral obesity and cardiovascular disease (CVD). More importantly, obesity is thought to contribute to TD. This complex bidirectional interplay between TD and obesity promotes a vicious cycle, which further contributes to the adverse effects of TD and obesity and may increase the risk of CVD. Testosterone (T) therapy for men with TD has been shown to be safe and effective in ameliorating the components of the metabolic syndrome (Met S) and in contributing to increased lean body mass and reduced fat mass and therefore contributes to weight loss. We believe that appropriate T therapy in obese men with TD is a novel medical approach to manage obesity in men with TD. Indeed, other measures of lifestyle and behavioral changes can be used to augment but not fully replace this effective therapeutic approach. It should be noted that concerns regarding the safety of T therapy remain widely unsubstantiated and considerable evidence exists supporting the benefits of T therapy. Thus, it is paramount that clinicians managing obese men with TD be made aware of this novel approach to treatment of obesity. http://www.ncbi.nlm.nih.gov/pubmed/26590935
Cancer Causes Control. 2015 Nov 20. Serum androgens and prostate cancer risk: results from the placebo arm of the Prostate Cancer Prevention Trial. Schenk JM1, EA USA & Australian Univ. examined whether pre-diagnostic serum androgens were associated with PCA risk in the placebo arm of the Prostate Cancer Prevention Trial. In this 3 yr nested case-control study, cases (n = 1,032) were primarily local-stage, biopsy-detected cancers, and controls (n = 1,025) were biopsy-confirmed to be PCA-free.. We found no significant associations between serum androgens, estrogen-to-testosterone ratios, or SHBG and risk of total, low (Gleason <7) or high-grade (Gleason 7-10) PCA. http://www.ncbi.nlm.nih.gov/pubmed/26589415
by contrast,

seer.cancer.gov/statfacts/html/prost.htm reports:
In recent years, the number of prostate cancer deaths IN USA was 21.4 per 100,000 men per year ie 0.021%pa . c/f apparently no prostate cancer deaths in the TRT studies. These rates are age-adjusted and based on 2008-2012 cases and deaths. Lifetime Risk of Developing Cancer: Approximately 14.0 percent of men will be diagnosed with prostate cancer at some point during their lifetime, based on 2010-2012 data



for appointments for consultations,   or non-xray procedures by registered practitioners :  Sure Touch breast prescreening on  Saturday mornings next on  7 February 2015  by Sister Zeneath Ismail – cash R650 (then R450 if followup scan desired within 3 months);   -QUS  ultrasound quantitative bone density  cash R450 -tariff item 3612-  anytime;  Unlike radiologists’  and thermography reports (which describe only  the imaging finding), the rates quoted include relevant breast or bone consultation and management planning  by specialist nurse & physician.

IF BOOKED TOGETHER, (not necessarily the same morning) then combined breast and bone screening is R1000.

OTHER SERIOUS health problems ARE DEALT WITH BY CONSULTATION DURING THE WEEK (OR ON A DIFFERENT SATURDAY MORN) : heart- ECG,  fatigue, HRT, sexual health, hypertension, depression, memory/dementia, lung & lungfunction, anaemia-haematology; kidney/bladder/pelvic, hormone-endocrine, depression, osteoporosis, sleep, diabetes, thyroid, adrenal; cramp; skin,  infection including STDs & HIV/AIDs, stroke, epilepsy-neurology, dizziness, heartburn/digestive/liver,  neuropathy,  sexual health, menopause, HRT, genitourinary; immune problems, or arthritis relief;

Thermography no-touch infrared screening  for suspicious  cancer /inflammatory  changes:  by Radiographer Melinda-next 23 March 2015.   R900 breasts; R1100  head and  upper;  or lower body & pelvis;  R1300 whole body.

Bookings/queries contact Evelyn/ Reyhana / Val at  the Natural Medicine Clinic, 1st Floor no 15, Grove Medical Bldg, opp ABSA (parking ABSA Parkade )  near Warwick/Cavendish  Square Claremont Cape Town RSA, ph +27216831465 or a/h +2783 4385248 or reyhanadaya@yahoo.com  .

For the disabled – by arrangement  drive  up the ramp  to the Clinic door on the Grove Bldg 1st floor  parking deck.

Under CMS Council for Med Schemes Reg 10(6), open Medical schemes eg hospital plans  have to pay from their own funds (not members’ savings) for appropriate outpatient consultation (tariff item 0191) for  PMBs ie major conditions eg  cancer,   depression, neck/spinal problems, serious heart, lung, other disease., etc. Breast and osteoporosis concerns are generally part of menopause consultations N95.9   (if not already eg breast cancer code C50) and thus are often billable  med scheme benefits. The menopause billable item only applies if you are 45yrs upwards, unless you have had total hysterectomy.

On patients’ requests, appropriate invoice can be prepared and submitted to your scheme for refund of your due benefits. Some schemes eg hospital plans  falsely deny due benefits until reported to their regulator  CMS. For medical plans where the billable tariff benefit rate is higher than the breast screening fee paid, the med plan rate 0191  will be charged eg R790 by the contracted  specialist,  and refundable by Discovery to the member. some basic schemes eg Keycare, Bonitas require preauthorization, or referral by their contracted GP  .

The Nonscience Witch Hunt Against HRT for Deficiency Syndromes Must End: An A4M Position Paper on Physician-Prescribed HRT

Our Oct 2014 cover
The Nonscience Witch Hunt Against Hormone Replacement Therapies for Deficiency Syndromes Must End
An A4M Position Paper on Physician-Prescribed HRT

Introduction  “Unless we put medical freedom into the Constitution, the time will come when medicine will organize into an undercover dictatorship to restrict the art of healing to one class of Men and deny equal privileges to others; the Constitution of the Republic should make a Special privilege for medical freedoms as well as religious freedom.”~Benjamin Rush (1745–1813), physician, writer, educator,
humanitarian, and Founding Father of the US

Since the inception of the anti-aging medical movement in 1991, various establishment parties have ruthlessly leveraged their positions of power in academic, political, and regulatory arenas for the purpose of attempting to limit the use of hormone replacement therapies (HRT) in adults with documented clinical deficiencies. For over 15 years, a prolonged and calculated campaign of deceit, fraud, and suppression has threatened physician licensures and liberties to treat and prescribe life-improving therapies, leading potentially to the direct compromise of patients’ health and longevity. Dozens of physicians have been sanctioned and punished with loss of license and academic standing. This pernicious abuse of position and power is particularly prevalent with regard to recent challenges made against human growth hormone (HGH), testosterone (TRT), and DHEA replacement therapies that are trumpeted by the mainstream media. Biased reporters frequently – and inappropriately – demonize legitimate physicians and clinical compounding pharmacies that are reluctantly positioned on the frontline of a decades-old agenda to limit freedom of choice and information, and the physicians’ most essential responsibility to select the best course of therapy and medication for their patients.

This conflict is being played out of late in the arena of anti-aging medicine, a clinical specialty that has flourished in its 22 year long history, garnering the support of more than 100,000 physicians and scientists worldwide who practice or research life-enhancing, life-extending interventions today. Prof. Dr. Imre Zs.-Nagy, of the University of Debrecen Medical and Health Science Center (Hungary), and founder of the Archives of Gerontology and Geriatrics (published by Elsevier), observes: “In my role as a basic and clinical scientist, I have had an opportunity to witness more than four decades of advances and declines in the arena of preventive medical care … there has been little else as dramatic, important, beneficial, and significant as the anti-aging medical movement.”1
Continual vigilance is necessary to countermand those whose financial and professional successes depend on repeated, calculated attempts to discredit the science and substance of anti-aging medicine.
Remarks Tanjung Subrata, MD, of Udayana University School of Medicine (Indonesia):
Anyone who does not believe in evil is not paying attention to the recent affairs of the past twenty years. We are living in a time of unprecedented tribulation and changes at-large – and in health care, in particular. All that is necessary for evil to prevail is for men of good will to do nothing. In this modern age of zero tolerance for alternatives to establishment medicine, and the willingness of our governmental officials to resort to police state tactics to suppress innovative schools of thought, progress in medicine halts and dies.2

A4M Position
The American Academy of Anti-Aging Medicine (A4M), its numerous worldwide affiliated scientific and medical societies, and befriended organizations support the judicious application of modern and advanced medical technologies to address the changes in chemical, hormonal, physical, and nutritional needs that occur with aging. Such repletion includes the restoration of hormones to an optimal physiological state when deficiency is determined by objective assessment.
Hormone replacement therapy (HRT) is an essential and extensively documented protocol for clinical intervention in the disorders of aging. HRT maintains an unblemished safety and efficacy profile that has been documented by 20 years of clinical application. Yet, a perfect storm of misguided media, combined with biased parties whose livelihoods hinge on disparaging the anti-aging medical movement, has grossly compromised access to HRT, placing the lives of hundreds of thousands of patients worldwide in potential jeopardy.
Experienced anti-aging physicians have been prescribing HRT for more than 20 years. PubMed contains more than 20,000 peer-reviewed studies of HRT, of which a preponderance document the life-enhancing and/or life extending benefits of HRT in aging adults. See Appendix A “Literature Review,” which presents a selection of such studies that represent the objective evidence that supports the A4M position.

The Anti-Aging Medical Movement
The goal of anti-aging medicine is not to merely prolong the total years of an individual’s life, but to ensure that those years are enjoyed in a productive and vital fashion. As established in 1991 by the physicians of the American Academy of Anti-Aging Medicine (A4M), the field of anti-aging medicine developed as a direct extension to the science of elite sports medicine of the 1980s. Just as sports medicine aims to keep the athlete’s body functioning at its optimum level, anti-aging medicine seeks to keep the human physiology performing at its peak. In other words, the similar principle, of extending and maximizing the healthy human lifespan, is at the core of both anti-aging medicine and sports medicine.

The Official Definition of Anti-Aging Medicine
The clinical specialty of anti-aging medicine thus is defined as follows:      Anti-aging medicine is a clinical specialty is founded on the application of advanced scientific and medical technologies for the early detection, prevention, treatment, and reversal of age-related dysfunction, disorders, and diseases. It is a health-care model promoting innovative science and research to prolong the healthy lifespan in humans. As such, anti-aging medicine is based on principles of sound and responsible medical care that are consistent with those applied in other preventive health specialties. The phrase “anti-aging,” as such, relates to the application of advanced biomedical technologies focused on the early detection, prevention, and treatment of aging- related disease.

Anti-aging medicine utilizes diagnostic protocols that are supported by scientific evidence to arrive at an objective assessment upon which effective treatment is assigned. Physicians who dispense anti-aging medical care are concerned with the restoration of optimal functioning of the human body’s systems, organs, tissues, and cells. Attempting to rebrand what they cannot deny, those in positions of power in academic, political, and regulatory arenas are inventing new catchphrases including longevity medicine, successful aging, healthy aging, and the like, in an effort to dilute and absorb the A4M’s original definition of anti-aging medicine. To implement this campaign, we suspect that these individuals have pejoratively solicited major media outlets to denigrate the A4M, its officers, and its members.
Anti-aging medicine is, in essence, a euphemism for early detection and advanced preventative medicine. It is a health-care model that emphasizes personalized, patient-focused, high-quality metabolic-specific medical care.

Critics with A Dark Agenda (Political Elites)
Scientifically based and well documented in leading medical journals, anti-aging medicine is among the fastest-growing medical specialties throughout the world. As an innovative model for advanced preventive health care that cannot be denied, anti-aging medicine has been disparaged by individuals with their own political and financial agendas in attempts to restore monopolistic control over the field of aging intervention. Critics of the science of anti-aging medicine most commonly hail from academia: as such, these naysayers many times have little or no medical training in aging intervention and may be nonclinicians.
Perhaps the most inconceivable reality is that at the very highest levels of academia, government, and science, truth and objective scientific method are not at all sacred to the political elites. We in clinical medicine via our training, discipline, and conditioning naively believe and act in the public interest, for the good of our patients’ health, and by professional standards of medical ethics. The (elite) medical establishment operates contrary to this position, reports investigative reporter Tim Bolen (www.bolenreport.com), who for 30 years has amassed data and evidence exposing a calculated effort to deride innovative medical therapeutics. Bolen observes:  Without a doubt, a stealthy control group – a cabal, if you will, in status-quo medicine exists. Approved by Big Pharma, parts of academia, and segments of the government, this group exerts its control in many different ways. I have uncovered information showing anonymous, and not-so-anonymous, funding of groups, loosely describing themselves as “Quackbusters or Skeptics” whose only purpose is to attack cutting-edge health care offerings. Those groups, in turn, train, and fund sub-groups. Data suggests that the “Quackbusters or Skeptics” donated over $1 Million US to Wikipedia to purchase control over pages with medical content. More, the Skeptic training camps teach their recruits how to operate together to control that same Wikipedia and Search Engines. Further, these covert groups drive media on issues particularly pertaining to alternative health care, in an effort to limit coverage of innovative discoveries and to vilify therapies that are not part of AMA/FDA/Big Pharma establishment medicine health care.

There are TWO main “skeptic” organizations – the James Randi Educational Foundation (JREF) and the Center For Inquiry (CFI). Both are well funded from secret sources.

JREF reported, in 2010, a total income of $999,971.00 and a Total Asset claim of $1,736,101.

The Center For Inquiry, Inc (CFI), based in Amherst, New York shows on their Form 990 that they took in $5,242,304 in Total 2009 Income, and they had, that year, Total Assets of $3,017,144. Their Schedule B ANONYMOUS contributions totaled $2,318,652.

More, CFI claimed that they received, in 2009, in addition to their anonymous contributions, a so-called “Management Fee Income” of $2,458,156. What do you suppose they managed? And who paid them to manage it? Maybe they manage Wikipedia health care articles? How about Search Engine Optimization (SEO) bringing skeptic, including Stephen Barrett’s (Quackwatch), articles to the first page of Google?

Much more – This cabal minimizes and delays innovative medical advancements by lodging anonymous complaints to state licensing boards against cutting-edge practitioners. Their insidious campaign also controls grant monies and research funding, somewhat silencing the voices of innovative medicine in favor of mainstream views. By leveraging control of the media in direct jeopardy of journalistic integrity, this control group seeks to suppress all in medicine that is not fully controlled by the establishment. To permit this level of manipulation and disinformation is wrong and ethically corrupt. The fate of a valuable avenue of medical innovation for the public interest – anti-aging medicine – stands at-risk.3

A JAMA commentary purported to address the legality of human growth hormone (HGH, GH) treatment by physicians for growth–hormone deficient (GHD) patients.4 It is the view of A4M that the commentary contained a number of incorrect, misplaced references and studies, and multiple basic scientific errors, in an apparent attempt to damage the anti-aging medical profession and the physicians practicing solid, evidence-based medical health care focused on improving and maintaining patients’ quality of life. It is A4M’s further opinion that the authors selected self-serving studies, in which they failed to qualify the conclusions in an effort to bolster what A4M believes is a disinformation campaign. It is A4M’s opinion, for example, that they incorrectly intermingled Internet sales of homeopathic pseudo-“GH” sprays, amino acids, and sports nutritional over-the-counter products in order to inflate their incorrect claims suggesting an illegal diversion of HGH by physicians and pharmacies, implying a black market in FDA-approved prescription injectable HGH for hormone replacement treatments by anti-aging physicians where none exists.

Misrepresentation in Competitive Sports
As an unfortunate consequence of media confusion and outright deception aiming to deliberately misrepresent anti-aging medical care, the reality of the clinical practice of hormone replacement therapy has become muddled. A recent Sports Illustrated article states: “In the sports world, the term ‘anti-aging’ has often come to signify therapy that uses hormones – usually testosterone and HGH – and … DHEA.”5 This erroneous definition grossly misrepresents the legal and ethical physiological use of hormones and supplements as being synonymous with the inappropriate use of hormones for sports enhancement. The A4M is squarely opposed to this myopic interpretation of “anti-aging” and urges reference to the official definition of anti-aging medicine as presented above.

Page 1, 2, 3, 4, Appendix/Notes


: ABSTRACT:  since last review in  this column 5 years ago, what progress has there been with ovarian cancer OvCa? On Pubmed there are 81000 references,  45500 reviews on OvCa

5 Oct 2014:  Ovarian Cancer Often Arises from Precursor Endometriosis    Frontline Medical News, 2014 Sep 29, B Jancin

   29 Sept 2014  The good news is that if ovariectomy is not done at hysterectomy, then at least salpingectomy should be done- it does not cause earlier menopause.  And the modern fashion for progesterone cream as baseline hormone balancing in this age of estrogen dominance, the feminization of nature,  also adds major protection for heart, bone, memory, mood,  and against cancer, without the risks of estrogen.

Before this month’s update,  the latest, an Australian cancer review  Mette ea 2013, shows that cigarette smoking increases the risk of OvCa by 30% to 60%.

The latest   review 2013 Modugno ea at Univ Pittsburgh/Mayo Clinic  Hormone response in ovarian cancer: time to reconsider as a clinical target?   said “Ovarian cancer is the sixth most common cancer worldwide among women in developed countries and the most lethal of all gynecologic malignancies. There is a critical need for the introduction of targeted therapies to improve outcome. Epidemiological evidence suggests a critical role for steroid hormones in ovarian tumorigenesis. There is also increasing evidence from in vitro studies that estrogen, progestin, and androgen regulate proliferation and invasion of epithelial ovarian cancer cells. Limited clinical trials have shown modest response rates; however, they have consistently identified a small subset of patients that respond very well to endocrine therapy with few side effects. We propose that it is timely to perform additional well-designed trials that should include biomarkers of response.The most consistently reported reproductive and hormonally related factors found to protect against EOC are use of oral contraceptives (OCs), increasing parity, and having a tubal ligation. In contrast, increasing age and nulliparity have been consistently shown to increase EOC risk. 

    Recent studies, including the prospective Women’s Health Initiative (WHI) (Anderson et al. 2003) and the Million Women Study (Beral et al. 2007), report an increase in risk for both estrogen-only (ET) and estrogen–progestin (EPT) formulations, although the risk associated with EPT was lower than that of ET. A recent meta-analysis of 14 published studies found risk increases 22% per 5 years of ET use compared with only 10% per 5 years of EPT use, suggesting that risk differs by regimen (Pearce et al. 2009).               Exogenous androgens may be associated with EOC. One case–control study found that use of Danazol, a synthetic androgen commonly used in the treatment of endometriosis, significantly increased EOC risk (Cottreau et al. 2003), although this finding has not been replicated (Olsen et al. 2008). Ever use of testosterone (tablets, patches, troches, or cream) has been associated with a threefold increase in EOC (Olsen et al. 2008).             

     Reproductive disorders and other reproductive factors :  Factors affecting childbearing have also been shown to be associated with EOC. In most studies, infertility has been associated with an increased risk, which may be greatest among women who fail to conceive (Vlahos et al. 2010). In general, infertility treatment does not appear to increase EOC risk, although the subset of treated women who remain nulliparous may be at an increased risk (Vlahos et al. 2010).

         Endometriosis, defined as the presence and growth of endometrial tissue outside the uterine cavity, has also been associated with EOC. A recent pooled analysis of 13 case–control studies showed a threefold increase in the incidence of clear cell EOC and a twofold increase in endometrioid EOC among women with a self-reported history of endometriosis (Pearce et al. 2012).

    An increased risk of EOC was reported by one case–control study (Schildkraut et al. 1996) among women with polycystic ovary syndrome (PCOS), a condition associated with menstrual dysfunction, infertility, obesity, the metabolic syndrome, hyperandrogenism, and insulin resistance. However, the finding was based on a small number of cases (n=7) and the association was limited to nonusers of OCs and thin women. Further case–control and prospective studies have failed to confirm this relationship (Pierpoint et al. 1998, Olsen et al. 2008, Brinton et al. 2010).

   Tubal ligation has been consistently shown to be associated with reduction in EOC risk (Cibula et al. 2011). This protection appears similar in magnitude to OC use and child bearing (about 30%) and is protective in high-risk women (i.e. BRCA1/2 carriers) as well. Hysterectomy has also been shown to reduce EOC risk, although the magnitude of the association is not as great nor as consistent as that reported for tubal ligation (Riman et al. 2004). Finally, reproductive factors associated with other hormonally linked cancers, such as age at first menarche, age at menopause, and length of reproductive years, have not been consistently associated with EOC (Riman et al. 2004).

    Estrogens and androgens –  The evidence linking these  to EOC are mixed. The majority of women who develop ovarian cancer are postmenopausal at the time of diagnosis. In postmenopausal women, the major source of circulating estrogen is from the peripheral conversion (in skin and adipose tissue) of androstenedione by the enzyme aromatase.

    Progesterone and progestins- Epidemiological data suggest that progestins and progesterone may have a protective role against EOC. Importantly, there is some evidence that progesterone might synergize with chemotherapeutic drugs to induce apoptosis.

Now this month  comes exciting news about  a  Paradigm Shift: Prophylactic Salpingectomy for Ovarian Cancer Risk Reduction   Frontline Medical News, 2014 Sep 24, B Jancin     :   Removing the fallopian tubes at the time of pelvic surgeries as a potential means of reducing ovarian cancer risk appears to be a movement that’s picking up steam in clinical practice.
       A recent survey of 234 U.S. gynecologists showed prophylactic bilateral salpingectomy is catching on when performed in conjunction with hysterectomy, but far less so for tubal sterilization, Dr. Austin Findley observed at the annual Minimally Invasive Surgery Week.                                                                       A total of 54% of respondents indicated they routinely perform salpingectomy at the time of hysterectomy in an effort to reduce the risk of ovarian cancer as well as to avoid the need for reoperations. However, only 7% of the gynecologic surgeons said they perform salpingectomy for tubal sterilization, even though 58% of respondents stated they believe the procedure is the most effective form of tubal sterilization (J. Minim. Invasive Gynecol. 2013;20:517-21).
  “In my experience at various hospitals, I think these numbers are a pretty accurate reflection of what folks are doing,” commented Dr. Findley of Wright State University in Dayton, Ohio.
     The prophylactic salpingectomy movement is an outgrowth of the tubal hypothesis of ovarian cancer.
    “There is now increasing and dramatic evidence to suggest that most ovarian cancers actually originate in the distal fallopian tubes. I think this is a concept most people are unaware of or are just becoming accustomed to. The tubal hypothesis represents a major paradigm shift in the way we think about ovarian cancers. The previous belief that excessive ovulation is a cause of ovarian cancer is no longer regarded as accurate,” he explained at the meeting presented by the Society of Laparoscopic Surgeons and affiliated societies.
      Ovarian cancer is the No. 1 cause of mortality from gynecologic malignancy, accounting for more than 14,000 deaths per year, according to National Cancer Institute data. The lifetime risk of the malignancy is 1.3%, with the average age at diagnosis being 63 years.
       Only 10%-15% of ovarian cancers occur in women at high risk for the malignancy because they carry a BRCA mutation or other predisposing gene. The vast majority of ovarian cancer deaths are caused by high-grade serous tumors that have been shown to be strongly associated with precursor lesions in the distal fallopian tubes of women at low risk for the malignancy.
            There is no proven-effective screening program or risk-reduction method for these low-risk women. However, with 600,000 hysterectomies and 700,000 tubal sterilizations being performed annually in the United States, prophylactic salpingectomy has been advocated as an attractive opportunity to potentially reduce ovarian cancer risk. Other common pelvic surgeries in which it might be used for this purpose include excision of endometriosis and laparoscopy for pelvic pain. It also has recently been shown to be feasible and safe post partum at cesarean or vaginal delivery (Obstet. Gynecol. 2014 [doi: 10.1097/01.AOG.0000447427.80479.ae]).
   But the key word here is “potentially.” It must be emphasized that at present the ovarian cancer prevention benefit of prophylactic salpingectomy remains hypothetical; in theory, the procedure should reduce ovarian cancer risk, but there is not yet persuasive evidence that it actually does, Dr. Findley emphasized at the meeting, presented by the Society of Laparoendoscopic Surgeons and affiliated societies.
            In contrast, one well-established ancillary benefit of prophylactic salpingectomy is that it eliminates the need for future reoperation for salpingectomy. This was demonstrated in a large Danish cohort study including close to 10,000 women undergoing hysterectomy and a similar number undergoing sterilization procedures. Among the nearly two-thirds of hysterectomy patients who had both fallopian tubes retained, there was a 2.13-fold increased likelihood of subsequent salpingectomy, compared with nonhysterectomized women.
        Similarly, Danish women who underwent a sterilization procedure with retention of the fallopian tubes – typically tubal ligation with clips – were 2.42 times more likely to undergo subsequent salpingectomy, most often because of the development of hydrosalpinx, infection, ectopic pregnancy, or other complications (BMJ Open 2013;3 [doi:10.1136/bmjopen-2013-002845]).
     The most commonly cited potential risk of prophylactic salpingectomy – decreased ovarian function – now appears to be a nonissue. This was demonstrated in a recent retrospective Italian study (Gynecol. Oncol. 2013;129:448-51) as well as in a pilot randomized controlled trial conducted by Dr. Findley and his coworkers (Fertil. Steril. 2013;100:1704-8), which appears to have answered many skeptics’ concerns. Indeed, Dr. Findley’s coinvestigator Dr. Matthew Siedhoff said he has recently been approached by researchers interested in collaborating in a larger confirmatory randomized trial, but all parties eventually agreed it was a no-go.
    “It’s a little hard to demonstrate equipoise for a larger randomized controlled trial. We’re beyond that now, given that prophylactic salpingectomy really doesn’t seem to make a difference as far as ovarian function,” according to Dr. Siedhoff, director of the division of advanced laparoscopy and pelvic pain at the University of North Carolina, Chapel Hill.
         Another oft-expressed reservation about salpingectomy as a means of reducing ovarian cancer risk in women seeking sterilization is that salpingectomy’s irreversibility may lead to “tubal regret” on the part of patients who later change their mind about further pregnancies. However, Dr. Findley cited a recent editorial whose authors criticized colleagues who made that claim. The editorialists argued that the tubal regret concern indicates surgeons weren’t really listening to their patients’ true desires during the informed consent conversation.
     “We should not have started thinking about salpingectomy for female sterilization only once a decrease in ovarian cancer risk became part of the equation,” they declared (Obstet. Gynecol. 2014;124:596-9).
           Dr. Findley noted that Canadian gynecologists are leading the way forward regarding prophylactic salpingectomy as a potential method of ovarian cancer prevention. The Society of Gynecologic Oncology of Canada in a 2011 policy statement recommended patient/physician discussion of the risks and benefits of bilateral salpingectomy for patients undergoing hysterectomy or requesting permanent sterilization. The Society of Gynecologic Oncology followed suit with a similar clinical practice statement in late 2013.
        Additionally, the Canadian group declared that a national ovarian cancer prevention study focused on fallopian tube removal should be a top priority.
    Gynecologic oncologists in British Columbia recently reported the eye-catching results of a province-wide educational initiative targeting gynecologists and their patients. In 2010, all British Columbia gynecologists had to attend a course on the role of the fallopian tubes in the development of ovarian cancer, during which they were advised to consider performing bilateral salpingectomy for ovarian cancer risk reduction.
              Surgical practice changed dramatically in British Columbia in response. In 2009 – the year prior to the physician education initiative – salpingectomy was utilized in just 0.3% of permanent sterilization procedures. In 2010, it was 11.4%. By 2011, it was 33.3%.
           Similarly, only 7% of hysterectomies performed in British Columbia in 2009 were accompanied by bilateral salpingectomy. This figure climbed to 23% in 2010 and jumped further to 35% in 2011. Meanwhile the rate of hysterectomy with bilateral salpingo-oophorectomy remained steady over time at 44% (Am. J. Obstet. Gynecol. 2014;210:471.e1-11).
     This project was conducted in collaboration with the B.C. Cancer Agency, which maintains comprehensive province-wide registries. Over time, it will be possible to demonstrate whether prophylactic salpingectomy is indeed associated with a reduction in the incidence of ovarian cancer. “I think this study demonstrated that there’s a lack of awareness on this issue, but also [that there’s] potential effectiveness of introducing an educational initiative like this in changing our practice patterns. As we start talking more about this issue amongst our colleagues and our patients, we’re more likely to see a practice pattern shift in the United States as well,” Dr. Findley commented.

17 July 2009     A new cancer study of  over 7 million women years is another major coffin for unopposed estrogen ET, for progestin Pg, and for oral  sex hormone therapy SHT.

Danish  Universities prospectively document  the incidence of ovarian cancer OvCa in a million postmenopausal women PMW  from 1995 through 2005.  Compared to non-users, use of HT increased OvCa (mean age 62yrs) by about 40%   for up to 2 years after stopping Ht, ie increased the absolute incidence  of clinically diagnosed OvCa from ~ 0.04 to ~0.052% ie per 100 patient yrs.

Transdermal TD ET alone  increased risk by 13%; vaginal ET by 23%;                                            Oral ET alone increased  risk by  34%; oral E+ progestin Pg by  48%;          TDE+Pg by 67%.

Thus the relative incidence of OvCa rose about 33% by 7 years on HT, to 48% if HT continued beyond 7years.

In 2004 Glud ea reported an increase risk of 31% for OvCa in Danish women on OHT use – total ET dose of ~5gm ie for about  for 15yrs – at a time when the standard premarin  dose was 0.625mg/d (equivalent to l mg E2)  if not double that .

For perspective,  the relative incidence of cancers in similar mostly 1st world European women from the  the USA SEER data for 2006 age over 50  years  are: BrCa 0.33%,  uterus 0.07%, ovary o.03%(ie very similar to the baseline Danish figure of 0.04% above), colon 0.15%,and cervix 0.01%. The new (Norwegian)  analysis in the latest BMJ suggests that screening mammography may result in overdiagnosis of BrCa by up to 50% (the other 50% may arguably never have been clinically significant-diagnosed- during life) , so the provocative could argue that the relative incidence of clinically significant BrCa to OvCa is more like eg BrCa 0.2 to ovary 0.03 ie just below 10:1. But OvCa is notoriously about 70% fatal within a few years, so  the absolute  mortality rate – at age 60-64yrs-  from  the same SEER  source and period are as relevant: BrCa 0.063%, uterus 0.011%, ovary 0.033%, colon 0.03% & cervix 0.005%. ie new OvCa may be only 1/10th as common as newBrCa, but BrCa  kills only twice  as many PMW as OvCa.

And finally the 2007  survey by  Rossing ea of  Menopausal Hormone Therapy and Risk of Epithelial Ovarian Cancer in women in Washington State 2002-2005 showed that  ET -mostly premarin (but not ET + progestin- MPA medroxyprogesterone provera) – especially in  low-parity  younger slim women increased OvCa compared to non-users, and that this risk  was highest- up to 90%-  in  users of OET  for more than 6 years.

By comparison – BREAST CANCER BrCa and HT: Hoover ea  1976  are the first on Pubmed to report doubling in  risk of breast cancer  BrCA after 15yrs on premarin in USA ie at least 5gm cumulative dose.

In Denmark by 1994 Ravn ea reported that if there was a risk of BrCa from OHT, it was small, and only after prolonged use of estrogen (15-20 years).  But by 2004 -2005 Tjønneland ea , Stahlberg ea  and Ewertz ea  found increased risk for BrCa  of 61 to 112%  associated with current use of HT.  Stahlberg ea already in 2003 concluded from recent studies from both the USA and Europe that the combined treatment regimens with estrogen and progestin increase the risk of BrCa  beyond the risk of unopposed estrogen.

In Norway, a recent Tromso study suggested that the dominant HT therapy used in Norway was oral estradiol E2 plus the progestin norethisterone acetate. . An earlier Tromso study in only 35000 PMW was too small- it showed that use of such OHT for >5yrs trebled the incidence of breast cancer BRCa, but did not influence that of OvCa.

Apart from smokers’ lung cancer, the commonest cancer in older women- BrCa- clinically affects perhaps 5% of PMW  lifelong – but  with prompt therapy after clinical presentation kills as few as 5% of sufferers- and with appropriate OHT (premarin +- provera)  for up to 8years in the Women’s Health Initiative both the incidence of and mortality from BrCa, and all-cause mortality,  were reduced by about one-third. Hence appropriate HT saves many from both BrCa and from premature death and disability from the commonest degenerative diseases- vascular, dementing and fracturing. 75% of women who develop BrCa  die with it –  not from it but from far more prevalent degenerative diseases after an  otherwise normal lifespan. But the Danish evidence is that combined OHT will increase OvCa by >50%.

Ovarian Ca kills 70% of victims, and is it so rare compared to BrCa? .

Hence with the perhaps 2/3  lower incidence of OvCa, it is a relatively trivial problem for women overall- except for the 4  in  10 000 women  who develop it, who have <50% 5year survival, ie 3 out of 4  of whom it will kill within a few years- compared to <25% of breast cancer victims who will be killed by the BrCa.

However, it becomes clear that these hormone-dependent cancers are both  duration-  and total-dose HT related; but even more important, that unopposed OET is a risk if persisted more than about 12 yrs; and even if used in far lower dose parenterally, the risk of OvCa is far higher if combined with the European fashion of androgenic synthetic progestins Pg – even parenterally; whereas the American MPA for up to 8years at least apparently if anything mitigates the OvCa risk of ET..

By contrast this column has repeatedly reviewed evidence that balancing physiological ERT with physiological testosterone replacement TRT eliminates the risk  for BRCA and endometrial cancer of unopposed ERT +- PRT in PMW.  Intuitively this should also apply to ovarian cancer.

Hence the message strengthens that PMW should not be exposed for  any length of time at any stage to the much higher oro-hepatic HT doses (needed for symptom control) or OET+- Pg; but as in all other endocrine replacement for permanent  multisystem prevention – let alone sexual function-  patients with gonadal deficiency should have physiological sexhormone balance restored  ie with balanced parenteral  human androgen, estrogen and progesterone replacement.

It is common cause that (reproductive cycles and pregnancy aside) all the physiological  prime sex hormones-DHEAdehydroepiandrosterone, P4, T, E2, E3 – are as important as all other human hormones, essential life long  for optimal health; and that estrogen dominance (due to inadequate  androgen and progesterone levels) is deleterious. Hence most PMW require both physiological progesterone and androgen replacement- sometimes to balance excessively high endogenous estrogens, usually to accompany necessary ERT for full balance.



UPDATE: 2 Mar  2014: PARACETAMOL ACETAMINOPHEN, DIGOXIN AND SPIRACTIN are ESTROGENIC: even the most popular and perhaps safest synthetic designer painkiller paracetamol acetaminophen (Tylenol, Panado) discovered in 1877   has again been shown  (Harvard University 2014- the Nurses’ Health Study from 20 years ago) to be ( like the 250year old biological human hormone digitalis/digoxin, and the 50year old synthetic antihormone  spironolactone), a weak estrogenic ie they proliferate the breasts and thus cancer potential.                       Acetaminophen use was positively associated with total Estrogen Metabolites (2+ days/week vs. non-use: 236 vs. 198 pmol/mg creatinine; p difference = 0.02, p trend = 0.11),  Thus like its cousin phenacetin (never mind alcohol and smoking)  after decades of fraudulent promotion as safe,  paracetamol’s harms outweigh its utility

     Thus while it  is fairly safe in adults in moderation,  like all designer synthetic drugs eg NSAIDs and synthetic/xenohormones,  like even lowdose aspirin, paracetamol  has many risks (even for the eyes)  and doesnt cure anything- whereas digoxin and spiractin may have lifesaving benefits in serious heart/ hypertensive disease. .

As always, for pain best stick to physical cure by eg manipulation, massage, rest and exercise, heat or cold, acupuncture; or some natural safe biological analgesic/antipyretic combination– massage with   arnica/menthol/coconut oil/ DMSO/cayenne/Lugol’s iodine/magnesium oil;     or these orally with eg fish oil; vitamins C (eg citrus), D3 (sunshine) and B esp B5 (meat, whole grain, avocado, brassica);  magnesium, manganese, copper, iodine, selenium; GABA (but not gabapentin and pregabalin – Bad Medicine);  plant extracts eg  boswelia, bromelain, buchu,  catsclaw, curcumin, dandelion,  MSM, nettle, ginger, caffeine, ecchinacea, sage, cherries, Oregano, rosemary, thyme, mint, cannabis, angelica, valerian;  and  cartilage eg glucosamine-chondroitin .


CHEST/BREAST  PAIN: In men and women, nontraumatic pain in the front , back and sides  of the chest (and abdomen)  is mostly neuromusculoskeletal, and easily diagnosed  by  the history (absence of cough, central deep pain radiating especially to the jaw , back  or left shoulder, breathlessness, fever, heartburn),  and  physical examination –absence of  systemic signs or  significant  changes in pulse and bloodpressure);

and appropriate assessment of the neck and thoracic spine since these are so often where root pain (around the shoulder girdle, trunk and limbs)  originates and can be simply relieved ie cured and thus diagnosed.

    This is crucial in daily busy  primary care ie general practice where patients –especially the younger fitter ones without the common high  risks – want a quick opinion and fix so they can move on, not have to undergo xrays,  heart-  and blood-tests that specialists and hospitals, medical schemes, politicians and civil servants  thrive on..

    Older women of  course  usually have the   major extra anterior chest organs – pendulous  breasts – to  consider.  But the same  history and physical exam as in men  quickly mostly  sorts out the source and thus the cause of the pain:  a mammary cause eg hormonal congestion diffuse tenderness,  discharge, or tender  lump or gland, or root cause, is  quickly  apparent.

CASE REPORTS: at yesterday’s breast clinic we saw the usual spread of middle-age issues  in the eight  (mean age 45yrs, 32 to 65yrs) who booked  for breast prescreening imaging :



CHEST PAIN: clerk Ms  booked herself for screening with almost constant  discomfort in her left breast for about 10weeks.. Like her and her doctors’ examinations, mammography a  month earlier found nothing abnormal.. She had no history of trauma or pain elsewhere, just slight neck discomfort. Her last period was years earlier, still on contraception  progestin injections. Examination and  mechanical tactile breast imaging confirmed tender full breasts; with maximal palpation tenderness midthorax laterally  at the site of her complaint.          Pressure and rotation elicited no discomfort elsewhere.  Gentle traction manipulation of her neck halved the ‘breast’ discomfort, which disappeared with a final satisfying click with gentle prone rotational pressure on her appropriate upper thoracic vertebra – confirming the root  source of her pain had been cured; and obviated further concern , tests and  analgesia.

 Manageress  also on  longterm depot hormone contraception (Mirena), with growing breasts,    rising weight despite careful diet,   and  concern about hip osteoporosis on DXA screening that was not improving but worsening the past 3 years on some routine vitamins C, D3  2000iu/day. K2 and calcium supplements. Her husband (not she) observed that she had severe night sweats.

       Both of the  ladies on synthetic progestin contraception   were reminded that such depot synthetics  suppress the ovaries ie cause artificial menopause with all its longterm subtle adverse effects, and that such hormones are known to slightly increase the risk of breast cancer, fattening and osteoporosis.    Both   were recommended progesterone cream, vitamin D and metformin as well as the other almost 20 bone supplements, for (pro)hormone balance and to assist with body fat  and thus all-risk reduction

        Ms   mid-60s with no complaints except stress vertebral fracture from osteoporosis now on opioid patch!  mother died of breast cancer at 78yrs; she has had 10 mammograms;  just dense lumpy breasts;; advised vigorous vit D, Super C, K2; Triple Bone-Pain – antiarthritic blend; metformin; DHEA and melatonin 20mg/d;

    Ms  early  50s  with menopausal symptoms, hypertension ( on perindopril)   and lumpy breasts, now off Nuristerate, ,   was advised to take appropriate supplements including progesterone cream. There is a new report from Holmes ea Canada http://www.ncbi.nlm.nih.gov/pubmed/24075077  that ACEi/ARBs use eg perindopril  was associated with significant 22%  increased deaths from  breast cancer (95% CI: 1.04-1.44), let alone the risk with such drugs of recurrent persistent cough and insidious nephropathy; so is advised to swop over to the safest best and cheapest 1st-line antihypertensive regime of lowdose  reserpine with low dose amilozide,

Ms  mid-30s with a child despite endometriosis and  PCOS , 4 years after removal of Mirena (7 years) , had lumpy breasts. Advised metformin,  vits  D and Supervit C, minerals and vitamins.

Ms  early 30s with PCOS , two aunts in their 50s with breast  cancer, her granny from the other parent having died of breast cancer at 76years.. with  lumpy breasts; she was advised the supplements including progesterone cream, melatonin, and metformin.


 Ms   mastectomy and DXRT 2011, now off Nuristerate ,  given weeks to live 18 mo ago with brain metastases that have shrunk with chemoradiotherapy and her zealous work as a cancer counselor;  lumpy other breast; now advised metformin, sutherlandia, melatonin 20mg/d,  vigorous vit  K2,  D and Supervit C, DIM, mushroom, astragulus, selenium, minerals and vitamins within her means.

Ms   had lumpectomy and 3 positive glands/12 removed in 2011, refused further oncology/ radiochemotherapy.   Lumpy breasts confirmed . Advised metformin,  sutherlandia, melatonin 20mg/d,  vigorous vits K2,  D and Supervit C, DIM- I3C, mushroom, astragulus , selenium, minerals and vitamins;  if not Iscador, cesium, TCM,  and pancreas/gene therapy  within her means.

BREAST PREVENTION REGIME: apart from optimizing diet and lifestyle with appropriate obesity-reducing diet and avoidance of estrogenic foods and drugs,

Based on published evidence and our experience from patients of analgesics and anticancer benefit, all were advised to try  triple breast massage daily with coconut oil, Lugols iodine then DMSO  for a few weeks, and if they want reassurance, return in a month or two  for followup breast imaging to show the shrinkage in all lumps that  most show. Those with higher risks are advised to take the oils by mouth as well, and if iodine depleted, oral iodine , for their global benefits.

      However, short of  avoiding  sex, or use condoms and barrier creams, or ill-advised sterilization or dependence on coitus interruptus,  their contraceptive method is hard to improve, short of relying on the oldfashioned intrauterine device without any contraceptive hormone. The oldest naturally occurring pregnancy we have seen was at 55 years, so women have to take care past this age…Natural human contraception with depot human progesterone and estrogen was developed decades ago, but naturally not made available commercially because only synthetics are patentable and thus commercially viable raincheck drugs that profit Big Pharma, health professionals and politicians. .

     Instead, women are advised simply to protect the breasts, womb, brain, heart, skeleton,  face etc, and stop menopause symptoms, by adding just enough human  progesterone cream daily to their face makeup (+- vaginally); (testosterone cream sparingly  if indicated for frailty, depression  and poor sex) , and take a sensible daily blend of the twenty other natural bone and multisystem antioxidant anabolics  (as this website www.healthspanlife.wordpress.com details under osteoporosis) including vitamin D about 2500iu/kg/month ie about 150 000 to 200 000 iu/month for an average size adult.

         In people rapidly fattening due to lifestyle, stress and the bad marketed adverse food chain, wiser choices have to be promoted-which does not suit most  politicians, Big Business or the Disease Industry for whom Only Disease Pays-  Prevention Doesn’t Pay.. So to protect against fattening and insulin resistance perils, metformin to sensible tolerance is also an inevitable recommended  natural albeit prescription supplement until healthy robust lean weight can be maintained without it.

      The supplements listed  above – (fish oil, appropriate parenteral human sexhormone replacement and the other antioxidants/anabolic vitamins, minerals and natural biologicals including the prohormones metformin and vitamin D) also mostly obviate the deplorable high-risk use (for commercial profiteering) of risky synthetics eg  statins, bisphosphonates, psychotropes, analgesics, NSAIDS, patented xenohormones and chemotherapy   etc – none  of  which address the underlying stress, deficiency  and pollution ie primary causes of  disease.


16 June 2013 A new review by Carolanne Wright reviews how to combat estrogen overload – How environment and lifestyle contribute to hormonal imbalance while devastating the health of both men and women.

27 May 2013 Wikipedia reports that in 2008,  about half a million women   died from  breast cancers (out of some billion older women worldwide ie 0.5 per 1000 women, an annual deathrate of 0.05% pa),  23% of cancer deaths in women; with cancer overall accounting for about 13% of deaths -the commonest being stomach-colon-liver 2.8%;  lung cancer 1.4%, then breast 0.46%  of deaths. So breast cancer – mostly undetected globally  by the luxury of mammography till it presents clinically-  kills only perhaps  1:2000 older women per year, ie perhaps <25%  of the  perhaps  1:500 older women who develop clinical breast cancer-  995/1000 of older women’s deaths being from other causes than breast cancer.

These figures dispel the  dangerously fraudulent  fearmongering  lie  of the USA Radiological and Breast Cancer Associations and Curves International that “(screening) mammography saves lives”. Its good to see in the current Curves South Africa website that in this Celebrating Mothers’ Week at Curves, they have dropped the Mammography saving lives myth of 3 years ago that started this particular theme column.  That hasnt stopped USA doctors  from continuing to propogate the lie.

But some there  eg Dr Lissa Rankin MD – daughter of a mammography radiologist- are still brave enough to refute the lie. And even the American Cancer Society chief medical officer doesnt make such ludicrous  claims but points out how complex the issue of prescreening detection is. .

Johnson and Bleyer reported Feb 2013    from the SEER study  that advanced breast cancer in young USA  women 25-39yrs has doubled between 1976 and 2010.

South Africa (religion mostly African Christian) has the distinction  of being one of Earth’s  most corrupt and illiterate  countries,  with strange bedfellows –  Latin  America (mostly Catholic),  Egypt Lebanon & Pakistan(Islamic), and  South Korea(mixed religions)-  that follow the USA in defying evidence – in this case  of danger to cows and humans – and allow the use of rBGH recombinant Bovine Growth Hormone ; and  sex hormones   in dairy and meat production. The evidence of harm, eg  carcinogenicity and feminization  is so strong that such  use has been banned in many  countries for decades .

MORTALITY TREND AND CANCER IN RSA AND GLOBALLY: Breast cancer is usually a disease of postmenopausal women-who till a centry ago on average barely lived to that age. In South Africa at the   peak of the untreated AIDS epidemic around 2000, with average lifespan drastically fallen, of all deaths, overall infections (HIV  TB, pneumonias etc)  caused about 39%, external causes  12%, cardio/vascular disease 11%,  cervix cancer 1.4% and breast cancer 1.3%.    But Statistics SA report last month that by 2010, with antiretrovirals, life expectancy  had risen about 5years, and that of all deaths,  HIV+TB  deaths had  at least halved   to  15% (17% in Africans, 9% in coloureds, 2.4% in Indians), cardio/vascular deaths were 12% in blacks but 27.8% in whites; external causes down to 9%, cancers 9% (mostly digestive and respiratory); with only 20 breast cancer deaths ie 0.00% reported in RSA.

Breast cancer is still rare in a mostly young population with mean age of survival of women still half of that of the first world,  with virtually a generation gap due to the carnage of the untreated AIDS era and institutionalized male violence especially against women, children and minorities- xenophobia.

But meat  and dairy milk (in South Africa widely containing added rBGH and sex hormones) are  among widely used foodstuffs likely contributing, as Joe Mercola notes,  to the increasing occurrence of breast cancer in younger women. Never mind deadly  sugars, smoking and alcohol consumption on the rise here in RSA.

To   improve immunity,  insulin receptor sensitivity
,  lessen obesity and excessive estrogenization (from both outside your body,  and your own fat production):

  • Exercise;  Maintain a healthy body weight  -BMI < 24kg; waist girth<about 85- 90 cm; earthing- walk barefoot.
  •    AVOID:- added or concenrated sugar, (especially fructose- commercial fruitjuice; cornstarch, white flour); charred fats; smoking; alcohol;  unfermented soy products; licorice; GE genetically engineered foods. .  
  • BUT those with asthma, leaky gut/IBD, epilepsy or bad arthritis should also try excluding for a few weeks WHEAT; DAIRY; AND NIGHTSHADEs (potato, tomato, peppers/cayenne, eggplant).
  •              —synthetic sexhormones (progestins, xenoestrogens eg in meat, commercial milk, birth control and HRT,   BPA, phthalates, pesticides); spironolactin Spiractin; digoxin; and . 
  •              –physical trauma eg underwire bras;                        xray (eg airports and xray screening mammography), electromagnetic fields eg electroblankets.
  •              -other toxin overload –  aspartame,  marketed designer drugs (eg  painkillers, statins, psychotropes, bloodthinners, antiinflammatories- even paracetamol Panado acetaminophen Tylenol);                         and      –overload metals  (eg iron, fluoride, bromide, chloride,  aluminium, lead, mercury, – consider detox.
  •    Do (Lymphatic) breast massage with eg anticancer coconut oil, DMSO, Lugols iodine; 
  •   Breastfeed your babies;
  • &  To avoid common deficiencies (on our depleted polluted GMO-fastfood diet, especially with increasing longevity), which contribute to all common diseases,                             take plenty of
  •      –sunlight; melatonin & enough restful natural sleep and relaxation!
  •      -organics eg green/coloured  vegetables/ juice daily. .
  •      –fish oil ie marine  omega-3  (dont fry  in  Om6 plant oil)
  •      -for lipidemia,  overweight, diabetes, the prime insulin sensitizer-weight/appetite reducer galega/metformin to tolerance;
  •      –iodine as eg kelp, or Lugol’s iodine.
  •      -vitamin D3:  with cancer, target  blood vitamin D level 70 to  100 ng/ml ie we need about  70-100iu/kg/day – and   sunshine and food cant provide this. . .
  •      –natural vitamin A – organic eggs, raw butter, raw whole milk, and beef or chicken liver, or a supplement.
  •      -buffered vitamin C about 50mg/kg/day    up  to tolerance;- with acute infection/inflammation/cancer  in an  adult, this may be 1/2 up to >2gm hourly till better, or diarrhoea, then (like metformin) just enough to avoid diarrhea;
  •      -virgin coconut oil & DMSO each 1(-15) tsp/day;
  •      -magnesium about 5 mg/kg/d; calcium phosphate;
  •      -zinc, chromium, selenium, manganese, boron;  and
  •      –vits Bco, CoQ10, &  K2.
  •      -natural estrogen-aromtase inhibitors to lower adverse estrogen dominance, raise  the  2OH:16OH estrone balance to about 2:1 – eg exercise; lecithin/choline (from eg  eggs/seeds);  oranges/lemons, red grapes, passionfruit;  celery, parsley, basil, artichokes, avocado,coconut, onions, garlic, olives, olive leaves; asparagus, squash, cauliflower, broccoli/cabbage/spinach/Brussels (provide I3C/DIM di-indole methane), yams, milk thistle,  sawpalm, diet fibre,  black radish, mushroom-astragulus, sutherlandia, beet, dandelion, curcumin turmeric, cinnamon, ginger, honey, garlic,  black pepper; taurinemethionine; zinc, selenium, vits C/D3/E/K2; and/or balancing  progesterone/ testosterone – or just 7ketoDHEA in the elderly..

Just this  month, a major trial from UCLA (Smith, Kurzer ea) confirmed that in healthy sedentary young women, moderate exercise 2.5 hour a week significantly beneficially  lowered the risky  estrone level  and raised  the             2OH:16OH estrone ratio.

These preventative steps may remove justification for therapeutic mastectomy (which is known to reduce survival)  for localized breast cancer , let alone preventative bilateral mastectomy even in women with high penetration BRCA genes, as publicized this month  by filmstar Angela Jolie .


Health- slante, l’chaim!, hayah, sawubona! – in any country or language  is a blessing, a gift- not a right. It is insurance that has to be planned and enforced. Leaving it to fate, illness and hoping for a cure is often too late, sometimes crippling if not often  fatal. With comprehensive natural supplements, we can and should all die peacefully at an  active fit advanced  age  90years +  –   not old, incapacitated and demented. We owe this prevention to both ourselves, our  kids and our aging seniors.

So sensible lifestyle aside, promoting health  includes simple low-cost  (no-xray/no-laboratory) periodic screening:  for all,  from childhood:  of weight,  girth, eyes, teeth, bloodpressure, brainfunction- memory; and ultrasound bones – at any pharmacy/ optometrist, school or clinic;                         and  for women:  checking the breasts and pelvis for risk of  cancer.

The HealthSpanLife  South African Natural Medicine Clinic SANMC next to Cavendish Mall on the slopes of Table Mountain in beautiful Cape Town – one of the favourite world tourist  and heritage centres-  is a specialist clinic  staffed by experienced  registered professional practitioners- a medical internist specialist  (also UK registered);  a homeopath;  and a Muslim nursing sister.

It provides  one-stop holistic screening and diagnostics, and – uniquely-  evidence-based  natural remedies- nutritional support for all symptoms and chronic conditions-  also  for menopause-andropause-genitourinary- breast-sexual dysfunction- obesity-pain/headache –chiropractic  and detox ,

as well as if needed  appropriate modern specialized  testing and prescription medicines for all chronic major conditions including bio-identical hormone replacement for both genders (including implants);

and integrated referrals nearby (and in Gauteng)  as patients desire eg for autism, acupuncture, aromatherapy, physiotherapy, aquarobics,  advanced scopes, delicate restorative micro (eg hands, toes)-as well as major (eg bariatric, spinal,eye-, ear- neuro-)  surgery, infertility, xray/other scans, cancer, hyperbaric oxygen, spiritual intervention, psychiatric-hypno- therapy, and eg genetic profiling and counselling,   dialysis and transplantation, and stem cell therapy. …

Gentle Non-xray  ultrasound bone-density measurement (recommended by Cape Town , UK, and USA universities),  and tactile mechanical breast mapping (recommended by CANSA, UK, USA, Indian and Chinese studies) are available at SANMC (and in Gauteng) by appointment, and are covered by some medical aid plans;  whereas menopause consultations are covered by all open plans.

As typified by a new review last month,    World opinion is to use xray  mammography and  xray bone density imaging  only as last resort and only  in the elderly – or in staging those with breast cancer- because of the major problems and risks of xray imaging..   As world experts Profs Cornelia Baines epidemiologist in Canada, Mike Baum breast surgeon  in London and Peter Gotzsche epidemiologist  in Denmark  say,  there never has been any independent scientific evidence to support hazardous routine mass mammography crush xray screening of well women, let alone any repeated mass xray screening for decades, or the dangerous fictitious marketing hype of the American radiology-Breast Surgeons and Curves International nonsense  that xray mammo screening saves lives ..

While health tariffs must rise with inflation,  where med aid doesn’t cover, New Year 15% discount applies through January on cash-paid clinic services and in-house products. . .

For out-of-town/ overseas  visitors, accommodation and travel locally and throughout Africa and beyond can be arranged by outside experts around  clinic appointments. .  http://www.capetown.gov.za/en/visiting/Pages/default.aspx

For appointments visit  the SANMC at 1st floor no.  15 Grove Medical Bldg on Pearce St  cnr Grove Ave (parking opposite at ABSA on Grove);    or  phone +2721-6831465/  -6717415; or fax  +27865657215; or email the manageress, doctors or Sister at   sales@healthspanlife.co.za  to discuss needs,  timing and preliminary costing. For details, references  and rationale for screening and prevention,  see https://healthspanlife.wordpress.com/?s=screening.


24 Feb 2012  Sharifah Zainab asks about safety of tibolone after more than 10 years on it; and whether and how to wean off it.
No new singnificant studies change the hard evidence that tibolone may
do more harm (than good) eg may increase stroke, breast cancer, fatness and vaginal bleeding. The comprehensive Cochrane review of last week affirms this:          Cochrane Database Syst Rev. 2012 Feb 15;2:CD008536.Short and long term effects of tibolone in postmenopausal women. Formoso G ea WHO Collaborating Centre ,  Modena, Italy.  “Tibolone is an option available for the treatment of menopausal symptoms, based on short-term data on its efficacy. However, there is a need to consider the balance between the benefits and risks of tibolone as there are concerns about breast and endometrial cancer as well as stroke.   MAIN RESULTS: When compared to placebo, tibolone was more effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 847; OR 0.42), although only the 2.5 mg/day dose of tibolone was significantly better than placebo; but with increased vaginal bleeding (seven RCTs, n = 7462; OR 2.75). When compared to equipotent doses of combined HT, tibolone reduced vaginal bleeding (15 RCTs, n = 6342; OR 0.32) but was less effective in relieving the frequency of vasomotor symptoms (two RCTs, n = 545; OR 4.16).As for long term safety, two major RCTs of tibolone versus placebo provided the most relevant data. An RCT of 3098 women with breast cancer and menopausal symptoms was halted after 3.1 years because of increased tumour recurrence (OR 1.50). However, in another RCT that selected osteoporotic women with negative mammograms (n = 4506) tibolone was associated with a reduction in breast cancer compared to placebo after 2.8 years (OR 0.32) although the trial was not specifically designed to assess that outcome and the number of overall events was low. In the same RCT, an excess risk of stroke was observed (OR 2.18). There was no clear evidence of a tibolone effect on endometrial cancer compared with placebo given the low number of events (seven RCTs, n = 8152; OR 1.98).There was no evidence of a difference in long term safety between tibolone and combined HT. AUTHORS’ CONCLUSIONS: Tibolone, used at the daily dose of 2.5 mg, may be less effective than combined HT in alleviating menopausal symptoms although it reduced the incidence of vaginal bleeding. There was evidence that treatment with combined HT was more effective in managing menopausal symptoms than was tibolone. Available data on the long term safety of tibolone is concerning given the increase in the risk of breast cancer in women who had already suffered from breast cancer in the past and in a separate trial the increase in the risk of stroke in women whose mean age was over 60 years. Similar concerns may exist for estroprogestins but their overall benefit-risk profile is better known and is more directly related to women with menopausal symptoms.”

Why use a risky synthetic  drug designed for profit when as this column repeatedly stresses, there are so many safe natural supplements that reduce all risks?

update : Jan 2010:  WEIGHT GAIN ON TIBOLONE:

Hester asks about a better option HRT since she has gained 5kg in a few months on Livifem tibolone.

One cannot treat an unseen patient by email based on a one-line history.

all one can advise is,  read about the serious risks and deficiencies of quick-fix heavily marketed snakepills compared to finely tuned natural products eg human hormones and other natural supplements evolved/designed over millennia rather than recently in for-profit laboratories.

There are  two  new  illuminating papers on tibolone since the November review:

Dr Peter Kenemans writes from the Netherlands Vrije Universiteit:  Tibolone revisited: ‘still a good treatment option for healthy, early postmenopausal women‘.

Drs de Melo and Pompei from Sao Paolo UniversityTibolone reduces osteoporotic fracture risk and breast cancer risk, but increases the risk of stroke.

The Ziaei paper detailed below  addressed only weight issues, and describes average results.

In the  Royal Free Hospital  study in London in 1995, they found that  in their 300-patient experience over 8 years ie medium term –  an impressive 2400 patient years- that  “The major side effect was weight gain and/or a tendency to bloating and oedema which occurred in 11.28% of our women”.

This doesnt mean that tibolone increases fatness- most women inexorably get fatter and frailer once past menopause. Certainly they dont do this if they maintain good balance of human hormones- testosterone, estradiol, progesterone, thyroid and insulin-  with a sensible blend of  all the other other scores of useful  supplements, and  diet and exercise.

By contrast, shortterm controlled trials – 6 months from Turkey (2006, and 2009) and  Ziaei’s 9month trial- show that in the short term, tibolone reduced body fat and waist.

BEAR IN MIND THAT MANY STUDIES SHOW THAT EVEN JUST 10 YEARS OF APPROPRIATE SEXHORMONE THERAPY FROM EARLY IN MENOPAUSE HAS MAJOR LONGTERM BENEFITS ON REDUCING ALL RISKS eg FRACTURE, CARDIOVASCULAR AND DEMENTIA RISKS IN LATER LIFE – without any significant adverse effects. . There do not appear to be published any studies of tibolone or any other wannabe substitute  over  a mean of more than 5 years. But women now often survive more than one-third of  their lifespan post menopause- that is another 35+ years. No modern designer chronic drug  has been used and observed reasonably continuously to be safe for much more than 10years .  The only designer drugs which have been used continuously for much longer are perhaps the old diuretics and some  antihypertensives.

Tibolone is yet another designer progestin- and the Women’s Health Initiative showed that, even when started appropriately soon after menopause,  progestin (medroxyprogesterone MPA)  reversed the myriad benefits of  premarin alone  in respect of worsening fracture, breast and cardiovascular risks.

This contrasts with natural supplements like eg minerals and vitamins, the plant extracts reserpine and the  prohormone metformin,  and all the human hormones- thyroid, insulin, cortisone, testosterone, estradiol- which many patients have used continuously for over 40 years with nothing but benefits in appropriate doses.

So as always its up to  you the patient to decide whose advice, what to try. All any doctor can do is (in a brief consultation) offer advice from his experience and ongoing update studies – which may not be up to the minute. You have to decide about shortterm benefits versus long-term possible risks. In the few months on tibolone, are you just swollen-eg  needing to reduce salt?- or fatter  waist with higher bodyfat,  bloodpressure, insulin resistance etc?

Nov 18, 2009
a new study last month bears out the futility of spin,  focussing only on benefits in abstracts. The small short (9month) trial by Ziaei ea in Tehran Iran  on Comparative effects of continuous combined hormone therapy and tibolone on body composition in postmenopausal women concludes  that The effect of tibolone on body composition is favorable and therefore tibolone may be regarded as an alternative to continuous combined postmenopausal hormone therapy MHT .  Tibolone significantly increased weight, BMI and FFM and decreased WHR after the treatment in comparison with baseline (p < 0.05). However, only weight and BMI increased significantly in the CEE/MPA group after the treatment (p < 0.05). There were significant increases in weight, BMI and fat mass in the control group after 9 months..  So they confirmed what has been obvious all along: that postmenopausal women gain weight and fat post menopause, and on xenohormones (premarin+provera) gain even more fat at the expense of losing lean mass. A synthetic xenohormone progestin like tibolone increases weight, BMI,  and FFM (it’s androgenic property) –   but they ignored the multiple deficiencies of tibolone (unlike appropriate HRT), that it increases breast cancer,    stroke, vaginal bleeding and endometrial cancer and perhaps CVD, and fails to reduce either all-cause or breast cancer mortality, or depression or  dementia. .

SUMMARY: No published trials have yet shown any alternatives as good as appropriate HRT (ie estrogen -progesterone- testosterone) for overall long term benefits post menopause.
eg  with  the synthetic progestin tibolone – the 3 year LIFT trial had to be stopped early due to strokes, and in  the 3year LIBERATE trial breast cancer recurrence increased 44%. As the International Menopause Society IMS keeps stressing, all synthetic sex hormones are inferior to appropriate balanced sex hormone replacement for eg menopause symptom relief, and against osteoporosis fractures. Many different modalities relieve the short-term menopause symptoms, but these matter far less than the long term preventable degenerative effects of hormone deficiency- which are the primary concern of patients, carers, internists and geriatricians. The average gynecologist (surgeon) deals only with  menopause symptoms, which mostly subside well within 10 years ie by age 60years – but that’s when all aging medical not gynecological problems start,   increasing  incapacity problems – vascular, cancer, fracturing, mental, mood, fattening, frailty, sex, incontinence and thus loss of decades of quality life.

Analysis To August 18, 2008 ·

The LIFT trial report by Steve Cummings et al (NEJM   August 14, 2008  The Effects of Tibolone in over 4000 Older Postmenopausal Women -mean 68years)  is another nail in the coffin of tibolone.

The LIFT trial was stopped after a median of just 34 months because Tibolone doubled strokes – up from 0.34% to 0.66% per year. .

Tibolone,  unlike appropriate HRT, has no significant reported benefit on all-cause mortality, on cardiovascular disease (which increased by 37% – p0.28), on memory/ dementia and on depression , although  it almost halved fractures –  but  it doubled the risk of stroke, trebled rate of breast discomfort and vaginal bleeding- which  rose from 2.9% to 9.5%; even the incidence of cervical dysplasia rose from 3.2% to 7.6%. And it increased weight in this already overweight cohort by an excess of 0.6kg in 3years..

Breast and colon cancer rates were too low to draw conclusions about benefit. “The tibolonegroup also had a decreased risk of invasive breast cancer (relativehazard, 0.32; 95% CI, 0.13 to 0.80; P=0.02) and colon cancer(relative hazard, 0.31; 95% CI, 0.10 to 0.96; P=0.04)” – but the incidence of these and coronary artery disease were each only 2 – 3% pa on placebo..

So it finally  confirms tibolone as just another synthetic progestin looking for a disease to treat, much inferior to real supplements including  appropriate HRT (vitamin D and   lowdose parenteral human estradiol-testosterone-progesterone) for reduction of all the major diseases of aging. There are no contraindications to, only benefits from  such long term appropriate  steroid hormone replacement.

Update November 2009:

In a further LIFT trial report (Ettinger & Cummings Sept 2008), Tibolone treatment for 3 years minimally increased endometrial thickness, hyperplastic polyps, and endometrial carcinoma.

In a Danish trial , tibolone had no benefit on cartilage degeneration. whereas appropriate HRT has benefit (Forsblad Scandanavia 2004).

In the massive 31-country 2002-4 LIBERATE trial (Feb 2009 Kenemans ea ) in over 3000 women after breast cancer, recurrent breast cancer increased 44% with tibolone over a mean of 3.1yrs. Tibolone was not different from placebo with regard to other safety outcomes, such as mortality (respectively 72  vs 63 patients), cardiovascular events (14 vs 10), or gynaecological cancers (10 vs 10).

A report in September 2009 from Health and Human Services’ Agency for Healthcare Research and Quality suggests that tamoxifen, raloxifene, and tibolone used to treat breast cancer significantly reduce invasive breast cancer in midlife and older women, but also increase the risk of adverse side effects.

Regretfully, tibolone has not fulfilled early  hope that it might be the first designer drug since metformin to be another panacea, reduce all-cause morbidity and mortality even in postmenopausal  women.

It appears that despite 40years  use elsewhere, tibolone (not invented and marketed by a US corporate)  has still not been  and is unlikely to be licensed for use in USA – like SERMS (tamoxifen, raloxifene) its benefits are so limited that they are not  enough to balance it’s risks. .. doubling the risk of stroke and increasing the already high  general risk of breast cancer by 44% in only 3 years. Whereas  all (ie multisystem) risks and frailty are reversed by the safe threescore mix of natural supplements plus appropriate balanced physiological human hormone replacement as regularly set out in this column. .