Category Archives: Bioidentical Hormones

Revising guidelines for testosterone testing could more accurately diagnose deficiency

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One of the issues under discussion among patients and doctors in Singapore is how to determine when there is a need to treat men with supplemental testosterone therapy.  This new study shows that levels of free testosterone are more informative than total testosterone levels

European Society of Endocrinology     16 May 2015

A new study presented at the European Congress of Endocrinology in Dublin suggests that some men suffering from testosterone deficiency may be missed under current clinical guidelines while others are misdiagnosed with testosterone deficiency. The researchers call for a revision of the clinical guidelines to ensure that men are receiving the best possible care.

Testosterone deficiency, also known as male hypogonadism, can lead to decreased libido and infertility, but it has also been associated with a higher risk of developing metabolic syndrome, diabetes and osteoporosis. In men, testosterone levels gradually decline with age. In recent years, an increasing number of ageing men are presenting with symptoms suggestive of hypogonadism and testosterone levels that are around or below the lower limit for young men. To date, the diagnosis of hypogonadism in these middle-aged and elderly men and their management remains controversial.

Researchers at the University of Manchester, UK and the University of Leuven, Belgium (represented by Dr Leen Antonio) used data from the European Male Aging Study (EMAS) to determine the relative importance of total and free testosterone measurements in diagnosing testosterone deficiency in aging men.

Testosterone exists in the body in two states; bound to proteins (98 % of total testosterone) and non-protein bound or free (2% of total testosterone), the latter being the biologically active fraction. Current clinical guidelines suggest that testosterone deficiency is diagnosed by measuring total testosterone levels. However Dr Antonio’s study shows that levels of free testosterone are more informative.

Only free testosterone can enter cells and is responsible for testosterone action. When men get older, total testosterone levels decrease while the levels of the protein that binds it increases. This means that the level of free testosterone decreases more than the total testosterone with age.

Dr Antonio, “We show that middle-aged and elderly men with normal total testosterone levels but low free testosterone levels have more symptoms of hypogonadism compared to normal men than those with normal free but low total testosterone – these men currently miss out on treatment because they are not diagnosed with testosterone deficiency.”

“On the other hand, men with low total testosterone but normal levels of free testosterone do not suffer from testosterone deficiency, yet are misdiagnosed with the condition and can be treated with testosterone inappropriately.”

Dr Antonio and colleagues propose that new guidelines should recommend measuring free testosterone, in addition to total testosterone, in the evaluation of men with hypogonadal symptoms.

http://www.alphagalileo.org/ViewItem.aspx?ItemId=152794&CultureCode=en

 

Curing hearing loss with hormone therapy

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By Dr Nor Ashikin Mokhtar        5 April 2013

Several physicians and researchers have attempted to treat hearing loss with a hormone called aldosterone, which is produced in the cortex of the adrenal glands.

Who would have thought that a hormone could help reverse hearing loss? I certainly would not have made the connection if not for one of my patients who came to see me after having visited several ear, nose and throat (ENT) specialists, who could not help her with her hearing problems.

As I have an interest in the use of bio-identical hormones, I did some research of my own in this area. I was pleasantly surprised to find that several physicians and researchers have already done some work in treating hearing loss with a hormone called aldosterone.

It was gratifying for both me and my patient when we found that bio-identical replacement of aldosterone helped to reverse her hearing loss.

This can give hope to many other people, especially the elderly, who face poor quality of life issues due to progressive loss of their hearing.

Hearing loss

It has always been thought that one of the inevitable consequences of getting older is losing your hearing.

Many elderly (or just slightly older) people find it increasingly difficult to hear conversations around them. They keep having to ask people to repeat what they’re saying, they turn up the volume of the television and radio, and they can’t even hear themselves speak sometimes.

Hearing loss can have significant consequences on a person’s quality of life. When you can’t hear, your communication with family and friends suffers, as everything has to be repeated or shouted.

You also find that there is less enjoyment in the things that you used to love, such as music or movies. This can leave you feeling frustrated or helpless.

Hearing loss is most commonly caused by injury to the hair cells lining the middle ear. These tiny hairs are responsible for transmitting sound to the brain. These hair cells can be damaged by exposure to excessive noise or decreased blood flow due to atherosclerosis, hypertension or diabetes.

If, like my patient, you are at your wits’ end because you have already seen numerous ENT specialists who were unable to help you, you may want to consider bio-identical hormones. This may be the solution to help you stop or even reverse your hearing loss.

What is aldosterone?

Aldosterone is a steroid hormone from the mineralocorticoid family and is produced in the cortex of the adrenal glands.

This hormone plays a role in regulating kidney function and in controlling levels of two signalling chemicals – potassium and sodium – in the nervous system.

This is the first clue that aldosterone is important for hearing: potassium is needed in the inner ear, where a potassium-rich fluid converts sounds into signals that the nervous system can identify.

Therefore, aldosterone helps to maintain a healthy level of potassium in the body, which in turn, helps to maintain hearing.

However, as people age, the amount of aldosterone produced in the body decreases, because the adrenal glands do not work as well as they should.

At the same time, potassium levels fall as well. This may explain why age-related hearing loss develops, because low aldosterone could affect hearing both in the inner ear and in the part of the brain that processes sounds.

There is some scientific evidence to back this up. A study in mice several years ago found that aldosterone added to the drinking water of the mice had the same effect as glucocorticoid drugs for reversing hearing loss.

Research has also been carried out in humans. Scientists from the International Center for Hearing and Speech in the US measured levels of aldosterone in people with severe hearing loss and found that they have half the amount of aldosterone compared to people with normal hearing.

However, too much aldosterone in the body is not healthy either. Large amounts of aldosterone, caused when a benign tumour grows on the adrenal cortex, can lead to high blood pressure and low serum potassium values.

Bio-identical replacement

If low aldosterone is thought to contribute to hearing loss, then a logical intervention would be to replace the hormone in the body.

Dr Jonathan V. Wright is one of the physicians in the US who uses bio-identical replacement of aldosterone to treat hearing loss in his patients, and he claims to have had success with this therapy.

Bio-identical hormone therapy is also known as “natural hormone therapy”. Bio-identical hormones are not synthetic hormones, but they are made in a laboratory using a plant chemical extracted from yam and soy.

The difference between bio-identical hormones and synthetic ones are that the former behave exactly like the hormones our body produces.

Dr Wright prescribes bio-identical aldosterone to his patients in “physiologic” quantities, meaning amounts that are normally present in the body (no more than that). He found that this therapy had success in more than half of his patients suffering from hearing loss.

Aldosterone therapy is believed to not only restore hearing significantly within rapid time (from a couple of weeks to a couple of months), but is also effective in patients who had lost their hearing many years ago.

Other physicians are looking at different supplement-based interventions to help with hearing loss. Vitamin B12 and folic acid, as well as vitamin D, are among the micronutrients that are believed to boost hearing.

Gingko biloba and vinpocetine supplements are also believed to increase blood flow, which helps improve hearing. More research will have to be carried out to investigate the safety and efficacy of these supplements.

Meanwhile, bio-identical aldosterone therapy may be helpful for people with hearing loss who have not found success with other treatments.

When using bio-identical aldosterone therapy, it is important to monitor the levels of aldosterone, potassium and sodium in the body to ensure that they remain within normal levels.

Not just anyone can prescribe bio-identical hormones, so be sure to speak to a qualified physician or pharmacist, particularly one specialising in anti-ageing medicine or bio-identical hormone therapy. –

http://yourhealth.asiaone.com/content/curing-hearing-loss-hormone-therapy/page/0/2#sthash.tLlJZiLv.dpuf

 

 

 

S’pore Losing Medical Tourists to Neighbours

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At a time when the number of tourists coming to Singapore has dropped and the Singapore Tourist Promotion Board is planning to launch a $20 million campaign to boost tourism, the drop in the number of medical tourists to Singapore is contributing to the problem.

This article from The Straits Times by Marissa Lee discusses the danger of Singapore losing out to neighbouring countries in the market for medical tourism. Patients currently coming here for bioidentical hormone replacement therapy (BHRT) could be among those who “walk” (fly).

http://yourhealth.asiaone.com/content/spore-losing-medical-tourists-neighbours

Hormone Choice Singapore has spoken to a number of people living in neighbouring countries who currently come here for their BHRT treatment. They say that if this becomes unavailable in Singapore, they will be going to Kuala Lumpur or Bangkok.

 

The Non-Science Witch Hunt Against Hormone Replacement Therapies for Deficiency Syndromes Must End: An A4M Position Paper on Physician-Prescribed HRT

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The first paragraph of this Position Paper from The American Academy of Anti-Aging Medicine (A4A), 23 September 2013, seems to describe just what is happening in Singapore at the moment. (Bolding by HCS)

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 who are reluctantly positioned on the frontline of a decades’ old agenda to limit freedom of choice and information, and the physician’s most essential responsibility to select the best course of therapy and medication for their patients. . . .

A4M POSITION

The American Academy of Anti-Aging Medicine (A4M), its numerous worldwide affiliated scientific and medical societies, and befriended organizations, supports the judicious application of modern and advanced medical technologies to address the changes in chemical, hormonal, physical, and nutritional needs that occurs 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.

 

Read the rest of the paper at:

http://www.worldhealth.net/pdf/A4M-2013-Position-Statement-HRT.pdf

Mother Jailed for Getting Her Sick Daughter Hormone Therapy, Later Cleared. Her Lawyer’s Statement. A Letter from Dr Thierry Hertoghe.

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If it was “their” daughter surely “they” would want the help this British mother got from world renowned Dr Thierry Hertoghe, a Belgian physician and expert in hormone therapy, President of the International Hormone Society, which has 3000 physician members worldwide.

 

Mother jailed

Mail Online, 1 November 2014, Poison my daughter? No, I was trying to CURE her: Mother jailed for child cruelty after rejecting NHS care to seek treatment at foreign clinic for teenager’s hormone therapy http://www.dailymail.co.uk/femail/article-2817084/Poison-daughter-No-trying-CURE-Mother-jailed-child-cruelty-rejecting-NHS-care-seek-treatment-foreign-clinic-teenager-s-hormone-therapy.html

Mail Online, 3 November 2014, A cure for thyroid problems the NHS ignores – or quack doctor’s poison? Mary gave her daughter hormones prescribed for crippling tiredness. Then police arrested her for child cruelty  http://www.dailymail.co.uk/health/article-2819347/A-cure-thyroid-problems-NHS-ignores-quack-doctor-s-poison-Mary-gave-daughter-hormones-prescribed-crippling-tiredness-police-arrested-child-cruelty.html

 

Mother cleared

Thankfully the mother was cleared. Dr Thierry Hertoghe gave evidence at her trial. He described the British National Health Service as 40 years behind in this area of treatment. He commented that the NHS only treats patients when they are 70% hormone deficient, where he and his colleagues treat when the patient is 25-30% deficient.

The Independent, 30 October 2014, Mother cleared of poisoning teenager daughter with hormones supplied by Belgian doctor says case should be landmark for parents’ rights http://www.independent.co.uk/news/uk/crime/mother-cleared-of-poisoning-teenager-daughter-with-hormones-supplied-by-belgian-doctor-9829226.htm

 

Mary Kidson’s lawyer comments

From the website of Ken Hind CBE, one of Mary Kidson’s Lawyers, November 9, 2014 (bolding by HCS): http://kenhindbarrister.co.uk/press/

Lancashire Counsel and Solicitors secure acquittal for mother charged with poisoning her daughter in land mark case

Lancashire Barrister Ken Hind and Blackburn Solicitors Simon Farnsworth, Deborah Morgan of  FMB  took on the case of Mary Kidson a local woman from Nelson, who had moved to live in Herefordshire and secured her acquittal in a landmark case that could have long term  impacts on suffers from thyroid and cortisol hormone deficiencies throughout the NHS .

Ken Hind commented “We were initially approached by Mary Kidson’s family to take this case and we undertook it as this was the kind of case which we came into this profession to deal with and protect the man and woman in the street where we see the state has got things wrong. FMB is a medium sized 3 partner firm of solicitors who instructed me as an independent member of the bar”.

Mary Kidson’s daughter suffered with a number of physical problems , primarily she was constantly fatigued, had low blood pressure , lack of energy, pain in muscles and joints plus other problems. She was seen by 5 endocrine paediatric consultants in the (National Health Service) NHS – 4 of whom discharged her saying there was nothing wrong with her as it was all in the mind . Mary did not believe this , she researched on the internet , read books on hormone deficiency and accessed the web sites of Thyroid UK and the Thyroid Patients Advocacy Forum . She was convinced her daughter had deficiencies in cortisol, thyroid and oestrogen.

Taking advantage of section 13 in the Medicines Act 1968 she ordered hormones from  accredited pharmacies on the internet . She consulted Dr Durrant Peatfield an unregistered physician who had been criticised by the (General Medical Council) GMC for his views expressed in his book on the Thyroid Gland (can be downloaded off Amazon) who approved her treatments . She was still concerned to have a registered physician directing her daughter’s treatment and was recommended to Dr Thierry Hertoghe , the President of the  International Hormone Society with 3000 physician members worldwide. Dr Hertoghe has written 7 books including the Hormone Manual , one of the leading text books for physicians practising abroad in this field.

Mary took her daughter to Brussels where Dr Hertoghe carried out tests on 40 hormones and minerals , far more than carried out by the NHS and diagnosed chronic fatigue syndrome caused by hormone deficiencies. He prescribed hormones and nutrients and treated her for  5 months .

On the 5th March 2013 without having spoken to Mary, social workers and police officers turned up at her home & arrested her, took her daughter into interim care where she was placed with foster carers whom she did not know her for 2 months. Doctors examined Mary’s daughter who they said had nothing wrong with her, made no contact with Dr Hertoghe to ask about diagnosis and treatments , despite the fact he wrote to the police , doctors in the case and social services 3 times. NHS doctors ended all the hormone treatments. Mary’s daughter was interviewed on videotape by the police and said she felt better as a consequence of the treatments.

9 months later in January 2014, the police charged Mary Kidson with poisoning her daughter unlawfully and maliciously causing grievous bodily harm or endangering her life. Mary was only able to see her daughter for 2 hours a fortnight and that was under the supervision of a social worker until April 2014 . In breach of her bail conditions  Mary was phoning and texting her daughter in response to requests  for help and reassurance. Mary was remanded in custody to prison  for 6 months for a breach of this  bail condition, her daughter was certified under the Mental Health Act and sent to a psychiatric hospital where she remains.

The case came to Worcester Crown Court for trial for 3 weeks. Deborah Morgan who prepared the case for trial commented ‘One of our first requirements was to speak to Mary’s 16 year old daughter as the prosecution declined to call her but Hereford Social Services blocked it at every turn. Eventually a psychiatrist appointed by the defence was allowed into the hospital to speak to her, he found she was fit to give evidence and wanted to do so on behalf of her mother as she was within 2 weeks of being discharged by her psychiatrist. I turned up at the hospital to see her and was told I could not do so because Herefordshire Social Services blocked it. Eventually I was allowed in after application to the trial Judge which Herefordshire Social Services fiercely resisted in court.

Ken Hind stated  “Mary Kidson’s defence was that as a loving  caring mother who had struggled for years with her daughter’s ill health  she only wanted to see her get well, develop normally and have a happy, fulfilled adult life.  After 11 days in court, evidence from 5 consultants, 2 social workers , a forensic scientist and police officers,  the Judge directed the jury to acquit Mary Kidson as there was no evidence of grievous bodily harm (accepted by the prosecution) and that the alleged victim’s life had not been endangered”.

At the centre of the case was the treatment of NHS doctors for thyroid hormone deficiency. Dr Hertoghe from Brussels who gave evidence described the NHS as 40 years behind in this area of treatment. He commented that the NHS only treats patients when they are 70% hormone deficient, where he and his colleagues treat when the patient is 25-30% deficient . A major point of argument was the use of natural dessicated thyroid or liothyronine  a drug prescribed by Dr Hertoghe. The Royal College of Physicians directive for treatment of thyroid deficiency is the prescribing of levythyroxine which is an artificial type of thyroid hormone T4. This is converted by the body into T3 the main active ingredient of thyroid production and very necessary to sustain quality life. Doctors are disciplined by the GMC for stepping outside the dictat. There are estimated to be 1.3 million NHS patients who are thryroid deficient. For about a million of these patients levythyroxine works. For the remaining 300,000 their problems are different as their bodies cannot convert T4 to T3 in sufficient quantities.

Sheila Turner the Chairman of the Thyroid Patient Advocacy Forum commented thus “I suffered symptoms similar to Mary’s daughter, I found a doctor who diagnosed my problem and prescribed T3. My life was revolutionised – I felt normal again. The Forum had 1.25 million hits on its web site in just the months April and May this year to give some idea of the extent of the problem. We have seen 10,500 people who have come to seek meaningful information and guidance”.

“The defence team , Deborah Morgan , Sue Hind (researcher) and me are actually all strong supporters of the NHS , believing health care should be available tax funded at the point of delivery. To quote Dr Fraser however, the leading paediatrician for the prosecution in the witness box , ‘The NHS does not always get it right’.

“Thyroid UK one of the 2 major organisations campaigning for change have called for the government to fund research on the use of T3 in the NHS. They have placed on the Parliamentary web site an e petition , currently signed by 7130 people. We ask you to sign this petition as if  100,000 sign  there will be a parliamentary debate on this very subject and some positive good will come out of the tragic case of Mary Kidson. If the politicians listen to the views of many doctors throughout the world the whole issue can be is resolved by properly funded research for the benefit of many NHS patients” .

“Meanwhile Mary Kidson will fight in the courts for the return of her daughter. During our conduct of the case we have discovered that this is not an isolated tragedy which are mainly dealt with in Family Courts where anxious parents have been threatened with removal of their children into care . This has also been true in the case of ME sufferers, a condition very similar in some respects to chronic fatigue syndrome”.

Fund research into T3 and/or natural desiccated thyroid treatment for hypothyroidism

Responsible department: Department of Health

Many patients with hypothyroidism continue to have symptoms on levothyroxine (T4) but find that their symptoms are often greatly reduced when they take liothyronine (T3) or natural desiccated thyroid.

Natural desiccated thyroid is only manufactured in the US and Canada but can be prescribed in the UK on a “named patient” basis. Many doctors will not prescribe it because there are no randomised controlled trials as it was manufactured before licensing of medicines came into being.

Research has shown that some patients have benefited from natural desiccated thyroid but there needs to be more research done to investigate whether this would be a better treatment for patients.

More research also needs to be done on the addition of T3 to T4 because previous research has been inconclusive.

Note:

1.  Herefordshire Social Services Department was reviewed by Ofsted and found to inadequate on all 4 of the main categories and given a 6 month timetable to improve services .During this 6 month period they took Mary Kidson’s daughter way from her without speaking either to her or her physician.

2.  On the first day of the trial the Wye Valley Health Trust, from which 3 of the paediatric consultants called for the prosecution came, was put into special measures by the Department of Health.

 

Letter from Dr Thierry Hertoghe     (Bolding by HCS)

From: “Dr Thierry Hertoghe” <dr.hertoghe@hertoghe.eu>

Date: November 6, 2014 at 9:53:07 PM GMT+8

To:

Subject: SUCESS : the mother of the hormone-treated child, is CLEARED OF ALL CHARGES AND FREE, OUT OF PRISON – HORMONE RIGHTS INTERNATIONAL

Reply-To: office@hertoghe.eu

Dear Dr,

Many thanks for your testimonies and petitions.

MARY KIDSON, the mother of the hormone-treated child, is CLEARED OF ALL CHARGES AND FREE, OUT OF PRISON. Your testimonies and petitions were included in my medical report and have contributed to the success.

Mary Kidson is the mother who was imprisoned because she brought her daughter with six years of severe chronic fatigue syndrome (making it impossible for her to go to school) to my consultation and applied the hormone and nutritional treatments, which substantially improved her daughter’s health.

After two and a half weeks of a court trial with extensive media coverage the prosecution claims collapsed before defense witnesses would even provide their evidence.  I did however give evidence as an expert witness during the trial.

None of the absurd claims of potentially or actually harming the child made by the prosecution and the NHS were shown to have any grounds in reality.  In fact, the prosecution, child protection and NHS doctors have themselves severely traumatized child and mother, the child being now in a psychiatric institute with heavy psychotropic medication.

Links to the BBC: http://www.bbc.com/news/uk-england-hereford-worcester-29829946

Links to the Daily Mail: Lynne Wallis For The Mail On Sunday or: http://www.dailymail.co.uk/home/search.html?S=&authornamef=Lynne+Wallis+For+The+Mail+On+Sunday; http://www.dailymail.co.uk/health/article-2819347/A-cure-thyroid-problems-NHS-ignores-quack-doctor-s-poison-Mary-gave-daughter-hormones-prescribed-crippling-tiredness-police-arrested-child-cruelty.html

Links to the Independent: http://www.independent.co.uk/news/uk/crime/mother-cleared-of-poisoning-teenager-daughter-with-hormones-supplied-by-belgian-doctor-9829226.html

 

HORMONE RIGHTS INTERNATIONAL: Let’s make that this will not happen again. Your personal testimonies have shown that this is an international problem, not only limited to the UK. We are building an internet organization similar to Amnesty International called “HORMONE RIGHTS INTERNATIONAL”, organization of patients, physicians and other health professionals, to defend people’s right throughout the world for them and their family members to receive hormone therapy if they have hormone deficiencies.

Any attack against this right will put HORMONE RIGHTS INTERNATIONAL in action, launching internet news, emails and (post)mails from HORMONE RIGHTS INTERNATIONAL members to the institution that intervenes wrongly.  Patients should be free to attend a doctor of their choice without suffering interference by other medics or institutions.

Hormone deficiencies are as frequent as eye problems. Many of us are born hormone-deficient to some degree, and we all become more hormone-deficient with advancing age. Correcting these deficiencies with safe hormone doses gives to people their life and health back.

Become a free member by signing the membership form here below and sending it back to ihs@intlhormonesociety.org

I (fill in what fits):

O      become member of HORMONE RIGHTS INTERNATIONAL and engage once or more per year to send a testimony or sign a petition by email or post mail to any institution who attacks patients, parents of patients or their physicians or other health professionals, and tries to limit their right to hormone therapy.

O      wish to additionally participate more actively in the organization as active member preparing papers and actions, finding journalists, etc.

O      accept that my testimony(ies) is (are) published on websites or in books

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Family Name: I___I___I___I___I___I___I___I___I___I___I___I___I___I___I___I

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Signature: __________________________________

 

Thanks for all your wonderful input,

Warm regards,

Dr Thierry Hertoghe

President of the World Society of Anti-Aging Medicine

President of the International Hormone Society

Discover www.lifespan-journal.com and enjoy the latest breakthroughs in Lifespan Medicine.

7 Avenue Van Bever

1180 Brussels – Belgium

Phone +32 2 379 34 43 fax +32 2 732 57 43 office@hertoghe.eu www.hertoghe.eu  

Living healthier with hormone and nutritional therapies. Training for physicians

Mainstream Medicine Still Struggles to Comprehend What Women Want

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We thought one of the benefits of compounded hormone therapy was that it overcame concerns of overdosing or underdosing because it can be adjusted according to hormone levels in individual blood tests. The Endocrine Society seems not to agree . . .

Pharmacist survey shows huge growth in compounded menopausal hormone therapy 

6 March 2015, The Endocrine Society

Among prescriptions filled for menopausal hormone therapy (HT) in the U.S., almost half now are custom-compounded “bioidentical” hormones, according to analysis of a recent survey of nearly 500 pharmacists. The study results will be presented Friday March 6th at the Endocrine Society’s 97th annual meeting in San Diego.

Custom-compounded prescriptions, which are mixed for an individual according to a doctor’s prescription, are not well-regulated or monitored by the U.S. Food and Drug Administration (FDA).

“Despite the increased quality risks and the lack of safety and efficacy data for non-FDA regulated custom-compounded bioidentical hormones, their use by menopausal women is higher than expected and appears to be continuing to grow,” said lead researcher JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia Health System, Charlottesville.

Pinkerton cited statistics from Symphony Health Solutions that there were 36 million FDA-approved prescriptions filled for HT in 2012. That number is down 61 percent from the 93 million HT prescriptions filled in 2002.

Some postmenopausal women have been seeking alternatives to traditional hormone therapy since the Women’s Health Initiative study in 2002 linked it to certain increased health risks. Since then, customized bioidentical hormones have often been marketed as natural, safer alternatives to FDA-approved HT, with purported fewer side effects. However, according to the Endocrine Society, there is no scientific evidence supporting the safety or effectiveness of compounded bioidentical hormones.

Pinkerton and her colleagues analyzed results of a survey conducted last October on behalf of the International Journal of Pharmaceutical Compounding and in Thought Research, and sent to 12,250 pharmacists who provide compounding services. From 904 pharmacists who reported working at independent community pharmacies or independent compounding pharmacies, the number of completed survey responses totaled 483 (365 responses from community pharmacies and 118 from compounding pharmacies).

Based on the pharmacists’ responses of how many custom-compounded HT prescriptions they fill and the average percentage of compounding reported by the National Community Pharmacists Association and industry market research firm IBISWorld, the researchers estimated that 26 to 36 million total prescriptions custom-compounded HT were filled last year.

Of the responding pharmacists, 69 percent reported that they expected their HT compounding business to grow over the next two years. A greater proportion of compounding pharmacists anticipated growth than did community pharmacists: 75 percent versus 52 percent, respectively. Most pharmacists projected 5 to 25 percent growth of HT compounding by 2016, Pinkerton said.

In November of 2013, Congress passed the Drug Quality and Security Act (DQSA),14,15 which clarifies the FDA’s authority to enforce provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to pharmacy compounding. However, health providers and their patients should understand the differences in and the risks associated with less-regulated treatments of compounded menopausal hormone therapy,” she stated.

Possible risks of compounded HT, according to Pinkerton, include the lack of safety and efficacy data along with possible presence of contaminants and concerns of overdosing or underdosing.

Taken from: www.sciencedaily.com/releases/2015/03/150306132714.htm

 

 

 

Adrenal Exhaustion

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Many people being treated for low thyroid continue to have symptoms. This may be because they have concurrent low adrenal function, an issue frequently overlooked by doctors who are not aware of this connection. Indeed adrenal fatigue is perhaps the commonest cause of secondary low thyroid function,  hypothyroidism caused by a malfunction elsewhere in the body.

Treating low thyroid without treating adrenal fatigue can be dangerous. The weak adrenal system will not be able to cope with the extra energy output of the thyroid and this situation may lead to a complete break down of the adrenal system. Thus when treating the thyroid it is vital to ensure that the adrenal hormones are also balanced. Many bioidentical hormone options are available for this.

See The Adrenal Fatigue Solution, Fawne Hansen, Bioidentical Hormone Replacement

http://adrenalfatiguesolution.com/hormone-replacement/

The following article is an informative account of adrenal exhaustion.

The Mail Online, Wellbeing, 30 November 2014, Lucy Fry, Don’t go for the crash and burn 

http://www.dailymail.co.uk/home/you/article-2850605/Wellbeing-Don-t-crash-burn.html

 

 

FDA’s Latest Testosterone Bashing Proven Bogus… TWICE

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From Dr Mark Stengler’s House Calls Newsletter, 20 March 2015

http://www.besthealthnutritionals.com/blog/2015/03/20/new-testosterone-safety-confirmed/

(Bolding by HCS)

It’s always fun watching the FDA fall flat on its face, and it happens all the time – but it doesn’t always happen out in public for everyone to see.

But last week, the agency took a spectacular tumble in full view of the entire world.

Just one day after issuing a new warning on testosterone – just one day after claiming that hormone supplements could pose heart risks in men – two new studies proved just the opposite.

Both studies found no statistical increase in the risk of heart problems, and one of them even found no difference in the risk of heart attack, stroke and death.

Yes, on Tuesday, the FDA issued a warning claiming testosterone is dangerous. On Wednesday, it’s proven wrong . . . TWICE.

It’s almost funny, but this is no laughing matter – because the two studies proving testosterone is safe didn’t get the big headlines. The FDA’s warning, on the other hand, did. It was seen by millions of American men, including many who may need testosterone therapy and perhaps won’t get it now because of the warning.

These men will needlessly suffer from conditions such as low energy, weight gain, depression and sexual dysfunction.

Even worse, some of them may die – because testosterone therapy isn’t only safe for the heart, in some cases it could be absolutely essential to your very survival.

One study last year found testosterone therapy can cut the risk of heart attack by 30 percent in men who are at risk for cardiac problems. And just a few months ago, a major study found testosterone therapy can reduce the risk of heart attack and even death.

Low testosterone becomes increasingly common as we get older. If you’re past middle age yourself, there’s a good chance your own hormone levels have dropped – especially if you’ve been suffering from weight gain, low energy, mood disorders and erectile dysfunction.

In some cases, you can boost your levels with supplements. In others, you may need natural bioidentical hormones.

A holistic doctor can run a simple test to determine what your levels are and then help you decide the best way to increase them if necessary

The Studies:

Effect Of Testosterone Therapy On Adverse Cardiovascular Events Among Men: A Meta-Analysis, presented on 15 March 2015 at the American College of Cardiology’s 64th Annual Scientific Session in San Diego.

http://www.google.com.sg/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CBwQFjAA&url=http%3A%2F%2Fcontent.onlinejacc.org%2Fpdfaccess.ashx%3FResourceID%3D9514124%26PDFSource%3D13&ei=6aAfVYKhFoufugSQwoCYAQ&usg=AFQjCNEuefFBF1DwjnDyi_DEkSfrbH-C5Q&sig2=cxwva8FsMo0lmq5N5wHjdA&bvm=bv.89947451,d.c2E

Effects of Testosterone Supplement Therapy on Cardiovascular Outcomes in Men with Low Testosterone, presented on 14 March 2015 at the American College of Cardiology’s 64th Annual Scientific Session in San Diego.

https://www.google.com.sg/#q=content.onlinejacc.org%2Fdata%2FJournals%2FJAC%2F933568%2F13468.pdf%3Fv…

 

 

The Confusion Continues

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Unfortunately, in the year since this Hormone Choice Singapore (HCS) website was started, the confusion about bioidentical hormone replacement therapy in Singapore has continued, creating a great deal of stress for patients who suddenly find their hormone treatment (including desiccated thyroid) no longer available or difficult to find and for doctors who are unsure whether they are    going to be penalised if they continue to give the healthcare they know is of such great benefit to their patients.

In March 2015 the Ministry of Health (MoH) sent two new circulars  to Licensees/Managers of Clinics.

Testosterone For Hormone Replacement – eLis – Ministry 

MoH Letter 2

Moh Letter 3

There was some confusion in the first circular in that none of the doctors consulted by HCS had heard of intravenous thyroid therapy being used for the conditions listed. The second circular containing a clarification of the first seemed to underline MoH’s own confusion. It is also not clear whether this guideline refers to synthetic or bioidentical testosterone hormone replacement.

In the second circular the second sentence in the second bullet is particularly interesting: “If there is laboratory confirmation of testosterone deficiency, then the use of testosterone would not be considered as non-evidence based”.  In the opinion of both the doctors and patients HCS has spoken to, if this definition is followed, none of the bioidentical hormone replacement therapy used in

Singapore is non-evidence based, since all doctors who use it only do so with the guidance of regular laboratory blood tests. Indeed this is the joy of it, in that doses can be individually adjusted to reflect the tiniest change shown up in a blood test. This exact matching of the treatment to the individual patient is something that synthetic drugs cannot accommodate.

The circulars continue to call for “evidence based medicine”. One of the reference sources (Duke University, Introduction to Evidence-Based Medicine)  on the MoH website gives us this definition from David Sackett, the founding father of the concept of evidence-based medicine (bolding by HCS):

Evidence Based Practice (EBP) is the integration of clinical expertise, patient values, and the best research evidence into the decision making process for patient care. Clinical expertise refers to the clinician’s cumulated experience, education and clinical skills. The patient brings to the encounter his or her own personal and unique concerns, expectations, and values. The best evidence is usually found in clinically relevant research that has been conducted using sound methodology.

(Sackett, D. (2002) Evidence-based Medicine: How to Practice and Teach EBM, 2nd edn. London: Churchill Livingstone.)

The Duke University website goes on (bolding by HCS):

The evidence, by itself, does not make the decision, but it can help support the patient care process. The full integration of these three components into clinical decisions enhances the opportunity for optimal clinical outcomes and quality of life. The practice of EBP is usually triggered by patient encounters which generate questions about the effects of therapy, the utility of diagnostic tests, the prognosis of diseases, and/or the etiology of disorders.

(The analysis below is taken from Evidence Based Practice, McGraw-Hill Education: https://www.mheducation.co.uk/openup/chapters/9780335244737.pdf  )

Sackett acknowledges and values the different types of knowledge held by the clinician, for example, knowledge acquired through cultural and personal experiences, logical and critical knowledge gained through curriculum and the extra insight that can only be acquired through cumulative clinical expertise. He values the patient as an empowered decision maker and highlights that not all research is transferable into practice due to flaws in either design or reason.

Note that Sackett states that the best evidence is usually  found in what the MoH would call “relevant research”. However, when the evidence found in laboratory tests is responded to with finely adjusted bioidentical hormone replacement (including desiccated thyroid) there is ample evidence available provided by well respected doctors worldwide (some of it on this site) that patients are receiving the care they need and, further, the care that addresses “the patient’s unique concerns, expectations, and values”.

Since bioidentical hormone therapy is derived from a plant source that cannot be patented, little money is likely to be made available  for expensive studies to match those funded by drug companies who stand to make mega-bucks from any drug produced as a result. Nevertheless, those patients who continue to use the hormones all over the world constitute a huge body of “evidence” of their value, while well-run studies continue to point out the flaws, clinical and ethical, in synthetic hormone replacement therapy.

Management of perimenopause and male andropause with bioidentical hormone replacement therapy – Dr Bill Reeder

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Another very interesting letter written by Dr Bill Reeder in New Zealand to General Practitioners regarding the use of bioidentical hormone replacement therapy.

The summary, reproduced here, bolding by HCS, is succinct:

Summary

The overarching factor is that with diminished quality of life, and it can vary from nuisance level to serious, hormone replacement can be very effective.

The answer to these questions, which to me is logical, then is to replace using safe, physiological dosing, transdermal where possible, bio-Identical hormones. 

And maintain healthy patient surveillance using meaningful lab methodology. 

I always recommend patients be their own advocates and read as widely on the subject as they can. We doctors guide, council and at best we do no harm.

(See below for full letter.)___________________________________________________________________________

                                                     Dr Bill Reeder                                                                       

Integrative and Biomedical Medicine

458 Airport Rd Hamilton 3282 New Zealand

Tel 64 7 856 8568 Fax 07 859 1212 wjr@medcom.co.nz

 Dear Doctor,

Management of perimenopause and male andropause with  Bio-identical Hormone Replacement (BHRT) 

Firstly, bio-identical means exactly the same molecular structure steroid as human – so not a derivative or equine sourced.

There is some confusion about the ‘natural’ word. Bio-identical hormones have a plant derived source and then synthesised into human hormones. So are most pharmaceutical hormones but they are analogues or altered. Pharmaceutically compounded hormones (BHRT) are not natural’ i.e. from humans, they’re still synthesised but remain bio-identical. Most, but not all are used as a transdermal form – for good reason.

One of my several special interests is bio-identical hormone management. It is controversial for a number of reasons for some critics of the treatment: 

  • “Its not an ‘approved’ or ‘guideline’ medicine”. 

* Most drugs by their synthetic nature and non-human occurrence    require extensive RCT testing and approval processes. ‘Bioidentical Replacement Hormones’ (BHRT) have already been ‘proven’ biologically. That’s common sense. Moreover, these natural hormones have been used by many doctors world-wide for at least 2 decades now. There is no evidence of any higher risk than in the non-treated population when prescribed correctly.

* What is up for discussion is long term exposure to even natural hormones. Are we designed to have minimal hormones at mid-life for some safety reason or is it just that we are living beyond fertility use by date. Its unlikely that continuation of low dose replacement would be harmful when used according to natural cycles and in appropriate dosage.

  • Unfamiliarity with the method.

 *There are no drug reps or promotional materials. Information is via doctor personal education, international conferences, workshops etc.

  • There are no large RCTs.

*No pharmaceutical company or other agency is willing to fund  the high expense for no return. No RCT’s – means just that – the large trials haven’t been done – it does not mean the treatment may not be effective.

*There are good data nevertheless.

  • BHRT hasn’t been proven to be of benefit? 

*Actually there is good data and clinical experience showing effective benefits.

*In my own experience using BHRT over 18 years, I have no doubt at all of the efficacy and safety. I listen to the patients, they know.

  • Studies show the risks of past HRT – particularly the 2002 WHI data.

*Bio-identical hormones are NOT the same as the hormones used in the WHI studies. Here the estrogens were equine (horse) species derived and the ‘progesterone’ was synthetic MPA progestin – neither has been in the human before. Progesterone (the only form in the human) is NOT a ‘progestin’. Whilst the biochemical steroid composition may appear similar, the effects can be very different just as estrogen and testosterone – with their subtle substitutions, have totally different physiological responses.

*Cohort WHI studies actually showed that using natural progesterone instead of MPA (progestin) was not associated with the risks in the WHI data (CEE and Progestin).

*Its very salient to examine even the WHI data itself – in fact the risks even with oral HRT were extremely low considering the benefits. Its just that the reporting method as % risk rather than absolute was emotive and caused panic. 25% increase in breast cancer is far more compelling than expressing as about 7 chances in 10,000 risk.

For example, ask a woman whose life has turned upside down from menopause the question of risk acceptance using standard pharmaceutical HRT in two ways – consider the reaction to the question put different ways:

  • You have a 25% increased risk of breast cancer – is that OK?
  • Or, you have about 7 more chances in 10,000 of breast cancer risk – is that OK?

Same thing, different perspective.

Women I pose this question to, usually respond quite differently to the use of HRT. Using bio-identical products the risk is almost certainly minimised further the gains in QOL very significant.

 

Advantages in using BHRT.

This communication is meant to be brief so the discussion is limited for that reason. There are many publications on the subject of ‘natural’ hormone supplementation for women and men.

  • It replaces deficient levels with the exact same human substance.
  • The dosing is low, never reaching physiological levels of younger fertile women – those levels are not necessary to resolve menopause or andropause symptoms. This is in line with WHI later recommendations.
  • Most BHRT hormones are in transdermal cream applications. Hence avoiding liver first-pass. The evidence for the benefits over oral routes, especially estrogens, is well documented in mainstream literature. It appears not so well established a need for progesterone or DHEA, which seem to be safe orally. It’s the first pass through liver that’s important for E2 and E3 – conversion to 16-OH metabolytes is variable as is reduced safe methylation and likely the source for unwanted risk.

Is there a place for single unopposed hormone replacement?

  •  With intact uterus, micronized oral progesterone is used to reduce risk of endometrial neoplasia as with traditional estrogen treatments.
  • Post hysterectomy – we still advocate the addition of progesterone as the philosophy is to mimic nature as close as possible. Also we may add testosterone and DHEA where these are sub-optimal. There is ample evidence of improved QOL in so doing. Hard data on prevention of disease is less robust as there is little gain in this research.
  • Some women have hormone ‘imbalance’ for example estrogen dominance as evidenced by symptoms and lab workup. She may do very well on transdermal progesterone only.
  • Some women may have very low testosterone and clinical symptoms supporting this – she may respond to gentle T supplementation for libido, muscle strength, vitality and so on.

So are there risks?

Nothing is guaranteed in medicine. It is good practice to screen for risk factors, to ensure ‘healthy woman’ ongoing screening. I ask patients on BHRT to ensure they work with their GP for regular checks. There is still some belief that long term exposure to estrogen may enhance risk of BCa. The data on this when considering protection with concomitant progesterone, healthy diet, exercise etc. is still being worked on. It is still a very small risk. As always, consider the risks to benefits.

Testosterone replacement for men.

Another large discussion point, which I will not cover other than to say, similar principles apply. The major criticisms are again not supported by the literature:

  • Testosterone supplementation especially bio-identical does NOT cause prostate cancer. Sure, if PCa occurs, and statistically it does as we age, then T replacement is contra-indicated.
  • T does not cause or aggravate heart disease – in fact it is PROTECTIVE.
  • Recent literature has pointed to higher risk of cardiac events for older men on T replacement. It appears to contradict other studies. This year there have been criticisms of the study with major flaws in design. We await further analysis. To date T appears protective when used in sufficient dose to place T in the upper protective centiles.
  • So for men the data on testosterone replacement efficacy is well established.
  • What formulation is less clear. As a general rule in integrative medicine, we prefer to use exact biological equivalents where possible. So T is available as actual testosterone, applied transdermally. Six months use will determine efficacy. Some men will prefer the injectables when T creams are not effective.

Ongoing surveillance

  • As mentioned above, serum levels are useless when using transdermals. Urine is better. In fact I have access to a US lab that can determine what we do with our testosterone metabolically – DHT, aromatising to E2 etc.
  • Must watch for excess aromatisation to estrogens and treat.
  • Regular prostate checking especially in first 12 months.
  • CBC for Hb.

When we look at the long list of potential loss of vitality symptoms for men as we age and lose testosterone production, as evidenced by the loss of vitality, depression, increased abdominal size, metabolic syndrome, libido etc – it seems to me astounding that go to lengths to avoid this area of management. Women have long understood the huge benefits of HRT for them.  

I’m sure if a drug was produced to make men feel younger and vital again, as testosterone does, it would be a block-buster – even if it had side-effects and some risk.

 

What a strange profession we are in sometimes… 

Summary

The overarching factor is that with diminished quality of life, and it can vary from nuisance level to serious, hormone replacement can be very effective.

The answer to these questions, which to me is logical, then is to replace using safe, physiological dosing, transdermal where possible, bio-Identical hormones.

And maintain healthy patient surveillance using meaningful lab methodology.

I always recommend patients be their own advocates and read as widely on the subject as they can. We doctors guide, council and at best we do no harm.

Dr Bill Reeder

Biomedical Clinic

Hamilton

See original document at:

http://www.hormonechoicesingapore.com/wp-content/uploads/2014/09/Bioidentical-Hormones-Thyroid-Report-for-Doctors-Bill-Reeder.pdf