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Feature
Much Ado About Nothing?
A prefix of 'bio' added to the conventional 'Hormone Replacement
Therapy' has evinced a renewed interest and zing in not only the medical fraternity
but the common man as well. But is it as 'natural' as it appears to be, asks
Nancy Singh
 If
you are aware of 'organic food' being better than 'in organic food', then you
can probably relate to the notion that Bio-Identical Hormone Replacement Therapy
(BHRT) is better than traditional Hormone Replacement Therapy (HRT). 'Natural'
is anyways back in vogue and why this so-called therapy is making waves in the
West is due to aggressive promotion by celebs like Oprah Winfrey and the likes.
Earlier confined as a 'therapy' for the menopausal women, it has now broken
the shackles to even include 'man-o-pausal men' and all other deformities resulting
due to hormones or their lack of it.
Today, hormone replacement is not limited to just estrogen and progesterone
for menopausal women. Now, it encompasses replacing all of the vanishing hormones
in both men and women— testosterone, cortisol, pregnenolone, DHEA, thyroid,
etc. "Men too are suffering from the loss of hormones, just like women,
but they do it quietly. Men feel ignored, and when they have a doctor on their
side, they feel like their concerns are being taken seriously," highlights
Dr Praveen Kumar Saxena, Founder and Director, Dr Saxena Centre for Progressive
Medicine, Hyderabad. A very 'young' term and therapy in the medicine world,
BHRT got introduced around 1992 in the US and the treatment is just picking
up there. BHRT is recommended for both men and women, to alleviate poor libidos,
calm restlessness and eliminate the symptoms of menopause. The goal, as the
therapists put it, is to remain healthy and vital by replacing the depleting
hormones so that the levels in our body return to normal, youthful levels.
Your Body is Ageing
 When
it comes to nature and the way we are designed biologically, humans are not
programmed to live after the birth-giving age. But, with the advancements in
modern medicine and our greater understanding of nutrition and our body's physiological
function, many people survive even their 100th birthday. Anyways, natural occurrences
in our bodies, like decreased levels of hormone production, still continue to
take place. Having said this, it does not imply that after 50, you have to succumb
to the pitfalls of getting older, as per the new 'anti-aging' brigade. Says
Dr S Ali Mohamed, Founder and Chairman of Yuvanesse Clinic, Mumbai, "BHRT
is an emerging form of treatment in India which is slowly getting accepted as
the most effective way towards treating many ills affecting the body. Bio-identical
hormones can be taken safely by anyone who needs them. A trained specialist
needs to determine who needs them and how much. The therapies can be used to
improve strength, body composition and stamina, as these are natural human functions.
They can also be used to improve many other functions such as the immune system,
general health and appearance, treat infertility and gynaecological issues."
What Does it Exactly Mean?
Bio-identical means that the hormones are an exact match to the hormones produced
by the human body. They could also be called human-identical. Current example
is insulin. Bio-identical hormones are created in a lab to produce an exact
match for the hormone that is being replaced. Though it sounds a little odd,
an example on how the hormones are developed as identical, experts explain that
hormone estrogen is extracted from yams. Interestingly, the yam molecule is
quite similar to ones in the humans. Once the hormones are extracted, they are
transferred into a lab wherein they are re-modified to match the lost human
estrogen molecule. "Biologically, identical hormones are derived from plants,
such as the wild yam or soybean plant. The wild yam is rich in precursor molecules
that can be converted into estrogens and other hormones whose molecular structure
is the same as those produced naturally in the human body," informs Dr
Saxena. Every treatment regimen is custom-tailored to the individual based on
the results of blood tests, medical history, physical examination, and symptoms
presented. These hormones get their start in nature, found in soy beans and
wild yams, they can then be easily converted into the exact hormones that the
body makes. The body recognises these bio-identical hormones and uses them just
as it would, if they were being produced by the ovaries, testes, or adrenal
glands. By working with compounding pharmacies, physicians are able to prescribe
dosages more precisely and then properly adjust the dosage, in response to symptoms
and laboratory data.
| The central role of hormones in both the human life
cycle and the body is well known. As a woman ages, or due to external circumstances
such as severe physical or mental stress, hormone levels decline. This can
result in decreased fertility or infertility. Today, gynaecologists routinely
utilise synthetic and non-bio-identical hormones to interfere with the body's
natural hormone cycles. If this fails, painful, emotionally and financially
demanding in-vitro fertilisation is performed, with mixed results. Commonly,
no attempt is made to evaluate the patient's hormone imbalances and bring
them to a norm, in order to re-create the patient's natural, internal environment
or milieu and thereby resolve the condition. The aim of this paper is to
discuss the role of patient evaluation and the use of bio-identical hormone
replacement therapy (BIHRT) to treat Infertility.
In order to illustrate the ability of BIHRT to
treat infertility, Yuvanesse Clinic, Mumbai illustrates a case study of
a 38-year-old white female. She wanted another baby, but was finding it
difficult to conceive. Blood tests indicated infertility, her Follicle
Stimulating Hormone (FSH) ranged between 70 MIU/ml and 110 MIU/ml. Infertility
is defined as an FSH level above 20 MIU/ml. Her gynecologist correctly
diagnosed her with premature ovarian failure, based on her FSH blood levels
and inability to conceive. Her gynaecologist tried to treat her with birth
control pills and all sorts of synthetic hormones, but nothing worked.
So, in the end, the gynaecologist recommended In-Vitro Fertilisation (IVF)
with donor eggs, as her eggs were supposedly not viable. "Not once
did anybody try to determine why she had become infertile," says
Dr S Ali Mohamed, Founder and Chairman of Yuvanesse Clinic, Mumbai. She
was informed that with IVF, which would cost at least $30,000, she could
probably become pregnant. "Fed up with feeling unwell all the time
and not having $30,000, she decided against expensive, painful, and often
disappointing IVF, and instead, came to us for an evaluation and a second
opinion," says Dr Mohamed.
The doctors carried out her blood tests and she
completed a comprehensive 14-page questionnaire. Bio-identical Hormone
Replacement Therapy (BHRT) was instituted and her overall well-being improved.
Three months later, the female was pregnant. "Today, she is the proud
mother of what we believe is the World's first BIHRT baby. Painless and
inexpensive bio-identical hormone replacement, without any invasive procedures,
allowed her to have her own baby, using her own eggs," claims the
clinic. The doctors at the clinic conclude that it is very important to
evaluate the patient comprehensively with a detailed questionnaire and
blood work which can reveal the underlying hormone deficits. These can
then be treated with BIHRT, to obtain some very gratifying results, both
for the patient and the doctor!
Though the claims sound very promising and heartening
to hear for all the couples facing infertility, doctors do not seem to
be overtly enthusiastic and excited by such claims. The Immediate Past
President of FOGSI, Dr Narendra Malhotra, has to say this, "Though,
BHRT definitely sounds promising for menopausal women, but as far as producing
eggs from ovaries, using BHRT, I seriously doubt such propositions and
as far as I know or think that such hormones cannot make ovaries start
producing eggs. A lot of research and authentication has to go in this."
Source: The Yuvanesse Clinic
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BHRT Versus HRT
Identical hormones are derived from plants, such as the wild yam or soybean
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The conventional hormones used in replacement therapy are
synthetic, and are intentionally designed to be different from the natural hormones
in the body. For instance, estrogen is actually not one single hormone, but
a group of three hormones: estrone (E1), estradiol (E2), and estriol (E3) are
natural human hormones. A high ratio of estriol to the other estrogens has been
associated with a lower risk of breast cancer. Premarin, a drug commonly used
in estrogen replacement therapy, is derived from pregnant mare urine. Because
horse estrogen is foreign to the human body, people may lack the enzymes and
cofactors to metabolise it safely. "Progesterone may be needed to balance
the effects of estrogen on the uterus as well as the rest of the body and also
may help build bone. Natural progesterone might be safer than synthetic progestins
(like Provera), which may have a negative effect on the cardiovascular system.
Likewise, natural testosterone (typically thought of as a male hormone but also
produced in the ovaries) may be safer than synthetic methyltestosterone for
treating problems with libido," elaborates Dr Saxena. They typically are
available in the form of creams or pills, and marketed to help control the symptoms
of menopause. "As a gynaecologist, I am very enthusiastic and interested
in this form of natural therapy for menopausal women. The ones available today
are bovine originated and does have serious repercussions. Lot of pharma companies
are investing huge amount of money in their R&D to create natural molecules,
as anything that is 'artificial' is outdated and rejected," feels Dr Narendra
Malhotra, Immediate Past President, Federation of Gynaecological and Obstetrics
Society of India (FOGSI). In contrast to the bio-identical hormones, non-bio-identical
hormones are not easily recognised by the body, even though they may produce
some similar effects.
- Custom-made, balanced formulations of natural
hormones, tailored to the individuals unique needs.
- Effective relief of hot flushes, night
sweats, fatigue, dry skin and vaginal irritation.
- Improves sleep.
- Better mood.
- Improves memory and concentration.
- Enhances libido, sex drive.
- Prevent and reverse osteoporosis.
- Maintain muscle mass and strength.
- Excellent long-term health benefits.
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Research and Studies
Most of the studies undertaken on BHRT have taken place in
Europe and not in the US. In Europe, the studies conducted have produced quite
positive results. One study, in particular, has studied 10,000 women over a
10-year time frame, and found that unlike HRT, Bio-Identical Hormone Replacement
Therapy did not increase the risks of heart disease or cancer. In fact, on the
reverse, the women who participated decreased their risk of breast cancer.
All that Glitters is Not Gold
 "As
a gynaecologist, I am very enthusiastic and interested in this form of natural
therapy for menopausal women
- Dr Narendra Malhotra
Immediate Past President
FOGSI
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 "BHRT's
efficacy is not tested and its safety is not yet proven. Hence, it is more
or less as safe or unsafe as HRT"
- Dr Pankaj Desai
Consultant, Obstetrics and Gynaecology specialist
Janani Maternity Hospital
Baroda
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Well, on the surface of it, this therapy seems to be like
the stem cell therapy — 'the holy grail of all medicines'. But hang on!
If this is 'the' answer to all the woes, what makes this one such a laggard
in popularity? Well, that is where the catch is. The critics dismiss this therapy
as a 'marketing gimmick' and guess what, they claim that it is just an old wine
in a new bottle, as there is no trademark difference between HRT and BHRT. Here's
why — BHRT has been openly criticised in many peer-reviewed sources for
making uncorroborated claims about being effective against an array of health
conditions, for lack-of-evidence of safety, for unsubstantiated claims to be
more 'natural' than conventional HRT and for the frequently-associated practices
of compounding and saliva testing. But, advocates for BHRT argue that commonly
compounded BHRT preparations are not commercially available, which is quite
untrue. There is very little peer reviewed evidence for or against BHRT and
thereby a lack of consensus with respect to its appropriateness, effectiveness
and adverse effects. Some literature reviews do suggest the benefits of BHRT
over conventional counterparts while others state that there is still insufficient
evidence to support the claims made about BHRT with a lack of randomised controlled
trials needed to form firm conclusions. Avers Dr Malhotra, "There is till
date no clinical trial conducted in India. They may start in the near future
and there is very little evidence and high uncertainty about how hormones will
act on Indian women." The Food and Drug Association (FDA), US has already
warned that claims about compounded BHRT products are unsupported by medical
evidence, unlike claims made by manufacturers of FDA-approved products.
Voices Dr Pankaj Desai, Consultant, Obstetrics and Gynaecology
specialist, Janani Maternity Hospital, Baroda and Former Dean, Medical College,
Baroda, "I will say that BHRT's efficacy is not tested and its safety is
not yet proven. Hence, it is more or less as safe or unsafe as HRT. It was the
mind-blowing WHI study on HRT which revealed that it increased the risks of
breast cancer, that resulted in scientists and pharma companies worldwide to
look for a 'bio' alternative. But, with critical bodies like FDA not convinced
with its claims and also other influential and reliable bodies like Mayo Clinic
and the Endocrine Society falsifying these claims, I would rather be very skeptical
of BHRT." The chief medical editor of Endocrine Today quotes BHRT as a
'marketing concept' with no scientific backing. Apparently, bioidentical hormones
and compounded BHRT are expected to have the same risks and benefits as conventional
HRT, though atleast the latter has the advantage of being heavily studied and
regulated while BHRT has no scientific data to support claims of safety or efficacy.
Despite all of this, a variety of specific claims have been made for the effectiveness
of bioidentical hormones and BHRT, with varying evidence to support or contradict
them. But Dr Saxena argues, "I am a mainstream modern medicine doctor and
with all due respect to this stream, one thing is for sure that we doctors start
subjecting medicine only after it has appeared in journals. It is safe to say
that for this alternative form of therapy, the awareness level is still quite
low and it is still in its very infancy, not only in our country, but in the
US too."
With all the clouds of uncertainty, it is quite unsure whether BHRT is a result
of en-cashing upon the 'natural' wave and money spinning venture or it is as
substantial as it appears to be. It is a wait and watch scenario, until the
truth unfolds gradually. But for sure, all that glitters is certainly not gold.
healthcare@expressindia.com
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