The Guardian - 27.08.2019

Section:GDN 1N PaGe:13 Edition Date:190827 Edition:01 Zone: Sent at 26/8/2019 17:51 cYanmaGentaYellowb

Tuesday 27 August 2019 The Guardian •

National^13

Menopause

Women told not to use ‘natural’ HRT

over fears of increased cancer risk

Hannah Devlin
Science correspondent

When Elena Sanchez-Heras realised
the menopause was upon her, she
did what she always does when
faced with a biological unknown.
“I’m a scientist,” she said. “I’ve
been trained that when you
encounter a problem and want to
fi gure it out, you go and seek out
original sources.”
Sanchez-Heras, 56, is a cell
biologist at University College
London and has access to a vast
online library of peer-reviewed
scientifi c literature. But she
was surprised by the number
of questions that remained
unanswered – and by the relative
lack of research on a process that
directly aff ects women.
“We have half of the population ...
who ha ve this problem and we don’t
know what to do,” she said.
It is striking that while there is
no shortage of tests being marketed
to women – none of which are very
accurate – the biological intricacies
of the middle-aged ovary remain
relatively uncharted territory.
Scientists are yet to decipher the

chemical signals that stop ovarian

follicles maturing into eggs when the

overall egg reserve becomes low or

uncover the role that other ovarian

cells play in this process.

Another vague area is why about

a quarter of women have almost

no discernible symptoms, while

another quarter have hot fl ushes

that are seriously problematic and,

in extreme cases, can persist for a

decade. “We don’t fully understand

that aspect of it,” said Waljit Dhillo ,

a professor in endocrinology and

metabolism at Imperial College

London. “Why in some patients you

don’t get any symptoms and in some

they’re very severe.”

Even the way the fall in a woman’s

oestrogen relates to her symptoms

is a mystery. In basic terms, hot

fl ushes are known to be caused by

the decline in oestrogen when the

fertility cycle comes to an end, and

more sudden drops in oestrogen

tend to cause more extreme

symptoms, but beyond that,

scientifi c knowledge tapers off.

Some scientists say they are

met with puzzlement when trying

to justify new research. Hormone

replacement therapy has long been

an intervention, but there is still a

lack of understanding about how

HRT interacts with a woman’s body.

“One of the reviewers for our

grant asked, ‘Aren’t you medicalising

a physiological process?’,” said

Dhillo, who led a recent trial of a

compound that it is hoped could

become an alternative treatment

to HRT. The implication was that

“women should put up with it,” he

said. “You would never say that to

someone with heart disease .”

Janet Lindsay , CEO of the charity

Wellbeing of Women, agreed when

women seek medical advice they

are being told what they are going

through are just “women’s issues”.

However, both Lindsay and Dhillo

say attitudes are shifting. “The more

you have ... people saying this is

really important area that you’ve

missed , the more funders will

recognise it,” said Dhillo.

Amelia Hill

Women are being warned not to use a
form of hormone replacement therapy
marketed as being “more natural” than
that available from NHS doctors, with
experts saying it is unsafe, expensive
and could increase the risk of devel-
oping cancer.
Compounded bioidentical hor-
mone replacement therapy (cBHRT)
is tailor-made for each person, using
hormones identical to those produced
in a woman’s body.
The hormone combinations are
put together, usually as creams or gels,
by pharmacists working in private
clinics. The dose of the diff erent hor-
mones used varies from one woman
to the next.
The British Menopause Society
(BMS) and the Royal College of Obste-
tricians and Gynaecologists (RCOG)
have warned women away from the
products, which are becoming increas-
ingly popular.
Menopause experts said women

should opt instead for the pre-packed

regulated bioidentical HRT (rBHRT).

These therapies, available on the

NHS, are also duplicates of human

hormones but are in fi xed doses and

licensed by the medicines regulator.

Hormone replacement therapy is

the main form of treatment for severe

menopause symptoms, such as hot

flushes, insomnia and low mood.

Taken in the form of pills, patches,

gels or implants, it acts by replacing

oestrogen, or oestrogen and proges-

terone, in the body.

The unregulated version has

recently increased in popularity

because of a proliferation of online

pharmacies and active marketing to

consumers.

However, the BMS and RCOG said

there could be problems with over-

dosing or underdosing, the presence

of impurities or lack of sterility, a lack

of scientifi c effi cacy and safety data

(compounded products are not tested

on humans) and a lack of labelling to

outlin e risks.

The experts also said the cBHRT

practice of saliva and serum hormone

testing to determine dosing was

unreliable. The BMS and RCOG have

become so concerned by the increas-

ing use of cBHRT that they have taken

the unprecedented step of issuing a

full consensus statement.

“Every expert in the fi eld shares

the same view and concerns about

compounded hormones: it’s unsafe,

untested and unnecessary. “We are

concerned by its purity, potency and

safety,” said Haitham Hamoda , the

chair of the BMS, spokesperson for the

RCOG and a consultant gynaecologist

at King’s College hospital foundation

trust.

“You can get bioidentical HRT on

the NHS: 95% of my 2,500 patients

at King’s are on it. But the key thing

is that it’s not compounded: rBHRT

is prescribed and manufactured

under very strict regulations. In con-

trast, there is no medical evidence to

support cBHRT.”

The experts said the dose of oes-

trogen in cBHRT may be higher or

lower than it needs to be to control

symptoms, and that the dose of pro-

gesterone may not always be suffi cient

to protect the womb. “If the womb is

not suffi ciently protected, there is a

cancer risk,” Hamoda said.

Many cBHRT applications deliver

progesterone through the skin.

“Absorption is variable with fl uctuat-

ing tissue availability and as a result

may not provide suffi cient protection

for wombs,” Hamoda said. “Again,

that’s a cancer risk.”

Dr Louise Newson , a menopause

expert, said: “We see many women at

Newson Health clinic who have spent

considerable amounts of money on

these bioidentical products and have

experienced numerous side eff ects.

“Compounded bioidentical prod-

ucts are not regulated or approved

and so could potentially be harmful.

In addition, there is no evidence that

these bioidentical hormones have

fewer side eff ects or are more eff ec-

tive than prescribed HRT.”

In 2017, the Advertising Standards

Authority ruled against the promotion

of cBHRT as having greater safety and

effi cacy than rBHRT, and said there

was insuffi cient evidence to back the

practice of cBHRT practitioners using

expensive serum and saliva tests to

individualise therapy.

However, the Marion Gluck Clinic,

which claims to be the leading UK

medical clinic specialising in the use

of bioidentical hormones , defend ed

cBHRT.

“Just like any other medical

practice, the Marion Gluck Train-

ing Academy is registered with the

Care Quality Commission (CQC) ,” a

spokesperson said. “In addition, com-

pounding cBHRT is carried out under

the strict supervision of a qualifi ed

pharmacist on a named patient basis.”

The popularity of cBHRT rose after

the publication of fi ndings in 2002

that conventional HRT carried a can-

cer risk.

In the following years , there were a

number of high-profi le endorsements

for cBHRT, including from Oprah Win-

frey and Jeanette Winterson.

There are no statistics for the use of

cBHRT in the UK. But a recent national

population-weighted US survey found

that 35% of women currently using

HRT, and 41% of American women,

aged 40–49 who have used HRT , were

using the compounded version.

A survey of US pharmacies esti-

mated there were 26m to 33m annual

cBHRT prescriptions, with a total

value of $1.3bn to $1.6bn (£1bn-£1.3bn).

Most of these pharmacies predicted

that the use of compound ed bioiden-

tical HRT would grow by 5% to 25%

over the next two years.

 The scientist

Elena Sanchez-

Heras says she

was shocked by

the relative lack

of research into

the menopause

PHOTOGRAPH: ELENA

SANCHEZ-HERAS

Research

Funding gap

has left

questions

unanswered

‘We have half of the

population who

ha ve this problem

and we don’t know

what to do’

Elena Sanchez-Heras

Cell biologist at UCL

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