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(2)IT'S HIGH TIME WE REGISTERED
ALL CLINICAL TRIALS
SAY EDITORS OF LANCET AND
BMJ
(1)CLAIMS OF CARDIOVASCULAR
BENEFITS OF HRT
MAY BE PREMATURE
(Pre-existing risk factor profiles
in users and non-users of
hormone replacement therapy: prospective
cohort in
Gothenburg, Sweden)
http://www.bmj.com/cgi/content/full/319/7214/890
It is too early to recommend hormone replacement
therapy
(HRT) for the prevention of cardiovascular
disease, concludes
a Swedish study in this week's BMJ. Dr
Kerstin Rdstrm from
Gothenburg University and colleagues report
that women who
used HRT were at a lower risk of cardiovascular
problems
before the start of their treatment than
women who did not
use HRT.
The research team studied 1201 women over
a 24 year period
and found that 14.9 per cent of them used
HRT at some point
over the study period. Before the
start of their treatment, these
women, say the authors, had significantly
lower blood pressure,
were less obese and belonged to a higher
social group than the
women who did not use HRT.
Rdstrm et al report that over the last
thirty years, many studies have
reported beneficial effects of postmenopausal
hormone replacement
therapy on morbidity and mortality from
cardiovascular disease
- some indicating an almost fifty per
cent risk reduction.
The authors say that, based on their findings,
reports suggesting
beneficial effects of HRT during menopause
are likely to have been
confounded by the pre-existing differences
in the health of
users as opposed to non-users - ie users
of HRT tend to be
women who are less at risk of cardiovascular
disease from
the outset of their treatment.
On the basis of their findings, say the
authors, it is too early to
recommend HRT for the prevention of cardiovascular
disease
before further studies, taking account
of such confounding factors,
have been conducted.
Contact: Dr Kerstin Rdstrm, General
Practitioner, Department of
Primary Health Care, Vasa Hospital, Gothenburg,
Sweden
Email:Kerstin.Rodstrom@allmed.gu.se
(2)IT'S HIGH TIME WE
REGISTERED ALL CLINICAL TRIALS
SAY EDITORS OF LANCET AND BMJ
(Time to register randomised trials)
http://www.bmj.com/cgi/content/full/319/7214/865
The public has a right to know what medical
research is being funded,
argue the editors of the Lancet and the
BMJ in a joint editorial
published in this week's issues. What's
more, researchers and their
financial backers don't want to waste
resources running trials that are
already being conducted elsewhere, write
the authors. They claim that
the solution is to make sure that all
clinical trials that are underway are
registered for all to see.
Dr Richard Horton, editor of the Lancet
and Dr Richard Smith, editor
of the BMJ write that each year a vast
financial investment is made by
national funding agencies, medical research
charities, and drug and
device manufacturers in randomised controlled
trials. The problem is,
they say, that the process of undertaking
research is "chaotic" and
"..takes little account of concurrent
research".
Another area of concern, say the authors,
is that researchers
conducting 'systematic reviews' (a systematic
review is an overview of
all the original research conducted into
a certain subject area) need to
know about ALL the trials that have been
conducted on a subject to
avoid 'publication bias' (where only the
positive results of trials have
been recorded). By ensuring that all trials
are recorded, this problem
could be overcome, they say.
The difficulty in undertaking to register
all clinical trials is "who will
take the lead?" say Horton and Smith.
There are registration initiatives
already underway (such as the NHS National
Research Register and
the Cochrane controlled trials register)
but there are others within the
medical research world who have roles
to play, such as editors of
journals and publishers.
The most significant recent lead has been
taken by the pharmaceutical
industry say the authors and they note
that GlaxoWellcome and
Schering Health Care have committed themselves
to registering clinical
trials, making a commitment to "..a climate
of openness". According to
Horton and Smith, such initiatives have
led to critisism that the
companies are opening up a "..window of
vulnerability±in (their)
commercial armour." How can this be, ask
the authors, when all they
are doing is releasing administrative
information and not actual data?
Horton and Smith conclude that the pressure
to register trials will only
come when research ethics committees,
medical research charities and
drug and device manufacturers start to
encourage trialists to register.
Only then will the structure exist to
"help to deliver high quality
evidence to the clinical setting."
Contact: Dr Richard Horton, Editor, The Lancet
Or
Dr Richard Smith, Editor, BMJ c/o Jill Shepherd, BMJ Press Office
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