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HO 15
Memorandum submitted by the Leeds Institute of
Diagnostics and Therapeutics, University
of Leeds
1. In addressing the questions posed in relation
to the Government's use of evidence in policy-making regarding homeopathy;
(1) What is the policy? (2) On what
evidence is the policy based? it is important to recognise that
clinical evidence is characterised by its incremental and sometimes less than
perfect nature. Many clinical decisions
are made on the balance of probabilities suggested by the evidence, rather than
clear, unequivocal evidence to support particular decisions. Scientific
evidence is supplemented by clinical experience and knowledge when clinical
decisions are made in practice. Evidence used for policy-making is no different
in that it too can only represent the best information
available at a particular time, and equally must be balanced against other
types of evidence, including economic and ethical considerations.
1. The proposed 'evidence check' for homeopathy should
therefore be undertaken within the context of our wider understanding of the
nature and value of evidence in other clinical spheres.
2. In particular, it is important to have a
clear framework for assessing the existing evidence which takes into account
the gradations of certainty that are apparent in any systematic review of the
literature. One such framework would be
that provided by the British Medical Journal's "Best Health" project. http://besthealth.bmj.com This Web-based project aims to inform patients and practitioners of the extent and
certainty of existing scientific evidence for particular treatments and
conditions. The following is extracted
from this website;
2.1. "Best
Health looks at medical research that is published in journals all
over the world. It does this by using Clinical
Evidence, a collection of the best research evidence for doctors. Clinical Evidence gives
doctors and other health care workers a good, up-to-date summary of what's
known and what isn't about treating a wide range of clinical conditions. It's
published by the BMJ Publishing Group.
2.2. Clinical
Evidence looks at all the evidence and decides how well treatments
work, whether the research is good enough and how serious the side effects are.
Sometimes no one knows for certain whether a treatment works because the
research that's been done isn't good enough. Or it could be that not enough
research has been done.
2.3. Best
Health adds to the Clinical
Evidence research. It makes the evidence easy to read. It also
enables patients to see the same research evidence that doctors see. Clinical
Evidence gives doctors and other health care workers a good up-to-date
summary of what's known and what isn't about treating a wide range of clinical
conditions. It's published by the BMJ Publishing Group.
2.4. We follow a strict process to develop each
topic on Best Health.
Here are the key steps:
2.4.1. Step
1: Selecting a topic
2.4.2. Best
Health covers serious, long-lasting illnesses that affect many
people in the UK.
It also looks at more minor conditions that affect a lot of people, such as
coughs and colds. We are guided by national health statistics, doctors and
patient groups. The conditions we look at have been included in Clinical Evidence.
2.4.3. Step 2: Asking the right questions
2.4.4. We cover the treatment options for each
condition and give background information
to explain the condition itself. Best
Health works with the Clinical Evidence team, an
international team of doctors, and patient groups to find out what matters most
to doctors and patients. They might ask questions such as: What does the
research say about exercise helping people with heart failure? What are the
side effects of treatments for childhood asthma?
2.4.5. Step
3: Finding the evidence
2.4.6. All our information
is based on research evidence and high-quality medical papers. Here is how we
gather this evidence:
2.4.7. Information
about treatments -This information
in Best Health
is based on Clinical Evidence. To answer each question about a
treatment, the Clinical Evidence medical information
specialists do a thorough search for studies that measure how well treatments
work. First the information
specialists look for the best types of studies (called systematic reviews) and
other good-quality studies called randomised controlled trials. If there are
none of these studies, the information
specialists look for other studies and say how much they can be relied on and
what problems there are with the research.
2.4.8. Once the research has been collected, the information specialists weigh up the evidence and
take out the studies that aren't good enough. They do this using a method
developed by experts in how research is carried out.1 2 .This
thorough research helps us find out which treatments work best for a condition,
and also why certain treatments work. If you would like to read more about how
we search for and select studies, see the Clinical Evidence website (http://clinicalevidence.bmj.com).
2.4.9. Information
about conditions - The information
that we provide to explain medical conditions is based on high-quality original
medical papers and textbooks chosen by our information
specialists. On each page of the site, you will find the details of the sources
of information we have used.
2.4.10. Step
4: Making sense of the evidence
2.4.11. The research evidence for each treatment is
studied and summarised by a doctor who is an important expert in a particular
specialty. Each topic is then checked by at least three more doctors. Then, a
leading expert provides advice on how doctors can use this research evidence.
We ask people with the condition to tell us what they think the important
questions are about their condition and treatments.
2.4.12. A team of experienced medical writers makes
sure this evidence can easily be understood by the general public and writes
the extra information that explains
each condition.
2.4.13.
Deciding which treatments work - We group treatments into categories according
to how good the evidence is that they work. We use slightly different language
to describe the categories than you'll find in Clinical Evidence, but
the treatments are grouped in the same way. Here is an explanation of what each
category means:
|
Category
|
What it
means
|
|
Treatments that
work
|
There's
clear evidence from randomised controlled trials that the treatment works. Also, the evidence
shows that the chance of problems is small compared with the benefits.
|
|
Treatments that are
likely to work
|
There
is some evidence that the treatment works. But we can't be as certain that
the treatment works as we can for those listed under 'Treatments that work'.
|
|
Treatments that
work, but whose harms may outweigh benefits
|
There's
some good evidence that the treatment works. But there's also good evidence
that it can have serious side effects. Doctors and patients need to weigh up
the benefits and risks according to what each person needs and wants.
|
|
Treatments that
need further study
|
We
don't know if the treatment is effective because there is either too little
research to tell or the quality of the research is not good enough.
|
|
Treatments that are
unlikely to work
|
There
is evidence that the treatments probably don't work. But we can't be as
certain that the treatments don't work as we can for the ones in the group
'Treatments that are likely to be ineffective or harmful'.
|
|
Treatments that are
likely to be ineffective or harmful
|
Clear
evidence shows the treatments don't work or will be harmful.
|
2.5. Step
5: Presenting the answers
All
the information on Best Health is edited by a
team of editors and checked by our doctors. The information
about drugs has been reviewed by a team of qualified pharmacists working in
association with PharmacyHealthLink. PharmacyHealthLink is a leading national
charity that works to improve the health of the public through the expertise of
pharmacists and their staff.
2.6. Sources
for the information on this page:
Sackett DL, et al. Clinical
epidemiology: a basic science for clinical medicine. Little, Brown and Co,
Boston, USA; 1991.
Jadad A. Randomised controlled
trials. In: Assessing the quality of RCTs: why, what, how and by whom? London, UK; 1998.
3.
Using this
framework, the BMJ group have assessed 2,500 commonly used treatments and their
summarised findings are shown in the figure below.
4. Again, it seems appropriate that the
committee's deliberations regarding the evidence relating to homeopathy are
conducted with reference to the larger picture regarding the imperfect and
emerging evidence base informing
policy for commonly provided treatments within the NHS.
5. While evidence-based
policy is a laudable goal, something to be strived for, it can only happen in
the prevailing climate of imperfect and emerging knowledge. If, as seems
likely, an unacceptable gap is identified between the level of reported use of
homeopathy and the evidence available to help inform
the public or the NHS of its value, the most objective and ethical way forward
would be to support the generation of high quality research findings to close
this gap. The current structures of the NIHR are adequate to facilitate this.
6. The above
recommendations for further research echo those made in relation to homeopathy in the GO-Science Review of the
Department of Health:
"[...]. Flagship trials should be run in the most promising
areas, chosen on plausibility, and patient demand. [...] The Health Technology
Assessment Programme provided a framework that should be as applicable to
research on homeopathy as to any other therapy."
GO-Science
Review of the Department of Health, Annex 1 (2008). Government Office for
Science: Department for Innovation, Universities and Skills; Paragraph 3.16.
7. Declaration of interest
The author of this submission,
Professor Katharine Thomas, is an academic researcher at the University of Leeds;
she is not a homeopathic practitioner, and has no financial interest in the
provision of homeopathy.
Katharine
Thomas BA (Hons) MA
Professor
of Complementary and Alternative Medicine Research
Leeds
Institute of Diagnostics and Therapeutics
Faculty
of Medicine and Health
University of Leeds
November
2009
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