| Homoeopathy and Clinical
Evidence Based Medicine Roy Steiner
reports.
Much of
this article has been produced from
information kindly provided by Dr. David
Reilly, Consultant Physician at the
Glasgow Homoeopathic Hospital, and a
booklet provided by the Royal London
Homoeopathic Hospital, (The Evidence Base
of Complementary Medicine. 1997). I would
also like to thank Dr. Peter Fisher,
Director of Research at the Royal London
Homoeopathic Hospital for his advice with
the final draft.
Homoeopathy
has been around for over 200 years and
despite much rejection from the medical
profession, this therapy has established
itself throughout the world. Much of the
scepticism has stemmed from a lack of
plausible mechanism of action and it has
been assumed that any response is solely
a placebo action.
Is it
effective when examined scientifically
Four
double blind placebo controlled trials
have been conducted at Glasgow University
to examine the placebo hypothesis, 3
published, (see below) and the fourth is
being analysed. All four trials have
shown positive results.
Reilly DT,
Taylor MA - Potent placebo or potency? A
proposed study model with initial
findings using homoeopathically prepared
pollens in hay fever.
- Br.
Homoeopathic J 1985; 74: 65-75
This paper
aimed to create and test a clinical study
model using homoeopathically prepared
pollens in hay fever. There was a
definite need to test these preparations
against placebo under double-blind
placebo-controlled conditions using a 30c
potency of Mixed Grass Pollens, (a
dilution beyond Avogadro's number). The
crucial issue under test was that of the
process of potentization, (the act of
dilution and succussion). 39 patients
entered the study, 25 receiving placebo
and 13 receiving the active drug. The
patients taking the Mixed Grass Pollens
differed greatly from placebo, with a
definite therapeutic effect after fifteen
days of treatment, and an initial
aggravation of symptoms, (which we would
expect from a homoeopathic preparation),
and a lower withdrawal rate from the
trial. It was noteworthy that despite the
small numbers involved in the active
group, the clinical response demonstrated
reached statistical significance. The
results illustrated that key issues
relevant to homoeopathy could be studied
using standard trial designs, and in this
study a difference in effect between a
30c potency and a placebo was seen. A
larger definitive study was then planned
for.
Reilly DT,
Taylor MA, McSharry C, Aitchinson T. - Is
homoeopathy a placebo response?
Controlled trial of homoeopathic potency,
with pollen in hay fever as model.
- Lancet
1986;ii: 881-886
The
hypothesis that homoeopathic potencies
are placebos was tested in a randomised,
double-blind, placebo-controlled trial.
The study model chosen compared the
effects of a homoeopathic preparation of
mixed grasses with placebo in 144
patients with active hayfever. The
homoeopathically treated patients showed
a significant reduction in patient and
doctor assessed symptom scores. The
significance of this response was
increased when results were corrected for
pollen count and response was associated
with a halving of the need for
antihistamines. An initial aggravation of
symptoms was noted more often in patients
receiving the potency and was followed by
an improvement in that group. No evidence
emerged to support that placebo action
fully explains the clinical response to
homoeopathic drugs.
Reilly DT,
Taylor MA, Campbell J, Beattie N,
McSharry C, Aitchinson T, Carter R,
Stevenson R. - Is evidence for
homoeopathy reproducible?
- Lancet
1994;344:1601-06
Under
independent conditions, the
reproducibility of evidence from the two
previous trials, that homoeopathy differs
from placebo was put to the test. The
test model was again homoeopathic
immunotherapy, (isopathy). 28 patients
with allergic asthma, most of them
sensitive to house-dust mite, were
randomly allocated to receive either oral
homeopathic immunotherapy, (at 30c
potency), to their principle allergen or
identical placebo. The test treatments
were given as a complement to their
unaltered conventional care. A daily
visual analogue scale of overall symptom
intensity was the outcome measure. A
difference in visual analogue score in
favour of homoeopathic immunotherapy
appeared in one week of starting
treatment and persisted for up to 8
weeks, (p=0.003). There were similar
trends in respiratory function and
bronchial reactivity tests.
A
meta-analysis of all three trials
strengthened the evidence that
homoeopathy does more than placebo,
(p=0.0004). Is the reproducibility of
evidence in favour of homoeopathy proof
of it's activity or proof of the clinical
trial's capacity to produce
false-positive results?
Editorial:
Anon. Reilly's challenge. Lancet
1994;344:1585
In the
same edition of Lancet the above
Editorial was included. It highlighted
what it called the absurd, namely that a
substance is therapeutically active in
dilutions so great that the patient is
unlikely to receive a single molecule of
it. The two possible interpretations were
considered. Either there is something
amiss with the clinical trial as
conventionally conducted, (theirs was
done with exceptional rigour), or the
effects of homoeopathic immunotherapy
differ from those of placebo.
Homoeopathic
therapy in Rheumatoid Arthritis:
Evaluation by Double-Blind Clinical
Therapeutic Trial. R.G. Gibson et al. Br.
J. Pharmac. 1980; 9, 453-459
Reprinted:
Homoeopathic therapy in Rheumatoid
Arthritis: Evaluation by Double-Blind
Clinical Therapeutic Trial. R.G. Gibson
et al. B.H.J. 1986 Jul; 75 (3): 148-57
23
patients with rheumatoid arthritis on
orthodox first-line anti-inflammatory
treatment plus homoeopathy were compared
with a similar group of 23 patients on
orthodox first line treatment plus
placebo. Treatment was administered for
periods ranging from 2-6 months. There
was significant improvement in subjective
pain, articular index, stiffness and grip
strength in those patients receiving
homoeopathic remedies whereas there was
no significant change in patients who
received placebo. Two physicians were
involved in prescribing for the patients
and there were no significant differences
in the results obtained. No side effects
were observed with the homoeopathic
remedies.
Clinical
trials of Homoeopathy. Jos Kleijnen, Paul
Knipschild, Gerben ter Riet. BMJ
1991;302:316-23
The
authors of this paper were conventional
epidemiologists who were sceptical about
homoeopathy. In an earlier paper, (Belief
in the efficacy of alternative medicine
among GP's in the Netherlands. Soc. Sci.
Med. 1990;31(5):625-6), they had
described GP's beliefs in complementary
medicine as irrational. In the
introduction to this paper, they stated
that they, "could not believe the
positive result" of one of David
Reilly's trials.
This
review was the result of two years
extensive search of the literature
resulting in 107 controlled trials in 96
published reports. Trials were scored
using a list of pre-defined criteria of
good methodology, and the outcome of the
trials was interpreted in relation to
their quality.
Overall,
of the 105 trials with interpretable
results, 81 were positive. The reviewers
undertook a sub-group analysis of trials
which scored more than 55 points from a
total of 100 for methodological quality,
(ie the most rigorous trials). Fifteen
out of 22 trials, (68%), found
homoeopathy to be superior to placebo.
The reviewers concluded that,
"evidence of clinical trials is
positive but not sufficient to draw
definitive conclusions".
Are the
Clinical Effects of Homoeopathy Placebo
Effects? A Meta-analysis of
Placebo-controlled trials. K.Linde, N.
Clausius, D. Melchart, Florian Eital, L.
Hedges and W. Jonas.
- Lancet
1997;350: 834-843
A more
recent review identified 186 clinical
trials of which 119 were double-blind
and/or randomised placebo-controlled
trials. 89 had adequate data for
meta-analysis. The combined odds ratio
for the 89 studies was 2.45, (95% CI
2.05, 2.93) in favour of homoeopathy. 26
trials met the pre-defined criteria for
high quality. The odds ratio for these
studies was 1.66, (95% CI 1.33, 2.08) and
when corrected for publication bias,
1.78, (95% CI 1.03, 3.1).
The
results of the meta-analysis are not
compatible with the hypothesis that the
clinical effects are completely due to
placebo. There was insufficient evidence
from these studies that homoeopathy is
clearly efficacious for any single
clinical condition. Further research on
homoeopathy is warranted provided it is
rigorous and systematic.
Unfortunately
there are significant problems facing
researchers in all the complementary
fields which severely inhibits such
progress.
The
problems facing research in Complementary
Therapies.
i) Lack of
funding
Funding
bodies have been disinterested in
Complementary therapies and in view of
the low profit margin for remedies, drug
companies equally share this disinterest.
For example, in 1993, the total amount
spent on medical research was estimated
at about £2bn. Of this, a mere £200,000
was spent on complementary medicine,
about 1p out of every £100!
ii) Lack
of research skills
With
notable exceptions, few colleges of
complementary medicine teach research as
part of their curriculum.
iii) Lack
of academic infrastructure
Colleges
of complementary medicine are private
institutions, with no links to
universities. Students studying in this
area receive no state support for fees or
maintenance. As a result researchers
cannot call on these resources for help
in research.
iv) Lack
of patients
Complementary
medicine research is a "Catch
22". Therapies can only be available
on the NHS once there is convincing
evidence of their efficacy. The best way
of producing good evidence is good
quality trials involving large numbers of
patients, which is in the NHS!
v)
Methodological Problems
In
homoeopathy, two patients with exactly
the same diagnosis may receive two
entirely different treatments. Commonly,
in clinical trials, all patients in the
treatment group receive the same drug. To
fit in this research design, many
researchers have chosen to test the
effects of a single homoeopathic remedy
on a particular condition. In practice,
homoeopaths would tend to use a variety
of different remedies. In David Reilly's
work, (illustrated later), subjects were
randomised to receive a single
homoeopathic remedy or placebo.
Homoeopaths do not usually treat hayfever
solely with this remedy but prescribe
more specifically for each patient.
Researchers
have been known to investigate a
condition that could fit into the
restrictions already mentioned rather
than conditions well treated by
homoeopathy. For example, clinical trials
in homoeopathy have included gas
poisoning, recovery of bowel movements
after surgery and acute stroke,
conditions not commonly treated by
homoeopaths. There have been no good
quality trials of skin diseases, which
homoeopaths commonly treat and claim to
manage successfully.
In view of
the difficulties described, homoeopathy
should not be assessed on clinical trials
alone but also from hospital audit. With
this in mind, more important issues can
be evaluated, such as, "does it work
in practice, is it cost-effective?"
Is it
effective when applied clinically
Clinical
trials usefully test the placebo
hypothesis, audit of outcome is a better
test of clinical results
Glasgow
Homoeopathic Hospital (GHH) has audited
outcome results:
Audit of
100 sequential Out-patients at GHH from
July 1992, followed up after one year
with 80% returns, (work in progress: Alix
Boardman et al).
At
presentation: 81% had failed to
conventional treatment
47% had
seen a Consultant for the problem
After 1
year: 60% improved in the presenting
complaint
61%
improved in well being
49% had a
sustained improvement of value in daily
living
37% had a
sustained reduction in conventional
therapy
Audit of
100 In-patients at GHH, (work in
progress: Harrison and Reilly).
At
presentation 100% had already had
conventional care
97% had
seen a Consultant for the problem
67% had
previously needed hospitalisation for the
problem
At a mean
of three months after treatment, (with a
73% response rate):
58% had a
useful improvement in the presenting
complaint
67% had a
useful improvement in general mood and
well being
The Royal
London Homoeopathic Hospital
It is
important to bear in mind that patients
seen are commonly have the most severe
and refractory disease, often having
exhausted more conventional treatment
options.
Adults
with asthma (24 patients)
Nearly two
thirds reported an improvement in their
condition
67%
reported a decrease in their
bronchodilator use
Half
reported visiting their GP less
frequently for urgent asthma treatment.
Children
with asthma (25 children)
Four out
of five reported improvement
Just over
half reported a decrease in
bronchodilator use 60% reported visiting
their GP less frequently for urgent
asthma treatment.
Additional
comments included greater exercise
tolerance.
Eczema (30
adults)
60%
reported an improvement
Similar
number reported a decrease in their need
to use topical steroids.
Gynaecological
Problems (54 patients)
70%
reported an improvement
Over half
had marked improvement in more than one
symptom.
Rheumatology
(64 patients)
59% showed
improvement, outcome measured with
standardised tests e.g. visual analogue
scores, grip strength
Is it able
to be integrated with orthodox
approaches?
Reilly DT,
Taylor MA. Developing Integrated
Medicine. Report of the RCCM Research
Fellowship in Complementary Medicine,
Glasgow University 1987-90.
Complementary
Therapies in Medicine 1993;1, Suppl 1.
1-49
The above
results illustrate that homoeopathy in
secondary care can offer therapeutic
options. In addition some GPs are now
opting for homoeopathy as first line in
certain problems, keeping the more costly
and toxic conventional treatment as
second line.
Practicable
examples include:
- using
homoeopathic colocynthis for colic in
infants under 6 months of age
-
complications of surgery can be reduced
by using homoeopathic arnica at time of
procedure
-
homoeopathic immunotherapy is a safer
alternative to desensitisation injections
Information
from the Glasgow Homoeopathic Hospital
show almost 20% of Scottish GPs have
completed basic level training at their
course, and research has shown that 2
years following the course 78% of
attending doctors were still integrating
elements of homoeopathy in their NHS
care. Links with the Pain Clinic and
General Medical Clinic at the Glasgow
Royal Infirmary has demonstrated a
similar capacity for integration at
secondary and tertiary level care.
Because of
it's safety profile it can be used in
pregnancy and the extremes of life
without the worries of drug interaction
or medical contraindications. There is
however a possibility of danger in
homoeopathy being misapplied, a risk not
intrinsic to homoeopathy.
The main
cost of homoeopathic care is in increased
practitioner time, the costs of
medication is small and the savings in
orthodox drug and procedure bills has
been illustrated. A recent out-patient
survey at Glasgow found that one year on,
37% of patients have managed a sustained
reduction in their conventional
medicines.
Summary
Homoeopathy
has been constantly ridiculed and
described as non-scientific. Despite
opposition it has existed for the last
200 years and is growing in popularity.
It was initially developed by a doctor
whose scientific methodology was
rigorous. Despite the difficulties
concerning the concept of serially
vibrating and diluting substances to
produce remedies, the positive
double-blind trial results illustrate an
activity in the preparations which is
beyond that of placebo. Furthermore, the
more rigorous the trial the more positive
the data illustrates these substances to
be potent or challenges the methodology
with which we currently evaluate drugs.
Outcome studies have further illustrated
that these preparations can be useful in
clinical practice and could potentially
reduce on-going drug costs. With so much
evidence in favour of Homoeopathy I
believe it is not scientific of
professionals to remain cynical of the
subject. It is not the, "Modern Age
Panacea", and if the profession
could accept it's principles much work
could be done to illustrate it's
strengths and weaknesses instead of
efficacy against placebo. In this way we
could work forward to integrate
homoeopathy into daily practice and have
another therapeutic arm instead of a
threatening alternative system of
medicine.
© Roy
Steiner January 1998
For more
information about homeopathic studies,
check out the following links:
Research
in Homeopathy
Clinical
Studies
Scientific
Evidence
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