Memorandum submitted by The British Homeopathic
Association (HO 12)
1.1 Homeopathic medicines are normally prescribed
to patients by homeopathic practitioners and on an individualised
basis, with importance placed on the unique character and lifestyle
of the person concerned. Some randomised controlled trials (RCTs)
of homeopathy have reflected this approach. Others have investigated
a given, standardised, homeopathic medicine taken by the entire
sample of eligible patients, and where the input of a homeopathic
practitioner may or may not have been involved.
1.2 This document is a summary and update
of the overview submitted jointly by the British Homeopathic Association
and the Faculty of Homeopathy in 2008 to the Government Office
It is a factual account of best clinical research evidence in
homeopathy published in peer-reviewed scientific journals up to
and including October 2009. It focuses primarily on systematic
reviews of published RCTs and reconciles those data with results
obtained in the original RCT literature. Findings from non-randomised
clinical studies are presented in brief. We conclude with a number
of recommendations for future research development in homeopathy.
2.1 Comprehensive systematic reviews (all
medical conditions with homeopathy research)
Four out of five comprehensive systematic reviews
of RCTs in homeopathy have reached the qualified conclusion that
homeopathy differs from placebo.[1,2,3,4] One of those four reviews
also stated there was "insufficient evidence [
draw conclusions about the efficacy of homeopathy for any specific
medical condition". The fifth systematic review concluded
there was "weak evidence for a specific effect of homeopathic
remedies"; the methodology of that review and its conclusions
have been challenged. The value of any comprehensive systematic
review, moreover, is limited by the small number of RCTs in homeopathy,
the differing criteria used by reviewers for data extraction,
the disparate modes of homeopathy investigated, the narrow focus
typically on placebo controlled trials, and by the heterogeneous
range of medical conditions being examined collectively.
2.2 Systematic reviews focusing on particular
The issue of heterogeneity of medical condition
has been avoided in each of 17 systematic reviews that have
focused, to date, on homeopathy RCTs (individualised or standardised
treatment) in one of 16 particular clinical conditions. Five
reviews concluded there was positive evidence for homeopathy (childhood
diarrhoea; post-operative ileus; seasonal allergic rhinitis;[9,10]
vertigo); three concluded there was little or no evidence
(attention-deficit hyperactivity disorder; delayed-onset muscle
soreness; headache and migraine prevention); nine did
not offer a clear conclusion either way (anxiety; chronic
asthma; dementia; depression; headache and migraine
treatment; HIV/AIDS; induction of labour; influenza;
2.3 Systematic reviews focusing on particular
groups of diagnoses
There are seven systematic reviews in this category.
Four of these reviews were positive (allergies; upper respiratory
tract infections;[25,26] rheumatic diseases); two were negative
(ailments of childhood and adolescence; cancer); one was
non-conclusive (cancer side-effects). Homeopathic Arnica
montana (often used in RCTs of post-operative pain or swelling)
has itself been the subject of two systematic reviews: one was
negative; a more recent one was non-conclusive.
3.1 Criteria and methods for data extraction
3.1.1 We set clear criteria for including
research papers in this overview. Non peer-reviewed research such
as book chapters, conference proceedings and theses were excluded
from consideration, as were papers in which the medicine tested
had concentration greater than the homeopathic dilution 1X. This
overview therefore contains references to all full papers of RCTs
of homeopathy (any medical condition, treatment or prevention)
that have been published in explicitly peer-reviewed journals
in any country and in any language from 1950 to October 2009 inclusive.
RCTs were categorised by whether: (a) they were controlled by
placebo or by other than placebo (usual treatment or no treatment);
and (b) the mode of homeopathic treatment was individualised or
3.1.2 A peer-reviewed trial was eligible
for inclusion only if a minimum standard of intrinsic quality
was met. A study was defined as an RCT if the paper unequivocally
stated there had been prospective random assignment to treatment.
In the case of placebo-controlled trials, explicit mention of
double blinding was also required; for other-than-placebo controlled
(including equivalence) trials, observer blinding was sufficient
for inclusion. These and a number of additional criteria of quality
were met by a total of 142 RCTs in 129 peer-reviewed
3.1.3 Fewer than half the eligible RCTs
included a power calculation and the associated pre-defined minimum
effect that would be regarded as clinically important. In view
of this low proportion of properly powered trials, positive or
negative RCT findings are described here in terms only of their
statistical significance, not their clinical importance.
3.1.4 A statistically conclusive trial result
required that the 95% confidence interval (CI) of the mean difference
in the outcome variable did not include 0 (or P<0.05);
a statistically non-significant trial result meant that the 95%
CI included 0 (or P>0.05). A study reporting statistically
significant findings was either "positive" or "negative",
depending on whether the homeopathy group was superior or inferior
to control in at least one principal outcome. Relevant corresponding
criteria were applied to other-than-placebo controlled trials.
3.1.5 To be regarded as statistically conclusive,
we required at least one significant finding out of no more than
three statistical analyses of a given study's principal outcomes.
Secondary outcomes were disregarded. This approach avoided the
possibility of interpreting a trial as statistically conclusive
based on merely one statistically significant positive or negative
result out of many.
3.2 Randomised controlled trial findings
3.2.1 Summary based on nature of control
group: One hundred and twenty out of the total of 142 RCTs
(85%) were placebo controlled. The other 22 RCTs (15%) were
controlled by other than placebo. Of the 142 trials overall,
the summary finding was positive in 44%, negative in 8% and statistically
non-conclusive in 48%. Findings in the other-than-placebo controlled
RCTs were conclusively positive or negative more frequently than
those in placebo controlled RCTs:
|Summary trial finding: no. of RCTs (%)
||3 (3%)||65 (54%)
|Other than placebo||11 (50%)
||8 (36%)||3 (14%)
|TOTAL||63 (44%)||11 (8%)
3.2.2 Summary based on mode of homeopathy: Forty out
of the total of 142 RCTs (28%) have reflected the normal
individualised mode of homeopathic treatment. Each of the other
102 RCTs (72%) has investigated a standardised homeopathic
medicine. The percentage distribution of the summary findings
does not differ between the two modes of treatment:
|Summary trial finding: no. of RCTs (%)
|Mode of homeopathy||Positive
||3 (8%)||19 (47%)
||8 (8%)||49 (48%)
|TOTAL||63 (44%)||11 (8%)
3.2.3 The above RCTs represent research in a total of
80 different medical conditions. There is replicated research
(>2 peer-reviewed RCTs per medical condition) in each
of 28 conditions (90 RCTs in total). There is a singleton
RCT for each of the other 52 conditions.
3.2.4 Of the 28 conditions for which there is replicated
research in RCTs, there are 13 that have not been the subject
of formal systematic review to date. Viewed per condition, the
balance of evidence from these RCTs is positive for fibromyalgia[33,34,35]
and sinusitis,[36,37,38,39] and non-conclusive for insect bites,[40,41]
menopause in breast cancer survivors,[42,43] post-operative pain
or swelling (Arnica montana used in the majority of trials),[44,45,46,47,48,49,50]
stroke,[51,52] and warts.[53,54] There was no identifiable balance
of evidence in dermatitis, irritable bowel syndrome,[56,57]
leg ulcers, otitis media[59,60] or post-operative analgesic
4.1 Controlled trials
Non-randomised, controlled, parallel-group design has been
applied to homeopathy. It has focused on homeopathy for either
a particular medical condition (eczema; insomnia; otitis
media; vertigo) or a specified range of complaints.[66,67,68]
Results have been positive; in the absence of group randomisation,
however, one cannot infer a clear causal relationship between
the intervention and the clinical outcome in this type of trial.
4.2 Non-controlled studies
Non-randomised, non-controlled, studies can make a useful
contribution to developmental research in complementary medicine
including homeopathy.[70,71] Findings from studies in this category
may be considered as an adjunct to research evidence obtained
from RCTs and from non-randomised controlled trials; they do not
in themselves constitute research evidence. Findings have been
strongly positive, including those for dysmenorrhoea, headache,
menopausal flushes and sinusitis. A cross-sectional survey
undertaken collectively by the five NHS homeopathic hospitals
reported improved patient-reported outcome whose extent and timing
varied between the different principal medical complaints (eczema,
chronic fatigue syndrome, menopausal symptoms and osteoarthritis).
This paper emphasised homeopathy's contribution to the healthcare
of patients with multiple, complex, morbidities.
5. SUMMARY OF
5.1 Most comprehensive systematic reviews of RCTs in
homeopathy (individualised or standardised treatment) have concluded
there is evidence that the homeopathic intervention differs from
5.2 Condition-specific systematic reviews have indicated
effectiveness of homeopathy (individualised or standardised treatment)
in childhood diarrhoea, post-operative ileus, seasonal allergic
rhinitis, and vertigo. They indicate non-effectiveness in attention-deficit
hyperactivity disorder, delayed-onset muscle soreness, and in
prevention of headache and migraine. Findings are non-conclusive
for all other conditions that have been the subject of review.
5.3 Homeopathy research has focused on a total of 80 different
medical conditions, in which there is a total of 142 peer-reviewed
RCTs that met a number of key quality criteria for this overview.
Findings in 44% of those RCTs were positive, 8% were negative
and 48% were non-conclusive. The majority of trials have examined
standardised homeopathy and used placebo-controlled design. There
has been replicated RCT research in each of only 28 medical
conditions; of those without formal systematic review to date,
there is a balance of positive RCT evidence for fibromyalgia and
6.1 New and independently conducted RCTs are essential
to confirm or refute the currently available research evidence
in homeopathy for specific conditions. There is a need to enhance
the quantity and the quality of research on the effectiveness
of individualised homeopathy, particularly in chronic conditions,
as well as on efficacy of specific homeopathic medicines compared
with placebo. Future trials must be statistically powered to ensure
conclusions may be made about clinically relevant effects.
6.2 Greater collaboration between homeopathic practitioners,
conventional physicians and basic scientists would enhance the
scope and quality of homeopathy research. Integration of homeopathic
research in existing academic and clinical settings (by practitioners
of homeopathy working within the NHS, where regulated and safe
clinical practice is assured) raises standards of research in
homeopathy, encouraging mutual understanding and promoting agreement
on the interpretation of findings. An example of this approach
recently has been the effective collaboration between the Universities
of Leeds and Sheffield with Barnsley Hospital NHS Foundation Trust
in an RCT of individualised homeopathy for fibromyalgia.
6.3 In focusing research on areas in homeopathy where
positive findings from RCTs might be corroborated, the most promising
targets include those with already replicated findings, such as
fibromyalgia, seasonal allergic rhinitis, sinusitis, and vertigo.
Attention must also be paid to areas where there is mainly non-conclusive
or negative trial evidence to date.
6.4 Moreover, emphasis should be placed on those clinical
areas where RCT evidence is currently scanty but where homeopathy
is frequently used in NHS practice,[76,77] particularly in diagnoses
that are difficult to treat using conventional medicine and that
have promising data from non-randomised studies. In this respect,
especially worthwhile research targets include atopic eczema,
chronic fatigue, depression, irritable bowel syndrome, menopausal
symptoms, otitis media and premenstrual syndrome. Patients with
complex medical predicaments are not normally eligible for RCT
research but should be included in suitable clinical outcome studies,
most notably in the clinical context of the homeopathic hospitals.
6.5 The above recommendations for research development
are consistent with comments made about homeopathy in the GO-Science
Review of the Department of Health:
"A programme for a stronger evidence base would necessitate
agreement between practitioners, patients and researchers on what
should be evaluated, and on relevant endpoints. Flagship trials
should be run in the most promising areas, chosen on plausibility,
and patient demand. These should be well planned, including pre-defined
agreement on what constitutes a minimally important clinical effect,
and adequate resource, so that the results were clear-cut. [
The Health Technology Assessment Programme provided a framework
that should be as applicable to research on homeopathy as to any
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
The author of this overview is Robert T Mathie PhD, Research
Development Adviser, British Homeopathic Association; he is not
a homeopathic practitioner. The sole aim of this document is to
provide a transparent, balanced and constructive summary of the
clinical research evidence in homeopathy.
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Robert T Mathie PhD
Research Development Adviser
a Fisher P, Mathie RT. The research evidence base in homeopathy.
Government Office for Science, January 2008. Back
The review reported that Oscillococcinum reduced the length
of influenza illness by 0.28 days (95% confidence interval,
0.50 to 0.06). The authors concluded "though promising,
the data are not strong enough to make a general recommendation
to use Oscillococcinum for first-line treatment of influenza". Back
This and further aspects of intrinsic trial quality in homeopathy
are included in a new evaluation of the research literature that
the British Homeopathic Association is currently pursuing. Back