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HO
24
Memorandum submitted
by the Complementary Medicine Research Group, University of York
The context
Homeopathy is regarded with scepticism
by the establishment yet it is widely used by the general public who often
experience it as a useful adjunct to conventional medicinal care. While the
plausibility of homeopathy is of concern to many scientists, its widespread use
leads those of us who conduct health services research to call for more and
better research into the evidence in the interests of the public good. In
parallel with the increased public interest in homeopathy is the demand to show
evidence of clinical efficacy. While
the evidence base is currently patchy for homeopathy, as it is for quite a
number of conventional medical interventions, the imperative from the research
point of view is to conduct research that reflects the way homeopathy is used,
whether as over-the-counter remedies or with a consultation by a homeopath.
Such research should build on the current evidence base, which is summarised
below.
The
evidence base
Since
the early 1970s, there have been a total of 99 randomised controlled trials
investigating homeopathy with over half of those conducted since 2000. The reports of those trials have been
published in good quality peer reviewed journals, and the results show a mixed
picture.
In
44% (n=60) the studies report positive findings, where the homeopathy treatment
showed statically significant superior effect compared to placebo, and those
effects have been replicated by two or more studies in conditions of Childhood
diarrhoea (individualized treatment)1-3, Fibromyalgia 4,5,
Influenza 6, 7, Osteoarthritis 8,9,10, Seasonal
allergic rhinitis 11, 12-21, Sinusitis 22-25 and
Vertigo.26,27
There
have also been positive findings in RCTs investigating: Chronic fatigue
syndrome28, Premenstrual syndrome 29, Post-partum
bleeding30, Sepsis 31, and Stomatitis32,
however, for these conditions conducted between 2001 and 2005, there has been
no replication to verify the findings.
In
contrast 7% of the RCTs reported negative findings, where the homeopathy was
considered to have a worse effect than the placebo, whilst nearly half (49%
n=68) find inconclusive results.
Negative
or inconclusive results have been observed for: Anxiety33-35,
Childhood asthma36,37 Insect bites38,39 Menopausal
symptoms in breast cancer 41,41, Migraine 42-44, Muscle
soreness45-49, Post-operative bruising / haematoma / pain / swelling50,
51-57, Rheumatoid arthritis 58-60 , Stroke 61,62,
Upper respiratory tract infection (prevention) 63,64 and Warts
65,66.
The
most robust evidence presented is from several major systematic reviews of
randomised controlled trials. The aim of the systematic review is to assess the
quality and rigour of the individual trials that are included, and then compare
and contrast the findings of each and comment on the consistency or
inconsistency of the findings as a body of work. To date there are eight systematic reviews
that provide evidence that the effects of homeopathy are beyond placebo when
used as a treatment for childhood diarrhoea, influenza, post-operative ileus,
respiratory tract infection and vertigo, and three providing consistent
evidence of effectiveness for hay fever and associated pollenitis.
Future research into homeopathy
Although there is an increasing body of trials
available, the
lack of independent confirmation of reported trials and the presence
of conflicting results is a major limitation to homeopathy research.
Furthermore the general field is bedevilled by the lack
of well-designed replicable studies conducted by independent research
teams. Two key factors inhibiting current and future homeopathy research are
the lack of adequate funding and lack of well-trained homeopaths who
are sufficiently qualified and interested in engaging in objective
research.
Of those studies
that have been conducted, a common finding by systematic reviewers is the poor
quality research and weak methodology. Also problematic is the lack of
reporting the key components such as allocation concealment after
randomisation, pre-specified outcome measures, and the reporting of attrition
rates and numbers of participants withdrawing from trials. The influence of
indicators of methodological quality on study outcome cannot be underestimated.
Linde and colleagues67 find that studies with higher-quality scores
had a tendency to be less positive than those with lower-quality scores. After
discarding the lower-quality trials, however, they still found homeopathic
treatment to be more effective than placebo.
A common refrain
among reviewers is to call for more trials and larger trials. However, it would
be more meaningful to consider not only the need for more and larger trials,
but for trials of more rigorous quality. Furthermore, we suggest that there
should be a greater emphasis on comparisons to conventional treatments. There
is a need for to develop pragmatic randomised controlled trials that compare
homeopathy to the usual care available for the condition. For placebo
controlled trials of homeopathic remedies prescribed by a homeopath, there
needs to be a placebo control that adequately emulates the therapeutic
relationship.
Reporting of homeopathy trials will be enhanced by
the implementation of the recent 'RedHot'68 supplement
to the widely adopted CONSORT guidelines. The RedHot recommendations support the inclusion of information on consultations,
practitioners, theoretical models, and case analysis strategies. These
recommendations were developed as part of our research endeavour at the University of York to
facilitate the replication of homeopathy trials and support the development of a more robust evidence
base for homeopathy.
References:
1
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2 Jacobs J, Jimenez LM, Gloyds SS, et al. Treatment of acute childhood diarrhea
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3 Jacobs J, Jimenez LM, Malthouse S, et al. Homeopathic treatment of acute
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12
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25 Zabolotnyi DI, Kneis KC, Richardson A, et al. Efficacy of a complex
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26 Issing W, Klein P, Weiser M. The homeopathic preparation Vertigoheel versus
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27
Weiser M, Strösser W, Klein P. Homeopathic vs. conventional treatment of
vertigo: a randomized double-blind controlled clinical study. Archives of
Otolaryngology - Head and Neck Surgery, 1998; 124: 879-885.
28 Weatherley-Jones E, Nicholl JP, Thomas KJ, et al. A randomized, controlled,
triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue
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29 Yakir M, Kreitler S, Brzezinski A, et al. Effects of homeopathic treatment
in women with premenstrual syndrome: a pilot study. British Homeopathic
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30 Oberbaum M, Galoyan N, Lerner-Geva L, et al. The effect of the homeopathic
remedies Arnica and Bellis perennis on mild postpartum bleeding - a randomized,
double-blind, placebo-controlled study -preliminary results. Complementary
Therapies in Medicine, 2005; 13: 87-90.
31 Frass M, Linkesch M, Banyai S, et al. Adjunctive homeopathic treatment in
patients with severe sepsis: a randomized, double-blind, placebo-controlled
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32 Oberbaum M, Yaniv I, Ben-Gal Y, et al. A randomized, controlled clinical
trial of the homeopathic medication Traumeel S in the treatment of
chemotherapy-induced stomatitis in children undergoing stem cell
transplantation. Cancer, 2001; 92: 684-690.
33 Baker DG, Myers SP, Howden I, Brooks L. The effects of homeopathic Argentum
nitricum on test anxiety. Complementary Therapies in Medicine, 2003; 11: 65-71.
34 Bonne O, Shemer Y, Gorali Y, et al. A randomized, double-blind,
placebo-controlled study of classical homeopathy in generalized anxiety
disorder. Journal of Clinical Psychiatry, 2003; 64: 282-287.
35 McCutcheon LE. Treatment of anxiety with a homeopathic remedy. Journal of
Applied Nutrition, 1996; 48: 2-6.
36 Freitas L, Goldenstein E, Sanna OM. [The indirect patient-doctor
relationship and the homeopathic treatment of childhood asthma]. Revista de
Homeopatia, 1995; 60: 26-31.
37 White A, Slade P, Hunt C, et al. Individualised homeopathy as an adjunct in
the treatment of childhood asthma: a randomized placebo controlled trial.
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38 Hill N, Stam C, Tuinder S, van Haselen RA. A placebo controlled clinical
trial investigating the efficacy of a homeopathic after-bite gel in reducing
mosquito bite induced erythema. European Journal of Clinical Pharmacology,
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39 Hill N, Stam C, van Haselen RA. The efficacy of Prrrikweg gel in the
treatment of insect bites: a double-blind, placebo-controlled clinical trial.
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40 Jacobs J, Herman P, Heron K, et al. Homeopathy for menopausal symptoms in
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41 Thompson EA, Montgomery
A, Douglas D, Reilly D. A pilot, randomized, double-blinded, placebo-controlled
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42 Brigo B, Serpelloni G. Homoeopathic treatment of migraines: a randomized
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43 Straumsheim P, Borchgrevink C, Mowinckel P, et al. Homeopathic treatment of
migraine: a double blind, placebo controlled trial of 68 patients. British
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44 Whitmarsh TE, Coleston-Shields DM, Steiner TJ. Double-blind randomized
placebo-controlled study of homoeopathic prophylaxis of migraine. Cephalalgia,
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45 Jawara N, Lewith G, Mullee M, Smith C. Homoeopathic Arnica and Rhus
Toxicodendron for delayed onset muscle soreness: a randomized, double-blind,
placebo-controlled trial. British Homeopathic Journal, 1997; 86: 10-15.
46 Tveiten D, Bruseth S, Borchgrevink CF, Løhne K. [Effect of Arnica D30 on
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48 Vickers AJ, Fisher P, Smith C, et al. Homoeopathy for delayed onset muscle
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49 Vickers AJ, Fisher P, Smith C, et al. Homeopathic Arnica 30X is ineffective
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65 Kainz JT, Kozel G, Haidvogl M, Smolle J. Homoeopathic versus placebo therapy
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67 Linde
K, Scholz M, Ramirez G, et al. Impact of study quality on outcome in placebo
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68 Dean ME, Coulter MK, Fisher P, Jobst K, Walach H.
Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT.
HOMP 2007; 96(1): 42-45.
Dr
Hugh MacPherson
Complementary
Medicine Research Group
University of York
November 2009
About the Complementary Medicine Research Group, University of York
The Complementary
Medicine Research Group is based within Department of Health
Sciences, which in the 2008 Research Assessment Exercise, was rated joint first
nationally for health services research. We have a strong track record of
conducting clinical evaluations of osteopathy, chiropractic, acupuncture and
homeopathy.
We have five primary aims:
1. To establish the clinical, economic and
individual impact of complementary therapies for specific conditions
2. To evaluate the safety of complementary
therapies
3. To develop evaluative methodologies
appropriate to complementary medicine
4. To build capacity for rigorous research
into complementary and alternative medicine
5. To disseminate the results of research in
order to inform the public and influence policy and practice
We have been successful in attracting
a range of funding from the National Institute for Health Research (NIHR),
including a Career Scientist Award (for Hugh
MacPherson at £365,000 from 2007 to 2012), a Research for Patient Benefit Grant
(£250,000 from October 2008 to September 2011) and a Programme Grant for
Applied Research (£1,300,000 from 2009 to 2014). More information about our
projects and publications can be obtained from:
https://hsciweb.york.ac.uk/research/public/Group.aspx?ID=4.
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