Memorandum submitted by the Complementary
Medicine Research Group, University of York (HO24)
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.
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 syndrome, [28] Premenstrual syndrome,
[29] Post-partum bleeding, [30] Sepsis [31] and Stomatitis [32],
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: Anxiety, [33-35] Childhood asthma, [36,37 ] Insect bites,
[38,39] Menopausal symptoms in breast cancer, [41,41] Migraine,
[42-44] Muscle soreness, [45-49] Post-operative bruising/haematoma/pain/swelling,
[50,51-57] 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 colleagues [67] 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. Jacobs J, Jiminez L M, Gloyds S S, et al.
Homoeopathic treatment of acute childhood diarrhoea. A randomized
clinical trial in Nicaragua. British Homeopathic Journal, 1993;
82: 83-86.
2. Jacobs J, Jimenez L M, Gloyds S S, et al.
Treatment of acute childhood diarrhea with homeopathic medicine;
a randomized clinical trial in Nicaragua. Pediatrics, 1994; 93:
719-725.
3. Jacobs J, Jimenez L M, Malthouse S, et
al. Homeopathic treatment of acute childhood diarrhoea: results
from a clinical trial in Nepal. Journal of Alternative and Complementary
Medicine, 2000; 6: 131-139.
4. Bell I, Lewis D, Brooks A, et al. Improved
clinical status in fibromyalgia patients treated with individualized
homeopathic remedies versus placebo. Rheumatology, 2004; 43: 577-582.
5. Fisher P. An experimental double-blind clinical
trial method in homoeopathy. Use of a limited range of remedies
to treat fibrositis. British Homeopathic Journal, 1986; 75: 142-147.
6. Ferley J P, Zmirou D, D'Adhemar D, Balducci
F. A controlled evaluation of a homoeopathic preparation in the
treatment of influenza like syndromes. British Journal of Clinical
Pharmacology, 1989; 27: 329-335.
7. Papp R, Schuback G, Beck E, et al.
Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled
double-blind evaluation. British Homeopathic Journal, 1998; 87:
69-76.
8. Shealy C N, Thomlinson R P, Cox R H, Borgmeyer
R N. Osteoarthritic pain: a comparison of homeopathy and acetaminophen.
American Journal of Pain Management, 1998; 8: 89-91.
9. Shipley M, Berry H, Broster G, et al.
Controlled trial of homoeopathic treatment of osteoarthritis.
Lancet, 1983; i: 97-98.
10. van Haselen R A, Fisher P A G. A randomized
controlled trial comparing topical piroxicam gel with a homeopathic
gel in osteoarthritis of the knee. Rheumatology, 2000; 39: 714-719.
11. Taylor M A, Reilly D, Llewellyn-Jones R H,
et al. Randomised controlled trials of homoeopathy versus
placebo in perennial allergic rhinitis with overview of four trial
series. British Medical Journal, 2000; 321: 471-476.
12. Aabel S, Laerum E, Dølvik S, Djupesland
P. Is homeopathic "immunotherapy" effective? A double-blind,
placebo-controlled trial with the isopathic remedy Betula 30c
for patients with birch pollen allergy. British Homeopathic Journal,
2000; 89: 161-168.
13. Aabel S. No beneficial effect of isopathic
prophylactic treatment for birch pollen allergy during a low-pollen
season: a double-blind, placebo-controlled clinical trial of homeopathic
Betula 30c. British Homeopathic Journal, 2000; 89: 169-173.
14. Aabel S. Prophylactic and acute treatment
with the homeopathic medicine Betula 30c for birch pollen allergy:
a double-blind, randomized, placebo-controlled study of consistency
of VAS responses. British Homeopathic Journal, 2001; 90: 73-78.
15. Kim L S, Riedlinger J E, Baldwin C M, et
al. Treatment of seasonal allergic rhinitis using homeopathic
preparation of common allergens in the southwest region of the
US: a randomized, controlled clinical trial. Annals of Pharmacotherapy,
2005; 39: 617-624.
16. Reilly D T, Taylor M A. Potent placebo or
potency? A proposed study model with initial findings using homoeopathically
prepared pollens in hayfever. British Homeopathic Journal, 1985;
74: 65-75.
17. Reilly D T, Taylor M A, McSharry C, Aitchison
T. Is homeopathy a placebo response? Controlled trial of homeopathic
potency, with pollen in hayfever as model. Lancet, 1986; ii: 881-885.
18. Wiesenauer M, Häussler S, Gaus W. [Treatment
of pollinosis with Galphimia glauca]. Fortschritte der Medizin,
1983; 101: 811-814.
19. Wiesenauer M, Gaus W. Double-blind trial
comparing the effectiveness of the homoeopathic preparation Galphimia
potentization D6, Galphimia dilution 10-6 and placebo on
pollinosis. Arzneimittelforschung, 1985; 35: 1745-1747.
20. Wiesenauer M, Gaus W, Häussler S. [Treatment
of pollinosis with the homeopathic preparation Galphimia glauca.
A double-blind trial in clinical practice]. Allergologie, 1990;
13: 359-363.
21. Weiser M, Gegenheimer L H, Klein P. A randomized
equivalence trial comparing the efficacy and safety of Luffa comp.-Heel
nasal spray with cromolyn sodium spray in the treatment of seasonal
allergic rhinitis. Forschende Komplementärmedizin und Klassische
Naturheilkunde, 1999; 6: 142-148.
22. Friese K-H, Zabalotnyi D I. [Homeopathy in
acute rhinosinusitis. A double-blind, placebo controlled study
shows the effectiveness and tolerability of a homeopathic combination
remedy]. HNO, 2007; 55: 271-277.
23. Weiser M, Clasen B. [Randomized, placebo-controlled,
double-blind study of the clinical efficacy of the homeopathic
Euphorbium compositum-S nasal spray in cases of chronic sinusitis].
Forschende Komplementärmedizin, 1994; 1: 251-259.
24. Wiesenauer M, Gaus W, Bohnacker U, Häussler
S. [Effectiveness trial of homeopathic drug combinations for the
treatment of sinusitis. Results of a randomized double-blind study
in primary care]. Arzneimittelforschung, 1989; 39: 620-625.
25. Zabolotnyi D I, Kneis K C, Richardson A,
et al. Efficacy of a complex homeopathic medication (Sinfrontal)
in patients with acute maxillary sinusitis: a prospective, randomized,
double-blind, placebo-controlled, multicenter clinical trial.
Explore (NY), 2007; 3: 98-109.
26. Issing W, Klein P, Weiser M. The homeopathic
preparation Vertigoheel versus Ginkgo biloba in the treatment
of vertigo in an elderly population: a double-blinded, randomized,
controlled clinical trial. Journal of Alternative and Complementary
Medicine, 2005; 11: 155-160.
27. Weiser M, Strüsser 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 J P, Thomas K
J, et al. A randomized, controlled, triple-blind trial
of the efficacy of homeopathic treatment for chronic fatigue syndrome.
Journal of Psychosomatic Research, 2004; 56: 189-197.
29. Yakir M, Kreitler S, Brzezinski A, et
al. Effects of homeopathic treatment in women with premenstrual
syndrome: a pilot study. British Homeopathic Journal, 2001; 90:
148-153.
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 trial in an intensive
care unit. Homeopathy, 2005; 94: 75-80.
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 D G, Myers S P, 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 L E. Treatment of anxiety with
a homeopathic remedy. Journal of Applied Nutrition, 1996; 48:
2-6.
36. Freitas L, Goldenstein E, Sanna O M. [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. Thorax, 2003; 58: 317-321.
38. Hill N, Stam C, Tuinder S, van Haselen R
A. 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, 1995; 49:
103-108.
39. Hill N, Stam C, van Haselen R A. The efficacy
of Prrrikweg gel in the treatment of insect bites: a double-blind,
placebo-controlled clinical trial. Pharmacy World and Science,
1996; 18: 35-41.
40. Jacobs J, Herman P, Heron K, et al.
Homeopathy for menopausal symptoms in breast cancer survivors:
a preliminary randomized controlled trial. Journal of Alternative
and Complementary Medicine, 2005; 11: 21-27.
41. Thompson E A, Montgomery A, Douglas D, Reilly
D. A pilot, randomized, double-blinded, placebo-controlled trial
of individualized homeopathy for symptoms of estrogen withdrawal
in breast-cancer survivors. Journal of Alternative and Complementary
Medicine, 2005; 11: 13-20.
42. Brigo B, Serpelloni G. Homoeopathic treatment
of migraines: a randomized double-blind study of sixty cases (homoeopathic
remedy versus placebo). Berlin Journal on Research in Homeopathy,
1991; 1: 98-106.
43. Straumsheim P, Borchgrevink C, Mowinckel
P, et al. Homeopathic treatment of migraine: a double blind,
placebo controlled trial of 68 patients. British Homeopathic
Journal, 2000; 89: 4-7.
44. Whitmarsh T E, Coleston-Shields D M, Steiner
T J. Double-blind randomized placebo-controlled study of homoeopathic
prophylaxis of migraine. Cephalalgia, 1997; 17: 600-604.
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 C F, L¾hne
K. [Effect of Arnica D30 on hard physical exertion. A double-blind
randomized trial during the 1990 Oslo Marathon]. Tidsskrift
for den Norske Lœgeforening, 1991; 111: 3630-3631.
47. Tveiten D, Bruseth S, Borchgrevink C F, Norseth
J. Effects of the homoeopathic remedy Arnica D30 on marathon
runners: a randomized, double-blind study during the 1995 Oslo
Marathon. Complementary Therapies in Medicine, 1998; 6: 71-74.
48. Vickers A J, Fisher P, Smith C, et al.
Homoeopathy for delayed onset muscle soreness: a randomized double
blind placebo controlled trial. British Journal of Sports Medicine,
1997; 31: 304-307.
49. Vickers A J, Fisher P, Smith C, et al.
Homeopathic Arnica 30X is ineffective for muscle soreness after
long-distance running: a randomized, double-blind, placebo-controlled
trial. Clinical Journal of Pain, 1998; 14: 227-231.
50. Hart O, Mullee M A, Lewith G, Miller J. Double-blind,
placebo-controlled, randomized clinical trial of homoeopathic
arnica C30 for pain and infection after total abdominal hysterectomy.
Journal of the Royal Society of Medicine, 1997; 90: 73-78.
51. Kaziro GS. Metronidazole (Flagyl) and Arnica
montana in the prevention of post-surgical complications, a comparative
placebo controlled clinical trial. British Journal of Oral &
Maxillofacial Surgery, 1984; 22: 42-49.
52. Lükken P, Straumsheim P A, Tveiten D,
et al. Effect of homoeopathy on pain and other events after
acute trauma; placebo controlled trial with bilateral oral surgery.
British Medical Journal, 1995; 310: 1439-1442.
53. Seeley B M, Denton A B, Ahn M S, Maas C S.
Effect of homeopathic Arnica montana on bruising in face-lifts:
results of a randomized, double-blind, placebo-controlled clinical
trial. Archives of Facial Plastic Surgery, 2006; 8: 54-59.
54. Stevinson C, Devaraj V S, Fountain-Barber
A, et al. Homeopathic arnica for prevention of pain and
bruising: randomized placebo-controlled trial in hand surgery.
Journal of the Royal Society of Medicine, 2003; 96: 60-65.
55. Robertson A, Suryanarayanan R, Banerjee A.
Homeopathic Arnica montana for post-tonsillectomy analgesia: a
randomised placebo control trial. Homeopathy, 2007; 96: 17-21.
56. Wolf M, Tamaschke C, Mayer W, Heger M. [Efficacy
of Arnica in varicose vein surgery: results of a randomized, double-blind,
placebo-controlled pilot study]. Forschende Komplementär-medizin
und Klassische Naturheilkunde, 2003; 10: 242-247.
57. Andrade L, Ferraz M B, Atra E, et al.
A randomized controlled trial to evaluate the effectiveness of
homoeopathy in rheumatoid arthritis. Scandinavian Journal of Rheumatology,
1991; 20: 204-208.
58. Fisher P, Scott D L. A randomized controlled
trial of homeopathy in rheumatoid arthritis. Rheumatology, 2001;
40: 1052-1055.
59. Wiesenauer M, Gaus W. [A randomized double-blind
trial on the efficacy of a homeopathic drug for rheumatoid arthritis].
Aktuelle Rheumatologie, 1991; 16: 1-9.
60. Savage R H, Roe P F. A double blind trial
to assess the benefit of Arnica mo ntana in acute stroke illness.
British Homeopathic Journal, 1977; 66: 207-220.
61. Savage R H, Roe P F. A further double blind
trial to assess the benefit of Arnica montana in acute stroke
illness. British Homeopathic Journal, 1978; 67: 210-222.
62. Davies A E. Clinical investigations into
the actions of potencies. British Homeopathic Journal, 1971; 60:
36-41.
63. Steinsbekk A, Bentzen N, F¾nneb¾
V, Lewith G. Self treatment with one of three self selected, ultramolecular
homeopathic medicines for the prevention of upper respiratory
tract infections in children. A double-blind randomized placebo
controlled trial. British Journal of Clinical Pharmacology, 2005;
59: 447-455.
64. Steinsbekk A, F¾nneb¾ V, Lewith
G, Bentzen N. Homeopathic care for the prevention of upper respiratory
tract infections in children: a pragmatic, randomized, controlled
trial comparing randomized homeopathic care and waiting-list controls.
Complementary Therapies in Medicine, 2005; 13: 231-238.
65. Kainz J T, Kozel G, Haidvogl M, Smolle J.
Homoeopathic versus placebo therapy of children with warts on
the hands: a randomized, double-blind clinical trial. Dermatology,
1996; 193: 318-320.
66. Labrecque M, Audet D, Latulippe L G, Drouin
J. Homoeopathic treatment of plantar warts. Canadian Medical Association
Journal, 1992; 146: 1749-1753.
67. Linde K, Scholz M, Ramirez G, et al.
Impact of study quality on outcome in placebo controlled trials
of homeopathy. Journal of Clinical Epidemiology, 1999; 52: 631-636.)
68. Dean M E, Coulter M K, 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
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