THE PLACE OF HOMEOPATHY IN CLINICAL CARE
i. Shortcomings of RCT’s (randomized controlled trials)
ii. Systematic review nullifying the hypothesis that homeopathy does not have an effect superior to that of other active treatment
iii. Randomized controlled trials showing positive effect of homeopathy
iv. Non-exclusionary guidelines for conditions in which homeopathy may be used
Shortcomings of RCT’s
Meta-analyses of randomized clinical trials analyse end-points and are dependent on the quality of research of the individual randomized controlled trials which are included in the metanalysis. In the previous section which highlighted the meta-analyses that have shown that homeopathy has an effect greater than that of placebo, less than half of the RCT’s were considered by the authors of these reviews to be of superior research quality. The other RCT’s may have been flawed in their design, for example studying homeopathic medicines in situations in which they would not be used, such as bruising after carpal tunnel surgery (bruising is an infrequent complication after this procedure due to use of tourniquets intra-operatively) or using end-points which are inappropriate (for example measuring the effect of homeopathy in asthma compared to a group of control-patients in whom lung function was minimally impaired: you cannot improve patients beyond normal!), or have insufficient numbers of patients for meaningful statistical analysis. This last obstacle may be overcome by the methodology used in the meta-analysis, but other weaknesses in study design remain as flaws.
Other evidence may also be used to ‘make the case’ for homeopathy, such as systematic reviews, or case series, or case studies.
Systematic review nullifying the hypothesis that homeopathy does not have an effect superior to that of other active treatment
A fresh approach to the homeopathic database was taken by Dr. Robert Mathie, research consultant to the U.K. Faculty of Homeopathy, who conducted a systematic review of the homeopathic literature, which was published in the peer-reviewed journal, Homeopathy, in 200310. Dr. Mathie set out to examine the novel hypothesis that homeopathic treatment does not have an effect superior to that of other active treatment. His findings nullified this hypothesis.
Dr. Mathie defined four levels of strength of evidence in the trials that he reviewed:
i. Multiple trials that showed a positive outcome
ii. Single trials, of good design, that showed a positive outcome
iii. Single trials of poor design that showed a positive outcome
iv. Trials reflecting consensual / experiential validation
He concluded that the present weight of evidence favours homeopathic treatment effectiveness in eight conditions:
1. Childhood diarrhea
2. Fibrositis (fibromyalgia)
3. Hayfever / allergic rhinitis
5. Pain (of various origins)
6. Side-effects of radio-/chemotherapy
8. Upper respiratory tract infection
This remarkable paper demonstrates clinical effectiveness of homeopathy in the above conditions.
Randomised Clinical Trials showing positive effect of homeopathy
There is an ever-growing database of randomized controlled trials highlighting the effectiveness of homeopathy in various clinical situations. The following selection includes studies in infants, women in labour and brain-injured people, who are less susceptible to the power of suggestion, which is part of the placebo effect. This selection also includes studies in which there are objectively measured end-points, such as sperm count or pain-points, grip strength and mobility, demonstrating that homeopathy is not ‘all in the mind’.
Dr. Jennifer Jacobs, M.D. Ph.D., studied children with acute diarrhoea in Nicaragua, where diarrhoea is the primary cause of mortality during the first year of life and accounts for 19% of all outpatient consultations in children aged 1-4 years. Her study, published in the prestigious medical journal, Paediatrics, showed a statistical difference in favour of children treated with homeopathy: they recovered faster, at less cost to the health system 11.
This is of particular relevance to South Africa, where child-hood diarrhoea is a significant drain on scarce resources.
Dr. K. Friese and colleagues published their results of a prospective trial on children with acute middle ear infection in Biomedical Therapy, in 1997. They showed that the homeopathically treated children became pain-free in a shorter time period than those treated conventionally and had a lower rate of recurrence of infection 12.
A group of Swiss physicians looked at whether homeopathic treatment of acute otitis media could be demonstrated not to be due to spontaneous resolution, which happens frequently in acute otitis media, whether treated with antibiotics or not. The authors found that pain control was achieved in 39% of patients treated homeopathically within 6 hours of onset of treatment and another 33% after 12 hours. This rate of resolution was 3.4 times faster than placebo controls 13.
Dr. Chapman M.D., published a pilot study of 60 patients with mild traumatic brain dysfunction conducted in Boston, which showed a significant improvement from homeopathic treatment versus the control 14.
Duration of labour
A homeopathic medicine, Caulophyllum 7C, has been shown in double-blind trials to reduce the duration of labour, defined as period of cervical dilatation 15.
A study published in the ENT-specialists journal, the Archives of Otolaryngology 16, showed the homeopathic preparation, Vertigoheel® to be as effective as betahistine, a pharmaceutic preparation, in significantly reducing frequency and severity of vertigo .
Dr. Gibson compared a group of patients with rheumatoid arthritis treated with homeopathy to those only on conventional pharmaceuticals 17. The objective tests, for example grip strength and articular mobility were more improved in the homeopathic group. 42% of these patients were able to cease taking their pharmaceutical agents within one year of taking part in the study.
An additional two points were of interest in this study: objective tests were carried out to measure effectiveness, it was not just subjective and also it shows that homeopathic medicines often work for a long time.
Dr. Brigo found that homeopathically-treated patients with migraines showed significant improvement in frequency, intensity and characteristics of pain 18.
Note that whilst conventional medicine has some powerful drugs to squash acute migraine attacks, it is not as effective in decreasing the frequency or intensity of recurrent attacks.
Dr. Ferley looked at the treatment of influenza with a single homeopathic medicine and found that a statistically significant greater number of homeopathically-treated patients got better (and faster), than those treated with conventional medicines 19.
A group of Swiss paediatricians compared the efficacy of homeopathic treatment of ADHD children 20 with that of children treated with methylphenidate (Ritalin).
* 75% of the children treated with homeopathy reached a clinical improvement rating of 73% versus 65% of children treated with methylphenidate.
* In only 22% of the children in whom initial treatment with homeopathy did not reach required levels of improvement was it deemed necessary to transfer them onto methylphenidate.
A clinical outcomes-based study showed that individualized homeopathy improved sperm count in men with infertility problems 21.
A noted skeptic of homeopathic scientific validity, Professor E. Ernst of the Complementary Medicine department of the Postgraduate Medical School, University of Exeter, U.K., performed a meta-analysis of
clinical trials using homeopathy for post-operative ileus 22. His conclusion, published in the peer-reviewed Journal of Clinical Gastroenterology in 1997:
“There is evidence that homeopathic treatment can reduce the duration of ileus after abdominal or gynecologic surgery”.
It is note-worthy that a published skeptic (regarding homeopathy vis á vis placebo) would reach such a conclusion.
Topical treatment of osteoarthritis
Homeopathy can also be effective when used locally. Dr. P.A. Fisher of the Royal London Homeopathic Hospital, homeopathic physician to H.R.H. Queen Elizabeth, found that a homeopathic gel used to treat osteo-arthritis of the knee was at least as effective and as well tolerated as an anti-inflammatory gel, in a comparative study published in 2000 in the British Society for Rheumatology’s journal, Rheumatology23.
A study conducted by the Department of Psychiatry at the University of Tucson, USA, published in Rheumatology in 200424, assessed the efficacy of individualized classical homeopathy in the treatment of fibromyalgia. This was a double-blind, randomized, parallel-group, placebo-controlled trial in which 62 persons with physician-confirmed fibromyalgia were allocated ‘LM’ homeopathic medicines, or indistinguishable placebo in consultation with two experienced homeopaths. The primary clinical outcomes were tender point count and tender point pain on examination by a medical assessor uninvolved in providing care, as well as self-rating scales on quality-of-life, pain, mood and global health. 43 people completed the protocol. Participants on active treatment showed significantly greater improvements in tender point count and tender point pain, quality of life, global health, and a trend towards less depression, compared to those on placebo.
Guidelines for conditions in which homeopathy may be used
The U.K. Faculty has published the following (non-exclusionary) guide-lines for conditions in which homeopathy may be used.
I: No effective allopathic treatment
This is an important group of conditions in which allopathic medicine is relatively ineffective and homeopathy offers a good alternative.
• Allergies • Anal fissures • Chilblains
• Anger • Bruises • Colic
• Fear/phobias • Glandular fever • Grief
• Intermittent claudication • Impotence • Mastalgia
• Chronic Fatigue Syndrome • Nightmares/terrors • Warts
• Pre-menstrual syndrome • Teething • Urethral syndrome
II: Unsafe situation for allopathy
• Pregnant women • The elderly • Young children • Anticipatory anxiety
III: Complementary: reduce long-term allopathic treatment
• Neuralgias • Menopause • Dysmenorrhoea • Asthma
• AD/HD • Migraine • Otitis media • Constipation
• Eczema • Convulsions
IV: Complementary: reduce symptoms / improve well-being
• Malignancy • Multiple sclerosis • Parkinson’s disease
It is emphasized that these guide-lines are merely that: homeopathy may be used in almost every clinical condition, often alone. No system of medicine can claim to be complete. Whilst this assuredly applies to modern ‘conventional’ medicine, as the search for additional methods of treatment by doctors and their patient’s attests, this also applies to homeopathy, which may then be usefully employed alongside whatever other modality of treatment is being used.
10. Mathie R.T. The research evidence base for homeopathy: a fresh assessment of the literature Homeopathy 2003 92:84-91
11. Jacobs, J. et al. Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics 1998 93(5):719-725.
12. Friese K.H.Y. et.al. Acute otitis media in children: a comparison of conventional and homeopathic treatment. Biomedical Therapy 1997 15:113-122
13. Frei H., Thurneysen A. homeopathy in acute otitis media in children: treatment effect or spontaneous resolution? Br Homeopath J 2001 90(4):180-2
14. Chapman E.H. et.al. Homeopathic treatment of mild traumatic brain injury: A randomized, double-blind, placebo-controlled clinical trial. J. Head Trauma Rehabil 1999. 14(6) 521-542
15. Eid P. Applicability of homoeopathic caulophyllum during labour. Brit. Hom. J. 1993 82 245.
16. Weiser, M. et al. Treatment of vertigo: a randomized double-blind controlled study. Archives of Otolaryngology – Head and Neck surgery. 1998. 124:8. 879-885.
17. Gibson R.G. Homeopathic Therapy in Rheumatoid Arthritis: Evaluation by Double-Blind Clinical Therapeutic Trial Br. J. Clin. Pharm. 1960. 9. 453-459
18. Brigo B. et al Homeopathic treatment of migraines. Berlin J. Res. Homeopathy 1991. 1(2): 98
19. Ferley J.P. et al Controlled evaluation of a homeopathic preparation in the treatment of influenza-like syndrome Br. J. Clin. Pharm. 1989. 3: 329-325
20. Frei H., Thurneysen A. Treatment for hyperactive children: homeopathy and methylphenidate compared in a family setting Br Hom J 2001 90(4):183-8
21. Gerhard I., Wallis E. Individualized homeopathic therapy for male infertility Homeopathy 2002 91:133-144
22. Barnes J. et al Homeopathy for post-operative ileus? A meta-analysis. J Clin Gastroenterol 1997 25(4):628-33
23. Van Haselen R.A. and Fisher P.A. A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee. Rheumatology 2000 39:714-719
24. Bell I.R. et al Improved clinical status in fibromyalgia patients treated with individualised homeopathic remedies versus placebo Rheumatology 2004 43(5): 577-82