Clinical effectiveness of homeopathy:
the evidence from published research
Homeopathy aids the body’s homeostatic processes in self-repair, and achieves this through the use of natural remedies which, at much higher concentrations, would cause similar symptoms in a healthy person. Its origins lie in early 19th century Germany, where Dr Samuel Hahnemann first noticed the principle in the treatment of malaria using Peruvian bark (quinine). He took some bark extract himself – even though he was not ill – and subsequently developed malaria-like symptoms. This observation led him to explore whether other medicines also produced a pattern of illness in healthy people that was similar to the pattern of illness that these medicines could treat in the sick. When he diluted and agitated (or ‘succussed’) such remedies, he observed greater and greater therapeutic results, and so the principle of ultradilution was also inspired.
We take the view that current effort should be concentrated not on how homeopathy works, but in identifying more evidence that it truly works – for there is little sense in seeking a mechanism of action for a therapy that has no properly established treatment effectiveness. In fact, homeopathy is a clinically effective treatment for an array of chronic and acute medical complaints. The evidence in support of this statement no longer lies merely in the personal experience of homeopathic practitioners and their satisfied patients, for a growing research base confirming the therapeutic effectiveness of homeopathy is now clearly discernable in the medical literature.
The aim of this review is to highlight those medical conditions for which the clinical effectiveness of homeopathy has been demonstrated in published research trials. It should be noted that, although the essential focus of the present analysis is founded on conventional medical diagnosis/prescribing, homeopathy usually aims to treat the totality of a patient’s medical condition, rather than a specific (single) morbidity. However, virtually all the existing research trials in homeopathy have adopted a standardised symptom-led approach that enables comparison with conventional medicine.
In 1997, The Lancet published a thorough meta-analysis which showed that, of 89 clinical trials, 44 reported homeopathy to be significantly more effective than placebo;1 none of the 89 trials found placebo to be more effective than homeopathy. Even accounting for any publication bias towards ‘positive’ trials, the authors came to the conclusion that clinical benefit from homeopathic therapy cannot be explained by the placebo effect alone. Similar general conclusions were drawn from other recent meta-analyses or systematic reviews of homeopathy.2–4 Further research is needed to identify, in particular, those medical conditions that respond most effectively to homeopathy.
In the past 4–5 years, a number of new reports have provided additional supportive research evidence in favour of homeopathy for a variety of clinical conditions – compared with placebo or compared with conventional medical therapy. Our analysis of the research evidence for homeopathy takes these recent reports fully into account. We have taken a deliberate decision in this review to concentrate mainly on those ailments for which there has been more than a single research report demonstrating a significant positive effect of homeopathy in at least one measured clinical outcome. We have focused our attention exclusively on original research articles that have been subjected to scientific peer-review.
This approach does not seek to mask the existence of ‘neutral’ trials (i.e. those that report no difference between homeopathy and any other treatment or placebo) or any ‘negative’ trials (homeopathy less effective than any other treatment or placebo). Rather, the aim here is to emphasise those medical conditions for which homeopathy has been objectively shown to be an effective therapy.
We have included mention of a number of medical conditions that also seem to respond well to homeopathy but for which there is more limited research evidence typically just one ‘positive’ published clinical trial for the given ailment. The existence of even a solitary positive trial is indicative of homeopathy’s therapeutic benefit, and infers the need to carry out further research in that particular area.
There is a third set of medical conditions where planned investigations suggest a good response to homeopathy, but for which only ‘neutral’ evidence exists in published trial/s together with positive clinical outcome reports published by the Tunbridge Wells Homoeopathic Hospital5 and/or the Liverpool Regional Department of Homoeopathic Medicine6 in the UK. And we have included a fourth category: clinical improvement reported in outcome evaluation studies only. Although there is a lack of proper research evidence for conditions in these third and fourth categories, such patients can experience real clinical improvement following homeopathic treatment. Preliminary information of this kind offers important targets for future research into the therapeutic effectiveness of homeopathy.
The medical conditions for which the published literature substantiates the clinical value of homeopathic treatment can thus be ranked in four categories: (1) Promising research evidence (more than one published clinical trials favouring homeopathy); (2) Indicative research evidence (one ‘positive’ published clinical trial only); (3) ‘Neutral’ research evidence and/or clinical improvement reported in outcome evaluation studies; (4) Clinical improvement reported in outcome evaluation studies …
· childhood diarrhoea11,12
· glue ear13–15
· hay fever / allergic rhinitis16–21
· muscle soreness24,25
· pain (miscellaneous)26–29
· radiotherapy (side effects)30,31
· rheumatoid arthritis32–34
· tissue trauma35,36
· upper respiratory tract infections.37–43
2) Indicative research evidence for homeopathy:
· attention-deficit hyperactivity disorder44
· insect-bite induced erythema46
· irritable bowel syndrome47
· pre-menstrual syndrome50
· allergic conjunctivitis52
· burns (minor)54
· childbirth (tissue recovery after)55
· chronic fatigue syndrome56
· female infertility57
· headache (non-migrainous)58
· leg ulcers59
· menopausal syndrome60
· Crohns disease5
· multiple sclerosis5
· ulcerative colitis5
This section comprises specific examples of ‘positive’ clinical trials for the 12 medical conditions in this category of research evidence for homeopathy.
Treatment of anxiety with a homeopathic remedy7
This trial examined the effect of a complex homeopathic remedy called ‘Anti-anxiety’ on four clinical outcome measures in a double-blind study format. The active ingredients of ‘Anti-Anxiety’ includes Ignatia, Asa foetida, and Valeriana officionalis.
72 adults with above average anxiety scores were randomly assigned to either ‘Anti-anxiety’ or a placebo for 15 days. Pre-test measures of resting pulse, lost sleep, state and trait anxiety, age and gender showed no significant differences between groups.
Post-test comparisons showed a significantly reduced amount of sleep loss favouring the ‘Anti-anxiety’ group (P<0.05). Mean sleep loss in the subjects who received ‘Anti-anxiety’ improved by 1.3 hours, whereas there was a mean improvement of only 0.5 hour in the placebo group. Supplementary analyses suggested that subjects were unable successfully to identify the group to which they had been assigned. It appears as though this homeopathic remedy can aid in reducing the sleep loss often associated with anxiety.
Homeopathic immunotherapy for the treatment of chronic asthma9
Subjects were chosen from people attending an asthma outpatient clinic. Their symptoms and compliance were monitored for a four-week run-in period and they were asked not to take any new allergen-avoidance measures during the trial. At the beginning of the run-in each patient was assessed by a homeopathic and an asthma clinic doctor. A nurse did skin tests and a respiratory physiologist measured pulmonary function and bronchial reactivity to histamine.
The study design was a randomized double-blind assessment of two parallel groups, one receiving homeopathic treatment and the other a placebo. Twenty-eight patients with allergic asthma, most of them sensitive to house-dust mite, were randomly allocated to receive either oral homeopathic immunotherapy to their principal allergen or an placebo of identical appearance. The homeopathic doctor selected the homeopathic prescription on the basis of the largest skin-test weal concordant with allergy history. The test treatments were given as a complement to patients' usual conventional care.
At the main end-point 4 weeks after the treatment began, patients were reassessed by both doctors, diaries were checked and pulmonary function tested. A difference in visual analogue score in favour of homeopathic immunotherapy appeared within one week of starting treatment and persisted for up to eight weeks (P=0.003). There were similar trends in respiratory function and bronchial reactivity tests.
Treatment of acute childhood diarrhoea11
Jacobs' work sets out to discover whether homeopathic treatment was useful in the treatment of acute diarrhoea in children, the leading cause of paediatric morbidity and mortality. This randomized double-blind trial took place in two clinics in poor districts of Nicaragua, a country 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 from one to four years.
The researchers thought that acute childhood diarrhoea was an ideal condition for a homeopathic study because the short duration of illness would allow for intensive follow up, there was no standard allopathic treatment that would have to be withheld during the trial, and the public health importance was great.
Eighty-one children aged between 6 months and 5 years took part. An initial history was taken for each child, a physical examination was carried out, a stool specimen obtained and a diarrhoea index score was assigned to each child. The children were then given a homeopathic interview and examination. Information about the nature of stools, abdominal pain, vomiting, mood and temperature, degree of thirst and appetite, presence of fever, abdominal bloating, sleep disturbance, perspiration and other signs and symptoms was collected. Each child was then prescribed one homeopathic medication on an individual basis. Identical tablets without medication were used as a placebo. Follow up was daily for five days.
The homeopathic treatment group had a statistically significant (P<0.05) decrease in duration of diarrhoea, defined as the number of days until there were less than three unformed stools daily for two consecutive days. There was also a significant difference (P<0.05) in the number of stools per day between the two groups after 72 hours of treatment.
A randomized comparison of homeopathic and standard care for the treatment of glue ear in children14
The authors’ objective in this randomized controlled trial was to pilot a model for determining whether homeopathic treatment of children suffering from glue ear is more effective than standard GP care at producing a return to normal hearing (a hearing loss of less than 20 dB) within 12 months. The setting for the study was General Practice in two locations in southern England.
The trial included thirty-three children aged 18 months to 8 years suffering from otitis media with effusion, hearing loss >20 dB and an abnormal tympanogram. The principal outcome measures were hearing loss, tympanogram, referrals to specialists and number of courses of antibiotics at 12 month follow-up.
More homeopathy patients than controls had a normal tympanogram (75 vs 31%, P=0.015). Referrals to specialists and antibiotic consumption were lower in the homoeopathy group, though differences between groups did not reach statistical significance. A higher proportion of children receiving homeopathic care had a hearing loss less than 20 dB at follow-up (64 vs 56%), though this difference did not reach statistical significance.
The authors conclude that further research comparing homeopathy to standard care is warranted. Assuming recovery rates of 50 and 30% in homeopathy and standard care groups respectively, 270 patients would be needed for a definitive trial. This is probably typical of the number of patients required for the conduct of homeopathy trials of adequate power to detect an actual treatment effect for many medical conditions.
Homeopathy versus placebo in perennial allergic rhinitis20
The study was a randomized controlled trial of 51 patients in five centres in London (four GP practices and one hospital outpatients clinic) with perennial allergic rhinitis. All patients were given a placebo remedy at the start of the trial when the diagnosis of the indicated allergen was made. The patients were then randomly assigned to an oral 30c homeopathic preparation of the principal inhalant allergen or to placebo. 27 patients were given the placebo remedy and 24 verum (homeopathic remedy).
Patients’ nasal inspiratory peak flow measurements were taken by the doctor on the initial consultation and on the third and fourth week after randomisation. Patients were also asked to record the level of symptoms using a visual analogue scale on a daily basis during the trial period.
After four weeks, the homeopathy group had a significant improvement in nasal airflow compared with the placebo group (mean difference 19.8 1/min; 95% confidence interval 10.429.1; P=0.0001). Both groups reported improvement in symptoms, with patients taking homeopathy reporting more improvement in all but one of the centres. On average, no significant difference between the groups was seen on visual analogue scales. Interestingly, initial aggravations of rhinitis symptoms were more common with homeopathy than with placebo (30% vs 7%; P=0.04).
This trial is important as it objectively reinforces earlier evidence that specific effects of homeopathy can be observed above those of placebo.
Treatment of influenza-like syndromes22
This placebo-controlled trial looked at the effectiveness of a homeopathic preparation in the treatment of influenza and influenza-like syndromes. The researchers recognised that, while a regular feature of homeopathic treatment is that two patients who have the same disease are liable not to benefit from the same remedy, there are certain diseases especially some acute conditions that can be treated with a remedy or remedy-mixtures tailored to the disease characteristics alone. OscillococcinumR – made of Anas Barbariae Hepatis and Cordis Extractum – is one such remedy.
The study took place during an influenza epidemic. Patients who took part in the study were chosen from those attending GP surgeries with influenza-like syndromes, defined as a rectal temperature equal to or above 38°C or above and at least two of the following cardinal symptoms: headache, stiffness, lumbar and articular pain, shivers. Most of the participating GPs were not homeopathic clinicians.
The first of five doses of OscillococcinumR was given at the medical practice, and the patients took the remaining four on the subsequent mornings and evenings. 237 patients received the test drug and 241 the placebo. Rectal temperature was recorded twice a day, as well as the presence or absence of cardinal symptoms, plus cough, coryza and fatigue. Recovery was defined as a rectal temperature of less than 37.5°C and complete resolution of the cardinal symptoms.
The proportion of patients who recovered within 48 hours of treatment was significantly greater amongst those receiving homeopathy (17.1%) than in those belonging to the placebo group (10.3%; P=0.03).
Effects of homoeopathic Arnica on runners during the 1995 Oslo Marathon24
The objective of this randomized, double-blind placebo-controlled trial was to examine whether the homoeopathic remedy Arnica D30 has an effect on cell damage and muscle soreness after long-distance running. Five pills of Arnica D30 or placebo were given morning and evening. Treatment started the evening before the marathon, continued the running day and for three days following. Runners assessed the sense of muscle soreness on a visual analogue scale (VAS). Measurement of cell damage was assessed by serological enzyme tests.
Muscle soreness was significantly lower in the Arnica group than in the placebo group immediately after the marathon (P=0.017). Cell damage measured by enzymes was essentially the same whether the runners were treated with Arnica D30 or placebo. Conclusions: In this study Arnica D30 had a positive effect on muscle soreness after marathon running, but not on cell damage as measured by enzymes.
The efficacy and safety of a homeopathic gel in the treatment of acute low back pain26
In most cases of acute low back pain, analgesics or topical medications are prescribed at first encounter with the GP. The aim of this study was to investigate whether the homeopathic gel Spiroflor SRL gel (SRL) is equally effective and better tolerated than Cremor Capsici Compositus FNA (CCC) in patients with acute low back pain.
A multi-centre, randomised, double-blind, controlled clinical trial was conducted in the practices of 19 GPs in the districts of Bristol and Manchester, UK. One hundred and sixty-one subjects suffering from acute low back pain were treated for one week either with SRL or with CCC. Pain was scored on a 100 mm visual analogue scale (VAS). Main efficacy parameter VAS reduction was compared between treatments. Evaluation of safety was primarily based on the number of subjects with adverse events (AEs), withdrawals due to an AE and adverse drug reactions (ADRs).
The mean difference between the VAS reduction in the SRL group and the CCC group (adjusted for VAS at baseline and age) was –0.6mm (90% CI = –6.5mm – 5.3mm). Fewer subjects in the SRL group (11%) experienced an AE than in the CCC group (26%). The same applies to the number of subjects with an ADR (4% vs 24%) and to the number of subjects withdrawn due to an ADR (0% vs 11%).
It was concluded that SRL and CCC were equally effective in the treatment of acute low back pain. Importantly, however, SRL had a better safety profile. Spiroflor SRL gel is preferable to Capsicum-based products for the topical treatment of low back pain, because of the lower risk of adverse effects.
Randomised, double-blind clinical trial of homeopathic treatment of skin reactions during radiotherapy for breast cancer30
The aim of this study was to assess the effects of Belladonna 7cH and X-ray 15cH associated with the treatment of acute radio-dermatitis. A randomised double-blind placebo-controlled clinical trial was conducted on 66 patients who had been operated on for breast cancer and were undergoing radiotherapy. The following parameters were assessed over 10 weeks: breast skin colour, warmth, swelling and pigmentation. The efficacy of the treatment was assessed by the comparison of these parameters taken individually and by calculating an Index of Total Severity (sum of the scores of the four parameters) during radiotherapy, and during recovery, 15 and 30 days after the end of the radiotherapy.
The differences in the scores of the Index of Total Severity during radiotherapy showed a trend towards a better activity of the homoeopathic medicine compared to placebo. Analysis of the data on Total Severity during recovery showed a statistically significant benefit of the active medicines over placebo. The homeopathic medicines had particular effectiveness on the heat of the skin.
Double-blind randomized study of homeopathy for rheumatoid arthritis33
Six general practitioners treated 111 patients with rheumatoid arthritis with the complex homeopathic preparation ‘Rheumaselect’ or placebo over 12 weeks in a randomized, double blind, controlled trial.
Outcome criteria were: pain at night; resting; movement; inflammatory signs; morning stiffness; fatigue; patient's assessment of pain; functional index; and the overall assessment of the therapy by the treating physician and by the patient.
A ‘remarkable’ improvement in these criteria was found in both groups, but the improvement was more marked with the homeopathic remedy than with placebo.
Importantly, the consumption of anti-rheumatic and analgesic drugs and the assessment of pain by the patient were combined into a single outcome variable for statistical analysis. The result was a significant effectiveness of the homeopathic remedy compared with placebo.
Homeopathic treatment of mild traumatic brain injury35
No effective, standard pharmacological treatment exists specifically for mild traumatic brain injury (MTBI). The authors designed a pilot research project to study the clinical effectiveness of homeopathic medicine in the treatment of persistent MTBI. A randomized, double-blind, placebo-controlled trial was conducted on 60 patients, with a 4-month follow-up (N=50), at Spaulding Rehabilitation Hospital (SRH), Massachusetts USA.
Patients with persistent MTBI (mean 2.93 years since injury) were randomly assigned to receive a homeopathic medicine or placebo. The primary outcome measure was the subject-rated SRH-MTBI Functional Assessment, composed of three sub-tests: a Difficulty with Situations Scale (DSS), a Symptom Rating Scale (SRS), and a Participation in Daily Activities Scale (PDAS). The SRH Cognitive-Linguistic Test Battery was used as the secondary measure.
Analysis of covariance demonstrated that the homeopathic treatment was the only significant or near-significant predictor of improvement on DSS subtests (P=0.009), SRS (P=0.058) and the Ten Most Common Symptoms of MTBI (P=0.027). These results indicate a significant improvement from the homeopathic treatment versus the control and translate into clinically significant outcomes.
This study suggests that homeopathy may have a role in treating persistent MTBI. Like most studies in clinical homeopathy, the findings require large-scale, independent replication.
Treatment of children with recurrent upper respiratory tract infections37
This study investigated the intrinsic effects of individually prescribed homeopathic medicines in a randomized double-blind placebo controlled protocol. 170 children with frequently recurring upper respiratory tract infections were randomized to homoeopathic medicines (47 boys, 39 girls; median age at start 4.2 years; median number of episodes in past year 4) and to placebo (43 boys, 41 girls; median age at start 3.6 years; median number of episodes in past year 4). Measurements included: mean score for daily symptoms; number of antibiotic courses; number of adenoidectomies and tonsillectomies over one year of follow up.
The mean daily symptom score was 2.21 in the treatment group compared with 2.61 in the placebo group (difference 0.41; 95% confidence interval –0.02 to 0.83). This represents evidence of a difference between the groups, at a level only just greater than 5% significance.
In both groups, the use of antibiotics was greatly reduced compared with that in the year before entering the trial. The proportion of children in the treatment group having adenoidectomies was somewhat lower in the treatment group (16%, 8/50) than in the placebo group (21%, 9/42). The proportion having tonsillectomies was the same in both groups (5%).
Interestingly, the authors concluded that individually prescribed homeopathic medicines may add little to careful counselling of children with recurrent upper respiratory tract infection in reducing the daily burden of symptoms, use of antibiotics, and need for adenoidectomy and tonsillectomy. Given the trial’s results for daily symptom score, however, there is reason to propose a more positive conclusion regarding the impact of homeopathy on these children’s recovery from illness.
The above are robust clinical trials in homeopathy. What is desirable now is that further high quality studies be conducted on these medical conditions and by more groups of researchers – so that evidence might become more secure.
Close attention should also be paid by researchers to those clinical conditions that appear within the second, third and fourth categories of evidence. These are the categories of conditions where positive evidence is beginning to emerge but, as yet, it is too early to draw definitive conclusions. Nevertheless, a lack of secure evidence of effectiveness should not be interpreted as evidence of lack of effectiveness. Rather, single positive trials or clinical outcome evaluations should give direction to further research in these areas. Moreover, alternative research designs, such as equivalence trials, should be increasingly considered as a means of examining the relative safety and cost-effectiveness of homeopathy compared with conventional medications of similar clinical effectiveness.
Given the wide-ranging clinical benefits that homeopathy brings, there might be many more medical conditions – not presently listed in any category of evidence that can become included in a future list of those confirmed by research to be effectively treated by homeopathy.
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