Clinical trials are experiments carried out on patients to compare the effects of two or more treatments under highly controlled conditions. One type of clinical trial – the randomised controlled trial (RCT) is considered by many scientists to be the ‘gold standard’ of research methods for determining whether medical treatments are effective. RCTs have been used to investigate various different aspects of homeopathy, such as how homeopathic medicines compare with placebo an inactive 'dummy' medicine or treatment and how effective homeopathic treatment is for specific conditions. Systematic reviews a summary of the total research evidence available on a particular subject, designed to provide more accurate information than single studies have also been carried out to draw firmer conclusions.
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Summary of randomised controlled trials
Evidence for specific conditions
Comparing homeopathy and conventional medicine
Systematic reviews
Summary of randomised controlled trials
By the end of 2009, 142 RCTs of homeopathy had been published in peer-reviewed process by which articles are selected for publication in academic journals by a panel of experts journals. In terms of statistically significant results, 74 of these trials were able to draw firm conclusions:
The fact that the remaining 68 trials were inconclusive highlights the need for changes in the way homeopathy research is conducted in future to generate meaningful results. Two key factors are the need for larger scale trials (commonly prevented by a lack of funding) and the use of more appropriate research methods such as pragmatic trials a study designed to test how effective a medical treatment is when given under 'real life' clinical conditions, which are better-suited to the task of testing a complex individualised therapy such as homeopathy.
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Evidence for specific conditions
There is sufficient research evidence being defined as one or more positive systematic reviews, two or more positive RCTs or one un-refuted positive RCT to support the use of homeopathic treatment for the following medical conditions:[1] 1. Mathie, R. The Research Evidence Base for Homeopathy. British Homeopathic Association, 2009.
www.britishhomeopathic.org
Click on a condition to find out more...
Allergies and upper respiratory tract infections Evidence: Systematic review Bornhoft G, Wolf U, Ammon K, et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice - summarized health technology assessment. Forsch Komplementarmed 2006; 13 (2): 19-29 Evidence: One un-refuted RCT
Zell J, Connert WD, Mau J, Feuerstake G. Treatment of acute sprains of the ankle. Controlled double-blind trial to test the effectiveness of a homeopathic ointment. Fortschr Med 1988; 106: 96-100 Evidence: Systematic review
Barnes J, Resch K-L, Ernst E. Homeopathy for postoperative ileus? A meta-analysis. J Clin Gastroenterol 1997; 25: 628-33 Evidence: One un-refuted RCT
Diefenbach M, Schilken J, Steiner G, Becker HJ. Homeopathic therapy in respiratory tract diseases. Evaluation of a clinical study in 258 patients. Z Allgemeinmed 1997; 73: 308-14 Evidence: Systematic review
Jacobs J, Jonas WB, Jimenez-Perez M, Crothers D. Homeopathy for childhood diarrhea: combined results and metaanalysis from three randomized, controlled clinical trials. Pediatr Infect Dis J 2003; 22: 229-34 Evidence: One un-refuted RCT
Weatherley-Jones E, Nicholl JP, Thomas KJ, et al. A randomized, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. J Psychosom Res 2004; 56: 189-97 Evidence: One un-refuted RCT
Jacobs J, Springer DA, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001; 20: 177-83 Evidence: Two or more RCTs
Fisher P. An experimental double-blind clinical trial method in homoeopathy. Use of a limited range of remedies to treat fibrositis. BrHomeopath J 1986; 75: 142-7
Bell I, Lewis D, Brooks A, et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology 2004; 43: 577-82
Relton C, Smith C, Raw J, Walters C, Adebajo AO, Thomas KJ. Healthcare provided by a homeopath as an adjunct to usual care for Fibromyalgia (FMS): results of a pilot Randomised Controlled Trial. Homeopathy, 2009; 98: 77-82. Evidence: Systematic reviews
Wiesenauer M, Ludtke R. A meta-analysis of the homeopathic treatment of pollinosis with Galphimia glauca. Forsch Komplementarmed Klass Naturheilkd 1996; 3: 230-6
Taylor MA, Reilly D, Llewellyn-Jones RH, et al. Randomised controlled trials of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. Br Med J 2000; 321: 471-6
Bellavite P, Ortolani R, Pontarollo F, et al. Immunology and homeopathy. 4. Clinical studies - Part 2. eCAM 2006; 3: 397-409. Evidence: Systematic review
Vickers A, Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes (Cochrane Review). In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd. 2006 Evidence: Two or more RCTs
Shealy CN, Thomlinson RP, Cox RH, Borgmeyer RN. Osteoarthritic pain: a comparison of homeopathy and acetaminophen. Am J Pain Manage 1998; 8: 89-91
van Haselen RA, Fisher PAG. A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee. Rheumatology 2000; 39: 714-9 Evidence: One un-refuted RCT
Yakir M, Kreitler S, Brzezinski A, et al. Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study. Br Homeopath J 2001; 90: 148-53 Evidence: Systematic review
Jonas WB, Linde K, Ramirez G. Homeopathy and rheumatic disease - Complementary and alternative therapies for rheumatic diseases II. Rheum Dis Clin North Am 2000; 26: 117-23 Evidence: Two or more RCTs
Friese K-H, Zabalotnyi DI. Homeopathy in acute rhinosinusitis. A double-blind, placebo controlled study shows the effectiveness and tolerability of a homeopathic combination remedy. HNO 2007; 55: 271-7
Zabolotnyi DI, Kneis KC, Richardson A, et al. Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, doubleblind, placebo-controlled, multicenter clinical trial. Explore (NY) 2007; 3: 98-109 Evidence: Systematic review
Schneider B, Klein P, Weiser M. Treatment of vertigo with a homeopathic complex remedy compared with usual treatments: a meta-analysis of clinical trials. Arzneimittelforschung 2005; 55: 23-9
Ankle sprain
Bowel inactivity after surgery (post-operative ileus)
Bronchitis
Childhood diarrhoea
Chronic Fatigue
Ear infections (acute otitis media)
Fibromyalgia
Hay fever (seasonal allergic rhinitis)
Influenza treatment
Osteoarthritis
Premenstrual syndrome
Rheumatic diseases
Sinusitis
Vertigo
| As homeopaths treat the whole person rather than individual diseases, it can appear contradictory to have research trials testing homeopathic treatment of specific medical conditions, but there are good reasons why researchers work through this apparent clash of philosophies to contribute to the evidence base for homeopathy. |
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Find out more... Holistic medicine versus disease labels - a clash of philosophies?
Homeopathy is a holistic therapy, treating the person as a whole rather than treating specific diseases. This is one of the main differences between homeopathy and conventional medicine. For example, if you are suffering from anxiety, arthritis and a skin condition the conventional route might involve entirely separate courses of treatment from a psychologist, rheumatologist and dermatologist; by contrast a homeopath would consider all of these mental-emotional and physical symptoms to be linked and therefore treat them as a whole.
However, even in complicated cases such as this where there are multiple health problems the person will usually ask the homeopath for help with one particular condition which is bothering them the most. This 'presenting complaint' or 'chief complaint' identified at the first appointment can be used to allocate someone to a clinical trial investigating homeopathic treatment of that condition.
There are three main reasons why homeopathy researchers are gathering evidence from trials assessing how effective homeopathic treatment is for specific diseases:
1. Patients considering seeing a homeopath often ask whether homeopathy can help with their chief complaint
2. When another medical professional refers a patient to a homeopath they may want to know what track record the therapy has in treating that specific disease
3. The NHS provides the majority of medical services according to disease categories so for homeopathy to be included in the range of services offered - e.g. in a rheumatology department - research needs to demonstrate that homeopathic treatment is effective in treating fibromyalgia, osteoarthritis etc.
Research in homeopathy is a wide field and this is just one of many different avenues being pursued by researchers world-wide to build on the evidence base for homeopathy.
For more examples of positive trials please see the Research Downloads page.
| Comparing homeopathy and conventional medicine Research studies comparing homeopathic treatment and conventional care have generated some interesting results; for example it has been found that, |
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This study published in the International Journal of Clinical Pharmacology and Therapeutics concluded that homeopathy should be the first line treatment for acute ear infections in children. The group of 103 children who received individualised homeopathic treatment had faster pain relief during the initial infection and fewer ear infections over the following year, compared with the children who received conventional treatment.
In a prospective observational study carried out by 1 homoeopathic and 4 conventional ENT practitioners, the 2 methods of treating acute pediatric otitis media were compared. Group A received treatment with homoeopathic single remedies (Aconitum napellus, Apis mellifica, Belladonna, Capsicum, Chamomilla, Kalium bichromicum, Lachesis, Lycopodium, Mercurius solubilis, Okoubaka, Pulsatilla, Silicea), whereas group B received nasal drops, antibiotics, secretolytics and/or antipyretics. The main outcome measures were duration of pain, duration of fever, and the number of recurrences after 1 year, whereby alpha < 0.05 was taken as significance level. The secondary measures were improvement after 3 hours, results of audiometry and tympanometry, and necessity for additional therapy. These parameters were only considered descriptively. The study involved 103 children in group A and 28 children in group B, aged between 6 months and 11 years in both groups. For duration of pain, the median was 2 days in group A and 3 days in group B. For duration of therapy, the median was 4 days in group A and 10 days in group B: this is due to the fact that antibiotics are usually administered over a period of 8-10 days, whereas homoeopathics can be discontinued at an earlier stage once healing has started. Of the children treated, 70.7% were free of recurrence within a year in group A and 29.3% were found to have a maximum of 3 recurrences. In group B, 56.5% were free of recurrence, and 43.5% had a maximum of 6 recurrences. Out of the 103 children in group A, 5 subsequently received antibiotics, though homoeopathic treatment was carried through to the healing stage in the remaining 98. No permanent sequels were observed in either group.
Friese K-H, et al. Homeopathic treatment of otitis media in children: comparisons with conventional therapy. Int J Clin Pharmacol Ther, 1997; 35: 296-301
In this double-blind* trial 65 sufferers of Osteoarthritis (OA) were split into 2 groups were given either a homoeopathic medicine or Acetaminophen, a commonly prescribed drug for pain relief in OA. Researchers found that homoeopathy provided a level of pain relief that was superior to Acetaminophen, and produced no adverse reactions.
* To minimise bias, neither the researchers nor the participants knew what treatment each person was given
This double-blind* randomised controlled trial carried out in Brazil involved 91 patients - half received fluoxetine and half received individualised treatment by a homeopath.
* To minimise bias, neither the researchers nor the participants knew what treatment each person was given
Homeopathy is a complementary and integrative medicine used in depression. The aim of this study is to investigate the non-inferiority and tolerability of individualized homeopathic medicines [Quinquagintamillesmial (Q-potencies)] in acute depression, using fluoxetine as active control. Ninety-one outpatients with moderate to severe depression were assigned to receive an individualized homeopathic medicine or fluoxetine 20 mg day-1 (up to 40 mg day-1) in a prospective, randomized, double-blind double-dummy 8-week, single-center trial. Primary efficacy measure was the analysis of the mean change in the Montgomery & Asberg Depression Rating Scale (MADRS) depression scores, using a non-inferiority test with margin of 1.45. Secondary efficacy outcomes were response and remission rates. Tolerability was assessed with the side effect rating scale of the Scandinavian Society of Psychopharmacology. Mean MADRS scores differences were not significant at the 4th (P = 0.654) and 8th weeks (P = 0.965) of treatment. Non-inferiority of homeopathy was indicated because the upper limit of the confidence interval (CI) for mean difference in MADRS change was less than the non-inferiority margin: mean differences (homeopathy-fluoxetine) were -3.04 (95% CI -6.95, 0.86) and -2.4 (95% CI -6.05, 0.77) at 4th and 8th week, respectively. There were no significant differences between the percentages of response or remission rates in both groups. Tolerability: there were no significant differences between the side effects rates, although a higher percentage of patients treated with fluoxetine reported troublesome side effects and there was a trend toward greater treatment interruption for adverse effects in the fluoxetine group. This study illustrates the feasibility of randomized controlled double-blind trials of homeopathy in depression and indicates the non-inferiority of individualized homeopathic Q-potencies as compared to fluoxetine in acute treatment of outpatients with moderate to severe depression.
Adler UC, et al. Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate to Severe Depression: Double-blind, Randomized Non-inferiority Trial. eCAM, 2009
Systematic reviews
A systematic review is a summary of the total research evidence available on a particular subject, designed to provide more reliable information than single studies. Specific methods are used to search academic journals and identify which studies are suitable for inclusion in the review (e.g. those of suitably high quality). From these identified trials a smaller number may be found suitable to go into a meta-analysis A statistical technique used to analyse the combined results of multiple studies to generate a more meaningful overall result.
Five major systematic reviews have been carried out to analyse the balance of evidence from RCTs of homeopathy – four were positive and one was negative:
Conclusion: Homeopathy is more effective than placebo "The evidence presented in this review would probably be sufficient for establishing homoeopathy as a regular treatment for certain indications. There is no reason to believe that the influence of publication bias, data massage, bad methodology, and so on is much less in conventional medicine, and the financial interests for regular pharmaceutical companies are many times greater."
Kleijnen et al. 1991 105 trials identified; results based on 105 trials.[5] 5. Kleijnen J, et al. Clinical trials of homeopathy. Br Med J, 1991; 302: 316-23
Authors' Comments
Linde et al. 1997 186 trials identified; results based on 89 trials.[6] 6. Linde K, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet, 1997; 350: 834-43 "The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition."
Authors' Comments
Linde et al. 1999 Re-analysis of same data but low quality trials excluded. Smaller but still significant difference found between homeopathy and placebo.[7] 7. Linde K, et al. Impact of study quality on outcome in placebo controlled trials of homeopathy. J Clin Epidemiol, 1999; 52: 631-6 "We conclude that in the study set investigated, there was clear evidence that studies with better methodological quality tended to yield less positive results."
Authors' Comments
Cucherat et al. 2000 118 trials identified; results based on 16 trials.[8] 8. Cucherat M, et al. Evidence of clinical efficacy of homeopathy - A meta-analysis of clinical trials. Eur J Clin Pharmacol, 2000; 56: 27-33 "There is some evidence that homeopathic treatments are more effective than placebo; however, the strength of this evidence is low because of the low methodological quality of the trials."
Authors' Comments
Conclusion: Homeopathy is no more effective than placebo "Biases are present in placebo-controlled trials of both homoeopathy and conventional medicine. When account was taken for these biases in the analysis, there was weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects."
Shang et al. 2005
110 homeopathy trials identified; results based on 8 trials.
110 conventional medicine trials identified; results based on 6 trials.[9] 9. Shang A, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet, 2005; 366: 726-32
Authors' Comments
Common findings throughout these studies included problems with variable trial quality, variable trial design, publication bias Tendency for studies with a positive result to be published more readily than those which are negative or inconclusive. and the small number of studies available in total. Despite these limitations, four of the five reviews found that even high quality trials produced positive results in favour of homeopathy. The authors called for more research with a focus on the role of homeopathy in the treatment of specific disease conditions and an emphasis on larger, high quality studies.
The most recent review by the Swiss team of Shang et al. was published in the Lancet alongside an editorial entitled The End of Homeopathy. This understandably sparked an intense media debate. The study now lacks credibility since scientists worldwide have drawn attention to serious flaws in how the study was conducted and how the results were presented.[10] 10. Bell, I. All Evidence is Equal, but Some Evidence is More Equal than Others: Can Logic Prevail over Emotion in the Homeopathy Debate? 2005, JACM, 11(5): 763-9 ,[11] 11. Frass, M et al. Bias in the Trial and Reporting of Trials of Homeopathy: A Fundamental Breakdown in Peer Review and Standards? JACM, 2005, 11(5): 780-2 ,[12] 12. Helmut K, et al. Failure to Exclude False Negative Bias: A Fundamental Flaw in the Trial of Shang et al. JACM, 2005; 11(5): 783 . Most notably the study does not meet the ‘quality-control’ criteria for publication of meta-analyses as described in the Lancet itself in 1999.[13] 13. Moher D, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet, 1999; 354(9193):1896-900 Systematic reviews should be 'transparent and reproducible' (Ernst, 2007) yet the initial study gave no information about which trials had been used in the analysis. This is unacceptable in scientific publications. When the necessary information was finally released allowing other researchers to replicate the study, a team produced two articles challenging Shang's findings, describing flaws which make the results unreliable (Ludtke 2008, Rutten 2008).
Ernst E. Understanding Research in Complementary and Alternative Medicine. Holistic Therapy Books, 2007
Ludtke R, Rutten ALB. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol, 2008
Rutten ALB, Stolper CF. The 2005 meta-analysis of homeopathy: the importance of post-publication data. Homeopathy, 2008
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A small number of systematic reviews have confirmed that homeopathy can be effective for specific conditions, but more research of this kind is needed to investigate a wider range of conditions.
Limitations of systematic reviews The need for clarity
The term 'homeopathy' is used with several different meanings in the context of homeopathy research.* This means that studies investigating very different approaches are all described as trials of 'homeopathy' and are frequently analysed together in systematic reviews e.g.:
A standard single homeopathic medicine given to all participants
A standard combination of several homeopathic medicines given to all participants
Individualised prescribing without a homeopathic consultation
Treatment by a homeopath including individualised prescription and consultation
Isopathic trials e.g. homeopathic pollen for treatment of hay fever
For future homeopathy research to be meaningful, specific definitions within the umbrella term of 'homeopathy' are needed to promote clarity in the reporting, design and interpretation of homeopathy research i.e. stating whether a trial is investigating treatment by a homeopath, the action of a homeopathic medicine or the principles of homeopathy.'
* Relton C et al. 'Homeopathy': Untangling the debate. Homeopathy, 2008; 97: 152-5
Systematic reviews
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References
1. Mathie, R. The Research Evidence Base for Homeopathy. British Homeopathic Association, 2009. www.facultyofhomeopathy.org/export/sites/faculty_site/research/evidencesummary.pdf
2. Friese K-H, et al. Homeopathic treatment of otitis media in children: comparisons with conventional therapy. Int J Clin Pharmacol Ther, 1997; 35: 296-301
3. Shealy C.N., Thomlinson P.R., Cox R.H., and Bormeyer V. Osteoarthritis Pain: A Comparison of
Homoeopathy and Acetaminophen. American Journal of Pain Management, 1998; 8 (3): 89-91
4. Adler UC, et al. Homeopathic Individualized Q-potencies versus Fluoxetine for Moderate to Severe Depression: Double-blind, Randomized Non-inferiority Trial. eCAM, 2009
5. Kleijnen J, et al. Clinical trials of homeopathy. Br Med J, 1991; 302: 316–23
6. Linde K, et al. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet, 1997; 350: 834–43
7. Linde K, et al. Impact of study quality on outcome in placebo controlled trials of homeopathy. J Clin Epidemiol, 1999; 52: 631–6
8. Cucherat M, et al. Evidence of clinical efficacy of homeopathy – A meta-analysis of clinical trials. Eur J Clin Pharmacol, 2000; 56: 27–33
9. Shang A, et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet, 2005; 366: 726–32
10. Bell, I. All Evidence is Equal, but Some Evidence is More Equal than Others: Can Logic Prevail over Emotion in the Homeopathy Debate? 2005, JACM, 11(5): 763-9
11. Frass, M et al. Bias in the Trial and Reporting of Trials of Homeopathy: A Fundamental Breakdown in Peer Review and Standards? JACM, 2005, 11(5): 780-2
12. Helmut K, et al. Failure to Exclude False Negative Bias: A Fundamental Flaw in the Trial of Shang et al. JACM, 2005; 11(5): 783
13. Moher D, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of Reporting of Meta-analyses. Lancet, 1999; 354(9193):1896-900
