Randomised controlled trials in homeopathy

Criteria and methods for data extraction

This section is an overview of papers reporting randomised, placebo-controlled, trials (RCTs) of homeopathic treatment that have been published in the peer-reviewed literature in any country and in any language from 1950 to 2014 inclusive. Any form of homeopathy (individualised or non-individualised) was eligible for inclusion. For the present overview we reflect only those RCTs that have been accepted for formal systematic review and potential meta-analysis in the BHA’s ongoing programme of systematic reviews. It is founded on our thorough literature review of homeopathy RCTs and on the associated papers reporting the findings. Trials in which the control group was not placebo have been put aside for full analysis at a later date.

Note on statistical significance
A minority of RCTs in homeopathy have defined a relevant threshold for clinical importance, with consequent absence of prospective power calculation. On this web-page, the original authors’ positive or negative findings have therefore been described consistently in statistical terms only.

A statistically conclusive RCT result requires that the 95% confidence interval of the mean difference in outcome measure did not include 0 (or P<0.05); a statistically non-significant trial result is one in which the confidence interval included 0 (or P>0.05). An RCT reporting statistically significant findings is labelled either ‘positive’ or ‘negative’, depending on whether the homeopathy group was superior or inferior to placebo in at least one per three main outcomes presented in the paper. Statistically non-significant trials are described as ‘non-conclusive’.

Overall summary of trial findings, 1950–2014

During this period, there were 104 eligible RCT papers published in homeopathy. Only 32 RCTs (31%) of the 104 papers have studied individualised homeopathy; each of the other 72 papers (69%) has studied non-individualised homeopathy (i.e. selected a single homeopathic medicine for investigation).

Of the 104 papers in total, 43 (41%) reported positive findings; 5 (5%) were negative; 56 (54%) were non-conclusive.

The 104 papers represent placebo-controlled research in a total of 61 different medical conditions. In 22 of those conditions, there has been replicated research (i.e. there have been two or more trials); for each of the other 39 conditions there are singleton RCTs. Though some account is taken here of the intrinsic quality of the research, this important matter of quality is reflected prominently in the BHA’s ongoing programme of systematic reviews.

Direction of RCT evidence per medical condition

A score of +1 is given to a positive RCT0 to a non-conclusive RCT–1 to a negative RCT.

For replicated research, the overall direction of RCT evidence for each medical condition relates to the sum of the scores derived from the RCT research for that particular condition:

Sum of +3 or more: Clearly positive direction of evidence
Sum of +2: Tentatively positive direction of evidence
Sum of +1 or 0 or –1: Non-conclusive direction of evidence
Sum of –2: Tentatively negative direction of evidence
Sum of –3 or less: Clearly negative direction of evidence.

This method of summarising direction of evidence in sets of RCTs is similar in essence to that adopted previously [Ernst E, Pittler MH, Wider B (2006). The Desktop Guide to Complementary and Alternative Medicine; an evidence-based approach. Mosby Elsevier]. It is not meant as a replacement for formal assessment procedures, such as systematic review and/or meta-analysis, which determine a trial’s intrinsic quality and/or the size of treatment effect for a specified outcome measure.

The summary method is intended to give an overall impression about the current nature of the placebo-controlled RCT evidence per medical condition, pending formal systematic review overall. Such formal review will also take account of whether evidence has been reported by independent research groups.

As shown in the detailed reference list below, there is:

Clearly positive direction of RCT evidence in 2 conditions:

Seasonal allergic rhinitis 1-8
Sinusitis 9-12

Tentatively positive direction of RCT evidence in 26 conditions (including singleton trials):

Allergic skin reaction 13
Arsenic toxicity 14-17
Brain injury 18
Bronchitis 19
Childhood diarrhoea 20-23
Chronic fatigue syndrome 24
Female infertility 25, 26
Fibromyalgia 27
Influenza 28, 29
Insomnia 30-32
Menopausal syndrome 33
Otitis media (acute) 34
Perennial allergic rhinitis 35
Plantar fasciitis 36
Postpartum bleeding 37
Postpartum lactation 38
Premenstrual syndrome 39
Psoriasis 40
Radiodermatitis 41
Sepsis 42
Snoring 43
Stomatitis 44
Tonsillitis 45
Tracheal secretions 46
Uraemic pruritus 47
Varicose veins 48

Non-conclusive direction of RCT evidence in 31 conditions (including singleton trials):

Allergic asthma 49, 50
Adenoid 51
ADHD 52, 53
Anxiety 54-56
Body weight loss 57
Cerebral palsy 58
Childhood Asthma 59, 60
Cholera 61
Dengue fever symptoms 62
Depression 63
Eczema 64, 65
Headache 66
HIV 67
Hypertension 68, 69
Induction of labour 70
Irritable bowel syndrome 71, 72
Lead poisoning 73
Menopause post breast cancer 74, 75
Migraine 76, 77
Minor burns 78
Mucositis 79
Muscle Soreness 80-82
Post-Operative bleeding/bruising 83-85
Post-Operative pain/swelling 86-91
Postpartum pain 92
Proctocolitis 93
Rheumatoid arthritis 94-96
Tuberculosis 97
URTI 98, 99
Warts 100, 101
Withdrawal of benzodiazepines 102

Tentatively negative direction of RCT evidence in 2 conditions (singleton trials):

Post-operative analgesic intake 103
Post-operative ileus 104

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2 Aabel S (2000). 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; 89:169–173.
3 Aabel S (2001). 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; 90:73–78.
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13 Naidoo P, Pellow J (2013). A randomized placebo-controlled pilot study of Cat saliva 9cH and Histaminum 9cH in cat allergic adults. Homeopathy; 102: 123-129.
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15 Khuda-Bukhsh AR, Pathak S, Guha B, Karmakar SR, Das JK, Banerjee P, Biswas SJ, Mukherjee P, Bhattacharjee N, Choudhury SC, Banerjee A, Bhadra S, Mallick P, Chakrabarti J, Mandal B (2005). Can homeopathic arsenic remedy combat arsenic poisoning in humans exposed to groundwater arsenic contamination? A preliminary report on first human trial. Evidence-Based Complementary and Alternative Medicine; 2:537-548.
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18 Chapman EH, Weintraub RJ, Milburn MA, Pirozzi TO, Woo E (1999). Homeopathic treatment of mild traumatic brain injury: a randomized, double-blind, placebo-controlled clinical trial. Journal of Head Trauma Rehabilitation; 14: 521–542.
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24 Weatherley-Jones E, Nicholl JP, Thomas KJ, Parry GJ, McKendrick MW, Green ST, Stanley PJ, Lynch SP (2004). A randomized, controlled, triple-blind trial of the efficacy of homeopathic treatment for chronic fatigue syndrome. Journal of Psychosomatic Research; 56:189–197.
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27 Bell I, Lewis D, Brooks A, Schwartz G, Lewis S, Walsh B, Baldwin C (2004). Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology; 43:577–582.
28 Ferley JP, Zmirou D, D’Adhemar D, Balducci F (1989). A controlled evaluation of a homoeopathic preparation in the treatment of influenza like syndromes. British Journal of Clinical Pharmacology; 27:329–335.
29 Papp R, Schuback G, Beck E, Burkard G, Bengel J, Lehrl S, Belon P (1998). Oscillococcinum® in patients with influenza-like syndromes: a placebo-controlled double-blind evaluation. British Homoeopathic Journal; 87:69–76.
30 Kolia-Adam N, Solomon E, Bond J, Deroukakis M (2008). The efficacy of Coffea cruda on insomnia: a double blind trial. Simillimum; 21: 91-99.
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32 Harrison CC, Solomon EM, Pellow J (2013). The effect of a homeopathic complex on psychophysiological onset insomnia in males: a randomized pilot study. Altern Ther Health Med;19(5):38-43.
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34 Jacobs J, Springer DA, Crothers D (2001). Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatric Infectious Disease Journal; 20:177–183.
35 Taylor MA, Reilly D, Llewellyn-Jones RH, McSharry C, Aitchison TC (2000). Randomised controlled trial of homoeopathy versus placebo in perennial allergic rhinitis with overview of four trial series. British Medical Journal; 321:471–476.
36 Clark J, Percivall A (2000). A preliminary investigation into the effectiveness of the homeopathic remedy, Ruta graveolens, in the treatment of pain in plantar fasciitis. British Journal of Podiatry; 3:81–85.
37 Oberbaum M, Galoyan N, Lerner-Geva L, Singer SR, Grisaru S, Shashar D, Samueloff A (2005). 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; 13:87–90.
38 Berrebi A, Parant O, Ferval F, Thene M, Ayoubi JM, Connan L, Belon P (2001). Traitement de la douleur de la montée laiteuse non souhaitée par homéopathie dans le postpartum immédiat [Treatment of pain due to unwanted lactation with a homeopathic preparation given in the immediate post-partum period]. Journal de gynécologie, obstétrique et biologie de la reproduction; 30:353–357.
39 Yakir M, Kreitler S, Brzezinski A, Vithoulkas G, Oberbaum M, Bentwich Z (2001). Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study. British Homeopathic Journal; 90:148–153.
40 Bernstein S, Donsky H, Gulliver W, Hamilton D, Nobel S, Norman R (2006). Treatment of mild to moderate psoriasis with Reliéva, a Mahonia aquifolium extract – a double-blind, placebo-controlled study. American Journal of Therapeutics; 13:121-126.
41 Balzarini A, Felisi E, Martini A, De Conno F (2000). Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomized, double-blind clinical trial. British Homeopathic Journal; 89:8–12.
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76 Straumsheim P, Borchgrevink C, Mowinckel P, Kierulf H, Hafslund O (2000). Homeopathic treatment of migraine: a double blind, placebo controlled trial of 68 patients. British Homeopathic Journal; 89:4–7.
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78 Leaman AM, Gorman D (1989). Cantharis in the early treatment of minor burns. Archives of Emergency Medicine; 6:259–261.
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90 Kaziro GS (1984). Metronidazole (Flagyl) and Arnica montana in the prevention of post-surgical complications, a comparative placebo controlled clinical trial. British Journal of Oral & Maxillofacial Surgery; 22:42–49.
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