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Evidence summary

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Randomised controlled trials in homeopathy

Criteria and methods for data extraction

This section contains references to full papers of RCTs of homeopathy (any medical condition, treatment or prevention, placebo-controlled design or otherwise) that have been published in the peer-review literature in any country and in any language from 1950 to 2009 inclusive. Any form of homeopathy was eligible for inclusion. RCTs were primarily categorized as placebo controlled or non-placebo controlled.

A study was defined as an RCT only if the paper explicitly stated there had been prospective random assignment to treatment. In the case of placebo-controlled trials, explicit mention of double blinding was also required; for non-placebo controlled (including equivalence) trials, observer blinding was sufficient for inclusion. It was also required that inter-group statistical analysis had been reported, with total sample size for analysis > 10 patients for a two-group study (and > 5 patients per group).

Note on statistical significance
A minority of placebo-controlled trials in homeopathy have defined a relevant threshold for clinical importance, with consequent absence of prospective power calculation. In this document, therefore, positive or negative findings have been described consistently in statistical terms only. “Statistically not significant” means either there was no difference between the groups or there were too few subjects to demonstrate such a difference if it truly existed – in the absence of a power calculation, it is not possible to determine which of these possibilities has been the case.

A statistically conclusive trial result required that the 95% confidence interval of the mean difference in symptom score or relevant variable did not include 0 (or P<0.05); a statistically non-significant trial result meant that the confidence interval included 0 (or P>0.05). A study reporting statistically significant findings was either ‘positive’ or ‘negative’, depending on whether the homeopathy group was superior or inferior to control in at least one principal outcome of no more than three presented in a paper. Importance was placed on conclusions from replicated research per medical condition (i.e. more than a single trial, by any research group).

Summary of trial findings, 1950–2009

There are a total of 142 peer-reviewed RCTs in 129 papers reporting placebo controlled or non-placebo controlled RCTs of homeopathy: 63 (44%) had positive findings; 11 (8%) were negative; 68 (48%) were non-conclusive. These trials represent research in a total of 74 different medical conditions. Two or more studies are available for each of 28 conditions. It is clear that more research is required to determine whether these current conclusions might be substantiated or refuted.

There are replicated studies with a majority of positive findings in 7 conditions:
Childhood diarrhoea (individualized treatment) 35–37   
Fibromyalgia 38, 39, 40 
Influenza 41, 42
Osteoarthritis 43–45   
Seasonal allergic rhinitis 14, 46–55           
Sinusitis 56–59     
Vertigo 60, 61

Replicated trials with a majority of statistically non-significant or (more rarely) negative findings have been reported in 11 areas:

Anxiety 62–64    
Childhood asthma 65, 66
Insect bites 67, 68  
Menopausal symptoms in breast cancer 69, 70  
Migraine 71–73    
Muscle soreness 74–78      
Post-operative bruising / haematoma / pain / swelling 33, 79–85        
Rheumatoid arthritis 86–88    
Stroke 89, 90  
Upper respiratory tract infection (prevention) 91–93    
Warts 94, 95

There are non-replicated trials in many medical conditions. Research in singleton trials shows positive evidence in 25, including the following:

Chronic fatigue syndrome 96
Premenstrual syndrome 97
Post-partum bleeding 98
Sepsis 99
Stomatitis 100 


References
For references 1-34 go to the systematic reviews page.

35 Jacobs J, Jiminez LM, Gloyds SS, et al. Homoeopathic treatment of acute childhood diarrhoea. A randomized clinical trial in Nicaragua. British Homeopathic Journal, 1993; 82: 83–86.

36 Jacobs J, Jimenez LM, Gloyds SS, et al. Treatment of acute childhood diarrhea with homeopathic medicine; a randomized clinical trial in Nicaragua. Pediatrics, 1994; 93: 719–725.

37 Jacobs J, Jimenez LM, 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.

38 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.

39 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.

40 Relton C, Smith C, Raw J, et al. 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.

41 Ferley JP, 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.

42 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.

43 Shealy CN, Thomlinson RP, Cox RH, Borgmeyer RN. Osteoarthritic pain: a comparison of homeopathy and acetaminophen. American Journal of Pain Management, 1998; 8: 89–91.

44 Shipley M, Berry H, Broster G, et al. Controlled trial of homoeopathic treatment of osteoarthritis. Lancet, 1983; i: 97–98.

45 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: 714–719.

46 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.

47 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.

48 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.

49 Kim LS, Riedlinger JE, Baldwin CM, 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.

50 Reilly DT, Taylor MA. Potent placebo or potency? A proposed study model with initial findings using homoeopathically prepared pollens in hayfever. British Homeopathic Journal, 1985; 74: 65–75.

51 Reilly DT, Taylor MA, 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.

52 Wiesenauer M, Häussler S, Gaus W. [Treatment of pollinosis with Galphimia glauca]. Fortschritte der Medizin, 1983; 101: 811–814.

53 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.

54 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.

55 Weiser M, Gegenheimer LH, 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.

56 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: 271–277.

57 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.

58 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.

59 Zabolotnyi DI, Kneis KC, 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.

60 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.

61 Weiser M, Strösser 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.

62 Baker DG, Myers SP, Howden I, Brooks L. The effects of homeopathic Argentum nitricum on test anxiety. Complementary Therapies in Medicine, 2003; 11: 65–71.

63 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.

64 McCutcheon LE. Treatment of anxiety with a homeopathic remedy. Journal of Applied Nutrition, 1996; 48: 2–6.

65 Freitas L, Goldenstein E, Sanna OM. [The indirect patient-doctor relationship and the homeopathic treatment of childhood asthma]. Revista de Homeopatia, 1995; 60: 26–31.

66 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.

67 Hill N, Stam C, Tuinder S, van Haselen RA. 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.

68 Hill N, Stam C, van Haselen RA. 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.

69 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.

70 Thompson EA, 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.

71 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.

72 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.

73 Whitmarsh TE, Coleston-Shields DM, Steiner TJ. Double-blind randomized placebo-controlled study of homoeopathic prophylaxis of migraine. Cephalalgia, 1997; 17: 600–604.

74 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.

75 Tveiten D, Bruseth S, Borchgrevink CF, Løhne 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.

76 Tveiten D, Bruseth S, Borchgrevink CF, 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.

77 Vickers AJ, 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.

78 Vickers AJ, 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.

79 Hart O, Mullee MA, 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.

80 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.

81 Lökken P, Straumsheim PA, 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.

82 Seeley BM, Denton AB, Ahn MS, Maas CS. 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.

83 Stevinson C, Devaraj VS, 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.

84 Robertson A, Suryanarayanan R, Banerjee A. Homeopathic Arnica montana for post-tonsillectomy analgesia: a randomised placebo control trial. Homeopathy, 2007; 96: 17–21.

85 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.

86 Andrade L, Ferraz MB, 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.

87 Fisher P, Scott DL. A randomized controlled trial of homeopathy in rheumatoid arthritis. Rheumatology, 2001; 40: 1052–1055.

88 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.

89 Savage RH, Roe PF. A double blind trial to assess the benefit of Arnica mo ntana in acute stroke illness. British Homeopathic Journal, 1977; 66: 207–220.

90 Savage RH, Roe PF. A further double blind trial to assess the benefit of Arnica montana in acute stroke illness. British Homeopathic Journal, 1978; 67: 210–222.

91 Davies AE. Clinical investigations into the actions of potencies. British Homeopathic Journal, 1971; 60: 36–41.

92 Steinsbekk A, Bentzen N, Fønnebø 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.

93 Steinsbekk A, Fønnebø 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.

94 Kainz JT, 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.

95 Labrecque M, Audet D, Latulippe LG, Drouin J. Homoeopathic treatment of plantar warts. Canadian Medical Association Journal, 1992; 146: 1749–1753.

96 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. Journal of Psychosomatic Research, 2004; 56: 189–197.

97 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.

98 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.

99 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.

100 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.