Download PDF
Homeopathy 2015; 104(03): 164-169
DOI: 10.1016/j.homp.2015.02.004
Original Paper
Copyright © The Faculty of Homeopathy 2015

Model validity of randomised placebo-controlled trials of individualised homeopathic treatment

Robert T Mathie
1   British Homeopathic Association, Hahnemann House, 29 Park Street West, Luton LU1 3BE, UK
,
Michel Van Wassenhoven
2   Belgian Homeopathic Medicines Registration Commission, FAMHP, Rue Taille Madame 23, B-1450 Chastre, Belgium
,
Jennifer Jacobs
3   School of Public Health and Community Medicine, University of Washington, Seattle, WA 98195, USA
,
Menachem Oberbaum
4   Center for Integrative Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel
,
Helmut Roniger
5   Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK
,
Joyce Frye
6   Center for Integrative Medicine, University of Maryland School of Medicine, Baltimore, MD 21201, USA
,
Raj K Manchanda
7   Central Council for Research in Homeopathy, Department of AYUSH, Ministry of Health & Family Welfare, Government of India, New Delhi 110058, India
,
Laurence Terzan
8   Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France
,
Gilles Chaufferin
8   Boiron, 20 Rue de la Liberation, 69110 Sainte Foy-lès-Lyon, France
,
Flávio Dantas
9   Department of Clinical Medicine, Universidade Federal de Uberlândia, Uberlândia, Brazil
,
Peter Fisher
5   Royal London Hospital for Integrated Medicine, 60 Great Ormond Street, London WC1N 3HR, UK
› Author Affiliations
Further Information

Publication History

Received13 March 2014
revised16 January 2015

accepted04 February 2015

Publication Date:
02 January 2018 (online)

Also available at
    Permissions and Reprints

Background: Though potentially an important limitation in the literature of randomised controlled trials (RCTs) of homeopathy, the model validity of homeopathic treatment (MVHT) has not previously been systematically investigated.

Objective: As an integral part of a programme of systematic reviews, to assess MVHT of eligible RCTs of individualised homeopathic treatment.

Methods: From 46 previously identified papers in the category, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were thus the subject of the study. For each of six domains of assessment per trial, MVHT was judged independently by three randomly allocated assessors from our group, who reached a final verdict by consensus discussion as necessary.

Results: Nineteen trials were judged overall as ‘acceptable’ MVHT, nine as ‘uncertain’ MVHT, and four as ‘inadequate’ MVHT.

Conclusions: These results do not support concern that deficient MVHT has frequently undermined the published findings of RCTs of individualised homeopathy. However, the 13 trials with ‘uncertain’ or ‘inadequate’ MVHT will be a focus of attention in supplementary meta-analysis. New RCTs of individualised homeopathy must aim to maximise MVHT and to enable its assessment through clear reporting.

Keywords

Individualised homeopathy - Model validity - Randomised controlled trial - Systematic review

Supplementary data

 

  • References

  • 1 Verhoef M.J., Lewith G., Ritenbaugh C., Boon H., Fleishman S., Leis A. Complementary and alternative whole systems research: Beyond identification of inadequacies of the RCT. Complement Ther Med 2005; 13: 206-212.
    CrossrefPubMedSearch in Google Scholar
  • 2 Wein C. Qualitätsaspekte klinischer Studien zur Homöopathie. Quality aspects of clinical trials of homeopathy 2002. Essen: KVC Verlag.;
    Search in Google Scholar
  • 3 Bornhöft G., Maxion-Bergemann S., Wolf U. et al. Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity. BMC Med Res Methodol 2006; 6: 56.
    CrossrefPubMedSearch in Google Scholar
  • 4 Boon H., MacPherson H., Fleishman S. et al. Evaluating complex healthcare systems: a critique of four approaches. Evid Based Complement Altern Med 2007; 4: 279-285.
    CrossrefPubMedSearch in Google Scholar
  • 5 Aickin M.. Commentary on Mathie RT et al. Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study. BMC Med Res Methodol 2012; 12: 240.
    PubMedSearch in Google Scholar
  • 6 Mathie R.T., Roniger H., van Wassenhoven M. et al. Method for appraising model validity of randomised controlled trials of homeopathic treatment: multi-rater concordance study. BMC Med Res Methodol 2012; 12: 49.
    CrossrefPubMedSearch in Google Scholar
  • 7 Mathie R.T., Legg L.A., Clausen J. et al. Systematic Review and Meta-analysis of Randomised, Placebo-controlled, Trials of Individualised Homeopathic Treatment: Study Protocol. Version 1.0. 2013. 25 January http://www.britishhomeopathic.org/wp-content/uploads/2013/05/Study_protocol_for_systematic_review.pdf.
    Search in Google Scholar
  • 8 Mathie R.T., Hacke D., Clausen J., Nicolai T., Riley S., Fisher P. Randomised controlled trials of homeopathy in humans: characterising the research journal literature for systematic review. Homeopathy 2013; 102: 3-24.
    Thieme ConnectPubMedSearch in Google Scholar
  • 9 Mathie R.T., Lloyd S.M., Legg L.A. et al. Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014; 3: 142.
    CrossrefPubMedSearch in Google Scholar
  • 10 Mathie RT, van Wassenhoven M, Jacobs J, et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Submitted for publication.
    PubMed
  • 11 Higgins JPT, Altman DG (eds). Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (eds). Cochrane Handbook for Systematic Reviews of Interventions; Version 5.1.0. The Cochrane Collaboration; 2011.
    PubMed
  • 12 Rastogi D.P., Singh V.P., Singh V., Dey S.K., Rao K. Homeopathy in HIV infection: a trial report of double-blind placebo controlled study. Br Homoeopath J 1999; 88: 49-57.
    PubMedSearch in Google Scholar
  • 13 Thompson E.A., 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. J Altern Complement Med 2005; 11: 13-20.
    CrossrefPubMedSearch in Google Scholar
  • 14 Weatherley-Jones E., Thompson E.A., Thomas K.J. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment. Homeopathy 2004; 93: 186-189.
    Thieme ConnectPubMedSearch in Google Scholar
  • 15 Fisher P., McCarney R., Hasford C., Vickers A. Evaluation of specific and non-specific effects in homeopathy: feasibility study for a randomised trial. Homeopathy 2006; 95: 215-222.
    Thieme ConnectPubMedSearch in Google Scholar
  • 16 Dean M.E., Coulter M.K., Fisher P., Jobst K., Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT . Homeopathy 2007; 96: 42-45.
    Thieme ConnectPubMedSearch in Google Scholar
  • 17 Moher D., Liberati A., Tetzlaff J., Altman D.G. PRISMA Group Preferred reporting Items for systematic reviews and meta-analyses: the PRISMA statement. J Clin Epidemiol 2009; 62: 1006-1012.
    CrossrefPubMedSearch in Google Scholar
  • 18 Liberati A., Altman D.G., Tetzlaff J. et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration. J Clin Epidemiol 2009; 62: e1-34.
    CrossrefPubMedSearch in Google Scholar
  • 19 Bell I., Lewis D., Brooks A. et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology (Oxford) 2004; 43: 577-582.
    CrossrefPubMedSearch in Google Scholar
  • 20 Brien S., Lachance L., Prescott P., McDermott C., Lewith G. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology (Oxford) 2011; 50: 1070-1082.
    CrossrefPubMedSearch in Google Scholar
  • 21 Jacobs J., Springer D.A., Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001; 20: 177-183.
    CrossrefPubMedSearch in Google Scholar
  • 22 Jacobs J., Jimenez L.M., Gloyds S.S., Gale J.L., Crothers D. Treatment of acute childhood diarrhea with homeopathic medicine; a randomized clinical trial in Nicaragua. Pediatrics 1994; 93: 719-725.
    PubMedSearch in Google Scholar
  • 23 Jacobs J., Jimenez L.M., Malthouse S. et al. Homeopathic treatment of acute childhood diarrhoea: results from a clinical trial in Nepal. J Altern Complement Med 2000; 6: 131-139.
    CrossrefPubMedSearch in Google Scholar
  • 24 Jacobs J., Herman P., Heron K., Olsen S., Vaughters L. Homeopathy for menopausal symptoms in breast cancer survivors: a preliminary randomized controlled trial. J Altern Complement Med 2005; 11: 21-27.
    CrossrefPubMedSearch in Google Scholar
  • 25 Jacobs J., Williams A.-L., Girard C., Njike V.Y., Katz D. Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial. J Altern Complement Med 2005; 11: 799-806.
    CrossrefPubMedSearch in Google Scholar
  • 26 Siebenwirth J., Lüdtke R., Remy W., Rakoski J., Borelli S., Ring J. Wirksamkeit einer klassisch-homöopathischen Therapie bei atopischem Ekzem. Eine randomisierte, placebokontrollierte Doppelblindstudie. Effectiveness of classical homeopathic treatment in atopic eczema. A randomised placebo-controlled double-blind clinical trial Forsch Komplementmed 2009; 16: 315-323.
    CrossrefPubMedSearch in Google Scholar
  • 27 Cavalcanti A.M., Rocha L.M., Carillo Jr. R., Lima L.U., Lugon J.R. Effects of homeopathic treatment on pruritus of haemodialysis patients: a randomized placebo-controlled double-blind trial. Homeopathy 2003; 92: 177-181.
    Thieme ConnectPubMedSearch in Google Scholar
  • 28 Chapman E.H., Weintraub R.J., Milburn M.A., Pirozzi T.O., Woo E. Homeopathic treatment of mild traumatic brain injury: a randomized, double-blind, placebo-controlled clinical trial. J Head Trauma Rehabil 1999; 14: 521-542.
    CrossrefPubMedSearch in Google Scholar
  • 29 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.
    Thieme ConnectPubMedSearch in Google Scholar
  • 30 Jacobs J., Jiminez L.M., Gloyds S.S., Casares F.E., Gaitan M.P., Crothers D. Homoeopathic treatment of acute childhood diarrhoea. A randomized clinical trial in Nicaragua. Br Homoeopath J 1993; 82: 83-86.
    PubMedSearch in Google Scholar
  • 31 Jansen G.R.H.J., van der Veer A.L.J., Hagenaars J., van der Juy A. Lessons learnt from an unsuccessful clinical trial of homoeopathy. Results of a small-scale, double-blind trial in proctocolitis. Br Homoeopath J 1992; 81: 132-138.
    PubMedSearch in Google Scholar
  • 32 Yakir M., Kreitler S., Brzezinski A., Vithoulkas G., Oberbaum M., Bentwich Z. Effects of homeopathic treatment in women with premenstrual syndrome: a pilot study. Br Homeopath J 2001; 90: 148-153.
    Thieme ConnectPubMedSearch in Google Scholar
  • 33 Bonne O., Shemer Y., Gorali Y., Katz M., Shalev A.Y. A randomized, double-blind, placebo-controlled study of classical homeopathy in generalized anxiety disorder. J Clin Psychiatry 2003; 64: 282-287.
    CrossrefPubMedSearch in Google Scholar
  • 34 Katz T., Fisher P., Katz A., Davidson J., Feder G. The feasibility of a randomised, placebo-controlled clinical trial of homeopathic treatment of depression in general practice. Homeopathy 2005; 94: 145-152.
    Thieme ConnectPubMedSearch in Google Scholar
  • 35 Naudé D.F., Couchman I.M.S., Maharaj A. Chronic primary insomnia: efficacy of homeopathic simillimum. Homeopathy 2010; 99: 63-68 [Published erratum: Homeopathy 2010; 99: 151].
    Thieme ConnectPubMedSearch in Google Scholar
  • 36 Straumsheim P., Borchgrevink C., Mowinckel P., Kierulf H., Hafslund O. Homeopathic treatment of migraine: a double blind, placebo controlled trial of 68 patients. Br Homeopath J 2000; 89: 4-7.
    Thieme ConnectPubMedSearch in Google Scholar
  • 37 de Lange de Klerk E.S.M., Blommers J., Kuik D.J., Bezemer P.D., Feenstra L. Effects of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. Br Med J 1994; 309: 1329-1332.
    CrossrefPubMedSearch in Google Scholar
  • 38 Walach H., Häusler W., Lowes T. et al. Classical homeopathic treatment of chronic headaches. Cephalalgia 1997; 17: 119-126.
    CrossrefPubMedSearch in Google Scholar
  • 39 Sajedi F., Alizad V., Alaeddini F., Fatemi R., Mazaherinezhad A. The effect of adding homeopathic treatment to rehabilitation on muscle tone of children with spastic cerebral palsy. Complement Ther Clin Pract 2008; 14: 33-37.
    CrossrefPubMedSearch in Google Scholar
  • 40 Whitmarsh T.E., Coleston-Shields D.M., Steiner T.J. Double-blind randomized placebo-controlled study of homoeopathic prophylaxis of migraine. Cephalalgia 1997; 17: 600-604.
    CrossrefPubMedSearch in Google Scholar
  • 41 Gaucher C., Jeulin D., Peycru P., Amengual C. A double blind randomized placebo controlled study of cholera treatment with highly diluted and succussed solutions. Br Homoeopath J 1994; 83: 132-134.
    PubMedSearch in Google Scholar
  • 42 Andrade L., Ferraz M.B., Atra E., Castro A., Silva M.S.M. A randomized controlled trial to evaluate the effectiveness of homoeopathy in rheumatoid arthritis. Scand J Rheumatol 1991; 20: 204-208.
    CrossrefPubMedSearch in Google Scholar
  • 43 White A., Slade P., Hunt C., Hart A., Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003; 58: 317-321.
    CrossrefPubMedSearch in Google Scholar
  • 44 Kainz J.T., 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.
    CrossrefPubMedSearch in Google Scholar
  • 45 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. Br J Clin Pharmacol 2005; 59: 447-455.
    CrossrefPubMedSearch in Google Scholar