Homeopathic trial design in influenza treatment

R. Kirkby; P. Herscu

doi:10.1016/j.homp.2009.09.001

Homeopathy, Table of Contents

Homeopathy 2010; 99(01): 69-75
DOI: 10.1016/j.homp.2009.09.001

Homeopathic trial design in influenza treatment

R. Kirkby

¹Herscu Laboratory, Clinical Research Division, 356 Middle Street, Amherst, MA 01002, United States

,

P. Herscu

¹Herscu Laboratory, Clinical Research Division, 356 Middle Street, Amherst, MA 01002, United States

²New England School of Homeopathy, Amherst, MA, United States

› Author Affiliations
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Abstract

This review presents a critical evaluation of methodological quality in controlled trials on homeopathic treatment of influenza. First, a short summary on the prevalence, quality, and most commonly cited shortcomings of homeopathic controlled trials in general is presented to support the more specific points within influenza trials alone. To this end, three areas of the homeopathic literature are examined; large meta-analyses looking at study quality and results across research areas, reviews on research within specific diagnostic categories, and the available reviews and primary studies on influenza treatment trials. The specific methodological designs of homeopathic influenza treatment trials are then compared, on a point by point basis, to pharmaceutical trials on influenza antiviral drugs. The goal of the evaluation is to highlight frequently cited problems in homeopathic trial design, suggest possible improvement for future studies, and make specific recommendations for homeopathic influenza trials based on a comparison to standard antiviral trials.

Keywords

Influenza - Homeopathic controlled trials - Randomized controlled trials - Homeopathy - Study quality - Design methodology

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References

References
1 Kirkby R, Calabrese C, Kaltman K, Monnier J, Herscu P. Methodological considerations for future controlled influenza treatment trials in complementary and alternative medicine. J Altern Complement Med (JACM) in the April, 2010 issue.
2 Vickers A.J., Smith C. Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes. Cochrane Database Syst Rev 2006; 3: CD001957.
3 Shang A., Huwiler-Muntener K., Nartey L. et al. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Lancet 2005; 366: 726-732.
4 Mathie R.T. The research evidence base for homeopathy: a fresh assessment of the literature. Homeopathy 2003; 92: 84-91.
5 Zabolotnyi D.I., Kneis K.C., 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.
6 Steinsbekk A., Lewith G., Fonnebo V., Bentzen N. An exploratory study of the contextual effect of homeopathic care. A randomised controlled trial of homeopathic care vs. self-prescribed homeopathic medicine in the prevention of upper respiratory tract infections in children. Prev Med 2007; 45: 274-279 discussion 80–1.
7 Steinsbekk A., Fonnebo V., Lewith G., Bentzen N. Homeopathic care for the prevention of upper respiratory tract infections in children: a pragmatic, randomised, controlled trial comparing individualised homeopathic care and waiting-list controls. Complement Ther Med 2005; 13: 231-238.
8 Steinsbekk A., Bentzen N., Fonnebo 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.
9 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.
10 Frei H., Thurneysen A. Homeopathy in acute otitis media in children: treatment effect or spontaneous resolution?. Br Homeopath J 2001; 90: 180-182.
11 Ferley J.P., Zmirou D., D'Adhemar D., Balducci F. A controlled evaluation of a homoeopathic preparation in the treatment of influenza-like syndromes. Br J Clin Pharmacol 1989; 27: 329-335.
12 de Lange de Klerk E.S., Blommers J., Kuik D.J., Bezemer P.D., Feenstra L. Effect of homoeopathic medicines on daily burden of symptoms in children with recurrent upper respiratory tract infections. BMJ 1994; 309: 1329-1332.
13 Attena F., Toscano G., Agozzino E., Del Giudice N. A randomized trial in the prevention of influenza-like syndromes by homeopathic management. Rev Epidemiol Sante Publique 1995; 43: 380-382.
14 Guo R., Pittler M.H., Ernst E. Complementary medicine for treating or preventing influenza or influenza-like illness. Am J Med 2007; 120: 923-929 e3.
15 Carr R.R., Nahata M.C. Complementary and alternative medicine for upper-respiratory-tract infection in children. Am J Health Syst Pharm 2006; 63: 33-39.
16 Kleijnen J., Knipschild P., ter Riet G. Clinical trials of homoeopathy. BMJ 1991; 302: 316-323.
17 Linde K., Clausius N., Ramirez G. et al. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet 1997; 350: 834-843.
18 Ludtke R., Rutten A.L. The conclusions on the effectiveness of homeopathy highly depend on the set of analyzed trials. J Clin Epidemiol 2008; 61: 1197-1204.
19 Jonas W.B., Anderson R.L., Crawford C.C., Lyons J.S. A systematic review of the quality of homeopathic clinical trials. BMC Complement Altern Med 2001; 1: 12.
20 Walach H., Jonas W.B., Ives J., van Wijk R., Weingartner O. Research on homeopathy: state of the art. J Altern Complement Med 2005; 11: 813-829.
21 Merrell W.C., Shalts E. Homeopathy. Med Clin North Am 2002; 86: 47-62.
22 Linde K., Melchart D. Randomized controlled trials of individualized homeopathy: a state-of-the-art review. J Altern Complement Med 1998; 4: 371-388.
23 Cucherat M., Haugh M.C., Gooch M., Boissel J.P. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol 2000; 56: 27-33.
24 Linde K., Scholz M., Ramirez G., Clausius N., Melchart D., Jonas W.B. Impact of study quality on outcome in placebo-controlled trials of homeopathy. J Clin Epidemiol 1999; 52: 631-636.
25 Linde K., Hondras M., Vickers A., ter Riet G., Melchart D. Systematic reviews of complementary therapies – an annotated bibliography. Part 3: homeopathy. BMC Complement Altern Med 2001; 1: 4.
26 Ernst E. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002; 54: 577-582.
27 Jonas W.B., Kaptchuk T.J., Linde K. A critical overview of homeopathy. Ann Intern Med 2003; 138: 393-399.
28 van der Wouden J.C., Bueving H.J., Poole P. Preventing influenza: an overview of systematic reviews. Respir Med 2005; 99: 1341-1349.
29 Papp R., Schuback G., Beck E. Oscillococcinum in patients with influenza-like syndromes: a placebo-controlled double blind evaluation. Br Homeopath J 1998; 87: 69-76.
30 Casanova P. Homeopathie, syndrome grippal et duble insu. Tonus 1984: 25-26.
31 Casanova P, Gerard R. Bilan de 3 annees d'etudes randomisees multicentriques Oscillococcinum/placebo. In: Oscillococcinum – rassegna della letterature internationale, 1992.
32 Jadad A.R., Moore R.A., Carroll D. et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17: 1-12.