Double-blind, placebo-controlled homeopathic pathogenetic trials: Symptom collection and analysis

Abstract

Background: Homeopathic pathogenetic trials (provings) are fundamental to homeopathy. Since most of the data from available provings have not been statistically evaluated, it is unclear how specific reported symptoms are and how they differ from those reported by people taking placebo.

Method: We combine and analyse data from two different homeopathic pathogenic trials—including 10 and 11 provers, respectively, and both including 30% placebo—to test the null hypothesis that there is no significant difference between the number of symptoms in placebo and verum groups.

Results: The principal results were:

• Placebo reported less symptoms than verum groups.

• Symptom distribution according to predefined classes (common symptoms increased in intensity and/or duration-, cured, old, new and exceptional) was statistically different between placebo and verum group at a high level of significance (P<0.001). Compared to verum, placebo provers reported less new and old but more common (increased in duration or intensity) symptoms.

• Within repertory categories, other differences were detected.

• The two groups differ in terms of the duration of each symptom and kinetics of symptoms: most symptoms were more persistent in verum than in placebo groups and verum provers recorded a decreasing number of symptoms with time. Placebo provers did not show such a temporal pattern.

Conclusions: If confirmed by other studies these results would demonstrate the non-equivalence between homeopathic medicines in high dilution and placebo and contribute to the improvement of proving methodology and evaluation.

Keywords

homeopathic proving - placebo - symptoms classification - standardized methodology - pathogenetic trial

• References

• 1 Herrick N. Animal Mind, Human Voices: Provings of Eight New Animal Remedies. Nevada City, CA: PA Hahnemann Clinic Publishing; 1998.
• 2 Evans M. Meditative Provings. York: The Rose Press; 2000.
• 3 Brunnthaler-Tscherten R. Calcarea muriatica—remedy proving and experience in practice. Proceedings of 58th Congress LMHI, Graz, April 22–26, 2003.
• 4 Brien S., Lewith G., Bryant T. Ultramolecular homeopathy has no observable clinical effects. A randomized, double-blind, placebo-controlled proving trial of Belladonna 30C. Br J Clin Pharmacol 2003; 56 (05) 562-568.
• 5 Walach H., Koster H., Hennig T., Haag G. The effects of homeopathic belladonna 30CH in healthy volunteers. A randomized, double-blind experiment. J. Psychosom Res 2001; 50: 155-160.
• 6 Walach H., Sherr J., Schneider R., Shabi R., Bond A., Rieberer G. Homeopathic proving symptoms: result of a local, non-local, or placebo process? A blinded, placebo-controlled pilot study. Homeopathy 2004; 93 (04) 179-185.
• 7 Brien S. Attitudes about complementary and alternative medicine did not predict outcome in a homeopathic proving trial. J Altern Complement Med 2004; 10 (03) 503-505.
• 8 Vickers A., McCarney R., Fisher P., van Haselen R. Can homeopaths detect homeopathic medicines? A pilot study for a randomised, double-blind, placebo controlled investigation of the proving hypothesis. Br Homeopath J 2001; 90 (03) 126-130.
• 9 Gulia P, Pitari G, Dominici G. Etna lava. Sperimentazione omeopatica della lava del vulcano Etna. Il medico omeopata. Giornale FIAMO (www.fiamo.it), VII,21, 26–35.
• 10 Wieland F. Good homeopathic provings. The need for GHP guidelines. A brief survey of recent developments in methodology of homeopathc drug provings in Europe. Br Homeopath J 1997; 86: 229-234.
• 11 International Council for Classical Homoeopathy. Recommendation guidelines for good provings, International Council for Classical Homoeopathy. Hom Links 1999; 12 (01) 29-33.
• 12 Fayeton S., van Wassenhoven M. Clinical verification of symptom pictures of homoeopathic medicines. Br Homeopath J 2001; 90: 29-32.
• 13 Zecca L., Youdim M.B., Riederer P., Connor J.R., Crichton R.R. Iron, brain ageing and neurodegenerative disorders. Nat Rev Neurosci 2004; 5 (11) 863-873.
• 14 Evans M.D., Dizdaroglu M., Cooke M.S. Oxidative DNA damage and disease: induction, repair and significance. Mutat Res 2004; 567 (01) 1-61.
• 15 Watt B.E., Proudfoot A.T., Vale J.A. Hydrogen peroxide poisoning. Toxicol Rev 2004; 23 (01) 51-57.
• 16 Kamsler A., Segal M. Hydrogen peroxide as a diffusible signal molecule in synaptic plasticity. Mol Neurobiol 2004; 29 (02) 167-178.
• 17 Kent J.T. Repertory of Homeopathic Materia Medica. New Delhi: B. Jain Publisher, Pvt Ltd; 1990.
• 18 Schrojens F. Radar Synthesis 8.1. Archibel, Assesse, Belgium (www.archibel.com.)
• 19 Goodyear K., Lewith G., Low J.L. Randomized double-blind placebo-controlled trial of homoeopathic ‘proving’ for Belladonna C30. J R Soc Med 1998; 91 (11) 579-582.
• 20 Vickers A.J., van Haselen R., Heger M. Can homeopathically prepared mercury cause symptoms in healthy volunteers? A randomized, double-blind placebo-controlled trial. J Altern Complement Med 2001; 7 (02) 141-148.
• 21 Signorini A., Lubrano A., Manuele G. et al. Classical and new proving methodology: Provings of Plumbum metallicum and Piper methysticum and comparison with a classical proving of Plumbum metallicum. Homeopathy 2005; 94 (03) 164-174.
• 22 Mollinger H., Schneider R., Loffel M., Walach H. A double-blind, randomized, homeopathic pathogenetic trial with healthy persons: comparing two high potencies. Forsch Komplementarmed Klass Nat 2004; 11 (05) 274-280.
• 23 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 (01) 12.
• 24 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 (9081): 834-843.
• 25 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 (07) 631-636.
• 26 Hyland M.E., Lewith G.T. Oscillatory effects in a homeopathic clinical trial. Homeopathy 2002; 91: 145-149.
• 27 Bellavite P. Complexity science and homeopathy: a synthetic overview. Homeopathy 2003; 92: 203-212.