Homeopathic drug proving of Okoubaka aubrevillei: a randomised placebo-controlled trial

Michael Teut, Joern Dahler, Ute Hirschberg, Rainer Luedtke, Henning Albrecht, Claudia M Witt, Michael Teut, Joern Dahler, Ute Hirschberg, Rainer Luedtke, Henning Albrecht, Claudia M Witt

Abstract

Background: Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo.

Methods: This multicentre, randomised, double-blind, placebo-controlled phase 1 trial consisted of a 7-day run-in period, a 5-day intervention period and a 16-day post-intervention observation period. Subjects, investigators and statisticians were blinded for intervention groups and identity of the homeopathic drug. Subjects in the intervention group received Okoubaka aubrevillei (potency C12) and subjects in the placebo group received the optically identical sucrose globules. Dosage in both groups was five globules taken five times per day over a maximum period of 5 days. Subjects documented the symptoms they experienced in a semistructured online diary. The primary outcome parameter was the number of characteristic proving symptoms compared with placebo after a period of 3 weeks. Characteristic symptoms were categorised using content analysis. Secondary outcome parameters were the qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms was quantitatively analysed on an intention-to-treat basis using analyses of covariance with the subject's expectation and baseline values as covariates.

Results: Thirty-one subjects were included (19 Okoubaka and 12 placebo). Data for 29 participants could be analysed. No significant differences in number of characteristic symptoms in both groups were observed between Okoubaka (mean±standard deviation 5.4±6.0) and placebo (4.9±5.6). The odds ratio for observation of a characteristic symptom was 1.11 (95% confidence interval 0.4 to 3.05, P=0.843). Females and subjects expecting a higher number of symptoms at baseline or feeling more sensitive to homeopathic drugs experienced more characteristic symptoms regardless of allocation. The qualitative analysis showed an inter-coder reliability of 0.69 (95% confidence interval 0.62 to 0.76). The qualitative comparison of symptom profiles was inconclusive.

Conclusions: Combined results of qualitative and quantitative methods did not result in a significant difference of characteristic proving symptoms between O. aubrevillei C12 and placebo. The qualitative comparison of the symptom profiles leaves some open questions. The nocebo effect might be a plausible explanation for most of the phenomena observed in this trial.

Trial registration: ClinicalTrials.gov: NCT01061229.

Figures

Figure 1
Figure 1
Flowchart of participants.

References

    1. Dantas F, Fisher P, Walach H, Wieland F, Rastogi DP, Texeira H, Koster D, Jansen JP, Eizayaga J, Alvarez MEP, Marim M, Belon P, Weckx LLM. A systematic review of the quality of homeopathic pathogenetic trials published from 1945 to 1995. Homeopathy. 2007;96:4–16. doi: 10.1016/j.homp.2006.11.005.
    1. European Committee for Homeopathy. Homeopathic drug proving guidelines. Brussels; 2004. [ ]
    1. Teut M, Dahler J, Lucae C, Koch U. Kursbuch Homöopathie. München: Urban und Fischer; 2008.
    1. Walach H. In: Naturheilverfahren und Unkonventionelle Medizinische Richtungen. Bd. 4. Bühring M, Kemper FH, editor. Berlin/Heidelberg: Springer; 2005. Methoden der Homöopathischen Arzneimittelprüfung, Teil 1: Historische Entwicklung und Stand der Forschung.
    1. Hahnemann S. In: Organon der Heilkunst. Textkritische Ausgabe. Schmidt JM, editor. Stuttgart: Haug Publishers; 1999.
    1. Walach H. Wissenschaftliche Homöopathische Arzneimittelprüfung. Doppelblinde Crossover-Studie einer homöopathischen Hochpotenz gegen Placebo. Heidelberg: Haug; 1992.
    1. Möllinger H, Schneider R, Löffel M, Walach H. A double-blind, randomised, homeopathic pathogenetic trial with healthy persons: comparing two high potencies. Forsch Komplementarmed Klass Naturheilkd. 2004;11:274–280. doi: 10.1159/000082120.
    1. Walach H, Sherr J, Schneider R, Shabi R, Bond G, Rieberer G. Homeopathic proving symptoms: result of a local, non-local, or placebo-process? A blinded, placebo-controlled pilot study. Homeopathy. 2004;93:179–185. doi: 10.1016/j.homp.2004.07.006.
    1. Möllinger H, Schneider R, Walach H. Homeopathic pathogenetic trials produce specific symptoms different from placebo. Forsch Komplementarmed. 2009;16:105–110. doi: 10.1159/000209386.
    1. Walach H, Möllinger H, Sherr J, Schneider R. Homeopathic pathogenetic trials produce more specific than non-specific symptoms: results from two double-blind placebo controlled trials. J Psychopharmacol. 2008;22:543–552. doi: 10.1177/0269881108091259.
    1. Teut M, Dahler J, Schnegg C. Wilsede Study Group for Homeopathic Provings. A homeopathic proving of Galphimia glauca. Forsch Komplementarmed. 2008;15:211–217. doi: 10.1159/000148825.
    1. Teut M, Hirschberg U, Luedtke R, Schnegg C, Dahler J, Albrecht H, Witt CM. Protocol for a phase 1 homeopathic drug proving trial. Trials. 2010;11:80. doi: 10.1186/1745-6215-11-80.
    1. Homöopathisches Arzneibuch 2009 (HAB 2009). Amtliche Ausgabe. Stuttgart: Deutscher Apotheker Verlag; 2009.
    1. Mayring P. Qualitative Inhaltsanalyse. Grundlagen und Techniken. 7. Auflage. Weinheim: Deutscher Studien Verlag; 2000.
    1. Rubin DB. Multiple Imputations for Nonresponse in Surveys. New York: John Wiley & Sons; 1987.
    1. Kunst M. Okoubaka, ein neues homöopathisches Arzneimittel. AHZ. 1972;3:116–121.
    1. Wagner H, Kreutzkamp B, Jurcic K. Inhaltsstoffe und Pharmakologie der Okoubaka aubrevillei-Rinde. Planta Med. 1985;5:404–407.
    1. Schlüren E. Okoubaka aubrevillei – ein klinischer Erfahrungsbericht. AHZ. 1991;236:225–231.
    1. Boericke W. Homöopathische Mittel und ihre Wirkungen. Materia Medica und Repertorium. 9. Leer: Grundlagen und Praxis Wissenschaftlicher Autorenverlag; 2008.
    1. Riley DS. Materia Medica of New and Old Homeopathic Medicines. Berlin Heidelberg: Springer Verlag; 2012.
    1. Stübler M. Die Arzneimittelprüfung am gesunden Menschen. Geschichte und Aufbau der heutigen Prüfungsmethoden in der Homöopathie. Deutsche Apotheker Zeitung. 1986;126:575–578.
    1. Sherr J. Dynamics and Methodology of Homeopathic Provings. London: Dynamis School; 1994.
    1. Walach H, Kösters H, Henning T, Haag G. The effects of homeopathic belladonna 30 CH in healthy volunteers – a randomised, double blind experiment. J Psychosom Res. 2001;50:155–160. doi: 10.1016/S0022-3999(00)00224-5.
    1. Häuser W, Hansen E, Enck P. Nocebo phenomena in medicine: their relevance in everyday clinical practice. Dtsch Arztebl Int. 2012;109:459–465.
    1. Klosterhalfen S, Kellermann S, Braun S, Kowalski A, Schrauth M, Zipfel S, Enck P. Gender and the nocebo response following conditioning and expectancy. J Psychosom Res. 2009;66:323–328. doi: 10.1016/j.jpsychores.2008.09.019.
    1. Rief W, Nestoriuc Y, von Lilienfeld-Toal A, Dogan I, Schreiber F, Hoffmann SG, Barsky AJ, Avorn J. Differences in adverse effect reporting in placebo groups in SSRI and tricyclic antidepressant trials: a systematic review and meta-analysis. Drug Saf. 2009;32:1041–1056. doi: 10.2165/11316580-000000000-00000.
    1. Bayr G. A model for homeopathic drug tests including statistical analysis. Br Homeopath J. 1986;75:80–88. doi: 10.1016/S0007-0785(86)80085-0.
    1. Mitsikostas DD, Mantonakis LI, Chalarakis NG. Nocebo is the enemy, not placebo. A meta-analysis of reported side effects after placebo treatment of headaches. Cephalgia. 2011;31:550–561. doi: 10.1177/0333102410391485.
    1. Häuser W, Bartram C, Bartram-Wunn E, Tölle T. Adverse events attributable to nocebo in randomised controlled drug trials in fibromyalgia syndrome and painful diabetic peripheral neuropathy: a systematic review. Clin J Pain. 2012;28:437–451. doi: 10.1097/AJP.0b013e3182321ad8.
    1. Mora MS, Nestoriuc Y, Rief W. Lessons learned from placebo groups in antidepressant trials. Philos Trans R Soc Lond B Biol Sci. 2011;366:1879–1888. doi: 10.1098/rstb.2010.0394.
    1. Amanzio M, Corazzini LL, Vase L, Benedetti F. A systematic review of adverse events in placebo groups of anti-migraine clinical trials. Pain. 2009;146:261–269. doi: 10.1016/j.pain.2009.07.010.
    1. Link J, Haggard R, Kelly K, Forrer D. Placebo/nocebo symptom reporting in a sham herbal supplement trial. Eval Health Prof. 2006;29:394–406. doi: 10.1177/0163278706293403.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi