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Protocol for a phase 1 homeopathic drug proving trial

BACKGROUND: This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design. METHOD: Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day inte...

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Autores principales: Teut, Michael, Hirschberg, Ute, Luedtke, Rainer, Schnegg, Cristoph, Dahler, Joern, Albrecht, Henning, Witt, Claudia M
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917434/
https://www.ncbi.nlm.nih.gov/pubmed/20649979
http://dx.doi.org/10.1186/1745-6215-11-80
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author Teut, Michael
Hirschberg, Ute
Luedtke, Rainer
Schnegg, Cristoph
Dahler, Joern
Albrecht, Henning
Witt, Claudia M
author_facet Teut, Michael
Hirschberg, Ute
Luedtke, Rainer
Schnegg, Cristoph
Dahler, Joern
Albrecht, Henning
Witt, Claudia M
author_sort Teut, Michael
collection PubMed
description BACKGROUND: This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design. METHOD: Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 10(24)), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure. DISCUSSION: Homeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01061229.
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spelling pubmed-29174342010-08-07 Protocol for a phase 1 homeopathic drug proving trial Teut, Michael Hirschberg, Ute Luedtke, Rainer Schnegg, Cristoph Dahler, Joern Albrecht, Henning Witt, Claudia M Trials Study Protocol BACKGROUND: This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design. METHOD: Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 10(24)), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure. DISCUSSION: Homeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01061229. BioMed Central 2010-07-22 /pmc/articles/PMC2917434/ /pubmed/20649979 http://dx.doi.org/10.1186/1745-6215-11-80 Text en Copyright ©2010 Teut et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Study Protocol
Teut, Michael
Hirschberg, Ute
Luedtke, Rainer
Schnegg, Cristoph
Dahler, Joern
Albrecht, Henning
Witt, Claudia M
Protocol for a phase 1 homeopathic drug proving trial
title Protocol for a phase 1 homeopathic drug proving trial
title_full Protocol for a phase 1 homeopathic drug proving trial
title_fullStr Protocol for a phase 1 homeopathic drug proving trial
title_full_unstemmed Protocol for a phase 1 homeopathic drug proving trial
title_short Protocol for a phase 1 homeopathic drug proving trial
title_sort protocol for a phase 1 homeopathic drug proving trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2917434/
https://www.ncbi.nlm.nih.gov/pubmed/20649979
http://dx.doi.org/10.1186/1745-6215-11-80
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