[Omeo33] Art 1133 - Trials, 2010, 11 (80)

[Gino Santini]

Protocol for a phase 1 homeopathic drug proving trial
Michael Teut, Ute Hirschberg, Rainer Luedtke, Christoph Schnegg, Joern  
Dahler, Henning Albrecht and Claudia M Witt

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 = 1024), 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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