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

[Tiziana Di Giampietro]

Lo prendo io, stavo  già facendo la recensione dell'abstract assegnatomi da
Simonetta e aspettavo il full text
Tiziana Di Giampietro

Il giorno 04 agosto 2010 18:18, Gino Santini <g.santini a ismo.it> ha scritto:

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> SIOMI / Redazione di Omeopatia33
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>  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
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> 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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