How would you estimate your sensitivity to homeopathic remedies in general?

Protocol for a phase 1 Homeopathic drug proving trial

By: Michael Teut, Ute Hirschberg, Rainer Luedtke, Cristoph Schnegg, Joern Dahler1, Henning Albrecht,C laudia M Witt. (Teut et al. Trials 2010).

Source: Teut et al. Protocol for a phase 1 homeopathic drug
proving trial. Trials 2010 11:80.


Abstract

Background: This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.

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.

Methods

Study design: The homeopathic drug proving trial is to be conducted as a multi-centre, randomised, double-blind, placebo controlled phase 1 trial. Subjects and investigators are not only blinded to the group allocation process but also to the identity of the drug.

Subjects: Volunteer medical students or medical doctors are invited to take part in the trial by their investigators via
email or phone. Subjects can be included if they fulfil the following
criteria: Medical doctors or medical students, over 18 years of age, who are not being treated for any acute or chronic diseases on the day of inclusion, plus written
informed consent.

Investigators: The investigators are homeopathic medical doctors with knowledge of HDP and who have at least three years practical experience in homeopathic therapy.

Questions to subject:
A) "How would you estimate your sensitivity to homeopathic remedies in general?" - possible answers: strong reaction/reaction/slight reaction/no reaction;
B) "How do you expect to react to the homeopathic drug?" - answers: a very high number of symptoms/many symptoms/low number of symptoms/no symptoms.

Questions to investigators:
A) “How would you estimate your subject’s sensitivity to homeopathic remedies in general?”
B) “What is your expectation about your subjects reaction to the homeopathic drug?”

After starting the trial, subjects are required to document daily any new or uncommon symptoms in a semistructured trial diary accessed through a secure internet connection. It will provide a head-to-feet structure to be filled in with free text. Every third day each subject will be contacted by phone by his or her investigator. This optimizes the homeopathic quality of documentation,which is considered crucial.

Qualitative analysis: In the homeopathic community there is no consensus to date on how to qualitatively analyse the trial data which consists of large bodies of text. Criteria defining proving symptoms exist, but it is unclear how to analyse them and how reliable these criteria are.
In this paper we suggest the use of content analysis, according to Mayring, to analyse the texts, because it fulfils five basic criteria:
1. the opportunity to categorise, 2. a combination of fixed and open categorisation, 3. the applicability to the homeopathic terminology, 4. the possibility to use software and 5. the possibility to reproduce the analysis.
However, this method is used for homeopathic purposes and it is unclear whether the chosen methodology will be fully suitable.
Indeed, this is a very crucial point: The qualitative analysis is necessary following any quantitative analysis. If it fails, all statistical results (including p-values), are potentially biased.
Therefore, we will test for reliability of the coding of the primary outcome parameter characteristic proving symptoms, which will be performed independently by two experienced homeopaths. Therefore the results are also dependent on the experience of the coding raters.

To optimally fulfil homeopathic criteria according to Hahnemanns Organon (§143), we will use characteristic proving symptoms as the primary outcome parameter.
We feel that this aligns with the homeopathic philosophy of emphasizing the superior role of individualistic and peculiar symptoms.

Source: Teut et al. Protocol for a phase 1 homeopathic drug
proving trial. Trials 2010 11:80.

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