Homeopathic pathogenetic trials produce more specific than non-specific symptoms: Results from two double-blind placebo controlled trials

School of Social Sciences and European Office of the Samueli Institute for Information Biology, University of Northampton, Northampton, UK.
Journal of Psychopharmacology (Impact Factor: 3.59). 08/2008; 22(5):543-52. DOI: 10.1177/0269881108091259
Source: PubMed


We conducted two parallel, blinded homeopathic pathogenetic trials conducted at two different sites to determine whether symptoms reported by healthy volunteers were significantly different for homeopathic remedies than for placebos. Study 1 used a two-armed design, testing ozone against placebo. Study 2 used a three-armed design, testing ozone and iridium against placebo. We found significantly more remedy-specific symptoms in provers taking ozone or iridium than in provers taking placebo in the three-armed trial and in both trials pooled for ozone and placebo. We, therefore, conclude that homeopathic remedies produce more symptoms typical for a remedy than non-typical symptoms. The results furthermore suggest a somewhat non-classical pattern because symptoms of one remedy appear to be mimicked in the other trial arm. This might be indicative of entanglement in homeopathic systems.

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    • "HPT was delayed until after the present study was conducted, so as to preserve the blinding required for the present study. The full list of symptoms from the Walach et al. 2008 replication has not yet been published, nor included in the materia medica. A total of 53 participants took part in the replicated trial, 17 were novice volunteers from UK/Canada and 36 were experienced volunteers from Freiburg, Germany. "
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    ABSTRACT: Background Homeopathic Pathogenetic Trials (HPTs) are a pillar of homeopathy, a key source of the symptoms characteristic of a particular homeopathic medicine. Homeopaths choose homeopathic medicines by comparing these remedy pictures with the symptoms the patient is presenting. Thus, recognition of these symptom sets underpins the clinical practice of homeopathy. Objective To test whether HPTs generate consistent and recognisable sets of symptoms in consecutive trials. Design Practising homeopaths, blinded to the homeopathic medicine under investigation, were given the set of symptoms generated during an unpublished HPT and asked to identify the homeopathic medicine used. Homeopathic trial substance Ozone, prepared by homeopathic method to the ultramolecular dilution of 30c (10−60 dilution), was chosen at random from twenty potential medicines. Results Seven practising homeopaths were asked to make three guesses as to the identity of the remedy. Initially from the full list of possible remedies (N = 2372). Two of the seven homeopaths guessed the identity of the remedy correctly (p < 0.0001). Subsequently, when their choice of possible medicines was restricted to a list of 20, the same two homeopaths selected the correct medicine, however none of the other practising homeopaths did so (p = 0.2). Discussion The selection of the correct homeopathic medicine from the unrestricted list (N = 2372 medicines) by two homeopaths is noteworthy given that the homeopathic medicine used during the HPT was diluted well beyond Avogadro's number and would not be expected to produce any detectable or recognisable symptomatology. Possible reasons why the remaining five homeopaths did not guess correctly are discussed. Conclusion The results show that practising homeopaths may be able to correctly identify a homeopathic medicine from the set of symptoms generated during an HPT. This suggests that such symptom pictures generated by taking an ultramolecular homeopathic medicine are recognisable and specific to the substance taken. Since identification of the remedy was based on past HPT information held in the materia medica, this demonstrates that HPT-generated symptom pictures are reproducible, thus validating the HPT methodology. These promising preliminary findings warrant replication; possible improvements to the trial design to be incorporated in future studies were identified.
    Full-text · Article · Apr 2014 · Homeopathy: the journal of the Faculty of Homeopathy
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    • "Jeremy Sherr, who actively re-established HDPs in the 1980s and 1990s, writes in his manual The Dynamics and Methodology of Homeopathic Provings: ‘… Furthermore it is interesting to note that placebo proving occasionally seem to produce similar symptoms to the proving symptoms, thus casting further doubt on the use of this medium in proving’ [22]. Walach observed in two more recent HDPs (Atropa belladonna, and Cantharis) symptoms that were considered highly specific for the homeopathic drug also in the placebo group [8,10,23]. However, these results were in contrast to another homeopathic proving, where a specific effect was observed [9]. "
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    ABSTRACT: Homeopathic drug proving is a basic concept in homeopathy. This study aimed to record symptoms produced by a homeopathic drug compared with placebo. 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. 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. 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 NCT01061229
    Full-text · Article · Apr 2013 · Trials
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    • "The blinded homeopaths identified only Arsenicum album-specific symptoms in the Arsenicum album group, only Natrium muriatricum specific symptoms in the Natrium muriaticum group and only non-specific symptoms in the placebo group. The results of this and a previous HDP showed that specific symptoms of the HDP could be identified and allocated by blinded raters with a high statistical significance [8,9,11]. To our knowledge, it is not clear whether the identification of drug-specific symptoms may also be achieved for new and unknown homeopathic drugs. "
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    ABSTRACT: This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design. 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. 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. identifier: NCT01061229.
    Full-text · Article · Jul 2010 · Trials
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