Homeopathy as Boundary Object and Distributed Therapeutic Agency. A Discussion on the Homeopathic Placebo Response.

BACKGROUND: We discuss homeopathy's placebo effect as the result of a distributed therapeutic agency involving humans, objects, and texts. Homeopathy has been involved in controversies for centuries, and the dispute whether it is therapy or quackery is as lively as ever. Still, homeopathy has retained significant popularity and acceptance within the medical establishment. AREAS OF UNCERTAINTY: We bracket the issue of biochemical effectiveness of homeopathic remedies as we only discuss homeopathy's potential to elicit a placebo response within its therapeutic alliance, in virtue of its social, symbolic, and material features. DATA SOURCES: The review is based on literature discussing homeopathic effectiveness, including historical, biographical, sociological, and epistemological perspectives. We build upon research that clarifies the therapeutic relationship, examining its activities and meanings for practitioners and patients. RESULTS: Previous analyses discussing homeopathy's placebo effect stress the importance of the individualized consultation that functions as psychotherapy and generates empathy and hope. We enlarge the discussion, highlighting homeopathy's distributed therapeutic agency across humans, texts, and materials. The historical evolution of homeopathy in relation to biomedicine and science is important to understand its institutional integration into mainstream medicine and its appeal to scientifically minded doctors. Anecdotes of healing and the message of no-harm encourage patients to try homeopathy and hope for the best. The esthetics and ritual of remedies, coupled with computers' scientific legitimacy and time-saving power constitute a material infrastructure of therapeutic persuasion. CONCLUSIONS: Through its relation with biomedicine, its doctrine, consultation design, and treatment rituals, homeopathy offers a powerful medium to elicit a placebo response in a therapeutic alliance. By virtue of its proximity and radical difference from the scientific and biomedical enterprises, its material and textual organization, its storytelling and esthetics, homeopathy offers doctors and patients the opportunity and the tools to collaborate, to witness healing, and to hope for success against adversity.

Symptom Similarity versus Disease Similarity: Revisiting the Application of the Law of Similars and Challenging the Symptom-Centric Approach in Homeopathy.

The system of homeopathic medicine is based on the Law of Similars. It is often implied by students and practitioners of homeopathy that the fundamental principle suggests that if the substance is capable of producing certain 'symptoms', it can also remove, treat, or 'annihilate' similar symptoms if the same substance is administered in a small dose. Hahnemann clearly highlights the importance of pathogenesis or 'disease-producing power', and not just the symptoms-producing power, as a part of the 'totality of the disease'. The author perceives the need for a rectification in the symptom-centric approach in homeopathy. The pathogenesis of disease includes the mechanisms and the cause, which are more complete than the consideration of mere symptoms. Thus, the fundamental approach needs to be extended beyond the symptoms' similarity to the disease-pathogenesis similarity. Several clinical examples are given based on the imaginary expansion that is constructed on the 'mind' symptoms without the inclusion of the pathogenesis of the medicinal substance, suggesting the limitations and the risks to homeopathy of a purely symptom-centric approach.

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

INTRODUCTION: Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma. OBJECTIVE: The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents. METHODS: Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit. RESULTS: Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported. CONCLUSIONS: This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol. CLINICAL TRIAL REGISTRATION: RBR-6XTS8Z.

"Placebo effect is probably what we refer to as patient healing power": A qualitative pilot study examining how Norwegian complementary therapists reflect on their practice.

BACKGROUND: Complementary therapists spend considerable time with their patients, especially in the first consultation. The communication between patients and their therapists is important for raising consciousness and activation of the patient's self-healing power. Thus, the aims in this study were to delineate what complementary therapists regard as essential in patient consultations, their view of the healing process, and how the therapists understand the placebo effect and its position in the healing process. METHODS: Semi-structured individual interviews (n = 4), focus group interview (n = 1) and participant observation were conducted among four different complementary therapists in a Norwegian community. The text data was transcribed verbatim and the analysis of the material was conducted according to conventional and direct content analysis. Some codes were predefined and others were defined during the analysis. RESULTS: The pilot study showed that the implemented methods seems feasible and fit well with the aims of this study. Complementary therapists (chiropractor, naprapath (musculoskeletal therapist), acupuncturist and acupuncturist/homeopath) representing four different complementary modalities participated. A combination of the conversation and examination during the first consultation formed the basis for the therapist's choice of treatment. A successful consultation was characterized by a fruitful relationship between the therapist and the patient. Moreover, the therapist needs to be humble and show the patient respect. Patients' positive beliefs and expectations about the treatment play a significant role in the healing process. The more hope the therapist can bring about, the more easily the patient can start believing that it is possible to get well. CONCLUSION: This was a pilot study. Therefore the findings should be appreciated as limited and preliminary. Therapists' and patients' mutual understanding and treatment goals were essential for a successful consultation. The therapists emphasized their professional skills and therapeutic competence as important when building fruitful relationships with their patients. Exerting authority and making the patient feel confident were essential factors for a successful healing process. The complementary therapists understood the placebo effect as the patient's self-healing power, resulting from establishing trust and belief in the treatment process.

The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals.

Scientists and neuroethicists have recently drawn attention to the ethical and regulatory issues surrounding the do-it-yourself (DIY) brain stimulation community, which comprises individuals stimulating their own brains with transcranial direct current stimulation (tDCS) for self-improvement. However, to date, existing regulatory proposals and ethical discussions have been put forth without engaging those involved in the DIY tDCS community or attempting to understand the nature of their practices. I argue that to better contend with the growing ethical and safety concerns surrounding DIY tDCS, we need to understand the practices of the community. This study presents the results of a preliminary inquiry into the DIY tDCS community, with a focus on knowledge that is formed, shared and appropriated within it. I show that when making or acquiring a device, DIYers (as some members call themselves) produce a body of knowledge that is completely separate from that of the scientific community, and share it via online forums, blogs, videos and personal communications. However, when applying tDCS, DIYers draw heavily on existing scientific knowledge, posting links to academic journal articles and scientific resources and adopting the standardised electrode placement system used by scientists. Some DIYers co-opt scientific knowledge and modify it by creating their own manuals and guides based on published papers. Finally, I explore how DIYers cope with the methodological limitations inherent in self-experimentation. I conclude by discussing how a deeper understanding of the practices of DIY tDCS has important regulatory and ethical implications.

Physiological effects of homeopathic medicines in closed phials--a critical evaluation.

BACKGROUND: Phials containing high dilutions of homeopathic remedies are commonly utilized in diagnostic tools in combination with electro acupuncture measuring electrical conductivity of the skin. The present research aimed to elucidate the interaction of the homeopathic remedy and the human organism. METHOD: The study protocol included the transition of a healthy subject to a diseased state utilizing a sub-harmful dose of a toxin. Subsequently, the subject was exposed to a homeopathic or placebo remedy in a closed glass phial and electrical conductivity was measured in open as well as in blind trials. A total of 229 data were collected from open trials and 750 data from blind trials. RESULT: The experimental data showed that homoeopathic remedies in closed glass phials may influence the electrical skin conductivity. The results of the blind trials differed considerably from those of the open trials. The percentage of correctly identified (verum and placebo) phials in the open trials (85%) was statistically different from those in the blind trials (65%). In both types of trials, however, the difference between the sealed phials containing the homeopathic medicine and the placebo was statistically significant. The results of measurements are directly linked to the way in which the tester holds the electrode in one hand and the subject's finger in the other, while putting pressure on the electrode. CONCLUSION: It was concluded that the tester's muscle tone is the intermediary in unconsciously selecting which phial influenced him in his specific contact with the subject.

Scientific proving of ultra high dilutions on humans.

BACKGROUND: Homeopathic drug provings or pathogenetic trials (HPTs) are the pillar of homeopathy. This review summarizes the authors' findings and interpretations derived from a series of homeopathic drug proving between 1994 and 2015. It gives an overview over a series of attempts to use modern scientific experimental methodology to answer the question, whether such HPTs produce symptoms in healthy volunteers that can be distinguished from placebo symptoms. METHODS: Various experimental models were used: repeated crossover trials with categorical data collection, and a single-case, randomised study. Final models use diligent qualitative data-collection in experienced volunteers. In those, raters decide whether symptoms are typical for a remedy delivered or not. The design is triple-blind and placebo-controlled. RESULT: While previous attempts were inconclusive, this new model allowed to separate placebo symptoms from verum symptoms repeatedly in a series of two definitive studies following promising pilot studies. Results were statistically significant. Also, some signs of the purported non-local signature of homeopathic effects were visible, and the consequences for future methodology is discussed. CONCLUSION: Provided some cautionary notes are taken into account, HPTs can be used to separate out true specific symptoms from placebo symptoms. By the same token this is a road to experimental proof that homeopathic remedies are not just placebos. However, this needs to be taken forward by independent groups.

Hahnemann and placebo.

Samuel Hahnemann (1755-1843) known today as the founder of homoeopathy, was - as far as we know - the first physician who administrated placebos to his patient on a systematic and regular basis. This study is based upon unpublished documents (e.g. patients' letters) in the Archives of the Institute for the History of Medicine of the Robert Bosch Foundation in Stuttgart. It also profited from the critical edition of Hahnemann's case journals and the editorial comments which have also been published in this series. Hahnemann differentiated clearly between homeopathic drugs and pharmaceutical substances which he considered as sham medicine (e.g. milk sugar). A close look at Hahnemann's case journals reveals that the percentage of placebo prescriptions was very high (between 54 and 85 percent). In most instances Hahnemann marked placebos with the paragraph symbol (§). The rationale behind this practice was that Hahnemann had encountered the well-known problem that patients were used to taking medicine on a daily basis as it was typical for the age of heroic medicine. The main reason for giving placebo was therefore to please the impatient patient who was used to frequent medications in allopathic medicine, not only every day but sometimes also hourly.

Do Homeopathic Pathogenetic Trials generate recognisable and reproducible symptom pictures?: Results from a pilot pathogenetic trial of Ozone 30c.

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.

A quantum-like model of homeopathy clinical trials: importance of in situ randomization and unblinding.

BACKGROUND: The randomized controlled trial (RCT) is the 'gold standard' of modern clinical pharmacology. However, for many practitioners of homeopathy, blind RCTs are an inadequate research tool for testing complex therapies such as homeopathy. METHODS: Classical probabilities used in biological sciences and in medicine are only a special case of the generalized theory of probability used in quantum physics. I describe homeopathy trials using a quantum-like statistical model, a model inspired by quantum physics and taking into consideration superposition of states, non-commuting observables, probability interferences, contextuality, etc. RESULTS: The negative effect of blinding on success of homeopathy trials and the 'smearing effect' ('specific' effects of homeopathy medicine occurring in the placebo group) are described by quantum-like probabilities without supplementary ad hoc hypotheses. The difference of positive outcome rates between placebo and homeopathy groups frequently vanish in centralized blind trials. The model proposed here suggests a way to circumvent such problems in masked homeopathy trials by incorporating in situ randomization/unblinding. CONCLUSION: In this quantum-like model of homeopathy clinical trials, success in open-label setting and failure with centralized blind RCTs emerge logically from the formalism. This model suggests that significant differences between placebo and homeopathy in blind RCTs would be found more frequently if in situ randomization/unblinding was used.

Against homeopathy--a utilitarian perspective.

I examine the positive and negative features of homeopathy from an ethical perspective. I consider: (a) several potentially beneficial features of homeopathy, including non-invasiveness, cost-effectiveness, holism, placebo benefits and agent autonomy; and (b) several potentially negative features of homeopathy, including failure to seek effective healthcare, wastage of resources, promulgation of false beliefs and a weakening of commitment to scientific medicine. A utilitarian analysis of the utilities and disutilities leads to the conclusion that homeopathy is ethically unacceptable and ought to be actively rejected by healthcare professionals.

[Placebo and the relationship between doctors and patients. Overview]. / Placeboaspekte der Arzt-Patienten-Beziehung. Übersicht.

In medicine, placebos are used both in scientific studies and for practical therapeutic purposes. In evidence-based medicine, the efficacy of treatment may be determined as the difference between the effects of the verum (the active study drug) and the placebo, the latter being a substance lacking specific action on the disease under consideration. However, the improvements in patients' conditions under placebo treatment may be substantial and comparable to those with verum. Genuine placebos predominate in clinical studies, while pseudoplacebos prevail in practical therapy. The term pseudoplacebo can also be applied to many procedures in complementary medicine, including homeopathic medicine (Büchel et al., Placebo in der Medizin, 2011). The comprehensive definition of placebo, as used in a report by the German Medical Association (Büchel et al., Placebo in der Medizin, 2011), states that a placebo effect may occur even when treating with verum. The placebo effect is modulated by the context of the treatment, by the expectations of the patients and the doctors, and by the success of the relationship between doctors and patients. A number of unspecific effects, e.g., spontaneous alleviation, statistical effects, variance with time, methodological errors, in addition to the placebo effect make up the total response that is called"placebo reaction." A complete list of the effectiveness of placebo for all important diseases is still lacking. Further, it is not possible to predict which patients will respond to placebo. Which characteristics of doctors are important (competence, empathy, communicative ability and partnership, trust) in order to achieve a placebo effect, particularly in addition to the verum effect measures of evidence-based medicine? Are there doctors who are better in this than others? Could the nocebo effect weaken the efficacy of treatment in evidence-based medicine? Since a placebo effect may occur in almost any standard therapy, information about placebos should be provided during medical education and continuing medical education (CME). The use of placebo in clinical studies is ethically justified and lawful in consenting patients if there is no other effective treatment available with which the test substance could be compared. For daily practical therapeutic purposes, placebos may be ethically acceptable and lawful if there is no effective therapy available, if the complaints are minor, if the patient expressly wishes treatment, and if there is a reasonable likelihood of success. However, an explanation of the expected benefits and risks must be provided to the patients. At present, there are two explanatory theories for the mechanism of action of placebo, namely, the associative and the mentalistic explanation (Büchel et al., Placebo in der Medizin, 2011). Interestingly, effects of placebo and of verum can be localized in the brain by physiological and anatomical techniques. With many open questions remaining, research on placebo is currently very active. These aspect and neurobiological findings in particular may facilitate for "scientifically" educated doctors to accept that ineffective materials, i.e., placebos, are in fact effective.

To feel what others feel: two episodes from 18th century medicine.

In the late 18th century two medical fashions--Mesmerism in France and the Perkins 'tractor' in the USA and England--appealed to the principle that a single universal force acts on all of us and is responsible for health and illness. This principle served both fashions well, as it made it all the easier for those who came within their force fields to experience the sort of sensations that other subscribers to the fashion also seemed to feel. The first research on what is now known as the placebo effect was in connection with these two movements. The propensity to feel what we suppose or imagine that others like us feel remains even now one of the channels of the placebo effect.

Placebo effect sizes in homeopathic compared to conventional drugs - a systematic review of randomised controlled trials.

BACKGROUND: It has been hypothesised that randomised, placebo-controlled clinical trials (RCTs) of classical (individualised) homeopathy often fail because placebo effects are substantially higher than in conventional medicine. OBJECTIVES: To compare placebo effects in clinical trials on homeopathy to placebo effects on trials of conventional medicines. METHODS: We performed a systematic literature analysis on placebo-controlled double-blind RCTs on classical homeopathy. Each trial was matched to three placebo-controlled double-blind RCTs from conventional medicine (mainly pharmacological interventions) involving the same diagnosis. Matching criteria included severity of complaints, choice of outcome parameter, and treatment duration. Outcome was measured as the percentage change of symptom scores from baseline to end of treatment in the placebo group. 35 RCTs on classical homeopathy were identified. 10 were excluded because no relevant data could be extracted, or less than three matching conventional trials could be located. RESULTS: In 13 matched sets the placebo effect in the homeopathic trials was larger than the average placebo effect of the conventional trials, in 12 matched sets it was lower (P=0.39). Additionally, no subgroup analysis yielded any significant difference. CONCLUSIONS: Placebo effects in RCTs on classical homeopathy did not appear to be larger than placebo effects in conventional medicine.

The placebo effect and homeopathy.

BACKGROUND: Like other forms of medicine, including Complementary and Alternative Medicine (CAM), homeopathy elicits expectations in patients. The physician-patient relationship, personal and comprehensive treatment and lack of adverse effects are elements in creating positive expectations. Other elements may be associated with negative expectations. METHODS: We conducted a systematic literature review on placebo and nocebo effects in acupuncture and homeopathy using Medline. RESULTS: Findings on the psychophysiological and neuromediating mechanisms of the placebo-nocebo phenomenon are reviewed. Studies of these effects reveal how expectations and unconscious conditioning can be measured by imaging and EEG methods. They result in significant, non-specific therapeutic effects, which may confuse the evaluation of the specific therapeutic effects treatment, hampering selection of the simillimum. CONCLUSIONS: Directions for future research on non-specific therapeutic effects of homeopathy to improve clinical practice and clinical research are discussed.

[Homeopathy]. / Homöopathie.

Even after 200 years, homeopathy has remained a highly disputed method. Its principles fly in the face of science. The totality of about 200 clinical trials fails to demonstrate its efficacy beyond placebo. Its use as a benign placebo is ethically unjustifiable. It follows that homeopathy cannot be recommended for use in medical routine.