Veterinary homeopathy: systematic review of medical conditions studied by randomised trials controlled by other than placebo.

BACKGROUND: No systematic review has previously been carried out on randomised controlled trials (RCTs) of veterinary homeopathy in which the control group was an intervention other than placebo (OTP). For eligible peer-reviewed RCTs, the objectives of this study were to assess the risk of bias (RoB) and to quantify the effect size of homeopathic intervention compared with an active comparator or with no treatment. METHODS: Our systematic review approach complied fully with the PRISMA 2009 Checklist. Cochrane methods were applied to assess RoB and to derive effect size using standard meta-analysis methods. Based on a thorough and systematic literature search, the following key attributes of the published research were distinguished: individualised homeopathy (n = 1 RCT)/non-individualised homeopathy (n = 19); treatment (n = 14)/prophylaxis (n = 6); active controls (n = 18)/untreated controls (n = 2). The trials were highly diverse, representing 12 different medical conditions in 6 different species. RESULTS: No trial had sufficiently low RoB to be judged as reliable evidence: 16 of the 20 RCTs had high RoB; the remaining four had uncertain RoB in several domains of assessment. For three trials with uncertain RoB and without overt vested interest, it was inconclusive whether homeopathy combined with conventional intervention was more or was less effective than conventional intervention alone for modulation of immune response in calves, or in the prophylaxis of cattle tick or of diarrhoea in piglets. CONCLUSION: Due to the poor reliability of their data, OTP-controlled trials do not currently provide useful insight into the effectiveness of homeopathy in animals.

A new geometrical description of entanglement and the curative homeopathic process.

INTRODUCTION: The Memory of Water, a "local" explanation of homeopathy's efficacy, has been supplemented recently by complementary "nonlocal" hypotheses. One of these envisages "quantum macro-entanglement" among patient, practitioner, and remedy to form a "PPR" entangled state, from which the possibility of cure may manifest. METHODS: Semiotic analysis affords a geometrical description of this entangled state as a patient-centered chiral tetrahedron. Its four corners depict three different types of symptoms (of the patient, the dis-ease, and the remedial substance) and the potentized remedy. RESULTS: Reflecting this state in a practitioner-derived mirror-like "therapeutic state space" generates two notional patient-centered chiral tetrahedra: cure may be thought to arise from their patient-driven combination "through the looking glass" of the therapeutic state space, into one polyhedron called a stella octangula or stellated octahedron; in essence, a 3-dimensional Star of David. CONCLUSIONS: The practitioner helps in forming these notional semiotic polyhedra, but the patient is at their epicenters (i.e., the practitioner facilitates but ultimately does not control the curative process).

Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials.

Although all Chinese materia medica (CMM) come from nature, CMM interventions have both therapeutic effects and adverse effects (AEs). Normally, AEs in randomized controlled trial (RCT) with traditional Chinese medicine (TCM) could be divided into five types as follows: 1) AEs under proper TCM principles and guidelines, such as the toxicity (acute and chronic) and allergy; 2) AEs due to improper usage without following TCM principles, involving without following the TCM therapeutic principles, over-dosage, improper processing and preparation methods, improper formula strategy, etc; 3) AEs due to contamination in CMM, such as heavy metal and pesticides contaminations in Chinese herbal medicine interventions, and intentional or unintentional contamination with drug(s); 4) AEs due to replacement of CMMs; 5) AEs due to drug-herb interaction. AEs of TCM should be treated properly. Overestimation or underestimation about AEs of TCM intervention will bring a wrong message to patients and health care providers. In order to give readers a more comprehensive understanding about the safety issue of study intervention, Consolidated Standards of Reporting Trials (CONSORT) for TCM should involve the background information on side effects of each CMM constituents and/or the study intervention, specific outcome assessment on AEs, the details of reported AEs and the interpretation of the AEs occurrence in a structural RCT report.

Toward a unified theory of homeopathy and conventional medicine.

INTRODUCTION: Could theoretical links exist between homeopathy and conventional medicine? In homeopathy, disturbance of the self-regulating Vital Force (Vf) results in dis-ease as multileveled symptom expression. Treatment aids the Vf as it attempts to restore holistic balance. Conventional medicine (allopathy) deterministically considers external agents (viruses, bacteria, etc.) or internal biochemical imbalances as disease causes. Treatment is geared to eradicating causative factors, sometimes at the expense of the homeostatic immune system. METHOD: A previous mathematical model described the Vf as a quantized gyroscopic "wave function," equating strength of symptom expression to degree of Vf gyroscopic "precession." Diseases and homeopathic remedies were interpreted respectively as braking and accelerating "torques" on Vf "angular momentum." In this paper, approximations applied to the Vf "wave function" could provide insights into why conventional medicine dismisses the action of highly potentized homeopathic remedies. In addition, a simple geometric force diagram provides another mathematical model for allopathic drug action and immune system reaction. RESULTS: The 2 models converge on the same result, delivering conventional biomedicine's conclusion: potentized homeopathic remedies should exert no clinically observable effects. CONCLUSIONS: Following the logic of these models, conventional medicine could be seen as a special case of a broader therapeutic paradigm also containing homeopathy.

Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT.

When homeopathy is tested in clinical trials, understanding and appraisal is likely to be improved if published reports contain details of prescribing strategies and treatments. An international Delphi panel was convened to develop consensus guidelines for reporting homeopathic methods and treatments. The panel agreed on 28 treatment- and provider-specific items that supplement the CONSORT (Consolidated Standards of Reporting Trials) Statement items 2, 3, 4, and 19. The authors recommend these for adoption by authors and journals when reporting trials of homeopathy.

Randomised, double-blind, placebo-controlled trials of non-individualised homeopathic treatment: systematic review and meta-analysis.

BACKGROUND: A rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment. METHODS: Literature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised 'reliable evidence' if its risk of bias was low or it was unclear in one specified domain of assessment. 'Effect size' was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy. RESULTS: Forty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as 'high risk of bias' and 23 as 'uncertain risk of bias'; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was -0.33 (95% confidence interval (CI) -0.44, -0.21), which was attenuated to -0.16 (95% CI -0.31, -0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: -0.18 (95% CI -0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence. CONCLUSIONS: The quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.

Entanglement, knowledge, and their possible effects on the outcomes of blinded trials of homeopathic provings.

INTRODUCTION: In two recent studies of double-blind placebo-controlled homeopathic provings, entanglement was reported to have occurred between verum and placebo arms of the trials. This contrasts directly with the entanglement-disrupting effects of blinding, recently proposed as the reason for the failure of randomized controlled trials (RCTs) to demonstrate unequivocally the efficacy of homeopathy. It is proposed here that such entanglement between remedy and placebo during these double-blind placebo controlled provings is the direct result of the blinding process. METHOD: A previously developed theoretical model of entanglement in homeopathy among patient, practitioner, and remedy (called PPR entanglement) was used in this investigation. RESULTS: In agreement with the results from the proving studies, the model predicts that application of the double-blind RCT methodology to homeopathic provings leads to entanglement between both remedy and placebo arms of the trial. CONCLUSIONS: These theoretical findings can be understood in terms of the act of blinding leading to loss of information because of quantum-like state superposition of the verum and placebo proving groups. This is compared to conclusions drawn from the well-known double-slit experiment of quantum physics, and quantum information processing. It leads to a suggestion for testing entanglement in homeopathic provings.

Is homeopathy possible?

As a therapeutic intervention, homeopathy is the target of increased scepticism because in the main, its remedies are diluted and succussed (potentized) out of material existence. This puts homeopathy seemingly at odds with the paradigm of conventional science, in particular, that atoms and molecules are the fundamental building blocks of all matter. Accordingly, homeopathy cannot work, so that any reported beneficial effects must, at best, be due to the placebo effect. The purpose of this article is to challenge that conclusion and to suggest that there may well be conventional science-based explanations of how homeopathy could be possible. Homeopathy's key principles are first described. Then the double-blind randomized controlled trial (RCT), the chief means by which homeopathic remedies and prescribing are tested, is shown to be based on a linear reductionism that is too blunt an instrument with which to test the efficacy of complex interventions such as homeopathy The memory of water hypothesis, as a mechanism for how potentized remedies might work, is reviewed, along with some evidence for its existence. A possible rationale for the water memory effect is proposed in terms of a dynamic 'ordering' of water's constantly switching network of intermolecular hydrogen bonds, induced by the manufacturing process of homeopathic remedies. This could lead to a long-range molecular 'coherence' between trillions of mobile water molecules. However, the water memory effect is an essentially pharmacological explanation of homeopathy's putative efficacy. It is pointed out that healing also entails an interaction between consenting beings. From this point of view, an explanation of any therapeutic procedure should include an attempt to describe the nature of the patient-practitioner interaction. From this perspective, a quantum theoretical treatment of the therapeutic process, involving a form of macro-entanglement between patient, practitioner and remedy (PPR), is advanced as another possible explanation of the homeopathy's efficacy. This shows that the reason double-blind RCTs deliver at best only equivocal results on homeopathy's efficacy is because it effectively breaks the PPR entangled state. A comparison is made between the entanglement-breaking effect of double-blind RCTs and the wave-function 'collapsing' effect of observation in orthodox quantum theory. The article concludes by suggesting that the memory of water and PPR entanglement are not competing but most likely complementary hypotheses, and that both are probably required in order to provide a complete description of the homeopathic process. While awaiting experimental evidence of these hypotheses, it is suggested that observations of clinical outcomes would be superior to RCTs for further testing homeopathy's efficacy.

Research on homeopathy: state of the art.

In this paper, we review research on homeopathy from four perspectives, focusing on reviews and some landmark studies. These perspectives are laboratory studies, clinical trials, observational studies, and theoretical work. In laboratory models, numerous effects and anomalies have been reported. However, no single model has been sufficiently widely replicated. Instead, researchers have focused on ever-new models and experiments, leaving the picture of scattered anomalies without coherence. Basic research, trying to elucidate a purported difference between homeopathic remedies and control solutions has also produced some encouraging results, but again, series of independent replications are missing. While there are nearly 200 reports on clinical trials, few series have been conducted for single conditions. Some of these series document clinically useful effects and differences against placebo and some series do not. Observational research into uncontrolled homeopathic practice documents consistently strong therapeutic effects and sustained satisfaction in patients. We suggest that this scattered picture has to do with the fourth line of research: lack of a good theory. Some of the extant theoretical models are reviewed, including placebo, water structure, silica contamination, energy models, and entanglement models. It emerges that local models, suggesting some change in structure in the solvent, are far from convincing. The nonlocal models proposed would predict that it is impossible to nail down homeopathic effects with direct experimental testing and this places homeopathy in a scientific dilemma. We close with some suggestions for potentially fruitful research.

Are randomized controlled trials (RCTs) redundant for testing the efficacy of homeopathy? A critique of RCT methodology based on entanglement theory.

INTRODUCTION: Randomized controlled trials (RCTs) have yet to deliver unequivocal results demonstrating the efficacy (or otherwise) of homeopathic remedies and individualized homeopathic prescribing. This could be caused by an implicit assumption inherent in RCT methodology that specific effects of a remedy and any nonspecific effects of consultation are independent of each other. Reported here is a theoretical investigation of the consequences arising from this assumption proving to be false. METHODS: A previously developed theoretical model of entanglement in homeopathy between patient, practitioner, and remedy (called PPR entanglement) was used in this investigation. RESULTS: The adherence to RCT methodology could result in such trials completely disrupting the formation or survival of any three-way PPR entangled state. CONCLUSIONS: Assuming the PPR entangled state is a necessary condition for therapeutic interaction, alternatives to RCTs are urgently required that can take into account possible entangled specific and nonspecific effects during trials of homeopathy. That RCTs sometimes deliver positive results for the use of homeopathic remedies may be caused by residual entanglement arising from homeopathic remedy manufacture.

Randomized controlled trials of individualized homeopathy: a state-of-the-art review.

BACKGROUND AND OBJECTIVE: Individualized homeopathy is the most controversial form of this therapy. This review aims to summarize the actual state of clinical efficacy research on individualized homeopathy. METHODS: Electronic databases as well as other sources were searched for possibly relevant studies. Randomized or quasirandomized controlled clinical trials comparing an individualized homeopathic treatment strategy with placebo, no treatment, or another treatment were eligible. Information on patients, methods, interventions, outcomes, and results was extracted in a standardized manner and quality was assessed using a checklist and two scoring systems. Trials providing sufficient data were pooled in a quantitative meta-analysis. RESULTS: A total of 32 trials (28 placebo-controlled, 2 comparing homeopathy and another treatment, 2 comparing both) involving a total of 1778 patients met the inclusion criteria. The methodological quality of the trials was highly variable. In the 19 placebo-controlled trials providing sufficient data for meta-analysis, individualized homeopathy was significantly more effective than placebo (pooled rate ratio 1.62, 95% confidence interval 1.17 to 2.23), but when the analysis was restricted to the methodologically best trials no significant effect was seen. CONCLUSION: The results of the available randomized trials suggest that individualized homeopathy has an effect over placebo. The evidence, however, is not convincing because of methodological shortcomings and inconsistencies. Future research should focus on replication of existing promising studies. New randomized studies should be preceded by pilot studies.

Are the therapeutic effects of homeopathy attributed to the consultation, the homeopathic remedy, or both? A protocol for a future exploratory feasibility trial in patients with rheumatoid arthritis.

Systematic reviews suggest that homeopathy has a greater effect than placebo, however, the mechanisms of its action are unknown. The clinical effects of homeopathy could be attributed to the specific effects of the remedy and/or to the contextual effects of the consultation process; these factors have not been critically evaluated. We have developed a model that attempt to separate the consultation effects from the specific effects because of the remedy. We propose to investigate this design in a chronic condition, rheumatoid arthritis, for which previous research has evaluated both classical and complex homeopathic interventions. The following protocol describes the study design. The aims of this exploratory trial are to assess the feasibility of the study design, identify effect sizes of the consultation, the complex treatment, and the individualized remedy, as well as possibly efficacy, for the two types of homeopathic treatment and the homeopathic consultation. Data collection will take place in 2004.

Veterinary clinical research database for homeopathy: placebo-controlled trials.

BACKGROUND: Veterinary homeopathy has led a somewhat shadowy existence since its first introduction. Only in the last three decades has the number of clinical trials increased considerably. This literature is generally not well perceived, which may be partly a consequence of the diffuse and somewhat inaccessible nature of some of the relevant research publications. The Veterinary Clinical Research Database for Homeopathy (VetCR) was launched in 2006 to provide information on existing clinical research in veterinary homeopathy and to facilitate the preparation of systematic reviews. OBJECTIVE: The aim of the present report is to provide an overview of this first database on clinical research in veterinary homeopathy, with a special focus on its content of placebo controlled clinical trials and summarising what is known about placebo effects in animals. RESULTS: In April 2012, the VetCR database contained 302 data records. Among these, 203 controlled trials were identified: 146 randomised and 57 non-randomised. In 97 of those 203 trials, the homeopathic medical intervention was compared to placebo. COMMENT: A program of formal systematic reviews of peer-reviewed randomised controlled trials in veterinary homeopathy is now underway; detailed findings from the program's data extraction and appraisal approach, including the assessment of trial quality (risk of bias), will be reported in due course.

Implications of the 'placebo effect' for CAM research.

The 'placebo effect' concept is intrinsic to the architecture of the double blind placebo randomised controlled trial (RCT), the oft quoted 'gold standard' method of clinical research whose findings are supposed to inform our understanding of the interventions used in clinical practice. The 'placebo effect' concept is often used in discussions of both clinical practice and clinical research, particularly when discussing why patients report improvements with complementary and alternative medicines (CAMs). Despite its frequent use, 'placebo effect' is a non-sequitur, thus confusion abounds. In routine healthcare patients are not told that they might receive placebo. However, in clinical trials the opposite is true. Telling people that they might receive a placebo really complicates things. The uncertainty invoked by information that a placebo may be given can impact trial recruitment, the delivery of the intervention, and the reporting of outcomes, as can the 'meaning responses' invoked by other types of information provided to patients in standard RCT designs. Future CAM research should consider alternative RCT designs that help ensure that participants' experiences are uncontaminated by 'meaning responses' to information that they may receive fake treatments, i.e. placebos.