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Homeopathy has been the cause of much debate in the scientific literature with respect to the plausibility and efficacy of homeopathic preparations and practice. Nonetheless, many consumers, pharmacists, physicians, and other health care providers continue to use or practice homeopathic medicine and advocate its safety and efficacy. As drug experts, pharmacists are expected to be able to counsel their patients on how to safely and effectively use medications, which technically includes homeopathic products. Yet many pharmacists feel that the homeopathic system of medicine is based on unscientific theories that lack supporting evidence. Since consumers continue to use homeopathic products, it is necessary for pharmacists to have a basic knowledge of homeopathy and to be able to counsel patients about its general use, the current state of the evidence and its use in conjunction with other medications.

Background

Research in homeopathy has traditionally addressed itself to defining the effectiveness of homeopathic potencies in comparison to placebo medication. There is now increasing awareness that the homeopathic consultation is in itself a therapeutic intervention working independently or synergistically with the prescribed remedy. Our objective was to identify and evalute potential "active ingredients" of the homeopathic approach as a whole, in a prospective formal case series, which draws on actual consultation data, and is based on the MRC framework for the evaluation of complex interventions.

Methods

Following on from a theoretical review of how homeopathic care might mediate its effects, 18 patients were prospectively recruited to a case series based at Bristol Homeopathic Hospital. Patients, who lived with one of three index conditions, were interviewed before and after a five visit "package of care". All consultations were recorded and transcribed verbatim. Additional data, including generic and condition-specific questionnaires, artwork and "significant other" reports were collected. Textual data was subject to thematic analysis and triangulated with other sources.

Results

We judged that around one third of patients had experienced a major improvement in their health over the study period, a third had some improvement and a third had no improvement. Putative active ingredients included the patients' "openness to the mind-body connection", consultational empathy, in-depth enquiry into bodily complaints, disclosure, the remedy matching process and, potentially, the homeopathic remedies themselves.

Conclusion

This study has has identified, using primary consultation and other data, a range of factors that might account for the effectiveness of homeopathic care. Some of these, such as empathy, are non-specific. Others, such as the remedy matching process, are specific to homeopathy. These findings counsel against the use of placebo-controlled RCT designs in which both arms would potentially be receiving specific active ingredients. Future research in homeopathy should focus on pragmatic trials and seek to confirm or refute the therapeutic role of constructs such as patient "openness", disclosure and homeopathicity.

While intuition plays a role in clinical decision making within conventional medicine, little is understood about its use in complementary and alternative medicine (CAM). The aim of this qualitative study was to investigate intuition from the perspective of homeopathic practitioners; its' manifestation, how it was recognized, its origins and when it was used within daily clinical practice. Semi-structured interviews were carried out with clinically experienced non-National Health Service (NHS) UK homeopathic practitioners. Interpretative phenomenological analysis was used to analyze the data. Homeopaths reported many similarities with conventional medical practitioner regarding the nature, perceived origin and manifestation of their intuitions in clinical practice. Intuition was used in two key aspects of the consultation: (i) to enhance the practitioner-patient relationship, these were generally trusted; and (ii) intuitions relating to the prescribing decision. Homeopaths were cautious about these latter intuitions, testing any intuitive thoughts through deductive reasoning before accepting them. Their reluctance is not surprising given the consequences for patient care, but we propose this also reflects homeopaths' sensitivity to the academic and medical mistrust of both homeopathy and intuition. This study is the first to explore the use of intuition in decision making in any form of complementary medicine. The similarities with conventional practitioners may provide confidence in validating intuition as a legitimate part of the decision making process for these specific practitioners. Further work is needed to elucidate if these findings reflect intuitive use in clinical practice of other CAM practitioners in both private and NHS (i.e., time limited) settings.

Background

One of the cardinal principles of homeopathy is the "law of similarities", according to which patients can be treated by administering substances which, when tested in healthy subjects, cause symptoms that are similar to those presented by the patients themselves. Over the last few years, there has been an increase in the number of pre-clinical (in vitro and animal) studies aimed at evaluating the pharmacological activity or efficacy of some homeopathic remedies under potentially reproducible conditions. However, in addition to some contradictory results, these studies have also highlighted a series of methodological difficulties.

The present study was designed to explore the possibility to test in a controlled way the effects of homeopathic remedies on two known experimental models of acute inflammation in the rat. To this aim, the study considered six different remedies indicated by homeopathic practice for this type of symptom in two experimental edema models (carrageenan- and autologous blood-induced edema), using two treatment administration routes (sub-plantar injection and oral administration).

Methods

In a first phase, the different remedies were tested in the four experimental conditions, following a single-blind (measurement) procedure. In a second phase, some of the remedies (in the same and in different dilutions) were tested by oral administration in the carrageenan-induced edema, under double-blind (treatment administration and measurement) and fully randomized conditions. Seven-hundred-twenty male Sprague Dawley rats weighing 170–180 g were used. Six homeopathic remedies (Arnica montana D4, Apis mellifica D4, D30, Atropa belladonna D4, Hamamelis virginiana D4, Lachesis D6, D30, Phosphorus D6, D30), saline and indomethacin were tested. Edema was measured using a water-based plethysmometer, before and at different times after edema induction. Data were analyzed by ANOVA and Student t test.

Results

In the first phase of experiments, some statistically significant effects of homeopathic remedies (Apis, Lachesis and Phosporus) were observed (the reduction in paw volume increase ranging from 10% to 28% at different times since edema induction). In the second phase of experiments, the effects of homeopathic remedies were not confirmed. On the contrary, the unblinded standard allopathic drug indomethacin exhibited its anti-inflammatory effect in both experimental phases (the reduction in paw volume increase ranging from 14% to 40% in the first phase, and from 18% to 38% in the second phase of experiments).

Conclusion

The discrepancies between single-blind and double-blind methods in animal pharmacological research are noteworthy and should be better investigated, also in non-homeopathic research.

Verona's School of Homeopathic Medicine (www.omeopatia.org) organized a day of full immersion in the field of homeopathy, focusing on the validity of this much-debated discipline. There is widespread consensus in the medical community that evidence-based medicine is the best standard for assessing efficacy and safety of healthcare practices, and systematic reviews with strict protocols are essential to establish proof for various therapies. Students, homeopathic practitioners, academic and business representatives, who are interested in or curious about homeopathic practices attended the conference.

Background: Homeopathy is frequently used to treat asthma in children. In the common classical form of homeopathy, prescriptions are individualised for each patient. There has been no rigorous investigation into this form of treatment for asthma.

Methods: In a randomised, double blind, placebo controlled trial the effects of individualised homeopathic remedies were compared with placebo medication in 96 children with mild to moderate asthma as an adjunct to conventional treatment. The main outcome measure was the active quality of living subscale of the Childhood Asthma Questionnaire administered at baseline and follow up at 12 months. Other outcome measures included other subscales of the same questionnaire, peak flow rates, use of medication, symptom scores, days off school, asthma events, global assessment of change, and adverse reactions.

Results: There were no clinically relevant or statistically significant changes in the active quality of life score. Other subscales, notably those measuring severity, indicated relative improvements but the sizes of the effects were small. There were no differences between the groups for other measures.

Conclusions: This study provides no evidence that adjunctive homeopathic remedies, as prescribed by experienced homeopathic practitioners, are superior to placebo in improving the quality of life of children with mild to moderate asthma in addition to conventional treatment in primary care.

Objectives. To assess whether any benefits from adjunctive homeopathic intervention in patients with RA are due to the homeopathic consultation, homeopathic remedies or both.

Methods. Exploratory double-blind, randomized placebo-controlled trial conducted from January 2008 to July 2008, in patients with active stable RA receiving conventional therapy. Eighty-three participants from three secondary care UK outpatient clinics were randomized to 24 weeks of treatment with either homeopathic consultation (further randomized to individualized homeopathy, complex homeopathy or placebo) or non-homeopathic consultation (further randomized to complex homeopathy or placebo). Co-primary outcomes: ACR 20% improvement (ACR20) criteria and patient monthly global assessment (GA). Secondary outcomes: 28-joint DAS (DAS-28), tender and swollen joint count, disease severity, pain, weekly patient and physician GA and pain, and inflammatory markers.

Results. Fifty-six completed treatment phase. No significant differences were observed for either primary outcome. There was no clear effect due to remedy type. Receiving a homeopathic consultation significantly improved DAS-28 [mean difference 0.623; 95% CI 0.1860, 1.060; P = 0.005; effect size (ES) 0.70], swollen joint count (mean difference 3.04; 95% CI 1.055, 5.030; P = 0.003; ES 0.83), current pain (mean difference 9.12; 95% CI 0.521, 17.718; P = 0.038; ES 0.48), weekly pain (mean difference 6.017; 95% CI 0.140, 11.894; P = 0.045; ES 0.30), weekly patient GA (mean difference 6.260; 95% CI 0.411, 12.169; P = 0.036; ES 0.31) and negative mood (mean difference − 4.497; 95% CI −8.071, −0.923; P = 0.015; ES 0.90).

Conclusion. Homeopathic consultations but not homeopathic remedies are associated with clinically relevant benefits for patients with active but relatively stable RA.

Trial registration. Current controlled trials, http://www.controlled-trials.com/, ISRCTN09712705.

Background

Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history.

Methods/Design

A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 × 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history.

Discussion

For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathy

Trial registration

ClinicalTrials.gov: NCT01178255

Background

While a number of reviews of homeopathic clinical trials have been done, all have used methods dependent on allopathic diagnostic classifications foreign to homeopathic practice. In addition, no review has used established and validated quality criteria allowing direct comparison of the allopathic and homeopathic literature.

Methods

In a systematic review, we compared the quality of clinical-trial research in homeopathy to a sample of research on conventional therapies using a validated and system-neutral approach. All clinical trials on homeopathic treatments with parallel treatment groups published between 1945–1995 in English were selected. All were evaluated with an established set of 33 validity criteria previously validated on a broad range of health interventions across differing medical systems. Criteria covered statistical conclusion, internal, construct and external validity. Reliability of criteria application is greater than 0.95.

Results

59 studies met the inclusion criteria. Of these, 79% were from peer-reviewed journals, 29% used a placebo control, 51% used random assignment, and 86% failed to consider potentially confounding variables. The main validity problems were in measurement where 96% did not report the proportion of subjects screened, and 64% did not report attrition rate. 17% of subjects dropped out in studies where this was reported. There was practically no replication of or overlap in the conditions studied and most studies were relatively small and done at a single-site. Compared to research on conventional therapies the overall quality of studies in homeopathy was worse and only slightly improved in more recent years.

Conclusions

Clinical homeopathic research is clearly in its infancy with most studies using poor sampling and measurement techniques, few subjects, single sites and no replication. Many of these problems are correctable even within a "holistic" paradigm given sufficient research expertise, support and methods.

Background

A method for assessing the model validity of randomised controlled trials of homeopathy is needed. To date, only conventional standards for assessing intrinsic bias (internal validity) of trials have been invoked, with little recognition of the special characteristics of homeopathy. We aimed to identify relevant judgmental domains to use in assessing the model validity of homeopathic treatment (MVHT). We define MVHT as the extent to which a homeopathic intervention and the main measure of its outcome, as implemented in a randomised controlled trial (RCT), reflect 'state-of-the-art' homeopathic practice.

Methods

Using an iterative process, an international group of experts developed a set of six judgmental domains, with associated descriptive criteria. The domains address: (I) the rationale for the choice of the particular homeopathic intervention; (II) the homeopathic principles reflected in the intervention; (III) the extent of homeopathic practitioner input; (IV) the nature of the main outcome measure; (V) the capability of the main outcome measure to detect change; (VI) the length of follow-up to the endpoint of the study. Six papers reporting RCTs of homeopathy of varying design were randomly selected from the literature. A standard form was used to record each assessor's independent response per domain, using the optional verdicts 'Yes', 'Unclear', 'No'. Concordance among the eight verdicts per domain, across all six papers, was evaluated using the kappa (κ) statistic.

Results

The six judgmental domains enabled MVHT to be assessed with 'fair' to 'almost perfect' concordance in each case. For the six RCTs examined, the method allowed MVHT to be classified overall as 'acceptable' in three, 'unclear' in two, and 'inadequate' in one.

Conclusion

Future systematic reviews of RCTs in homeopathy should adopt the MVHT method as part of a complete appraisal of trial validity.

Research into the homeopathic consultation has largely focused on patients' experiences, although the practitioner is a crucial component of the therapeutic context and may have an important part in optimizing health outcomes. Therefore the aim of this qualitative research was to gain an in-depth understanding of homeopathic practitioners' perceptions and experiences of the consultation. Medical and non-medical homeopaths were sampled from the registers of the Faculty and Society of Homeopaths. Two phases of data collection were employed. Phase 1 used in depth face-to-face interviews enabling the development of an initial model of the homeopathic consultation. Phase 2 involved observations of homeopathic consultations and practitioner reflective diaries in order to confirm, refute, or enlarge the model. Using the constant comparative method of grounded theory five main categories emerged, exploring the journey, finding the level, responding therapeutically, understanding self, and connecting, forming a model entitled “a theoretical model of a UK classical homeopathic consultation” which describes how homeopaths view and enact the consultation process. This study suggests that the process of identifying and prescribing the remedy is embedded in the consultation, highlighting the interconnectedness of the whole homeopathic consultation and aspects of the consultation that are unique and specific to homeopathy.

In homeopathy, many difficulties are encountered in understanding theoretical presuppositions because they represent different paradigms from those of hegemonic science. In our medical school, we developed a brief homeopathic pathogenetic experimentation course to be added as curricular content and a didactic method in homeopathic disciplines to add practical experience to the theoretical approach of homeopathic presuppositions. In accordance with the premises laid out by Hahnemann, the father of homeopathy, brief pathogenetic experimentation was offered on a voluntary basis for students who were free of chronic diseases and who had not regularly used medication in the last 3 months. The clinical test, either crossed or sequential (randomized and blind), was used as a study model. Single weekly doses of a homeopathic medicine of 30 cH or placebo were taken by participants during 4 weeks after which crossover of the experimented substances took place for another 4 weeks. Polycrest medicines were used so that symptoms developed by the participants could be compared to those described in Homeopathic Materia Medica. Thirty-three of the 50 students who studied homeopathy as an elective discipline over the last 4 years at the School of Medicine of the University of São Paulo (FMUSP) participated. Participants described symptoms according to specific methodology including many comments with peculiar characteristics and notable idiosyncrasies. All these students endorsed the course because it contributed to their understanding of how dynamized substances produced symptoms in healthy participants as well as the cure of symptoms according to the casual similitude principle. Brief homeopathic pathogenetic experimentation proved to be an effective method to observe the idiosyncratic manifestations of human individuality based on qualitative methodology, thus building a basis of understanding of homeopathy.

Background

Homeopathy, a common form of alternative medicine worldwide, relies on subjective patient reports for diagnosis and treatment. Polysomnography offers a modern methodology for evaluating the objective effects of taking homeopathic remedies that clinicians claim exert effects on sleep quality in susceptible individuals. Animal studies have previously shown changes in non rapid eye movement sleep with certain homeopathic remedies.

Methods

Young adults of both sexes (ages 18–31) with above-average scores on standardized personality scales for either cynical hostility or anxiety sensitivity (but not both), and a history of coffee-induced insomnia, participated in the month-long study. At-home polysomnographic recordings were obtained on successive pairs of nights once per week for a total of eight recordings (nights 1, 2, 8, 9, 15, 16, 22, 23). Subjects (N=54) received placebo pellets on night 8 (single-blind) and verum pellets on night 22 (double-blind) in 30c doses of one of two homeopathic remedies, Nux Vomica or Coffea Cruda. Subjects completed daily morning sleep diaries and weekly Pittsburgh Sleep Quality Index scales, as well as Profile of Mood States Scales at bedtime on polysomnography nights.

Results

Verum remedies significantly increased PSG total sleep time and NREM, as well as awakenings and stage changes. Changes in actigraphic and self-rated scale effects were not significant.

Conclusions

The study demonstrated the feasibility of using in-home all-night sleep recordings to study homeopathic remedy effects. Findings are similar though not identical to those reported in animals with the same remedies. Possible mechanisms include initial disruption of the nonlinear dynamics of sleep patterns by the verum remedies.

Homeopathy was born as an experimental discipline, as can be seen from the enormous amount of homeopathic data collected over more than two centuries. However, the medical tradition of homeopathy has been separated from that of conventional science for a long time. Conventional scientific wisdom dictates that homeopathy should have no effect above placebo but experiments on ultra-high dilutions of solutes together with some clinical data suggest the intriguing possibility that it might do in some circumstances. Today, an osmotic process between disciplines, previously seen as in conflict, is facilitated because over the last few decades homeopathy has initiated the methods of current medical science and a substantial number of experimental studies—at molecular, cellular and clinical levels—are available. One area of dialogue and of common progress is that of inflammation and immunity, probably because these are closely related to the traditional ‘vital force’ of the body's self-healing power. In a series of papers we review the historical origins of homeopathy, the laboratory and animal models related to the field of immunopharmacology, the clinical evidence in favor and against the use of homeopathy in the inflammatory diseases and the hypotheses regarding its action mechanism(s). Finally, we will enlighten the specific characteristics of the homeopathic approach, which places great emphasis on identifying a cure for the whole organism.

Background

Two main pathways exist for the development of knowledge in clinical homeopathy. These comprise clinical trials conducted primarily by university-based researchers and cases reports and homeopathic "provings" compiled by engaged homeopathic practitioners. In this paper the relative merits of these methods are examined and a middle way proposed. This consists of the "Formal Case Study" (FCS) in which qualitative methods are used to increase the rigour and sophistication with which homeopathic cases are studied. Before going into design issues this paper places the FCS in an historical and academic context and describes the relative merits of the method.

Discussion

Like any research, the FCS should have a clear focus. This focus can be both "internal", grounded in the discourse of homeopathy and also encompass issues of wider appeal. A selection of possible "internal" and "external" research questions is introduced. Data generation should be from multiple sources to ensure adequate triangulation. This could include the recording and transcription of actual consultations. Analysis is built around existing theory, involves cross-case comparison and the search for deviant cases. The trustworthiness of conclusions is ensured by the application of concepts from qualitative research including triangulation, groundedness, respondent validation and reflexivity. Though homeopathic case studies have been reported in mainstream literature, none has used formal qualitative methods – though some such studies are in progress.

Summary

This paper introduces the reader to a new strategy for homeopathic research. This strategy, termed the "formal case study", allows for a naturalistic enquiry into the players, processes and outcomes of homeopathic practice. Using ideas from qualitative research, it allows a rigorous approach to types of research question that cannot typically be addressed through clinical trials and numeric outcome studies. The FCS provides an opportunity for the practitioner-researcher to contribute to the evidence-base in homeopathy in a systematic fashion. The FCS can also be used to inform the design of clinical trials through holistic study of the "active ingredients" of the therapeutic process and its clinical outcomes.

Background

One in five children visiting a homeopathic physician suffers from atopic eczema.

Objectives

We aimed to examine the long-term effectiveness, safety and costs of homoeopathic vs. conventional treatment in usual medical care of children with atopic eczema.

Methods

In this prospective multi-centre comparative observational non-randomized rater-blinded study, 135 children (48 homoeopathy, 87 conventional) with mild to moderate atopic eczema were included by their respective physicians. Depending on the specialisation of the physician, the primary treatment was either standard conventional treatment or individualized homeopathy as delivered in routine medical care. The main outcome was the SCORAD (SCORing Atopic Dermatitis) at 36 months by a blinded rater. Further outcomes included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months after baseline. A multilevel ANCOVA was used, with physician as random effect and the following fixed effects: age, gender, baseline value, severity score, social class and parents’ expectation.

Results

The adjusted mean SCORAD showed no significant differences between the groups at 36 months (13.7 95% CI [7.9–19.5] vs. 14.9 [10.4–19.4], p = 0.741). The SCORAD response rates at 36 months were similar in both groups (33% response: homoeopathic 63.9% vs. conventional 64.5%, p = 0.94; 50% response: 52.0% vs. 52.3%, p = 0.974). Total costs were higher in the homoeopathic versus the conventional group (months 31–36 200.54 Euro [132.33–268.76] vs. 68.86 Euro [9.13–128.58], p = 0.005).

Conclusions

Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs.

Interest in alternative medicine is increasing. Family physicians, frequently asked by patients about the merits of these practices, must increase their knowledge in order to develop an enlightened, scientific approach to the subject. Homeopathy is one such system of medicine; it was founded by Dr. Samuel Hahnemann nearly 200 years ago. Clinical research in homeopathy is in the very early stages. To date, clinical trials to determine the efficacy of individual homeopathic remedies and the validity of homeopathic theory generally have been inconclusive. It is to be hoped that clinical research in homeopathy will continue so that we can increase our knowledge and provide our patients with better answers to their questions.

Background

The efficacy of homeopathy is controversial. Homeopathic remedies are made via iterated shaking and dilution, in ethanol or in water, from a starting substance. Remedies of potency 12 C or higher are ultra-dilute (UD), i.e. contain zero molecules of the starting material. Various hypotheses have been advanced to explain how a UD remedy might be different from unprepared solvent. One such hypothesis posits that a remedy contains stable clusters, i.e. localized regions where one or more hydrogen bonds remain fixed on a long time scale. High sensitivity proton nuclear magnetic resonance spectroscopy has not previously been used to look for evidence of differences between UD remedies and controls.

Methods

Homeopathic remedies made in water were studied via high sensitivity proton nuclear magnetic resonance spectroscopy. A total of 57 remedy samples representing six starting materials and spanning a variety of potencies from 6 C to 10 M were tested along with 46 controls.

Results

By presaturating on the water peak, signals could be reliably detected that represented H-containing species at concentrations as low as 5 μM. There were 35 positions where a discrete signal was seen in one or more of the 103 spectra, which should theoretically have been absent from the spectrum of pure water. Of these 35, fifteen were identified as machine-generated artifacts, eight were identified as trace levels of organic contaminants, and twelve were unexplained. Of the unexplained signals, six were seen in just one spectrum each. None of the artifacts or unexplained signals occurred more frequently in remedies than in controls, using a p < .05 cutoff. Some commercially prepared samples were found to contain traces of one or more of these small organic molecules: ethanol, acetate, formate, methanol, and acetone.

Conclusion

No discrete signals suggesting a difference between remedies and controls were seen, via high sensitivity 1H-NMR spectroscopy. The results failed to support a hypothesis that remedies made in water contain long-lived non-dynamic alterations of the H-bonding pattern of the solvent.

Background

There is a paucity of information describing patients with musculoskeletal disorders (MSDs) using complementary and alternative medicines (CAMs) and almost none distinguishing homeopathy from other CAMs. The objective of this study was to describe and compare patients with MSDs who consulted primary care physicians, either certified homeopaths (Ho) or regular prescribers of CAMs in a mixed practice (Mx), to those consulting physicians who strictly practice conventional medicine (CM), with regard to the severity of their MSD expressed as chronicity, co-morbidity and quality of life (QOL).

Methods

The EPI3-LASER study was a nationwide observational survey of a representative sample of general practitioners and their patients in France. The sampling strategy ensured a sufficient number of GPs in each of the three groups to allow comparison of their patients. Patients completed a questionnaire on socio-demographics, lifestyle and QOL using the Short Form 12 (SF-12) questionnaire. Chronicity of MSDs was defined as more than twelve weeks duration of the current episode. Diagnoses and co-morbidities were recorded by the physician.

Results

A total of 825 GPs included 1,692 MSD patients (predominantly back pain and osteoarthritis) were included, 21.6% in the CM group, 32.4% Ho and 45.9% Mx. Patients in the Ho group had more often a chronic MSD (62.1%) than the CM (48.6%) or Mx (50.3%) groups, a result that was statistically significant after controlling for patients' characteristics (Odds ratio = 1.43; 95% confidence interval (CI): 1.07 - 1.89). Patients seen by homeopaths or mixed practice physicians who were not the regular treating physician, had more often a chronic MSD than those seen in conventional medicine (Odds ratios were1.75; 95% CI: 1.22 - 2.50 and 1.48; 95% CI: 1.06 - 2.12, respectively). Otherwise patients in the three groups did not differ for co-morbidities and QOL.

Conclusion

MSD patients consulting primary care physicians who prescribed homeopathy and CAMs differed from those seen in conventional medicine. Chronic MSD patients represented a greater proportion of the clientele in physicians offering alternatives to conventional medicine. In addition, these physicians treated chronic patients as consulting rather than regular treating physicians, with potentially important impacts upon professional health care practices and organisation.

Background

Chemotherapy induced nausea and vomiting (CINV) remains a major problem that seriously impairs the quality of life (QoL) in cancer patients receiving chemotherapy regimens. Complementary medicines, including homeopathy, are used by many patients with cancer, usually alongside with conventional treatment. A randomized, placebo-controlled Phase III study was conducted to evaluate the efficacy of a complex homeopathic medicine, Cocculine, in the control of CINV in non-metastatic breast cancer patients treated by standard chemotherapy regimens.

Methods

Chemotherapy-naïve patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy including at least three initial cycles of FAC 50, FEC 100 or TAC were randomized to receive standard anti-emetic treatment plus either a complex homeopathic remedy (Cocculine, registered in France for treatment of nausea and travel sickness) or the matching placebo (NCT00409071 clinicaltrials.gov). The primary endpoint was nausea score measured after the 1st chemotherapy course using the FLIE questionnaire (Functional Living Index for Emesis) with 5-day recall. Secondary endpoints were: vomiting measured by the FLIE score, nausea and vomiting measured by patient self-evaluation (EVA) and investigator recording (NCI-CTC AE V3.0) and treatment compliance.

Results

From September 2005 to January 2008, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea FLIE scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis FLIE scores were not statistically different at any time between the two study arms. The frequencies of severe (Grade ≥ 2) nausea and vomiting were low in our study (nausea: P: 17.6% vs C: 15.7%, p=0.62; vomiting: P: 10.8% vs C: 12.0%, p=0.72 during the first course).

Conclusion

This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.

Background

The aim of this study was to assess the effectiveness of homeopathy compared to conventional treatment in acute respiratory and ear complaints in a primary care setting.

Methods

The study was designed as an international, multi-centre, comparative cohort study of non-randomised design. Patients, presenting themselves with at least one chief complaint: acute (≤ 7 days) runny nose, sore throat, ear pain, sinus pain or cough, were recruited at 57 primary care practices in Austria (8), Germany (8), the Netherlands (7), Russia (6), Spain (6), Ukraine (4), United Kingdom (10) and the USA (8) and given either homeopathic or conventional treatment. Therapy outcome was measured by using the response rate, defined as the proportion of patients experiencing 'complete recovery' or 'major improvement' in each treatment group. The primary outcome criterion was the response rate after 14 days of therapy.

Results

Data of 1,577 patients were evaluated in the full analysis set of which 857 received homeopathic (H) and 720 conventional (C) treatment. The majority of patients in both groups reported their outcome after 14 days of treatment as complete recovery or major improvement (H: 86.9%; C: 86.0%; p = 0.0003 for non-inferiority testing). In the per-protocol set (H: 576 and C: 540 patients) similar results were obtained (H: 87.7%; C: 86.9%; p = 0.0019). Further subgroup analysis of the full analysis set showed no differences of response rates after 14 days in children (H: 88.5%; C: 84.5%) and adults (H: 85.6%; C: 86.6%). The unadjusted odds ratio (OR) of the primary outcome criterion was 1.40 (0.89–2.22) in children and 0.92 (0.63–1.34) in adults. Adjustments for demographic differences at baseline did not significantly alter the OR. The response rates after 7 and 28 days also showed no significant differences between both treatment groups. However, onset of improvement within the first 7 days after treatment was significantly faster upon homeopathic treatment both in children (p = 0.0488) and adults (p = 0.0001). Adverse drug reactions occurred more frequently in adults of the conventional group than in the homeopathic group (C: 7.6%; H: 3.1%, p = 0.0032), whereas in children the occurrence of adverse drug reactions was not significantly different (H: 2.0%; C: 2.4%, p = 0.7838).

Conclusion

In primary care, homeopathic treatment for acute respiratory and ear complaints was not inferior to conventional treatment.

Homeopathic preparations are used in homeopathy and anthroposophic medicine. Although there is evidence of effectiveness in several clinical studies, including double-blinded randomized controlled trials, their nature and mode of action could not be explained with current scientific approaches yet. Several physical methods have already been applied to investigate homeopathic preparations but it is yet unclear which methods are best suited to identify characteristic physicochemical properties of homeopathic preparations. The aim of this study was to investigate homeopathic preparations with UV-spectroscopy. In a blinded, randomized, controlled experiment homeopathic preparations of copper sulfate (CuSO4; 11c–30c), quartz (SiO2; 10c–30c, i.e., centesimal dilution steps) and sulfur (S; 11×–30×, i.e., decimal dilution steps) and controls (one-time succussed diluent) were investigated using UV-spectroscopy and tested for contamination by inductively coupled plasma mass spectrometry (ICP-MS). The UV transmission for homeopathic preparations of CuSO4 preparations was significantly lower than in controls. The transmission seemed to be also lower for both SiO2 and S, but not significant. The mean effect size (95% confidence interval) was similar for the homeopathic preparations: CuSO4 (pooled data) 0.0544% (0.0260–0.0827%), SiO2 0.0323% (–0.0064% to 0.0710%) and S 0.0281% (–0.0520% to 0.1082%). UV transmission values of homeopathic preparations had a significantly higher variability compared to controls. In none of the samples the concentration of any element analyzed by ICP-MS exceeded 100 ppb. Lower transmission of UV light may indicate that homeopathic preparations are less structured or more dynamic than their succussed pure solvent.

Background

On the range of diagnoses, course of treatment, and long-term outcome in patients who chose to receive homeopathic medical treatment very little is known. We investigated homeopathic practice in an industrialized country under everyday conditions.

Methods

In a prospective, multicentre cohort study with 103 primary care practices with additional specialisation in homeopathy in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: Patient and physician assessments (numeric rating scales from 0 to 10) and quality of life at baseline, and after 3, 12, and 24 months.

Results

A total of 3,981 patients were studied including 2,851 adults (29% men, mean age 42.5 ± 13.1 years; 71% women, 39.9 ± 12.4 years) and 1,130 children (52% boys, 6.5 ± 3.9 years; 48% girls, 7.0 ± 4.3 years). Ninety-seven percent of all diagnoses were chronic with an average duration of 8.8 ± 8 years. The most frequent diagnoses were allergic rhinitis in men, headache in women, and atopic dermatitis in children. Disease severity decreased significantly (p < 0.001) between baseline and 24 months (adults from 6.2 ± 1.7 to 3.0 ± 2.2; children from 6.1 ± 1.8 to 2.2 ± 1.9). Physicians' assessments yielded similar results. For adults and young children, major improvements were observed for quality of life, whereas no changes were seen in adolescents. Younger age and more severe disease at baseline were factors predictive of better therapeutic success.

Conclusion

Disease severity and quality of life demonstrated marked and sustained improvements following homeopathic treatment period. Our findings indicate that homeopathic medical therapy may play a beneficial role in the long-term care of patients with chronic diseases.

Background

Homeopathy is a highly debated but often used medical treatment. With this cohort study we aimed to evaluate health status changes under homeopathic treatment in routine care. Here we extend former results, now presenting data of an 8-year follow-up.

Methods

In a prospective, multicentre cohort study with 103 homeopathic primary care practices in Germany and Switzerland, data from all patients (age >1 year) consulting the physician for the first time were observed. The main outcome measures were: The patients' perceived change in complaint severity (numeric rating scales from 0 = no complaint to 10 = maximal severity) and quality of life as measured by the SF-36 at baseline, and after 2 and 8 years.

Results

A total of 3,709 patients were studied, 73% (2,722 adults, 72.8% female, age at baseline 41.0 ± 12.3; 819 children, 48.4% female, age 6.5 ± 4.0) contributed data to the 8-year follow-up. The most frequent diagnoses were allergic rhinitis and headache in adults, and atopic dermatitis and multiple recurrent infections in children. Disease severity decreased significantly (p < 0.001) between baseline, 2 and 8 years (adults from 6.2 ± 1.7 to 2.9 ± 2.2 and 2.7 ± 2.1; children from 6.1 ± 1.8 to 2.1 ± 2.0 and 1.7 ± 1.9). Physical and mental quality of life sores also increased considerably. Younger age, female gender and more severe disease at baseline were factors predictive of better therapeutic success.

Conclusion

Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

In 1849, Charles Darwin was so ill that he was unable to work one out of every 3 days, and after having various troubling symptoms for 2–12 years, he wrote to a friend that he was ‘going the way of all flesh’. He sought treatment from Dr James Manby Gully, a medical doctor who used water cure and homeopathic medicines. Despite being highly skeptical of these treatments, he experienced a dramatic improvement in his health, though some of his digestive and skin symptoms returned various times in his life. He grew to appreciate water cure, but remained skeptical of homeopathy, even though his own experiments on insectivore plants using what can be described as homeopathic doses of ammonia salts surprised and shocked him with their significant biological effect. Darwin even expressed concern that he should publish these results. Two of Darwin's sons were as incredulous as he was, but their observations confirmed the results of his experiments. Darwin was also known to have read a book on evolution written by a homeopathic physician that Darwin described as similar to his own but ‘goes much deeper.’