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1.  Low Potency Homeopathic Remedies and Allopathic Herbal Medicines: Is There an Overlap? 
PLoS ONE  2013;8(9):e74181.
Classical homeopathy is based on the therapeutic application of highly diluted homeopathic stocks. The indications of such medicines are determined by proving, i.e. by applying the remedies in healthy subjects. However, there are several complex homeopathic medicinal products on the market with approved therapeutic indications. The efficacy of these medicines has been assessed in clinical trials on patients. There is no upper limit of dosing for such homeopathic remedies, and these products often contain undiluted mother tincture. The aim of our study was to compare an allopathic herbal medicine and a homeopathic product containing undiluted mother tincture based on the same plant. Two products (an allopathic herbal medicine and a homeopathic product) containing Vitex agnus-castus extract were analyzed by HPLC-DAD for their agnuside and casticin contents. The agnuside content of the allopathic product was approximately four times higher, while the amount of casticin was in the same order of magnitude. Our experiments revealed the presence of active ingredients in allopathic quantity in a homeopathic preparation, highlighting the controversy between the principles of classical and practice of contemporary homeopathy. According to the principles of classical homeopathy these remedies cannot be considered as homeopathic remedies but rather as (allopathic) herbal ones. This phenomenon necessitates a case-by-case approach towards the possible adverse effects and drug interactions of homeopathics in the daily medical practice. Homeopathic products containing active agents in allopathic doses should be treated the same way as allopathic medicines from the point of view of quality assurance and pharmacovigilance.
doi:10.1371/journal.pone.0074181
PMCID: PMC3760822  PMID: 24019954
2.  Homeopathy – what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions 
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.
doi:10.1186/1472-6882-6-37
PMCID: PMC1676018  PMID: 17101037
3.  Homeopathic Treatment of Headaches: A Systematic Review of the Literature 
Abstract
Objective
To systematically review published prospective trials relating to the homeopathic treatment of tension type, cervicogenic, and migraine headache.
Data Sources
Pre-MEDLINE, MEDLINE, MANTIS, Cochrane Database of Systematic Reviews, and AMED were searched from the initial indexing year of each database through May 2002. Studies were further identified through a manual search of obtained article references.
Study Selection
English and non-English randomized clinical trials and prospective observational trials were included if there were at least ten subjects in the homeopathic portion of the trial and, for randomized clinical trials, if there was a placebo group. Treatment in these studies included single dose and individualized homeopathic prescription. Case studies, homeopathic provings, unpublished material, non-peer reviewed papers, and studies that combined multiple homeopathic remedies, introduced other complementary and alternative medicine therapies and/or introduced additional medical therapy for patients in the homeopathic treatment groups were excluded.
Data Extraction
Qualitative data were extracted from each paper and entered into an evidence table.
Data Synthesis
A critical evaluation list of 20 methodological items and their operational definitions was used, resulting in a validity score determined for each paper.
Results
Six papers met criteria for inclusion. Three out of the six papers studied migraine headache, two studied cervicogenic and tension type headache, and one included all types of headaches. Four studies were randomized clinical trials, and two were prospective observational studies. Validity scores ranged from 25.0% to 63.4%. Homeopathy was superior to placebo in one randomized clinical trial and equal to placebo in three randomized trials. In no study was homeopathy less effective than placebo in treating headache, or harmful. Two prospective observational studies demonstrated improvement in patients receiving homeopathic care.
Conclusion
There is insufficient evidence to support or refute the use of homeopathy for managing tension type, cervicogenic, or migraine headache. The studies reviewed possessed several flaws in design. Given these findings, further research is warranted to better investigate the effectiveness of homeopathic treatment of headaches.
doi:10.1016/S0899-3467(07)60085-8
PMCID: PMC2646987  PMID: 19674623
Homeopathy; Headache; Review of the Literature
4.  Brief Homeopathic Pathogenetic Experimentation: A Unique Educational Tool in Brazil 
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.
doi:10.1093/ecam/nem128
PMCID: PMC2722208  PMID: 18955242
Homeopathy; medical education; undergraduate medical education; pathogenesis; homeopathic pathogenetic trial; homeopathic pathogenetic experimentation
5.  Where Does Homeopathy Fit in Pharmacy Practice? 
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.
PMCID: PMC1847554  PMID: 17429507
homeopathy; pharmacist; education; complimentary and alternative medicine
6.  A Grounded Theory Study of Homeopathic Practitioners' Perceptions and Experiences of the Homeopathic Consultation 
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.
doi:10.1155/2011/957506
PMCID: PMC2958658  PMID: 20981269
7.  Homeopathy satisfaction in Iran 
Background:
Patient satisfaction is a key indicator of the quality and effectiveness of a therapeutic method. Assessing the satisfaction of patients undergoing homeopathic therapy is essential in the early steps of educating the community, if suitable outcomes are to be achieved.
Materials and Methods:
This descriptive cross-sectional study was conducted in 2008 on 125 patients from the city of Isfahan. Patients aged above 15 years who had referred to the homeopathic practitioners and received homeopathic drugs for at least three times were randomly selected and included in the study. Patient satisfaction was assessed in three main areas (general health, physician performance, and symptoms relief) using a valid questionnaire. The results were compared with those of a similar study conducted in 2004 on 240 patients.
Results:
Mean score of satisfaction with homeopathic treatment was 77.48 ± 6.36 out of 100. In 2004, it was 77.4 ± 8.13. Median age was 36.41 ± 11.25 years. Median time of therapy was 16.80 ± 17.94 months. The highest level of satisfaction was related to relief of symptoms. Satisfaction of physician performance and improvement of general health came next. The degree of satisfaction with therapy was not significant between the different groups with regard to their sex and different levels of education, but there was significant difference in the duration of treatment. The four symptoms that showed better improvement in 2008 were headache, gastrointestinal (GI) disturbances, fatigue, and insomnia.
Conclusions:
After using homeopathy for several years, patients’ satisfaction was found to be still high. Shifting the area of satisfaction from general health to relief of symptoms could be related to physicians’ experiments for remedy selection. Scientific centers should do more surveys about the effectiveness of homeopathic treatment. Integration of homeopathy with medicine may bring in more success at less cost. It seems rational to support homeopathy as an effective practice.
PMCID: PMC4223967  PMID: 25400678
Complementary therapies; homeopathy; Iran; Isfahan; patient satisfaction
8.  Homeopathy for Depression - DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study 
Trials  2011;12:43.
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
doi:10.1186/1745-6215-12-43
PMCID: PMC3045905  PMID: 21320338
9.  Homeopathic Medications as Clinical Alternatives for Symptomatic Care of Acute Otitis Media and Upper Respiratory Infections in Children 
The public health and individual risks of inappropriate antibiotic prescribing and conventional over-the-counter symptomatic drugs in pediatric treatment of acute otitis media (AOM) and upper respiratory infections (URIs) are significant. Clinical research suggests that over-the-counter homeopathic medicines offer pragmatic treatment alternatives to conventional drugs for symptom relief in children with uncomplicated AOM or URIs. Homeopathy is a controversial but demonstrably safe and effective 200-year-old whole system of complementary and alternative medicine used worldwide. Numerous clinical studies demonstrate that homeopathy accelerates early symptom relief in acute illnesses at much lower risk than conventional drug approaches. Evidence-based advantages for homeopathy include lower antibiotic fill rates during watchful waiting in otitis media, fewer and less serious side effects, absence of drug-drug interactions, and reduced parental sick leave from work. Emerging evidence from basic and preclinical science research counter the skeptics' claims that homeopathic remedies are biologically inert placebos. Consumers already accept and use homeopathic medicines for self care, as evidenced by annual US consumer expenditures of $2.9 billion on homeopathic remedies. Homeopathy appears equivalent to and safer than conventional standard care in comparative effectiveness trials, but additional well-designed efficacy trials are indicated. Nonetheless, the existing research evidence on safety supports pragmatic use of homeopathy in order to “first do no harm” in the early symptom management of otherwise uncomplicated AOM and URIs in children.
doi:10.7453/gahmj.2013.2.1.007
PMCID: PMC3833578  PMID: 24381823
Homeopathy; pediatric; acute care; upper respiratory infections; otitis media; adverse drug reactions; cost effectiveness; comparative effectiveness; benefit risk assessment
10.  The Use of Intuition in Homeopathic Clinical Decision Making: An Interpretative Phenomenological Study 
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.
doi:10.1093/ecam/nep153
PMCID: PMC3139511  PMID: 19773389
11.  Rat models of acute inflammation: a randomized controlled study on the effects of homeopathic remedies 
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.
doi:10.1186/1472-6882-7-1
PMCID: PMC1783669  PMID: 17233886
12.  Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial 
Thorax  2003;58(4):317-321.
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.
doi:10.1136/thorax.58.4.317
PMCID: PMC1746635  PMID: 12668794
13.  Efficacy of individualized homeopathic treatment and fluoxetine for moderate to severe depression in peri- and postmenopausal women (HOMDEP-MENOP): study protocol for a randomized, double-dummy, double-blind, placebo-controlled trial 
Trials  2013;14:105.
Background
The perimenopausal period refers to the interval when women’s menstrual cycles become irregular and is characterized by an increased risk of depressive symptoms. Use of homeopathy to treat depression is widespread but there is a lack of clinical trials about its efficacy in depression in peri- and postmenopausal women. Previous trials suggest that individualized homeopathic treatments improve depression. In classical homeopathy, an individually selected homeopathic remedy is prescribed after a complete case history of the patient. The aim of this study is to assess the efficacy and safety of the homeopathic individualized treatment versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression.
Methods/design
A randomized, placebo-controlled, double-blind, double-dummy, three-arm trial with a six-week follow-up study was designed. The study will be conducted in a public research hospital in Mexico City (Juárez de México Hospital) in the outpatient service of homeopathy. One hundred eighty nine peri- and postmenopausal women diagnosed with major depression according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (moderate to severe intensity) will be included. The primary outcome is change in the mean total score among groups on the 17-item Hamilton Rating Scale for Depression after the fourth and sixth week of treatment. Secondary outcomes are: Beck Depression Inventory change in mean score, Greene’s Scale change in mean score, response and remission rates and safety. Efficacy data will be analyzed in the intention-to-treat population. To determine differences in the primary and secondary outcomes among groups at baseline and weeks four and six, data will be analyzed by analysis of variance for independent measures with the Bonferroni post-hoc test.
Discussion
This study is the first trial of classical homeopathy that will evaluate the efficacy of homeopathic individualized treatment using C-potencies versus placebo or fluoxetine in peri- and postmenopausal women with moderate to severe depression. It is an attempt to deal with the obstacles of homeopathic research due to the need for individual prescriptions in one of the most common psychiatric diseases.
Trial registration
ClinicalTrials.gov Identifier: NCT01635218.
doi:10.1186/1745-6215-14-105
PMCID: PMC3748824  PMID: 23782520
Perimenopause; Postmenopause; Depression; Homeopathy; Fluoxetine; Hamilton Rating Scale for Depression; Beck Depression Inventory
14.  Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial 
Rheumatology (Oxford, England)  2010;50(6):1070-1082.
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.
doi:10.1093/rheumatology/keq234
PMCID: PMC3093927  PMID: 21076131
Clinical trial; Homeopathy; Rheumatoid arthritis; Consultation
15.  Homeopathic and conventional treatment for acute respiratory and ear complaints: A comparative study on outcome in the primary care setting 
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.
doi:10.1186/1472-6882-7-7
PMCID: PMC1831487  PMID: 17335565
16.  13B. Experience With the “Banerji Protocols“ in Treatment of Chronic Disease 
Focus Areas: Integrative Approaches to Care
Specific effects of homeopathic treatment are often dismissed as unbelievable due to use of remedies diluted beyond Avogadro's number. Recent basic science research suggests that this argument will no longer hold water with the demonstration that classically prepared ultradilute homeopathic medicines (HM) contain measurable source nanoparticles (NP) and/or silica NP with adsorbed source materials that are heterogeneously dispersed in colloidal solution and have biological properties that differ substantially from bulk forms of the same substance. These findings will soon address the plausibility question; however, individualized homeopathy may remain obscure due to the need for hundreds of hours of training required for effective practice where a different remedy may be needed for every patient regardless of condition. The Banerji Protocols help to alleviate this obstacle.
The Prasanta Banerji Homeopathic Research Foundation (http://pbhrfindia.org) is well known for its cancer treatment protocols, having been identified by NCI in 1999 for its Best Case Series with subsequent translational research on specific homeopathic medicines (HM) being done at MD Anderson. Less known are the Protocols for numerous serious conditions that have been developed over four generations of homeopathic practice with thousands of patients in Kolkata, India. The new book from Drs Prasanta and Pratip Banerji, published in June 2013, contains dozens of protocols for the treatment of conditions such as chronic renal failure, dysfunctional uterine bleeding, hepatitis, inflammatory bowel disease, and traumatic brain injury. Dr Barbara Sarter has spent many months collecting data in the Kolkata clinic. She and Dr Joyce Frye have already used many of these protocols in their respective US homeopathic practices with excellent results. The Protocols suggest highly efficacious and cost-effective treatments of numerous conditions for which conventional medicine has limited options.
doi:10.7453/gahmj.2013.097CP.S13B
PMCID: PMC3875062
17.  Homeopathy for allergic rhinitis: protocol for a systematic review 
Systematic Reviews  2014;3:59.
Background
Allergic rhinitis is a global health problem that is often treated with homeopathy. The objective of this review will be to evaluate the effectiveness of homeopathic treatment of allergic rhinitis.
Methods/Design
The authors will conduct a systematic review. We will search Medline, CENTRAL, CINAHL, EMBASE, AMED, CAM-Quest, Google Scholar and reference lists of identified studies up to December 2013.
The review will include randomized controlled trials that evaluate homeopathic treatment of allergic rhinitis. Studies with participants of all ages, with acute or chronic comorbidities will be included. Patients with immunodeficiency will not be included. The diagnosis will be based on the published guidelines of diagnosis and classification. Studies of all homeopathy modalities (clinical, complex and classical homeopathy, and isopathy) will be included. We will include trials with both active controls (conventional therapy, standard care) and placebo controls.
The primary outcomes are: an improvement of global symptoms recorded in validated daily or weekly diaries and any scores from validated visual analogue scales; the total Quality of Life Score (such as the Juniper RQLQ);individual symptoms scores which include any appropriate measures of nasal obstruction, runny nose, sneezing, itching, and eye symptoms; and number of days requiring medication. Secondary outcomes selected will include serum immunoglobin E (IgE) levels, individual ocular symptoms, adverse events, and the use of rescue medication.
Treatment effects will be measured by calculating the mean difference and the standardized mean difference with 95% confidence interval (CI) for continuous data. Risk ratio or, if feasible, odds ratio will be calculated with 95% CI for dichotomous data. After assessing clinical and statistical heterogeneity, meta-analysis will be performed, if appropriate. The individual participant will be the unit of analysis. Descriptive information on missing data will be included about participants missing due to drop out, whether there was intention to treat or per protocol analysis and missing statistics. A number of subgroups, homeopathic potency, age groups, and types of allergic rhinitis (seasonal or perennial) will be analyzed. Sensitivity analysis will be performed to explore the impact of risk of bias on overall treatment effect.
Systematic review registration
PROSPERO CRD42013006741
doi:10.1186/2046-4053-3-59
PMCID: PMC4057901  PMID: 24913155
Homeopathy; Homeopathic; Allergic; Allergy; Rhinitis; Hay fever; Pollinosis; Rhinorrhea; Hypersensitivity
18.  Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine 
Background
This study is part of a nationwide evaluation of complementary medicine in Switzerland (Programme Evaluation of Complementary Medicine PEK) and was funded by the Swiss Federal Office of Public Health. The main objective of this study is to investigate patient satisfaction and perception of side effects in homeopathy compared with conventional care in a primary care setting.
Methods
We examined data from two cross-sectional studies conducted in 2002–2003. The first study was a physician questionnaire assessing structural characteristics of practices. The second study was conducted on four given days during a 12-month period in 2002/2003 using a physician and patient questionnaire at consultation and a patient questionnaire mailed to the patient one month later (including Europep questionnaire).
The participating physicians were all trained and licensed in conventional medicine. An additional qualification was required for medical doctors providing homeopathy (membership in the Swiss association of homeopathic physicians SVHA).
Results
A total of 6778 adult patients received the questionnaire and 3126 responded (46.1%). Statistically significant differences were found with respect to health status (higher percentage of chronic and severe conditions in the homeopathic group), perception of side effects (higher percentage of reported side effects in the conventional group) and patient satisfaction (higher percentage of satisfied patients in the homeopathic group).
Conclusion
Overall patient satisfaction was significantly higher in homeopathic than in conventional care. Homeopathic treatments were perceived as a low-risk therapy with two to three times fewer side effects than conventional care
doi:10.1186/1472-6882-8-52
PMCID: PMC2562361  PMID: 18801188
19.  P03.10. Homeopathy, an Effective, Practical, and Safe Therapeutic Approach: Principles, Evidence and Examples of Practical Application 
Focus Area: Integrative Approaches to Care
Homeopathy has been in use for more than 200 years and is currently practiced by thousands of physicians worldwide. Homeopathic medicines are safe, non-toxic, without adverse effects or drug interactions and are regulated as drugs by the US Food and Drug Administration in the United States. While homeopathy is gaining popularity in the United States, there is poor understanding and misconceptions about it among physicians. Many medical conditions (eg, pertussis cough, recurrent croup) do not have effective drugs and cannot prevent recurrences or require medications with undesirable side effects. Due to the nature of its preparation, homeopathy is an extremely safe modality that can be used as first-line treatment for many acute or chronic conditions or in conjunction with conventional or other nonconventional therapies. While formal training is necessary in order to use homeopathy for chronic conditions, many acute medical problems can be effectively treated by physicians with a basic understanding of homeopathic principles through the use of simple protocols for certain commonly encountered conditions. The poster will cover basic homeopathic principles, review the evidence for efficacy, and present cases from the authors' experiences. Protocols for common acute medical problems that the participants can use immediately in their clinics or offices will be presented and discussed.
doi:10.7453/gahmj.2013.097CP.P03.10
PMCID: PMC3875027
20.  Homeopathic treatment of elderly patients - a prospective observational study with follow-up over a two year period 
BMC Geriatrics  2010;10:10.
Background
Very little is known about the range of diagnoses, course of treatment and long-term outcome in elderly patients who choose to receive homeopathic medical treatment. We investigated homeopathic practice in an industrialised country under everyday conditions.
The aim of the study was to determine the spectrum of diagnoses and treatments, as well as to describe the course of illness over time among older patients who chose to receive homeopathic treatment.
Methods
In this subgroup analysis of a prospective, multicentre cohort study totally including 3981 patients treated by homeopathic physicians in primary care practices in Germany and Switzerland, data was analysed from all patients > 70 years consulting the physician for the first time. The main outcome measures were: assessment by patient of the severity of complaints (numeric rating scales) and quality of life (SF-36) and by the physician of the severity of diagnoses (numeric rating scales) at baseline, and after 3, 12, and 24 months.
Results
A total of 83 patients were included in the subgroup analysis (41% men, mean age 73.2 ± (SD) 3.1 years; 59% women, 74.3 ± 3.8 years).
98.6 percent of all diagnoses were chronic with an average duration of 11.5 ± 11.5 years. 82 percent of the patients were taking medication at baseline.
The most frequent diagnoses were hypertension (20.5%, 11.1 ± 7.5 years) and sleep disturbances (15.7%, 22.1 ± 25.8 years).
The severity of complaints decreased significantly between baseline and 24 months in both patients (from 6.3 (95%CI: 5.7-6.8) to 4.6 (4.0-5.1), p < 0.001) and physicians' assessments (from 6.6 (6.0-7.1) to 3.7 (3.2-4.3), p < 0.001); quality of life (SF 36) and the number of medicines taken did not significantly change.
Conclusion
The severity of disease showed marked and sustained improvements under homeopathic treatment, but this did not lead to an improvement of quality of life. Our findings might indicate that homeopathic medical therapy may play a beneficial role in the long-term care of older adults with chronic diseases and studies on comparative effectiveness are needed to evaluate this hypothesis.
doi:10.1186/1471-2318-10-10
PMCID: PMC2841176  PMID: 20175887
21.  Protocol for a phase 1 homeopathic drug proving trial 
Trials  2010;11:80.
Background
This study protocol adapts the traditional homeopathic drug proving methodology to a modern clinical trial design.
Method
Multi-centre, randomised, double-blind, placebo-controlled phase 1 trial with 30 healthy volunteers. The study consists of a seven day run-in period, a five day intervention period and a 16 day post-intervention observation period. Subjects, investigators and the statisticians are blinded from the allocation to the study arm and from the identity of the homeopathic drug. The intervention is a highly diluted homeopathic drug (potency C12 = 1024), Dose: 5 globules taken 5 times per day over a maximum period of 5 days. The placebo consists of an optically identical carrier substance (sucrose globules). Subjects document the symptoms they experience in a semi-structured online diary. The primary outcome parameter is the number of specific symptoms that characterise the intervention compared to the placebo after a period of three weeks. Secondary outcome parameters are qualitative differences in profiles of characteristic and proving symptoms and the total number of all proving symptoms. The number of symptoms will be quantitatively analysed on an intention-to-treat basis using ANCOVA with the subject's expectation and baseline values as covariates. Content analysis according to Mayring is adapted to suit the homeopathic qualitative analysis procedure.
Discussion
Homeopathic drug proving trials using the terminology of clinical trials according GCP and fulfilling current requirements for research under the current drug regulations is feasible. However, within the current regulations, homeopathic drug proving trials are classified as phase 1 trials, although their aim is not to explore the safety and pharmacological dynamics of the drug, but rather to find clinical indications according to the theory of homeopathy. To avoid bias, it is necessary that neither the subjects nor the investigators know the identity of the drug. This requires a modification to the informed consent process and blinded study materials. Because it is impossible to distinguish between adverse events and proving symptoms, both must be documented together.
Trial registration
ClinicalTrials.gov identifier: NCT01061229.
doi:10.1186/1745-6215-11-80
PMCID: PMC2917434  PMID: 20649979
22.  New Canadian natural health product regulations: a qualitative study of how CAM practitioners perceive they will be impacted 
Background
New Canadian policy to regulate natural health products (NHPs), such as herbs and vitamins were implemented on January 1st, 2004. We explored complementary and alternative medicine (CAM) practitioners' perceptions of how the new regulations may affect their practices and relationships with patients/consumers.
Methods
This was an applied ethnographic study. Data were collected in fall 2004 via qualitative interviews with 37 Canadian leaders of four CAM groups that use natural products as a core part of their practises: naturopathic medicine, traditional Chinese medicine (TCM), homeopathic medicine and Western herbalism. All interviews were transcribed verbatim and coded independently by a minimum of two investigators using content analysis.
Results
Three key findings emerged from the data: 1) all CAM leaders were concerned with issues of their own access to NHPs; 2) all the CAM leaders, except for the homeopathic leaders, specifically indicated a desire to have a restricted schedule of NHPs; and 3) only naturopathic leaders were concerned the NHP regulations could potentially endanger patients if they self-medicate incorrectly.
Conclusion
Naturopaths, TCM practitioners, homeopaths, and Western herbalists were all concerned about how the new NHP regulations will affect their access to the products they need to practice effectively. Additional research will need to focus on what impacts actually occur as the regulations are implemented more fully.
doi:10.1186/1472-6882-6-18
PMCID: PMC1481533  PMID: 16686960
23.  Nonlinear Dynamical Systems Effects of Homeopathic Remedies on Multiscale Entropy and Correlation Dimension of Slow Wave Sleep EEG in Young Adults with Histories of Coffee-Induced Insomnia 
Homeopathy  2012;101(3):182-192.
Background
Investigators of homeopathy have proposed that nonlinear dynamical systems (NDS) and complex systems science offer conceptual and analytic tools for evaluating homeopathic remedy effects. Previous animal studies demonstrate that homeopathic medicines alter delta electroencephalographic (EEG) slow wave sleep. The present study extended findings of remedy-related sleep stage alterations in human subjects by testing the feasibility of using two different NDS analytic approaches to assess remedy effects on human slow wave sleep EEG.
Methods
Subjects (N=54) were young adult male and female college students with a history of coffee-related insomnia who participated in a larger 4-week study of the polysomnographic effects of homeopathic medicines on home-based all-night sleep recordings. Subjects took one bedtime dose of a homeopathic remedy (Coffea cruda or Nux vomica 30c). We computed multiscale entropy (MSE) and the correlation dimension (Mekler-D2) for stage 3 and 4 slow wave sleep EEG sampled in artifact-free 2-minute segments during the first two rapid-eye-movement (REM) cycles for remedy and post-remedy nights, controlling for placebo and post-placebo night effects.
Results
MSE results indicate significant, remedy-specific directional effects, especially later in the night (REM cycle 2) (CC: remedy night increases and post-remedy night decreases in MSE at multiple sites for both stages 3 and 4 in both REM cycles; NV: remedy night decreases and post-remedy night increases, mainly in stage 3 REM cycle 2 MSE). D2 analyses yielded more sporadic and inconsistent findings.
Conclusions
Homeopathic medicines Coffea cruda and Nux vomica in 30c potencies alter short-term nonlinear dynamic parameters of slow wave sleep EEG in healthy young adults. MSE may provide a more sensitive NDS analytic method than D2 for evaluating homeopathic remedy effects on human sleep EEG patterns.
doi:10.1016/j.homp.2012.05.007
PMCID: PMC3402916  PMID: 22818237
homeopathy; polysomnography; electroencephalography; Coffea cruda; Nux vomica; nonlinear dynamics, multiscale entropy; correlation dimension; slow wave sleep; complex systems; time-dependent sensitization
24.  Effects of Homeopathic Medicines on Polysomnographic Sleep of Young Adults with Histories of Coffee-Related Insomnia 
Sleep medicine  2010;12(5):505-511.
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.
doi:10.1016/j.sleep.2010.03.013
PMCID: PMC2972403  PMID: 20673648
Complementary and alternative medicine; Homeopathy; Polysomnography; Coffee; Insomnia; Young Adults; Coffea Cruda; Nux Vomica
25.  Testing the Nanoparticle-Allostatic Cross Adaptation-Sensitization Model for Homeopathic Remedy Effects 
Key concepts of the Nanoparticle-Allostatic Cross-Adaptation-Sensitization (NPCAS) Model for the action of homeopathic remedies in living systems include source nanoparticles as low level environmental stressors, heterotypic hormesis, cross-adaptation, allostasis (stress response network), time-dependent sensitization with endogenous amplification and bidirectional change, and self-organizing complex adaptive systems.
The model accommodates the requirement for measurable physical agents in the remedy (source nanoparticles and/or source adsorbed to silica nanoparticles). Hormetic adaptive responses in the organism, triggered by nanoparticles; bipolar, metaplastic change, dependent on the history of the organism. Clinical matching of the patient’s symptom picture, including modalities, to the symptom pattern that the source material can cause (cross-adaptation and cross-sensitization). Evidence for nanoparticle-related quantum macro-entanglement in homeopathic pathogenetic trials.
This paper examines research implications of the model, discussing the following hypotheses: Variability in nanoparticle size, morphology, and aggregation affects remedy properties and reproducibility of findings. Homeopathic remedies modulate adaptive allostatic responses, with multiple dynamic short- and long-term effects. Simillimum remedy nanoparticles, as novel mild stressors corresponding to the organism’s dysfunction initiate time-dependent cross-sensitization, reversing the direction of dysfunctional reactivity to environmental stressors.
The NPCAS model suggests a way forward for systematic research on homeopathy. The central proposition is that homeopathic treatment is a form of nanomedicine acting by modulation of endogenous adaptation and metaplastic amplification processes in the organism to enhance long-term systemic resilience and health.
doi:10.1016/j.homp.2012.10.005
PMCID: PMC3539158  PMID: 23290882
nanoparticle; homeopathy; allostasis; time-dependent sensitization; metaplasticity; crosssensitization; research design; complex adaptive systems; physiological stress response

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