CORE-Hom: a powerful and exhaustive database of clinical trials in homeopathy.

The CORE-Hom database was created to answer the need for a reliable and publicly available source of information in the field of clinical research in homeopathy. As of May 2014 it held 1048 entries of clinical trials, observational studies and surveys in the field of homeopathy, including second publications and re-analyses. 352 of the trials referenced in the database were published in peer reviewed journals, 198 of which were randomised controlled trials. The most often used remedies were Arnica montana (n = 103) and Traumeel(®) (n = 40). The most studied medical conditions were respiratory tract infections (n = 126) and traumatic injuries (n = 110). The aim of this article is to introduce the database to the public, describing and explaining the interface, features and content of the CORE-Hom database.

Homeopathic treatment of elderly patients--a prospective observational study with follow-up over a two year period.

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.

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

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

Homeopathic treatment of patients with dysmenorrhea: a prospective observational study with 2 years follow-up.

PURPOSE: Evaluating homeopathic treatment for dysmenorrhea. METHODS: Prospective multicenter observational study in primary care, using standardized questionnaires to record for 2 years diseases, quality of life, medical history, consultations, all treatments, other health services use. RESULTS: Fifty-seven physicians treated 128 women (age 32.4 +/- 7.5 years, mean +/- SD) and 11 girls (13.7 +/- 4.0). Women had dysmenorrhea for 11.6 +/- 9.0 (girls 3.1 +/- 1.5) years. Patients received 7.5 +/- 6.5 (5.9 +/- 3.7) homeopathic prescriptions. Diagnoses and complaints severity improved markedly [at 24 months, dysmenorrhea relieved by > 50% of baseline rating in 46.1% (59) of the women and 45.5% (5) of the girls] with large effect sizes (24 months: Cohen's d from 1.18 to 2.93). In addition, QoL improved (24 months: SF-36 physical component score: 0.25, mental component score 0.25, KINDL sum score 0.27). Conventional medication changed little and use of other health services decreased. CONCLUSIONS: Patients with dysmenorrhea improved under homeopathic treatment. Controlled studies should investigate efficacy and effectiveness.

Homeopathic treatment of patients with chronic sinusitis: A prospective observational study with 8 years follow-up.

BACKGROUND: An evaluation of homeopathic treatment and the outcomes in patients suffering from sinusitis for >or=12 weeks in a usual care situation. METHODS: Subgroup analysis including all patients with chronic sinusitis (ICD-9: 473.9; >or=12 weeks duration) of a large prospective multicentre observational study population. Consecutive patients presenting for homeopathic treatment were followed-up for 2 years, and complaint severity, health-related quality of life (QoL), and medication use were regularly recorded. We also present here patient-reported health status 8 years post initial treatment. RESULTS: The study included 134 adults (mean age 39.8 +/- 10.4 years, 76.1% women), treated by 62 physicians. Patients had suffered from chronic sinusitis for 10.7 +/- 9.8 years. Almost all patients (97.0%) had previously been treated with conventional medicine. For sinusitis, effect size (effect divided by standard deviation at baseline) of complaint severity was 1.58 (95% CI 1.77; 1.40), 2.15 (2.38; 1.92), and 2.43 (2.68; 2.18) at 3, 12, and 24 months respectively. QoL improved accordingly, with SF-36 changes in physical component score 0.27 (0.15; 0.39), 0.35 (0.19; 0.52), 0.44 (0.23; 0.65) and mental component score 0.66 (0.49; 0.84), 0.71 (0.50; 0.92), 0.65 (0.39; 0.92), 0.74 (0.49; 1.00) at these points. The effects were still present after 8 years with SF-36 physical component score 0.38 (0.10; 0.65) and mental component score 0.74 (0.49; 1.00). CONCLUSION: This observational study showed relevant improvements that persisted for 8 years in patients seeking homeopathic treatment because of sinusitis. The extent to which the observed effects are due to the life-style regulation and placebo or context effects associated with the treatment needs clarification in future explanatory studies.

How healthy are chronically ill patients after eight years of homeopathic treatment?--Results from a long term observational study.

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.

Does potentized HgCl2 (Mercurius corrosivus) affect the activity of diastase and alpha-amylase?

BACKGROUND: Homeopathic drugs even with dilutions beyond 10(23) (high potencies) are frequently used, although their working mechanism is still unknown. Curative information preserved in solvent structure is postulated to exert biologic effects. OBJECTIVE: The objective was to test for a stimulating or inhibiting effect of high potencies of the homeopathic remedy HgCl2 (Mercurius corrosivus) on two sugar hydrolases. METHODS: High potencies were produced using stepwise dilution plus shaking. Controls included potentized solvent (aqua bidestillata), equimolar dilutions without shaking, and enzyme-free references. Tested were potencies with dilution factors 1:200 (CC) on diastase extract from winter barley, and 1:100 (C) on alpha-amylase from hog pancreas. Enzyme activity was colorimetrically determined by Lugol's iodine-starch reaction. RESULTS: An inhibiting effect of HgCl2 on enzyme activities was observed only in low potencies and dilutions. Statistically significant differences between potencies and controls were not found in randomized and blinded experiments. CONCLUSIONS: This experimental design provided independent reproducible results of cell-free in vitro assays. However, it did not indicate an effect of potentized HgCl2 on hydrolases. Demonstrating potency effects may require additional experimental features.

Amount of systemic steroid medication is a strong predictor for the use of complementary and alternative medicine in patients with inflammatory bowel disease: results from a German national survey.

OBJECTIVES: Previous studies have suggested that inflammatory bowel disease (IBD) patients rank high among users of complementary and alternative medicine (CAM). To further elucidate this phenomenon, we sent questionnaires to a large sample of IBD patients in Germany to determine the patterns and predictors of their CAM use. METHODS: Pretested 73-item questionnaires were mailed to a randomly selected representative sample of 1000 IBD patients from the approximately 16,000 members and associates of the German Crohn's and Colitis Association. Predictors of CAM use were evaluated by logistic regression models. RESULTS: Completed questionnaires were returned by 684 patients (female patients, 61.4%; Crohn's disease patients, 58.3%; ulcerative colitis patients, 38.2%). Of the 671 adult respondents, 344 (51.3%) had experience with CAM, and significantly more of the ulcerative colitis patients (59.8%) than the Crohn's disease patients (48.3%) had experience with CAM. There was no difference by gender. Homeopathy (52.9%) and herbal medicine (43.6%) were the most commonly used types of CAM. The most frequent personal reasons for CAM use were the search for an "optimum treatment" (78.9%) and the wish to stop taking steroids (63.8%). Using logistic regression, we found that total cortisone intake (P = 0.0077), but not duration of disease, was a strong predictor of CAM use. Other predictors were experience with psychosomatic and psychotherapeutic support (P = 0.0029), relaxation techniques (P = 0.0284), an academic education (P = 0.0173), a diet utilizing whole grains (P = 0.0123), and a normal body weight (P = 0.0215). Although 80% of patients indicated that they were interested in using CAM in the future, only 24.7% felt sufficiently informed about it. CONCLUSIONS: More than 50% of a large group of German IBD patients had used CAM. Prolonged or intensive steroid treatment, an academic education, active ways of coping, and a health-conscious life-style are associated with CAM use. Given the potential side effects and interactions, the treating physician should focus on thorough information about the benefits and limitations of conventional and complementary treatment options, especially for IBD patients who have received prolonged or intensive steroid treatment.

Homeopathic medical practice: long-term results of a cohort study with 3981 patients.

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.

High homeopathic potencies are different from potentized solvent when investigated with the REDEM technology.

OBJECTIVE: To determine in a series of randomized blinded experiments using the REDEM technology whether differences between high homeopathic potencies and similarly potentized solvent can be detected. DESIGN AND ANALYSIS: A REDEM device was employed as a black box. Samples were measured in a capacitor that was connected to 60 individual oscillator circuits at frequencies between 250 and 930 KHz; their oscillation damping was recorded. In two experiments (3 and 4 replications) stable differences between a potentized 'mother tincture' and potentized solvent were assessed. Statistical analysis was done using ANCOVA. RESULTS: Significant differences (p < 0.01) between remedy and control were found, mostly at the same oscillator frequencies. Those differences found for only one remedy always were at frequencies adjacent to frequencies with differences for other remedies. VISUAL ANALYSIS: Where output curves were not near 0, remedy values were higher than controls. Curves within a replication ran parallel, their distances varied. Between replications, curve shapes and remedy- control differences were similar, however, control curves varied in height. Control and remedy curves between experiments varied in shape. Effects increased with time and sample conductivity. Ethanol 43% as solvent eliminated the observed effects, use of polyethylene containers considerably attenuated them. CONCLUSIONS: A probably physical difference was seen between potentized homeopathic remedies and potentized solvent. The differences are associated with sample age, solvent, and container material. The REDEM technology requires further investigation to determine the nature of the underlying mechanisms of the observed differences.

Quality assessment of physical research in homeopathy.

OBJECTIVES: To assess the evidence of published experiments on homeopathic preparations (potencies) that target physical properties (i.e., assumed structural changes in solvents). METHOD: A suitable instrument (the Score for Assessment of Physical Experiments on Homeopathy [SAPEH]) was developed through consensus procedure: a scale with 8 items covering 10 criteria, based on the 3 constructs, methodology, presentation, and experiment standardization. REVIEWED PUBLICATIONS: Written reports providing at least minimal details on physical experiments with methods to identify structural changes in solvents were collected. These reports were scored when they concerned agitated preparations in a dilution less than 10(-23), with no other restrictions. We found 44 publications that included 36 experiments (the identity of 2 was unclear). They were classified into 6 types (dielectric strength, 6; galvanic effects, 5; light absorption, 4; nuclear magnetic resonance [NMR], 18; Raman spectroscopy, 7; black boxes of undisclosed design, 4). RESULTS: Most publications were of low quality (SAPEH < 6), only 6 were of high quality (SAPEH > 7, including 2 points for adequate controls). These report 3 experiments (1 NMR, 2 black boxes), of which 2 claim specific features for homeopathic remedies, as does the only medium-quality experiment with sufficient controls. CONCLUSIONS: Most physical experiments of homeopathic preparations were performed with inadequate controls or had other serious flaws that prevented any meaningful conclusion. Except for those of high quality, all experiments should be repeated using stricter methodology and standardization before they are accepted as indications of special features of homeopathic potencies.

Are the effects of homeopathy attributable to a statistical artefact? A reanalysis of an observational study.

Background. Cohort studies have reported that patients improve considerably after individualised homeopathic treatment. However, these results may be biased by regression to the mean (RTM). Objective. To evaluate whether the observed changes in previous cohort studies are due to RTM and to estimate RTM adjusted effects. Methods. SF-36 quality-of-life (QoL) data from a German cohort of 2827 chronically diseased adults treated by a homeopath were reanalysed by Mee and Chua's modified t-test. Results. RTM adjusted effects, standardized by the respective standard deviation at baseline, were 0.12 (95% CI: 0.06-0.19, P < 0.001) in the mental and 0.25 (0.22-0.28, P < 0.001) in the physical summary score. Small-to-moderate effects were confirmed for the most individual diagnoses in physical, but not in mental component scores. Under the assumption that the true population mean equals the mean of all actually diseased patients, RTM adjusted effects were confirmed for both scores in most diagnoses. Conclusions. Changes in QoL after treatment by a homeopath are small but cannot be explained by RTM alone. As all analyses made conservative assumptions, true RTM adjusted effects are probably larger than presented.

Homeopathy for depression: a randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM).

BACKGROUND: The specific clinical benefit of the homeopathic consultation and of homeopathic remedies in patients with depression has not yet been investigated. AIMS: To investigate the 1) specific effect of individualized homeopathic Q-potencies compared to placebo and 2) the effect of an extensive homeopathic case taking (case history I) compared to a shorter, rather conventional one (case history II) in the treatment of acute major depression (moderate episode) after six weeks. METHODS: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2×2 factorial design with a six-week study duration per patient was performed. RESULTS: A total of 44 from 228 planned patients were randomized (2∶1∶2∶1 randomization: 16 homeopathic Q-potencies/case history I, 7 placebo/case history I, 14 homeopathic Q-potencies/case history II, 7 placebo/case history II). Because of recruitment problems, the study was terminated prior to full recruitment, and was underpowered for the preplanned confirmatory hypothesis testing. Exploratory data analyses showed heterogeneous and inconclusive results with large variance in the sample. The mean difference for the Hamilton-D after 6 weeks was 2.0 (95%CI -1.2;5.2) for Q-potencies vs. placebo and -3.1 (-5.9;-0.2) for case history I vs. case history II. Overall, no consistent or clinically relevant results across all outcomes between homeopathic Q-potencies versus placebo and homeopathic versus conventional case taking were observed. The frequency of adverse events was comparable for all groups. CONCLUSIONS: Although our results are inconclusive, given that recruitment into this trial was very difficult and we had to terminate early, we cannot recommend undertaking a further trial addressing this question in a similar setting. Prof. Dr. Claudia Witt had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. TRIAL REGISTRATION: clinicaltrials.gov identifier NCT01178255. Protocol publication: http://www.trialsjournal.com/content/12/1/43.

[Legal status and organization of homeopathic drug testing in Germany]. / Arzneirechtlicher Status und Organisation homöopathischer Arzneimittelprüfungen in Deutschland.

For more than 200 years, homeopathic doctors have been carrying out homeopathic drug provings (HDPs),which embodies the traditional self drug testing, an integral part of the homeopathic medical profession. However,according to national authorities, testing homeopathic drugs is a phase I clinical trial for which the German Federal Drug Law applies. Adapting a 200-year-old primary qualitative study design to modern drug law and Good Clinical Practice Guidelines generates several difficulties, in particular, blinding, informed consent and the classification of adverse events. In addition, in Germany naturopaths (German: 'Heilpraktiker') are excluded from leading HDP trials. The costs are climbing, and the organizational over heads for a HDP are enormous. Implications for the future are discussed.

Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study.

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 x 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.

Homeopathic treatment of patients with migraine: a prospective observational study with a 2-year follow-up period.

OBJECTIVES AND BACKGROUND: The objective of this study was to evaluate treatment details and possible effects of an individualized homeopathic treatment in patients with migraine in usual care. DESIGN: This was a prospective multicenter observational study. Consecutive patients beginning homeopathic treatment in primary care practices were evaluated over 2 years using standardized questionnaires. The data recorded included diagnoses (International Classification of Diseases, Ninth Revision) and current complaints, including their severity (numeric rating scale = 0-10), health-related quality of life (QoL, 36-item Short-Form Health Survey), medical history, consultations, homeopathic and conventional treatments, as well as other health service use. RESULTS: Two hundred and twelve (212) adults (89.2% women), mean age 39.4 +/- 10.7 years were treated by 67 physicians. Patients had suffered from migraine for a period of 15.2 +/- 10.9 years. Most patients (90.0%) were conventionally pretreated. The physician workload included taking the initial patient history (120 +/- 45 minutes), case analysis (40 +/- 47 minutes), and follow-ups (7.3 +/- 7.0, totaling 165.6 +/- 118.8 minutes). Patients received 6.2 +/- 4.6 homeopathic prescriptions. Migraine severity showed marked improvement with a large effect size (Cohen's d = 1.48 after 3 months and 2.28 after 24 months. QoL improved accordingly (Mental Component Score and Physical Component Score after 24 months: 0.42 and 0.45). The use of conventional treatment and health services decreased markedly. CONCLUSIONS: In this observational study, patients seeking homeopathic treatment for migraine showed relevant improvements that persisted for the observed 24 month period. Due to the design of this study, however, it does not answer the question as to whether the effects are treatment specific or not.