Searching for the Genus Epidemicus in Chinese Patients: Findings from the Clificol COVID-19 Clinical Case Registry.

BACKGROUND: The Clificol COVID-19 Support Project is an innovative international data collection project aimed at tackling some of the core questions in homeopathy. This paper reports on the further investigation of the genus epidemicus concept during the first wave of the pandemic in the Chinese population. METHODS: The design is an observational clinical case registry study of Chinese patients with confirmed or suspected coronavirus disease 2019 (COVID-19). The symptoms were prospectively collected via a 150-item questionnaire. The concept of genus epidemicus, including the role of treatment individualization, was investigated by analyzing whether presenting symptoms clustered into distinct groups. Two standard statistical analysis techniques were utilized: principal component analysis for extracting the most meaningful symptoms of the dataset; the k-means clustering algorithm for automatically assigning groups based on similarity between presenting symptoms. RESULTS: 20 Chinese practitioners collected 359 cases in the first half of 2020 (766 consultations, 363 prescriptions). The cluster analysis found two to be the optimum number of clusters. These two symptomatic clusters had a high overlap with the two most commonly prescribed remedies in these sub-populations: in cluster 1 there were 297 prescriptions, 95.6% of which were Gelsemium sempervirens; in cluster 2 there were 61 prescriptions, 95.1% of which were Bryonia alba. CONCLUSION: This is the first study to investigate the notion of genus epidemicus by using modern statistical techniques. These analyses identified at least two distinct symptom pictures. The notion of a single COVID-19 genus epidemicus did not apply in the studied population.

Case Reporting in Homeopathy-An Overview of Guidelines and Scientific Tools.

Case reports have been of central importance to the development of homeopathy over the past 200 years. With a special focus on homeopathy, we give an overview on guidelines and tools that may help to improve the quality of case reports. Reporting guidelines such as CARE (Case Report), HOM-CASE (Homeopathic Clinical Case Reports), and the WissHom Documentation Standard help to improve the quality of reporting and strengthen the scientific value of a case report. Additional scientific tools such as prospective outcome assessment, prognostic factor research, cognition-based medicine, and the Modified Naranjo Criteria for Homeopathy (MONARCH) score may be helpful in improving case documentation and evaluation.

Data Collection during the COVID-19 Pandemic: Learning from Experience, Resulting in a Bayesian Repertory.

BACKGROUND: A novel pandemic disease offered the opportunity to create new, disease-specific, symptom rubrics for the homeopathic repertory. OBJECTIVE: The aim of this study was to discover the relationship between specific symptoms and specific medicines, especially of symptoms occurring frequently in this disease. MATERIALS AND METHODS: Worldwide collection of data in all possible formats by various parties was coordinated by the Liga Medicorum Homeopathica Internationalis. As the data came in, more symptoms were assessed prospectively. Frequent analysis and feedback by electronic newsletters were used to improve the quality of the data. Likelihood ratios (LRs) of symptoms were calculated. An algorithm for combining symptom LRs was programmed and published in the form of an app. The app was tested against 18 well-described successful cases from Hong Kong. RESULTS: LRs of common symptoms such as 'Fatigue' and 'Headache' provided better differentiation between medicines than did existing repertory entries, which are based only on the narrow presence or absence of symptoms. A mini-repertory for COVID-19 symptoms was published and supported by a web-based algorithm. With a choice of 20 common symptoms, this algorithm produced the same outcome as a full homeopathic analysis based upon a larger number of symptoms, including some that are traditionally considered more specific to particular medicines. CONCLUSION: A repertory based on clinical data and LRs can differentiate between homeopathic medicines using a limited number of frequently occurring epidemic symptoms. A Bayesian computer algorithm to combine symptoms can complement a full homeopathic analysis of cases.

Evaluation of the Modified Naranjo Criteria for Assessing Causal Attribution of Clinical Outcome to Homeopathic Intervention as Presented in Case Reports.

OBJECTIVES: The objective of this study was to establish the reliability and content validity of the "Modified Naranjo Criteria for Homeopathy-Causal Attribution Inventory" as a tool for attributing a causal relationship between the homeopathic intervention and outcome in clinical case reports. METHODS: Purposive sampling was adopted for the selection of information-rich case reports using pre-defined criteria. Eligible case reports had to fulfil a minimum of nine items of the CARE Clinical Case Reporting Guideline checklist and a minimum of three of the homeopathic HOM-CASE CARE extension items. The Modified Naranjo Criteria for Homeopathy Inventory consists of 10 domains. Inter-rater agreement in the scoring of these domains was determined by calculating the percentage agreement and kappa (κ) values. A κ greater than 0.4, indicating fair agreement between raters, in conjunction with the absence of concerns regarding the face validity, was taken to indicate the validity of a given domain. Each domain was assessed by four raters for the selected case reports. RESULTS: Sixty case reports met the inclusion criteria. Inter-rater agreement/concordance per domain was "perfect" for domains 1 (100%, κ = 1.00) and 2 (100%, κ = 1.00); "almost perfect" for domain 8 (97.5%, κ = 0.86); "substantial" for domains 3 (96.7%, κ = 0.80) and 5 (91.1%, κ = 0.70); "moderate" for domains 4 (83.3%, κ = 0.60), 7 (67.8%, κ = 0.46) and 9 (99.2%, κ = 0.50); and "fair" for domain 10 (56.1%, κ = 0.38). For domains 6A (46.7%, κ = 0.03) and 6B (50.3%, κ = 0.18), there was "slight agreement" only. Thus, the validity of the Modified Naranjo Criteria for Homeopathy tool was established for each of its domains, except for the two that pertain to direction of cure (domains 6A and 6B). CONCLUSION: The MO: dified NAR: anjo C: riteria for H: omeopathy-Causal Attribution Inventory was identified as a valid tool for assessing the likelihood of a causal relationship between a homeopathic intervention and clinical outcome. Improved wordings for several criteria have been proposed for the assessment tool, under the new acronym "MONARCH". Further assessment of two MONARCH domains is required.

Model validity of randomised placebo-controlled trials of non-individualised homeopathic treatment.

BACKGROUND: The comprehensive systematic review of randomised placebo-controlled trials (RCTs) in homeopathy requires examination of a study's model validity of homeopathic treatment (MVHT) as well as its risk of bias (extent of reliable evidence). OBJECTIVE: To appraise MVHT in those RCTs of non-individualised homeopathy that an associated investigation had judged as 'not at high risk of bias'. DESIGN: Systematic review. METHODS: An assessment of MVHT was ascribed to each of 26 eligible RCTs. Another 49 RCTs were ineligible due to their high risk of bias. MAIN OUTCOME MEASURES: MVHT and the prior risk of bias rating per trial were merged to obtain a single overall quality designation ('high', 'moderate', 'low'), based on the GRADE principle of downgrading. RESULTS: The trials were rated as 'acceptable MVHT' (N = 9), 'uncertain MVHT' (N = 10) and 'inadequate MVHT' (N = 7); and, previously, as 'reliable evidence' (N = 3) and 'non-reliable evidence' (N = 23). The 26 trials were designated overall as: 'high quality' (N = 1); 'moderate quality' (N = 18); 'low quality' (N = 7). CONCLUSION: Of the 26 RCTs of non-individualised homeopathy that were judged 'not at high risk of bias', nine have been rated 'acceptable MVHT'. One of those nine studies was designated 'high quality' overall ('acceptable MVHT' and 'reliable evidence'), and is thus currently the only reported RCT that represents best therapeutic practice as well as unbiased evidence in non-individualised homeopathy. As well as minimising risk of bias, new RCTs in this area must aim to maximise MVHT and clarity of reporting.

Development of a Prognostic Factor Prediction Model in Patients with Musculoskeletal Pain Treated with Homeopathy: An Individual Patient Data Meta-Analysis of Three Randomized Clinical Trials.

BACKGROUND: Prognostic factor research methodology has not yet been applied to randomized clinical trial data of homeopathic medicines. OBJECTIVES: To investigate the principle of individualization in homeopathy by developing a prognostic factor prediction model. METHOD: A pooled, in-dividual patient data meta-analysis of 3 randomized trials -investigating the efficacy of a homeopathic gel (Spiroflor SRL®) containing Rhus toxicodendron as a key ingredient in osteoarthritis of the knee and acute low back pain. The prognostic value of a predefined set of 5 typical R. toxicodendron symptoms was investigated by assessing treatment-by-symptom interactions on pain as an outcome measure in a regression model. RESULTS: The pooled dataset consisted of 284 patients in the Spiroflor SRL group and 275 patients in the control group. Adjusted for pain at baseline, a statistically significant effect modification for the symptoms "numbness or tingling of the affected part" (+2.0 mm VAS; p = 0.02), "amelioration by movement" (-5.6 mm VAS; p = 0.01), and "amelioration of pain by local heat" (+7.0 mm VAS; p = 0.02) was found. CONCLUSIONS: Investigating aspects of treatment individualization in homeopathy using randomized trial data and standard meta-analytical techniques is possible. The symptom amelioration by local heat is of possible value as a homeopathic symptom (prognostic factor) predicting an increased likelihood of pain relief following treatment with the homeopathic product.

Homeopathic medicines for adverse effects of cancer treatments.

BACKGROUND: Homeopathic medicines are used by patients with cancer, often alongside conventional treatment. Cancer treatments can cause considerable morbidity and one of the reasons patients use homeopathic medicines is to help with adverse effects. OBJECTIVES: Evaluate effectiveness and safety of homeopathic medicines used to prevent or treat adverse effects of cancer treatments. SEARCH STRATEGY: The following were searched up to November 2008: Cochrane PaPaS Trials Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; CINAHL; BNI; CancerLIT; AMED; CISCOM; Hom-Inform; SIGLE; National Research Register; Zetoc; www.controlled-trials.com; http://clinicaltrials.gov; Liga Medicorum Homeopathica Internationalis (LMHI, Liga) conference proceedings; reference lists of relevant studies were checked; and homeopathic manufacturers, leading researchers and practitioners were contacted. SELECTION CRITERIA: Randomised controlled trials (RCTs) of homeopathic medicines in participants with a clinical or histological diagnosis of cancer where the intervention was aimed at preventing or treating symptoms associated with cancer treatments. All age groups, and all stages of disease were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion and two review authors extracted data. Three review authors independently assessed trial quality using the Delphi List and the Cochrane Collaboration's tool for assessing risk of bias. Disagreements were resolved by consensus. Where available, data were extracted for analysis. MAIN RESULTS: Eight controlled trials (seven placebo controlled and one trial against an active treatment) with a total of 664 participants met the inclusion criteria. Three studied adverse effects of radiotherapy, three studied adverse effects of chemotherapy and two studied menopausal symptoms associated with breast cancer treatment.Two studies with low risk of bias demonstrated benefit: one with 254 participants demonstrated superiority of topical calendula over trolamine (a topical agent not containing corticosteroids) for prevention of radiotherapy-induced dermatitis, and another with 32 participants demonstrated superiority of Traumeel S (a proprietary complex homeopathic medicine) over placebo as a mouthwash for chemotherapy-induced stomatitis. Two other studies reported positive results, although the risk of bias was unclear, and four further studies reported negative results.No serious adverse effects or interactions were reported attributable to the homeopathic medicines used. AUTHORS' CONCLUSIONS: This review found preliminary data in support of the efficacy of topical calendula for prophylaxis of acute dermatitis during radiotherapy and Traumeel S mouthwash in the treatment of chemotherapy-induced stomatitis. These trials need replicating. There is no convincing evidence for the efficacy of homeopathic medicines for other adverse effects of cancer treatments. Further research is required.

Effectiveness of the homeopathic preparation Neurexan compared with that of commonly used valerian-based preparations for the treatment of nervousness/restlessness - an observational study.

Mild anxieties, nervousness, and restlessness are common in the general population and are commonly treated by complementary and alternative medical (CAM) therapies. A prospective, nonrandomized, noninterventional, observational study, using conventional or CAM practices, was conducted in 49 German practices. Each practice could include up to 15 subjects treated with either the homeopathic preparation Neurexan or with combination formulations based on valerian extracts. There was no placebo group. Choice and doses of study therapies were at the respective physician's discretion. The planned treatment duration was 2 weeks. A total of 826 subjects were included in the study and 777 (553 Neurexan and 224 valerian) subjects were available for the final examination. Subjects receiving Neurexan tended to weigh less, to have fewer concomitant illnesses and slightly milder severity of nervousness/restlessness, and were likelier to be female than the subjects receiving valerian therapies. The summary score for nervousness/restlessness was reduced from 19.0 +/- 6.1 at baseline to 7.4 +/- 6.8 at the end of the observation period in the Neurexan group, a reduction of 11.5 +/- 7.3 score units. In the valerian group, the summary score was reduced from 21.4 +/- 6.0 to 12.6 +/- 7.3, a reduction of 9.0 +/- 6.6 score units. The changes from baseline and the differences between the groups were statistically significant. Similar significant differences in effects were seen on the subscores and on the subjects' assessments of effectiveness. Both study therapies were well tolerated. Neurexan appears to be an effective and well-tolerated alternative to valerian-based combination therapies for the treatment of nervousness/restlessness in subjects favorable towards a CAM-based therapy.

The role of a homoeopathic preparation compared with conventional therapy in the treatment of injuries: an observational cohort study.

OBJECTIVES: To assess the use, effectiveness and safety of a homoeopathic preparation (Traumeel) compared with conventional therapies in the treatment of trauma and injuries. METHODS: Multi-centre, prospective, comparative observational cohort study of patients with various musculoskeletal injuries. German physicians who were using homoeopathy in addition to conventional medicine included patients. Patients treated with Traumeel were compared with patients managed conventionally. The primary outcome measure was the rate of resolution of the principal symptoms (i.e. pain and inflammatory symptoms) at the end of therapy. RESULTS: Sixty-nine Traumeel treated and 64 conventionally treated patients fitted the selection criteria. The most common diagnoses were acute injuries (sprains, strains, contusions, etc.) of the ankles, knees and hands. There were no significant differences between demographic and anamnestic baseline characteristics of both groups. Complete resolution of the principal symptom at the end of therapy occurred in 41 (59.4%) patients in the homoeopathy group versus 37 (57.8%) patients in the conventional group. No adverse events were reported in the Traumeel group compared to six adverse events (6.3%) in the conventional group. Physician-assessed tolerability was significantly better in the Traumeel group (P=0.001). CONCLUSION: Traumeel is as effective as conventional medicines in the management of mild to moderate injuries in this population. Traumeel was safe in use and judged by physicians to be better tolerated than conventional medicines. This study contributes to the case for a broad clinical effectiveness of Traumeel in the treatment of acute injuries and trauma.

A fresh look at the concept of Genus Epidemicus: findings from the Clificol Project

The Clificol® COVID-19 Support Project is an innovative international data collection project aimed at tackling some of the core questions in homeopathy, including the notion of Genus Epidemicus. Aims:To shed some light on the notion of Genus Epidemicus in the context of this infection. Going beyond that, the project aims to use these data to tackle more fundamental questions, such as the role of symptoms and rubrics in treatment individualisation. Methodology:This online multi-national data-collection project is supported by the ECH, ECCH, ICH, HRI, LMHI, and other professional associations. The collected data includes demographic information, severity, conventional diagnosis and treatment, presenting symptoms as well as the remedies prescribed. The outcome of treatment was tracked using the ORIDL scale. The concept of Genus Epidemicus, including the role of treatment individualisation, was investigated by analysing whether presenting symptoms cluster into distinct groups (K-Means clustering approach). The symptom data originating from China was obtained using a questionnaire. Results and discussion: 20 Chinese practioners collected 359 cases, primarily in the first half of 2020 (766 consultations, 363 prescriptions). The cluster analysis found two to be the optimum number of clusters. These two symptomatic clusters had a high overlap with the two most commonly prescribed remedies in that population: In cluster 1 there were 297 prescriptions, 95.6% of which were Gelsemium sempervirens, incluster 2, there were 61 prescriptions, 95.1% of which were Bryonia alba. Under the assumption of a single genus epidemicuswe would expect to see a single cluster of symptoms. The data from the Chinese population were not compatible with this assumption. Conclusion:This was the first study that investigated the notion of Genus Epidemicus by using modern statistical techniques. These analyses identified at least two distinct symptom pictures. The notion of a single COVID-19 Genus Epidemicus did not apply to this population.

Update from the Clificol Project: Omicron in Hong-Kongand worldwide overview of the pandemic

The Clificol® COVID-19 Support Project is an innovative international data collection project aimed at documenting the presenting symptoms, use of homeopathy through the pandemic and tackling some of the core questions in homeopathy. The Covid-19 pandemic raised many questions and mobilised many resources. In order to make good use of resources, sound knowledge of the presenting complaints and demographics are required. In particular, we aimed to characterise the recent Omicron wave in Hong-Kong and to get an overall picture of the global pandemic as experienced by the homeopathic community. This online multi-national data-collection project is supported by the ECH, ECCH, ICH, HRI, LMHI, and other professional associations. The collected data includes demographic information, severity, conventional diagnosis and treatment, presenting symptoms as well as the remedies prescribed. The outcome of treatment was tracked using the ORIDL scale. More recently a 23-items prospective questionnaire was added to the input in order to gather targeted data about the presenting complaints. The recent wave of the Omicron variant in Hong-Kong, was analysed (N=372 cases) in terms of the symptomatology of this variant. The data from the 23-items questionnaire is compared to the longer questionnaire (150 items) used by the Hong-Kong team (21 practitioners). The most frequently reported common Clinical symptoms were extreme tiredness (60%), sore throat (46%), headache during fever (45%), dryness of mouth (37%), poor appetite (37%), runny nose (34%) and unusual muscle pains (31%).Also, the cases collected from around the world over the course of the pandemic (N=1300) were analysed, providing an overall picture of the pandemic and its specificities per country and over time. Clificol has shown and continues to show the value of data collection for the homeopathy community, providing important information for the management of future pandemics and opening new avenues for research in homeopathy.

Clinical trials of classical homeopathy: reflections on appropriate research designs.

The growing popularity of complementary medicine has been accompanied by a call for controlled clinical studies to examine the efficacy and validity of its various methods. The difficulties encountered in applying the evaluation methods of conventional medicine to complementary medicine are the result of the different paradigms underlying these two methods of medicine, and the differences in the healing process. This paper attempts to bridge the gap between these two approaches and to suggest a possibility to use conventional research methodology in clinical studies of classical homeopathy. Two methods are described. One is the randomization into a placebo or a treatment group after an individual remedy is chosen for each patient. This method requires an experienced homeopath and is reproducible only by the same homeopath in the same population. On the other hand, the expected success rate will be high. Another method is prescribing and treating according to so-called keynotes, a set of symptoms known to respond to a particular remedy that must be present in a patient in order to elicit a reaction from the remedy. This method is more suitable to a conventional design of a clinical study and is reproducible by anyone. Yet the expected success rate is much lower. Some general design issues that may have a particular impact on clinical trials of classical homeopathy are discussed, including the need for sufficiently powered trials to detect relatively small effects, strategies to deal with patient preference and embracing the use of "active-control" pragmatic trial designs.

To which extent should potency choice in homeopathy be "regulated": has European legislation gone too far?

Despite ongoing controversy, homeopathy has become increasingly accepted as a "medical reality" by patients and doctors alike. This process has been accompanied by an increased quality of manufacturing, education, research, and regulation of homeopathy. This paper argues that European regulation may now have gone too far by indiscriminately prescribing that homeopathic medicines should be used in a potency of D4 and higher. Low potencies and tinctures are an important and integral part of the homeopathic heritage. The regulatory environment therefore appears to be hampering one of its own principal aims: the availability of safe and high-quality homeopathic products that practitioners, patients and consumers want and need.

Systematic investigation of the decision process in homoeopathy

Plans for two pilot studies concerning the homoeopathic treatment of chronic and acute otitis media are presented. The intention of these studies is not only to look at the efficacy of the homoeopathic treatment as a whole but also to investigate the efficacy of the individualized decision strategies. Based on the homoeopathic literature a selection of decision strategies has been made. The reader is asked to criticize and supplement the chosen decision strategies