Traditional, complementary and integrative healthcare: global stakeholder perspective on WHO's current and future strategy.

As the 'WHO Traditional Medicine Strategy: 2014-2023' is entering its final phase, reflection is warranted on progress and the focus for a new strategy. We used WHO documentation to analyse progress across the objectives of the current strategy, adding the role of traditional, complementary and integrative healthcare (TCIH) to address specific diseases as a dimension absent in the current strategy. Our analysis concludes on five areas. First, TCIH research is increasing but is not commensurate with TCIH use. TCIH research needs prioritisation and increased funding in national research policies and programmes. Second, WHO guidance for training and practice provides useful minimum standards but regulation of TCIH practitioners also need to reflect the different nature of formal and informal practices. Third, there has been progress in the regulation of herbal medicines but TCIH products of other origin still need addressing. A risk-based regulatory approach for the full-range of TCIH products seems appropriate and WHO should provide guidance in this regard. Fourth, the potential of TCIH to help address specific diseases is often overlooked. The development of disease strategies would benefit from considering the evidence and inclusion of TCIH practices, as appropriate. Fifth, inclusion of TCIH in national health policies differs between countries, with some integrating TCIH practices and others seeking to restrict them. We encourage a positive framework in all countries that enshrines the role of TCIH in the achievement of universal health coverage. Finally, we encourage seeking the input of stakeholders in the development of the new WHO Traditional Medicine Strategy.

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.

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.

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.

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.

Treatment of Dyspepsia, Heartburn, and Related Symptoms with Gastricumeel Compared to Proton Pump Inhibitors: A Prospective Reference-Controlled Observational Study.

BACKGROUND: Dyspepsia and heartburn are extremely common conditions, thus a search for safe and effective treatment alternatives is justified. OBJECTIVES: To demonstrate the noninferiority of Gastricumeel (Ga6) in terms of effectiveness and safety to proton pump inhibitors (PPIs) in the treatment of patients with dyspepsia and/or heartburn. METHODS: Prospective, comparative, observational cohort study. Patients with dyspepsia or heartburn were treated either with Ga6 or with PPIs as monotherapy during approximately 6 weeks. The intensity of eight symptoms was assessed as well as overall condition, treatment compliance and tolerability, and any adverse drug reactions. Adjustment for covariates was done via the calculation of propensity scores in logistic regression. RESULTS: A total of 640 patients (447 Ga6, 193 PPIs) from 48 German general practices participated. More than half the patients had suspected acute gastritis and around 40% of patients had heartburn. Adjusted between-treatment difference scores of changes in the intensity of the eight assessed symptoms were within the bounds for noninferiority of Ga6 compared to PPIs. Effectiveness ratings were comparable; compliance and tolerability were rated better in the Ga6 group. CONCLUSION: It is worth considering Ga6 as a safe and effective treatment option in the management of dyspepsia and heartburn.

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.

Acupuncture for smoking cessation: A systematic review and meta-analysis of 24 randomized controlled trials.

INTRODUCTION: We evaluate the effectiveness and safety of transdermal acupuncture by needles for smoking cessation. METHODS: A literature search for randomized controlled trials (RCTs) was performed in seven electronic databases from inception to February 2017. Meta-analysis was conducted using Revman 5.3.0 software. We used either a random effects model (REM) or a fixed effects model (FEM) for pooling data according to the result of a heterogeneity test (defined as significant if I2>75%). Trial sequential analysis (TSA) was applied by TSA 0.9.5.10 Beta software. RESULTS: Twenty-four trials involving 3984 participants were included. The methodological quality was generally low. With regard to smoking abstinence, meta-analysis showed acupuncture was more effective compared to no intervention/waiting list for short-term (4 weeks) cessation (1 trial, RR=2.37, 95% 1.41, 3.97) and long-term (longer than 6 months) (2 trials, RR=2.66, 95% CI: 1.50, 4.70). Compared to acupuncture/auricular acupressure alone, acupuncture plus auricular acupressure showed more benefit for short-term cessation (3 trials, RR=1.52, 95% CI: 1.03, 2.25). Acupuncture plus auricular acupressure was more effective compared to sham acupuncture plus sham auricular acupressure for short-term cessation (3 trials, RR=2.50, 95% CI: 1.44, 4.33) and long-term (2 trials, RR=3.61, 95% CI: 1.37, 9.48). Acupuncture in combination with counseling, educational smoking cessation program or moxibustion had more benefit compared to acupuncture for short-term cessation (3 trials, RR=0.75, 95% 0.63, 0.91) and long-term (2 trials, RR=0.77, 95% CI: 0.56, 1.05), and TSA illustrated the cumulative Z-curve of this comparison for long-term across the traditional boundary of 5% significance and monitoring boundaries. No serious adverse events occurred. CONCLUSIONS: Acupuncture combined with counseling, educational smoking cessation program or moxibustion was more effective than acupuncture as monotherapy with regard to long-term smoking cessation. Further, high quality trials are needed to confirm the result.

The Safety and Effectiveness of a Novel Annular Keratopigmentation Method: A Case Report.

BACKGROUND: We investigated the safety and effectiveness of a novel aesthetic femtosecond-assisted annular keratopigmentation technique. CASE REPORT: A 21-year-old female patient in good general and ophthalmological health with the wish to change the colour of her eyes was treated with a femtosecond-assisted annular keratopigmentation technique. Pigment was inserted in a channel in the cornea (external diameter 9.3 mm; internal diameter 5.5 mm) created with a femtosecond laser at a depth of 225 µm. Eight months post-operatively, there were no signs of leakage, diffusion, inflammation or any other detrimental effects on the cornea both objectively and subjectively. CONCLUSION: This procedure is a promising safe and effective option for those who want annular keratopigmentation for aesthetic reasons.

A bibliometric analysis of clinical study literature of traditional Chinese medicine therapies for smoking cessation.

INTRODUCTION: Traditional Chinese medicine (TCM) is commonly used for smoking cessation in China. The aim of this study is to perform a comprehensive literature search to identify clinical studies on TCM therapies for smoking cessation. METHODS: Publications of randomized controlled trials, controlled clinical studies, cohort studies, case-control studies, case series and case reports, reviews and cross-sectional studies on smoking cessation using TCM therapies were retrieved from seven databases from their inception to February 2017. The following data were extracted and analyzed: study type, year of publication, language, country or region, journals, participants, intervention and comparison, and outcome. RESULTS: In total, 260 publications on TCM therapies for smoking cessation were identified from 1980 to 2016, including 52 randomized clinical trials, 7 controlled clinical studies, 1 cohort study, 110 case series, 18 case reports, 50 narrative reviews, 17 systematic reviews, and 5 cross-sectional studies. Of these, 68.5% (178) were published in Chinese and the remaining published in English. Mainland China (n=129, 49.6%) was the leading country in this field, followed by USA (n=27, 10.4%) and UK (n=25, 9.6%). A total of 36 645 participants from 40 countries with age ranging from 12 to 86 years were involved in 188 clinical studies (excluding reviews and cross-sectional studies). The most commonly reported therapies were auricular acupressure (25, 13.3%), body acupuncture (14, 7.4%), and body acupuncture plus auricular acupressure (14, 7.4%). Composite outcomes were most frequently reported (110, 58.5%). CONCLUSIONS: A substantial number of clinical studies have been conducted and published on TCM therapy for smoking cessation, mainly focusing on acupuncture stimulation techniques. The findings suggest that future research should pay more attention to acupuncture for smoking cessation.

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.

The placebo effect and its ramifications for clinical practice and research. Villa La Collina at Lake Como, Italy, 4-6 May 2012.

INTRODUCTION: The purpose of this workshop was to further explore the implications of the placebo effect for both research and clinical practice from a variety of angles with a group of selected experts. METHOD/APPROACH: The use of placebos in both clinical practice and research was explored in depth from a historical, methodological, ethical, legal and cultural point of view. The current state of knowledge regarding the placebo effect was established, knowledge gaps were identified, and the implications for both clinical research and practice were discussed in depth. KEY MESSAGES: • Placebos have been consciously used in clinical practice since the 18th century, but only emerged as a research topic in the western world in the second half of the 20th century. • The placebo response consists of the placebo effect plus the natural course of the disease, and is a meaningful part of all medical treatments. • A variety of not fully understood individual, context and cultural factors contribute to the placebo response and interact in a non-linear way with the specific effects of medicines. • The assessment of a therapeutic effect in placebo-controlled RCTs is often difficult due to a strong placebo response, e.g. in Central Nervous System (CNS) indications like major depression or in Irritable Bowel Syndrome. • Placebo effects occur, and can affect the validity and appropriateness of placebo controlled trials in conventional as well as Complementary and Alternative Medicine (CAM) research. • It may be impossible to fully disentangle the verum and sham effects of both CAM and conventional medical procedures such as for instance acupuncture and surgery. • Context/meaning effects, including doctor empathy, are highly relevant and under-researched in both conventional and complementary medicine. • The use of 'impure placebos' (non-indicated/ineffective medicines) in clinical practice may be common, but little reliable data is available due to complexities around the definition of impure placebos and underreporting. • The assumption that placebo effects do not occur in veterinary research is likely to be incorrect, e.g. owner empathy and vet expectations can affect outcomes. • Various innovative trial designs that better deal with the placebo issue are available, but only as partial solutions. • Patient treatment will benefit from better understanding and appropriately utilising meaning/context effects. CONCLUSIONS: There are many remaining knowledge gaps with regard to the placebo response. The evolving knowledge challenges the paradigm of the placebo controlled RCT as a gold standard for demonstrating benefit of treatments. There are a number of pointers towards alternative research designs and paradigms worthy of further exploration. The evolving knowledge can contribute to the further development of a 'meaning orientated' and patient centred healthcare system.

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.