International policies and challenges on the legalization of traditional medicine/herbal medicines in the fight against COVID-19.

The coronavirus disease 2019 (COVID-19) has now rapidly spread around the world, causing an outbreak of acute infectious pneumonia. To develop effective and safe therapies for the prevention and treatment of COVID-19 has become the major global public health concern. Traditional medicine (TM)/herbal medicines (HMs) have been used to treat multiple epidemics in human history, which brings hope for the fight against COVID-19 in some areas. For example, in China, India, and South Korea with traditional medication history and theory, the governments issued a series of guidelines to support TM/HMs in the medication of COVID-19. In contrast, other countries e.g. North American and European governments are typically silent on these practices, unless to warn of possible harm and overselling. Such difference is due to the discrepancy in culture, history and philosophical views of health care and medication, as well as unharmonized policies and standards in the regulation and legalization of TM/HMs among different areas. Herein, we reviewed the responses and scientific researches from seven selected countries on the policies and legalization of TM/HMs to treat COVID-19, and also analyzed the major challenges and concerns to utilize the traditional knowledge and resource.

"Then I went to a hospital abroad": acknowledging implications of stakeholders' differing risk understandings related to use of complementary and alternative medicine in European health care contexts.

BACKGROUND: Complementary and alternative medicine (CAM) is a rather novel issue within public healthcare and health policy-making. CAM use in Europe is widespread, patient-initiated, and patient-evaluated, and the regulation across countries has been evaluated as disharmonized. CAM users are left in an uncertain position, and patient safety may be threatened. How "risk" is understood by individuals in health policy-making and clinical encounters involving the use of CAM has not yet been much debated. The aim of this article is to explore and discuss the existence and possible consequences of differing risk understandings among stakeholders maneuvering in the complex landscape of CAM practice and CAM regulation contextualized by European public healthcare systems. METHODS: Qualitative data were derived from two studies on CAM in European healthcare contexts. Findings from the EU project CAMbrella on legislation and regulation of CAM were mixed with data from an interview study exploring risk understandings, communication, and decision-making among Scandinavian CAM users and their doctors. In a secondary content analysis, we constructed the case Sara as a typology to demonstrate important findings with regard to risk understandings and patient safety involving European citizens' use of CAM in differing contexts. RESULTS: By combining and comparing individual and structural perspectives on risk and CAM use, we revealed underexplored gaps in risk understandings among individuals involved in European CAM regulation and legislation, and between CAM users and their medical doctors. This may cause health risks and uncertainties associated with CAM use and regulation. It may also negatively influence doctor-CAM user communication and CAM users' trust in and use of public healthcare. CONCLUSION: Acknowledging implications of stakeholders' differing risk understandings related to CAM use and regulation may positively influence patient safety in European healthcare. Definitions of the concept of risk should include the factors uncertainty and subjectivity to grasp the full picture of possible risks associated with the use of CAM. To transform the findings of this study into practical settings, we introduce sets of questions relevant to operationalize the important question "What is risk?" in health policy-making, clinical encounters and risk research involving European patients' use of CAM.

Regulating Alternative Healing in France, And the Problem of 'Non-Medicine'.

This article explores the ambiguities of the legal system that, in France, regulates 'alternative healing', and determines the boundaries of legitimate medical care. While the law suggests that the delivery of therapeutic care should be the monopoly of biomedically-trained professionals, alternative healers operate very widely, and very openly, in France. They practice, however, on the verge of (il)legality, often organising their activities, individually and collectively, so as to limit the likelihood of state intervention. This creates a high degree of precarity for both practitioners and, crucially, for patients. Efforts to change the system are being deployed, but while healers themselves have increasingly organised to seek recognition by the state, alternative healing occupies an uncertain policy space: they are not fully constituted as a social and policy matter by the state, and occupy a liminal position between medicine and spirituality that "unsettles" republican ideals of scientific rationality, and of secularism. This article explores some of those tensions, at the crossroad between law, science, and medicine. It reflects on why tensions seem to persist around the regulatory questions at stake, and suggests that ways forward may depend on moving away from science as a sole arbiter in drawing boundaries of legitimate and illegitimate care in regulation.

Which risk understandings can be derived from the current disharmonized regulation of complementary and alternative medicine in Europe?

BACKGROUND: Many European citizens are seeking complementary and alternative medicine (CAM). These treatments are regulated very differently in the EU/EFTA countries. This may demonstrate differences in how risk associated with the use of CAM is perceived. Since most CAM treatments are practiced fairly similarly across Europe, differing risk understandings may influence patient safety for European CAM users. The overall aim of this article is thus to contribute to an overview and awareness of possible differing risk understandings in the field of CAM at a policymaking/structural level in Europe. METHODS: The study is a re-analysis of data collected in the CAMbrella EU FP7 document and interview study on the regulation of CAM in 39 European countries. The 12 CAM modalities included in the CAMbrella study were ranked with regard to assumed risk potential depending on the number of countries limiting its practice to regulated professions. The 39 countries were ranked according to how many of the included CAM modalities they limit to be practiced by regulated professions. RESULTS: Twelve of 39 countries generally understand the included CAM treatments to represent "high risk", 20 countries "low risk", while the remaining 7 countries understand CAM treatments as carrying "very little or no risk". The CAM modalities seen as carrying a risk high enough to warrant professional regulation in the highest number of countries are chiropractic, acupuncture, massage, homeopathy and osteopathy. The countries understanding most of the CAM modalities in the study as potentially high-risk treatments are with two exceptions (Portugal and Belgium) all concentrated in the southeastern region of Europe. CONCLUSION: The variation in regulation of CAM may represent a substantial lack of common risk understandings between health policymakers in Europe. We think the discrepancies in regulation are to a considerable degree also based on factors unrelated to patient risk. We argue that it is important for patient safety that policy makers across Europe address this confusing situation. This could be done by applying the WHO patient safety definitions and EU's policy to facilitate access to "safe and high-quality healthcare", and regulate CAM accordingly.

Integrative medicine or infiltrative pseudoscience?

Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.

Complementary medicine products: interpreting the evidence base.

Many patients use complementary medicine (CM) products, such as vitamins, minerals and herbs as part of self-care without professional advice or disclosure to their doctors. While use of CM products is gaining awareness by the medical community and there is mounting evidence for their safety, efficacy and cost-effectiveness, there is also the potential for adverse events from inappropriate use and/or withdrawal, as well as interactions with other medicines. Due to the unique and complex properties of many CM products, research evidence is specific to individual preparations and this can lead to confusion when assessing label claims and interpreting the results of clinical trials and systematic reviews. While the Australian regulatory environment for CM products is the same as for prescription medicines and is based on risk, there is a great need for consumers and clinicians to have access to easily understood, evidence-based information to facilitate informed decision-making.

The Need to Develop a Regulatory Body for the Practice of Al-Hijama.

Al-Hijama is a traditional therapy which has been extensively used in the Middle East. It has an Islamic basis but is used in many cultures in the form of wet cupping. There has been a significant growth in its availability in most Western countries during the last decade. In none is it subject to statutory regulation and the training and quality of practitioners is variable. It has both a preventive and therapeutic element and so there are appropriate concerns about the potential for incorrect diagnoses and delays in other effective treatments. In the past, the apprenticeship model in which a trainee worked for some years with an experienced ijazah ensured such problems did not arise. However, there is now an urgent need to recognise the widespread practice of this therapy and ensure that it has the benefits of statutory regulation, be this through specific regulatory bodies or a negative licensing model.

Supportive but "worried": perceptions of naturopaths, homeopaths and Chinese medicine practitioners through a regulatory transition in Ontario, Canada.

BACKGROUND: In line with recent World Health Organization recommendations, many jurisdictions are taking steps to regulate practitioners of traditional, complementary and alternative medicine (TCAM). Previous studies have examined TCAM practitioners' generally-supportive views about professional regulation; however, little research has been conducted on TCAM practitioners' experiences and perspectives amidst an active regulatory process. In 2006 and 2007, the province of Ontario, Canada announced it would grant self-regulatory status to three TCAM practitioner groups--homeopaths, naturopaths and Chinese medicine practitioners/acupuncturists. METHODS: In 2011 and 2012, part-way through each group's regulatory process, we surveyed all practitioners from these three groups (n=1047) that could be identified from public registries and professional associations. The data presented here are derived from the sub-sample of homeopaths (n=234), naturopaths (n=273) and Chinese medicine practitioners/acupuncturists (n=181) who provided answers to an open-ended question about their opinions of the regulatory process at the end of the survey. An inductive, thematic analysis of qualitative survey responses was conducted. RESULTS: Survey responses affirmed a pro-regulatory stance across all groups, but revealed considerable 'worry' amongst practitioners as to how the regulations might be implemented. Four primary 'worry-related' themes emerged: a) regulation's potential administrative and financial burden on practitioners; b) scope-related concerns; c) implementation of fair registration standards; and d) whether regulation might erode the groups' distinctive worldviews. Some occupationally-specific concerns appeared related to each group's particular stage of professionalization. Other 'worries' may be related to the relative marginality of TCAM practitioner groups within biomedically-dominant national health care systems, and the possibility that inter-professional hierarchies may be emerging between particular TCAM groups. Specific concerns around overlapping practice scopes between TCAM and other professions raised questions about the implementation of non-monopolistic regulatory models such as Ontario's. CONCLUSIONS: Overall, this study will help inform regulators and TCAM practitioner groups to navigate the unique challenge of regulating health care providers long excluded from national health care systems, who frequently work from within paradigms distinct from mainstream biomedicine.

Complementary and alternative medicine: assessing the evidence for immunological benefits.

With words such as AIDS, allergy and autoimmunity embedded in the popular lexicon, we often equate health with the precision and the tenor of responses to allergens and microorganisms. This leads many people to seek their own solutions to sustain, restore or even boost their immune competence, hoping to live more comfortably and longer. Here, we consider the social and clinical contexts in which these promises of enhanced immunity are pursued through popular practices known as complementary and alternative medicine and the evidence that supports these.

Ethical and legal issues in cross-system practice in India: Past, present and future.

Recent changes in policies allowing practitioners of Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) to integrate into the mainstream of healthcare and also allowing practitioners of Ayurveda and Homoeopathy to perform medical termination of pregnancy (MTP) under the proposed amendment to the MTP bill have brought crosssystem practice into the limelight. We evaluate cross-system practice from its legal and ethical perspectives. Across judgments, the judiciary has held that cross-system practice is a form of medical negligence; however, it is permitted only in those states where the concerned governments have authorized it by a general or special order. Further, though a state government may authorize an alternative medicine doctor to prescribe allopathic medicines (or vice versa), it does not condone the prescription of wrong medicines or wrong diagnosis. Courts have also stated that prescribing allopathic medicines and misrepresenting these as traditional medicines is an unfair trade practice and not explaining the side-effects of a prescribed allopathic medicine amounts to medical negligence. Finally, the Supreme Court has cautioned that employing traditional medical practitioners who do not possess the required skill and competence to give allopathic treatment in hospitals and to let an emergency patient be treated by them is gross negligence. In the event of an unwanted outcome, the responsibility is completely on the hospital authorities. Therefore, there is an urgent need to abolish cross-system practice, invest in healthcare, and bring radical changes in health legislations to make right to healthcare a reality.

Molecular mechanisms of pharmacological doses of ascorbate on cancer cells.

Intravenous application of high-dose ascorbate (vitamin C) has been used in complementary medicine since the 1970s to treat cancer patients. In recent years it became evident that high-dose ascorbate in the millimolar range bears selective cytotoxic effects on cancer cells in vitro and in vivo. This anticancer effect is dose dependent, catalyzed by serum components and mediated by reactive oxygen species and ascorbyl radicals, making ascorbate a pro-oxidative pro-drug that catalyzes hydrogen peroxide production in tissues instead of acting as a radical scavenger. It further depends on HIF-1 signaling and oxygen pressure, and shows a strong epigenetic signature (alteration of DNA-methylation and induction of tumor-suppressing microRNAs in cancer cells). The detailed understanding of ascorbate-induced antiproliferative molecular mechanisms warrants in-depth preclinical evaluation in cancer-bearing animal models for the optimization of an efficacious therapy regimen (e.g., combination with hyperbaric oxygen or O2-sensitizers) that subsequently need to be evaluated in clinical trials.

Treatment failure in atopic dermatitis as a result of parental health belief.

The gold standard for treatment of atopic dermatitis is topical corticosteroids. Parental alternative health beliefs and fear of topical corticosteroids may lead to non-adherence and treatment failure. At the extreme end, such beliefs may result in neglect constituting reportable child maltreatment. We examine the legal repercussions of such abuse in the criminal case resulting from the death of Gloria Sam.

Pre-trial beliefs in complementary and alternative medicine: whose pre-trial belief should be considered?

Subjective probabilities play a significant role in the assessment of evidence: in other words, our background knowledge, or pre-trial beliefs, cannot be set aside when new evidence is being evaluated. Focusing on homeopathy, this paper investigates the nature of pre-trial beliefs in clinical trials. It asks whether pre-trial beliefs of the sort normally held only by those who are sympathetic to homeopathy can legitimately be disregarded in those trials. The paper addresses several surprisingly unsuccessful attempts to provide a satisfactory justification for ignoring the pre-trial beliefs of the homeopathic community. The ensuing diagnosis of the difficulties here emphasizes that the reason the arguments for choosing the pre-trial beliefs of the conventional community seem insufficient is not the arguments per se. It is rather that there is no cogent argument for choosing the conventional stance which would at the same time rationally persuade a member of the homeopathic community. The paper concludes that, once we understand that this is the predicament, there is no genuine reason to doubt the reasoning that leads us to reject the pre-trial beliefs of the homeopathic community.

Comparative effectiveness research: does the emperor have clothes?

With the recent allocation ofa $1.1 billion "down payment" to fund comparative effectiveness research (CER) from the American Recovery and Reinvestment Act of 2009 (generally referred to as the stimulus package) and with $300 million being allocated for the Agency for Healthcare Research and Quality (AHRQ), $400 million for the National Institutes of Health, and $400 million for allocation at the discretion of the Secretary of Health and Human Services and with the National Center for Complementary Alternative Medicine putting out a request for research proposals for Comparative Effectiveness Studies of Complementary and Alternative Medicine, it is safe to say CER has entered a new era. CER solves two historical concerns for complementary and alternative medicine (CAM) researchers; first it focuses on effectiveness not efficacy; second it tests holistic approaches to care. Because it allows the providers to give care in any way they choose, it avoids the problem of reductionism inherent in standard random controlled trials. In CER, the provider can continue to practice holistically and to use individualized medicine to treat the patient. However, amid the largely positive responses to this move among researches in CAM, a more critical evaluation might be in order. This article argues that while the move to effectiveness research is a positive move for CAM, CER as currently being talked about and funded may just be a new form of privileging certain forms of evidence at the expense of other equally important and perhaps more relevant evidence.

Stakeholders' perspectives on the regulation and integration of complementary and alternative medicine products in Lebanon: a qualitative study.

BACKGROUND: The regulation of the markets for Complementary and Alternative Medicine (CAM) products presents a global challenge. There is a dearth of studies that have examined or evaluated the regulatory policies of CAM products in the Eastern Mediterranean Region (EMR). We investigate the regulatory frameworks and the barriers for the proper regulation and integration of CAM products in Lebanon, as an example of an EMR country with a weak public infrastructure. METHODS: We utilized a qualitative study design involving a series of semi-structured interviews with stakeholders of the CAM market in Lebanon. Snowball sampling was used to identify interviewees; interviews continued until the "saturation" point was reached. A total of 16 interviews were carried out with decision makers, representatives of professional associations, academic researchers, CAM product importers, policy makers and a media representative. Interviews were transcribed and thematic analysis of scripts was carried out. RESULTS: There was a consensus among all stakeholders that the regulation of the market for CAM products in Lebanon needs to be strengthened. Thematic analysis identified a number of impediments jeopardizing the safety of public consumption and hindering the integration of CAM therapies into mainstream medicine; including: weak infrastructure, poor regulation, ineffective policies and politics, weak CAM awareness and sub-optimal coordination and cooperation among stakeholders. With respect to policy instruments, voluntary instruments (self regulation) were deemed ineffective by stakeholders due to poor awareness of both users and providers on safe use of CAM products. Stakeholders' rather recommended the adoption of a combination of mixed (enhancing public awareness and integration of CAM into medical and nursing curricula) and compulsory (stricter governmental regulation) policy instruments for the regulation of the market for CAM products. CONCLUSIONS: The current status quo with respect to the regulation of CAM products in Lebanon is not conducive to public safety, nor does it support the integration of CAM products into the healthcare system. The Ministry of Health indeed plays a dominant role in the regulation of these products through a combination of mixed and compulsory policy instruments. Yet, the proper implementation of these regulations requires political resolve coupled with the cooperation of all CAM stakeholders.

Complementary therapies in health care.

In the past two decades, complementary therapies have grown in popularity in Western countries. The interest in complementary therapies could be explained by a "new consciousness" and the shift to a postmodern society. These therapies, embracing holistic practice, are derived from traditions of Eastern healing. There are many advantages of the complementary therapies that are playing a therapeutic role in the health care of individuals and, through the use of such therapies, nursing is developing a richness in holistic care. However, there are still barriers to be overcome; namely, the reluctance to accept complementary therapies in many contemporary healthcare settings. Through research and education, these barriers can be overcome.

[Complementary medicine--Jewish medical ethics].

In Israel, as in the Western world, the use of different methods of complementary and alternative medicine ICAM) is spreading. CAM raises ethical questions of concern to healthcare providers and to the public: Can physicians recommend a treatment that has no scientific evidence? Should the government include such therapies in the health budget? Can complementary therapists receive protection against lawsuits if their treatment is recognized? The purpose of this article is to present a Jewish perspective on these issues. The fundamental sources that deal with the subject are based on the approach of rabbinic authorities toward unproven medicine, as expressed in the "Mishnah" and "Talmud" (200-500 C.E). The great Jewish scholar who discusses the subject in detail is Maimonides (1135-1204), who defines what "medicine" is and claims that medicine has to rely on reason or experience. Contemporary Jewish commentators present their position based on the interpretation of Maimonides' texts. In this article we claim that treatments can be divided into four groups, each group having a different halachic status: (1) Treatment that might be dangerous--should not be used. (2) Treatment that is safe--can be used, but has no other special status. (3) Treatment recognized by alternative therapists--has consequences for the observant Jew, such as laws of Kashrut and Shabbat. (4) Treatment that was tested and proven using modern medical methods has public significance--the therapist is entitled to legal defense if he made a reasonable mistake; the government can consider funding such treatment using public money. This article presents the Jewish halachic sources upon which we propose an ethical-practical approach to CAM.

[Blood letting by cupping--a "medical" vignette].

This is a report on a "clinic" in northern Israel, in which a considerable number of people are treated by bloodletting. The authors witnessed the procedures of cupping various areas of the body and puncturing them by needles. The person in charge, who does not have any medical education or Licensing, and a client were interviewed. This report aims to bring to the attention of the medical community a procedure that spreads within the framework of so-called alternative medicine.