Analysis on the current quality standards of Chinese materia Medica used in COVID-19 prevention and treatment.

PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.

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.

Salve and Burdock: A Safe, Effective Amish Remedy for Treatment of Traumatic Wounds?

BACKGROUND: Amish patients show a demonstrated preference for traditional, herbal remedies over modern medical interventions such as skin grafting. One such remedy is a mixture of Burn & Wound Ointment (B & W Ointment; Holistic Acres, LLC; Newcomerstown, Ohio) and steeped burdock leaves. Although both have demonstrated some antimicrobial and wound healing properties, burdock and/or the combination of B & W Ointment and burdock has never been studied to determine its purported ability to reduce pain, prevent infection, and accelerate wound healing. METHODS: A retrospective chart review was performed on 6 Amish patients treated with salve and burdock leaves instead of skin grafting following complex traumatic wounds to determine whether the traditional treatment incurred any patient harm. RESULTS: The time of wound epithelialization and healing complications were noted, among other data points. Time to full epithelialization ranged from 1 to 7 months. Time to full wound healing was proportional to wound size. CONCLUSIONS: Although the treatment presented here is unconventional, it did not cause harm to the patients studied.

The Red flag! risk assessment among medical homeopaths in Norway: a qualitative study.

BACKGROUND: Homeopathy is widely used, and many European physicians practice homeopathy in addition to conventional medicine. Adverse effects in homeopathy are not expected by homeopaths due to the negligible quantities of active substances in a remedy. However, we questioned if homeopathic aggravation, which is described as a temporary worsening of existing symptoms following a correct homeopathic remedy, should be regarded as adverse effects or ruled out as desirable events of the treatment. In order to improve knowledge in an unexplored area of patient safety, we explored how medical homeopath discriminate between homeopathic aggravations and adverse effects, and how they assessed patient safety in medical practice. METHOD: A qualitative approach was employed using focus group interviews. Two interviews with seven medical homeopaths were performed in Oslo, Norway. The participants practiced homeopathy besides conventional medicine. Qualitative content analysis was used to analyze the text data. The codes were defined before and during the data analysis. RESULTS: According to the medical homeopaths, a feeling of well-being may be a criterion to distinguish homeopathic aggravations from adverse effects. There was disagreement among the participants whether or not homeopathic treatment produced adverse effects. However, they agreed when an incorrect remedy was administrated, it may create a disruption or suppressive reaction in the patient. This was not perceived as adverse effects but a possibility to prescribe a new remedy as new symptoms emerge. This study revealed several advantages for the patients as the medical homeopaths looked for dangerous symptoms which may enhance safety. The patient was given time and space, which enabled the practitioner to see the complete picture. A more comprehensive toolkit gave the medical homeopaths a feeling of professionalism. CONCLUSION: This explorative study investigated how Medical Homeopaths understood and assessed risk in their clinical practice. A feeling of well-being emerging soon after taking the remedy was the most important criterion for discriminating between Homeopathic Aggravations and Adverse Effects in clinical practice. The Medical Homeopaths used the view of both professions and always looked for red flag situations in the consultation room. They combined knowledge from two treatment systems which may have advantages for the patient. These tentative results deserve further research efforts to improve patient safety among users of homeopathy. For further research we find it important to improve and develop concepts that are unique to homeopathy in order to validate and modernize this medical practice.

¿Los medicamentos homeopáticos provocan agravación o efectos adversos dependientes de los fármacos? / Do homeopathic medicines cause aggravation or drug-dependent adverse effects?

La valoración crítica de la seguridad de los medicamentos homeopáticos se ha desarrollado recientemente. Esta cuestión es relevante para la toma de decisiones de los médicos, pacientes y dependencias regulatorias de fármacos. A pesar de la aparente inverosimilitud de la acción de los medicamentos homeopáticos debido a los procesos farmacotécnicos de la dilución y agitación empleados para su preparación, existen reportes en la literatura médica convencional sobre la toxicidad de los medicamentos homeopáticos, incluyendo eventos que aparentemente ponen en riesgo la vida. Las revisiones sistemáticas de estudios clínicos controlados aleatorizados muestran que los medicamentos homeopáticos provocan más efectos adversos que el placebo, aunque leves y transitorios. El establecimiento de un sistema de monitoreo en línea para la recolección de datos sobre los efectos adversos de los medicamentos homeopáticos, herbolarios o convencionales, es relevante para una evaluación no sesgada de la información reunida a partir de los consumidores y proveedores de atención médica.

Critical appraisal of the safety of homeopathic medicines developed recently. This matter is relevant for decision making by doctors, patients and drug regulatory agencies. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation used for their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews of randomized controlled trials show that homeopathic medicines cause more adverse effects than placebo, albeit mild and transient. Establishing an online monitoring terapéusystem for collection of data on the adverse effects of homeopathic, herbal or conventional medicines is relevant for non-biased assessment of the information gathered from consumers and health care providers.

Adverse effects of homeopathy, what do we know? A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVES: Homeopathy is a popular treatment modality among patient, however there is sparse research about adverse effects of homeopathy. A concept unique for homeopathy, is homeopathic aggravation that is understood as a transient worsening of the patients' symptoms before an expected improvement occurs. From a risk perspective it is vital that a distinction between homeopathic aggravations and adverse effects is established. There is a lack of systematic information on how frequent adverse effects and homeopathic aggravations are reported in studies. Therefore, a systematic review and meta-analysis were performed. DESIGN AND SETTING: Sixteen electronic databases were searched for Randomized Controlled Trials (RCTs). The searches were limited from the year 1995 to January 2011. Forty-one RCTs, with a total of 6.055 participants were included. A subtotal of 39 studies was included in the additional meta-analysis. RESULTS: A total of 28 trials (68%) reported adverse effects and five trials (12%) reported homeopathic aggravations. The meta-analysis (including six subgroup comparisons) demonstrated that no significant difference was found between homeopathy and control with OR 0.99, 95% CI 0.86-1.14, I(2)=54%. More than two third of the adverse effects were classified as grade 1 (68%) and two third were classified as grade 2 (25%) and grade 3 (6%) according to the Common Terminology Criteria for Adverse Effects. Homeopathic aggravation was classified as grade 1 (98%) and grade 3 (2%), suggesting that homeopathic aggravations were reported to be less severe than adverse effects. The methodological quality according to a method recommended in the Cochrane handbook for RCTs, was high. CONCLUSION: Adverse effects including the concept of homeopathic aggravations are commonly reported in trials. The meta-analysis demonstrated that the proportion of patients experiencing adverse effects to be similar for patients randomized to homeopathic treatment compared to patients randomized to placebo and conventional medicine.

A systematic review: Are herbal and homeopathic remedies used during pregnancy safe?

BACKGROUND: Herbal and homeopathic remedies have been used to assist with child bearing and pregnancy for centuries. Allopathic ('Western') medicine is traditionally avoided during pregnancy because of limited drug trials and the suspected teratogenic effects of these medications. This has led to an increase in the use of herbal and homeopathic remedies, asthey are viewed to have no teratogenic effect on the developing foetus. Health providers are faced with questions from their clients regarding the safety of these remedies, but much of the evidence about these herbal and homeopathic remedies is anecdotal and few remedies havebeen tested scientifically. OBJECTIVES: By conducting a systematic review, the primary objective was to evaluate maternal and neonatal outcomes of ingested herbal and homeopathic remedies during pregnancy. METHOD: A systematic review was conducted to synthesise all the evidence with the purpose of evaluating the safety of herbal and homeopathic remedies based on adverse maternal and neonatal outcomes. Only randomised and quasi-randomised controlled trials that met allinclusion criteria were included in the review. RESULTS: The ingestion of ginger for nausea and vomiting during pregnancy was shown to have no harmful maternal or neonatal effects. Ingestion of castor oil for induction of labour showed a tendency towards an increase in the incidence of caesarean section and meconiumstained liquor, warranting further research into its safety issues. CONCLUSION: Larger randomised controlled trials need to be conducted, especially in South Africa, to establish the safety and efficacy of commonly-used remedies.

How to handle worsening of condition during treatment - risk assessment in homeopathic practice.

Even though homeopathy is regarded as a harmless intervention, homeopathic practice may not be entirely risk-free. Risk in homeopathy can be divided into direct and indirect risk. Direct risk refers to traditional adverse effects of an intervention; indirect risk is related to adverse effects in a treatment context, e.g. the practitioner. Available data suggest that the risk profile of homeopathic remedies in ultra-molecular potencies is minor, but there is a potential for indirect risk related to homeopathic practice. The concept of 'homeopathic aggravation' which is unique for homeopathy may impose a particular risk as it allows the health status of the patients to deteriorate before there is a possible improvement. In that respect it is imperative to distinguish homeopathic aggravations from adverse effects. In a general risk evaluation of the homeopathic treatment it may be useful to assess the patient's symptoms in accordance with the natural course of disease and to evaluate any negative deviation from the normal curve as a possible adverse effect of the treatment. It is imperative that more emphasis is placed on patient safety during the education in homeopathy, and that students are trained to identify serious and red flag situations.

Medication errors in anaesthetic practice: a report of two cases and review of the literature.

BACKGROUND: Mistakes in the identification and administration of drugs may be fatal. This is especially so in the practice of anaesthesia. This is a report of 2 cases of near fatality due to mistakes in drug administration from look-alike medications. OBJECTIVE: To highlight the significance of medication errors in our practice and to discuss the best methods of prevention. METHOD: A report of two cases of errors in the administration of drugs during the conduct of anaesthesia. The subsequent management of the cases is presented, and the findings from the literature are discussed. RESULT: In case 1, an adult male presented for herniorrhaphy and after induction with propofol 1mg/kg intravenously, Pancuronium bromide injection 4 mg was administered intravenously, in the place of suxamethonium chloride injection. In case 2, For induction of anaesthesia, 100mg of thiopentone sodium was administered in place of 25mg of the same drug because Thiopentone 1 gm vial was mistaken for Thiopentone 500 mg vial in a 2 year old girl. In both cases, the errors were detected early and there were no adverse sequelae. CONCLUSION: Medication errors are a potential source of iatrogenic harm to patients undergoing anaesthesia. Strict adherence to principles as well as constant vigilance would minimize this problem.

Do homeopathic medicines cause drug-dependent adverse effects or aggravations?

Critical appraisal of the safety of homeopathic medicines developed recently. This matter is relevant for decision making by doctors, patients and drug regulatory agencies. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation used for their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews of randomized controlled trials show that homeopathic medicines cause more adverse effects than placebo, albeit mild and transient. Establishing an online monitoring system for collection of data on the adverse effects of homeopathic, herbal or conventional medicines is relevant for non-biased assessment of the information gathered from consumers and health care providers.

O medicamento homeopático provoca efeitos adversos ou agravações medicamentos-dependentes? / Does the homeopathic medicine cause adverse effects or drug-dependent aggravations?

A apreciação crítica sobre a segurança do medicamento homeopático tem sido desenvolvida recentemente, sendo muito importante para a tomada de decisões por parte de médicos, pacientes e agências reguladoras de medicamentos. Apesar da aparente implausibilidade arguida sobre a possibilidade dos medicamentos homeopáticos serem ativos, em função dos procedimentos farmacotécnicos de diluição e agitação a que são submetidos, observa-se na literatura médica relatos de casos atribuindo efeitos tóxicos aos mesmos, até com sérios riscos à vida. Revisões sistemáticas sobre os efeitos adversos de medicamentos homeopáticos indicam que os medicamentos homeopáticos produzem mais efeitos adversos do que o placebo em estudos randomizados controlados, embora os mesmos sejam leves e transitórios. A implantação de um sistema eficiente online de monitoramento de efeitos adversos dos medicamentos – homeopáticos, convencionais ou fitoterápicos – pode ser de grande importância, facilitando a coleta de dados e a avaliação imparcial das informações geradas por consumidores ou profissionais da saúde. (AU)

Critical appraisal of the safety of homeopathic medicines developed recently. This is an important matter for decision making by doctors, patients and medicines regulatory authorities. Despite the apparent implausibility of the action of homeopathic medicines due to the pharmacotechnical processes of dilution and agitation involved in their preparation, there are reports in the conventional medical literature on the toxicity of homeopathic medicines, including apparently life-threatening events. Systematic reviews on adverse effects of homeopathy show that homeopathic medicines provoke more adverse effects than placebo in randomized controlled trials, albeit mild and transient. It would be very important to establish an online monitoring system for collection of data on the adverse effects of homeopathic, herbal or conventional medicines to attain an impartial evaluation of the information gathered from consumers or health professionals. (AU)

Do homeopathic medicines cause drug-dependent adverse effects oraggravations?

Critical appraisal of the safety of homeopathic medicines developed recently. Thismatter is relevant for decision making by doctors, patients and drug regulatoryagencies. Despite the apparent implausibility of the action of homeopathic medicinesdue to the pharmacotechnical processes of dilution and agitation used for theirpreparation, there are reports in the conventional medical literature on the toxicity ofhomeopathic medicines, including apparently life-threatening events. Systematicreviews of randomized controlled trials show that homeopathic medicines cause moreadverse effects than placebo, albeit mild and transient. Establishing an onlinemonitoring system for collection of data on the adverse effects of homeopathic, herbalor conventional medicines is relevant for non-biased assessment of the informationgathered from consumers and health care providers. (AU)

O medicamento homeopático provoca efeitos adversos ou agravações medicamentos-dependentes? / Do homeopathic medicines cause drug-dependent adverse effects or aggravations?

A apreciação crítica sobre a segurança do medicamento homeopático tem sido desenvolvida recentemente, sendo muito importante para a tomada de decisões por parte de médicos, pacientes e agências reguladoras de medicamentos. Apesar da aparente implausibilidade arguida sobre a possibilidade dos medicamentos homeopáticos serem ativos, em função dos procedimentos farmacotécnicos de diluição e agitação a que são submetidos, observa-se na literatura médica relatos de casos atribuindo efeitos tóxicos aos mesmos, até com sérios riscos à vida. Revisões sistemáticas sobre os efeitos adversos de medicamentos homeopáticos indicam que os medicamentos homeopáticos produzem mais efeitos adversos do que o placebo em estudos randomizados controlados, embora os mesmos sejam leves e transitórios. A implantação de um sistema eficiente online de monitoramento de efeitos adversos dos medicamentos – homeopáticos, convencionais ou fitoterápicos – pode ser de grande importância, facilitando a coleta de dados e a avaliação imparcial das informações geradas por consumidores ou profissionais da saúde. (AU)

Midwives' support for Complementary and Alternative Medicine: a literature review.

OBJECTIVE: There is evidence that the use of Complementary and Alternative Medicine by childbearing women is becoming increasingly popular in industrialised countries. The aim of this is paper is to review the research literature investigating the midwives' support for the use of these therapies. METHOD: A search for relevant research published from 2000 to 2009 was undertaken using a range of databases and by examining relevant bibliographies. A total of thirteen studies were selected for inclusion in this review. RESULTS: The findings indicate that the use of Complementary and Alternative Medicine is widespread in midwifery practice. Common indications for use include; labour induction and augmentation, nausea and vomiting, relaxation, back pain, anaemia, mal-presentation, perineal discomfort, postnatal depression and lactation problems. The most popular therapies recommended by midwives are massage therapy, herbal medicines, relaxation techniques, nutritional supplements, aromatherapy, homeopathy and acupuncture. Midwives support the use Complementary and Alternative Medicine because they believe it is philosophically congruent; it provides safe alternatives to medical interventions; it supports the woman's autonomy, and; incorporating Complementary and Alternative Medicine can enhance their own professional autonomy. CONCLUSIONS: There is considerable support by midwives for the use of Complementary and Alternative Medicine by expectant women. Despite this enthusiasm, currently there are few educational opportunities and only limited research evidence regarding CAM use in midwifery practice. These shortfalls need to be addressed by the profession. Midwives are encouraged to have an open dialogue with childbearing women, to document use and to base any advice on the best available evidence.

Examination regarding the tolerability of the homochord Acidum L(+)-lacticum at a dosage of sixty drops three times daily

In Germany, the commission D recommends in its current dosage guidelines from March 17, 2004, that homeopathic dilutions higher than 24x will be prescribed in a daily application of five drops once. This recommendation is decisive for the German Regulatory Authority. Even though the homochord Acidum L(+)-lacticum 4x/6x/12x/30x/200x contains dilutions above 24x, it is commonly used in clinical practice for over 30 years in a dosage of 60 drops three times daily. In order to explore the clinical safety and tolerability of Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily, as well as lower dosages, a therapist survey was designed to address the questions. Highly experienced and licensed therapists, including general and alternative practitioners, reported their usual dosage of homochord, incidences of drug reactions, initial homeopathic aggravations as well as the diagnoses that led to the prescription of Acidum L(+)-lacticum 4x/6x/12x/30x/200x. 167 therapist responses were analyzed. Only four therapists reported occurrences that classify as initial aggravation, (2.40 %), compared to 159 with no incidences (95.21 %). Four therapists made no statement. Nevertheless, there were no adverse drug reactions documented in the survey. Consequently, Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily or lower dosages may be construed to be clinically tolerable and safe. This evidence might lead to further re-evaluations of other homochords, and rigorous clinical trials for its safety and tolerability...

Examination regarding the tolerability of the homochord Acidum L(+)-lacticum at a dosage of sixty drops three times daily

In Germany, the commission D recommends in its current dosage guidelines from March 17, 2004, that homeopathic dilutions higher than 24x will be prescribed in a daily application of five drops once. This recommendation is decisive for the German Regulatory Authority. Even though the homochord Acidum L(+)-lacticum 4x/6x/12x/30x/200x contains dilutions above 24x, it is commonly used in clinical practice for over 30 years in a dosage of 60 drops three times daily. In order to explore the clinical safety and tolerability of Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily, as well as lower dosages, a therapist survey was designed to address the questions. Highly experienced and licensed therapists, including general and alternative practitioners, reported their usual dosage of homochord, incidences of drug reactions, initial homeopathic aggravations as well as the diagnoses that led to the prescription of Acidum L(+)-lacticum 4x/6x/12x/30x/200x. 167 therapist responses were analyzed. Only four therapists reported occurrences that classify as initial aggravation, (2.40 %), compared to 159 with no incidences (95.21 %). Four therapists made no statement. Nevertheless, there were no adverse drug reactions documented in the survey. Consequently, Acidum L(+)-lacticum 4x/6x/12x/30x/200x at a dosage of 60 drops three times daily or lower dosages may be construed to be clinically tolerable and safe. This evidence might lead to further re-evaluations of other homochords, and rigorous clinical trials for its safety and tolerability. (AU)

Princípios de prescrição médica hospitalar para estudantes de medicina / In-Hospital prescription guidelines for undergraduate medical students

A Prescrição médica intra-hospitalar é uma etapa dentro de um complexo processo de fornecimento de medicamentos, sendo apontada como uma das principais fontes de erros inesperados na evolução do tratamento de pacientes internados. Esse artigo tem como objetivos caracterizar a Prescrição médica como uma etapa do processo de fornecimento de medicação intra-hospitalar, fornecer base conceitual sobre a natureza desse processo, de modo a auxiliar a detecção de erros potenciais, e prover uma estrutura básica sobre a Prescrição, tendo como público-alvo principal o estudante de medicina no ciclo do internato. Não obstante, esse artigo também pode ser interessante para médicos em outras etapas da carreira e para outros profissionais que estejam envolvidos no processo.

The in-hospital prescription is one step in a complex process of drug supply, being identified as a major source of unexpected errors in the evolution of in-patient treatment. This paper aims to characterize the prescription as a step in the process of providing in-hospital medication providing conceptual basis of the nature of this process in order to help detect potential errors and provide a basic structure on prescription as having public main target medical student in the boarding cycle. Nevertheless, this article may be of interest to physicians in other stages of career professionals and others who are involved in the process.