[Problems and thoughts in clinical safety evaluation of traditional Chinese medicine].

Amid the modernization and internationalization of traditional Chinese medicine(TCM), the safety of TCM has attracted much attention. At the moment, the government, scientific research teams, and pharmaceutical enterprises have made great efforts to explore methods and techniques for clinical safety evaluation of TCM. Although considerable achievements have been made, there are still many problems, such as the non-standard terms of adverse reactions of TCM, unclear evaluation indicators, unreasonable judgment methods, lack of evaluation models, out-of-date evaluation standards, and unsound reporting systems. Therefore, it is urgent to further deepen the research mode and method of clinical safety evaluation of TCM. Based on the current national requirements for the life-cycle management of drugs, this study focused on the problems in the five dimensions of clinical safety evaluation of TCM, including normative terms, evaluation modes, judgment methods, evaluation standards, and reporting systems, and proposed suggestions on the development of a life-cycle clinical safety evaluation method that conformed to the characteristics of TCM, hoping to provide a reference for future research.

Setting Guidelines for Electromagnetic Exposures and Research Needs.

Current limits for exposures to nonionizing electromagnetic fields (EMF) are set, based on relatively short-term exposures. Long-term exposures to weak EMF are not addressed in the current guidelines. Nevertheless, a large and growing amount of evidence indicates that long-term exposure to weak fields can affect biological systems and might have effects on human health. If they do, the public health issues could be important because of the very large fraction of the population worldwide that is exposed. We also discuss research that needs to be done to clarify questions about the effects of weak fields. In addition to the current short-term exposure guidelines, we propose an approach to how weak field exposure guidelines for long-term exposures might be set, in which the responsibility for limiting exposure is divided between the manufacturer, system operator, and individual being exposed. Bioelectromagnetics. © 2020 Bioelectromagnetics Society.

The ethics of innovation for Alzheimer's disease: the risk of overstating evidence for metabolic enhancement protocols.

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer's disease has motivated "innovative practice" to improve patients' well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients (clinical ethics); second, about the way in which data from new non-validated practice are communicated via the scientific and lay press (scientific communication ethics); and third, about the prospect of making new non-validated interventions widely available before more definitive testing (public health ethics). We argue that the authors of metabolic enhancement protocols for Alzheimer's disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer's disease.

Recuperação clínica e laboratorial dos pacientes submetidos à cirurgia combinada de lipoaspiração corporal e lipoabdominoplastia / Clinical and laboratory recovery of patients undergoing body liposuction associated with lipoabdominoplasty

Introdução: A lipoaspiração corporal e abdominoplastia são cirurgias muitas vezes realizadas em conjunto para obter melhores resultados na modelagem corporal. Cirurgias associadas sempre aumentam a espoliação, por isto conhecer o comportamento da hemoglobina (Hb) no pós-operatório e a recuperação do paciente submetido a estas cirurgias combinadas é importante para sua segurança. O objetivo deste trabalho foi estudar a queda da Hb e a recuperação clínica e laboratorial dos pacientes submetidos à cirurgia combinada de lipoaspiração corporal e lipoabdominoplastia. Métodos: Realizou-se um estudo prospectivo em pacientes submetidos à lipoaspiração corporal e lipoabdominoplastia, coletando-se hemogramas antes da indução anestésica, ao final da cirurgia, antes da alta hospitalar, após a 1ª, 2ª e 4ª semanas de pós-operatórios e também acompanhando suas evoluções clínicas. Resultados: A média da Hb ao final da cirurgia e na alta hospitalar foi de 10,4g/dl (desvio padrão (DP) 0,76) e 8,92g/dl (DP 0,86), respectivamente. A recuperação em média da Hb após 1ª, 2ª e 4ª semanas foi de 2,4% (DP 18,07), 41,6% (DP 18,4) e 74% (DP 15,2), respectivamente, em relação a redução que ocorreu entre a Hb inicial e a da alta hospitalar. Queixas de fraqueza e lipotimia foram frequentes até o segundo dia. Conclusão: A melhora clínica ocorreu até o segundo dia de pós-operatório (DPO) e a hemoglobina levou aproximadamente 1 mês para normalizar na maioria dos pacientes tratados apenas com reposição oral de ferro, sem necessidade de hemotransfusão.

Introduction: Body liposuction and abdominoplasty are surgeries often performed together to obtain superior results in body modeling. Since associated surgeries often increase spoliation, being aware of the evolution of hemoglobin (Hb) in the postoperative period and during the recovery of the patients undergoing these associated surgeries is important for their safety. This study aimed to analyze the decrease in Hb and the clinical and laboratory results throughout the recovery of patients undergoing body liposuction associated with lipoabdominoplasty. Methods: A prospective study was conducted with patients undergoing body liposuction and lipoabdominoplasty. CBCs were collected before anesthetic induction, at the end of the surgery, before hospital discharge, after the 1st, 2nd, and 4th postoperative weeks, and during their clinical follow-up period. Results: The average Hb values at the end of surgery and hospital discharge were 10.4 g/dL (standard deviation (SD) 0.76) and 8.92 g/dL (SD 0.86), respectively. The average values during the recovery of Hb after the 1st, 2nd, and 4th weeks were 2.4% (SD 18.07), 41.6% (SD 18.4), and 74% (SD 15.2), respectively. This is in relation to the reduction between the initial Hb and at hospital discharge. Complaints of weakness and lipothymia were frequent until the second day. Conclusion: Clinical improvement was observed until the second postoperative day (PO day). Hemoglobin required approximately 1 month to normalize in most patients. These patients were treated only with oral iron replacement and did not require blood transfusions.

The life-cycle of your manuscript: From submission to publication.

Though the basics of peer review are common knowledge in the scientific community, to many authors the publication process is mystifying, frustrating, and often confusing. The purpose of this editorial is to lift the curtain between authors and editors and provide insight into the actual life-cycle of a manuscript from submission to publication, including practical tips regarding editorial processes, explanations of the most common reasons for rejection and advice on how to avoid it. While the detail is specific to the editorial setup at JBMT, it aims to provide useful insight to all authors seeking publication in a scientific journal, and to function as a teaching tool for educators guiding their students towards publication.

Commentary: Statistical significance and clinical significance - A call to consider patient reported outcome measures, effect size, confidence interval and minimal clinically important difference (MCID).

In healthcare research an intervention may be statistically significant based on quantitative analysis; however, simultaneously it may be relatively insignificant to the health or quality of life of patients affected by a particular condition or disease being treated by the intervention - thus may be interpreted as having low clinical significance. An understanding of statistics is fundamental for evidence informed healthcare. Patient-reported outcome measures (PROMs) direct patients to evaluate aspects of their own health, including quality of life, disability and function. Data obtained from PROMs can be used to demonstrate the impact of healthcare interventions on these elements of a person's quality of life. To interpret outcome measure data for clinical decision making, a clinician must understand the concepts of statistical significance and clinical significance. This commentary explores the concepts of patient reported outcome measures (PROMs), their statistical and clinical significance, and explores their relationship with a practical example for the clinician. Limitations of research that only reports p-values and the need to consider effect size, confidence intervals, and minimal clinically important difference are also discussed. Together, these concepts can assist the clinician to evaluate whether an intervention may be suitable for their clinical practice.

Scientific Papers and Patents on Substances with Unproven Effects. Part 2.

Several examples are discussed in this review, where substances without proven effects were proposed for practical use within the scope of evidence-based medicines. The following is discussed here: generalizations of the hormesis concept and its use in support of homeopathy; phytoestrogens and soy products potentially having feminizing effects; glycosaminoglycans for the treatment of osteoarthritis and possibilities of their replacement by diet modifications; flavonoids recommended for the treatment of chronic venous insufficiency and varicose veins; acetylcysteine as a mucolytic agent and its questionable efficiency especially by an oral intake; stem cells and cell therapies. In conclusion, placebo therapies can be beneficial and ethically justifiable but it is not a sufficient reason to publish biased information. Importantly, placebo must be devoid of adverse effects, otherwise, it is named pseudo-placebo. Therapeutic methods with unproven effects should be tested in high-quality research shielded from the funding bias. Some issues discussed in this review are not entirely clear, and the arguments provided here can initiate a constructive discussion.

Protocol for the development of consensus-based clinical case reporting guideline extension: CARE for acupuncture.

BACKGROUND: Health research reporting guidelines for case reports (CARE - CAse REport) published in 2013 and 2017 have become a generally accepted standard for publishing case reports. The CARE guidelines represent an architectural framework for writing an evidence-based case report that can be customized as need for a specialty (or disease) if needed. We aim to develop a CARE guideline extension for acupuncture following the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research) and the 2010″Guidance for Developers of Health Research Reporting". We have established a group of international experts including; clinicians, researchers and methodologists. We performed a needs assessment based on a review of acupuncture case reports published in the indexed medical literature. The needs assessment will be followed by (1) a series of expert interviews to establish a draft, (2) a modified Delphi process, and (3) a consensus meeting. Following the consensus meeting we will pilot test the CARE draft before publishing the CARE extension for acupuncture. METHODS: We will develop the CARE extensions for acupuncture following recommendations of the EQUATOR Network and the 2010 "Guidance for Developers of Health Research Reporting". We will establish an international multidisciplinary group including clinical practitioners, acupuncturists, researchers of reporting guidelines on acupuncture, clinical epidemiologists and statisticians. We performed a needs assessment, reviewing published case reports using acupuncture as a therapeutic intervention from indexed medical journals (PubMed-PMC and Medline, Scopus, Embase, the Allied and Complementary Medicine Database (AMED), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Wan Fang database, Chinese BioMedicine database (CBM), China National Knowledge Infrastructure (CNKI), and VIP). In consultations with advisors we will develop a draft of potential items to be included in the CARE extension for acupuncture. Then we will conduct a modified Delphi process of at least three rounds, hold a face-to-face consensus meeting, pilot test and submit the CARE extension for acupuncture for publication. CONCLUSION: The development of a widely accepted CARE extension for acupuncture for case reports published in indexed medical journals. These guidelines will follow the EQUATOR Network recommendations and the 2010 "Guidance for Developers of Health Research Reporting".

Intervention of artemisinin in macular edema associated with retinal vein occlusion: A protocol for a systematic review and meta-analysis.

BACKGROUND: Artemisinin was discovered to be highly effective antimalarial drugs shortly after the isolation of the parent artemisinin in 1971 in China. It is derived from extracts of sweet wormwood (Artemisia annua) and are well established for the treatment of malaria. Recently, artemisinin has been shown that it might have therapeutic value for several other diseases. The purpose of this review is to assess the efficacy of artemisinin as a treatment for macular edema associated with retinal vein occlusion. METHODS AND ANALYSIS: A systematic literature search will be performed in all available databases to quantitatively review eligible studies and identify all relevant data. We will include randomized controlled trials assessing efficacy of artemisinin as a treatment for macular edema associated with retinal vein occlusion. The methodological qualities, including the risk of bias, will be evaluated using the Cochrane risk of bias assessment tool, while confidence in the cumulative evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. ETHICS AND DISSEMINATION: Ethical approval is not required, as this study is based on the review of published research. This review will be published in a peer-reviewed journal and disseminated both electronically and in print. PROSPERO REGISTRATION NUMBER: The protocol for this systematic review has been registered on PROSPERO under the number CRD42019131408.

State of midwifery research in France.

OBJECTIVE: We describe French midwives' experience and perception of research and publication as well as their publications in scientific and professional journals. DESIGN: We conducted an online cross sectional survey of midwives from June to November 2016; complemented by a bibliometric analysis of their publications in any language. SETTING: This study was conducted in France, where it is necessary to question some midwifery and obstetrical practices. PARTICIPANTS: 146 midwives working/residing in France or holding/studying in France for a PhD or a Masters' degree at the time of the study; or having already published articles in any scientific or professional journal. FINDINGS: Of the 146 eligible midwives, 91.8% were female; 15 (10.3%) had a PhD degree, 26 (17.8%) and 80 (54.8%) were preparing a PhD and a Master's degree, respectively. A total of 140 midwives (95.8%) were working in midwifery and 54 (37.0%) respondents reported having already participated in midwifery research programs. Publication experience was reported by 73 midwives, including 26 (17.8%) who have published at least one article on midwifery in a journal accessible online and peerreviewed. 97.2% of midwives with publication experience consider it useful to publish but 75.7% consider that it is a difficult process. Lack of time, not mastering scientific writing and English language are their main barriers to publication. We identified 218 articles published by these midwives before January 2016, including 180 (82.6%) on maternal and perinatal health. Of their 134 unique articles on midwifery accessible online, 77 (57.5%) dealt with bio-medical topics, 49 (36.6%) with health system issues, and 17 (12.7%) used human and social sciences approaches. Pregnancy and birth were the two most studied reproductive life phases. Eighty-nine (28.4%) of these 314 articles were about midwifery practices or interventions. Since 1990, 93 articles have been published on midwifery in peer-reviewed journals, including 32 in the French language. The number of publications increased significantly with time with a progression coefficient at +1.18% per year, in particular in scientific journals (+0.78% per year). KEY CONCLUSIONS AND IMPLICATION: We evidenced that even though midwives in France have a still limited experience of research, and few of them have completed a PhD degree, or receive a salary for doing research, they publish an increasing number of scientific articles on midwifery topics. However, very few research programs in France examine aspects of midwifery. This scarcity is a major barrier to the involvement of midwives in research. Scientific publications about midwifery in French language are limited mainly due to the lack of adequate and specialized journal in French. However, publishing in French would facilitate the access to knowledge and evidence of midwifery practitioners in Frenchspeaking countries, including French-speaking Africa, where maternal mortality ratios can be very high. We suggest and discuss a number of approaches to increase access to scientific knowledge on midwifery in France and French-speaking countries.

Quantitative Outcomes of a One Health approach to Study Global Health Challenges.

Having gained momentum in the last decade, the One Health initiative promotes a holistic approach to address complex global health issues. Before recommending its adoption to stakeholders, however, it is paramount to first compile quantitative evidence of the benefit of such an approach. The aim of this scoping review was to identify and summarize primary research that describes monetary and non-monetary outcomes following adoption of a One Health approach. An extensive literature search yielded a total of 42,167 references, of which 85 were included in the final analysis. The top two biotic health issues addressed in these studies were rabies and malaria; the top abiotic health issue was air pollution. Most studies described collaborations between human and animal (n = 42), or human and environmental disciplines (n = 41); commonly reported interventions included vector control and animal vaccination. Monetary outcomes were commonly expressed as cost-benefit or cost-utility ratios; non-monetary outcomes were described using disease frequency or disease burden measurements. The majority of the studies reported positive or partially positive outcomes. This paper illustrates the variety of health challenges that can be addressed using a One Health approach, and provides tangible quantitative measures that can be used to evaluate future implementations of the One Health approach.

"Dancing on the edge of research" - What is needed to build and sustain research capacity within the massage therapy profession? A formative evaluation.

BACKGROUND: Conducting research on massage therapy (MT) continues to be a significant challenge. PURPOSE: To explore and identify the structures, processes, and resources required to enable viable, sustainable and high quality MT research activities in the Canadian context. PARTICIPANTS: Academically-based researchers and MT professionals involved in research. RESEARCH DESIGN: Formative evaluation and a descriptive qualitative approach were applied. RESULTS: Five main themes regarding the requirements of a productive and sustainable MT research infrastructure in Canada were identified: 1) core components, 2) variable components, 3) varying perspectives of stakeholder groups, 4) barriers to creating research infrastructure, and 5) negative metaphors. In addition, participants offered a number of recommendations on how to develop such an infrastructure. CONCLUSIONS: While barriers exist that require attention, participants' insights suggest there are various pathways through which a productive and sustainable MT research infrastructure can be achieved.

Avances y líneas de investigación en el tratamiento y diagnóstico del tabaquismo / Advances research in the treatment and diagnosis of smoking

En el momento actual con el arsenal terapéutico disponible para ayudar a dejar de fumar las tasas de abstinencia se elevan hasta el 50% en el mejor de los casos. Es por ello que estamos en la necesidad de buscar nuevos tratamientos que consigan mejorar las tasas de abstinencia al año, teniendo en cuenta que los fumadores que van quedando son aquellos con una mayor dependencia. Debemos ahondar en el análisis de nuevas posibilidades con la vareniclina. Disponemos de investigación activa en la búsqueda de nuevas dianas terapéuticas como son los agonistas y antagonistas del GABA y del glutamato, receptores de acetilcolina, agonistas serotoninérgicos, inhibidores selectivos de la monoaminooxidasa, y agonistas noradrenérgicos. Por otra parte, el cigarrillo electrónico requiere posicionarse en el momento actual como tratamiento para dejar de fumar, debiendo profundizar en la investigación de las posibilidades de la estimulación intracraneal magnética, el mindfullness y la vacuna antinicotina, además de buscar biomarcadores que consigan unidos una mayor abstinencia

At the present time, the tobacco abstinence rates increase up to 50% with the therapeutic arsenal available, in the best-case scenario. That is why we are in the need for new treatments that achieve higher abstinence rates per year, given that smokers who remain are those with greater dependence. Also, we must give a thorough look into new possibilities for varenicline. There are on-going investigations searching for new therapeutic targets such as agonists and antagonists of GABA and glutamate, acetylcholine receptors, serotonin agonists, selective inhibitors of monoamine oxidase, and noradrenergic agonists. Moreover, the electronic cigarette requires a position at the present time as a treatment for smoking cessation, and other therapeutic approaches like magnetic intracranial stimulation, mindfulness or nicotine vaccine should be explored as well, added to seeking biomarkers in order to obtain higher abstinence with all these combined

Innovative development path of ethnomedicines: the interpretation of the path.

One of the primary purposes of the innovative development of ethnomedicines is to use their excellent safety and significant efficacy to serve a broader population. To achieve this purpose, modern scientific and technological means should be referenced, and relevant national laws and regulations as well as technical guides should be strictly followed to develop standards and to perform systemic research in producing ethnomedicines. Finally, ethnomedicines, which are applied to a limited extent in ethnic areas, can be transformed into safe, effective, and quality-controllable medical products to relieve the pain of more patients. The innovative development path of ethnomedicines includes the following three primary stages: resource study, standardized development research, and industrialization of the achievements and efforts for internationalization. The implementation of this path is always guaranteed by the research and development platform and the talent team. This article is based on the accumulation of long-term practice and is combined with the relevant disciplines, laws and regulations, and technical guidance from the research and development of ethnomedicines. The intention is to perform an in-depth analysis and explanation of the major research thinking, methods, contents, and technical paths involved in all stages of the innovative development path of ethnomedicines to provide useful references for the development of proper ethnomedicine use.

The revised Declaration of Helsinki: cosmetic or real change?

The Declaration of Helsinki, adopted by the World Medical Association's General Assembly in 1964, is the most important set of guidelines about research on human participants. It both reflects and shapes the ethos of international research ethics. It is a living instrument and is reviewed and revised regularly. Its latest revision was in 2013. There are four substantial changes, reflected in the new Paragraph 15 (which deals with compensation for trial related injuries), Paragraph 33 (relating to placebos), Paragraph 20 (relating to vulnerable groups) and the new Paragraph 34 (relating to post-trial provisions). This article analyses these changes, and asks whether they indicate any shift in the overall philosophy of the Declaration. We conclude that these changes, though significant, are not tectonic. They accord with the spirit that has motivated the Declaration through all its iterations, and indicate a steady, incremental evolution towards a holistic code of research ethics for research on human participants. Patient autonomy, though crucial, is no longer the only concern of the Declaration; distributive justice and beneficence are motivating forces too. While the Declaration is aware of the need to facilitate research, it is equally aware of the need to protect the vulnerable, and of the practical difficulties involved in that protection.