Terms Of Evidence-based Medicine Research Articles

Prescriptions of homeopathic remedies at the expense of the German statutory health insurance from 1985 to 2021: scientific, legal and pharmacoeconomic analysis.

The prescription of homeopathic remedies at the expense of the statutory health insurance (SHI) system in Germany has been criticized for years due to a lack of evidence. Now, on the planned abolition of the reimbursement of homeopathic medicines in Germany, the debate on this topic has been reignited. The aim of this paper is to show the costs and their development over time incurred by homeopathic remedies in the healthcare system from 1985 to 2021. For this purpose, 15 selected homeopathic medicines were chosen from the drug prescription report (Arzneiverordnungsreport) and analyzed with regard to their development of DDD (Defined Daily Dose) using data from the Wissenschaftliches Institut der Ortskrankenkassen (WidO, Scientific Institute of the General Local Health Insurance Funds) and compared with their respective rational pharmacological alternatives. The price comparison was based on the DDD costs and the pharmacy retail price of the smallest packaging in each case. The clinicalstudy situation for the preparations was also analyzed. For this purpose, the clinicalstudies provided by the manufacturer and those on PubMed were divided into evidence levels and analyzed. In addition, the presentation of homeopathic remedies on company websites, in online pharmacies, in specialist information and package leaflets was analyzed with regard to side effects, interactions, indication, and information on the alleged effect/proof of efficacy. In many media, information on homeopathic medicines remained incomplete, and non-compliance with the Therapeutic Product Advertising Act (Heilmittelwerbegesetz) was noted. Naming of the products if often very suggestive, too. Manufacturers' claims of efficacy go far beyond what can be considered proven in terms of evidence-based medicine and the quality of most clinical studies is poor. Homeopathic remedies are on average significantly more expensive than their rational pharmacological alternatives. Furthermore, DDD costs have continued to rise over the years analyzed. In aggregate, from a pharmacoeconomic, legal, and scientific perspective, abolition of reimbursement of homeopathic medicines in Germany at the expense of the SHI system is well justified.

Pharmacotherapy of glaucoma in terms of evidence-based medicine

Glaucoma is a disease associated with increased intraocular pressure (IOP). Of the pharmacological agents for treating glaucoma, there are drugs of the first (most effective and safe) and second-line treatment. First-line treatment includes prostaglandin analogs and beta-blockers. The currently used prostaglandin analogs (latanoprost, bimatoprost, tafluprost and travoprost) are PG F2α analogs that act through stimulation of FP receptors. They are distinguished by the optimal ratio of effectiveness and risk of side effects. They are convenient for the patient because for the therapeutic effect, it is enough to prescribe 1 time per day. As a result, it is rational to start the treatment of glaucoma with a drug in this group. In terms of pharmacoeconomics, the most affordable prostaglandin drug is latanoprost, which is generally as effective as other prostaglandin analogs. β-adrenergic blockers reduce the production of intraocular fluid, the formation of which is controlled by β1- and β2-adrenergic receptors. Therefore, non-selective β-blockers (timolol, levobunolol, metipranolol, and carteolol) have a pharmacodynamic advantage over selective β1-adrenergic antagonists (betaxolol). Conducted clinical studies of β-blockers have shown that given the cost, efficacy and safety, timolol was the most preferable treatment for glaucoma. In the presence of medical contraindications to the use of first-line drugs or to enhance their effectiveness, α2-agonists (apraclonidine and brimonidine), carbonic anhydrase inhibitors (usually local action: dorzolamide and brinzolamide), M-cholinomimetics (pilocarpine, carbachol and echothiopate), and also Rho-kinase inhibitors (ripasudil)

Trends in Health Quality–Related Publications Over the Past Three Decades: Systematic Review

BackgroundQuality assessment in health care is a process of planned activities with the ultimate goal of achieving a continuous improvement of medical care through the evaluation of structure, process, and outcome measures. Physicians and health care specialists involved with quality issues are faced with an enormous and nearly always increasing amount of literature to read and integrate. Nevertheless, the novelty and quality of these articles (in terms of evidence-based medicine) has not been systematically assessed and described.ObjectiveThe objective of this study was to test the hypothesis that the number of high-evidence journal articles (according to the pyramid of evidence), such as randomized control trials, systematic reviews, and ultimately, practice guidelines, increases over time, relative to lower-evidence journal articles, such as editorials, reviews, and letters to the editors.MethodsWe used PubMed database to retrieve relevant articles published during the 31-year period between January 1, 1989, and December 31, 2021. The search was conducted in April 2022. We used the keywords “quality care,” “quality management,” “quality indicators,” and “quality improvement” and limited the search fields to title and abstract in order to limit our search results to articles nearly exclusively related to health care quality.ResultsDuring this 31-year evaluation period, there was a significant cubic increase in the total number of publications, reviews, clinical trials (peaking in 2017, with a sharp decline until 2021), controlled trials (peaking in 2016, with a sharp drop until 2021), randomized controlled trials (peaking in 2017, with a sharp drop until 2021), systematic reviews (nearly nonexistent in the 1980s through 1990s to a peak of 222 in 2021), and meta-analyses (from nearly none in the 1980s through 1990s to a peak of approximately 40 per year in 2020). There was a linear increase in practice guidelines from none during 1989-1991 to approximately 25 per year during 2019-2021, including a cubic increase in editorials, peaking in 2021 at 125 per year, and in letters to the editor, peaking at 50-78 per year in the last 4 years (ie, 2018-2021).ConclusionsOver the past 31 years, the field of quality in health care has seen a significant yearly increase of published original studies with a relative stagnation since 2015. We suggest that contributors to this dynamic field of research should focus on producing more evidence-based publications and guidelines.

Омолодження інфарктів міокарда та інсультів: сучасні методи профілактики

Серцево-судинні захворювання (ССЗ) є основною причиною смерті та інвалідності населення в більшості країн світу. Також відмічається небезпечна тенденція омолодження інфарктів міокарда та інсультів. Очікується, що до 2030 р. смертність від ССЗ буде становити понад 23 млн людей і ССЗ утримають першість серед причин смерті населення планети. Проте якщо в розвинених країнах світу кількість смертей від ССЗ знижується, то в інших стрімко зростає. Україна — в числі останніх. За даними Всесвітньої організації охорони здоров’я (ВООЗ), Всесвітньої федерації серця і Всесвітньої організації боротьби з інсультом, 30 % випадків смерті від ССЗ у світі передчасні і 2/3 таких випадків можна уникнути завдяки профілактиці, основні напрями якої на основі доказової медицини розглянуті в цьому огляді.

Клінічні аспекти діагностики та лікування внутрішньосуглобових переломів п’яткових кісток

В аналітичному огляді літератури розглянуті питання діагностики та лікування внутрішньосуглобових переломів п’яткових кісток. Висвітлені основні тенденції і напрямки діагностики та лікування: механогенез, сучасні класифікації, стандарти обстеження, можливості оптимізації надання медичної допомоги постраждалим із внутрішньосуглобовими переломами п’яткових кісток. У результаті проведеного аналізу встановлено, що існує проблема діагностики й якісного лікування внутрішньосуглобових переломів п’яткових кісток, яка потребує вирішення шляхом розробки, впровадження комплексних методик діагностики та лікування на засадах доказової медицини.

Вертеброгенний і суглобовий больовий синдром. Сучасна проблематика з позицій доказової медицини

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The efficacy of acupuncture on suicidal behavior: A protocol for systematic review and meta-analysis.

One of the leading causes of death worldwide is suicide. Acupuncture has been reported to be related to clinical improvement of some risk factors for suicide including depression. Moreover, practitioner-patient communication is an important component of the acupuncture procedure, which may contribute to suicide risk reduction as a social contact. This systematic review was performed to evaluate the effectiveness and safety of acupuncture for suicidal behavior. A comprehensive search will be conducted in electronic medical databases including MEDLINE, the Cochrane Central Register of Controlled Trials, EMBASE, Allied and Complementary Medicine Database, PsycARTICLES, Cumulative Index to Nursing and Allied Health Literature, China National Knowledge Infrastructure, Wanfang data, VIP Chinese Science and Technology Periodicals, Citation Information by NII, Koreanstudies Information Service System, Korea Citation Index, Research Information Sharing Service, Oriental Medicine Advanced Searching Integrated System, and Korean Medical database. Interventional studies regardless of its design to assess the role of acupuncture on suicide prevention will be included. The validated measure of suicidal ideation including Beck scale for suicidal ideation will be considered as a primary outcome. The validated tools will be used to assess methodological quality of included studies according to its design (e.g., Cochrane Collaboration's risk of bias tool-2). If sufficient homogeneous data from controlled clinical trials exist, a quantitative synthesis will be performed. According to the heterogeneity of included studies, either a random-effects or fixed-effects model will be used. The findings of this systematic review and meta-analysis will help to address the emerging major public health problem, suicide, in terms of evidence-based medicine.

Features of early enteral nutrition in patients with intraabdominal hypertension syndrome in severe acute pancreatitis

The problem of treating severe acute pancreatitis is currently not solved. It was suggested that a large number of treatments. But unfortunately, that it seems to be working in experimental and initial clinical trials have not proved their effectiveness in the major randomized trials and cannot be recommended for widespread use in terms of evidence-based medicine. This statement relates to antimicrobial prophylaxis in the enzymatic step using antiproteaznyh, 5-fluorouracil, somatostatin drugs, anti-inflammatory drugs. Volumetric fluid therapy, sufficient early nutritional support is considered effective and recommended for use in severe acute pancreatitis. This article describes the importance of using early enteral nutrition in patients with this pathology.

Efficacy of treatment of patients with coronary heart disease using a fixed combination of L-arginine and L-carnitine in terms of evidence-based medicine. Review of international scientific sources

Efficacy of treatment of patients with coronary heart disease using a fixed combination of L-arginine and L-carnitine in terms of evidence-based medicine. Review of international scientific sources

Diagnostics of mechanical asphyxia – experience of foreign countries (literature review)

The aim of this study is to establish modern, global trends in the diagnosis of mechanical asphyxia.
 Materials and methods: search and bibliographic method (theoretical analysis, systematization and classification of library catalogues, printed and electronic sources on mechanical asphyxia) from open anchor databases Scopus preview, Web of Science and using information retrieval systems Google Scholar, Open Ukrainian Citation Index (OUCI), ScienceDirect on the Internet.
 Results: mechanical asphyxia, as one of the most common types of violent death, ranks first among deaths from mechanical injuries. Its study is of great interest among medical scientists in various fields, especially for resuscitators and forensic experts. Establishing the causes of asphyxia, clinical and morphological manifestations, and the consequences that unfortunately most often lead to death. With the rapid development of society, science is also developing rapidly, and the latest sensitive methods of diagnosing diseases are emerging. However, unfortunately, in the post-Soviet space, the diagnosis of most pathological conditions, including asphyxia, is determined by experience and sensory organs, which are determined using instrumental research methods in compliance with the requirements of evidence-based medicine.
 Given the peculiarities of the pathophysiological processes of the asphyxiation state and their manifestations in the body, doctors should rely primarily on general knowledge about hypoxic and asphyxiation disorders, which are determined using instrumental research methods in compliance with the requirements of evidence-based medicine.
 Conclusions: at present, the diagnosis of asphyxia consists of many morphological features. Failure to take into account the state of the body, the presence of chronic diseases, and drug or alcohol intoxication at the time of asphyxiation complicate the diagnosis. Detection of individual clinical manifestations or morphological features does not allow asserting its lifelong origin. Therefore, it is necessary to use modern research methods that should expand the possibilities of forensic diagnosis of the viability of injuries in terms of evidence-based medicine and provide forensic experts with a scientific basis for their results. One such method is immunohistochemical, which is gaining popularity and consolidating its position in the EU, China, Japan and America. In addition, this method is well-established and widespread in morphological studies of differential diagnosis of tumours. Some scientific works prove the expediency of using the immunohistochemical method to solve the problems of forensic expert practice, which is an actual scientific and practical task

Investigation of Biochemical Data in Pregnant Women Diagnosed with Restless Legs Syndrome

Objective: Restless legs syndrome is a disorder that negatively affects quality of life. Pregnancy increases the frequency of restless leg syndrome. Symptoms that occur during pregnancy can become permanent. This study aimed to investigate the possible relationship between restless legs syndrome and biochemical parameters. Method: Alanya Alaaddin Keykubat University Education and Research Hospital was included in our randomly selected 100 pregnant women that applied to the Gynecology and Obstetrics outpatient clinic. The demographic characteristics and laboratory results of the patients were recorded. Patients were divided into two groups: one group with restless leg syndrome, and one group without. It was investigated whether there is a statistically significant difference between the demographic characteristics, blood biochemical levels, and hormonal levels between the two groups. Results: Age, height, weight, body mass index, ferritin with pregnancy week, magnesium, vitamin D, vitamin B12, thyroid stimulant hormone (TSH), hemoglobin, calcium, and aspartate aminotransferase / alanine aminotransferase (AST/ALT) levels were similar between the two groups (p>0.05). Conclusion: Restless legs syndrome is seen in about a third of the pregnancies. Pregnant patients do not come to the doctor with this complaint, because leg complaints are a normal condition caused by pregnancy. For this reason, they continue to live with symptoms of restless leg syndrome and endure this problem. However, this disease can be diagnosed with specific inquiries of physicians regarding restless leg syndrome. Although this study could establish no significant relationship between routine biochemical parameters and RLS, it is essential to examine the possible relationship in larger patient groups in terms of evidence-based medicine.

Rehabilitation of patients with multiple sclerosis in terms of evidence-based medicine: techniques for digitizing the results

A number of clinical trials, reviews, and meta-analyses have been recently published, which show the effectiveness of rehabilitation in patients with multiple sclerosis (MS). It is necessary to investigate the evidence basis of various rehabilitation methods that have proven to be effective in the combination treatment of other neurological diseases. At the same time, the simple transfer of these methods to the practice of managing patients with MS may not only improve, but even worsen their condition. An important task is to analyze methods for evaluating the effectiveness of physical rehabilitation, which in some cases are not without drawbacks. Owing to up-to-date technologies, there are more accurate, clear, and informative analysis methods as numerical values, the use of which can most objectively evaluate the effectiveness of rehabilitation measures before and after their implementation, which is necessary to standardize rehabilitation algorithms in patients with MS.

Diagnostic and treatment options for patients with COPD as part of real clinical practice. Approaches to the treatment of patients with various phenotypes according to GOLD (2019): materials of the Council of Experts of the Siberian Federal District, Chita and Buryatia, dated 03.15.19

Chronic obstructive pulmonary disease (COPD) is a global problem in modern medicine. In recent years, the medical community’s understanding of COPD has changed significantly, which is primarily due to the emergence of a new classification and the identification of various phenotypes of the disease. These changes could not affect the tactics of COPD treatment. The article discusses not only the debatable issues of treating COPD; it provides an overview of changes in international (Global Initiative for Chronic Obstructive Lung Disease, 2018) and national (2019) recommendations, but also the significance and benefits of triple therapy in terms of evidence-based medicine as well as the benefits of extra-fine drugs in the treatment of bronchial obstructive syndrome.

Sclerotherapy: step by step – liquid sclerotherapy

Classic sclerotherapy using drugs in the native (liquid) state is almost the oldest method of minimally invasive treatment of various forms of varicose veins of lower extremities and not only. Despite more than 300 years of development of the sclerotherapy methodology, enormous international experience and almost thorough study of its mechanisms, the development of new sclerosing drugs and technologies of their delivery to the lumen of the target vein continues. Measures aimed at reducing the frequency of undesirable side effects after sclerotherapy and improving the quality of life of patients during treatment and after its completion are discussed separately. Currently, there are several guidelines that regulate phlebosclerosing treatment in various clinical situations in terms of evidence-based medicine. This publication provides a brief historical background on the formation of sclerotherapy technology, presents basic principles for liquid sclerotherapy based on the analysis of international and Russian recommendations for the treatment of chronic venous diseases. Indications, contraindications and the basic methods of carrying out sclerotherapy with the use of officinal, registered in the Russian Federation phlebosclerosing detergent agents are presented, their actual physical and chemical properties, similarities and distinctions, and also optimal concentrations and doses are discussed. The classic sclerotherapy technique which has become known as “empty vein technique” is described in detail and illustrated.In addition, current clinical examples demonstrating successful use of compression sclerotherapy are presented. Again, the authors conclude that liquid sclerotherapy with the use of modern phlebosclerosing agents such as lauromacrogol 400 and sodium tetradecyl sulfate, performed according to the classical “empty vein” technology, demonstrates high efficiency and safety regarding large varicose veins of various localizations.

Non-pharmaceutical treatment of dyslipidemia: review of current methods of diet and nutraceuticals

The role of nutrition in the development and progression of atherosclerosis is well known. The correction of diet in patients with dyslipidemia is important as an independent intervention (in the group of patients with low and, partially, moderate cardiovascular risk), and as an addition to drug therapy in patients with at higher risk of cardiovascular events. The current review describes the effect of modern methods of diet therapy, as well as the use of a number of nutraceutical agents in terms of evidence-based medicine.

Modular Optic Force Sensor for a Surgical Device Using a Fabry–Perot Interferometer

The ability to sense force in surgery is in high demand in many applications such asforce feedback in surgical robots and remote palpation (e.g., tumor detection in endoscopic surgery).In addition, recording and analyzing surgical data is of substantial value in terms of evidence-basedmedicine. However, force sensing in surgery remains challenging because of the specific requirementsof surgical instruments, namely, they must be small, bio-compatible, sterilizable, and tolerant tonoise. In this study, we propose a modular optic force sensor using a Fabry–Perot interferometer thatcan be used on surgical devices. The the proposed sensor can be implemented like a strain gauge,which is widely used in industrial applications but not compatible with surgery. The proposed sensorincludes two key elements, a fiber-optic pressure sensor using a Fabry–Perot interferometer thatwas previously developed by one of the authors and a structure that includes a carbide pin thatcontacts the pressure sensor along the long axis. These two elements are fixed in a guide channelfabricated in a 3 × 2 × 0.5 mm sensor housing. The experimental results are promising, revealinga linear relationship between the output and the applied load while showing a linear temperaturecharacteristic that suggests temperature compensation will be needed in use.

Efficacy and cost-effectiveness of HER2+ early breast cancer therapies.

e18380 Background: Human Epidermal Growth Factor Receptor 2 (HER2) overexpression occurs in up to 25% of breast cancer (BC) cases. Patients with HER2+ tumors have a poor prognosis even when the disease is detected at an early stage with a recurrence rate of 15-19%. The aim of this study is to assess the best approach (pertuzumab plus trastuzumab [T+P], trastuzumab for 12 months [T12], trastuzumab for 6 months [T6], or T-DM1) in terms of evidence-based medicine and cost-effectiveness. Methods: The authors extracted individual patient data and estimated Invasive Disease-Free Survival (IDFS) and Overall Survival (OS) over a 30-years lifetime horizon. We considered only direct costs from adjuvant treatment as well as recurrence treatment from a Brazilian payer perspective. Heart events were considered for utility and cost analysis. After the base case, the authors assessed cost-effectiveness among N+ patients. In the meta-analysis, we included individual patient data for the intention-to-treat (ITT) population and Bayesian comparisons for subgroup analysis (HR+/HR- and N+/N). Results: We included individual patient data from 12,753 patients. The 4-year IDFS rate was 92.9% for T+P, 89.8% for T12 (HR 1.37, 95%CI 1.16-1.63) and 87.1% for T6 (HR 1.73, 95%CI 1.45-2.06). The 4-year OS rate was 96.7% for T+P, 95% for T12 (HR 1.37, 95%CI 1.07-1.75) and 93% for T6 (HR 1.82, 95%CI 1.42-2.34). T+P, T12 and T6 had similar efficacy among patients with HR+ tumors. T+P and T12 were superior to T6 among HR- patients. T+P was superior to T12 and T6 among N+ patients. T+P, T12 and T6 had similar efficacy among N- patients. In the base case, T+P had an ICER of $332,903 compared to T12. T12 had an ICER of $42,774 compared to T6. Among N+ patients, T+P had an ICER of $308,019 compared to T12. Among patients without complete response after neoadjuvant treatment, T-DM1 had an ICER of $3,233 compared to trastuzumab. Conclusions: T+P had a modest benefit in terms of 4-years IDFS and OS, although it was not cost-effective due to its high cost. T12 remained above the cost-effectiveness threshold compared to T6, but further studies are needed in order to define patients for T6. T-DM1 was cost-effective compared to trastuzumabe for patients who did not achieve complete response after neoadjuvant treatment.

Rhesus conflict during pregnancy: what one need to know

Rhesus-conflict is a pathological condition that manifests itself in the formation of antibodies against fetal erythrocytes in the body of pregnant woman due to the incompatibility of maternal and fetal Rh-factors. The main causes of morbidityand mortality in rhesus conflict are intrauterine hemolytic anemia, fetal hydrops, hemolytic neonatal disease. In addition, an important factor contributing to the increase in perinatal losses in this pathology is the high birth rate of extremely immature children. The reason for this is a preterm labor induction in case of a threat to the life of the fetus, as well as premature births associated with a variety of fetal manipulations. The number of cases of this pathology has declined dramatically throughout the world over the last decades, due to the widespread coverage of women at risk of immunization (anti-D - immunoglobulin). Unfortunately, in Ukraine this situation is not uncommon to this day.The article covers the main modern views on the causes, pathogenesis, course and prevention of immunological conflict associated with incompatibility of the Rh factor in terms of evidence-based medicine. The article describes the experience gained during recent years and attempts to unify the prognostic and preventive approaches in this area.Conclusions:1. Rhesus-conflict remains a serious problem of domestic medicine with a significant contribution to perinatal loss.2. Proper and timely anti-Rh immune prophylaxis among all non-immunized women can significantly reduce the incidence of severe disease in fetuses and newborns.3. There are no remedies for Rhesus conflict. Treatment is subjected to severe hemolytic disease only that occurs before the fetal maturity. Intrauterine hemotransfusion allows prolonging such pregnancy and preventing antenatal fetal death.

The role of b-blockers in the new revision of the 2018 European guidelines for the diagnosis and treatment of arterial hypertension in the patients with comorbidities

The review from the standpoint of the newest European guidelines for the diagnosis and treatment of arterial hypertension discusses the role of highly selective b-blockers and, above all, the superior member of these drugs - bisoprolol in blood pressure lowering therapy in comorbid patients with arterial hypertension. In terms of evidence-based medicine, the benefits of bisoprolol in patients with comorbid coronary heart disease, chronic heart failure, atrial fibrillation, and aortic pathology are discussed. The data on the feasibility and the possibility of including in the therapy highly selective b-adrenergic blockers in patients with chronic obstructive pulmonary disease, peripheral artery disease, diabetes and sexual dysfunction are presented

Фармакологическая и нутрициологическая поддержка функции опорно-двигательного аппарата квалифицированных спортсменов

Objective. To develop a concept of the modern system of pathogenetically sound application of pharmacological preparations and dietary supplements for the prevention and treatment of joint diseases in elite athletes. Methods. Analysis and synthetic generalization of research and methodological literature, as well as the Internet resources that are relevant to the matter under study. Results. The data on the prevalence and the causes of joint disorders in highly qualified athletes are presented. The categories of pharmacological and nutritional aids are described that are used in the world practice to prevent and treat such diseases in athletes. The emphasis was placed on the inappropriateness of the transfer of the treatment program for patients with rheumatoid arthritis to the system of prevention and treatment of joint disorders in athletes, where the development of this pathology is primarily mediated by a traumatic factor. The most common side effects of non-steroid anti-inflammatory drugs therapy most often used in such cases are described and current classification of these drugs is presented. The paper describes in detail supplementary aids of prevention and therapy for joint disorders using the nutritional supplements as well as provides the data on their effectiveness in terms of evidence-based medicine. Conclusion. The approach of a sports doctor to the prevention and treatment of the pathology of the articular apparatus in athletes in terms of the application of the entire spectrum of necessary drugs and nutritional supplements should be comprehensive and should take into account the specifics of the sport, especially the anti-doping legislation that regulates the systemic, local, and intra-articular application of glucocorticoids. Key words: high performance sport, diseases of the ligamentous-articular apparatus, pharmaceutical preparations, nutritional supplements.