randomized controlled clinical trials
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2022 ◽  
pp. 1-11
Author(s):  
Bo Wang ◽  
Zhuoshu Li ◽  
Longfei Mao ◽  
Mingyi Zhao ◽  
Bingchang Yang ◽  
...  

<b><i>Background:</i></b> Hydrogen is a chemical substance that has yet to be widely used in medicine. However, recent evidence indicates that hydrogen has multi-faceted pharmacological effects such as antioxidant, anti-inflammatory, and antiapoptotic properties. An increased number of studies are being conducted on the application of hydrogen in various diseases, especially those affecting the renal system. <b><i>Summary:</i></b> Hydrogen can be inhaled, as a gas or liquid, and can be administered orally, intravenously, or locally. Hydrogen can rapidly enter suborganelles such as mitochondria and nucleus by simple diffusion, producing reactive oxygen species (ROS) and triggering DNA damage. Hydrogen can selectively scavenge hydroxyl radical (•OH) and peroxynitrite (ONOO<sup>−</sup>), but not other reactive oxygen radicals with physiological functions, such as peroxyanion (O<sub>2</sub><sup>−</sup>) and hydrogen peroxide (H<sub>2</sub>O<sub>2</sub>). Although the regulatory effect of hydrogen on the signal transduction pathway has been confirmed, the specific mechanism of its influence on signal molecules remains unknown. Although many studies have investigated the therapeutic and preventive effects of H<sub>2</sub> in cellular and animal experiments, clinical trials are few and still far behind. As a result, more clinical trials are required to investigate the role of hydrogen in kidney disease, as well as the effect of its dose, timing, and form on the overall efficacy. Large-scale randomized controlled clinical trials will be required before hydrogen can be used to treat renal illnesses. <b><i>Key Messages:</i></b> This article reviews the mechanisms of hydrogen in the treatment of renal disease and explores the possibilities of its use in clinical practice.


2022 ◽  
Vol 2022 ◽  
pp. 1-13
Author(s):  
Xi Guo ◽  
Xiaojun Chen ◽  
Jinlan Chen ◽  
Zhiping Tan ◽  
Yifeng Yang ◽  
...  

Traditional Chinese medicine has long been applied to various diseases in China for a few thousand years. In recent years, its market has gradually developed from Asian countries to Western countries. At present, due to the lack of evidence-based medicine research, the effect of traditional Chinese medicine on the prevention and treatment of cardiovascular disease remains unclear. In evaluating the efficacy and safety of drugs, randomized controlled clinical trials (RCTs) are recognized as the gold standard for testing the effectiveness and safety of treatments and could offer the best evidence for the formulation of clinical treatment guidelines. Although traditional Chinese medicine has long been used to treat cardiovascular diseases, the research on the application of RCT to test the combination of traditional Chinese and Western medicine therapy or single traditional Chinese medicine therapy started late, and the number is comparably small. In order to summarize and objectively evaluate the research results of integrated traditional Chinese and Western medicine in intervention of cardiovascular diseases, we reviewed the literature of RCTs in this field by searching some Chinese and English databases and put forward some suggestions for the future development and research of traditional Chinese medicine.


2022 ◽  
Vol 75 (1) ◽  
Author(s):  
Nathaly Bianka Moraes Fróes ◽  
Francisca Ariane de Souza Arrais ◽  
Priscila de Souza Aquino ◽  
Juliana Cunha Maia ◽  
Marianne Maia Dutra Balsells

ABSTRACT Objectives: to identify the effectiveness of auriculotherapy in the treatment of nausea and vomiting through a systematic review of the scientific literature. Methods: it was performed a systematic review of the literature making use of the following data basis: The Scopus, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), Web of Science, LILACS and Cochrane databases were used. Articles from complete research from randomized controlled clinical trials that describe using auriculotherapy in nausea and vomiting treatment were selected, without restriction of date or language. Results: eleven articles were selected for analysis. The majority approached the population in surgical situations, followed by patients undergoing chemotherapy and pregnant women. As for results, 81% (n=8) of the articles reported that nausea and vomiting were lower in incidence and/or intensity in the intervention group. Conclusions: the review provided relevant data on the effects of auriculotherapy in nausea and vomiting treatment, with a decrease in the intensity and frequency of these symptoms in different populations.


2021 ◽  
Vol 7 (3) ◽  
pp. 375-380
Author(s):  
Dewi Nurlaela Sari ◽  
Anri Anri

Mual muntah merupakan salah satu ketidaknyamanan kehamilan yang dapat mengganggu dan menimbulkan komplikasi. Asuhan yang diberikan untuk mengatasi mual muntah dapat dilaksanakan dengan pendekatan farmakologi dan nonfarmakologi. Terapi non farmakologi yang dapat dikembangkan untuk mengurangi mual muntah yaitu hand massage dan pemberian minuman herbal. Sehingga asuhan mual muntah dapat dilakukan baik secara internal dan eksternal. Tujuan dari penelitian ini yaitu mengetahui pengaruh pemberian terapi hand masaage dan minuman herbal jahe pada ibu hamil dengan mual muntah trimester 1. Jenis metode yang digunakan adalah quasy eksperiment dengan pre-post test design. Sampel di bagi menjadi  2 kelompok yaitu kelompok kontrol dan kelompok perlakuan. Pengambilan sampel secara Randomized Controlled Clinical Trials (RCT). Jumlah sampel sebanyak 30 responden untuk masing-masing kelompok sehingga total responden yaitu 60 orang. Instrumen yang digunakan adalah Pregnancy-Unique Quantification Of Emesis/Nausea (PUQE). Penelitian dilakukan selama 3 bulan. Jenis analisa univariat menggunakan distribusi frekuensi dan analisa bivariat menggunakan analisis Wilcoxon Signed Rank Test. Hasil penelitian menunjukkan intervensi yang dilakukan efektif terlihat dari selisih penurunan intensitas mual muntah pada ibu hamil dan nilai p-value 0,000 < dari nilai alpha (0.05). Simpulan didapatkan adanya pengaruh yang signifikan antara yang di berikan terapi hand massage dan konsumsi minuman herbal dengan yang tidak diberikan perlakuan terhadap ketidaknyamanan mual muntah pada ibu hamil. Berdasarkan penelitian di atas, hand massage dan terapi minuman herbal dapat diterapkan sebagai salah satu penanganan mual muntah pada ibu hamil.


2021 ◽  
Vol 11 (40) ◽  
pp. 157-158
Author(s):  
Stephan Baumgartner ◽  
Beate Stock-Schröer

Background: Specific efficacy of homeopathically prepared substances in high dilution levels is controversial due to the comparably low number of randomized controlled clinical trials and due to the low concentrations of the substances potentised. No generally accepted theoretical model is currently available to explain specific effects of such preparations. In order to unequivocally demonstrate any such effects, experimental research has to meet very high standards. Aims: Objective was to compile guidelines for homeopathic basic research regarding experimental design, implementation, execution, evaluation and publication. Methods: A Delphi Process was conducted, involving European researchers who published experimental work within the last five years. The Delphi process included a total of five rounds, three rounds of adjusting and phrasing plus two consensus conferences [1]. Eligible criteria were collected from existing publications concerned with the quality of homeopathic basic research. In advance a short questionnaire was sent to a selection of research institutes in Germany active in non-homeopathic basic research. Results: Regarding experimental design, the most important points to consider are: randomized and coded (blinded) allocation of the treatments, several independent experiments (including independent production lots), potentised or succussed controls, positive controls (to control reactivity of the system) and systematic negative control experiments to document test system stability and adequacy of the statistical evaluation [1–4]. A detailed publication guideline for authors was developed. REHBaR (Reporting experiments in Homeopathic Basic Research) provides a checklist of 23 items, supplemented with detailed examples [4]. Background, objectives and possible hypotheses should be given in the part ‘introduction’. Special emphasis is put on the ‘materials and methods’ section, where a detailed description of chosen controls, object of investigation, experimental setup, replication, parameters, intervention, allocation, blinding, and statistical methods is required. The section ‘results’ should present sufficient details on analyzed data, descriptive as well as inferential. Authors should discuss their results and give an interpretation in the context of current evidence. Conclusions: Guidelines how to prepare detailed and informative publications are very common in clinical research [5]. To the best to our knowledge REHBaR is the first guideline to be applied by authors when preparing their manuscripts and to be used by scientific journals in the reviewing process in the field of homeopathic basic research. Furthermore the REHBaR guideline can be helpful for planning and conducting experiments as it includes fundamental qualitative standards. To which extent REHBAR can be used also as an instrument to evaluate the quality of a publication will be discussed.


Author(s):  
Majd A. Hamaly ◽  
Karem H. Alzoubi ◽  
Omar F. Khabour ◽  
Ruba A. Jaber ◽  
Wael Al-delaimy

Background: The current standards that govern clinical research have been shaped over the years through many historical, social, and political events. The third principle of the Belmont report, Justice, guides the scientific community toward equal distribution of benefits and risks in research involving human subjects. Clinical equipoise is the status of genuine uncertainty by the investigator about the superiority of one treatment arm over the other. The term clinical equipoise was proposed to provide an ethical ground to conduct randomized controlled clinical trials. Objective: The objective of this review is to provide the reader with an overview about the emergence of the term equipoise and its utilization in randomized controlled trials. Methods: In the current review article, the major oncology clinical trials and relevant patents were reviewed for the application/utilization of clinical equipoise. Results: The concept of clinical equipoise has been challenged and different alternatives were proposed. Yet, these alternatives received numerous critiques and failed to fully replace equipoise. In addition, several patents related to anticancer agents tested in the described studies were examined. No specific reference was made as part of the patent to the status of clinical equipoise. Alternatively, a description of the study arms was provided. Conclusion: There is a need for revisiting the concept of equipoise and its suggested alternatives, for its ethical essence while addressing related challenges.


2021 ◽  
Vol 11 (4(42)) ◽  
pp. 45-52
Author(s):  
T. Znamenska ◽  
O. Vorobiova

The issue of feasibility and effectiveness of probiotics use in newborns is still discussable. A position letter of the Committee on nutrition of the European Society for Pediatric NutritionGastroenterology, Hepatology, and(ESPGHAN) and the Working group of the ESPGHAN on probiotics and prebiotics issues was published in May 2020 in “Pediatric Gastroenterology and Nutrition” magazine as for the use of probiotics in premature newborns. The third part of the literature continues with the position paper and the results of many randomized controlled clinical trials of probiotics. The article considers the answers to 6 clinical questions posed by the working group of the Committee to assess the feasibility of use, routes of administration, dosage and duration of use, as well as the effectiveness and quality of probiotic drugs. It was proved that probiotics, in general, could decrease the level of necrotising enterocolitis, sepsis, and mortality. On the other hand, an increasing number of commercial products containing probiotics of non optimal quality are available. In addition, a large number of departments in the world regularly suggest probiotic supplements as a treatment standard despite the absence of any solid evidence. Moreover, the emphasis was placed on issues of safety of probiotic supplements for premature newborns. Guarantee of quality of probiotic product is deliverance of probiotic strains by transfer genes of resistance to antibiotics, the ability to regularly detect sepsis while using probiotics.


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