针刺临床试验干预措施报告标准的修订:CONSORT声明的扩展

"针刺临床试验干预措施报告标准"(STandards for Reporting Interventions in Clinical Trials of Acupuncture,STRICTA)于2001年和2002年在5种期刊上发表。该指南以对照检查清单及解释的形式供作者和期刊编辑使用,旨在提高针刺临床试验报告的质量,尤其是对其中干预措施的报告,因而有助于对这些试验的解释和重复。随后对STRICTA的应用及影响的述评都强调了STRICTA的价值,也提出了改进和修订的建议。为使修订过程顺利进行,STRICTA工作组、CONSORT工作组和中国Cochrane中心于2008年开始合作。召集成立的有47名成员的专家组对清单的修改稿提出了电子版反馈意见。在后来于弗莱堡(Freiburg)召开的见面会上,由21名专家组成的工作组进一步修订了STRICTA对照检查清单,并计划如何对其进行发布。新的STRICTA对照检查清单作为CONSORT的正式扩展版,包含6项条目及17条二级条目。这些条目为报告针刺治疗的合理性、针刺的细节、治疗方案、其他干预措施、治疗师的背景以及对照或对照干预提供了指南。而且,作为修订工作的一部分,对每一条目作了详尽解释,并针对每一条目给出了报告良好的实例。此外,STRICTA中的"对照"(controlled)一词被替换成了"临床"(clinical),以示STRICTA适用于更广泛的各类临床评价设计,包括非对照结局研究和病例报道。修订的STRICTA对照检查清单有望与CONSORT声明及其非药物治疗扩展版一起共同提高针刺临床试验的报告质量。

CONSORT 2010声明:报告平行对照随机临床试验指南的更新

CONSORT声明被广泛用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT2010声明",本文可从bmj.com免费获取,也将在Lancet,Obstetrics and Gynecology,PLoS Medicine,Annals of Internal Medicine,Open Medicine,Journal of Clinical Epidemiology,BMC Medicine和Trials等杂志发表。

CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新

大量证据显示随机对照临床试验(randomised controlled trial,RCT)的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准(Consolidated Standards of Reporting Trials,CONSORT)声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即"CONSORT2010声明"。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。"CONSORT2010声明"、其说明与详述文件,以及相关网站(www.consort-statement.org),对于改进随机临床试验报告必将有所裨益。

系统综述和荟萃分析优先报告的条目:PRISMA声明

为了提高系统综述和荟萃分析文章报告的质量,2009年由国际著名专家组成的系统综述和荟萃分析优先报告的条目(Preferred Reporting Items for Systematic Reviews and Meta-Analyses,PRISMA)小组在国际重要医学期刊包括《英国医学杂志》、《临床流行病学杂志》、《内科学年鉴》和美国《公共科学图书馆医学杂志》等同步发表了《系统综述与荟萃分析优先报告条目:PRISMA声明》。该标准的制定对于改进和提高系统综述和荟萃分析的报告质量将起到重要作用。该声明较以往制定的《随机对照试验荟萃分析报告质量》(Quality of Reporting of Meta-Analyses),即《QUOROM声明》更加全面、完善。由于近年采国内外对系统综述的高度重视,发表的文章数量也越来越多,因此,有必要规范报告的标准,提高报告的质量。这份声明对系统综述和荟萃分析类文章报告的27个条目及流程图进行了定义和介绍,对相关条目进行了详细的解释和说明。及时向国内读者和临床试验研究人员介绍该声明具有重要的现实意义和学术价值。北京中医药大学循证医学中心刘建平等在第一时间内翻译了该声明,本刊希望通过介绍中文版《系统综述与荟萃分析优先报告的条目:PRISMA声明》,以进一步提高国内系统综述文章撰写和报告的质量,同时也有助于改进研究设计的方法学质量。本文的英文原文"Preferred reporring items for systematic reviews and meta-analyses:the PRISMAstatement"发表于PLoS Med.2009;6(7):e1000097.doi:10.1371/journal.pmed.1000097。该文中文版本由北京中医药大学循证医学中心李迅、曹卉娟翻译,刘建平审校(Tel:010-64286760;E-mail:jianping_l@hotmail.com)。中文译文的翻译出版由国家重点基础研究发展计划(973计划)项目资助(No.200608504602)。

An Example of Apiphytotherapy Studies in Azerbaijan: Herbal

Ginger, turmeric, black seed, artichoke leaves, Azerbaijani thistle honey, and BB (bee bread) have a hepatoprotectiveeffect;therefore, they show effective results separately in case of alcohol-dependent and non-alcoholic liver obesity, hepatitis andtoxic liver damage. We studied how it can affect liver enzymes and hepatocytes in this group of patients. We took all these naturalplants and bee products in the optimal dose required by the body and prepared a paste called Herbal, so that everyday people couldeat comfortably as a food supplement, as well as see the therapeutic and prophylactic results. HERBAL paste for liver ingredients:flaxseed, ginger, seed of thistle, powder of yellow ginger, black cumin, and honey. Benefits: Herbal paste prepared based onwell-tested recipes improves the function of the liver and gallbladder. As a hepatoprotector, it affects the recovery of liver cells inliver diseases (hepatitis and cirrhosis), spleen disease, bile ductinfections, gallstones in gallbladders, inflammatory bowel disease,colitis, cholecystitis. It helps to remove toxic substances while taking medicine (antibiotics, chemotherapy, painkillers, etc.). Sideeffects: Individual sensitiveness to the contents of the product. Usage: In acute process 1 teaspoon, during chronic diseases 1dessertspoon twice a day before eating. Results: 48 women and 54 men with the third level of fatty liver dystrophy decreased to thesecond level (fibrosis did not occur). During the treatment of 114 patients who had an HCV (hepatitis C virus), I used HERBALpaste as a protector for the liver. After the analyses, 24 patients, who had liver cirrhosis ALT (alanine aminotransferase) and AST(aspartate aminotransferase) in the blood reduced twice. Another 81 patients from 90 who had virus had disappeared in bloodanalyses and in the exogenous factor of liver and GGT in the blood get normal.

Immunostimulator Api-phytotherapy for the Treatment of Upper Respiratory Tract Infection and Chronic Bronchitis

Throughout history, respiratory tract infections due to viruses, especially influenza viruses, continue to cause serious diseases, up to death, all over the world, as a result of the inability to develop effective treatment methods or vaccines. Due to changes in the antigenic structures of respiratory viruses, especially RNA viruses, there are difficulties in the production of effective vaccines. The World Health Organization estimates 150,000 hospitalizations and 30,000 to 40,000 deaths due to the flu epidemic in the United States alone, with a total of 25 to 50 million cases each year. Respiratory viruses are a major cause of influenza-like illness symptoms in children and adults, causing significant illness and death each year. Various herbal remedies have been used for the prevention and treatment of viral respiratory diseases in many parts of the world. Among those found to be effective are propolis, licorice root, ginger, black cumin, carob, but there is also scientific evidence for the effectiveness of several complementary treatments for the common cold. For example, oral zinc intake can reduce the severity of the common cold. Regular intake of vitamin C supplements can reduce the duration and severity of viral infections. Various herbs are widely used as medicine to clear viral respiratory infections. Influenza control and treatment mainly depend on chemical or biochemical agents isolated from plants. These agents include various polyphenols, flavonoids, saponins, glucosides, and alkaloids. We added such plants, propolis, and licorice honey to the content of bronxbal paste, which is a combination of supportive therapy, bronchial dilator, immunomodulator, mucolytic, and born antiviral and antibacterial effects during coronavirus and other bacterial-virus-caused pneumonia. We prepared it as a paste and used it in patients who do not have allergies. The plant and bee products in the bronxbal content we have prepared are natural pastes to solve problems that need ongoing rehabilitation, such as coronavirus pneumonia and chronic bronchitis caused by other viruses and bacteria, or Covid-19.

CONSORT-公平性2017扩展版及解释:在随机对照试验中更好地报告健康公平性

临床试验报告的统一规范(CONSORT)扩展版之CONSORT-公平性(Equity)2017,旨在改善与健康公平性相关的随机对照试验中干预效果的报告质量。健康不公平性是指通过恰当干预可避免的不公平健康差异。健康公平性相关的随机对照试验主要评估对健康公平性的影响,包括评价针对社会弱势群体的干预措施,探索2个(或2个以上有梯度特征的)处于不同水平的社会弱势群体间干预效果的差异,或两者皆有。我们与来自高、中、低收入国家的多种类型的相关人员进行了共识会议,其中包括知识用户(如患者)和方法学家等。我们围绕各条目讨论了来自实证研究、系统评价、方法学研究、关键人物访谈以及在线调查的证据,在提高报告清晰度的同时尽量避免给作者增加不必要的负担。CONSORT-公平性2017对CONSORT 2010声明中的16个条目进行了扩展,补充了1个有关伦理报告的条目,同时就每个条目提供了报告质量好的实例和简要的解释。广泛应用CONSORT-公平性2017来报告健康公平性相关试验,可促进决策者发现有关的随机对照试验证据并加以应用,从而减少健康不公平性。

CONSORT 2010声明:报告平行对照随机临床试验指南的更新

CONSORT声明被广泛应用于提高随机对照临床试验的报告质量。Kenneth Schulz等对CONSORT声明的最新版本CONSORT 2010作了详细说明,该版本基于新获得的方法学证据和经验的积累对报告指南作了更新。为了鼓励更多的人使用"CONSORT 2010声明",本文可从www.bmj.com免费获取,也将在Lancet,Obstetrics and Gynecology,PLoS Medicine,Annals of Internal Medicine,Open Medicine,Journal of Clinical Epidemiology,BMC Medicine和Trials等杂志发表。