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| 1 | 规范中医药临床研究方案内容2018声明:建议、说明与详述显示文摘中医学是古老的医学体系之一,但临床试验质量的参差不一限制了其被广泛接受。2013年出版的规范临床研究方案内容声明(Standard Protocol Items:Recommendations for Interventional Trials SPIRIT 2013声明)确立了运作临床试验的规范,从而保证结果准确可靠。由于中医药特殊的理论体系和干预措施特征,中医临床研究直接应用SPIRIT 2013声明存在诸多问题。因此,本文对原始SPIRIT 2013声明进行了中医药扩展。由于中药复方、针刺和灸法是中医药临床实践中最常用且最具代表性的三项干预措施,执行工作组决定SPIRIT-TCM扩展声明应基于此三项干预措施开发。邀请中医药领域的专家,开展三轮Delphi共识调研。执行工作组鼓励所有参与专家提出针对预设条目的意见,并建议新的扩展条目。SPIRIT-TCM扩展声明的条目清单基于共识调研的反馈进行了修改,最终经由一次共识会议定稿了SPIRIT-TCM扩展声明的内容。工作组修订了SPIRIT 2013原始条目中的7项条目,即'题目'、'背景和理念'、'目的'、'合格标准'、'干预措施'、'结局指标'和'数据收集方法'。扩展内容引入了中医学中证候的概念和三项主要的中医药干预措施,同时匹配了实例及说明。SPIRIT-TCM扩展声明为研究者设计高质量的临床试验提供了依据。其原则的广泛传播和应用将有助于持续推进中医药在医疗健康实践的国际化应用。 | 戴亮 郑颂华 田然 钟丽丹 李幼平 吕爱平 陈安文 商洪才 卞兆祥 | 2019 | 中国中西医结合杂志2019，39，6： | 30 |
| 2 | 基于CONSORT和STRICTOM评价灸法治疗膝骨性关节炎随机对照试验报告质量显示文摘采用CONSORT声明和STRICTOM标准评价国内艾灸治疗膝骨性关节炎临床随机对照试验的报告质量。利用计算机检索与手工检索,检索中国期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、维普(VIP)和万方(WF)等4个数据库,结合手工检索相关期刊,筛选出符合研究标准的文献,采用CONSORT声明和STRICTOM标准进行质量评价。共纳入合格文献52篇,发现多数文献存在随机方法叙述不清和盲法使用率低、无随机分配隐藏、无样本量准备、无治疗用意剖析、艾灸细节报道不充分、无艾灸治疗医生资历等问题。尽管目前大多数灸法治疗膝骨性关节炎临床随机对照试验质量较低,影响报道的可靠性和同质可比性,但热敏灸关于这方面的文章质量较高。认为为提高艾灸临床随机试验可靠性和质量,应该将CONSORT声明和STRICTOM标准引入艾灸临床随机试验设计并严格执行。 | 熊俊 朱道成 陈日新 叶文国 | 2015 | 中国针灸2015，35，8： | 22 |
| 3 | Consensus-Based Recommendations for Case Report in Chinese Medicine(CARC)显示文摘Case reports are valuable clinical evidence in traditional Chinese medicine(TCM).However,the general reporting quality is suboptimal.A working group comprising 20 members was set up to develop systematic recommendations on case report in Chinese medicine(CARC).The working group(CARC group) developed a primary checklist based on reviewing the general reporting quality of case reports in TCM and thorough internal discussion.Two-round consensus process had been carried out among clinical experts,evidence-based medicine methodologists,medical journal editors and clinical practitioners with designated questionnaire embedded with the primary checklist.In total,118 participants from 17 provinces of China and Korea completed the questionnaires.Their feedback was analyzed and discussed by the CARC group.The checklist was amended accordingly,and the final version,comprising 16-item,is presented here.Under the framework of CARC recommendations,the reporting quality of case reports in TCM can be improved. | 付姝菲 郑颂华 张莉 钟丽丹 管伟 林佳 张伯礼 王永炎 商洪才 卞兆祥 无 | 2016 | Chinese Journal of Integrative Medicine2016，22，1： | 19 |
| 4 | 针刺与艾灸对气虚证心率变异性的不同影响:随机对照研究显示文摘目的:观察针刺与艾灸对气虚证患者症状的改善作用及对心率变异性指标的不同影响。方法:招募30例气虚证患者及15例健康受试者,将30例气虚证患者随机分为针刺组和艾灸组,每组15例;15例健康受试者作为健康对照组。针刺组与健康对照组接受针刺治疗,艾灸组接受艾灸治疗,所取穴位均为关元和足三里,隔日治疗1次,共10次。在患者治疗前、治疗4次及治疗结束后进行气虚证症状量化评分并检测受试者心率变异性。比较气虚证症状量化评分与心率变异性指标的相关性,比较治疗前、治疗4次及治疗结束后3组受试者心率变异性指标的变化。结果:针刺组与艾灸组气虚证症状量化评分在第4次治疗后和治疗结束后均较治疗前下降(均P<0.05),治疗结束后艾灸组气虚证评分低于针刺组(P<0.05);气虚证患者的心率变异性指标比健康对照组更低(均P<0.05),且相关系数更高;治疗结束后,艾灸组的平均心率较治疗前下降(P<0.05),心率变异性总功率、低频均较治疗前上升(均P<0.05),健康对照组平均心率较治疗前上升(P<0.05);针刺组各指标与治疗前比较差异均无统计学意义(均P>0.05)。结论:心率变异性总功率能一定程度上反映气虚证的严重程度,针刺与艾灸均能改善患者的气虚症状,艾灸作用更明显,原因可能与艾灸能够持续性地提高自主神经系统活性有关。 | 舒晴 孙丹红 王华 梁凤霞 Gerhard Litscher Daniela Litscher Ingrid Gaischek 陈丽 何文娟 王雅媛 | 2017 | 中国针灸2017，37，1： | 19 |
| 5 | Effectiveness and safety of moxibustion in treatment of lumbar disc herniation: a systematic review and Meta-analysis显示文摘OBJECTIVE: To evaluate the effectiveness and safety of moxibustion therapy in the treatment of lumbar disc herniation (LDH). METHODS: Four Chinese databases and three English databases were searched from their inception to April 2018.Randomized controlled trials (RCTs) were included if moxibustion was used as the sole treatment or as a part of combination therapy with other treatments in patients with LDH. Two reviewers independently extracted the data and assessed the methodological quality using the Cochrane criteria for the risk of bias. The Meta-analysis was performed using Review Manager 5.3 software. RESULTS: In total, 16 RCTs including 1186 patients with LDH were analyzed. The Meta-analysis showed favorable effects of moxibustion in combination with massage therapy on the visual analog scale score compared with massage therapy alone [mean difference (MD)=? 1.32, 95% confidence interval (CI)(? 2.12,? 0.51), P = 0.001]. The subgroup Meta-analysis failed to show favorable effects of electro-acupuncture plus moxibustion on the efficacy rate compared with electro-acupuncture alone [relative risk (RR)= 1.06, 95% CI (0.98, 1.14), P = 0.15]. However, acupuncture or massage therapy plus moxibustion improved the efficacy rates compared with acupuncture or massage therapy alone [RR = 1.33, 95% CI (1.18, 1.49), P < 0.000 01][χ^2 = 2.76, P = 0.25, I2 = 27%],[RR = 1.15, 95% CI (1.06, 1.25), P = 0.001][χ^2 = 0.00, P = 0.95, I2 = 0%]. With respect to the Japanese Orthopaedic Association (JOA) scores, acupuncture or massage therapy in addition to moxibustion produced results different from those of acupuncture or massage therapy alone [MD = 5.58, 95% CI (4.15, 7.00), P < 0.000 01][χ^2 = 0.58, P = 0.45, I2 = 0%],[MD = 3.61, 95% CI (3.01, 4.21), P < 0.000 01]. There were no significant differences in the JOA score for subjective symptoms, objective symptoms, daily living ability, and other parameters. In six RCTs, no adverse reactions occurred during moxibustion. CONCLUSION: Whether moxibustion is an effective intervention for LDH is unclear because of the small sample size of qualified RCTs and the high risk of bias. More high-quality RCTs that overcome the methodological shortcomings of the existing evidence are needed. | Wang Yang Zhang Huiling Xia Liping Sun Zhiling Xu Xiao Du Shizheng | 2019 | Journal of Traditional Chinese Medicine2019，39，5： | 11 |
| 6 | Wrist-Ankle Acupuncture and Ginger Moxibustion for Preventing Gastrointestinal Reactions to Chemotherapy:A Randomized Controlled Trial显示文摘Objective:To evaluate the effects of wrist-ankle acupuncture combined with ginger moxibustion against gastrointestinal tract reactions(nausea,vomiting,and constipation)to chemotherapy in cancer patients.Methods:A total of 60 patients with gynecological tumors treated by chemotherapy were randomly divided into two groups.The treatment group(30 cases)underwent wrist-ankle acupuncture and ginger moxibustion,whereas tropisetron hydrochloride and dexamethasone were intravenously administered to the control group(30 cases)during chemotherapy.Results:The frequency of nausea in the treatment group was significantly less than that of the control group from the 2nd to the 5th day of chemotherapy(P<0.01).The anti-emetic effect in the treatment group was significantly better than that in the control group on the 3rd day of therapy(P<0.05).The incidence rate of constipation was significantly lower in the treatment group than that in the control group(P<0.01).Furthermore,the cost of therapy for the treatment group was significantly lower than that of the control group(P<0.01).Only 1patient manifested a post-acupuncture side effect in the form of subcutaneous blood stasis.Conclusion:Wrist-ankle acupuncture combined with ginger moxibustion could prevent gastrointestinal tract reactions to chemotherapy in cancer patients.In addition,the proposed method had fewer side effects,lower cost,and less risk. | 刘益群 孙帅 董惠娟 翟东霞 张丹英 沈慰 白玲玲 俞瑾 周丽虹 俞超芹 | 2015 | Chinese Journal of Integrative Medicine2015，21，9： | 9 |
| 7 | 小儿推拿临床研究设计的方法学思考显示文摘目前小儿推拿临床研究中存在研究目的不明确、缺乏对现代科学研究方法的合理选择和运用的问题,使其在国内及国际范围的发展及推广受到一定程度的制约。评价小儿推拿治疗的特异性和整体性效应是小儿推拿临床研究面临的两大主要问题。基于小儿推拿的自身特点及其临床研究的特殊性,结合其临床研究可能的难点,从试验设计类型、盲法、对照组及疗效评价指标的选择等方面进行探讨和分析,为小儿推拿临床研究提供方法学思路。 | 李美玲 路桃影 王立新 刘建平 吴大嵘 | 2018 | 中医杂志2018，59，17： | 8 |
| 8 | Can moxibustion, an ancient treatment modality, be evaluated in a double-blind randomized controlled trial? —— A narrative review显示文摘For thousands of years, moxibustion has been used for various diseases in China and other Asian countries.Despite the recent surge in Chinese herbal studies, few randomized controlled trials have been conducted on this modality, possibly due to the lacking of suitable double blinding methodology.This is a review of extant sham moxa devices and an introduction to a recently developed device that needs further validation. | Bai-xiao Zhao Hai-Yong Chen Xue-yong Shen Lixing Lao | 2014 | Journal of Integrative Medicine2014，12，3： | 8 |
| 9 | 电子灸治疗仪治疗膝骨关节炎的临床疗效观察60例显示文摘目的:观察艾灸治疗膝骨关节炎的临床疗效。方法:选择60例符合条件的膝骨关节炎患者随机分为传统艾灸治疗组和电子灸治疗仪对照组,2组各30例,均连续治疗4 w,3次/w,共12次。分别于治疗前、治疗2 w、治疗4 w,患者膝关节疼痛及功能评定总分WOMAC量表积分变化作为临床观察指标。结果:治疗4 w后2组患者膝关节疼痛WOMAC评分较治疗前均显著降低,治疗组总有效率86.7%、对照组总有效率63.3%,组间WOMAC指数评分差异有统计学意义(P<0.05)。结论:传统艾灸可以有效的缓解膝关节疼痛并改善膝关节功能,且疗效优于电子灸治疗仪组,传统艾灸是一种较为有效及理想的治疗膝骨关节炎的方法。 | 李亚楠 张彩荣 陈德春 阮志忠 | 2017 | 成都中医药大学学报2017，40，4： | 7 |
| 10 | CONSORT结合STRICTOM对灸法治疗过敏性鼻炎RCT试验质量的评价显示文摘目的 :采用CONSORT声明2010和STRICTOM标准对国内灸法治疗过敏性鼻炎随机对照(RCT)试验报告质量进行评价。方法 :检索CNKI、CBM、VIP和万方四个数据库,查找并筛选符合纳入标准的灸法治疗过敏性鼻炎相关文献,采用CONSORT声明2010和STRICTOM标准评价其报告质量。结果 :共73篇文献纳入评价。大部分文献存在随机化不严格(43篇、58.9%)、欠缺样本量估计(72篇、98.6%)、结局评估欠缺效应大小及精度描述(73篇、100%)、艾灸原理叙述不清或未叙述(71篇,97.2%)、艾灸细节不完善(约60%)、无艾灸师资历描述(73篇,100%)等问题。结论 :目前灸法治疗过敏性鼻炎的RCT试验报告质量较差,研究结果的可信度及参考价值不高。 | 龚红斌 付勇 肖霞芳 金柳青 谢芳深 | 2016 | 江西中医药2016，47，4： | 6 |
| 11 | Effectiveness and Safety of Moxibustion Robots on Primary Dysmenorrhea:A Randomized Controlled Pilot Trial显示文摘Objective To conduct a pilot trial to explore the effectiveness and safety of moxibustion robots in treating primary dysmenorrhea(PD)and evaluate its feasibility in clinic.Methods A total of 70 participants with PD were allocated to either moxibustion robot(MR)group(35 cases)or manual moxibustion(MM)group(35 cases)using computer-generated randomization.One acupoint Guanyuan(CV 4)was selected to receive moxa heat stimulation.Two groups of participants were given 3 menstrual cycles of MM and MR treatment respectively(once a day,5 days a session)and received another 3 menstrual cycles follow-up.The degree of pain was evaluated by short-form McGill pain questionnaire(SF-MPQ)and the symptoms of dysmenorrhea were evaluated by Cox Menstrual Symptom Scale(CMSS).The safety was measured by the occurrence rate of adverse events(AEs),including burns(blisters,red and swollen),itching,bowel changes,menstrual cycle disorder,menorrhagia and fatigue,etc.Results A total of 62 patients completed the trial,32 in MR group and 30 in MM group.Compared with baseline,scores of SF-MPQ and CMSS significantly decreased in both groups(P<0.05),and no significant difference was observed between the two groups in the 3rd and 6th menstrual cycles(P>0.05).The total occurrence rate of AEs in MR group was 2.1%,which was significantly lower than MM group(7.2%,P<0.05).Conclusions MR has the same effect as MM at SF-MPQ and CMSS in patients with PD.However,MR is safer than MM(Trial registration No.ChiCTR1800018236). | ZHANG Han-rui TU Hai-yan WANG Yu XIA Shi-lin ZHAO Guo-you YANG Ting LI Ying-kun | 2021 | Chinese Journal of Integrative Medicine2021，27，8： | 4 |
| 12 | 近10年CONSORT系列报告标准评价针灸随机对照试验的运用现状分析显示文摘目的总结近10年国内外运用CONSORT系列报告标准评价针灸随机对照试验(randomized controlled trial,RCT)的现状。方法计算机检索CNKI、VIP、WF、CBM、WF、Cocharane Library、PubMed等大型文献数据库,筛选合格文献,采集文献信息,从发表年份、出版语种、研究类型、病症种类、干预方式、评价方法、报告形式等方面进行综合分析。结果共纳入65篇,其中使用单一标准的有15篇,采用联合标准有50篇。应用2001版CONSORT的10篇(15.38%),应用2010版的CONSORT的有41篇(63.08%),运用STRICTA的有60篇(92.31%),采用STRICTOM有4篇(6.15%)。在评价方法上由两位研究者独立进行评价,如遇分歧通过协商或第3位研究者解决48(73.85%)。采用二分法或赋值评分(0~1)的有56篇(86.15%),采用三分法或赋值评分(0~3)的有8篇(12.31%),采用四分法有1篇(1.54%)。结果使用图表结合文字描述有56篇(86.15%)。研究类型主要为二次研究,干预方式中针刺有16篇,灸法4篇,针灸43篇,针刺结合其他2篇。疾病集中在神经系统、肌肉骨骼系统和结缔组织疾病、消化系统疾病为主。结论研究者越来越重视CONSORT系列报告标准衡量针灸RCT的报告质量和规范性,但是运用方法存在一些不足,需要进一步提高。 | 杨骏 熊俊 袁婷 王雪 | 2021 | 中华中医药学刊2021，39，1： | 3 |
| 13 | Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration(SPIRIT-TCM Extension 2018)显示文摘Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, 'title', 'background and rationale', 'objectives', 'eligibility criteria', 'interventions', 'outcomes', and 'data collection methods'. The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world. | DAI Liang CHENG Chung-wah TIAN Ran ZHONG Linda LD LI You-ping LYU Ai-ping CHAN An-wen SHANG Hong-cai BIAN Zhao-xiang | 2019 | Chinese Journal of Integrative Medicine2019，25，1： | 2 |
| 14 | 中医药临床研究中传统文化差异所引起的伦理学问题显示文摘医学伦理学研究的相关问题通常会涉及生物伦理学的4个基本原则,包括研究的价值和完整性、尊重人、风险-受益比的衡量以及公正选择受试者。该原则是以评价涉及人的研究中相关伦理学问题为出发点,也适用于包括针灸和中药在内的传统医学和替代医学研究。WHO对补充和替代医学(CAM)临床研究指南中指出'应考虑到因社会、文化和历史问题所致的不同价值体系里所涉及到人类的权利',而且'对CAM临床研究中涉及的伦理问题应在进一步研究中应予以妥善处理'。本文围绕上述医学伦理学的4个基本原则进行展开论述并结合中国传统文化的若干特点,探讨具有西方文化的医学伦理学中关于知情同意、风险受益等问题的认识与设定,在引入对于中医药临床研究的伦理审查中可能出现的问题进行分析,以期为中医药临床试验的伦理学认识和伦理审查实践提供参考。 | 梁兆晖 曾令烽 潘建科 刘军 | 2013 | 世界科学技术-中医药现代化2013，15，4： | 2 |
| 15 | 灸法治疗溃疡性结肠炎的Meta分析和Meta回归显示文摘系统评价灸法治疗溃疡性结肠炎的临床疗效及安全性,分析最佳灸法和灸具。检索灸法治疗溃疡性结肠炎的随机对照实验,对文献结果进行Meta分析。并运用Meta回归进一步比较并分析不同灸法、灸具对疗效的影响。共纳入19项研究,Meta分析结果显示,灸法在有效率上优于常规药物治疗[RR=1.27,(1.20,1.33),p<0.001]。Meta回归结果显示,不同灸法不能解释干预疗效差异。得出结论,灸法治疗溃疡性结肠炎优于常规药物治疗。 | 徒文静 徐桂华 张苏闽 姜荣荣 | 2017 | 现代盐化工2017，44，6： | 2 |
| 16 | 灸法临床研究的方法学问题及其对策显示文摘在中医药现代化和国际化进程中,灸法的应用日益广泛。由于灸法临床研究起步较晚及灸法本身的特殊性,已发表的灸法随机对照试验(RCT)文章数量极少且存在方法学不足。但是,灸法临床试验设计标准不适合盲目照搬目前的临床研究方法。随着大数据时代到来,对建立适应灸法临床研究的试验设计标准起到重要的推动作用,对灸法的临床研究提供了新的思路。本文基于国际试验报告统一标准(CONSORT)和艾灸治疗临床试验的国际标准(STRICTOM),总结了灸法RCT研究中存在的问题,提出了解决措施,并对大数据研究在灸法试验中的应用进行了展望。 | 郑志坚 翟蓓蓓 生炜 张越 王洪杰 孟凡强 马增斌 倪国栋 | 2019 | 中国临床保健杂志2019，22，4： | 1 |
| 17 | 灸法治疗过敏性鼻炎RCT的方法学及报告质量评价显示文摘目的:评价灸法治疗过敏性鼻炎的文献质量,探讨提高灸法临床试验的措施。方法:全面检索大型文献数据库,以CNKI、WF、VP、CBM以及Pubmed、Cochrane Library数据库为主,辅以手工检索相关期刊及参考文献,筛选出符合标准的文献,并运用Cochrane偏倚风险评估工具、CONSORT声明和STRICTOM标准进行质量评价。结果:共纳入47篇合格RCT。方法学质量评价结果显示26篇(55.32%)描述了随机序列的产生,5篇(10.64%)详细说明了分配隐藏方法,另有1篇(2.13%)对研究者和参与者执行了盲法,有4篇(8.51%)对评估者执行了盲法。报告质量评价显示:32篇(68.01%)描述了纳入标准,42篇(89.36%)说明了准确的干预措施,但只有8篇(17.02%)叙述了主要和次要结局指标,评估的效应大小及其精度,4篇(8.51%)描述了盲法对象;45篇(95.74%)交代了操作中艾灸的量和或每穴艾灸时间,同时也有34篇(72.34%)未描述针对艾灸过程中出现意外的防范措施。结论:当前有关灸法的临床试验尚不严谨,质量有待提高,建议严格控制试验偏倚,按照标准撰写研究报告。 | 黄守强 熊俊 项洁 华芳慧 | 2021 | 江西中医药2021，52，2： | 1 |
| 18 | OLYMPUS AU 560全自动生化分析仪常见故障分析及排除方法显示文摘 | 李素真 常爱香 | 2000 | 陕西医学检验2000，15，2： | 1 |
| 19 | 中医药领域效果比较研究设计要素的思考显示文摘目前在中医药领域尚缺乏临床研究的效果比较研究相关设计要素的介绍。本研究在整合国内外相关研究论述的基础上,系统地整理出设计要素的实施细节,分别从相关指南介绍、研究设计、研究对象、处理组设置、研究结局、研究分配方法、盲法、受试者偏好和期望、样本量估算、亚组分析、统计分析等方面进行论述。本研究首次较为全面详细地介绍了中医药领域开展临床研究的效果比较研究设计要素,以期为此领域的后续研究者提供方法学的指导和启示。中医药辨证论治的个体化治疗方式与真实世界效果比较研究的设计理念相符,此二者的结合有望为中医药领域医疗卫生决策的制定提供更真实可靠的证据支持。 | 陆丽明 温泽淮 | 2017 | 中国中医基础医学杂志2017，23，3： | 1 |
| 20 | 艾灸治疗女性尿失禁的系统评价与meta分析显示文摘Background:Urinary incontinence(Ul)is a common condition that bothers women's lives,including stress urinary incontinence(SUI),urgency urinary incontinence(UUI)and mixed urinary incontinence(MuI).The current non-surgical treatment of Western medicine includes pelvic floor muscle training(PFMT),medication,electric stimulation,etc.,all of which have varied limitations.For instance,the patients are poor in compliance with PFMT and medication results in frequent adverse effects.Being one of the featured treatments of TCM,moxibustion has several merits including safety,low cost and simple operation.In recent years,the clinical evidences prove increasingly that moxibustion may be effective for women with Ul.However,there is no high-quality systematic review of moxibustion for this disease.Objective:To evaluate the effect and safety of moxibustion on UI(including SUI,UUI and MUI)among women.Methods:From the inception to October 13,2022,the data of the randomized controlled trials(RCTs)of moxibustion on UI among women were collected from CNKI,WanFang Data,VIP,SinoMed,Web of Science,Pubmed,EMBASE and Cochrane Library databases.Two investigators screened the articles independently and extracted the data according to the inclusion and exclusion criteria developed in advance.Using the risk of bias assessment tool of Cochrane Handbook,the included RCTs were evaluated.With RevMan 5.3 software,meta-analysis was performed,and the GRADE tool was adopted to assess evidence certainty of different outcomes.Results:A total of 1176 articles were retrieved and 19 of them with 1397 patients were eligible and included in the review.In experimental groups,moxibustion combined with PFMT was used,while in control groups PFMT was applied alone.And the subjects were all women with SUI.Meta-analysis showed that compared with PFMT alone,moxibustion combined with PFMT reduced the urine leakage volume(1-hour pad test)(MD=-1.95,95%CI[-2.32,-1.57],P<0.001),the frequency of Ul in 24-hour(MD=-0.64,95%CI[-0.88,-0.40],P<0.001)and the score of the short form of International Consultation on Incontinence Questionnaire(ICIQ-SF)of women with SUI(MD=-2.53,95%CI[-3.43,-1.63],P<0.001);and this combined intervention measure did not increase significantly the adverse events(RR=0.82,95%CI[0.15,4.6],P=0.82).GRADE assessment showed that the UI frequency in 24-hour and the incidence of adverse events were rated as low quality,the urine leakage volume of 1-hour pad test and ICIQ-SF score were very low quality.Conclusion:Compared with PFMT alone,the intervention combined with moxibustion greatly reduced the urine leakage volume and UI frequency and improved the quality of life(QoL)among women with SUI with favorable safety.Moxibustion could be effective supplementary therapy on sUI among women.However,due to the high risk of bias of the included trials and low certainty of evidence,more highquality clinical studies are needed to verify the above findings. | 杜朔 赵吉平 杜世豪 郭玮 解小龙 王冠群 韩冠雄 杨超 | 2023 | World Journal of Acupuncture-Moxibustion2023，33，4： | 0 |
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