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Proposing a novel research method for acupoint selection 提出一种新的穴位选择研究方法
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-21 DOI: 10.1016/j.eujim.2024.102372
Nick Lowe, Spod Dutton

Introduction

Acupoint selection in both clinical trials and practice is predominantly informed by traditional theory and experience rather than clinical or mechanistic research. In-clinic acupoint testing methods are used by some practitioners to help determine acupoint selection based on patient feedback, but to date no quantitative data on these approaches has been published. This paper reports preliminary data where an acupoint testing method was utilised to help inform acupoint selection. These results were then used to develop a theoretical framework to validate the acupoint testing approach as a novel research method.

Methods

Preliminary data on the acupoint testing method was collected as part of a routine clinic audit from a single private practice in the UK using an electronic health record (EHR) and included; patient clinical demographic data, health complaints categorised according to the International Classification of Primary Care (ICPC-2) codes and patient outcomes using a Patient Global Impression of Change (PGIC) scale. The acupoint testing method used acupressure and/or acupuncture on acupoints to establish whether there was an immediate positive therapeutic effect for a patient for either; i) local areas of pain, ii) restricted/painful range of movements (ROM) and/or iii) acute symptoms related to a patients’ health complaint.

Results

A total of 506 acupoint tests were recorded from 398 treatments delivered to 74 patients (63.5% female, 36.5% male, mean age 58 years) presenting with predominantly chronic (77.1%) musculoskeletal (65.7%) issues. Tests were recorded for 61/74 (82.4%) patients and the mean number of tests per patient was 8.3. The majority of test results were positive (78.5%). For most patients at least one positive and negative test was recorded (52.5%). Solely positive tests were recorded for 44.3% of patients and soley negative tests were recorded for 3.3% of patients. The mixture of positive and negative test results suggests acupoint specificity may be clinically relevant.

Conclusion

Preliminary data suggests the testing method was versatile and useful for informing acupoint selection in clinical practice. Further research is required to establish its validity and reliability. The acupoint testing approach may represent a valuable new research method to help inform acupoint selection for both clinical trials and practice.

导言 临床试验和实践中的穴位选择主要依据传统理论和经验,而非临床或机理研究。一些医生在诊室内使用穴位测试方法,根据患者的反馈来帮助确定穴位选择,但迄今为止,尚未公布有关这些方法的定量数据。本文报告了利用穴位测试方法帮助选择穴位的初步数据。关于穴位测试方法的初步数据是作为英国一家私人诊所使用电子健康记录 (EHR) 进行的常规诊所审计的一部分收集的,其中包括:患者临床人口学数据、根据国际初级保健分类 (ICPC-2) 代码分类的健康投诉以及使用患者整体变化印象 (PGIC) 量表得出的患者结果。穴位测试法采用穴位按压和/或针灸穴位的方法,以确定是否对患者的以下症状产生了立竿见影的积极治疗效果:i) 局部疼痛部位;ii) 活动范围(ROM)受限/疼痛;和/或 iii) 与患者健康主诉相关的急性症状。结果 在对 74 名患者(63.5% 为女性,36.5% 为男性,平均年龄 58 岁)进行的 398 次治疗中,共记录了 506 次穴位测试,这些患者主要有慢性(77.1%)肌肉骨骼问题(65.7%)。61/74(82.4%)名患者进行了测试记录,每名患者的平均测试次数为 8.3 次。大多数检测结果呈阳性(78.5%)。大多数患者至少有一次阳性和阴性检测记录(52.5%)。44.3%的患者检测结果完全呈阳性,3.3%的患者检测结果完全呈阴性。阳性和阴性测试结果的混合表明,穴位特异性可能与临床相关。需要进一步研究以确定其有效性和可靠性。穴位测试方法可能是一种有价值的新研究方法,有助于为临床试验和实践提供穴位选择信息。
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引用次数: 0
Efficacy and safety of acupuncture therapy for leukopenia after chemotherapy or radiotherapy: A systematic review and meta-analysis 针灸治疗化疗或放疗后白细胞减少症的有效性和安全性:系统回顾与荟萃分析
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-16 DOI: 10.1016/j.eujim.2024.102373
Yunpeng Deng , Huanhuan Zhang , Tengteng Wei , Guangshuai He , Zhixin Zhu , Shuning Zhang , Meijun Liu , Jingjing Xue , Weixing Zhang , Xuguang Yang

Introduction

Acupuncture-Moxibustion Therapy (AMT) has been used to treat leukopenia associated with cancer treatment. This systematic review and meta-analysis aimed to assess the clinical efficacy, safety, and degree of evidence of AMT in the treatment of post-chemoradiotherapy leukopenia.

Methods

Four English databases (The Cochrane Library, PubMed, EMBASE, Web of Science) and four Chinese databases (Chinese Biomedical Database (CBM), China National Knowledge Infrastructure (CNKI), Chinese Scientific Journal Database (VIP), and WanFang Database) were searched from inception to February 6, 2023 for randomized controlled trials (RCTs) regarding post-chemoradiotherapy leukopenia with AMT. Two authors extracted data and assessed the quality of trials through the Cochrane risk of bias tool 2.0 independently. All meta-analysis was performed using Review Manager 5.4.1 and GRADE was usually used to measure the certainty of evidence.

Results

The analysis included 18 RCTs with 1,377 patients. The results showed that in treating post-chemoradiotherapy leukopenia, AMT is more effective compared to Chinese herbal medicine (CHM) (e.g., the effective rate: risk ratio (RR)=1.33, 95 % confidence interval (CI) 1.16 to 1.53, 3 RCTs, 349 cases; the white blood cell count (WBC): standardized mean difference (SMD)=1.03, 95 %CI 0.04 to 2.01, 2 RCTs, 148 cases), experimental synthetic drugs (ESDs) (e.g., the effective rate: RR=1.35, 95 %CI 1.13 to 1.61, 3 RCTs, 184 cases; the WBC: SMD=1.43, 95 %CI 1.21 to 1.65, 3 RCTs, 244 cases). AMT in combination with myeloid growth factors (MGFs) significantly improved the effective rate (RR=1.21, 95 %CI 1.09 to 1.35, 3 RCTs, 187 cases) and WBC (SMD=1.86, 95 %CI 1.56 to 2.17, 2 RCTs, 117 cases) compared to MGFs. However, there are no data to support the benefits of AMT or in combination with drugs in terms of Karnofsky performance status scores. The certainty of the overall evidence is very low due to the small sample sizes and poor quality of the included RCTs.

Conclusions

Very low certainty evidence suggests that AMT may be an effective complementary therapy for post-chemoradiotherapy leukopenia. The present evidence does not support a definitive safety profile for AMT. However, the quality of the current studies are low, and these conclusions need to be further validated by conducting more high quality RCTs.

简介:针灸疗法(AMT)一直被用于治疗癌症治疗后的白细胞减少症。本系统综述和荟萃分析旨在评估 AMT 治疗化疗后白细胞减少症的临床疗效、安全性和证据程度。方法检索了四个英文数据库(The Cochrane Library、PubMed、EMBASE、Web of Science)和四个中文数据库(中国生物医学数据库(CBM)、中国知网(CNKI)、中文科技期刊数据库(VIP)和万方数据库)中从开始到2023年2月6日有关AMT治疗化疗后白细胞减少症的随机对照试验(RCT)。两位作者通过科克伦偏倚风险工具 2.0 独立提取数据并评估试验质量。所有荟萃分析均使用Review Manager 5.4.1进行,并通常使用GRADE来衡量证据的确定性。结果显示,在治疗化疗后白细胞减少症方面,AMT 比中草药(CHM)更有效(如:有效率:风险比(RR);有效率:风险比(RR);有效率:风险比(RR);有效率:风险比(RR)))、有效率:风险比(RR)=1.33,95 % 置信区间(CI)1.16 至 1.53,3 项研究,349 例;白细胞计数(WBC):标准化平均差(SMD)=1.03,95 %CI 0.04 至 2.01,2 项研究,148 例)、实验性合成药物(ESD)(如有效率:RR=1.35,95 %CI 1.13 至 1.61,3 项 RCT,184 例;WBC:SMD=1.43,95 %CI 1.21 至 1.65,3 项 RCT,244 例)。与骨髓生长因子(MGFs)相比,AMT与骨髓生长因子(MGFs)联合使用可显著提高有效率(RR=1.21,95 %CI 1.09 至 1.35,3 项研究,187 例)和白细胞计数(SMD=1.86,95 %CI 1.56 至 2.17,2 项研究,117 例)。然而,没有数据支持 AMT 或与药物联合使用对 Karnofsky 表 现状态评分的益处。由于纳入的 RCTs 样本规模小、质量差,因此总体证据的确定性很低。结论确定性很低的证据表明,AMT 可能是化疗后白细胞减少症的有效辅助疗法。目前的证据并不支持AMT的明确安全性。然而,目前的研究质量较低,这些结论需要通过进行更多高质量的临床试验来进一步验证。
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引用次数: 0
“Are we there yet?” – Green shoots of progress in acupuncture implementation in healthcare "我们到了吗?- 针灸在医疗保健领域的进展绿芽
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-10 DOI: 10.1016/j.eujim.2024.102371
Sandro Graca , Matthias Huemer , Beverley de Valois , Bobbee Vang , Lara McClure

Despite a growing body of research and clinical guidelines advocating for acupuncture, its adoption in healthcare systems remains limited. This manuscript explores the considerable gap between evidence-based recommendations for acupuncture and its implementation, while providing practical examples of collaborative and integrative use of acupuncture in healthcare settings in the UK, USA, and Austria. We aim to inspire and provide guidance for those seeking to replicate these successful initiatives and drive the integration of acupuncture in their own healthcare settings.

Narrative accounts of the experience of three clinician-researchers delivering acupuncture within mainstream healthcare systems in the UK, USA, and Austria respectively were captured. These are presented as standalone exemplars of the integration of acupuncture in real-world settings from the perspective of embedded professionals. Each of the three contributors explores and discusses the challenges faced and opportunities presented in their specific setting, as well as lessons learned in the process which may be more widely transferable. The collective relevance of these three narratives may extend beyond the individual settings, serving as possible blueprints and stimulating further professional discourse and innovation.

In the UK, thanks to a unique collaborative environment, research has provided a platform for the implementation of long-running, sustainable acupuncture services in the National Health Service. In the USA, the provision of acupuncture in a hospital setting is supported by an emphasis on communication and comprehensive multidisciplinary approach to integrative care, aided by the use of electronic medical records. In Austria, acupuncture is predominantly administered by medical doctors and its integration is attributed to evidence-based discussions with patients and caregivers within the hospital setting. These green shoots of acupuncture provision within healthcare systems in three different countries bridge the translational gap between guidelines and delivery, shedding light on the multi-faceted aspects of acupuncture implementation.

Concerted efforts focusing on education, dissemination, and fostering bidirectional communication between acupuncture research and clinical practice are essential for moving beyond the principle of “It Seemed Like A Good Idea At The Time” in acupuncture service provision, and consequently supporting the integration and implementation of acupuncture in healthcare systems utilising existing guidelines.

尽管提倡针灸的研究和临床指南越来越多,但针灸在医疗保健系统中的应用仍然有限。本手稿探讨了针灸的循证建议与实施之间存在的巨大差距,同时提供了英国、美国和奥地利在医疗机构中合作和综合使用针灸的实际案例。我们的目标是为那些寻求复制这些成功举措的人提供启发和指导,并推动针灸在其自身医疗机构中的整合。我们分别在英国、美国和奥地利的主流医疗保健系统中采集了三位临床研究人员的针灸经验。三位临床研究人员分别在英国、美国和奥地利的主流医疗系统中提供针灸服务,他们的叙述将作为独立的范例,从专业人员的角度介绍针灸在现实世界中的应用。三位作者分别探讨和讨论了在其特定环境中所面临的挑战和机遇,以及在此过程中吸取的可广泛借鉴的经验教训。在英国,得益于独特的合作环境,研究为在国民健康服务中实施长期、可持续的针灸服务提供了平台。在美国,医院提供针灸服务的重点是沟通和多学科综合治疗方法,并使用电子病历作为辅助。在奥地利,针灸主要由医生实施,在医院环境中与病人和护理人员进行循证讨论是针灸整合的基础。这三个不同国家的医疗系统在提供针灸服务方面的 "绿芽 "弥合了指南与实施之间的转化差距,揭示了针灸实施的多面性。要想在提供针灸服务方面超越 "当时看来是个好主意 "的原则,并进而支持医疗系统利用现有指南整合和实施针灸,就必须在教育、传播和促进针灸研究与临床实践之间的双向交流方面齐心协力。
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引用次数: 0
Developing the Social Cognitive Factor Scale (SCFS) to analyze the determinants influencing the utilization of traditional chinese medicine preventive health services among older adults 开发社会认知因素量表(SCFS)以分析影响老年人使用中医药预防保健服务的决定因素
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-10 DOI: 10.1016/j.eujim.2024.102368
Yan Chen , Yuhuan Sun , Yang Yi , Yujie Chang , Dahui Wang , Jiaqi Yang , Ying Sun , Lan Jiang , Binyan Zhu , Guozhong Chen

Introduction

Traditional Chinese medicine (TCM) boosts immunity, aids self-repair, and supports elderly health. Despite government efforts, older adults underutilize TCM preventive health services. This study aimed to develop a reliable and valid Social Cognitive Factor Scale (SCFS) to understand this from a behavioral psychology perspective.

Methods

The SCFS, a self-report questionnaire rooted in Bandura's social cognitive theory, was developed by an expert panel using insights from current literature, focus group qualitative research, and scale testing. Twenty experts in TCM public health research and 840 community-dwelling older adults were included in this study. Scale development involved a literature review to establish the initial item pool, two Delphi expert consultations for item screening and revision, and comprehensive testing for reliability and effectiveness.

Results

The SCFS consisted of 22 items classified into six dimensions: perceived environment, social support, belief and knowledge, self-efficacy, outcome expectations, and self-regulation. The overall Cronbach's alpha of the scale was 0.946, and the split-half reliability of the total scale was 0.828, showing good reliability. A total of six factors were extracted, explaining 78.85 % of the total variation. Exploratory factor analysis showed that the scale had good construct validity. Scores on the SCFS were significantly and positively correlated with the utilization rate of TCM preventive health services for older adults (r = 0.537, p < 0.01).

Conclusion

TCM plays a significant role in actively addressing the challenges of aging. The SCFS provides a reliable and valid tool for understanding the underutilization of TCM preventive health services among older adults. A positive correlation with service utilization rates highlights its potential for guiding interventions.

导言传统中医药(TCM)可提高免疫力,帮助自我修复,支持老年人健康。尽管政府做出了努力,但老年人对中医预防保健服务的利用率却很低。本研究旨在开发一个可靠有效的社会认知因素量表(SCFS),以便从行为心理学的角度来了解这一问题。方法SCFS是一个自我报告问卷,它植根于班杜拉的社会认知理论,由一个专家小组通过对现有文献的洞察、焦点小组定性研究和量表测试来开发。20 位中医公共卫生研究专家和 840 位居住在社区的老年人参与了本研究。量表开发包括文献回顾以建立初始项目库,两次德尔菲专家咨询以筛选和修订项目,以及可靠性和有效性综合测试。结果SCFS由22个项目组成,分为六个维度:感知环境、社会支持、信念和知识、自我效能、结果预期和自我调节。量表的总体 Cronbach's alpha 为 0.946,总量表的分半信度为 0.828,显示出良好的信度。共提取了 6 个因子,解释了 78.85 % 的总变异。探索性因素分析表明,量表具有良好的建构效度。SCFS的得分与老年人中医预防保健服务的使用率呈显著正相关(r = 0.537, p < 0.01)。SCFS 为了解老年人对中医预防保健服务利用不足的情况提供了可靠有效的工具。它与服务利用率之间的正相关性凸显了其指导干预措施的潜力。
{"title":"Developing the Social Cognitive Factor Scale (SCFS) to analyze the determinants influencing the utilization of traditional chinese medicine preventive health services among older adults","authors":"Yan Chen ,&nbsp;Yuhuan Sun ,&nbsp;Yang Yi ,&nbsp;Yujie Chang ,&nbsp;Dahui Wang ,&nbsp;Jiaqi Yang ,&nbsp;Ying Sun ,&nbsp;Lan Jiang ,&nbsp;Binyan Zhu ,&nbsp;Guozhong Chen","doi":"10.1016/j.eujim.2024.102368","DOIUrl":"10.1016/j.eujim.2024.102368","url":null,"abstract":"<div><h3>Introduction</h3><p>Traditional Chinese medicine (TCM) boosts immunity, aids self-repair, and supports elderly health. Despite government efforts, older adults underutilize TCM preventive health services. This study aimed to develop a reliable and valid Social Cognitive Factor Scale (SCFS) to understand this from a behavioral psychology perspective.</p></div><div><h3>Methods</h3><p>The SCFS, a self-report questionnaire rooted in Bandura's social cognitive theory, was developed by an expert panel using insights from current literature, focus group qualitative research, and scale testing. Twenty experts in TCM public health research and 840 community-dwelling older adults were included in this study. Scale development involved a literature review to establish the initial item pool, two Delphi expert consultations for item screening and revision, and comprehensive testing for reliability and effectiveness.</p></div><div><h3>Results</h3><p>The SCFS consisted of 22 items classified into six dimensions: perceived environment, social support, belief and knowledge, self-efficacy, outcome expectations, and self-regulation. The overall Cronbach's alpha of the scale was 0.946, and the split-half reliability of the total scale was 0.828, showing good reliability. A total of six factors were extracted, explaining 78.85 % of the total variation. Exploratory factor analysis showed that the scale had good construct validity. Scores on the SCFS were significantly and positively correlated with the utilization rate of TCM preventive health services for older adults (<em>r</em> = 0.537, <em>p</em> &lt; 0.01).</p></div><div><h3>Conclusion</h3><p>TCM plays a significant role in actively addressing the challenges of aging. The SCFS provides a reliable and valid tool for understanding the underutilization of TCM preventive health services among older adults. A positive correlation with service utilization rates highlights its potential for guiding interventions.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"68 ","pages":"Article 102368"},"PeriodicalIF":2.5,"publicationDate":"2024-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000386/pdfft?md5=3b9c7683630203e21b51c0e940604e6b&pid=1-s2.0-S1876382024000386-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141036869","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of breathing exercises during first stage of labor: A systematic review and meta-analysis 第一产程呼吸练习的有效性:系统回顾和荟萃分析
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-08 DOI: 10.1016/j.eujim.2024.102370
Alexandre Delgado , Geyson Marinho , Renato S. Melo , Filipe Pinheiro , Andrea Lemos

Introduction

Breathing appears to be an important outcome during labor. Therefore, this systematic review aims to evaluate, using the highest level of evidence, the benefits and potential risks of using breathing exercises during the first stage of labor on maternal and neonatal outcomes.

Methods

A search was conducted in the MEDLINE/PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, PEDro, EMBASE, CINAHL, Web of Science, Scopus databases and gray literature was also searched, with no restrictions on period or language. The terms "Breathing Exercises" and "Labor" were used. Randomized and quasi-randomized clinical trials comparing a group using breathing exercises during the first stage of labor with a control group receiving usual care were included. The Cochrane tool (RoB 2.0) was used to assess the risk of bias, and the certainty of evidence was evaluated using the GRADE system. Quantitative analysis was performed through meta-analyses.

Results

Thirteen studies were included. There was a reduction in pain by -1.64 (95 % CI: -2.81 to -0.46, eight studies, I2 99 %; T2 2.82; p < 0.00001), based on very low certainty of evidence, and a reduction in the duration of the second stage of labor by -7.23 min (95 % CI: -11.08 to -3.38, three studies, random-effects: I2 0 %; T2 0.00; p < 0.0002), based on moderate certainty of evidence.

Conclusion

There is moderate evidence that the use of breathing exercises during the first stage of labor can reduce the duration of the pushing stage and decrease pain intensity, although with very low certainty of evidence. However, there was no difference in other maternal and neonatal outcomes.

引言 呼吸似乎是分娩过程中的一个重要结果。因此,本系统综述旨在使用最高级别的证据,评估在第一产程中使用呼吸练习对产妇和新生儿预后的益处和潜在风险。方法在 MEDLINE/PubMed、Cochrane Central Register of Controlled Trials (CENTRAL)、LILACS、PEDro、EMBASE、CINAHL、Web of Science、Scopus 数据库中进行检索,同时还检索了灰色文献,检索时间和语言不限。关键词为 "呼吸练习 "和 "分娩"。纳入的随机和准随机临床试验比较了在第一产程中使用呼吸练习的小组和接受常规护理的对照组。使用 Cochrane 工具(RoB 2.0)评估偏倚风险,并使用 GRADE 系统评估证据的确定性。结果共纳入了 13 项研究。根据极低的证据确定性,疼痛减少了-1.64(95 % CI:-2.81 至-0.46,8 项研究,I2 99 %;T2 2.82;p <;0.00001),第二产程持续时间减少了-7.23 分钟(95 % CI:-11.08 至-3.38,3 项研究,随机效应:结论有中等证据表明,在第一产程中使用呼吸练习可缩短用力阶段的持续时间并降低疼痛强度,但证据的确定性很低。但是,其他产妇和新生儿结局没有差异。
{"title":"Effectiveness of breathing exercises during first stage of labor: A systematic review and meta-analysis","authors":"Alexandre Delgado ,&nbsp;Geyson Marinho ,&nbsp;Renato S. Melo ,&nbsp;Filipe Pinheiro ,&nbsp;Andrea Lemos","doi":"10.1016/j.eujim.2024.102370","DOIUrl":"10.1016/j.eujim.2024.102370","url":null,"abstract":"<div><h3>Introduction</h3><p>Breathing appears to be an important outcome during labor. Therefore, this systematic review aims to evaluate, using the highest level of evidence, the benefits and potential risks of using breathing exercises during the first stage of labor on maternal and neonatal outcomes.</p></div><div><h3>Methods</h3><p>A search was conducted in the MEDLINE/PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), LILACS, PEDro, EMBASE, CINAHL, Web of Science, Scopus databases and gray literature was also searched, with no restrictions on period or language. The terms \"Breathing Exercises\" and \"Labor\" were used. Randomized and quasi-randomized clinical trials comparing a group using breathing exercises during the first stage of labor with a control group receiving usual care were included. The Cochrane tool (RoB 2.0) was used to assess the risk of bias, and the certainty of evidence was evaluated using the GRADE system. Quantitative analysis was performed through meta-analyses.</p></div><div><h3>Results</h3><p>Thirteen studies were included. There was a reduction in pain by -1.64 (95 % CI: -2.81 to -0.46, eight studies, I<sup>2</sup> 99 %; T2 2.82; <em>p</em> &lt; 0.00001), based on very low certainty of evidence, and a reduction in the duration of the second stage of labor by -7.23 min (95 % CI: -11.08 to -3.38, three studies, random-effects: I<sup>2</sup> 0 %; T2 0.00; <em>p</em> &lt; 0.0002), based on moderate certainty of evidence.</p></div><div><h3>Conclusion</h3><p>There is moderate evidence that the use of breathing exercises during the first stage of labor can reduce the duration of the pushing stage and decrease pain intensity, although with very low certainty of evidence. However, there was no difference in other maternal and neonatal outcomes.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"68 ","pages":"Article 102370"},"PeriodicalIF":2.5,"publicationDate":"2024-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141055668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Guidance on assessing efficacy and harms in traditional Chinese medicine dietotherapy: Introducing the Dietotherapy Intention, Evaluation, and Harm Tracking (DIET) pathway 中药食疗疗效和危害评估指南:引入食疗意向、评估和危害追踪(DIET)途径
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-05-07 DOI: 10.1016/j.eujim.2024.102367
Lixia Yuan , Jianrong Chen , XunXun Yuan , Jieyi Zhou , Sheng Xu , Weifeng Zhu , Xu Zhou

Introduction

Traditional Chinese medicine (TCM) dietotherapy, based on the principle of “medicine and food homology”, is widely used across diverse healthcare domains. However, the dual attributes of “medicine” and “food” possessed by medicinal and edible herbs make it challenging to assess the efficacy and harms of TCM dietotherapy using currently available methodological systems. This limits the advancement of health services and regulations in this field. This study introduces the Dietotherapy Intention, Evaluation, and Harm Tracking (DIET) pathway, a staged approach for assessing the efficacy and harms of TCM dietotherapy.

Results

The DIET pathway was developed through comprehensive analysis and two rounds of Delphi expert consensus. Based on the distinct characteristics and management requirements of TCM dietotherapy, the DIET pathway divides the assessment process into three stages: Stage 1 (Intention) aims to establish intended efficacy goals, Stage 2 (Evaluation) aims to validate efficacy and harms, and Stage 3 (Harm Tracking) aims to assess harms in special scenarios. Elaborate methodological guidelines are provided for each stage.

Conclusion

The DIET pathway has created a methodological environment that enables systematic and efficient assessment of the efficacy and harms of TCM dietotherapy regimens, which will facilitate the application and management of TCM dietotherapy.

导言基于 "药食同源 "原理的传统中医食疗被广泛应用于各个医疗保健领域。然而,由于药材和食用中草药具有 "药 "和 "食 "的双重属性,利用现有方法系统评估中医食疗的疗效和危害具有挑战性。这限制了该领域医疗服务和法规的发展。本研究介绍了饮食疗法意向、评估和危害追踪(DIET)路径,这是一种分阶段评估中医饮食疗法疗效和危害的方法。根据中医食疗的显著特点和管理要求,DIET路径将评估过程分为三个阶段:第一阶段(意向)旨在确立预期疗效目标,第二阶段(评估)旨在验证疗效和危害,第三阶段(危害追踪)旨在评估特殊情况下的危害。结论DIET路径创建了一个方法学环境,能够系统、高效地评估中医食疗方案的疗效和危害,这将促进中医食疗的应用和管理。
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引用次数: 0
Chemical characterization of Thymus zygis L. (thyme) and Elettaria cardamomum L. (cardamom) essential oils and investigation of their inhibitory potentials against cervicovaginal Escherichia coli isolates 百里香和小豆蔻精油的化学特性及其对宫颈阴道大肠埃希氏菌的抑制潜力研究
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-04-20 DOI: 10.1016/j.eujim.2024.102366
Gulcan Sahal , Hanife Guler Donmez , Mehmet Sinan Beksac

Introduction

The cervicovaginal microbiota plays a crucial role in women's well-being and reproductive health. This study initially focuses on identifying the chemical components of the essential oils (EOs) from Elettaria cardamomum L. (cardamom) (Ec) and Thymus zygis L. (thyme) (Tz). Subsequently, this study aims to determine the antimicrobial and biofilm inhibitory effects of these EOs against both cervicovaginal mixed cultures and the microbial strains isolated from them.

Methods

The compositions of EOs were determined by GC–MS analysis using an Agilent 7890B GC/5977A Series MSD System. Cervicovaginal samples were obtained from two women presenting complaints of a strong odor and vaginal discharge. Samples were collected from the cervix using a sterile cytobrush, ensuring no contact with the urethra, rectum, or external parts of the vagina. The cytological examination was conducted using Papanicolaou staining. Isolated microorganisms were identified through 16S Ribosomal RNA Gene Sequence Analysis and characterized using antibiogram tests. Antimicrobial tests of the EOs were performed by broth microdilution and disc diffusion methods. Biofilm formation was assessed using a crystal violet binding assay.

Results

The major components of Ec EO were α-terpinyl acetate (41.95 %) and eucalyptol (28.58 %), whereas Tz EO contained significant amounts of o-cymene (38.76 %), carvacrol (22.66 %), and thymol (20.69 %). Escherichia coli codes OR651248 and OR651249 were isolated from CV 6 and CV 7 mixed cultures, respectively. E. coli OR651248 demonstrated a higher antibiotic resistance level than E. coli OR651249. Biofilm formation by mixed cultures was significantly higher than that by E. coli isolates (P < 0.05). The Ec EO displayed minimal to no effect against both mixed cultures, showing zero inhibition zone, 500 μL/mL minimum inhibitory concentrations (MICs), and 500 μL/mL minimum microbicidal concentrations (MMCs). However, the Tz EO exhibited antimicrobial activity against both mixed cultures and the E. coli isolates, with inhibition zones > 15 mm and MICs/MMCs < 4 μL/mL (P < 0.05). In all microbial cultures, 0.5 MIC of both EOs inhibited biofilm formation by more than 80 %.

Conclusion

The Tz EO exhibits promising potential as an antimicrobial and biofilm inhibitory agent for managing cervicovaginal E. coli infections.

引言 宫颈阴道微生物群对妇女的福祉和生殖健康起着至关重要的作用。本研究首先侧重于确定白豆蔻(Ec)和百里香(Tz)精油(EOs)的化学成分。随后,本研究旨在确定这些 EO 对宫颈阴道混合培养物和从其中分离出的微生物菌株的抗菌和生物膜抑制作用。方法使用 Agilent 7890B GC/5977A 系列 MSD 系统通过气相色谱-质谱分析确定 EO 的成分。宫颈阴道样本取自两名主诉有强烈异味和阴道分泌物的妇女。使用无菌细胞刷从宫颈采集样本,确保样本不接触尿道、直肠或阴道外部。细胞学检查采用巴氏染色法。通过 16S 核糖体 RNA 基因序列分析对分离出的微生物进行鉴定,并使用抗菌素试验对其进行鉴定。采用肉汤微量稀释法和盘扩散法对环氧乙烷进行抗菌测试。结果Ec环氧乙烷的主要成分是α-松油醇乙酸酯(41.95%)和桉叶油醇(28.58%),而Tz环氧乙烷则含有大量的邻伞花烃(38.76%)、香芹酚(22.66%)和百里酚(20.69%)。大肠杆菌 OR651248 和 OR651249 分别从 CV 6 和 CV 7 混合培养物中分离出来。OR651248 大肠杆菌的抗生素耐药性高于 OR651249 大肠杆菌。混合培养物形成的生物膜明显高于大肠杆菌分离物(P < 0.05)。Ec 环氧乙烷对两种混合培养物的抑制作用极小甚至没有,抑制区为零、最低抑菌浓度(MIC)为 500 μL/mL,最低杀菌浓度(MMC)为 500 μL/mL。然而,Tz 环氧乙烷对混合培养物和大肠杆菌分离物都具有抗菌活性,抑菌区为 15 毫米,MICs/MMCs 为 4 微升/毫升(P 为 0.05)。在所有微生物培养物中,0.5 MIC 的两种环氧乙烷都能抑制 80% 以上的生物膜形成。
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引用次数: 0
Design of clinical trials in integrative medicine: The issue of personalization 综合医学临床试验的设计:个性化问题
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-04-20 DOI: 10.1016/j.eujim.2024.102365
Kam Wa Chan , Jian-ping Liu , Zhao-xiang Bian

Introduction

Classic randomized controlled trial design provides information about the effectiveness of a treatment at population level. In clinical practice based on precision medicine, we seek study designs that provide estimates accounting for individual patients’ demographics and context. Integrative medicine has a strong emphasis on personalization, and there is a pressing need for advancements in trial design to support clinical decisions.

Discussion

To enhance the generalizability and implementation of research evidence, study designs first need to mimic the real-world from both the clinicians’ and patients’ perspectives, which could be optimized based on stakeholder analysis. Previous stakeholder analyzes showed that the lack of personalization in clinical trial design is a key challenge for the adoption of evidence clinically. Variations of randomized controlled trial design including better-powered and better-designed subgroup analysis, pragmatic design, the N-of-1 cross-over design, and adaptive design have been introduced to personalize clinical trials. Each of these variations has unique advantages, assumptions and limitations. Stratified randomization can be used to divide a disease population into subgroups according to different schools of theory to match with the corresponding treatment, while preserving the generalizability to general readership. Patient-level meta-analysis can improve the power and precision of subgroup analysis. Enrichment design can increase the efficiency of a trial in detecting treatment effect(s) and in mimicking actual clinical use. Practical issues, including bias control and assessment in pragmatic trials, and N-of-1 trials are also discussed with recent trials as examples. We suggest strategies to maximize the validity and translation potential of clinical trials in integrative medicine with pragmatic or personalized design.

Conclusion

Variations of randomized controlled trial design improve the precision of estimates at patient level, which should be carefully considered in the trial design of integrative medicine according to the context of the future application of evidence.

导言:经典的随机对照试验设计可提供群体水平的治疗效果信息。在以精准医学为基础的临床实践中,我们寻求的研究设计应能根据个体患者的人口统计学特征和具体情况提供估计值。讨论为了提高研究证据的可推广性和可实施性,研究设计首先需要从临床医生和患者的角度模拟真实世界,并在利益相关者分析的基础上进行优化。以往的利益相关者分析表明,临床试验设计缺乏个性化是临床采用证据的主要挑战。为了实现临床试验的个性化,随机对照试验设计出现了多种变体,包括更强大和设计更好的亚组分析、实用主义设计、N-of-1交叉设计和适应性设计。每种变体都有其独特的优势、假设和局限性。分层随机化可用于根据不同学派的理论将疾病人群划分为亚组,以匹配相应的治疗方法,同时保留对普通读者的普适性。患者层面的荟萃分析可以提高亚组分析的功率和精确度。丰富设计可以提高试验在检测治疗效果和模拟实际临床应用方面的效率。我们还以最近的试验为例,讨论了实用性问题,包括实用性试验中的偏倚控制和评估,以及 N-of-1 试验。结论随机对照试验设计的变异提高了患者水平的估计精度,在综合医学试验设计中应根据未来证据应用的背景加以仔细考虑。
{"title":"Design of clinical trials in integrative medicine: The issue of personalization","authors":"Kam Wa Chan ,&nbsp;Jian-ping Liu ,&nbsp;Zhao-xiang Bian","doi":"10.1016/j.eujim.2024.102365","DOIUrl":"10.1016/j.eujim.2024.102365","url":null,"abstract":"<div><h3>Introduction</h3><p>Classic randomized controlled trial design provides information about the effectiveness of a treatment at population level. In clinical practice based on precision medicine, we seek study designs that provide estimates accounting for individual patients’ demographics and context. Integrative medicine has a strong emphasis on personalization, and there is a pressing need for advancements in trial design to support clinical decisions.</p></div><div><h3>Discussion</h3><p>To enhance the generalizability and implementation of research evidence, study designs first need to mimic the real-world from both the clinicians’ and patients’ perspectives, which could be optimized based on stakeholder analysis. Previous stakeholder analyzes showed that the lack of personalization in clinical trial design is a key challenge for the adoption of evidence clinically. Variations of randomized controlled trial design including better-powered and better-designed subgroup analysis, pragmatic design, the N-of-1 cross-over design, and adaptive design have been introduced to personalize clinical trials. Each of these variations has unique advantages, assumptions and limitations. Stratified randomization can be used to divide a disease population into subgroups according to different schools of theory to match with the corresponding treatment, while preserving the generalizability to general readership. Patient-level meta-analysis can improve the power and precision of subgroup analysis. Enrichment design can increase the efficiency of a trial in detecting treatment effect(s) and in mimicking actual clinical use. Practical issues, including bias control and assessment in pragmatic trials, and N-of-1 trials are also discussed with recent trials as examples. We suggest strategies to maximize the validity and translation potential of clinical trials in integrative medicine with pragmatic or personalized design.</p></div><div><h3>Conclusion</h3><p>Variations of randomized controlled trial design improve the precision of estimates at patient level, which should be carefully considered in the trial design of integrative medicine according to the context of the future application of evidence.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"68 ","pages":"Article 102365"},"PeriodicalIF":2.5,"publicationDate":"2024-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140755582","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The effect of guided imagery pre-cesarean section on the perceived preoperative anxiety, surgical fear, and physiological parameters of women: A randomized controlled trial 剖腹产前引导想象对妇女术前焦虑感、手术恐惧和生理参数的影响:随机对照试验
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-04-19 DOI: 10.1016/j.eujim.2024.102362
Menekşe Nazlı Aker, Hatice Öner Cengiz, Neslihan Yilmaz Sezer

Introduction

Guided imagery (GI) helps patients feel happy, relaxed, calm, and safe while ensuring positive thinking. This study was conducted to investigate the impact of GI applied before cesarean section (CS) on preoperative anxiety, surgical fear, and physiological parameters.

Methods

Participants were randomized into the GI (n = 29) or control (n = 28) groups in this randomized controlled trial. Participants in the GI group were given a 15-minute GI audio recording three days before their CS and were allowed to listen to it every night for 3 days until the CS. Finally, they listened on the day of the CS, immediately after preparing for the CS. Anxiety levels were evaluated using the State Anxiety Inventory-S (STAI-S) 3 days before the CS (STAI-S1) and 15 min after the preparations on the CS morning (STAI-S2); while surgical fear was evaluated using the Surgical Fear Questionnaire (SFQ) 3 days before the CS (SFQ1-Total) and 15 min after the preparations on the CS morning (SFQ2-Total). Blood pressure, temperature, heart rate, respiratory rate, and fetal heart rate were also evaluated.

Results

A significant difference in the mean STAI-S scores was observed 15 min after the preparations for the CS between the GI and control groups (mean difference (MD) -4.51, 95 % confidence intervals (CIs) [-7.71, -1.31]). However, no significant difference was found in the mean SFQ scores between the groups (MD -5.53, 95 %CIs [-16.69, 5.63]). In the within group comparison of GI and the control group, no statistically significant difference was observed in the score means of the GI group (STAI-S1 with STAI-S2 and SFQ1-Total with SFQ2-Total). However, the score means of the control groups STAI-S2 was higher than STAI-S1 (MD -5.82, 95 %CIs [-8.16, -3.48]), and SFQ2-Total was higher than SFQ1-Total (MD -6.71, 95 %CIs [-10.97, -2.46]). No significant difference was found in physiological parameters between the groups.

Conclusion

This study revealed the effectiveness of GI during the period before CS in reducing preoperative anxiety and keeping surgical fear under control. Nurses and other healthcare professionals involved in preoperative care can utilize GI to reduce preoperative anxiety and manage surgical fear before a CS.

Clinical trial registration

NCT05790954

导读:引导想象(GI)可帮助患者感到愉悦、放松、平静和安全,同时确保积极思维。本研究旨在探讨在剖腹产手术(CS)前应用 GI 对术前焦虑、手术恐惧和生理参数的影响。方法在这项随机对照试验中,参与者被随机分为 GI 组(29 人)和对照组(28 人)。GI 组的参与者在手术前三天获得 15 分钟的 GI 录音,并在手术前三天每晚聆听。最后,他们在准备 CS 的当天立即收听。焦虑水平的评估采用状态焦虑量表-S(STAI-S),分别在 CS 前 3 天(STAI-S1)和 CS 上午准备工作结束后 15 分钟(STAI-S2)进行;手术恐惧的评估采用手术恐惧问卷(SFQ),分别在 CS 前 3 天(SFQ1-Total)和 CS 上午准备工作结束后 15 分钟(SFQ2-Total)进行。结果 观察到 GI 组和对照组在 CS 准备 15 分钟后的平均 STAI-S 评分有显著差异(平均差异 (MD) -4.51,95 % 置信区间 (CIs) [-7.71, -1.31])。然而,两组之间的 SFQ 平均得分并无明显差异(MD -5.53,95 % 置信区间 [-16.69, 5.63])。在消化道疾病组与对照组的组内比较中,消化道疾病组的得分均值(STAI-S1 与 STAI-S2 和 SFQ1-Total 与 SFQ2-Total)在统计学上未发现显著差异。然而,对照组 STAI-S2 的得分均值高于 STAI-S1(MD -5.82,95 %CIs [-8.16,-3.48]),SFQ2-总分高于 SFQ1-总分(MD -6.71,95 %CIs [-10.97,-2.46])。结论本研究显示,在 CS 前的一段时间内,消化道感染能有效减轻术前焦虑并控制手术恐惧。护士和其他参与术前护理的医护人员可以利用 GI 减少术前焦虑并控制 CS 前的手术恐惧。
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引用次数: 0
Collaborative design of a Chinese herbal medicine case report guideline (CHM-CARE) 合作设计中草药病例报告指南(CHM-CARE)
IF 2.5 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-04-18 DOI: 10.1016/j.eujim.2024.102364
Brigitte Linder , Guo-Yan Yang , Kathleen Lumiere , Lisa Taylor-Swanson , Sandro Graca , Mike Armour

Introduction

Case reports have a long history in Chinese herbal medicine (CHM), and even into the modern day, case reports are still a preferred format for traditional East Asian medicine (TEAM) practitioners. However, the tradition of case reports in teaching and research is not nearly as common in the English-speaking world as in China, possibly due to the lack of a specific case report guideline. This study aimed to co-design a CHM guideline (CHM-CARE) to assist practitioners in compiling structured and comprehensive case reports.

Methods

A two-phased mixed approach was used to develop the case report guideline. In phase one, focus groups of TEAM practitioners were used to determine what components of existing guidelines (e.g., Case Report (CARE) and Case Report in Chinese Medicine (CARC)) were relevant to include, along with any additions or changes. Content analysis of phase 1 provided the checklist items for a two-round Delphi process (Phase 2). All checklist items from the first Delphi round with a median of three or higher were included in the second round, with consensus set at >70 % for inclusion in the final guideline.

Results

A total of 18 CHM practitioners from four countries joined five separate focus group discussions. Focus group discussions led to 98 checklist items being used in the first round of the Delphi process. Fifteen international experts on case reports participated in two rounds of Delphi. A total of 69 checklist items moved forward into the second round where 61 items (88 %) reached consensus and formed the final CHM-CARE guideline.

Conclusion

Key elements of a herbal medicine case report checklist were identified, and a 61-item case report guideline (CHM-CARE) was produced, providing clear guidelines for case reports to TEAM practitioners operating in private practice.

引言病例报告在中药学(CHM)中有着悠久的历史,即使到了现代,病例报告仍然是传统东亚医学(TEAM)从业者的首选形式。然而,可能由于缺乏专门的病例报告指南,病例报告在教学和研究中的传统在英语国家并不像在中国那样普遍。本研究旨在共同设计一份CHM指南(CHM-CARE),以帮助从业人员编写结构化和全面的病例报告。在第一阶段,通过对 TEAM 从业人员进行焦点小组讨论,确定现有指南(如病例报告 (CARE) 和中医病例报告 (CARC))中哪些内容需要纳入,以及是否需要增加或修改。第 1 阶段的内容分析为两轮德尔菲过程(第 2 阶段)提供了核对表项目。来自四个国家的 18 名中医师参加了五个不同的焦点小组讨论。通过焦点小组讨论,98 个核对表项目被用于第一轮德尔菲程序。15 位病例报告方面的国际专家参与了两轮德尔菲过程。共有 69 个核对表项目进入第二轮,其中 61 个项目(88%)达成了共识,并形成了最终的 CHM-CARE 指南。
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引用次数: 0
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European Journal of Integrative Medicine
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