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Protective effect of Korean red ginseng water extract on levothyroxine-induced hyperthyroidism and propylthiouracil-induced hypothyroidism in rats 高丽红参水提取物对左甲状腺素诱导的甲状腺功能亢进和丙基硫氧嘧啶诱导的甲状腺功能减退大鼠的保护作用
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-17 DOI: 10.1016/j.imr.2024.101071

Background

Korean red ginseng extract (KRGE) (Family: Araliaceae) is one of the most widely used traditional herbs in Asia. Multiple studies have shown that KRGE has anti-inflammation, anti-fatigue, anti-obesity, anti-oxidant, and anti-cancer effects.

Methods

Sprague-Dawley rats were divided into five groups for PTU-induced hypothyroidism and six groups for LT4-induced hyperthyroidism. At the experiment's conclusion, rats were sacrificed, and blood, thyroid gland, and liver samples were collected. Body weight was recorded weekly, and serum hormone levels were assessed using enzyme-linked immunoassay. Thyroid gland and liver tissues were stained with hematoxylin and eosin. KRGE was prepared in 0.5% CMC and stored at 4 °C before administration.

Results

In the LT4-induced hyperthyroidism model, KRGE prevented decreases in body weight, thyroid gland weight, liver weight, serum glucose, and thyroid hormone levels compared to the PTU group. It also reduced increases in T3, T4, and serum aspartate aminotransferase levels after LT4 treatment. Additionally, KRGE improved thyroid gland and liver histopathology, effects not observed in the PTU-induced hypothyroidism model.

Conclusion

All things considered, our research points to KRGE's potential protective role in rat hyperthyroidism caused by LT4 by lowering thyroid hormone production.

背景韩国红参提取物(KRGE)(五加科)是亚洲使用最广泛的传统草药之一。方法将Sprague-Dawley大鼠分为5组进行PTU诱导的甲状腺功能减退症实验,6组进行LT4诱导的甲状腺功能亢进症实验。实验结束后,处死大鼠并采集血液、甲状腺和肝脏样本。每周记录体重,并使用酶联免疫法评估血清激素水平。甲状腺和肝组织用苏木精和伊红染色。结果 在 LT4 诱导的甲亢模型中,与 PTU 组相比,KRGE 可防止体重、甲状腺重量、肝脏重量、血清葡萄糖和甲状腺激素水平的下降。它还能降低 LT4 治疗后 T3、T4 和血清天冬氨酸氨基转移酶水平的升高。此外,KRGE 还能改善甲状腺和肝脏组织病理学,这在 PTU 诱导的甲状腺功能减退症模型中没有观察到。
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引用次数: 0
An evidence map on traditional medicine across health outcomes 传统医学在健康成果方面的证据图谱
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-25 DOI: 10.1016/j.imr.2024.101070

Background

Traditional medicine (TM) plays a significant role in healthcare either as part of the primary healthcare system or as an adjunct to conventional medicine. This study aimed to map systematic reviews (SRs) of TM modalities across health conditions and identify gaps in the research literature to facilitate priority setting in future TM research.

Methods

We searched 17 databases from January 2018 to December 2022. Reviewers in pairs independently performed the database search, screened each record for inclusion, extracted data, and performed quality assessments using the AMSTAR 2 - A Measurement Tool to Assess systematic Reviews. To be included in this evidence map, the studies had to be SRs of clinical studies that evaluated the effectiveness of a TM modalities. The included SRs were analyzed according to TM modality, ICD-11 disease classification, and health outcomes, and visualized using graphical plots.

Results

We retrieved 241,509 records. After excluding duplicate records, 181,616 titles and abstracts were screened and 20,856 records were selected for full-text assessment, of which 18,137 records were further excluded. The final 2719 included SRs were primarily in adults (2591) with only 128 SRs in the pediatric population. The most commonly evaluated health conditions were diseases of the digestive system, circulatory system, and genitourinary system, with herbal medicine (n = 1867) and acupuncture (n = 471) being the most investigated TM modalities in treating these illnesses. Based on AMSTAR 2 criteria, the methodology quality of the included SRs is considerably low.

Conclusion

This evidence map provides a comprehensive overview of the extent and nature of the available research onTM modalities across health conditions. It provides an initial step towards characterizing the global evidence base and outlining gaps in the existing evidence. We regard this study as laying the basis for future research of TM modalities.

Registration

The protocol of this map is registered in PROSPERO (CRD42023416355).

背景传统医学(TM)作为初级医疗保健系统的一部分或传统医学的辅助手段,在医疗保健领域发挥着重要作用。本研究旨在绘制不同健康状况下传统医学模式的系统综述(SR)图,并找出研究文献中的空白点,以便于确定未来传统医学研究的优先次序。方法我们检索了2018年1月至2022年12月期间的17个数据库。审稿人两人一组独立进行数据库检索、筛选每条记录以纳入、提取数据,并使用 AMSTAR 2 - 系统性综述评估测量工具进行质量评估。纳入本证据图谱的研究必须是评估 TM 方式有效性的临床研究 SR。我们根据 TM 方式、ICD-11 疾病分类和健康结果对纳入的 SR 进行了分析,并使用图表对其进行可视化。在排除重复记录后,我们筛选了 181616 条标题和摘要,并选择了 20856 条记录进行全文评估,进一步排除了其中的 18137 条记录。最终收录的 2719 条 SR 主要针对成年人(2591 条),只有 128 条 SR 针对儿童群体。最常评估的健康状况是消化系统、循环系统和泌尿生殖系统疾病,其中草药(n = 1867)和针灸(n = 471)是治疗这些疾病的最常用的中医疗法。根据 AMSTAR 2 标准,纳入的 SR 的方法学质量相当低。它为确定全球证据基础的特征和概述现有证据的差距迈出了第一步。我们认为本研究为未来的 TM 模式研究奠定了基础。注册本地图的协议已在 PROSPERO 注册(CRD42023416355)。
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引用次数: 0
Effectiveness and safety of Liriope Tuber (Liriopis seu Ophiopogonis Tuber, Maidong) included traditional herbal medicine for patients with paroxysmal atrial fibrillation: A systematic review, meta-analysis, and network analysis 包括麦冬在内的传统草药对阵发性心房颤动患者的有效性和安全性:系统综述、荟萃分析和网络分析
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-23 DOI: 10.1016/j.imr.2024.101069

Background

Conventional medicine (CM) for paroxysmal atrial fibrillation (PAF) have limitations and side effects. Integrative approaches, including traditional herbal medicines like Liriope Tuber, are being explored for potential benefits, although evidence remains limited.

Methods

In April 2023, a literature search was conducted across nine databases, focusing on randomized controlled trials assessing the effects of Liriope Tuber in traditional herbal medicine (LTHM) on PAF. The risk of bias was evaluated using Version 2 of the Cochrane risk-of-bias tool for randomized trials. A random-effects model was employed for the meta-analysis.

Results

A total of 43 studies with 3,743 participants were included. The meta-analysis indicated that adding LTHM to CM reduced PAF frequency (SMD = -0.99, 95 % CI = -1.40 to -0.57, I² = 88 %, N = 16, n = 1266), left atrium diameter (LAD) (MD = -2.39 mm, 95 % CI = -3.09 to -1.68), P-wave dispersion (Pd) (MD = -6.41 ms, 95 % CI = -8.44 to -4.37), high sensitive C-Reactive Protein (hs-CRP) (MD = -1.10 mg/l, 95 % CI = -1.73 to -0.47), and improved left ventricular ejection fraction (LVEF) (MD = 4.71 %, 95 % CI = 3.17 to 6.25). Thirty-four studies raised concerns about bias, with eight showing high risk. Certainty of evidence was rated as "low" for PAF frequency, LAD, Pd, hs-CRP, and LVEF.

Conclusion

LTHM combined with CM may reduce PAF frequency. However, due to the complexity of interventions, with Liriope Tuber being only one component of the regimen, high risk of bias, substantial heterogeneity, and indirectness, interpretations should be cautious.

Study registration

PROSPERO (ID: CRD42023477926).

背景治疗阵发性心房颤动(PAF)的传统药物(CM)具有局限性和副作用。2023 年 4 月,研究人员在 9 个数据库中进行了文献检索,重点是评估传统草药(LTHM)中 Liriope Tuber 对 PAF 影响的随机对照试验。采用科克伦随机试验偏倚风险工具第 2 版对偏倚风险进行了评估。结果 共纳入 43 项研究,3743 人参与。荟萃分析表明,在 CM 中加入 LTHM 可降低 PAF 频率(SMD = -0.99,95 % CI = -1.40 至 -0.57,I² = 88 %,N = 16,n = 1266)、左心房直径(LAD)(MD = -2.39 mm,95 % CI = -3.09 至 -1.68)、P 波频散(Pd)(MD = -6.41 ms,95 % CI = -8.44 to -4.37)、高敏感 C 反应蛋白(hs-CRP)(MD = -1.10 mg/l,95 % CI = -1.73 to -0.47)和左室射血分数(LVEF)改善(MD = 4.71 %,95 % CI = 3.17 to 6.25)。34项研究提出了偏倚问题,其中8项研究显示存在高风险。PAF频率、LAD、Pd、hs-CRP和LVEF的证据确定性被评为 "低"。然而,由于干预措施的复杂性(Liriope Tuber 只是治疗方案中的一个组成部分)、高偏倚风险、大量异质性和间接性,解释时应谨慎。
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引用次数: 0
How can meta-research be used to evaluate and improve the quality of research in the field of traditional, complementary, and integrative medicine? 如何利用元研究来评估和提高传统医学、补充医学和中西医结合医学领域的研究质量?
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-08 DOI: 10.1016/j.imr.2024.101068

The field of traditional, complementary, and integrative medicine (TCIM) has garnered increasing attention due to its holistic approach to health and well-being. While the quantity of published research about TCIM has increased exponentially, critics have argued that the field faces challenges related to methodological rigour, reproducibility, and overall quality. This article proposes meta-research as one approach to evaluating and improving the quality of TCIM research. Meta-research, also known as research about research, can be defined as “the study of research itself: its methods, reporting, reproducibility, evaluation, and incentives”. By systematically evaluating methodological rigour, identifying biases, and promoting transparency, meta-research can enhance the reliability and credibility of TCIM research. Specific topics of interest that are discussed in this article include the following: 1) study design and research methodology, 2) reporting of research, 3) research ethics, integrity, and misconduct, 4) replicability and reproducibility, 5) peer review and journal editorial practices, 6) research funding: grants and awards, and 7) hiring, promotion, and tenure. For each topic, we provide case examples to illustrate meta-research applications in TCIM. We argue that meta-research initiatives can contribute to maintaining public trust, safeguarding research integrity, and advancing evidence based TCIM practice, while challenges include navigating methodological complexities, biases, and disparities in funding and academic recognition. Future directions involve tailored research methodologies, interdisciplinary collaboration, policy implications, and capacity building in meta-research.

传统医学、补充医学和综合医学(TCIM)因其对健康和福祉的整体性研究方法而受到越来越多的关注。虽然发表的有关传统、补充和整合医学的研究数量呈指数增长,但批评者认为该领域在方法的严谨性、可重复性和整体质量方面面临挑战。本文提出元研究作为评估和提高 TCIM 研究质量的一种方法。元研究,也被称为关于研究的研究,可以定义为 "对研究本身的研究:研究方法、报告、再现性、评估和激励机制"。通过系统地评估研究方法的严谨性、识别偏差和提高透明度,元研究可以提高 TCIM 研究的可靠性和可信度。本文讨论的具体主题包括以下几个方面:1) 研究设计和研究方法;2) 研究报告;3) 研究道德、诚信和不当行为;4) 可复制性和可再现性;5) 同行评审和期刊编辑实践;6) 研究经费:拨款和奖励;7) 聘用、晋升和终身职位。对于每个主题,我们都提供了案例来说明元研究在 TCIM 中的应用。我们认为,元研究计划有助于维护公众信任、保障研究诚信和推进循证 TCIM 实践,而面临的挑战包括如何应对方法论的复杂性、偏见以及资金和学术认可方面的差异。未来的方向涉及量身定制的研究方法、跨学科合作、政策影响以及元研究的能力建设。
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引用次数: 0
A practical guide to implementing artificial intelligence in traditional East Asian medicine research 在传统东亚医学研究中应用人工智能的实用指南
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-07 DOI: 10.1016/j.imr.2024.101067

In this paper, we present a comprehensive guide for implementing artificial intelligence (AI) techniques in traditional East Asian medicine (TEAM) research. We cover essential aspects of the AI model development pipeline, including research objective establishment, data collection and preprocessing, model selection, evaluation, and interpretation. The unique considerations in applying AI to TEAM datasets, such as data scarcity, imbalance, and model interpretability, are discussed. We provide practical tips and recommendations based on best practices and our own experience. The potential of large language models in TEAM research is also highlighted. Finally, we discuss the challenges and future directions of AI application in TEAM, emphasizing the need for standardized data collection and sharing platforms.

本文介绍了在传统东亚医学(TEAM)研究中实施人工智能(AI)技术的综合指南。我们介绍了人工智能模型开发流程的基本方面,包括研究目标的确立、数据收集和预处理、模型选择、评估和解释。讨论了将人工智能应用于 TEAM 数据集的独特考虑因素,如数据稀缺性、不平衡性和模型可解释性。我们将根据最佳实践和自身经验提供实用的提示和建议。我们还强调了大型语言模型在 TEAM 研究中的潜力。最后,我们讨论了在 TEAM 中应用人工智能的挑战和未来方向,强调了标准化数据收集和共享平台的必要性。
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引用次数: 0
Herbal medicine Oryeongsan (Wulingsan): Cardio-renal effects via modulation of renin-angiotensin system and atrial natriuretic peptide system 草药 Oryeongsan(五灵山):通过调节肾素-血管紧张素系统和心房利钠肽系统实现心肾功效
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-06-22 DOI: 10.1016/j.imr.2024.101066

Background

Oryeongsan (Wulingsan, Goreisan) has long been used for the treatment of impaired body fluid metabolism. However, the action mechanisms have not been clearly defined. Recently, effects of Oryeongsan on the body fluid and Na+ metabolism and the action mechanisms have been shown more clearly. The present review focuses on the recent findings on the effects of Oryeongsan in the cardio-renal system in relation with body fluid metabolism and action mechanisms leading to a decrease in blood pressure in animal models of hypertension.

Methods

The new and recent findings were searched by using searching systems including PubMed-NCBI and Google-Scholar.

Results

Oryeongsan induced an increase in glomerular filtration rate, and natriuresis and diuresis with a decreased osmolality and resulted in a contraction of the body fluid and Na+ balance. These findings were associated with a suppression of abundance of Na+-H+-exchanger isoform 3 expression and V2 receptor/aquaporin2 water channel signaling pathway in the kidney. Further, treatment with Oryeongsan accentuated atrial natriuretic peptide secretion in the atria from spontaneously hypertensive rats in which the secretion was suppressed. In addition, Oryeongsan ameliorated impaired vasodilation in spontaneously hypertensive rats.

Conclusion

The effects of Oryeongsan in the kidney, atria, and vessel were accompanied by a suppression of AT1 receptor and concurrent accentuation of abundance of AT2/Mas receptors expression and modulation of the natriuretic peptide system in these organs from hypertensive rats. The review shows multiple sites of action of Oryeongsan and mechanisms involved in the regulation of volume and pressure homeostasis in the body.

背景御灵丹(五灵丹,Goreisan)长期以来一直被用于治疗体液代谢障碍。然而,其作用机制尚未明确。最近,奥利昂散对体液和 Na+ 代谢的影响及其作用机制得到了更明确的显示。本综述重点介绍了最近关于欧龙山对心肾系统的影响与体液代谢的关系以及导致高血压动物模型血压下降的作用机制的研究结果。方法使用 PubMed-NCBI 和 Google-Scholar 等搜索系统搜索最新研究结果。这些发现与抑制肾脏中 Na+-H+- exchanger isoform 3 的大量表达和 V2 受体/quaporin2 水通道信号通路有关。此外,用 Oryeongsan 治疗自发性高血压大鼠心房时,其心房钠尿肽的分泌受到抑制,而用 Oryeongsan 治疗自发性高血压大鼠心房时,其心房钠尿肽的分泌则会增加。结论欧龙山对高血压大鼠肾脏、心房和血管的作用是抑制 AT1 受体,同时提高 AT2/Mas 受体的表达量,并调节这些器官的利钠肽系统。综述显示了御灵散的多个作用位点以及参与调节体内容量和压力平衡的机制。
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引用次数: 0
Pharmacopuncture therapy for adhesive capsulitis: A pragmatic randomized controlled pilot study 粘连性囊炎的药物针刺疗法:实用随机对照试验研究
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-06-21 DOI: 10.1016/j.imr.2024.101065

Background

Although several studies have reported the effectiveness of acupuncture treatment for adhesive capsulitis (AC), research on pharmacopuncture therapy for AC remains limited. We compared the effectiveness and safety of pharmacopuncture and physiotherapy for AC.

Methods

This pragmatic, randomized, controlled, parallel-group pilot study enrolled patients with limitations of shoulder movement and a numeric rating scale (NRS) score for shoulder pain ≥5 randomized (1:1) to the pharmacopuncture therapy (PPT) and physiotherapy (PT) groups. Treatment sessions were administered twice weekly for 6 weeks, and the participants were followed up for 13 weeks after randomization. The primary outcome was the NRS score for shoulder pain, and the secondary outcomes were the visual analog scale (VAS), Shoulder Pain and Disability Index (SPADI), range of motion (ROM), patient global impression of change (PGIC), EuroQol 5-Dimension 5-Level (EQ-5D-5L), and Short Form 12 Health Survey (SF-12) scores. The intention-to-treat (ITT) analysis was set as the primary analysis.

Results

Among 50 participants, for the primary endpoint (week 7) the PPT group showed a significantly superior improvement in NRS, VAS, SPADI, ROM for flexion, ROM for abduction, and EQ-5D-5L scores. The ROM for extension, ROM for adduction, physical component summary, and patient global impression of change were significantly better in the PPT than in the PT group, and these effects were sustained until week 13.

Conclusion

In this pilot study, PPT showed better effects than PT, confirming the feasibility of a follow-up main study.

Trial registration

Clinicaltrials.gov (NCT05292482) and cris.nih.go.kr (KCT0007198).

尽管已有多项研究报道了针灸治疗粘连性关节囊炎(AC)的有效性,但有关针刺药物治疗 AC 的研究仍然有限。我们比较了药物针刺和物理疗法治疗粘连性囊炎的有效性和安全性。这项务实、随机、对照、平行组试验研究招募了肩部活动受限且肩部疼痛数字评分量表(NRS)评分≥5分的患者,随机(1:1)分为药针疗法组(PPT)和物理疗法组(PT)。治疗过程每周两次,持续 6 周,随机分组后对参与者进行 13 周的随访。主要研究结果为肩痛的 NRS 评分,次要研究结果为视觉模拟量表 (VAS)、肩痛与残疾指数 (SPADI)、活动范围 (ROM)、患者总体变化印象 (PGIC)、EQ-5D-5L (EuroQol 5-Dimension 5-Level) 和简表 12 健康调查 (SF-12) 评分。意向治疗(ITT)分析被定为主要分析。在50名参与者中,在主要终点(第7周),PPT组在NRS、VAS、SPADI、屈曲ROM、外展ROM和EQ-5D-5L评分方面的改善明显优于PPT组。PPT 组的伸展 ROM、外展 ROM、体能部分总结和患者总体变化印象明显优于 PT 组,而且这些效果一直持续到第 13 周。在这项试点研究中,PPT 比 PT 显示出更好的效果,证实了后续主要研究的可行性。请参阅 Clinicaltrials.gov (NCT05292482) 和 cris.nih.go.kr (KCT0007198)。
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引用次数: 0
Exploring the potential effect of electroacupuncture on cardiovascular function and lipid profiles in spontaneously hypertensive rats 探索电针对自发性高血压大鼠心血管功能和血脂谱的潜在影响
IF 3.4 4区 医学 Q1 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.imr.2024.101041
Hye-Yoom Kim , Sarah Shin , Jung-Joo Yoon , You-Mee Ahn , Ji-Hye Song , Da-Som Lee , Ji-Yeun Park , Ho-Sub Lee , Jeeyoun Jung

Background

Investigating the effects of electroacupuncture (EA) treatment on cardiovascular function and aortic lipid profiles in spontaneously hypertensive rats (SHR) constitutes the foundational focus of this study. The overarching goal is to comprehensively elucidate the alterations brought about by EA treatment and to assess its potential as an alternative therapy for hypertension.

Methods

Consecutive EA treatments were administered to SHR, and the effects on systolic blood pressure, cardiac function, and hypertension-related neuronal signals were assessed. Aortic lipid profiles in vehicle-treated SHR and EA-treated SHR groups were analyzed using mass spectrometry-based lipid profiling. Additionally, the expression of Cers2 and GNPAT, enzymes involved in the synthesis of specific aortic lipids, was examined.

Results

The study demonstrated that consecutive EA treatments restored systolic blood pressure, improved cardiovascular function, and normalized hypertension-related neuronal signals in SHR. Analysis of the aortic lipid profiles revealed distinct differences between the vehicle-treated SHR group and the EA-treated SHR group. Specifically, EA treatment significantly altered the levels of aortic sphingomyelin and phospholipids, including very long-chain fatty acyl-ceramides and ether phosphatidylcholines. These changes in aortic lipid profiles correlated significantly with systolic blood pressure and cardiac function indicators. Furthermore, EA treatment significantly altered the expression of Cers2 and GNPAT.

Conclusions

The findings suggest that EA may influence cardiovascular functions and aortic lipid profiles in SHR.

背景研究电针(EA)治疗对自发性高血压大鼠(SHR)心血管功能和主动脉脂质谱的影响是本研究的基础重点。本研究的首要目标是全面阐明 EA 治疗带来的改变,并评估其作为高血压替代疗法的潜力。方法对 SHR 连续进行 EA 治疗,并评估其对收缩压、心脏功能和高血压相关神经元信号的影响。使用基于质谱的脂质分析方法分析了车辆处理的 SHR 组和 EA 处理的 SHR 组的主动脉脂质概况。结果研究表明,连续 EA 治疗可恢复 SHR 收缩压、改善心血管功能并使高血压相关神经元信号正常化。对主动脉脂质谱的分析表明,车辆治疗的 SHR 组与 EA 治疗的 SHR 组之间存在明显差异。具体来说,EA 治疗明显改变了主动脉鞘磷脂和磷脂的水平,包括超长链脂肪酰基神经酰胺和醚磷脂酰胆碱。主动脉脂质谱的这些变化与收缩压和心脏功能指标密切相关。结论 研究结果表明,EA 可能会影响 SHR 的心血管功能和主动脉脂质状况。
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引用次数: 0
Adding thread-embedding acupuncture to auricular acupuncture enhances short-term weight reduction in overweight and obesity: A double-blinded, randomized, sham-controlled trial 在耳针的基础上加入绣线针灸可增强超重和肥胖症患者的短期减重效果:双盲随机临床试验与假对照试验
IF 3.4 4区 医学 Q1 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.imr.2024.101050
Dieu-Thuong Thi Trinh , Quoc-Viet Kieu , An Hoa Tran , Minh-Man Pham Bui , Nguyen Lam Vuong

Background

Auricular acupuncture (AA) has been widely used in overweight and obesity management due to its safety and effectiveness. The combination of other acupuncture therapies with thread-embedding acupuncture (TEA) has shown enhanced effects. However, there is a lack of evidence regarding AA plus TEA for overweight and obesity. This study was conducted to address this question.

Methods

A randomized placebo-controlled trial was conducted involving 66 overweight or obese participants, divided into two groups: 33 received AA plus TEA, and 33 received AA plus sham TEA over eight weeks. The primary outcome was body weight (BW) reduction. Secondary outcomes included changes in body mass index (BMI) and waist circumference (WC), hip circumference (HC), waist-hip ratio (WHR), food cravings questionnaire-trait-reduced (FCQ-Tr) and food craving visual analog scale (VAS) scores. Safety outcomes were adverse events (AEs).

Results

After eight weeks, BW decreased by a mean (SD) of -4.45 (1.29) kg and -2.05 (1.33) kg in the AA plus TEA and AA plus sham TEA groups, respectively (MD [95 % CI]: 2.40 [1.75; 3.05]). BMI, WC, WHR, and food craving VAS score decreased significantly more in the AA plus TEA group than in the AA plus sham TEA group. No significant differences were found in FCQ-Tr and HC between groups. Seven AEs were recorded that were mild and resolved without treatment.

Conclusion

The addition of TEA to AA is a safe and effective management of overweight and obesity. Further studies should incorporate dietary and lifestyle modifications and follow-up after the intervention to assess long-term effectiveness.

Trial registration

The study protocol had been registered on ClinicalTrials.gov (NCT06091761).

背景耳针(AA)因其安全性和有效性已被广泛用于超重和肥胖症的治疗。其他针灸疗法与埋线针灸(TEA)的结合显示出了更好的效果。然而,目前还缺乏 AA 加 TEA 治疗超重和肥胖症的证据。这项研究就是为了解决这个问题而进行的。方法进行了一项随机安慰剂对照试验,将 66 名超重或肥胖参与者分为两组:33 人接受 AA 加 TEA 治疗,33 人接受 AA 加假 TEA 治疗,为期八周。主要结果是体重(BW)下降。次要结果包括体重指数 (BMI) 和腰围 (WC)、臀围 (HC)、腰臀比 (WHR)、食物渴望问卷-特质降低 (FCQ-Tr) 和食物渴望视觉模拟量表 (VAS) 评分的变化。结果8周后,AA加TEA组和AA加假TEA组的体重分别平均(标清)减少了-4.45 (1.29) kg和-2.05 (1.33) kg(MD [95 % CI]: 2.40 [1.75; 3.05])。AA加TEA组的BMI、WC、WHR和食物渴望VAS评分的下降幅度明显高于AA加假TEA组。各组间的 FCQ-Tr 和 HC 无明显差异。结论:在 AA 中添加 TEA 是一种安全有效的治疗超重和肥胖的方法。进一步的研究应纳入饮食和生活方式的调整,并在干预后进行随访,以评估长期疗效。试验注册该研究方案已在ClinicalTrials.gov(NCT06091761)上注册。
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引用次数: 0
Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines ACUpuncture In The EmergencY Department for Pain Management (ACUITY) 试验中针灸干预方案的忠实性:扩展 STRICTA 和 CONSORT 指南的黄金标准。
IF 3.4 4区 医学 Q1 Medicine Pub Date : 2024-06-01 DOI: 10.1016/j.imr.2024.101048
Arya Nielsen , Natalie L. Dyer , Claudia Lechuga , M. Diane McKee , Jeffery A. Dusek

Background

Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported.

Methods

ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity.

Results

Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points (M = 13.2, range 2–22), needle retention time (M = 23.5 min, range 4–52), session length (M = 40.3 min, range 20–66), whether general recommendations were provided and completion of the session form.

Conclusion

To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs.

Protocol registration

The protocol of this study is registered at clinicaltrials.gov: NCT04880733.

背景针灸作为一种有效的非药物疗法,有望减轻急诊科(ED)的急性疼痛。根据 CONSORT 和 STRICTA 指南,随机对照试验(RCT)通常会报告干预细节和穴位选择,但对于干预研究可靠性至关重要的针灸干预的忠实性却很少报告。方法 ACUITY 是一项由 NCCIH 资助的多地点可行性 RCT,在 3 个急诊科(克利夫兰、纳什维尔和圣地亚哥)进行针灸治疗。ACUITY 针灸师在研究设计、响应性针灸手册协议、后勤以及通过 REDCap 表单实时记录疗程细节等方面接受了培训,以跟踪针灸的忠实性:女性占 51%,黑人/非裔美国人占 43%,基线急性疼痛部位各不相同:腰部 32%,四肢 22%,腹部 20%,头部 10%。根据实际情况,参与者在急诊室公共区域(52%)、私人病房(39%)和半私人病房(9%)接受治疗。客观追踪发现,98%的参与者遵守了针灸手册化方案的六项内容:分期、针刺点数量(M = 13.2,范围 2-22)、留针时间(M = 23.5 分钟,范围 4-52)、疗程长度(M = 40.3 分钟,范围 20-66)、是否提供一般性建议以及疗程表格的填写。忠实性监测对于 ACUITY2 将是至关重要的,ACUITY2 将是未来一项明确的多地点 RCT。此外,我们建议在未来的 RCT 中将针灸干预的忠实性加入 CONSORT 和 STRICTA 报告指南中:NCT04880733。
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引用次数: 0
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Integrative Medicine Research
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