Integrative Medicine Research最新文献_第3页

Prospective registration of guidelines and consensus statements of traditional and integrative medicine: Current status and experience from the PREPARE platform 传统和中西医结合指南和共识声明的前瞻性注册：PREPARE平台的现状和经验

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-10-03 DOI: 10.1016/j.imr.2025.101260

Xuan Yu , Jie Zhang , Janne Estill , Zhaoxiang Bian , Yaolong Chen

Background

Prospective registration of guidelines enhances transparency and reduces research waste. With the growing number of Traditional and Integrative Medicine (TIM) guidelines, the purpose of this study was to analyze the registrations of TIM guidelines and consensus statements on the Practice guideline REgistration for transPAREncy (PREPARE) platform.

Methods

All TIM guidelines and consensus statements registered on PREPARE by December 31, 2024, were included. Data on registration year, type, category, country, evidence grading, funding, use of systematic reviews, and protocols were extracted and summarized as frequencies and percentages.

Results

As of December 31, 2024, a total of 3434 projects had been registered on PREPARE, of which 587 (17.1%) pertained to traditional and integrative medicine. Among these, 380 (64.7%) were traditional medicine guidelines and consensus statements, and 207 (35.3%) involved integrative medicine. Of the TIM-related guidelines and consensus statements, 401 were standard guidelines and 150 were consensus statements; most (551/587, 93.9%) were registrations for original versions. Nearly half (268/587, 45.7%) addressed both diagnostic and treatment procedures. The majority of registrations (511/587, 87.1%) reported that systematic reviews would inform guidelines and consensus statements. Furthermore, 501 (85.3%) guidelines and consensus statements stated they would grade the strength of evidence and recommendations, with the grading methods specified. Approximately 80% (466/587) explicitly reported their sources of funding, amounting to 632 individual funding sources.

Conclusion

Despite increased use of public platforms for registration, further efforts are needed to improve awareness and practice. The PREPARE working group will collaborate with TIM guideline developers to implement initiatives that advance the rigor, transparency, and usability of TIM guidelines and consensus statements.

指南的前瞻性注册提高了透明度，减少了研究浪费。随着传统与中西医结合（TIM）指南的数量不断增加，本研究的目的是分析TIM指南的注册情况以及实践指南透明度注册（PREPARE）平台上的共识声明。方法纳入截至2024年12月31日在prep上注册的所有TIM指南和共识声明。提取有关注册年份、类型、类别、国家、证据分级、资金、系统评价的使用和方案的数据，并将其总结为频率和百分比。结果截至2024年12月31日，共登记项目3434个，其中中西医结合项目587个，占17.1%。其中，380份（64.7%）为传统医学指南和共识声明，207份（35.3%）涉及中西医结合。在与tim相关的指南和共识声明中，401份是标准指南，150份是共识声明；绝大多数（551/587,93.9%）为原版本注册。近一半（268/587,45.7%）涉及诊断和治疗程序。大多数注册者（511/587,87.1%）报告系统评价将为指南和共识声明提供信息。此外，501条（85.3%）指南和共识声明表示，他们将根据指定的分级方法对证据和建议的强度进行分级。大约80%（466/587）明确报告了其资金来源，共计632个个人资金来源。结论尽管公共注册平台的使用有所增加，但仍需进一步努力提高认识和实践。PREPARE工作组将与TIM指南开发人员合作，实施提高TIM指南和共识声明的严谨性、透明度和可用性的计划。

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引用次数: 0

A comprehensive value evaluation index system for provincial medical insurance access to traditional Chinese medicine preparations in medical institutions 省级医保医疗机构中药制剂可及性综合价值评价指标体系

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-28 DOI: 10.1016/j.imr.2025.101258

Xinyan Jin , Changgeng Su , Jiale Zhang , Yujuan Liu , Xiaoying Chen , Rui Zhao

Background

This study established a comprehensive value evaluation index system for provincial medical insurance access to traditional Chinese medicine (TCM) preparations in medical institutions from the insurance viewpoint. The system aims to provide a reference for insurance access applications and decision-making.

Methods

The index system was first established through systematic evaluation and expert consultation. The Delphi method and analytic hierarchy process were employed to reveal the index system and calculate each indicator’s weight. The indicator selection thresholds were based on the importance score thresholds and the coefficient of variation thresholds. Indicators with importance scores higher than the threshold and coefficient of variation less than the threshold were included in the index system.

Results

The researchers retrieved 6201 articles in total, 68 of which were retained following a review of the titles and full text. The initially established index system had six dimensions (i.e., basic information and TCM theory of the preparation, safety, effectiveness, economy, innovation, and fairness), 25 primary indicators, and 55 secondary indicators. Two expert consultation rounds were employed to collect the opinions of 13 and 11 experts. The final index system considered the index system’s aforementioned six dimensions, including safety (30.44 %), effectiveness (43.18 %), economy (14.72 %), innovation (6.48 %), and fairness (5.17 %), along with 22 primary indicators, and 26 secondary indicators. Moreover, the top three weight indicators were the prescription source (secondary indicator), effectiveness evaluation based on real-world evidence (primary indicator), and direct costs (secondary indicator).

Conclusion

The proposed index system elucidates the scope of evidence and basic research design for TCM preparations from the insurance viewpoint. It also integrates cost evaluation and value evaluation indicators and improves the definition of reference drugs, thus providing a reference for achieving rational clinical drug usage and a pricing policy for TCM preparations.

本研究从保险视角构建省级医保医疗机构中药制剂可及性的综合价值评价指标体系。该系统旨在为保险接入申请和决策提供参考。方法通过系统评价和专家咨询，初步建立指标体系。采用德尔菲法和层次分析法揭示指标体系，计算各指标的权重。指标选择阈值基于重要性评分阈值和变异系数阈值。将重要性得分高于阈值且变异系数小于阈值的指标纳入指标体系。结果研究人员共检索到6201篇文章，其中68篇在检索标题和全文后被保留。初步建立的指标体系包括制剂基础信息与中医理论、安全性、有效性、经济性、创新性、公平性6个维度，25个一级指标，55个二级指标。采用两轮专家咨询，分别收集了13位和11位专家的意见。最终的指标体系考虑了上述指标体系的6个维度，即安全性（30.44%）、有效性（43.18%）、经济性（14.72%）、创新性（6.48%）、公平性（5.17%）等22个一级指标和26个二级指标。权重前3位的指标分别是处方来源（次要指标）、基于真实证据的有效性评价（首要指标）和直接成本（次要指标）。结论提出的指标体系从保险角度阐明了中药制剂的证据范围和基础研究设计。整合成本评价和价值评价指标，完善参比药定义，为实现临床合理用药和中药制剂定价政策提供参考。

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引用次数: 0

Integrating artificial intelligence into Korean medicine: Insights from neural and pulse signal analysis 将人工智能融入韩国医学：来自神经和脉搏信号分析的见解

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-24 DOI: 10.1016/j.imr.2025.101257

In-Seon Lee

引用次数: 0

The impact of shared decision-making on patient-reported outcomes in Traditional Chinese Medicine in Shanghai, China: a cross-sectional study using structural equation modeling 共享决策对中国上海中医患者报告结果的影响：一项使用结构方程模型的横断面研究

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-23 DOI: 10.1016/j.imr.2025.101255

Fuming Li , Shimeng Liu , Yue Teng , Liu Liu , Juntao Yan , Yingyao Chen , Yan Wei

Background

Shared decision-making (SDM) is increasingly recognized as a preferred model for cancer care, yet its relationship with patient-reported outcomes remains unclear in the context of Traditional Chinese Medicine (TCM). This study examined the associations of SDM with decision-making satisfaction, treatment decision usefulness, and health-related quality of life (HRQoL) in TCM.

Methods

This multicenter cross-sectional study was conducted among lung cancer patients treated with TCM anti-cancer injections in Shanghai, China. Participants completed questionnaires assessing SDM, decision-making satisfaction, treatment decision usefulness, and HRQoL. Structural equation modeling was conducted to examine the hypothetical model.

Results

A total of 347 participants (46.1% female, 64.8 ± 8.7 years) were included. Using the EQ-5D-5 L index value to represent HRQoL, SDM not only directly positively affected both decision-making satisfaction (β = 0.438, 95%CI: 0.206 – 0.639) and treatment decision usefulness (β = 0.380, 95%CI: 0.172 – 0.577), but indirectly positively affected HRQoL through treatment decision usefulness (β = 0.117, 95%CI: 0.028 – 0.290). A similar pattern was identified using the EQ-VAS score, with significant direct effects on decision-making satisfaction (β = 0.438, 95%CI: 0.206 – 0.639) and treatment decision usefulness (β = 0.380, 95%CI: 0.172 – 0.577), as well as an indirect effect on HRQoL through treatment decision usefulness (β = 0.083, 95%CI: 0.009 – 0.224).

Conclusions

SDM plays a positive role in improving decision-making satisfaction, treatment decision usefulness, and HRQoL among patients receiving TCM. These findings indicate its intrinsic value in patient–provider interactions and its associated benefits, potentially fostering the practice of SDM in TCM.

共同决策（SDM）越来越被认为是癌症治疗的首选模式，但在中医（TCM）的背景下，其与患者报告的结果的关系尚不清楚。本研究考察了SDM与中医决策满意度、治疗决策有用性和健康相关生活质量（HRQoL）的关系。方法采用多中心横断面研究方法，对上海地区接受中药抗癌注射剂治疗的肺癌患者进行研究。参与者完成问卷评估SDM、决策满意度、治疗决策有用性和HRQoL。采用结构方程建模对假设模型进行检验。结果共纳入347例患者，其中女性46.1%，年龄64.8±8.7岁。以eq - 5d - 5l指数值代表HRQoL， SDM不仅直接正向影响决策满意度（β = 0.438, 95%CI: 0.206 ~ 0.639）和治疗决策有用性（β = 0.380, 95%CI: 0.172 ~ 0.577），而且通过治疗决策有用性间接正向影响HRQoL （β = 0.117, 95%CI: 0.028 ~ 0.290）。EQ-VAS评分也发现了类似的模式，对决策满意度（β = 0.438, 95%CI: 0.206 - 0.639）和治疗决策有用性（β = 0.380, 95%CI: 0.172 - 0.577）有显著的直接影响，通过治疗决策有用性对HRQoL有间接影响（β = 0.083, 95%CI: 0.009 - 0.224）。结论ssdm对提高中医患者决策满意度、治疗决策有用性和HRQoL具有积极作用。这些发现表明，它在医患互动中的内在价值及其相关益处，可能促进中医中SDM的实践。

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引用次数: 0

Efficacy of herbal medicine Xiao-Feng-San combined with auricular acupuncture for atopic dermatitis: A randomized controlled trial 中药消风散联合耳针治疗特应性皮炎的疗效：随机对照试验

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-23 DOI: 10.1016/j.imr.2025.101256

Nga Thu Tran , An Hoa Tran , Dieu-Thuong Thi Trinh

Background

Atopic dermatitis (AD) is a common chronic inflammatory skin disease with a considerable burden. Xiao-Feng-San (XFS) has been widely used in traditional medicine for the wind-dampness-heat pattern. Auricular acupuncture (AA) may relieve AD symptoms, but its added benefit with XFS is unclear.

Methods

In this randomized, sham-controlled clinical trial, 156 adults with non-severe AD and wind-dampness-heat pattern, all of whom were prescribed XFS decoction, were additionally assigned to receive either AA (XFS plus AA group, n=78) or sham AA (XFS plus Sham AA group, n=78) for four weeks. The primary outcome was the change in the SCORAD index from baseline to week 4. Secondary outcomes included fexofenadine use, Dermatology Life Quality Index (DLQI), serum total IgE, and adverse events.

Results

Compared with the XFS plus sham AA, the XFS plus AA group showed a significantly greater reduction in SCORAD at week 4 (mean difference [MD] −9.1; p < 0.0001), exceeding the minimal clinically important difference. DLQI also improved more in the XFS plus AA group (MD −1.8; p = 0.0362). Fexofenadine use was lower in this group, though not significantly; no significant differences in serum total IgE were found. Adverse events were mild and transient.

Conclusions

Adding AA to XFS enhanced clinical outcomes and quality of life in patients with non-severe AD, with a favorable safety profile. These findings support AA as a promising adjunctive therapy in integrative approaches for AD. Further studies should validate these results across broader populations, with post-intervention follow-up, and diverse traditional medicine regimens.

Trial registration information

ClinicalTrials.gov (NCT06492902).

背景：过敏性皮炎（AD）是一种常见的慢性炎症性皮肤病，负担相当重。小风散在中医中被广泛应用于风湿热证。耳针（AA）可能缓解AD症状，但其与XFS的附加益处尚不清楚。方法在随机、假对照的临床试验中，156例非重度AD、风湿热型成人患者，均给予XFS汤剂治疗，在此基础上分为AA组（XFS加AA组，n=78）和假AA组（XFS加假AA组，n=78），疗程4周。主要终点是SCORAD指数从基线到第4周的变化。次要结局包括非索非那定使用情况、皮肤病生活质量指数（DLQI）、血清总IgE和不良事件。结果与XFS +假性AA组相比，XFS + AA组在第4周时SCORAD的降低显著更大（平均差异[MD] - 9.1; p < 0.0001），超过了最小的临床重要差异。XFS + AA组DLQI改善更明显（MD = 1.8; p = 0.0362）。该组非索非那定的使用较低，但不明显；血清总IgE无显著差异。不良事件轻微且短暂。结论在XFS中加入AA可改善非重度AD患者的临床结果和生活质量，并具有良好的安全性。这些发现支持AA作为一种有希望的AD综合治疗辅助疗法。进一步的研究应该在更广泛的人群中，通过干预后随访和不同的传统医学方案来验证这些结果。临床试验注册信息clinicaltrials .gov （NCT06492902）。

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引用次数: 0

Chinese herbal medicine Ding Kun Dan for menopausal syndrome: A systematic review and meta-analysis of randomized controlled trials 中药定坤丹治疗绝经期综合征：随机对照试验的系统评价和荟萃分析

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-16 DOI: 10.1016/j.imr.2025.101254

Youzhu Su , Jia Liu , Yuxian Wang , Xiao Xiao , Rui Liu , Xinxin Liu , Chen Shen , Rui Su , Xuefei Wang , Jianping Liu

Background

Menopausal syndrome is a common condition in women during menopause, characterized by hormonal imbalances and various symptoms that negatively impact quality of life. Ding Kun Dan (DKD), a traditional Chinese herbal medicine, has been used to alleviate these symptoms, but its clinical efficacy and safety require further evaluation.

Methods

A systematic search of eight databases was conducted through March 15, 2025. Randomized controlled trials (RCTs) were included if DKD was used alone or with conventional Western treatments. The primary outcome was the Kupperman Index; secondary outcomes included the Pittsburgh Sleep Quality Index, SF-36, Self-Rating Anxiety Scale, Self-Rating Depression Scale, estradiol, follicle-stimulating hormone, luteinizing hormone, and adverse events. Meta-analysis was performed using RevMan 5.4.1 and Stata 17.

Results

A total of 21 RCTs involving 1981 participants were included. DKD combined with menopause hormone therapy (MHT) demonstrated superior efficacy in improving overall symptoms, sleep quality, quality of life, and reducing anxiety and depression, with a positive impact on hormone levels and fewer adverse events. DKD alone also showed comparable effects to MHT in improving symptoms and hormone levels. Additionally, DKD combined with oryzanol positively impacted hormone levels.

Conclusions

DKD, both alone and in combination with MHT or oryzanol, demonstrates potential therapeutic effects for managing menopausal symptoms, but due to the low quality of included studies, results should be interpreted cautiously. Larger, high-quality RCTs are needed to confirm these findings.

Protocol registration

PROSPERO, CRD42024621022.

绝经期综合征是绝经期妇女的一种常见疾病，其特点是激素失衡和各种症状对生活质量产生负面影响。中药定坤丹（DKD）已被用于缓解这些症状，但其临床疗效和安全性有待进一步评估。方法系统检索8个数据库至2025年3月15日。如果DKD单独使用或与传统西医治疗联合使用，则纳入随机对照试验（rct）。主要结果是库珀曼指数；次要结果包括匹兹堡睡眠质量指数、SF-36、焦虑自评量表、抑郁自评量表、雌二醇、促卵泡激素、促黄体生成素和不良事件。采用RevMan 5.4.1和Stata 17进行meta分析。结果共纳入21项随机对照试验，受试者1981人。DKD联合更年期激素治疗（MHT）在改善整体症状、睡眠质量、生活质量、减少焦虑和抑郁方面表现出卓越的疗效，对激素水平有积极影响，不良事件较少。单独DKD在改善症状和激素水平方面也显示出与MHT相当的效果。此外，DKD联合谷维素对激素水平有积极影响。结论sddd单独或联合MHT或米甲醇均显示出对绝经期症状的潜在治疗效果，但由于纳入研究的质量较低，结果应谨慎解释。需要更大规模、高质量的随机对照试验来证实这些发现。协议注册号prospero， CRD42024621022。

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引用次数: 0

Effect of electroacupuncture versus prucalopride for ultra-severe chronic constipation: Secondary analysis of a randomized controlled trial 电针与普芦卡必利治疗超重度慢性便秘的疗效：一项随机对照试验的二次分析

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-12 DOI: 10.1016/j.imr.2025.101253

Shuai Gao , Lili Zhu , Hao Yao , Jiufei Fang , Zhishun Liu

Background

To explore the effect and safety of electroacupuncture (EA) compared to prucalopride in patients with ultra-severe chronic constipation (USCC), a condition defined by the absence of weekly complete spontaneous bowel movements (CSBMs).

Methods

This study was a secondary analysis using data from a multicenter, non-inferiority randomized controlled trial, involving patients with USCC. Participants received either EA or prucalopride treatment. The primary outcome was the mean weekly CSBMs from weeks 1 to 8. Secondary outcomes included the mean weekly CSBMs, the proportion of overall and weekly responders, changes in straining and stool consistency scores, Patient Assessment of Constipation Quality of Life (PAC-QOL) scores, and the proportion of patients using rescue medication.

Results

A total of 317 participants with USCC were included (151 in the EA group and 166 in the prucalopride group). From weeks 1 to 8, both groups showed similar increases in the CSBMs (difference: -0.02; 95% confidence interval [CI], -0.34 to 0.30, P < 0.001 for noninferiority). However, during weeks 1 to 2, the prucalopride group showed greater effects than the EA group in increasing CSBMs, alleviating defecation difficulties, and improving stool consistency. The EA group experienced fewer adverse events (AEs) than the prucalopride group.

Conclusions

In participants with USCC, EA showed improvements in CSBMs, defecation-related symptoms, and quality of life that were comparable to those observed with prucalopride. The effects of EA might persist for 24 weeks, and EA exhibited a superior safety profile.

Trial registration number

NCT02047045 (ClinicalTrials.gov).

背景：探讨电针（EA）与普芦卡普利（prucalride）在特重度慢性便秘（USCC）患者中的疗效和安全性，USCC是指每周没有完全自发排便（CSBMs）的患者。方法本研究采用多中心、非劣效性随机对照试验的数据进行二次分析，纳入USCC患者。参与者接受EA或普鲁卡必利治疗。主要终点是第1至8周的平均每周CSBMs。次要结局包括平均每周CSBMs、总缓解者和每周缓解者的比例、紧张感和大便一致性评分的变化、患者便秘生活质量评估（PAC-QOL）评分以及使用救援药物的患者比例。结果共纳入317例USCC患者（EA组151例，普芦卡必利组166例）。从第1周到第8周，两组CSBMs均出现相似的增加（差异：-0.02；95%可信区间[CI]， -0.34至0.30，非劣效性P <； 0.001）。然而，在第1 ~ 2周，普芦卡必利组在增加CSBMs、缓解排便困难和改善大便一致性方面的效果优于EA组。EA组的不良事件（ae）少于普芦卡必利组。结论：在USCC患者中，EA在CSBMs、排便相关症状和生活质量方面的改善与普鲁卡必利相当。EA的效果可能持续24周，EA显示出优越的安全性。试验注册号bernct02047045 （ClinicalTrials.gov）。

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引用次数: 0

Early acupuncture exposure and mortality in older adults with ischemic heart disease: A nationwide cohort study in Korea 老年缺血性心脏病患者早期针灸暴露与死亡率：韩国一项全国性队列研究

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-10 DOI: 10.1016/j.imr.2025.101252

Hyungsun Jun , Dasol Park , Haerim Kim , Ye-Seul Lee , Jungtae Leem

Background

Cardiovascular disease is a leading cause of morbidity and mortality in older adults. However, older adults with ischemic heart disease (IHD) are often exposed to risks associated with polypharmacy, and standard treatments may not fully address their complex clinical needs. Therefore, integrative approaches, such as acupuncture, may play a complementary role. This study assessed the association between early acupuncture exposure and mortality among older adults with newly diagnosed IHD.

Methods

Using the Korean National Health Insurance Service database, we identified patients aged ≥65 years with newly diagnosed IHD. Those receiving ≥6 acupuncture sessions within six months post-diagnosis formed the acupuncture group; those without any acupuncture formed the conventional group. Primary outcomes were five-year all-cause and circulatory system disease-specific mortality. Exploratory analyses compared regular and irregular acupuncture exposure.

Results

Of 9865 patients, 667 received acupuncture. They were younger, included more females, and had more severe disabilities than the conventional group. After adjustment for confounders, the acupuncture group showed lower all-cause mortality (adjusted hazard ratio [aHR] 0.71, 95 % confidence interval [CI] 0.58–0.88) and circulatory system disease-specific mortality (aHR 0.54, 95 % CI 0.34–0.89). Regular acupuncture use conferred further survival benefits over irregular use and no acupuncture.

Conclusions

These findings suggest that early-phase acupuncture intervention may play a meaningful role in improving survival outcomes in this population. Prospective studies are needed to confirm these findings and determine causality.

背景：心血管疾病是老年人发病和死亡的主要原因。然而，患有缺血性心脏病（IHD）的老年人经常面临与多药相关的风险，标准治疗可能无法完全满足其复杂的临床需求。因此，针灸等综合疗法可能起到补充作用。本研究评估了新诊断为IHD的老年人早期针灸暴露与死亡率之间的关系。方法使用韩国国民健康保险服务数据库，我们确定年龄≥65岁的新诊断IHD患者。诊断后6个月内针灸疗程≥6次者为针灸组；那些没有接受任何针灸治疗的人组成了传统组。主要结局是5年全因和循环系统疾病特异性死亡率。探索性分析比较了定期和不定期针灸暴露。结果9865例患者中，667例接受了针灸治疗。他们更年轻，包括更多的女性，并且比传统组有更严重的残疾。校正混杂因素后，针灸组的全因死亡率（校正风险比[aHR] 0.71, 95%可信区间[CI] 0.58-0.88）和循环系统疾病特异性死亡率（aHR 0.54, 95% CI 0.34-0.89）较低。定期使用针灸比不定期使用和不使用针灸更能提高生存率。结论早期针灸干预可能对改善该人群的生存结局有重要作用。需要前瞻性研究来证实这些发现并确定因果关系。

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引用次数: 0

Pharmacopuncture for patients with psychological stress caused by traffic accidents: A pragmatic randomized controlled pilot trial 药物穿刺治疗交通事故引起的心理应激：一项实用的随机对照试验

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-09-01 DOI: 10.1016/j.imr.2025.101251

Ja-Yean Son , Seol Jung , Young-Hoon Lee , Dong-Gyu Kim , Joon-Woo Kim , Tae-Jun Lee , Sung-Hwan Cho , Jeong-Hyo Ji , Hyun-Woo Cho , Sang-Don Kim , Yoon Jae Lee , In-Hyuk Ha , Doori Kim , Byung-Cheul Shin

Background

The effectiveness and safety of stress-focused pharmacopuncture in patients experiencing psychological stress following a traffic accident remain unclear. We aimed to conduct a randomized controlled trial to determine the effectiveness and safety of pharmacopuncture for these patients.

Methods

A total of 50 patients were included in this randomized controlled pilot trial. Inpatients who scored ≥8 on the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) or Depression (HADS-D) subscales following a traffic accident were randomized to receive either integrative Korean medicine (IKM) treatment alone (comparison group) or IKM treatment combined with stress-focused pharmacopuncture (pharmacopuncture group). The primary outcomes were the changes in the Hospital Anxiety and Depression Scale (HADS) scores, HADS total score (HADS-T), HADS-A, and HADS-D, from baseline to discharge. Secondary outcomes included the Numeric Rating Scale (NRS) for anxiety, depression, and physical pain; the Korean version of the Impact of Event Scale-Revised (IES-R-K); the Korean version of the Insomnia Severity Index (ISI-K); the EuroQol 5-Dimension (EQ-5D); and the Patient Global Impression of Change (PGIC) score.

Results

Compared to the comparison group, the pharmacopuncture group showed statistically significant improvements in the HADS-T (difference: 2.30, 95 % CI 0.53 to 4.07), HADS-A (difference: 1.09, 95 % CI 0.17 to 2.02), HADS-D (difference: 1.25, 95 % CI 0.25 to 2.25), NRS of anxiety (difference: 0.85, 95 % CI 0.10 to 1.59), and PGIC (difference: 0.52, 95 % CI 0.07 to 0.97) at the primary endpoint. No serious adverse events were reported.

Conclusion

Stress-focused pharmacopuncture may alleviate anxiety and depression symptoms and potentially accelerate recovery after traffic accidents.

Trial registration

ClinicalTrials.gov, NCT06107777.

背景：压力聚焦药物穿刺治疗交通事故后心理应激患者的有效性和安全性尚不清楚。我们的目的是进行一项随机对照试验，以确定药物穿刺对这些患者的有效性和安全性。方法随机对照试验共纳入50例患者。交通事故后医院焦虑抑郁量表-焦虑（HADS-A）或抑郁（HADS-D）亚量表得分≥8分的住院患者被随机分为单独接受韩国中西医结合（IKM）治疗（对照组）或IKM治疗联合以压力为重点的药物穿刺治疗（药物穿刺组）。主要结局是医院焦虑和抑郁量表（HADS）评分、HADS总分（HADS- t）、HADS- a和HADS- d从基线到出院的变化。次要结局包括焦虑、抑郁和身体疼痛的数值评定量表（NRS）；韩国版事件影响量表修订版（IES-R-K）；韩国版失眠严重程度指数（ISI-K）；EuroQol 5维（EQ-5D）；以及患者整体变化印象（PGIC）评分。结果与对照组相比，药物穿刺组在主要终点的HADS-T（差异：2.30,95% CI 0.53 ~ 4.07）、HADS-A（差异：1.09,95% CI 0.17 ~ 2.02）、HADS-D（差异：1.25,95% CI 0.25 ~ 2.25）、焦虑NRS（差异：0.85,95% CI 0.10 ~ 1.59）和PGIC（差异：0.52,95% CI 0.07 ~ 0.97）方面均有统计学意义的改善。无严重不良事件报告。结论压力焦点药物穿刺可减轻交通事故后的焦虑和抑郁症状，并有可能促进康复。临床试验注册：clinicaltrials .gov, NCT06107777。

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引用次数: 0

Brain functional changes in chronic partial sleep-deprivation population by electroacupuncture at shenmen(HT7) and neiguan (PC6) acupoints: A BOLD-fMRI study 电针神门穴和内关穴对慢性部分睡眠剥夺人群脑功能改变的BOLD-fMRI研究

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-08-30 DOI: 10.1016/j.imr.2025.101250

Hui Zeng , Ganbin Qiu , Chunyan Wang , Peifan Liu , Chunxing Liu , Mouyuan Liu , Xiaotong Xie , Liheng Ma

Background

The aim of this study is to explore how electroacupuncture at the Shenmen (HT7) and Neiguan (PC6) acupoints can improve chronic partial sleep deprivation(CPSD) by regulating brain function, and to elucidate its potential neural mechanisms using resting state Blood Oxygen Level-Dependent functional magnetic resonance imaging (BOLD-fMRI).

Methods

43 CPSD participants and 48 healthy controls (HC) were recruited and underwent neuropsychological assessments before electroacupuncture. 3.0T BOLD-fMRI scans were conducted before and after receiving bilateral electroacupuncture at HT7 and PC6. Amplitude of low-frequency fluctuation (ALFF) regional homogeneity (ReHo) values and functional connectivity were analyzed between two groups before and after electroacupuncture.

Results

CPSD participants showed prolonged reaction time (RT), increased omission rate (OR), and decreased accuracy (ACC) compared to HC. Significant differences (P < 0.05) in ALFF, ReHo, and functional connectivity were observed between groups before and after electroacupuncture, particularly in the default mode network (DMN) and limbic system. ALFF in the right parahippocampal gyrus positively correlated with ACC (r = 0.637, P = 0.001) and negatively with OR (r = -0.427, P = 0.047). ReHo in the left superior frontal gyrus negatively correlated with RT (r = -0.514, P = 0.014).

Conclusion

CPSD disrupts functional brain activity, while electroacupuncture at HT7 and PC6 modulates resting-state brain function, offering neuroimaging insights into its potential mechanisms for treating emotional and cognitive impairments in CPSD.

本研究旨在探讨电针针刺神门穴（HT7）和内关穴（PC6）如何通过调节脑功能改善慢性部分睡眠剥夺（CPSD），并利用静息状态血氧水平依赖功能磁共振成像（BOLD-fMRI）阐明其潜在的神经机制。方法招募CPSD参与者43例和健康对照48例，在电针治疗前进行神经心理评估。3.0T BOLD-fMRI扫描分别于双侧HT7、PC6电针前后进行。分析两组患者电针前后的低频波动幅度（ALFF）、区域均匀性（ReHo）值及功能连通性。结果与HC相比，scpsd患者反应时间（RT）延长，漏检率（OR）升高，反应正确率（ACC）降低。电针前后各组间ALFF、ReHo、功能连通性差异有统计学意义（P < 0.05），特别是在默认模式网络（DMN）和边缘系统。右侧海马旁回ALFF与ACC呈正相关（r = 0.637, P = 0.001），与OR呈负相关（r = -0.427, P = 0.047）。左侧额上回ReHo与RT呈负相关（r = -0.514, P = 0.014）。结论CPSD破坏脑功能活动，而电针HT7和PC6调节静息状态脑功能，为其治疗CPSD患者情绪和认知障碍的潜在机制提供了神经影像学见解。

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