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Predicting traditional Chinese medicine constitutions in adults aged ≥ 65 years: A machine learning approach 预测≥65岁成人的中医体质:机器学习方法。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-11-05 DOI: 10.1016/j.joim.2025.11.003
Chen Sun , Zhen Yu , Zong-yuan Ge , Wen-jun Wang , Bi-ying Wang , Hua-ling Song , Guo-qun Xie , Hai-lei Zhao , Yang Zhang , Xiang-long Xu

Objective

This study aimed to predict biased traditional Chinese medicine (TCM) constitutions among individuals aged ≥ 65 years using machine learning models and to identify the key predictors of biased TCM constitutions.

Methods

This cross-sectional study enrolled 4403 older adults in Shanghai, China. Demographic, lifestyle and clinical data were collected. Six machine learning models were trained and compared: random forest (RF), gradient boosting machine (GBM), support vector machine (SVM), extreme gradient boosting (XGBoost), adaptive boosting classifier (AdaBoost) and logistic regression (LR).

Results

Among these 4403 participants, 29.2% presented with biased TCM constitutions. RF demonstrated the highest predictive performance with an area under the curve (AUC) of 0.847 (indicating excellent discrimination), followed by GBM (AUC = 0.842), XGBoost (AUC = 0.840), AdaBoost (AUC = 0.830), SVM (AUC = 0.764) and LR (AUC = 0.759). Key predictors included age, heart rate, and specific blood parameters such as monocytes, alanine aminotransferase, platelet distribution width, total bilirubin, and creatinine.

Conclusion

The high prevalence of biased TCM constitutions among elderly adults underscores the need for targeted health management strategies. Machine learning models, particularly RF, can accurately predict biased TCM constitutions, enabling early identification of at-risk individuals. The identified predictors provide valuable insights for developing personalised preventive strategies and inform future research on TCM-based elderly healthcare.

Please cite this article as: Sun C, Yu Z, Ge ZY, Wang WJ, Wang BY, Song HL, Xie GQ, Zhao HL, Zhang Y, Xu XL. Predicting traditional Chinese medicine constitutions in adults aged ≥ 65 years: A machine learning approach. J Integr Med. 2026; 24(1):98–104.
目的:本研究旨在利用机器学习模型预测≥65岁人群的偏倚中医体质,并确定偏倚中医体质的关键预测因素。方法:这项横断面研究在中国上海招募了4403名老年人。收集了人口统计、生活方式和临床数据。对随机森林(RF)、梯度增强机(GBM)、支持向量机(SVM)、极端梯度增强(XGBoost)、自适应增强分类器(AdaBoost)和逻辑回归(LR) 6种机器学习模型进行了训练和比较。结果:在这4403名参与者中,29.2%的人表现出偏颇的中医体质。RF的预测效果最好,曲线下面积(AUC)为0.847(表示优秀的判别),其次是GBM (AUC = 0.842)、XGBoost (AUC = 0.840)、AdaBoost (AUC = 0.830)、SVM (AUC = 0.764)和LR (AUC = 0.759)。关键的预测因素包括年龄、心率和特定的血液参数,如单核细胞、丙氨酸转氨酶、血小板分布宽度、总胆红素和肌酐。结论:中医体质偏倚在老年人中的高发突出了有针对性的健康管理策略的必要性。机器学习模型,特别是射频模型,可以准确预测有偏见的中医体质,从而能够早期识别有风险的个体。确定的预测因子为制定个性化预防策略提供了有价值的见解,并为未来基于中医的老年人医疗保健研究提供了信息。本文署名:孙晨,余志,葛志勇,王文杰,王碧,宋海龙,谢国强,赵海龙,张勇,徐晓林。预测≥65岁成人的中医体质:机器学习方法。集成医学[J];打印前Epub。
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引用次数: 0
Effectiveness and safety of manual therapy for inpatients with traffic accident-induced acute neck pain: A randomized controlled trial 手工疗法治疗交通事故致急性颈部疼痛的有效性和安全性:一项随机对照试验。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-11-01 DOI: 10.1016/j.joim.2025.10.008
Sung-Won Choi , Ka-Hyun Kim , Joo-Young Yoon , Si-Won Lee , Jae-Won Park , Hae-Won Hong , Da-Hyun Kyeong , Min-Kyung Kim , Su-Na Kim , Chang-Yeon Kim , Yoon-Jae Lee , Jin-Ho Lee , Ju-Yeon Kim , In-Hyuk Ha

Background

Research on the benefits of mobilization-focused manual therapy for whiplash syndrome is needed.

Objective

This study evaluated the effectiveness of manual therapy as an adjunct to integrative Korean medicine treatment (IKMT) for acute neck pain following traffic accidents.

Design, setting, participants and interventions

A single-center, two-arm, assessor-blinded, randomized clinical trial was conducted between 20 November 2020 and 26 July 2022. This study included 120 patients with acute neck pain after a traffic accident. IKMT was performed in the intervention and control groups during hospitalization. The intervention group also underwent four mobilization-focused manual therapy sessions.

Main outcome measures

The primary outcome was a change from the baseline in the numeric rating scale of neck pain on day 5 of hospitalization.

Results

A total of 120 participants were allocated to two groups (60 patients each), and the modified intention-to-treat analysis set included 60 and 59 patients in the intervention and control groups, respectively. On day 5, the intervention group showed more improvement in numeric rating (by 0.97 [0.38, 1.57]) and visual analogue (by 9.84 [4.15, 15.54]) scale scores, compared to the control group. The area under the curve of cumulative values up to day 5 was smaller in the intervention group than in the control group, with numeric rating and visual analogue scale scores of 2.81 (1.33, 4.29) and 31.02 (15.81, 46.22), respectively.

Conclusion

Administration of manual therapy as an adjunct to IKMT among patients with traffic accident-induced acute neck pain resulted in faster and better improvement in neck pain up to day 5 compared to IKMT alone. However, the outcomes showed no significant differences at the 12-week follow-up.

Trial registration

ClinicalTrials.gov (NCT04660175).
Please cite this article as: Choi SW, Kim KH, Yoon JY, Lee SW, Park JW, Hong HW, Kyeong DH, Kim MK, Kim SN, Kim CY, Lee YJ, Lee JH, Kim JY, Ha IH. Effectiveness and safety of manual therapy for inpatients with traffic accident-induced acute neck pain: A randomized controlled trial. J Integr Med. 2026; 24(1):81–89.
背景:需要研究以活动为中心的手法治疗颈椎扭伤综合征的益处。目的:本研究评价了手疗辅助韩医结合治疗交通事故后急性颈部疼痛的疗效。设计、环境、参与者和干预措施:在2020年11月20日至2022年7月26日期间进行了一项单中心、双臂、评估盲、随机临床试验。本研究包括120例交通事故后急性颈部疼痛的患者。干预组和对照组住院期间均行IKMT。干预组还进行了四次以活动为重点的手工治疗。主要结局指标:主要结局指标为住院第5天颈部疼痛数值评定量表的基线变化。结果:120名参与者被分为两组(每组60例),改良意向治疗分析集分别包括干预组60例和对照组59例患者。第5天,干预组在数值评分(提高0.97[0.38,1.57])和视觉模拟评分(提高9.84[4.15,15.54])方面较对照组有更大改善。干预组第5天累积值曲线下面积小于对照组,数值评分和视觉模拟评分分别为2.81(1.33,4.29)和31.02(15.81,46.22)。结论:在交通事故引起的急性颈部疼痛患者中,手工治疗作为IKMT的辅助治疗,与单独IKMT相比,在第5天颈部疼痛的改善更快、更好。然而,在12周的随访中,结果没有显着差异。试验注册:Clinicaltrials.gov (NCT04660175)。请将本文引用为:Choi SW, Kim KH, Yoon JY, Lee SW, Park JW, Hong HW, Kyeong DH, Kim MK, Kim SN, Kim CY, Lee YJ, Lee JH, Kim JY, Ha IH。手工疗法治疗交通事故致急性颈部疼痛的有效性和安全性:一项随机对照试验。集成医学[J];打印前Epub。
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引用次数: 0
Potential supplement-drug interactions and bleeding in patients with cancer: A UK Biobank study 潜在的补充药物相互作用和癌症患者出血:英国生物银行的一项研究。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-10-13 DOI: 10.1016/j.joim.2025.10.004
Chun Sing Lam , Rong Hua , Lung Wai Au-Doung , Yu Kang Wu , Ho Kee Koon , Keary Rui Zhou , Herbert Ho-Fung Loong , Vincent Chi-Ho Chung , Richard Lee , Alexandre Chan , Yin Ting Cheung

Objective

Interactions between supplements and drugs may potentially increase the risk of bleeding in patients with cancer. However, studies on drug interactions and bleeding risk in cancer patients in a real-world setting are limited. This study investigates supplement-drug interactions associated with bleeding risk using data from the UK Biobank database (https://www.ukbiobank.ac.uk).

Methods

Participants included in this study had a cancer diagnosis and had completed supplement-use assessment after their diagnosis. Potential supplement-drug interactions associated with bleeding were identified using four tertiary databases. Logistic regression was used to investigate the association between potential clinical predictors and the use of supplement-drug pairs with interactions that potentially increase the bleeding risk. Exploratory analysis utilized log-binomial regression to examine the association between potentially interacting supplement-drug pairs and the incidence rates of five major bleeding outcomes (gastrointestinal hemorrhage, intracranial hemorrhage, hematuria, hemorrhage from respiratory passages, and postmenopausal bleeding). All analyses were adjusted for relevant factors.

Results

This study analyzed data from 30,239 participants (mean age = 60.0 years; 61.9% female). Over half (n = 17,698, 58.5%) of the participants reported using supplements after their cancer diagnosis. Among those using both supplements and drugs, one-third (n = 4970/14,308, 34.7%) were taking potentially interacting pairs that increase bleeding risk. Younger age at cancer diagnosis, longer time since diagnosis, specific cancer types, and comorbidities were associated with the use of these interacting pairs. Exploratory analyses found no significant associations between the use of potentially interacting supplement-drug pairs and the incidence of major bleeding events (all P > 0.05), although the risk of minor bleeding cannot be ruled out.

Conclusion

Approximately one-third of cancer patients who used supplements and drugs had a potential risk for bleeding due to supplement-drug interactions, suggesting the need to raise awareness about bleeding risks among patients and healthcare providers. Further pharmacovigilance monitoring and prospective cohort studies are needed to better understand the clinical impact of specific interactions.

Please cite this article as: Lam CS, Hua R, Au-Doung LW, Wu YK, Koon HK, Zhou KR, Loong HHF, Chung VCH, Lee R, Chan A, Cheung AT. Potential supplement-drug interactions and bleeding in patients with cancer: A UK Biobank study. J Integr Med. 2026; 24(1):90–97.
目的:补充剂和药物之间的相互作用可能会增加癌症患者出血的风险。然而,关于药物相互作用和癌症患者出血风险的研究在现实世界中是有限的。本研究使用来自英国生物银行数据库(https://www.ukbiobank.ac.uk).Methods)的数据调查了与出血风险相关的补充药物相互作用:本研究的参与者被诊断为癌症,并在诊断后完成了补充药物使用评估。使用四个三级数据库确定与出血相关的潜在补充药物相互作用。使用逻辑回归来调查潜在的临床预测因素与使用可能增加出血风险的补充药物对之间的关联。探索性分析利用对数二项回归来检验可能相互作用的补充药物对与五种主要出血结局(胃肠道出血、颅内出血、血尿、呼吸道出血和绝经后出血)发生率之间的关联。所有分析均根据相关因素进行调整。结果:本研究分析了30,239名参与者的数据(平均年龄= 60.0岁,61.9%为女性)。超过一半(n = 17,698, 58.5%)的参与者报告在癌症诊断后服用补充剂。在同时服用补充剂和药物的人群中,三分之一(n = 4970/ 14308, 34.7%)服用了可能增加出血风险的药物。癌症诊断年龄较小、诊断时间较长、特定癌症类型和合并症与这些相互作用对的使用有关。探索性分析发现,尽管不能排除轻微出血的风险,但使用可能相互作用的补充药物对与大出血事件的发生率之间没有显著关联(P < 0.05)。结论:大约三分之一使用补充剂和药物的癌症患者由于补充剂和药物的相互作用而有出血的潜在风险,这表明有必要提高患者和医疗保健提供者对出血风险的认识。需要进一步的药物警戒监测和前瞻性队列研究来更好地了解特定相互作用的临床影响。请将本文的出处注明为:林志强,华瑞,刘au - dong,吴玉刚,孔孔明,周克仁,龙洪峰,钟伟奇,李锐,陈安,b张AT。潜在的补充药物相互作用和癌症患者出血:英国生物银行的一项研究。集成医学[J];打印前Epub。
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引用次数: 0
Comparative effectiveness of electroacupuncture and conventional acupuncture for rheumatoid arthritis pain: A network meta-analysis with emphasis on placebo control validity 电针与传统针刺治疗类风湿关节炎疼痛的比较疗效:一项强调安慰剂对照效度的网络meta分析。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-09-26 DOI: 10.1016/j.joim.2025.09.005
Shan Wang , Ye-hua Xue , Li-bing Liang , Kun-peng Li , Cai-qin Wu

Background

Acupuncture is recognized as an alternative therapy for rheumatoid arthritis (RA) pain, but its efficacy evaluations are often confounded by variability in sham acupuncture techniques. The accurate selection of sham acupuncture controls, which are administered at either therapeutic acupuncture points or non-acupuncture points, is crucial for the validity of assessment outcomes.

Objective

To assess the efficacy of acupuncture in treating RA pain and identify the most effective acupuncture methods.

Search strategy

Databases including MEDLINE, Embase, PubMed, Cochrane Library, Scopus, Web of Science, China National Knowledge Infrastructure Database, Chinese Science and Technology Journal Database, and Wanfang Database were searched from inception to October 11, 2024. Keywords included “rheumatoid arthritis,” “acupuncture,” “electroacupuncture,” and “pain.”

Inclusion criteria

Randomized controlled trials (RCTs) in adults with RA that assessed pain using a visual analog scale and joint swelling by swollen joint count. Eligible trials compared electroacupuncture, conventional acupuncture, or sham acupuncture, against standard pain medication.

Data extraction and analysis

Two reviewers independently extracted data on study design, participant characteristics, interventions and outcomes. Risk of bias was evaluated using the Cochrane Risk of Bias 2 tool, and evidence certainty was assessed via the confidence in network meta-analysis framework. A frequentist network meta-analysis with random-effect models was conducted, and standardized mean difference (SMD) and 95% confidence interval (CI) were reported.

Results

Ten RCTs involving 704 participants were analyzed. Electroacupuncture (SMD: –1.42; 95% CI: [–1.87, –0.98]) and conventional acupuncture (SMD: –1.11; 95% CI: [–1.49, –0.73]) outperformed conventional therapy and non-acupoint sham needling. Surface under cumulative ranking curve showed that electroacupuncture was most effective for pain reduction (97.7%), followed by conventional acupuncture (75.1%), non-acupoint sham (29.1%), same-acupoint sham (28.6%), and conventional therapy (19.5%).

Conclusion

Electroacupuncture demonstrated the highest efficacy for RA pain relief. Same-acupoint sham acupuncture may underestimate acupuncture’s true effect and is not recommended as a placebo control. Non-acupoint sham acupuncture is a more valid control for future trials.

Please cite this article as: Wang S, Xue YH, Liang LB, Li KP, Wu CQ. Comparative effectiveness of electroacupuncture and conventional acupuncture for rheumatoid arthritis pain: A network meta-analysis with emphasis on placebo control validity. J Integr Med. 2026; 24(1):57–64.
背景:针灸被认为是治疗类风湿关节炎(RA)疼痛的一种替代疗法,但其疗效评估常常因假针灸技术的可变性而混淆。在治疗性穴位或非针灸穴位进行假针灸对照的准确选择对于评估结果的有效性至关重要。目的:评价针刺治疗类风湿性关节炎疼痛的疗效,确定最有效的针刺方法。检索策略:从项目成立至2024年10月11日检索MEDLINE、Embase、PubMed、Cochrane Library、Scopus、Web of Science、中国国家知识基础数据库、中国科技期刊库、万方数据库等数据库。关键词包括“类风湿关节炎”、“针灸”、“电针”和“疼痛”。纳入标准:随机对照试验(rct)在成人RA患者中使用视觉模拟量表评估疼痛,通过肿胀关节计数评估关节肿胀。符合条件的试验比较了电针、传统针灸或假针灸与标准止痛药的疗效。数据提取和分析:两位评论者独立提取研究设计、参与者特征、干预措施和结果的数据。使用Cochrane Risk of bias 2工具评估偏倚风险,并通过网络元分析框架的置信度评估证据确定性。采用随机效应模型进行频率网络元分析,并报告标准化平均差(SMD)和95%置信区间(CI)。结果:共分析10项随机对照试验,共704名受试者。电针(SMD: -1.42; 95% CI:[-1.87, -0.98])和常规针刺(SMD: -1.11; 95% CI:[-1.49, -0.73])优于常规疗法和非穴位假针刺。累积排序曲线表显示,电针镇痛效果最佳(97.7%),其次为常规针刺(75.1%)、非穴位假手术(29.1%)、同穴位假手术(28.6%)、常规治疗(19.5%)。结论:电针对RA疼痛的缓解效果最好。同一穴位的假针灸可能低估了针灸的真实效果,不推荐作为安慰剂对照。在未来的试验中,非穴位假针灸是一种更有效的对照。本文署名:王思、薛玉华、梁宝玲、李kp、吴春青。电针与传统针刺治疗类风湿关节炎疼痛的比较疗效:一项强调安慰剂对照效度的网络meta分析。集成医学[J];打印前Epub。
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引用次数: 0
Research progress on the characteristics and essence of meridians and acupoints from an interdisciplinary perspective: A review 交叉学科视角下经穴特征与本质的研究进展综述。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-09-23 DOI: 10.1016/j.joim.2025.09.004
Yu-pei Cheng , Yang Guo , Can Wang , Bang-qi Wu , Qing Xia , Run-chen Zhang , Yi Guo
This study summarizes and discusses the characteristics and essence of meridians and acupoints from the perspectives of physics, chemistry and biology. An extensive body of literature from PubMed and the China National Knowledge Infrastructure was reviewed and categorized into three distinct groups: physical characteristics-related research (75 articles), which examined electrical, thermal, optical, acoustic and magnetic properties, and isotope migration; chemical characteristics-related literature (44 articles), focusing on chemical ions, oxygen partial pressure, nitric oxide and substance P; and biological essence-related research (52 articles), which primarily explored microcirculation, extracellular fluid channels, mast cells, telocytes, connexins, hilum of muscle and bone, and sensory nerve fibers. Current research emphasizes the electrical and thermal properties of the meridians and acupoints, whereas investigations into the essence of meridians are increasingly shifting from macroscopic to microscopic structures. It is essential to fully harness the advantages of interdisciplinary integration, which could significantly advance our understanding and applications in the realm of acupuncture and traditional medicine.

Please cite this article as: Cheng YP, Guo Y, Wang C, Wu BQ, Xia Q, Zhang RC, Guo Y. Research progress on the characteristics and essence of meridians and acupoints from an interdisciplinary perspective: A review. J Integr Med. 2026; 24(1):33–49.
本研究从物理、化学和生物学的角度对经络和腧穴的特点和本质进行了总结和探讨。我们回顾了PubMed和中国国家知识基础设施的大量文献,并将其分为三大类:物理特征相关研究(75篇),研究了电、热、光学、声学和磁性以及同位素迁移;化学特性相关文献44篇,重点是化学离子、氧分压、一氧化氮和P物质;生物本质相关研究(52篇),主要探讨微循环、细胞外液通道、肥大细胞、远端细胞、连接蛋白、肌肉和骨门、感觉神经纤维。目前的研究强调经络和穴位的电性和热性,而对经络本质的研究正日益从宏观结构转向微观结构。充分利用跨学科整合的优势,将极大地促进我们对针灸和传统医学领域的理解和应用。程玉萍,郭毅,王超,吴宝强,夏强,张荣成,郭毅。交叉学科视角下经络腧穴特征与本质研究进展综述。集成医学[J];打印前Epub。
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引用次数: 0
Research progress of tissue clearing and three-dimensional imaging on multiple effects of acupuncture and moxibustion 组织清除和三维成像对针灸多重效应的研究进展。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2026-01-01 Epub Date: 2025-11-05 DOI: 10.1016/j.joim.2025.11.001
Wen-hao Gao , Yu Wang , Xiao-yu Tong, Wei Hu, Yi-cong Wang, Yan Xiao, Jia-jia Li, Yi Feng
Acupuncture therapy has demonstrated therapeutic effects on various systemic diseases through the use of specific acupoints along meridians. However, due to the multi-target effect of acupuncture and the complexity of meridian pathways, the underlying mechanisms of acupuncture have not been well understood. Tissue clearing and three-dimensional (3D) imaging is an emerging medical technology that provides high-resolution 3D molecular information while preserving the structural integrity of tissues. In relevant research articles, tissue-clearing and 3D imaging techniques stood out for their ability to visualize the structural characteristics of meridians and acupoints of intact tissues, in order to reveal their intricate connections by means of topological principles. Specifically, this technology has managed to show that acupuncture points like Guilai (ST29) and Sanyinjiao (SP6), which are commonly used in traditional Chinese medicine for treating gynecological disorders, promote angiogenesis in the ovaries and thus improve follicle numbers in polycystic ovary syndrome-like ovaries. This article summarizes recent progress on tissue-clearing and 3D imaging technologies and anticipates the prospects of utilizing this technology to further explore the effects of acupuncture.

Please cite this article as: Gao WH, Wang Y, Tong XY, Hu W, Wang YC, Xiao Y, Li JJ, Feng Y. Research progress of tissue clearing and three-dimensional imaging on multiple effects of acupuncture and moxibustion. J Integr Med. 2026; 24(1):49–56.
针灸疗法通过使用经络的特定穴位,已经证明了对各种全身性疾病的治疗效果。然而,由于针刺的多靶点作用和经络的复杂性,其作用机制尚不清楚。组织清理和三维(3D)成像是一项新兴的医疗技术,它提供高分辨率的3D分子信息,同时保持组织的结构完整性。在相关的研究文章中,组织清理和三维成像技术以其能够可视化完整组织的经络和腧穴的结构特征,通过拓扑原理揭示其复杂的联系而脱颖而出。具体来说,这项技术已经成功地表明,在中医治疗妇科疾病中常用的Guilai (ST29)和Sanyinjiao (SP6)等穴位可以促进卵巢血管生成,从而提高多囊卵巢综合征样卵巢的卵泡数量。本文综述了组织清除和三维成像技术的最新进展,并展望了利用该技术进一步探索针灸效果的前景。高慧,王勇,童晓霞,胡伟,王玉春,肖勇,李建军,冯勇。组织清除和三维成像对针灸多效的研究进展。集成医学[J];打印前Epub。
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引用次数: 0
Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial. 复方中药红花如意丸改善子宫内膜异位症相关性痛经:多中心随机、双盲、安慰剂对照试验
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-12-29 DOI: 10.1016/j.joim.2025.12.011
Mei Han, Xue-Fang Liang, Jing Gao, Yan Wang, Li-Xing Cao, Bao-Jin Wang, Yue Wang, Zerang Zhuoma, Jian-Ping Liu, Hui-Lan Du
<p><strong>Background: </strong>Endometriosis is an estrogen-dependent, progesterone-resistant gynecological disorder, with dysmenorrhea being the most common manifestation.</p><p><strong>Objective: </strong>This study evaluates the efficacy and safety of the Tibetan herbal medication Honghua Ruyi Pill (HHRY) in managing endometriosis-related dysmenorrhea.</p><p><strong>Design, setting, participants and interventions: </strong>This is a multi-center, randomized, placebo-controlled, double-blinded clinical trial conducted in seven hospitals in China from July 2021 to January 2023. A total of 164 patients with endometriosis and moderate or severe dysmenorrhea (visual analog scale [VAS] score ≥ 4) were assigned to the treatment or placebo group in a 1:1 ratio by block randomization. Patients received HHRY or placebo twice a day for three consecutive menstrual cycles (MCs) and were followed up for three MCs after stopping the medication.</p><p><strong>Main outcome measures: </strong>Primary outcomes were VAS score of the maximum (VAS<sub>max</sub>) of dysmenorrhea, endometriosis health profile-5 (EHP-5) score, and 5-level EQ-5D version (EQ-5D-5L) score. Secondary outcomes were VAS<sub>max</sub> of non-menstrual pelvic pain, days of leave taken, emergent use of nonsteroidal anti-inflammatory drugs (NSAIDs) and changes in uterine, cyst and nodule sizes. Safety profiles were assessed based on adverse events, vital signs, serology markers, urinalysis, and liver and kidney function indicators.</p><p><strong>Results: </strong>VAS<sub>max</sub> of dysmenorrhea, EHP-5 score, EQ-5D-5 L score, and VAS<sub>max</sub> of non-menstrual pelvic pain were significantly lower in the HHRY group compared to the placebo group at the final follow-up (3.00 vs 5.50, P < 0.001; 4.00 vs 8.00, P < 0.001; 4.00 vs 9.00, P < 0.001; 0.00 vs 1.00, P < 0.001; respectively). The emergent use of NSAIDs for breakthrough pain showed no significant difference between groups (P > 0.999), but the number of patients who had taken time off was significantly different (5.00 vs 14.00, P = 0.028). Sonographic evaluations indicated no significant change in uterine size (P = 0.183) but showed a significant reduction in cyst size (2.09 cm vs 0.20 cm, P = 0.027, sum of 3 diameters of cysts) and nodule size (0.70 cm vs 0.00 cm, P < 0.001, maximum nodule diameter). Safety analysis showed no significant difference in the incidence of adverse events between groups (18.85% vs 28.05%, P = 0.059).</p><p><strong>Conclusion: </strong>HHRY can improve dysmenorrhea, chronic pelvic pain, and quality of life in patients with endometriosis. It has a good overall safety profile, and a 3-month treatment can maintain its effects for at least 3 months after the last dose. HHRY may be considered as a new therapeutic option for treating endometriosis-related dysmenorrhea.</p><p><strong>Trial registration: </strong>Trial registration at ClinicalTrials.gov with registration number: NCT04942015. Please cite this article
背景:子宫内膜异位症是一种雌激素依赖、黄体酮抵抗的妇科疾病,以痛经为最常见的表现。目的:评价藏药红花如意丸治疗子宫内膜异位症相关性痛经的疗效和安全性。设计、环境、参与者和干预措施:这是一项多中心、随机、安慰剂对照、双盲临床试验,于2021年7月至2023年1月在中国7家医院进行。164例子宫内膜异位症合并中度或重度痛经患者(视觉模拟评分[VAS]评分≥4)按照1:1的比例被分组分为治疗组或安慰剂组。患者接受HHRY或安慰剂治疗,每天两次,连续三个月经周期(MCs),停药后随访三个MCs。主要结局指标:主要结局为痛经最大VAS评分(VASmax)、子宫内膜异位症健康概况-5 (EHP-5)评分、5级EQ-5D版本评分(EQ-5D- 5l)。次要指标为非经期盆腔疼痛的VASmax、休假天数、非甾体抗炎药(NSAIDs)的紧急使用以及子宫、囊肿和结节大小的变化。安全性评估基于不良事件、生命体征、血清学指标、尿液分析和肝肾功能指标。结果:末次随访时,hhrry组痛经VASmax评分、EHP-5评分、eq - 5d - 5l评分、非经期盆腔疼痛VASmax评分均显著低于安慰剂组(3.00 vs 5.50, P 0.999),但休假患者数差异有统计学意义(5.00 vs 14.00, P = 0.028)。超声检查显示子宫大小无明显变化(P = 0.183),但囊肿大小(2.09 cm vs 0.20 cm, P = 0.027, 3个囊肿直径的总和)和结节大小(0.70 cm vs 0.00 cm, P)明显减少。结论:HHRY可改善子宫内膜异位症患者的痛经、慢性盆腔疼痛和生活质量。它具有良好的整体安全性,并且3个月的治疗可以在最后一次剂量后至少3个月保持其效果。HHRY可能被认为是治疗子宫内膜异位症相关痛经的一种新的治疗选择。试验注册:在ClinicalTrials.gov上注册试验,注册号:NCT04942015。本文署名:韩敏,梁晓峰,高军,王毅,曹立新,王炳杰,王毅,泽忠,刘金平,杜海龙。复方中药红花如意丸改善子宫内膜异位症相关性痛经:多中心随机、双盲、安慰剂对照试验集成医学[J];打印前Epub。
{"title":"Honghua Ruyi Pill, a compound herbal medicine, improves endometriosis-related dysmenorrhea: A multicenter randomized, double-blind, placebo-controlled trial.","authors":"Mei Han, Xue-Fang Liang, Jing Gao, Yan Wang, Li-Xing Cao, Bao-Jin Wang, Yue Wang, Zerang Zhuoma, Jian-Ping Liu, Hui-Lan Du","doi":"10.1016/j.joim.2025.12.011","DOIUrl":"https://doi.org/10.1016/j.joim.2025.12.011","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Endometriosis is an estrogen-dependent, progesterone-resistant gynecological disorder, with dysmenorrhea being the most common manifestation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study evaluates the efficacy and safety of the Tibetan herbal medication Honghua Ruyi Pill (HHRY) in managing endometriosis-related dysmenorrhea.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Design, setting, participants and interventions: &lt;/strong&gt;This is a multi-center, randomized, placebo-controlled, double-blinded clinical trial conducted in seven hospitals in China from July 2021 to January 2023. A total of 164 patients with endometriosis and moderate or severe dysmenorrhea (visual analog scale [VAS] score ≥ 4) were assigned to the treatment or placebo group in a 1:1 ratio by block randomization. Patients received HHRY or placebo twice a day for three consecutive menstrual cycles (MCs) and were followed up for three MCs after stopping the medication.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Main outcome measures: &lt;/strong&gt;Primary outcomes were VAS score of the maximum (VAS&lt;sub&gt;max&lt;/sub&gt;) of dysmenorrhea, endometriosis health profile-5 (EHP-5) score, and 5-level EQ-5D version (EQ-5D-5L) score. Secondary outcomes were VAS&lt;sub&gt;max&lt;/sub&gt; of non-menstrual pelvic pain, days of leave taken, emergent use of nonsteroidal anti-inflammatory drugs (NSAIDs) and changes in uterine, cyst and nodule sizes. Safety profiles were assessed based on adverse events, vital signs, serology markers, urinalysis, and liver and kidney function indicators.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;VAS&lt;sub&gt;max&lt;/sub&gt; of dysmenorrhea, EHP-5 score, EQ-5D-5 L score, and VAS&lt;sub&gt;max&lt;/sub&gt; of non-menstrual pelvic pain were significantly lower in the HHRY group compared to the placebo group at the final follow-up (3.00 vs 5.50, P &lt; 0.001; 4.00 vs 8.00, P &lt; 0.001; 4.00 vs 9.00, P &lt; 0.001; 0.00 vs 1.00, P &lt; 0.001; respectively). The emergent use of NSAIDs for breakthrough pain showed no significant difference between groups (P &gt; 0.999), but the number of patients who had taken time off was significantly different (5.00 vs 14.00, P = 0.028). Sonographic evaluations indicated no significant change in uterine size (P = 0.183) but showed a significant reduction in cyst size (2.09 cm vs 0.20 cm, P = 0.027, sum of 3 diameters of cysts) and nodule size (0.70 cm vs 0.00 cm, P &lt; 0.001, maximum nodule diameter). Safety analysis showed no significant difference in the incidence of adverse events between groups (18.85% vs 28.05%, P = 0.059).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;HHRY can improve dysmenorrhea, chronic pelvic pain, and quality of life in patients with endometriosis. It has a good overall safety profile, and a 3-month treatment can maintain its effects for at least 3 months after the last dose. HHRY may be considered as a new therapeutic option for treating endometriosis-related dysmenorrhea.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Trial registration at ClinicalTrials.gov with registration number: NCT04942015. Please cite this article ","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Distinct intensity of electroacupuncture ameliorates mechanical hypersensitivity by attenuating neuronal sensitization in spinal dorsal horn in a rat model of inflammatory muscle pain. 不同强度的电针通过减轻大鼠炎性肌肉疼痛模型中脊髓背角的神经元致敏来改善机械超敏反应。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-12-29 DOI: 10.1016/j.joim.2025.12.010
Qing-Quan Yu, Xiao-Yue Sun, Jun-Kang Chen, Meng Li, Xiao-Yu Wang, Yang-Shuai Su, Zhi-Yun Zhang, Xiang-Hong Jing

Objective: This study investigated the effects of distinct electroacupuncture (EA) intensities in alleviating mechanical hypersensitivity by attenuating spinal dorsal horn (SDH) neuronal sensitization in inflammatory muscle pain.

Methods: Male Sprague-Dawley rats received an intra-muscular injection of complete Freund's adjuvant (CFA) in the left gastrocnemius muscle to induce inflammatory muscle pain. EA with distinct intensities activating Aβ-, Aδ- and C-fibers (EA, EA and EAC) was applied after CFA injection. Pain behaviors were evaluated by weight-bearing asymmetry, the Randall-Selitto test, and the von Frey test. Spinal neuronal activities were observed by in vivo extracellular recordings with a microelectrode array. Neuronal sensitization was assessed through wind-up phenomenon of wide dynamic range (WDR) neurons and long-term potentiation (LTP) of spinal C-fiber-evoked field potential (CFEFP).

Results: Both EA and EAC significantly alleviated CFA-induced hyperalgesia. Moreover, EA and EAC interventions markedly reduced the activity of WDR neurons in response to stimulation. Importantly, the wind-up phenomenon of WDR neurons evoked by repetitive noxious stimuli was both immediately and sustainably reduced after EA intervention, with EAC showing a more pronounced effect. Furthermore, EA and EAC increased the threshold of the spinal CFEFP, while EAC intervention additionally significantly attenuated the occurrence of LTP.

Conclusion: Suppressing the SDH neuronal sensitization by activating Aδ- and C-fiber inputs may be the potential mechanism by which EA alleviates hyperalgesia in inflammatory muscle pain. Please cite this article as: Yu QQ, Sun XY, Chen JK, Li M, Wang XY, Su YS, Zhang ZY, Jing XH. Distinct intensity of electroacupuncture ameliorates mechanical hypersensitivity by attenuating neuronal sensitization in spinal dorsal horn in a rat model of inflammatory muscle pain. J Integr Med. 2025; Epub ahead of print.

目的:研究不同电针(EA)强度通过减轻炎性肌肉痛脊髓背角(SDH)神经元致敏来减轻机械超敏反应的作用。方法:雄性Sprague-Dawley大鼠左腓肠肌肌内注射完全弗氏佐剂(CFA),诱导炎性肌肉疼痛。注射CFA后,应用不同强度的EA激活Aβ-、Aδ-和c -纤维(EAAβ、EAAδ和EAC)。通过负重不对称、Randall-Selitto测试和von Frey测试评估疼痛行为。用微电极阵列在体内细胞外记录观察脊髓神经元的活动。通过宽动态范围(WDR)神经元的上弦现象和脊髓c纤维诱发场电位(CFEFP)的长时程增强(LTP)来评估神经元的致敏性。结果:EAAδ和EAC均能显著减轻cfa诱导的痛觉过敏。此外,EAAδ和EAC干预显著降低了WDR神经元对刺激的反应活性。重要的是,重复有害刺激引起的WDR神经元上弦现象在EA干预后立即和持续减少,EAC表现出更明显的效果。此外,EAAδ和EAC可提高脊髓CFEFP的阈值,而EAC干预可显著降低LTP的发生。结论:通过激活a -和c -纤维输入抑制SDH神经元致敏可能是EA减轻炎性肌痛痛觉过敏的潜在机制。本文署名:于QQ,孙学祥,陈建军,李敏,王学祥,苏玉英,张志勇,景晓华。不同强度的电针通过减轻大鼠炎性肌肉疼痛模型中脊髓背角的神经元致敏来改善机械超敏反应。集成医学[J];打印前Epub。
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引用次数: 0
Protective effects of Prunella vulgaris polysaccharides against herpes simplex virus type 1 infection through the STING-TBK1-IRF3 pathway. 枯草多糖通过STING-TBK1-IRF3途径对1型单纯疱疹病毒感染的保护作用
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-12-29 DOI: 10.1016/j.joim.2025.12.008
Yi-Bo Zhang, Lin Xu, Man Yuan, Meng-Fan Liu, Yang Li, Xuan-Lei Zhong, Zhi-Xiu Lin, Yan-Fang Xian, Ping Lu, Zhi-Chao Xi, Hong-Xi Xu

Objective: Enhancing innate immunity through interferons (IFNs) and IFN-stimulated genes (ISGs) offers a promising strategy for preventing herpes simplex virus type 1 (HSV-1) infection. Prunella vulgaris L., a medicinal herb, has demonstrated significant anti-HSV activity; in particular, its derived polysaccharide complex (PVE30) effectively inhibits viral replication. In this study, we investigate whether PVE30 exerts an anti-HSV-1 activity through activation of the innate immune response.

Methods: To determine the primary stage at which PVE30 exerts its effects during the HSV-1 life cycle, plaque reduction assays were conducted. Viral infection was further assessed by investigating the DNA copies, mRNA levels and protein expression of HSV-1 in infected cells using real-time polymerase chain reaction (RT-PCR) and Western blotting. The activation of the innate immune response was evaluated by detecting mRNA levels of ISGs, including MX dynamin-like GTPase 1 (Mx1), Mx2, 2'-5'-oligoadenylate synthetase 1 (OAS1), ISG15 and IFN regulatory factor 7 (IRF7) using RT-PCR, and levels of TANK-binding kinase 1 (TBK1) and IRF3 proteins using Western blotting. The translocation of phosphorylated IRF3 and stimulator of IFN genes (STING) was observed through fluorescence microscopy.

Results: PVE30 pre-treatment exerted protective effects against HSV-1 infection in human immortalized keratinocytes by enhancing the innate immune response. This was shown by increased transcriptional levels of IFN-β and antiviral ISGs, along with a significant reduction in HSV-1 DNA copies, mRNA expression and protein levels. Mechanistically, PVE30 promoted TBK1 phosphorylation, leading to nuclear translocation of IRF3 and subsequent IFN-β transcription; these effects were diminished by TBK1 inhibitor GSK8612. Additionally, STING was identified as a key mediator in PVE30-activated TBK1 signaling, as its inhibition induced by C-176 reduced PVE30's efficacy.

Conclusion: This study elucidated the molecular mechanisms underlying the protective effects of PVE30 against HSV-1 infection. PVE30 exerted its protective role by enhancing STING-TBK1-IRF3 pathway-mediated innate immune response. Please cite this article as: Zhang YB, Xu L, Yuan M, Liu MF, Li Y, Zhong XL, Lin ZX, Xian YF, Lu P, Xi ZC, Xu HX. Protective effects of Prunella vulgaris polysaccharides against herpes simplex virus type 1 infection through the STING-TBK1-IRF3 pathway. J Integr Med. 2025; Epub ahead of print.

目的:通过干扰素(IFNs)和干扰素刺激基因(ISGs)增强先天免疫是预防1型单纯疱疹病毒(HSV-1)感染的一种有希望的策略。夏枯草(Prunella vulgaris L.)是一种具有显著抗hsv活性的中药;特别是其衍生的多糖复合物(PVE30)能有效抑制病毒复制。在这项研究中,我们研究了PVE30是否通过激活先天免疫反应来发挥抗hsv -1的活性。方法:为了确定PVE30在HSV-1生命周期中发挥作用的初级阶段,进行了斑块减少试验。采用实时聚合酶链反应(RT-PCR)和Western blotting检测感染细胞中HSV-1的DNA拷贝数、mRNA水平和蛋白表达,进一步评估病毒感染情况。通过RT-PCR检测ISGs mRNA水平,包括MX动力学蛋白样GTPase 1 (Mx1)、Mx2、2'-5'-寡聚腺苷酸合成酶1 (OAS1)、ISG15和IFN调节因子7 (IRF7),以及Western blotting检测罐结合激酶1 (TBK1)和IRF3蛋白水平,评估先天免疫应答的激活。荧光显微镜下观察磷酸化IRF3和干扰素刺激因子基因(STING)的易位。结果:PVE30预处理通过增强人角化细胞的先天免疫应答,对HSV-1感染具有保护作用。IFN-β和抗病毒isg的转录水平增加,HSV-1 DNA拷贝数、mRNA表达和蛋白质水平显著降低,表明了这一点。在机制上,PVE30促进TBK1磷酸化,导致IRF3的核易位和随后的IFN-β转录;这些作用被TBK1抑制剂GSK8612所减弱。此外,STING被鉴定为PVE30激活TBK1信号的关键介质,因为C-176诱导的STING抑制降低了PVE30的功效。结论:本研究阐明了PVE30对HSV-1感染保护作用的分子机制。PVE30通过增强STING-TBK1-IRF3途径介导的先天免疫应答发挥保护作用。请以这篇文章为:张YB,徐L, M元,刘MF,李Y,钟XL,林ZX,西安YF,路P,ξ佐,徐HX。枯草多糖通过STING-TBK1-IRF3途径对1型单纯疱疹病毒感染的保护作用集成医学[J];打印前Epub。
{"title":"Protective effects of Prunella vulgaris polysaccharides against herpes simplex virus type 1 infection through the STING-TBK1-IRF3 pathway.","authors":"Yi-Bo Zhang, Lin Xu, Man Yuan, Meng-Fan Liu, Yang Li, Xuan-Lei Zhong, Zhi-Xiu Lin, Yan-Fang Xian, Ping Lu, Zhi-Chao Xi, Hong-Xi Xu","doi":"10.1016/j.joim.2025.12.008","DOIUrl":"https://doi.org/10.1016/j.joim.2025.12.008","url":null,"abstract":"<p><strong>Objective: </strong>Enhancing innate immunity through interferons (IFNs) and IFN-stimulated genes (ISGs) offers a promising strategy for preventing herpes simplex virus type 1 (HSV-1) infection. Prunella vulgaris L., a medicinal herb, has demonstrated significant anti-HSV activity; in particular, its derived polysaccharide complex (PVE30) effectively inhibits viral replication. In this study, we investigate whether PVE30 exerts an anti-HSV-1 activity through activation of the innate immune response.</p><p><strong>Methods: </strong>To determine the primary stage at which PVE30 exerts its effects during the HSV-1 life cycle, plaque reduction assays were conducted. Viral infection was further assessed by investigating the DNA copies, mRNA levels and protein expression of HSV-1 in infected cells using real-time polymerase chain reaction (RT-PCR) and Western blotting. The activation of the innate immune response was evaluated by detecting mRNA levels of ISGs, including MX dynamin-like GTPase 1 (Mx1), Mx2, 2'-5'-oligoadenylate synthetase 1 (OAS1), ISG15 and IFN regulatory factor 7 (IRF7) using RT-PCR, and levels of TANK-binding kinase 1 (TBK1) and IRF3 proteins using Western blotting. The translocation of phosphorylated IRF3 and stimulator of IFN genes (STING) was observed through fluorescence microscopy.</p><p><strong>Results: </strong>PVE30 pre-treatment exerted protective effects against HSV-1 infection in human immortalized keratinocytes by enhancing the innate immune response. This was shown by increased transcriptional levels of IFN-β and antiviral ISGs, along with a significant reduction in HSV-1 DNA copies, mRNA expression and protein levels. Mechanistically, PVE30 promoted TBK1 phosphorylation, leading to nuclear translocation of IRF3 and subsequent IFN-β transcription; these effects were diminished by TBK1 inhibitor GSK8612. Additionally, STING was identified as a key mediator in PVE30-activated TBK1 signaling, as its inhibition induced by C-176 reduced PVE30's efficacy.</p><p><strong>Conclusion: </strong>This study elucidated the molecular mechanisms underlying the protective effects of PVE30 against HSV-1 infection. PVE30 exerted its protective role by enhancing STING-TBK1-IRF3 pathway-mediated innate immune response. Please cite this article as: Zhang YB, Xu L, Yuan M, Liu MF, Li Y, Zhong XL, Lin ZX, Xian YF, Lu P, Xi ZC, Xu HX. Protective effects of Prunella vulgaris polysaccharides against herpes simplex virus type 1 infection through the STING-TBK1-IRF3 pathway. J Integr Med. 2025; Epub ahead of print.</p>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145935758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Efficacy and safety of auriculotherapy for insomnia disorder: a randomized controlled trial. 耳疗法治疗失眠症的疗效和安全性:一项随机对照试验。
IF 4 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-12-27 DOI: 10.1016/j.joim.2025.12.009
Hao Chen, Xi-Fen Zhang, Zi-Chun Yuan, Xue-Song Wang, Yuan-Bo Gao, Xu-Xin Li, Jun-Cha Zhang, Michele Dias da Silva Oliveira, Cynthia Assis de Barros Nunes, Jun Liu, Yan-Fen She

Background: Auriculotherapy is a simple, convenient, nonpharmacological option that has shown positive effects for insomnia patients, but its efficacy and safety remain unknown.

Objective: The aim of this study is to evaluate the efficacy and safety of auricular therapy for insomnia.

Design, setting, participants and intervention: An 18-week (2-week screening, 4-week treatment, and 12-week follow-up), recruiter- and assessor-blinded, randomized, sham-controlled trial was performed. Patients were recruited from outpatient settings at three clinical centers in China from 2 February 2023 to 26 January 2024. Participants had insomnia for more than 3 months and met the criteria classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Patients were randomly assigned in a 1:1 ratio to receive auricular therapy (AT) or sham AT (SAT) for 4 consecutive weeks, twice a week, and once every 3 days.

Main outcome measures: Primary outcome was the response rate at week 4 after treatment, defined as the percentage of patients with at least a 50% reduction in Pittsburgh Sleep Quality Index (PSQI) from baseline. Secondary outcomes consisted of response rates at other time points, PSQI and 4 related scales, actigraphy-recorded sleep efficiency, sleep arousal frequency, and total sleep time.

Results: A total of 234 participants were screened, and 156 patients (122 female [78.2%]; mean [SD] age, 37.2 [13.5] years) were included in the intention-to-treat analysis, with 78 participants randomized to each group. A total of 117 participants (75%) were followed up for 3 months. The AT group had a higher response rate at week 4 than the SAT group (39.73% [29/73] vs 23.29% [17/73], P = 0.03), and the response rates for the AT and SAT groups at week 2 were 28.38% (21/74) and 13.33% (10/75), respectively (P = 0.02). The differences between the two groups in the PSQI at each time point (P < 0.05) and the Insomnia Severity Index at weeks 4 and 12 (both P = 0.03) were also statistically significant. The other partial outcomes also showed statistically significant differences. Adverse events occurred in 2 cases in the AT group (2.60%).

Conclusion: Four-week AT treatment was an effective and safe alternative therapy for insomnia, although the difference with the SAT treatment did not reach the minimal clinically important difference. Adverse events were mild or transient.

Trial registration: Chinese Clinical Trial Registry, identifier ChiCTR2200065187. Please cite this article as: Chen H, Zhang XF, Yuan ZC, Wang XS, Gao YB, Li XX, Zhang JC, da Silva Oliveira MD, de Barros Nunes CA, Liu J, She YF. Efficacy and safety of auriculotherapy for insomnia disorder: A randomized controlled trial. J Integr Med. 2025; Epub ahead of print.

背景:耳疗是一种简单、方便、非药物的治疗失眠的方法,但其疗效和安全性尚不清楚。目的:评价耳穴疗法治疗失眠症的疗效和安全性。设计、设置、参与者和干预:进行了为期18周(2周筛选、4周治疗和12周随访)的招募者和评估者盲法、随机、假对照试验。从2023年2月2日至2024年1月26日,从中国三个临床中心的门诊环境中招募患者。参与者失眠超过3个月,符合精神障碍诊断与统计手册(第五版)的分类标准。患者按1:1的比例随机分配,接受耳穴治疗(AT)或假耳穴治疗(SAT),连续4周,每周2次,每3天1次。主要结局指标:主要结局指标为治疗后第4周的缓解率,定义为匹兹堡睡眠质量指数(PSQI)较基线降低至少50%的患者百分比。次要结局包括其他时间点的反应率、PSQI和4个相关量表、活动记录仪记录的睡眠效率、睡眠唤醒频率和总睡眠时间。结果:共筛选234例受试者,156例患者(女性122例[78.2%],平均[SD]年龄37.2[13.5]岁)纳入意向治疗分析,每组随机分组78例。117例(75%)随访3个月。AT组第4周的有效率高于SAT组(39.73% [29/73]vs 23.29% [17/73], P = 0.03), AT组和SAT组第2周的有效率分别为28.38%(21/74)和13.33% (10/75),P = 0.02。结论:4周at治疗是一种有效、安全的失眠替代疗法,但与SAT治疗的差异未达到临床重要的最小差异。不良事件是轻微或短暂的。试验注册:中国临床试验注册中心,标识符ChiCTR2200065187。本文署名:陈海,张晓峰,袁志成,王学祥,高玉波,李XX,张建杰,da Silva Oliveira MD, de Barros Nunes CA,刘健,She YF。耳疗法治疗失眠的疗效和安全性:一项随机对照试验。集成医学[J];打印前Epub。
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引用次数: 0
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