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Efficacy of Combined Herbal and Western Medicine Based on Traditional Chinese Medicine for Mild Cognitive Impairment and Dementia in Parkinson's Disease: A Systematic Review and Meta-Analysis. 以中医为基础的中西医结合治疗帕金森病轻度认知障碍和痴呆的疗效:系统综述和荟萃分析。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-05-15 DOI: 10.1159/000545937
Eunbyul Cho, Hui Yan Zhao, Purumea Jun, Jung-Hee Jang

Introduction: This systematic review aimed to assess the clinical evidence supporting the combination of syndrome differentiation (SD)-based herbal medicine (HM) and Western medicine (WM) in treating Parkinson's disease (PD)-mild cognitive impairment (PD-MCI) and -dementia (PDD).

Methods: Ten electronic bibliographic databases were searched from inception to March 4, 2024, for randomized controlled trials (RCTs) comparing SD-based HM plus conventional therapies with conventional therapies alone for PD-MCI and PDD. Two authors independently screened and selected studies and extracted data related to trial quality, characteristics, and results. The mean difference (MD) was used to analyze continuous variables, and meta-analysis was performed using Reviewer Manager 5.4 software. The risk of bias was assessed using the Cochrane Risk of Bias Tool.

Results: For the 15 articles selected for review, 12 trials were included in the meta-analysis: 9 comprising 688 patients with PD-MCI and 3 comprising 264 patients with PDD and with a type of SD, such as "blood stasis and stirring wind" or "deficiency of the liver-kidney." The meta-analysis showed significant differences favoring HM plus WM with respect to the Montreal Cognitive Assessment score for PD-MCI (MD = 2.30, 95% confidence interval [CI; 1.40, 3.19]; p < 0.00001, I2 = 76%) and PDD (MD = 3.14, 95% CI [0.48, 5.81]; p = 0.02, I2 = 82%) compared with WM alone. Improvement of cognitive impairment treated using "deficiency of the liver-kidney" SD-based HM plus WM in PD-MCI was more beneficial than that treated using WM alone.

Conclusions: SD-based HM may serve as an adjunctive treatment for PD-MCI and PDD, improving cognitive function and alleviating PD symptoms. No severe adverse event was observed in the HM plus WM group, suggesting that HM may be safe for patients with cognitive impairment in PD. However, evidence regarding the efficacy of HM based on SD for PD-MCI and PDD is of poor quality, and all studies were conducted in China. Thus, and rigorous, multicenter, and international RCTs are required.

本系统综述旨在评估中医辨证结合西药治疗帕金森病(PD)-轻度认知障碍(PD- mci)-痴呆(PDD)的临床证据。方法:从成立到2024年3月4日,检索10个电子书目数据库,比较基于sd的HM联合常规治疗与单独常规治疗PD-MCI和PDD的随机对照试验(rct)。两位作者独立筛选和选择研究,并提取与试验质量、特征和结果相关的数据。连续变量采用均数差异(MD)分析,meta分析采用Reviewer Manager 5.4软件。使用Cochrane偏倚风险工具评估偏倚风险。结果:在入选的15篇文章中,12项试验被纳入荟萃分析:9项包括688名PD-MCI患者,3项包括264名PDD患者和一种SD类型,如“血瘀浑风”或“肝肾虚”。meta分析显示HM + WM在PD-MCI蒙特利尔认知评估评分方面有显著差异(MD=2.30, 95%可信区间[CI;1.40、3.19);结论:基于sd的HM可作为PD- mci和PDD的辅助治疗,改善认知功能,缓解PD症状。HM + WM组未观察到严重不良事件,提示HM对PD认知障碍患者可能是安全的。然而,关于基于SD的HM对PD-MCI和PDD的疗效的证据质量较差,并且所有研究都在中国进行。因此,需要严格的、多中心的、国际化的随机对照试验。
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引用次数: 0
Critical Appraisal Tool for Homeopathic Intervention Studies: CATHIS. 顺势疗法干预研究的关键评估工具- CATHIS。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-02-12 DOI: 10.1159/000542920
Katharina Gaertner, Robert G Hahn, Radmila Razlog, Frauke Musial, Stephan Baumgartner, Martin Loef, Harald Walach

Background: The quality of homeopathic research studies is controversially discussed. In order to improve, the overall assessment of homeopathic studies and subsequently facilitate evidence-based clinical decision-making, we aimed to combine methodological tools for scientific rigor with tools for external and model validity into one global tool.

Method: Against the background of previous literature and the results of a preparatory survey, a first draft of a potential overarching tool was presented to an expert panel. Then, Delphi feedback rounds were conducted to elicit responses on the feasibility. The resulting preliminary tool was pilot-tested by five research experts on five randomly selected studies. After further optimization, another five studies were assessed by the same experts and another three experts tested the second version. The ratings were tested for interrater-reliability using Gwet's AC2.

Results: The appraisal tool comprises four domains. These are (1) the assessment of risk-of-bias using the Cochrane Tool, (2) the studies' credibility including the CONSORT statement and its extension on homeopathy, (3) the study interventions' coherence with homeopathic textbooks and previous research, and (4) the studies' clinical relevance. Each domain is assessed using a point system, which is then added up to an overall score. The instrument was evaluated as useful and "easy to apply" by the raters. The interrater reliability was 0.81 (95% CI 0.75-0.88) for five raters, and 0.64 (95% CI 0.49-0.79) for additional three raters in round 2, signifying good to moderate interrater reliability.

Conclusion: We have developed an applicable and reliable assessment tool for homeopathic intervention studies. Using it in systematic reviews and meta-analyses will increase their scientific value.

背景:顺势疗法研究的质量存在争议。为了改善顺势疗法研究的整体评估,并随后促进循证临床决策,我们的目标是将科学严谨性的方法学工具与外部和模型有效性的工具结合为一个全球性工具。方法:在先前文献和预备调查结果的背景下,向专家小组提交了一个潜在的总体工具的初稿。然后,进行德尔菲轮次反馈,以征求对可行性的回应。由此产生的初步工具由五位研究专家在五项随机选择的研究中进行了试点测试。在进一步优化后,另外五个研究由相同的专家评估,另外三个专家测试了第二个版本。使用Gwet的AC2对评级进行了inter - inter -reliability测试。结果:评价工具包括四个领域。这些评估包括使用Cochrane工具评估偏倚风险(1),研究的可信度(2),包括CONSORT声明及其对顺势疗法的延伸,研究干预措施与顺势疗法教科书和先前研究的一致性(3),以及研究的临床相关性(4)。每个领域都使用计分系统进行评估,然后将其加起来形成总分。该工具被评分者评价为有用且“易于应用”。在第2轮中,5个评分者的间信度为0.81 (95% CI 0.75至0.88),另外3个评分者的间信度为0.64 (95% CI 0.49至0.79),表明间信度良好至中等。结论:我们为顺势疗法干预研究开发了一种适用且可靠的评估工具。在系统评价和荟萃分析中使用它将增加它们的科学价值。
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引用次数: 0
The Effect of Acupoint Hot Compress on Postpartum Depressive Symptoms: A Secondary Analysis of a Randomized Controlled Trial. 穴位热敷对产后抑郁症状的影响:随机对照试验的二次分析。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-01-21 DOI: 10.1159/000543477
Yan Wu, Yuhang Zhu, Fangfang Wang, Fan Qu

Introduction: Postpartum depressive symptoms (PDS) are common in women after delivery and often progress to postpartum depression (PPD). This secondary analysis aimed to evaluate the effect of acupoint hot compress in patients with different PPD risks.

Methods: We conducted a secondary analysis of data from a multicenter randomized controlled trial involving 1,085 participants. Of these, 537 received acupoint hot compress treatment, while 548 received routine postpartum care. Participants were categorized into two groups based on Edinburgh Postnatal Depression Scale (EPDS) scores measured 76.5 h after delivery. Baseline demographic and clinical characteristics were compared, and logistic regression models were used to assess the association between acupoint hot compress and PDS. Subgroup analyses were used to determine the effect of acupoint hot compress on participants with different PPD risks.

Results: Among the 1,085 participants, 866 were in the low-risk PPD group (EPDS score <9), and 219 in the high-risk PPD group (EPDS score ≥9). Educational level, labor induction, postpartum uterine contraction pain intensity, sleep and appetite during pregnancy significantly impacted PDS. Acupoint hot compress significantly improved PDS after vaginal delivery, particularly in high-risk PPD patients with lower educational levels, abnormal pregnancy appetite or sleep, and serve postpartum uterine contraction pain.

Conclusion: Acupoint hot compress is an effective, non-invasive intervention with minimal side effects for improving PDS.

产后抑郁症状(PDS)在分娩后的妇女中很常见,并且经常发展为产后抑郁症(PPD)。本次要分析旨在评价穴位热敷在不同PPD风险患者中的效果。方法:我们对一项涉及1085名参与者的多中心随机对照试验的数据进行了二次分析。其中537人接受穴位热敷治疗,548人接受常规产后护理。参与者根据分娩后76.5小时测量的爱丁堡产后抑郁量表(EPDS)得分分为两组。比较基线人口学特征和临床特征,并使用logistic回归模型评估穴位热敷与PDS之间的关系。采用亚组分析来确定穴位热敷对不同PPD风险参与者的影响。结果:1085例受试者中,低危组866例(EPDS评分< 9),高危组219例(EPDS评分≥9),受教育程度、产程诱导、产后子宫收缩疼痛强度、妊娠期睡眠和食欲对PDS有显著影响。穴位热敷可显著改善阴道分娩后PDS,尤其对受教育程度较低、孕期食欲或睡眠异常的高危PPD患者,可缓解产后子宫收缩疼痛。结论:穴位热敷是一种改善产后抑郁症状的有效、无创、副作用小的干预方法。
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引用次数: 0
A Randomized Controlled Crossover Trial to Determine the Effects of Three Nostril-Regulated Breathing Practices on Attention and Mood. 一项确定三种鼻孔调节呼吸练习对注意力和情绪影响的随机对照交叉试验。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-02-05 DOI: 10.1159/000543934
Kumar Gandharva, Sachin Kumar Sharma, Acharya Balkrishna, Shirley Telles

Background: Previous studies on nostril-regulated breathing have contrasting findings attributed to lack of controls or not taking into account baseline nostril patency. This randomized crossover study on the effects of three nostril-regulated yoga breathing practices and two controls on mood states and attention attempted to address these issues.

Materials and methods: Forty-five participants between 20 and 45 years (group mean age ± SD; 24.3 ± 3.8 years; M:F: 23:22) were assessed in five sessions in random order on five separate days. Nostril patency-recorded pre-interventions in 225 sessions showed right nostril dominant at rest (RNDR) in 136 and left nostril dominant at rest (LNDR) in 89 sessions. The sessions were (i) SAV or right uninostril breathing, (ii) CAV or left uninostril breathing, (iii) AV or alternate nostril yoga breathing, (iv) breath awareness, and (v) quiet seated rest (QS). The practices were for 15 min each. Nostril patency was recorded pre, and Brief Mood Introspection Scale (BMIS), Global Vigor and Affect Scale (GVAS), and Six-Letter Cancellation Test (SLCT) were recorded pre- and post-each session. Data analysis used general linear mixed model analysis, with fixed effects of states (pre and post), sessions, and baseline nostril dominance (right or left).

Results: A significant interaction of sessions, states, and nostril dominance at baseline was observed for total global affect (F9,396.194 = 2.871, p = 0.003) which increased after SAV, CAV, AV, and QS in participants' RNDR (padj < 0.05 in all cases). A significant main effect of states was observed followed by significant post hoc pairwise comparison in RNDR for (i) pleasant mood after SAV, CAV, AV, and QS, (ii) positive mood after SAV and AV, (iii) global vigor (GV) after SAV, CAV, AV, and QS, and (iv) a decrease in negative mood after CAV and AV, while the volunteers who had LNDR showed a significant increase in (i) PU after CAV, AV, and QR, (ii) PT after CAV, and (iii) GV after CAV and QS.

Conclusion: Nostril dominance pre-intervention appears to influence the effects of nostril-regulated yoga breathing practices.

背景:先前关于鼻孔调节呼吸的研究有不同的结果,归因于缺乏控制或未考虑基线鼻孔通畅。这项随机交叉研究对三种调节鼻孔的瑜伽呼吸练习和两种控制情绪状态和注意力的效果进行了研究,试图解决这些问题。材料与方法:受试者45例,年龄在20 ~ 45岁之间(组平均年龄±SD;24.3±3.8年;M;F 23:22)在5天内随机进行5次评估。225次干预前记录的鼻孔通畅情况显示,在休息时右鼻孔占主导地位(RNDR) 136次,在休息时左鼻孔占主导地位(LNDR) 89次。这些阶段分别是:(i)单鼻孔呼吸法或右鼻孔呼吸法,(ii)单鼻孔呼吸法或左鼻孔呼吸法,(iii)单鼻孔呼吸法或鼻孔交替呼吸法,(iv)呼吸意识(BAW),以及(v)安静坐着休息(QS)。每次练习15分钟。在每次治疗前和治疗后分别记录鼻孔开度、简短情绪自省量表(BMIS)、整体活力和情绪量表(GVA)和六字母消除测试(SLCT)。数据分析采用一般线性混合模型分析,固定状态(前后),会话和基线鼻孔优势(右或左)的影响。结果:实验阶段、状态和基线时的鼻孔优势对总体情绪(GA)有显著的交互作用(f9396.194 =2.871, p=0.003),在参与者静止时右鼻孔优势(NDR)的SAV、CAV、AV和QS后总体情绪(GA)增加(结论:鼻孔优势干预前似乎影响了鼻孔调节呼吸练习的效果。
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引用次数: 0
Yoga Asana Increases Prefrontal Cortex Activity and Reduces Resting-State Functional Connectivity. 瑜伽体式增加前额叶皮层活动,减少静息状态功能连接。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-03-28 DOI: 10.1159/000545381
Michelle Goodrick, Eleazar Samuel Kolosovas-Machuca, Edgar Guevara

Introduction: Various aspects of yoga have been researched for their psychological benefits, yet the neurological mechanisms underlying physical yoga postures (asana) remain inadequately explored due to limitations in prior neuroimaging techniques. The prefrontal cortex (PFC) has been established as an important region of interest concerning psychological health. Therefore, this study aimed to characterize changes in the PFC before, during, and after asana by applying the functional near-infrared spectroscopy (fNIRS) mobile neuroimaging technique.

Methods: Twenty-seven healthy adults completed two 6-min, task-independent resting states before and after a 23-min asana routine. With the fNIRS device positioned on the frontal region of the skull, PFC activity was measured during each asana and resting state. The block design involved alternating between three active postures and one control posture. Each active posture was performed for 30 s and repeated 8 times, while the control posture was held during inter-trial intervals lasting 25-30 s. Across the session, this block design resulted in a total of 24 active blocks (8 repetitions of each active posture) and 25 baseline blocks (control posture intervals).

Results: All three active asanas significantly increased PFC activity versus baseline, particularly in the right PFC. Furthermore, analysis of short-term changes in resting-state functional connectivity (rsFC) revealed a significant decrease, primarily in the left medial PFC, a key region of the default mode network (DMN), an area known to exhibit heightened activity in individuals suffering from depression and anxiety.

Conclusion: This study provides neurological insight into the effects of yoga asana and supports fNIRS for assessing movement-based practices in real-world settings.

导读:人们对瑜伽的心理益处进行了多方面的研究,但由于先前的神经成像技术的限制,瑜伽体式(体式)背后的神经机制仍然没有得到充分的探索。前额叶皮层(PFC)已被确立为与心理健康相关的重要兴趣区域(ROI)。因此,本研究旨在通过应用功能近红外光谱(fNIRS)移动神经成像技术来表征体式前后PFC的变化。方法:27名健康成人在进行23分钟的体式练习前后分别完成两次6分钟的任务独立休息状态。fNIRS装置位于颅骨额叶区域,在每个体式和静息状态下测量PFC活动。block设计包括三种主动姿势和一种控制姿势之间的交替。每个主动姿势30秒,重复8次,对照姿势25-30秒。在整个实验过程中,这个模块设计总共产生了24个活动模块(每个活动姿势重复8次)和25个基线模块(控制姿势间隔)。此外,静息状态功能连接(rsFC)的短期变化分析显示,PFC的活性显著降低,主要发生在左内侧前额叶皮层(PFC),这是默认模式网络(DMN)的关键区域,已知该区域在患有抑郁症和焦虑症的个体中表现出较高的活性。这项研究为瑜伽体式的效果提供了神经学上的见解,并支持fNIRS在现实环境中评估基于运动的练习。
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引用次数: 0
Erratum. 勘误表。
IF 0.8 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-12-10 DOI: 10.1159/000549429

In the article "Commonality Analysis of High-Quality Acupuncture Clinical Trial Articles" [Complement Med Res. 2025;32:314-325; https://doi.org/10.1159/000547403] by Ou et al., the equal contribution of Silin Ou and Ming Dong as co-first authors was inadvertently omitted in the published version.Silin Ou and Ming Dong contributed equally to this work and are co-first authors.

文章《高质量针灸临床试验文章的共性分析》[补体医学杂志,2025;32:31 14-325;在Ou等人的https://doi.org/10.1159/000547403]中,作为共同第一作者的欧思林和董明的同等贡献在已发表的版本中被无意中省略了。欧思林和董明对这项工作做出了同样的贡献,并且是共同第一作者。
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引用次数: 0
Do Individuals with Vertigo or Dizziness Complaints Have a Tendency to Use Complementary and Alternative Medicine Approaches? A Case-Control Study. 个人抱怨眩晕或头晕是否倾向于使用补充和替代医学方法?病例对照研究。
IF 0.8 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-10-10 DOI: 10.1159/000548835
Özge Gedik Toker, Erdem Emre Yilmaz, Büşra Özbay, Elif İlayda Aksakal, Ayşe Güneş Bayir

Introduction: Dizziness and vertigo are prevalent reasons for medical consultation, stemming from various benign and pathological conditions. Although traditional treatments are available, complementary and alternative medicine (CAM) approaches are increasingly sought by patients for almost all diseases. This study aimed to investigate the use of CAM approaches in individuals with and without vertigo/dizziness and to compare the results.

Methods: The study enrolled 208 participants, 104 of them had complaints of vertigo/dizziness (patient group) and the remaining were without such symptoms (control group). Participants were queried about used CAM approaches, and study participants underwent vestibular assessment.

Results: It was revealed that there was a significant higher prevalence of herbal supplement usage among individuals with vertigo/dizziness complaints compared to without vertigo/dizziness. However, no significant differences were found in the usage of other CAM approaches between the groups. Among CAM users in the patient group, the majority did not aim to alleviate vertigo/dizziness symptoms.

Conclusions: This study contributes to understanding CAM utilization patterns among vertigo/dizziness patients and underscores the importance of further research to explore the efficacy and safety of CAM approaches in managing these symptoms. Future studies should take into account socioeconomic and sociocultural factors affecting the use of CAM approaches and should aim to evaluate the effectiveness of specific CAM approaches in the treatment of vertigo/dizziness.

简介:头晕和眩晕是医学咨询的普遍原因,源于各种良性和病理条件。虽然有传统治疗方法,但几乎所有疾病的患者都越来越多地寻求补充和替代医学方法。本研究旨在调查CAM方法在患有和不患有眩晕/头晕的个体中的使用情况,并比较结果。方法:本研究共招募208名受试者,其中有眩晕/头晕症状的104人(患者组),无眩晕/头晕症状的104人(对照组)。所有参与者都询问了使用的CAM方法,并进行了前庭评估。结果:与没有眩晕/头晕的人相比,有眩晕/头晕症状的人使用草药补充剂的比例明显更高。然而,在其他CAM方法的使用中,两组之间没有发现显著差异。患者组中大多数CAM使用者没有使用CAM方法来缓解眩晕/头晕症状。结论:本研究有助于更好地了解眩晕/头晕患者的CAM使用模式,并强调了进一步研究CAM方法治疗这些症状的有效性和安全性的重要性。未来的研究应考虑影响CAM方法使用的社会经济和社会文化因素,并旨在评估特定CAM方法治疗眩晕/头晕的有效性。
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引用次数: 0
Cognitive Benefits of Ginseng: A Systematic Review and Meta-Analysis of Changes in Mini-Mental State Examination and Alzheimer's Disease Assessment Scale-Cognitive Subscale Scores. 人参的认知益处:MMSE和ADAS-cog评分变化的系统回顾和荟萃分析。
IF 0.8 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-08-07 DOI: 10.1159/000547543
Junyeon Kim, Minji Kang, Hyunjung Lim

Background: Despite the potential cognitive benefits of ginseng, evidence of its effects on cognitive function remains limited. We aimed to evaluate the association between ginseng and cognitive function in individuals with cognitive or memory impairment including those with subjective memory impairment, mild cognitive impairment, and Alzheimer's disease through a systematic review and meta-analysis of recent randomized controlled trials (RCTs).

Methods: We searched six databases: PubMed, Embase, Cochrane Library, Korean Studies Information Service System (KISS), Research Information Sharing Service (RISS), and ScienceON, for RCTs investigating the effects of ginseng on cognitive function up to April 26, 2024. Two independent researchers assessed the methodological quality and risk of bias of the extracted studies. Data were presented as the mean difference (MD) with 95% confidence interval (CI), and a subgroup analysis was performed based on ginseng dosage.

Results: Eight studies were included in this meta-analysis. The results suggested that ginseng may have a potential effect on cognitive improvement. Ginseng consumption showed a significant effect on increasing Mini-Mental State Examination scores (MD = 0.68; 95% CI: 0.03, 1.32; p = 0.04; I2 = 66%). For Alzheimer's Disease Assessment Scale-Cognitive Subscale, a significant reduction in scores was observed in both the total (MD = -1.10; 95% CI: -1.82, -0.38; p = 0.003; I2 = 0%) and low-dose groups (MD = -1.09; 95% CI: -1.96, -0.22; p = 0.01; I2 = 0%).

Conclusion: Ginseng consumption was found to be beneficial for changes in certain cognitive function-related indicators. However, further research is required to determine the long-term effects of ginseng based on dosage.

背景:尽管人参具有潜在的认知益处,但其对认知功能影响的证据仍然有限。我们旨在通过最近的随机对照试验(RCT)的系统回顾和荟萃分析来评估人参与认知功能之间的关系。方法:检索PubMed、Embase、Cochrane Library、Korean Studies Information Service System (KISS)、Research Information Sharing Service (RISS)、ScienceON等6个数据库,检索截至2024年4月26日人参对认知功能影响的随机对照试验。两名独立研究人员评估了提取研究的方法学质量和偏倚风险。数据以95%可信区间(CI)的均值差(MD)表示,并基于人参剂量进行亚组分析。结果:本meta分析纳入8项研究。研究结果表明,人参可能具有改善认知能力的潜在作用。人参消费对提高最小精神状态检查(MMSE)分数有显著影响(MD = 0.68;95% ci: 0.03, 1.32;P = 0.04;I²= 66%)。对于阿尔茨海默病评估量表-认知子量表(ADAS-cog),两项总分均显著降低(MD = -1.10;95% ci: -1.82, -0.38;P = 0.003;I²= 0%)和低剂量组(MD = -1.09;95% ci: -1.96, -0.22;P = 0.01;I²= 0%)。结论:人参对某些认知功能相关指标的改变是有益的。然而,需要进一步的研究来确定人参基于剂量的长期效果。
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引用次数: 0
What a Study Is about Should Be Clear. 研究的目的应该是明确的。
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2024-06-10 DOI: 10.1159/000539409
Axel Wiebrecht
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引用次数: 0
Evaluation of Auricular Acupressure on Myopia Prevention among Children Aged 6-12 Years with Pre-Myopia in China: Study Protocol of a Prospective Multi-Center Randomized Controlled Trial. 耳穴按压对中国6-12岁近视前期儿童近视预防效果的评价:一项前瞻性多中心随机对照试验的研究方案
IF 1.1 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-01-01 Epub Date: 2025-01-07 DOI: 10.1159/000542442
Jianquan Wang, Yipeng Shi, Xin Yan, Xinru Wu, Ke'er Cao, Luquan Chen, Jun Liu, Hua Peng, Chunxia Li, Liqun Chu, Danlei Wu, Shangkun Zhou, Yingxin Yang, Yangzhong Wang, Xinquan Liu, Jike Song, Fengming Liang, Jing Yao, Zhihua Shen, Fengmei Zhang, Xiaolei Yao, Tao Zuo, Wei Shi, Wujun Li, Xinyue Hou, Zefeng Kang

Background: The increasing prevalence of myopia among Chinese children and adolescents, especially at younger ages, has emerged as a significant concern in recent years. Pre-myopia is a key period for myopia prevention and control in children and adolescents. Previous studies suggested auricular acupressure (AA) therapy might offer a viable approach to prevent and slow down myopia progression. Nonetheless, these studies lack robust, high-quality, large-scale, multi-center evidence to conclusively support such assertions. The purpose of this research is to evaluate the efficacy, safety, and economic benefits of AA therapy in preventing myopia in Chinese children aged 6-12 years with pre-myopia.

Methods: The single-blind, multi-center, parallel-group, randomized controlled trial will involve 318 pre-myopic children from 20 different centers across China. After recruitment, these participants will be randomly assigned to two groups (the AA group and the control group) at a 1:1 ratio. The AA group will receive auricular point sticking therapy along with health education for a period of 24 weeks, while the control group will be provided the sham AA treatment and routine health education. The assessments of outcomes will be conducted at the start of this study, and then after 4, 8, 12, and 24 weeks. The primary outcome is the change in spherical equivalent refraction at various follow-up times. The secondary outcomes include the number of myopia cases, uncorrected visual acuity, axial length, corneal curvature radius, accommodation amplitude, retinal and choroidal thickness, and eye behavior management. In addition, the cost-effectiveness analysis will be used as the evaluation index for economic assessment.

Discussion: The results of this research will provide evidence on the efficacy, safety, and economic benefits of AA therapy in preventing myopia among children aged 6-12 years with pre-myopia in China.

背景:近年来,中国儿童和青少年,特别是低龄儿童和青少年的近视发病率不断上升,这已成为一个值得关注的问题。近视前期是儿童青少年预防和控制近视的关键时期。以前的研究表明,耳穴压疗法可能是预防和减缓近视进展的可行方法。然而,这些研究缺乏可靠的、高质量的、大规模的、多中心的证据来结论性地支持这些断言。本研究的目的是评估AA治疗在中国6-12岁近视前期儿童中预防近视的有效性、安全性和经济效益。方法:采用单盲、多中心、平行组、随机对照试验,纳入来自全国20个不同中心的318名近视前期儿童。招募结束后,这些参与者将按1:1的比例随机分为AA组和对照组两组。AA组在进行健康教育的同时进行耳穴贴敷治疗,为期24周;对照组在进行假AA治疗的同时进行常规健康教育。结果评估将在本研究开始时进行,然后在4、8、12和24周后进行。主要结果是在不同的随访时间的球等效折射的变化。次要结果包括近视例数、未矫正视力、眼轴长度、角膜曲率半径、调节幅度、视网膜和脉络膜厚度以及眼行为管理。此外,将成本效益分析作为经济评价的评价指标。讨论:本研究结果将为AA治疗在中国6-12岁近视前期儿童中预防近视的有效性、安全性和经济效益提供证据。
{"title":"Evaluation of Auricular Acupressure on Myopia Prevention among Children Aged 6-12 Years with Pre-Myopia in China: Study Protocol of a Prospective Multi-Center Randomized Controlled Trial.","authors":"Jianquan Wang, Yipeng Shi, Xin Yan, Xinru Wu, Ke'er Cao, Luquan Chen, Jun Liu, Hua Peng, Chunxia Li, Liqun Chu, Danlei Wu, Shangkun Zhou, Yingxin Yang, Yangzhong Wang, Xinquan Liu, Jike Song, Fengming Liang, Jing Yao, Zhihua Shen, Fengmei Zhang, Xiaolei Yao, Tao Zuo, Wei Shi, Wujun Li, Xinyue Hou, Zefeng Kang","doi":"10.1159/000542442","DOIUrl":"10.1159/000542442","url":null,"abstract":"<p><strong>Background: </strong>The increasing prevalence of myopia among Chinese children and adolescents, especially at younger ages, has emerged as a significant concern in recent years. Pre-myopia is a key period for myopia prevention and control in children and adolescents. Previous studies suggested auricular acupressure (AA) therapy might offer a viable approach to prevent and slow down myopia progression. Nonetheless, these studies lack robust, high-quality, large-scale, multi-center evidence to conclusively support such assertions. The purpose of this research is to evaluate the efficacy, safety, and economic benefits of AA therapy in preventing myopia in Chinese children aged 6-12 years with pre-myopia.</p><p><strong>Methods: </strong>The single-blind, multi-center, parallel-group, randomized controlled trial will involve 318 pre-myopic children from 20 different centers across China. After recruitment, these participants will be randomly assigned to two groups (the AA group and the control group) at a 1:1 ratio. The AA group will receive auricular point sticking therapy along with health education for a period of 24 weeks, while the control group will be provided the sham AA treatment and routine health education. The assessments of outcomes will be conducted at the start of this study, and then after 4, 8, 12, and 24 weeks. The primary outcome is the change in spherical equivalent refraction at various follow-up times. The secondary outcomes include the number of myopia cases, uncorrected visual acuity, axial length, corneal curvature radius, accommodation amplitude, retinal and choroidal thickness, and eye behavior management. In addition, the cost-effectiveness analysis will be used as the evaluation index for economic assessment.</p><p><strong>Discussion: </strong>The results of this research will provide evidence on the efficacy, safety, and economic benefits of AA therapy in preventing myopia among children aged 6-12 years with pre-myopia in China.</p>","PeriodicalId":10541,"journal":{"name":"Complementary Medicine Research","volume":" ","pages":"3-12"},"PeriodicalIF":1.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142945918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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Complementary Medicine Research
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