Integrative Medicine Research最新文献_第5页

Modified Saengmaeksan, an herbal formula containing six herbs, improves hypertension through RhoA/Rho kinase-mediated vasorelaxation 含有6种草药的“生脉山”改良配方，通过RhoA/Rho激酶介导的血管松弛，改善高血压

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-26 DOI: 10.1016/j.imr.2025.101207

Young Mi Seok , Hye-Lin Kim , Hyo In Kim , Hobin Moon , Yohan Han , Eun Sang Cho , Hyun Hee Leem , Hyo Jung Kim , Sujin Shin , Se-Jin Kim , Jin Ki Jung , Wei Huang , Kyung Oh Jung , Doo Suk Lee , Sung Giu Jin , Hyunwoo Kim , Changsop Yang , Kyungjin Lee , Jinbong Park

Background

Saengmaeksan is a traditional herbal formula used in Korean medicine. We composed a modified formula based on Saengmaeksan (mSMS) with Puerariae Radix, Platycodonis Radix, Liriopis seu Ophiopogonis Tuber, Schisandrae Fructus, Coicis Semen, and Dioscoreae Rhizoma to investigate its in vivo and ex vivo antihypertensive effects and underlying mechanisms.

Methods

The antihypertensive efficacy of mSMS was assessed using l-NAME-induced hypertensive mice and spontaneously hypertensive rats (SHR). The animals were treated with mSMS, and blood pressure was monitored weekly. Vascular effects were evaluated through organ bath studies and aortic histology, while oxidative stress was assessed using DCF-DA staining. Renal protection was examined via H&E and immunofluorescence staining for AT1R expression. The molecular mechanisms were explored through Western blot analysis and GTP-RhoA assays.

Results

mSMS significantly reduced systolic and diastolic blood pressure in both hypertensive models, with the ethanol extract demonstrating superior efficacy. mSMS inhibited the RhoA/Rho kinase pathway, leading to reduced phosphorylation of MYPT1 and CPI17, and improved vascular relaxation. Additionally, mSMS attenuated aortic wall thickening, oxidative stress, and renal damage, with a marked decrease in AT1R expression in the kidneys.

Conclusions

mSMS exhibits potent antihypertensive effects through the inhibition of the RhoA/Rho-kinase pathway, reduction of vascular remodeling, oxidative stress, and renal protection. These findings support the potential of mSMS as a novel therapeutic agent for hypertension, offering a multi-targeted approach with fewer side effects compared to conventional therapies. Further clinical studies are required to confirm its clinical efficacy.

生麦散是韩国医学中使用的传统草药配方。以葛根、桔梗、麦冬、五味子、薏苡仁、薯蓣为原料，研制了以生脉散为主要成分的复方制剂，研究其体内外抗高血压作用及其机制。方法以l- name诱导的高血压小鼠和自发性高血压大鼠（SHR）为实验对象，观察mSMS的降压效果。这些动物接受mSMS治疗，并每周监测血压。血管效应通过器官浴研究和主动脉组织学评估，氧化应激采用DCF-DA染色评估。通过H&；E和免疫荧光染色检测AT1R表达对肾脏的保护作用。通过Western blot分析和GTP-RhoA分析探讨其分子机制。结果smsms可显著降低两种高血压模型的收缩压和舒张压，其中乙醇提取物效果更佳。mSMS抑制RhoA/Rho激酶途径，导致MYPT1和CPI17磷酸化降低，改善血管舒张。此外，mSMS减轻了主动脉壁增厚、氧化应激和肾脏损伤，肾脏中AT1R表达显著降低。结论smsms通过抑制RhoA/ rho激酶通路、减少血管重构、氧化应激和肾保护作用，具有较强的降压作用。这些发现支持mSMS作为一种新型高血压治疗剂的潜力，与传统疗法相比，mSMS提供了一种多靶点的治疗方法，副作用更少。其临床疗效有待进一步的临床研究证实。

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引用次数: 0

The efficacy and safety of multiple acupuncture therapies in primary insomnia: A Bayesian network meta-analysis 多种针灸疗法治疗原发性失眠的疗效和安全性：一项贝叶斯网络meta分析

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-25 DOI: 10.1016/j.imr.2025.101206

Liguo Liu , Yiming Chen , Minne Tian , Zhennan Wu , Peiming Zhang , Tiankang Zhang , Jinsong Yang , Haotian Qu , Zhiyong Fan , Shan Wu , Liming Lu , Yu Kui

Background

Acupuncture (AT) therapy is an effective treatment for primary insomnia. However, no comprehensive study has compared and evaluated the efficacy and safety of multiple AT therapies and hypnotics.

Methods

We searched eight databases from inception to July 2024 for randomized controlled trials (RCTs) of AT treatment for primary insomnia, including PubMed, Web of Science, Embase, Cochrane Library, Wanfang database, China National Knowledge Infrastructure database, and VIP Chinese Science and Technique Journals database. After screening, the Pittsburgh Sleep Quality Index (PSQI) score and clinical effectiveness rate were extracted from the included RCTs as outcome measures. We performed network meta-analysis using the Stata and R software.

Results

Sixty-four RCTs involving 4443 patients were included in this study. Multiple AT therapies had better efficacy in improving PSQI scores than hypnotics, with AT combined with moxibustion (MOX) and AT combined with auriculotherapy (AU) as the best interventions. Regarding clinical effectiveness, acupoint catgut embedding (ACE) had the greatest potential of being the best intervention, and no serious adverse events related to AT therapies were observed in any of the studies.

Conclusion

This review suggests that most AT therapies improve sleep indicators and have good clinical efficacy compared to hypnotics, especially AT combined with AU, AT combined with MOX, and ACE. The safety of AT therapies is reliable; however, the overall quality of the included trials was low, and higher-quality RCTs are required to provide sufficient evidence.

Protocol registration

PROSPERO, CRD42017067402.

背景：针灸治疗是治疗原发性失眠的有效方法。然而，目前还没有全面的研究对多种AT疗法和催眠药物的疗效和安全性进行比较和评估。方法检索PubMed、Web of Science、Embase、Cochrane图书馆、万方数据库、中国国家知识基础设施数据库、VIP中国科技期刊数据库等8个数据库，检索自成立以来至2024年7月AT治疗原发性失眠的随机对照试验（rct）。筛选后，从纳入的随机对照试验中提取匹兹堡睡眠质量指数（PSQI）评分和临床有效率作为结局指标。我们使用Stata和R软件进行网络meta分析。结果共纳入64项随机对照试验，共4443例患者。多种AT治疗对PSQI评分的改善效果优于催眠治疗，其中AT联合艾灸（MOX）和AT联合耳穴治疗（AU）是最佳干预措施。在临床效果方面，穴位埋线（ACE）最有可能成为最佳干预措施，所有研究均未观察到与AT治疗相关的严重不良事件。结论与催眠药相比，大多数AT治疗均能改善睡眠指标，临床疗效较好，尤其是AT联合AU、AT联合MOX和ACE。AT疗法的安全性是可靠的；然而，纳入试验的总体质量较低，需要更高质量的随机对照试验来提供足够的证据。协议注册号prospero， CRD42017067402。

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引用次数: 0

Development of core outcome set for healthy aging treatment in primary care settings 初级保健机构健康老龄治疗的核心结果集的发展

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-19 DOI: 10.1016/j.imr.2025.101205

Soobin Jang , Hyein Jeong , Jungi Park , Mi Mi Ko , Jeeyoun Jung

Background

Healthy aging is a global public health priority, with increasing interest in the promotion of functional ability and well-being among older adults. South Korea’s rapidly aging population highlights the need for standardized evaluation tools for interventions. This study aimed to develop a Core Outcome Set (COS) for healthy aging treatment in primary care.

Methods

The COS was developed following the COS-STAD guidelines and through a multiphase process, including a literature review and a modified Delphi consensus. A project management group (PMG) reviewed studies related to health promotion programs and generated an initial list of outcomes. This list was refined through two rounds of Delphi surveys involving 16 experts. Consensus was assessed using content validity ratio, degree of consensus, and convergence.

Results

Twenty-six studies informed the initial outcome list, resulting in 24 outcomes for the Delphi evaluation. Two Delphi rounds and a final review by the PMG established a COS comprising 12 outcomes. These included EQ-5D, Geriatric Depression Scale, Instrumental Activities of Daily Living, body weight, blood pressure, blood glucose, blood lipids, liver function, kidney function, Korean Frailty Index, Self-rated Health, and Kidney-Deficiency Score.

Conclusions

The COS provides a standardized set of outcomes for evaluating healthy aging interventions in primary care. Its application in primary care and health promotion programs may enhance comparability across studies and support evidence-based decision making. Future revisions are recommended based on clinical applications and emerging research findings.

健康老龄化是全球公共卫生的优先事项，人们对促进老年人的功能能力和福祉越来越感兴趣。韩国人口的迅速老龄化凸显了对干预措施标准化评估工具的需求。本研究旨在建立一个核心结局集（COS），用于初级保健中的健康老龄化治疗。方法COS遵循COS- stad指南，经过多阶段的过程，包括文献回顾和修改的德尔菲共识。一个项目管理小组（PMG）审查了与健康促进计划有关的研究，并产生了初步的结果清单。这份名单是通过16位专家参与的两轮德尔菲调查来完善的。共识评估使用内容效度比，共识程度，和收敛。结果26项研究提供了初步结果表，得到24个德尔菲评价结果。两轮德尔菲和PMG的最后审查建立了一个包含12个结果的COS。这些包括EQ-5D、老年抑郁量表、日常生活工具活动、体重、血压、血糖、血脂、肝功能、肾功能、韩国虚弱指数、自评健康和肾虚评分。结论COS为评价初级保健中健康老龄化干预措施提供了一套标准化的结果。它在初级保健和健康促进计划中的应用可以增强研究之间的可比性，并支持循证决策。未来的修订建议基于临床应用和新兴的研究成果。

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引用次数: 0

Effectiveness and safety of combining pharmacopuncture therapy and acupotomy for treating patients with degenerative lumbar spinal stenosis: A pragmatic, assessor-blinded, randomized, controlled trial 药物穿刺联合针刀治疗退行性腰椎管狭窄的有效性和安全性：一项实用、评估盲、随机、对照试验

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-18 DOI: 10.1016/j.imr.2025.101204

Jihun Kim , Chang-Hyun Han , Taewook Lee , Sookwang An , Changsop Yang , Young Eun Choi , Byoung-Kab Kang , Yoona Oh , Kun Hyung Kim , Gi Young Yang , Eunseok Kim

Background

In the clinical practice of Korean Medicine, pharmacopuncture therapy and acupotomy (PA) are being increasingly explored as potential treatment options for degenerative lumbar spinal stenosis (LSS). In this study, we aimed to evaluate the effectiveness and safety of combining PA with conventional Korean Medicine treatment (CKMT) in patients with degenerative LSS.

Methods

A pragmatic, assessor-blinded, randomized controlled trial was conducted with 104 participants aged 40–75 years diagnosed with degenerative LSS. The participants were randomly assigned to either the CKMT+PA or CKMT alone groups over a 6-week period. The primary outcome was the mean change in the visual analog scale (VAS) for pain/discomfort. Secondary outcomes included clinically important differences (CID), Zurich Claudication Questionnaire, self-reported maximum walking distance, Roland-Morris Disability Questionnaire, EuroQol 5-dimension 5-level questionnaire, and patients’ global impression of change. The adverse events (AEs) were assessed at each visit.

Results

The CKMT+PA group showed significant improvements in VAS scores compared to the CKMT group at 6 weeks (adjusted mean difference: 20.26; 95 % confidence interval: 13.79–26.72, p < 0.0001), and a higher proportion of patients in the CKMT+PA group achieved the minimal CID in pain reduction. These improvements persisted at weeks 10 and 14. Superior results were also observed with respect to secondary outcomes in the CKMT+PA group compared to the CKMT group across all time points. CKMT showed no AEs, while mild AEs occurred in 1.7 % of bee venom and 2.2 % of acupotomy sessions.

Conclusion

Compared to CKMT alone, CKMT+PA offers significant improvements in pain relief, functional capacity, and quality of life in patients with degenerative LSS.

Trial registration

Clinical Research Information Service (CRIS) registry, KCT0008557.

在韩国医学的临床实践中，药物穿刺疗法和针刀（PA）正越来越多地被探索作为退行性腰椎管狭窄症（LSS）的潜在治疗选择。在本研究中，我们旨在评估PA联合传统韩药治疗（CKMT）治疗退行性LSS患者的有效性和安全性。方法对104例年龄40 ~ 75岁的退行性LSS患者进行了一项实用、评估盲、随机对照试验。参与者在6周的时间内被随机分配到CKMT+PA组或CKMT单独组。主要结局是疼痛/不适的视觉模拟评分（VAS）的平均变化。次要结局包括临床重要差异（CID）、苏黎世跛行问卷、自述最大步行距离、Roland-Morris残疾问卷、EuroQol 5维5级问卷、患者整体印象变化。每次就诊时对不良事件（ae）进行评估。结果与CKMT组相比，CKMT+PA组在6周时VAS评分有显著改善（调整平均差值：20.26；95%可信区间：13.79-26.72,p < 0.0001）， CKMT+PA组中更高比例的患者在疼痛减轻方面达到最小CID。这些改善持续到第10周和第14周。与CKMT组相比，CKMT+PA组在所有时间点的次要结果也优于CKMT组。CKMT未显示不良事件，而1.7%的蜂毒组和2.2%的针刀组出现轻度不良事件。结论与单纯CKMT治疗相比，CKMT+PA治疗可显著改善退行性LSS患者的疼痛缓解、功能能力和生活质量。临床研究信息服务（CRIS）注册，KCT0008557。

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引用次数: 0

From sound to science: Enhancing transparency in music-based therapeutic research 从声音到科学：提高音乐治疗研究的透明度

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-17 DOI: 10.1016/j.imr.2025.101203

Hyun Ju Chong

引用次数: 0

Reporting guidelines for music-based interventions checklist: Explanation and elaboration guide 基于音乐的干预措施报告指南清单：解释和阐述指南

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-17 DOI: 10.1016/j.imr.2025.101200

Sheri L. Robb , K. Maya Story , Elizabeth Harman , Debra S. Burns , Joke Bradt , Emmeline Edwards , Tasha L. Golden , Christian Gold , John R. Iversen , Assal Habibi , Julene K. Johnson , Miriam Lense , Susan M. Perkins , Stacey Springs

Background

Detailed intervention reporting is essential to interpretation, replication, and eventual translation of music-based interventions (MBIs) into practice. Despite availability of Reporting Guidelines for Music-based Interventions (RG-MBI, published 2011), multiple reviews reveal sustained problems with reporting quality and consistency. To address this, we convened an interdisciplinary expert panel to update and improve the utility and validity of the existing guidelines using a rigorous Delphi approach. The resulting updated checklist includes 12-items across eight areas considered essential to ensure transparent reporting of MBIs.

Methods

The purpose of this explanation and elaboration document is to facilitate consistent understanding, use, and dissemination of the revised RG-MBI. Members of the interdisciplinary expert panel collaborated to create the resulting guidance statement.

Results

This guidance statement offers: (1) the scope and intended use of the RG-MBI, (2) an explanation for each checklist item, with examples from published studies, and (3) two published studies with annotations indicating where the authors reported each checklist item.

Conclusion

Broader uptake of the RG-MBIs by study authors, editors, and peer reviewers will lead to better reporting of MBI trials, and in turn facilitate greater replication of research, improve cross-study comparisons and meta-analyses, and increase implementation of findings.

详细的干预报告对于解释、复制和最终将基于音乐的干预（mbi）转化为实践至关重要。尽管有基于音乐的干预措施报告指南（RG-MBI， 2011年出版），但多次审查显示报告质量和一致性存在持续问题。为了解决这个问题，我们召集了一个跨学科专家小组，使用严格的德尔菲方法来更新和改进现有指南的实用性和有效性。由此产生的更新清单包括8个领域的12个项目，这些领域被认为是确保mbi报告透明的必要条件。方法本解释和阐述文件的目的是促进对修订后的RG-MBI的一致理解、使用和传播。跨学科专家小组的成员合作制定了最终的指导声明。本指导声明提供：(1)RG-MBI的范围和预期用途，(2)每个清单项目的解释，并从已发表的研究中举例，以及(3)两个已发表的研究，并附有注释，说明作者报告每个清单项目的位置。研究作者、编辑和同行审稿人更广泛地采用rg -MBI将有助于更好地报道MBI试验，从而促进研究的更多复制，改善交叉研究比较和荟萃分析，并增加研究结果的实施。

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引用次数: 0

Traditional Korean and Western medicine use after industrial accidents: A hurdle model analysis 韩西药在工业事故后的使用：一个障碍模型分析

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-16 DOI: 10.1016/j.imr.2025.101202

Sungmin Park , Bo-Hyoung Jang

Background

The number of injured workers using Traditional Korean Medicine (KM) soared from 752 in 2013 to 10,273 in 2023, yet this trend remains underexplored. This cross-sectional study examined the frequency and factors linked to KM and Western Medicine (WM) use among injured workers.

Methods

Data from 6,985 participants in the 2018 and 2023 waves of the Panel Study of Workers’ Compensation Insurance (PSWCI) were analyzed. A hurdle model assessed outpatient visits: logistic regression for the probability of use and negative binomial regression for visit intensity. Demographic, socioeconomic, and clinical factors were included as covariates.

Results

Of 6,985 participants, 182 used KM, 5,970 used WM, and 833 reported no outpatient visits. Having private medical insurance and lower limb injuries showed higher Total Marginal Effects (TME) of both KM and WM utilization. KM use showed higher TMEs among females and those with occupational diseases but lower TMEs for injuries to other body regions. Higher WM utilization was linked to workers with disabilities, hypertension, chronic conditions, and extended rehabilitation, while the 2023 cohort, higher education and income, alcohol consumption, and re-employment were linked to lower WM use.

Conclusions

Between 2018 and 2023, adjusted KM utilization remained unchanged, whereas WM visits declined. KM use was positively linked to being female and having occupational diseases. WM visits tended to rise with greater medical severity yet decreased as socioeconomic conditions improved. Still, the rise in total KM claims under WCI indicates a growing demand for conservative, pain-relieving musculoskeletal care.

▽使用韩医的受伤劳动者从2013年的752人增加到2023年的10273人，但这一趋势仍未得到充分的研究。本横断面研究调查了受伤工人中KM和西医（WM）使用的频率和因素。方法对2018年和2023年工人赔偿保险小组研究（PSWCI）的6,985名参与者的数据进行分析。障碍模型评估门诊访问：使用概率的逻辑回归和访问强度的负二项回归。人口统计学、社会经济和临床因素被纳入协变量。结果6985名参与者中，182人使用KM， 5970人使用WM， 833人没有门诊就诊。有私人医疗保险者和下肢损伤者在KM和WM利用上均表现出更高的总边际效应（TME）。KM的使用表明，女性和职业病患者的TMEs较高，但其他身体部位受伤的TMEs较低。较高的WM使用率与残疾、高血压、慢性病和长期康复的工人有关，而2023年队列、高等教育和收入、酒精消费和再就业与较低的WM使用率有关。结论2018年至2023年，调整后的KM利用率保持不变，而WM访问量下降。KM的使用与女性和患职业病呈正相关。就诊次数往往随着医疗严重程度的提高而增加，但随着社会经济条件的改善而减少。尽管如此，总KM索赔在WCI下的上升表明对保守的，缓解疼痛的肌肉骨骼护理的需求不断增长。

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引用次数: 0

Effects of LIPOSA-T pharmacopuncture on localized fat as a fat dissolving injection via regulation of fat metabolism LIPOSA-T药物穿刺术通过调节脂肪代谢对局部脂肪的影响

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-14 DOI: 10.1016/j.imr.2025.101201

Mi Hye Kim , Seong Chul Jin , Woong Mo Yang

Background

Excessive fat deposition in localized adiposity is known to induce severe medical diseases as well as aesthetic problems. Of late, LIPOSA-T pharmacopuncture, a new herbal pharmacopuncture consisting of the cortex of Morus alba and bark of Magnolia officinalis, is developed as a non-surgical injection for dissolving localized fat deposits.

Methods

The network pharmacology analysis was carried out with the target gene sets of constituents of M. alba and M. officinalis. Male C57BL/6 J mice were induced obesity and injected LIPOSA-T pharmacopuncture into inguinal fat pad. The fat weight and size were analyzed using dual energy X-ray absorptiometry.

Results

The possible pathways and mechanism of action of LIPOSA-T were found to be mainly related to the fatty acid biosynthesis, glycolysis and glycogenesis in KEGG Pathways database. Subcutaneous injection of the LIPOSA-T pharmacopuncture significantly reduced the inguinal fat tissues weight and enlarged adipocyte size. In addition, the phosphorylated IRS with the PEPCK and G6p expressions were increased by the LIPOSA-T injection. Following the increase of AMPK expression, the fatty acid synthesis enzyme and lipolytic enzymes were regulated by the LIPOSA-T.

Conclusions

Taken together, LIPOSA-T exerted the catabolic effects on fat deposition in obesity by regulating the glucose production, lipid synthesis and TAG hydrolysis in consistent with the prediction results. Based on the findings, LIPOSA-T pharmacopuncture is expected to be a dissolving injection for localized fat.

背景：已知在局部肥胖中过量的脂肪沉积会诱发严重的医学疾病以及美学问题。最近，LIPOSA-T药物穿刺，一种由桑皮质和厚朴树皮组成的新型草药药物穿刺，被开发为一种非手术注射，用于溶解局部脂肪沉积。方法采用网络药理学分析方法，对白芍和officinalis成分靶基因集进行分析。将雄性C57BL/6 J小鼠诱导肥胖，并在腹股沟脂肪垫注射LIPOSA-T药物穿刺。用双能x线吸收仪分析脂肪的重量和大小。结果在KEGG pathway数据库中发现LIPOSA-T可能的作用途径和机制主要与脂肪酸生物合成、糖酵解和糖生成有关。皮下注射LIPOSA-T药物穿刺可显著降低腹股沟脂肪组织重量，增大脂肪细胞大小。此外，通过注射LIPOSA-T，磷酸化的IRS与PEPCK和G6p的表达增加。随着AMPK表达的增加，脂肪酸合成酶和脂溶酶受到LIPOSA-T的调控。综上所述，LIPOSA-T通过调节葡萄糖生成、脂质合成和TAG水解对肥胖脂肪沉积发挥分解代谢作用，与预测结果一致。基于这些发现，LIPOSA-T药物穿刺有望成为局部脂肪的溶解性注射。

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引用次数: 0

Reporting guidelines for music-based interventions: An update and validation study 基于音乐干预的报告指南：一项更新和验证研究

IF 3 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-14 DOI: 10.1016/j.imr.2025.101199

Sheri L Robb , Stacey Springs , Emmeline Edwards , Tasha L. Golden , Julene K. Johnson , Debra S. Burns , Melita Belgrave , Joke Bradt , Christian Gold , Assal Habibi , John R. Iversen , Miriam Lense , Jessica A. MacLean , Susan M. Perkins

Background

Detailed intervention reporting is essential to interpretation, replication, and translation of music-based interventions (MBIs). The 2011 Reporting Guidelines for Music-Based Interventions were developed to improve transparency and reporting quality of published research; however, problems with reporting quality persist.

Methods

The purpose of this study was to update and validate the 2011 reporting guidelines using rigorous Delphi approach that involved an interdisciplinary group of MBI researchers; and to develop an explanation and elaboration guidance statement to support dissemination and usage. We followed the methodological framework for developing reporting guidelines recommended by the EQUATOR Network and guidance recommendations for developing health research reporting guidelines. Our three-stage process included: (1) an initial field scan, (2) a consensus process using Delphi surveys (two rounds) and Expert Panel meetings, and (3) development and dissemination of an explanation and elaboration document.

Results

First-Round survey findings revealed that the original checklist items were capturing content that investigators deemed essential to MBI reporting; however, it also revealed problems with item wording and terminology. Subsequent Expert Panel meetings and the Second-Round survey centered on reaching consensus for item language. The revised RG-MBI checklist has a total of 12-items that pertain to eight different components of MBI interventions including name, theory/scientific rationale, content, interventionist, individual/group, setting, delivery schedule, and treatment fidelity.

Conclusion

We recommend that authors, journal editors, and reviewers use the RG-MBI guidelines, in conjunction with methods-based guidelines (e.g., CONSORT) to accelerate and improve the scientific rigor of MBI research.

背景：详细的干预报告对于音乐干预（mbi）的解释、复制和翻译至关重要。制定了2011年基于音乐的干预措施报告指南，以提高已发表研究的透明度和报告质量；然而，报告质量的问题仍然存在。方法本研究的目的是更新和验证2011年的报告指南，采用严格的德尔菲法，涉及跨学科的MBI研究小组；并制定一个解释和阐述指导声明，以支持传播和使用。我们遵循赤道网络建议的编制报告准则的方法框架和编制卫生研究报告准则的指导性建议。我们的三个阶段过程包括：(1)初始现场扫描，(2)使用德尔菲调查（两轮）和专家小组会议达成共识的过程，以及(3)制定和传播一份解释和阐述文件。第一轮调查结果显示，最初的清单项目捕获了调查人员认为对MBI报告至关重要的内容；但是，它也暴露了项目措辞和术语方面的问题。随后的专家小组会议和第二轮调查的重点是就项目语言达成协商一致意见。修订后的RG-MBI检查表共有12个项目，涉及MBI干预措施的8个不同组成部分，包括名称、理论/科学依据、内容、干预者、个人/团体、环境、交付时间表和治疗保真度。我们建议作者、期刊编辑和审稿人将RG-MBI指南与基于方法的指南（如CONSORT）结合使用，以加速和提高MBI研究的科学严谨性。

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引用次数: 0

Self-medication and off-label prescribing in post COVID-19 syndrome: Baseline data of a randomized acupressure and qigong trial COVID-19综合征后自我用药和超说明书处方：一项随机指压和气功试验的基线数据

IF 2.8 4区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Integrative Medicine Research

Pub Date : 2025-07-05 DOI: 10.1016/j.imr.2025.101197

Theresa Bauer , Weronika Grabowska , Miriam Ortiz , Judith Bellmann-Strobl , Ute Engelhardt , Rainer Nögel , Josef Hummelsberger , Andreas Michalsen , Stephanie Roll , Barbara Stöckigt , Hosnya Batram , Anna Mietzner , Carmen Scheibenbogen , Stefan N. Willich , Friedemann Paul , Benno Brinkhaus , Joanna Dietzel

Background

Post COVID-19 syndrome (PCS), characterized by persistent fatigue and multi-systemic symptoms following SARS-CoV-2 infection, emerged as a clinical challenge with limited treatment options and high patient burden. This paper presents the medication history and clinical baseline characteristics of PCS patients recruited in a randomized controlled trial (RCT).

Methods

Patients who reported PCS symptoms of ≥12 weeks after SARS-CoV-2 infection and who met defined fatigue criteria were included in this study. At baseline we assessed among others demographic data, symptom burden, medication history including off-label drug use, dietary supplements, and complementary self-help strategies.

Results

Altogether 235 adult PCS-patients were recruited between June 2022 and June 2023. The study population (mean age 42.1 years, 85.1 % female) reported a mean PCS duration of 56.4 weeks, with 74 % on sick leave. Patients frequently used off-label medications (e.g. antihistamines 9.4 %), supplements (vitamin D 53.6 %, minerals 50.2 %), and herbal medicine products (32.3 %). Most PCS patients had prior experience with complementary medicine. Correlations between fatigue and depressive symptoms (PHQ-9) were modest but notable. No strong associations were found between fatigue and age, sex, PCS duration, or vaccination status.

Conclusion

PCS-patients suffered from long-term complaints that led to a long period of sick leave and resorted to diverse, largely unproven therapeutic strategies amid clinical uncertainty. This baseline analysis highlights the unmet needs of PCS patients. Understanding these baseline patterns is essential for optimizing care pathways and patient-centered management strategies in PCS.

Trial registration

Clinicaltrial.gov (NCT05289154).

COVID-19后综合征（PCS）以SARS-CoV-2感染后的持续疲劳和多系统症状为特征，是一项临床挑战，治疗方案有限，患者负担高。本文介绍了一项随机对照试验（RCT）中招募的PCS患者的用药史和临床基线特征。方法在SARS-CoV-2感染后报告PCS症状≥12周且符合规定的疲劳标准的患者纳入本研究。在基线时，我们评估了人口统计数据、症状负担、用药史（包括超说明书用药）、膳食补充剂和辅助自助策略。结果在2022年6月至2023年6月期间共招募了235名成年pcs患者。研究人群（平均年龄42.1岁，85.1%为女性）报告的平均PCS持续时间为56.4周，其中74%请病假。患者经常使用标签外药物（如抗组胺药9.4%），补充剂（维生素D 53.6%，矿物质50.2%）和草药产品（32.3%）。大多数PCS患者有补充医学的经验。疲劳和抑郁症状（PHQ-9）之间的相关性不大，但值得注意。没有发现疲劳与年龄、性别、PCS持续时间或疫苗接种状况之间有很强的关联。结论pcs患者长期主诉导致长时间的病假，在临床不确定的情况下采取了多种未经证实的治疗策略。这一基线分析突出了PCS患者未满足的需求。了解这些基线模式对于优化PCS的护理途径和以患者为中心的管理策略至关重要。试验注册：clinicaltrial .gov （NCT05289154）。

{"title":"Self-medication and off-label prescribing in post COVID-19 syndrome: Baseline data of a randomized acupressure and qigong trial","authors":"Theresa Bauer , Weronika Grabowska , Miriam Ortiz , Judith Bellmann-Strobl , Ute Engelhardt , Rainer Nögel , Josef Hummelsberger , Andreas Michalsen , Stephanie Roll , Barbara Stöckigt , Hosnya Batram , Anna Mietzner , Carmen Scheibenbogen , Stefan N. Willich , Friedemann Paul , Benno Brinkhaus , Joanna Dietzel","doi":"10.1016/j.imr.2025.101197","DOIUrl":"10.1016/j.imr.2025.101197","url":null,"abstract":"<div><h3>Background</h3><div>Post COVID-19 syndrome (PCS), characterized by persistent fatigue and multi-systemic symptoms following SARS-CoV-2 infection, emerged as a clinical challenge with limited treatment options and high patient burden. This paper presents the medication history and clinical baseline characteristics of PCS patients recruited in a randomized controlled trial (RCT).</div></div><div><h3>Methods</h3><div>Patients who reported PCS symptoms of ≥12 weeks after SARS-CoV-2 infection and who met defined fatigue criteria were included in this study. At baseline we assessed among others demographic data, symptom burden, medication history including off-label drug use, dietary supplements, and complementary self-help strategies.</div></div><div><h3>Results</h3><div>Altogether 235 adult PCS-patients were recruited between June 2022 and June 2023. The study population (mean age 42.1 years, 85.1 % female) reported a mean PCS duration of 56.4 weeks, with 74 % on sick leave. Patients frequently used off-label medications (e.g. antihistamines 9.4 %), supplements (vitamin D 53.6 %, minerals 50.2 %), and herbal medicine products (32.3 %). Most PCS patients had prior experience with complementary medicine. Correlations between fatigue and depressive symptoms (PHQ-9) were modest but notable. No strong associations were found between fatigue and age, sex, PCS duration, or vaccination status.</div></div><div><h3>Conclusion</h3><div>PCS-patients suffered from long-term complaints that led to a long period of sick leave and resorted to diverse, largely unproven therapeutic strategies amid clinical uncertainty. This baseline analysis highlights the unmet needs of PCS patients. Understanding these baseline patterns is essential for optimizing care pathways and patient-centered management strategies in PCS.</div></div><div><h3>Trial registration</h3><div>Clinicaltrial.gov (NCT05289154).</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"14 3","pages":"Article 101197"},"PeriodicalIF":2.8,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144662144","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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