Complementary Therapies in Clinical Practice最新文献

Chinese patent medicine in the treatment of Parkinson's disease: A systematic review and network meta-analysis 中成药治疗帕金森病：系统综述和网络荟萃分析

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-12-31 DOI: 10.1016/j.ctcp.2025.102042

Xiongying Huang , Qilai Cheng , Yuan Xie , Yufen Jiang , Yi Yu , Yingchen Li

Background and purpose

The growing prevalence of Parkinson's disease (PD) drives the need for better therapies. Chinese patent medicines (CPMs) can complement conventional western medicine (CWM) in treating PD, but their variety complicates clinical choices. This study systematically ranks CPMs combined with CWM to guide treatment decisions.

Methods

We systematically searched for randomized controlled trials (RCTs) of CPM for the treatment of PD in China National Knowledge Infrastructure (CNKI), Wanfang Database, China Weipu Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (CBM), PubMed, Embase, Web of Science, and Cochrane Library from the establishment of the database to January 2nd, 2025. R 4.4.2 and Stata 14.0 software were used for data analysis.

Results

We analyzed 35 RCTs comprising 3281 patients and 11 CPMs. Among the CPMs evaluated, Bushen Huoxue capsules (BSHX) showed higher total effective rates, while Tianma Gouteng granules (TMGT) led in reducing Unified Parkinson's Disease Rating Scale (UPDRS) total scores and improving Mini-Mental State Examination (MMSE) performance. Zishen Pingchan granules (ZSPC) were most effective in improving the Parkinson's Disease Sleep Scale (PDSS) score. Qishen Huanwu capsules (QSHW) excelled in reducing cystatin C (Cys-C) and homocysteine (Hcy). Xifeng Dingchan pills (XFDC) maximized superoxide dismutase (SOD) activity, and Tiandan Tongluo capsules (TDTL) lowered malondialdehyde (MDA) levels.

Conclusion

This study demonstrated the efficacy of combining CPMs with CWM for PD, identifying QSHW and TMGT as the optimal CPMs. QSHW markedly reduced Hcy and Cys-C levels, and TMGT improved MMSE and UPDRS scores. However, their personalized application necessitates validation in large-scale RCTs.

背景与目的帕金森氏症（PD）的日益流行促使人们需要更好的治疗方法。中成药是治疗帕金森病的有效补充，但中成药种类繁多，使临床选择复杂化。本研究对cpm联合CWM进行系统排名，以指导治疗决策。方法系统检索中国知网（CNKI）、万方数据库、中国唯普科技期刊数据库（VIP）、中国生物医学文献数据库（CBM）、PubMed、Embase、Web of Science、Cochrane图书馆自建库至2025年1月2日的CPM治疗PD的随机对照试验（RCTs）。采用R 4.4.2和Stata 14.0软件进行数据分析。结果我们分析了35项随机对照试验，包括3281例患者和11例cpm。在评估的cpm中，补肾活血胶囊（BSHX）的总有效率较高，而天麻狼藤颗粒（TMGT）在降低统一帕金森病评定量表（UPDRS）总分和改善基本精神状态检查（MMSE）成绩方面领先。紫参平禅颗粒（ZSPC）对帕金森病睡眠量表（PDSS）评分的改善效果最好。芪肾还五胶囊（QSHW）具有显著的降低胱抑素C （Cys-C）和同型半胱氨酸（Hcy）的作用。西风定禅丸（XFDC）能显著提高超氧化物歧化酶（SOD）活性，天丹通络胶囊（TDTL）能显著降低丙二醛（MDA）水平。结论cpm联合CWM治疗帕金森病的疗效明显，其中QSHW和TMGT为最佳cpm。QSHW显著降低Hcy和Cys-C水平，TMGT提高MMSE和UPDRS评分。然而，它们的个性化应用需要在大规模随机对照试验中进行验证。

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引用次数: 0

Mechanisms of sustained mindfulness practice in stroke survivors: A critical realist secondary analysis of the HEADS: UP intervention 脑卒中幸存者持续正念练习的机制：对HEADS: UP干预的批判性现实主义二次分析。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-12-23 DOI: 10.1016/j.ctcp.2025.102041

Naomi E. Clark , Ben Parkinson , Xu Wang , Bridget Davis , Lisa Kidd , Maggie Lawrence

Background and purpose

Post-stroke anxiety and depression symptoms are common after stroke and can persist long-term. Despite this, there is a lack of long-term psychological support for post-stroke anxiety and depression. Mindfulness-based interventions are emerging as feasible, acceptable and potentially effective interventions for post-stroke anxiety and depression. Sustained use of mindfulness practice can help stroke survivors to self-manage their anxiety and depression in the long-term. However, stroke survivors’ experiences of continued practice following a mindfulness-based intervention have yet to be explored. This study aims to identify mechanisms underpinning sustained mindfulness practice by stroke survivors following completion of an adapted, stroke-specific mindfulness-based intervention called HEADS: UP (Helping Ease Anxiety and Depression After Stroke).

Materials and methods

A secondary analysis of 6-month follow-up qualitative data from course participants (n = 12) in the HEADS: UP randomised controlled trial was analysed using critical realist thematic analysis.

Results

Seven mechanisms were identified as determining sustained mindfulness practice: 1) Believing continued practice brings benefits, 2) Personal preferences and accessibility, 3) Continued learning, 4) Attitudes of others and society, 5) Togetherness and connection, 6) Structuring and scaffolding practice, and 7) Competing priorities.

Conclusion

The mechanisms provide explanations behind stroke survivors’ experiences of sustained mindfulness practice following HEADS: UP. The findings highlighted the potential benefit of providing support following a mindfulness-based intervention to facilitate sustained practice. Awareness of the mechanisms could aid future intervention design and help clinical practitioners and stroke support professionals support continued mindfulness practice.

背景和目的：卒中后焦虑和抑郁症状是卒中后常见的，并可长期持续。尽管如此，对于中风后的焦虑和抑郁缺乏长期的心理支持。以正念为基础的干预措施正在成为中风后焦虑和抑郁的可行、可接受和潜在有效的干预措施。持续使用正念练习可以帮助中风幸存者长期自我管理他们的焦虑和抑郁。然而，中风幸存者在正念干预后继续练习的经验还有待探索。本研究旨在确定中风幸存者在完成一项名为HEADS: UP（帮助缓解中风后的焦虑和抑郁）的适应的、针对中风的正念干预后持续正念练习的机制。材料和方法：对HEADS: UP随机对照试验中课程参与者（n = 12）的6个月随访定性数据进行二次分析，采用批判现实主义主题分析。结果：确定了七个决定持续正念练习的机制：1)相信持续练习会带来好处，2)个人偏好和可及性，3)持续学习，4)他人和社会的态度，5)团结和联系，6)结构和脚手架练习，7)竞争优先级。结论：脑卒中幸存者在遵循HEADS: UP后进行持续正念练习的经历背后的机制提供了解释。研究结果强调了在以正念为基础的干预后提供支持以促进持续练习的潜在益处。意识到这些机制可以帮助未来的干预设计，并帮助临床医生和中风支持专业人员支持持续的正念练习。

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引用次数: 0

Acceptability and feasibility of two types of asynchronous online yoga interventions in adults with moderate-to-high stress 两种异步在线瑜伽干预在成人中高压力中的可接受性和可行性

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-12-04 DOI: 10.1016/j.ctcp.2025.102040

Sarah E. Ahmadi, Crystal L. Park, Erika K. Osherow

Background and purpose

Although yoga has traditionally been delivered in-person, yoga has recently shifted towards virtual delivery through live-streamed and pre-recorded classes. Asynchronous online yoga helps to resolve many drawbacks of in-person and synchronous online classes, but little research has explored this modality. The aim of this pilot study was to explore the acceptability and feasibility of two different types of yoga—movement-based and meditation-based—and preliminary evidence of efficacy on outcomes when delivered asynchronously online.

Materials and methods

Moderately-to-highly stressed participants (n = 40) completed a randomized clinical trial comparing movement-based yoga and meditation-based yoga delivered asynchronously online. Acceptability, feasibility, and pre- and post-intervention outcome measures for perceived stress and related outcomes were examined. Feedback on the interventions was also collected.

Results

Recruitment took less than four weeks to complete. Thirty-four participants (85.0 %) attended the follow-up visit. Twenty-four participants (60.0 %) engaged with at least six out of eight classes. Acceptability of the yoga interventions was rated an average of 36.71 (standard deviation [SD] = 3.35) out of 42. Participants demonstrated significant decreases in perceived stress and sleep disturbance as well as significant increases in mindfulness and mood. There were no group effects for any outcomes. Participants provided generally positive feedback as well as suggestions for improvement.

Conclusion

Both yoga interventions delivered asynchronously online were acceptable and feasible. Additionally, both yoga interventions led to improvements in perceived stress, sleep disturbance, mindfulness, and mood. Given the recent shifts towards online delivery of yoga, research should continue exploring this asynchronous online modality.

背景和目的虽然瑜伽传统上是面对面授课，但最近瑜伽已经转向通过直播和预先录制的课程进行虚拟授课。异步在线瑜伽有助于解决面对面和同步在线课程的许多缺点，但很少有研究探索这种模式。这项初步研究的目的是探索两种不同类型的瑜伽——基于运动和基于冥想——的可接受性和可行性，并初步证明异步在线交付对结果的有效性。材料和方法中等至高度压力的参与者（n = 40）完成了一项随机临床试验，比较基于运动的瑜伽和基于冥想的瑜伽异步在线授课。对感知压力和相关结果的可接受性、可行性、干预前后结果测量进行了检查。还收集了有关干预措施的反馈意见。结果招募时间不到四周。34名参与者（85.0%）参加了随访。24名参与者（60.0%）至少参加了8门课程中的6门。瑜伽干预的可接受性平均评分为36.71（标准差[SD] = 3.35）。参与者表现出明显的压力和睡眠障碍的减少，以及正念和情绪的显著增加。任何结果都没有组效应。参加者普遍给予正面反馈，并提出改善建议。结论两种异步在线瑜伽干预均可接受且可行。此外，两种瑜伽干预都能改善感知压力、睡眠障碍、专注力和情绪。鉴于最近瑜伽课程转向在线授课，研究应该继续探索这种异步在线模式。

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引用次数: 0

Japanese midwives' education, and use of complementary therapies in practice: A qualitative study 日本助产士的教育，并在实践中使用补充疗法：一项定性研究。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-11-01 DOI: 10.1016/j.ctcp.2025.102028

Lyndall Mollart , Chie Taniguchi , Mieko Omura , Atsuko Campbell , Allison Cummins

Background and purpose

Globally, women are the highest users of complementary therapies, often during the perinatal period [pregnancy, childbirth, and postnatal time]. Midwives who provide care to women throughout the perinatal period need to have evidence-based knowledge of complementary therapies. There is a lack of research on why midwives are interested in learning about complementary therapies. The purpose of this research is to explore the experiences of Japanese midwives in undertaking professional development in complementary therapies. The study explored what the midwives learnt, how they used these therapies in their practice, and what strategies can help midwives implement these complementary therapies.

Materials and methods

A qualitative study was undertaken using semi-structured interviews with 15 Japanese midwives who had completed a certificate in complementary therapy. Content analysis was used to analyse the data.

Results

Two themes were identified as reasons midwives undertook professional development in complementary therapies: supporting women during the perinatal period with complementary therapies, and factors that influence midwives to learn complementary therapies as a new skill. Strategies to address challenges in implementing complementary therapy into practice were identified as follows: Needing a supportive working environment and encouraging midwives to increase their knowledge and skills about complementary therapies.

Conclusion

Midwives in Japan undertook professional development in complementary therapy training as a new skill to support women in the perinatal period. Further research is warranted to assist midwives in implementing complementary therapies in practice by raising awareness of its evidence-based values among medical colleagues.

背景和目的：在全球范围内，妇女是补充疗法的最高使用者，通常在围产期[怀孕、分娩和产后]。在整个围产期为妇女提供护理的助产士需要具备补充疗法的循证知识。关于助产士为什么对学习补充疗法感兴趣的研究缺乏。本研究的目的是探讨日本助产士在辅助治疗中进行专业发展的经验。这项研究探讨了助产士学到了什么，他们如何在实践中使用这些疗法，以及什么策略可以帮助助产士实施这些补充疗法。材料和方法：采用半结构化访谈对15名获得补充治疗证书的日本助产士进行定性研究。采用内容分析法对数据进行分析。结果：确定了助产士在辅助疗法方面进行专业发展的两个主题：在围产期支持妇女使用辅助疗法，以及影响助产士学习辅助疗法作为新技能的因素。应对在实践中实施补充疗法的挑战的策略确定如下：需要一个支持性的工作环境，并鼓励助产士增加他们对补充疗法的知识和技能。结论：日本助产士将辅助治疗培训作为一种支持围产期妇女的新技能进行了专业发展。进一步的研究是有必要的，以帮助助产士在实践中实施补充疗法，提高认识，其循证价值的医疗同事。

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引用次数: 0

Corrigendum to: “Understanding haptotherapy for people with cancer: A qualitative interview study among patients and haptotherapists” [Compl. Ther. Clin. Prac. 61 (2025) 1–8] 对“了解癌症患者的触觉治疗：对患者和触觉治疗师的定性访谈研究”的更正[Compl。其他。中国。Prac. 61(2025) 1-8]。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-11-01 DOI: 10.1016/j.ctcp.2025.102026

Agnes M. van Swaay , Kris C.P. Vissers , Yvonne Engels , Marieke M. Groot

引用次数: 0

Efficacy of a self-heating Chinese medicine hot pack for postpartum urinary retention 自热中药热敷治疗产后尿潴留的疗效观察。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-11-01 DOI: 10.1016/j.ctcp.2025.102029

Mengyan Xu , Ruobing Yang , Fengcheng Cai

Background and purpose

Postpartum urinary retention (PUR) is a frequent complication following epidural anesthesia in primiparous women, elevating the risk of urinary tract infections and long-term bladder dysfunction. This study aimed to investigate the efficacy of a self-heating traditional Chinese medicine (TCM) hot pack in preventing PUR and enhancing postpartum maternal comfort.

Materials and methods

Eighty primigravid women receiving epidural anesthesia were randomly assigned to a control group receiving standard postpartum care, or a test group receiving standard care plus application of a self-heating TCM hot pack for 4 h. Key measures included time to first urination, voiding volume, residual urine volume, incidence of PUR, and maternal comfort assessed using Kolcaba's comfort scale 6–8 h after delivery.

Results

The incidence of PUR was significantly lower in the test group (2.56 %) compared to the control group (12.5 %). Participants using the TCM hot pack exhibited a markedly shorter time to first void, increased voiding volume, and significantly higher overall and dimensional comfort scores (all P < 0.05). No significant differences were found in 24-h vaginal bleeding or rates of postpartum hemorrhage.

Conclusion

The use of a self-heating TCM hot pack was associated with a reduced incidence of PUR and increased maternal comfort in this study, suggesting it may be a beneficial intervention for postpartum care. However, the specific contributions of thermal versus herbal components remain unclear. These findings indicate a simple and safe approach that warrants further investigation to confirm its efficacy and potential cost-effectiveness.

背景与目的：产后尿潴留（PUR）是初产妇硬膜外麻醉后常见的并发症，增加了尿路感染和长期膀胱功能障碍的风险。本研究旨在探讨自热式中药热敷对预防产后脓肿及提高产后产妇舒适度的作用。材料和方法：80例接受硬膜外麻醉的初产妇随机分为对照组和试验组，对照组接受标准产后护理，试验组接受标准产后护理加自热中药热敷4小时。主要测量指标包括初尿时间、排尿量、残余尿量、PUR发生率，分娩后6-8小时采用Kolcaba舒适量表评估产妇舒适度。结果：试验组PUR发生率（2.56%）明显低于对照组（12.5%）。使用中药热敷的参与者首次排尿时间明显缩短，排尿量增加，总体舒适度和维度舒适度得分显著提高（均为P）。结论：本研究中，使用自加热中药热敷与PUR发生率降低和产妇舒适度增加有关，表明它可能是一种有益的产后护理干预措施。然而，热成分与草药成分的具体贡献仍不清楚。这些发现表明了一种简单安全的方法，值得进一步研究以确认其有效性和潜在的成本效益。

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引用次数: 0

Current evidence on auriculotherapy for cancer-related fatigue: A systematic review and meta-analysis of randomized controlled trials 耳科治疗癌症相关疲劳的现有证据：随机对照试验的系统回顾和荟萃分析。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-10-13 DOI: 10.1016/j.ctcp.2025.102025

Hai-Li Ma , Ling Pan , Ai-Qin Lin , Liu Yang , Meng-Ge Ai

Background and purpose

Auriculotherapy for cancer-related fatigue has been investigated in various clinical trials; nonetheless, their conclusions remain inconsistent. In this systematic review and meta-analysis, the efficacy and safety of auriculotherapy for cancer-related fatigue were investigated.

Methods

Randomized controlled trials were identified by searching seven English databases (PubMed, Embase, AMED, Web of Science, CINAHL, CENTRAL, PsycINFO) and four Chinese databases (CNKI, Wanfang, VIP, CBMdisc), covering records from their inception to August 1, 2024. The version 2 of the Cochrane risk-of-bias tool for randomized trials was used to assess the risk of bias. Evidence certainty was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach with the GRADEprofiler software (version 3.6.1). Meta-analyses were performed using Review Manager 5.3.

Results

Fourteen studies involving 1033 patients were included. These studies had some methodological limitations. The certainty of evidence for all outcomes was graded as “very low”. Meta-analysis revealed that auriculotherapy significantly improved cancer-related fatigue (standardized mean difference [SMD] -1.26; 95 % confidence interval [CI] [-1.69, -0.82]; P < 0.00001) and quality of life (SMD 1.01; 95 % CI [0.55, 1.47]; P < 0.0001). Auriculotherapy was associated with a favorable safety profile and a low incidence of adverse events.

Conclusion

The results indicate that auriculotherapy is a promising, effective, and safe intervention for managing cancer-related fatigue, although higher-quality trials are needed to strengthen this conclusion owing to limitations in the current evidence base.

背景和目的：耳穴疗法治疗癌症相关性疲劳已在各种临床试验中进行了研究；尽管如此，他们的结论仍然不一致。在本系统综述和荟萃分析中，研究了耳穴疗法治疗癌症相关性疲劳的疗效和安全性。方法：通过检索PubMed、Embase、AMED、Web of Science、CINAHL、CENTRAL、PsycINFO等7个英文数据库和CNKI、万方、VIP、CBMdisc等4个中文数据库，检索自该数据库成立至2024年8月1日的随机对照试验。使用Cochrane随机试验风险偏倚工具第2版来评估偏倚风险。使用GRADEprofiler软件（版本3.6.1）采用推荐、评估、发展和评价分级（GRADE）方法评估证据确定性。使用Review Manager 5.3进行meta分析。结果：纳入14项研究，共1033例患者。这些研究有一些方法学上的局限性。所有结果的证据确定性都被评为“非常低”。荟萃分析显示，耳穴疗法显著改善了癌症相关疲劳(标准化平均差[SMD] -1.26； 95%可信区间[CI] [-1.69, -0.82]； P结论：结果表明，耳穴疗法是一种有希望的、有效的、安全的治疗癌症相关疲劳的干预措施，尽管由于目前证据基础的局限性，需要更高质量的试验来加强这一结论。

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引用次数: 0

Effect of different exercise types on level of inflammation in hemodialysis patients: a systematic review and network meta-analysis 不同运动类型对血液透析患者炎症水平的影响：系统回顾和网络荟萃分析。

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-10-13 DOI: 10.1016/j.ctcp.2025.102027

Kai Zhang , Chi Wang , Nan Zhang , Zeng Teng , Ruixue Wang , Shuimiao Wei , Cuiping Ni

Background and purpose

Although numerous pairwise meta-analyses have demonstrated the benefits of exercise on inflammation in hemodialysis patients, the comparative effectiveness of different exercise types on inflammation in this population remains unclear. This study aims to compare the effectiveness of intradialytic aerobic exercise (IAE), non-intradialytic aerobic exercise (NAE), intradialytic combined aerobic and resistance exercise (ICE), intradialytic resistance exercise (IRE), non-intradialytic aerobic exercise + intradialytic resistance exercise (NAE + IRE), and non-intradialytic resistance exercise (NRE) on inflammatory marker levels of hemodialysis patients using network meta-analysis (NMA) and to rank them subsequently.

Methods

We systematically searched PubMed, Web of Science, Embase, Cochrane Library, CINAHL, China National Knowledge Infrastructure (CNKI), Wanfang Data, China Science and Technology Journal Database (VIP), and China Biomedical Literature Database (CBM) from inception to August 13, 2025. We conducted an NMA using Stata 18.0. The interventions were ranked according to their effectiveness in reducing inflammation in hemodialysis patients using the surface under the cumulative ranking curve (SUCRA). Finally, the grading of recommendations, assessment, development, and evaluation (GRADE) framework was utilized to evaluate the reliability of evidence.

Results

This study included 46 studies across 9 countries involving 3073 hemodialysis patients. For the reduction of C-reactive protein, NAE + IRE (SUCRA = 85.3) and IRE (SUCRA = 59.6) were ranked first and second. For the reduction of interleukin-6, NAE + IRE (SUCRA = 93.0) and NRE (SUCRA = 66.5) were ranked first and second. For the reduction of tumor necrosis factor-α, NAE (SUCRA = 99.9) and NAE + IRE (SUCRA = 66.1) were ranked first and second. The GRADE evidence levels for the three outcome measures ranged from very low to low.

Conclusion

NAE + IRE consistently ranked among the top two interventions across all inflammatory markers, making it the optimal exercise strategy to reduce inflammation in hemodialysis patients.

背景和目的：尽管许多两两荟萃分析已经证明了运动对血液透析患者炎症的益处，但不同运动类型对该人群炎症的相对效果仍不清楚。本研究旨在通过网络荟萃分析（network meta-analysis， NMA）比较分析内有氧运动（IAE）、非分析内有氧运动（NAE）、分析内有氧与阻力联合运动（ICE）、分析内阻力运动（IRE）、非分析内有氧运动+分析内阻力运动（NAE + IRE）、非分析内阻力运动（NRE）对血液透析患者炎症标志物水平的影响并进行排名。方法：系统检索PubMed、Web of Science、Embase、Cochrane Library、CINAHL、中国知网（CNKI）、万方数据、中国科技期刊库（VIP）、中国生物医学文献库（CBM）自成立至2025年8月13日的数据库。我们使用Stata 18.0进行NMA。在累积排序曲线（SUCRA）下，根据干预措施在减少血透患者炎症方面的有效性对其进行排序。最后，采用推荐、评估、发展和评价分级（GRADE）框架来评估证据的可靠性。结果：本研究纳入了9个国家的46项研究，涉及3073名血液透析患者。对于c反应蛋白的减少，NAE + IRE （SUCRA = 85.3）和IRE （SUCRA = 59.6）分别排在第一位和第二位。对于白细胞介素-6的减少，NAE + IRE （SUCRA = 93.0）和NRE （SUCRA = 66.5）分别排在第一位和第二位。对于肿瘤坏死因子-α的降低，NAE （SUCRA = 99.9）和NAE + IRE （SUCRA = 66.1）分别排在第一位和第二位。三个结果测量的GRADE证据水平从非常低到低不等。结论：NAE + IRE在所有炎症指标中均稳居前两名，是血透患者减少炎症的最佳运动策略。

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引用次数: 0

Challenges in conducting a feasibility randomized controlled trial of medicinal cannabis for endometriosis pain in Australia 在澳大利亚进行药用大麻治疗子宫内膜异位症疼痛的可行性随机对照试验的挑战

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-09-23 DOI: 10.1016/j.ctcp.2025.102023

Susan Chesterman , Antonina Mikocka-Walus , Justin Sinclair , Marilla Druitt , Jeremy Furyk , Subhadra Evans , Jason Abbott , Alexandra Eathorne , Alexander Martin , Cecilia Ng , Lisa Nguyen , Karen Oldfield , Daniel Romano , Jerome Sarris , Alex Semprini , Katherine Stanley , Mike Armour

Background and purpose

People with endometriosis report consuming cannabis to manage their endometriosis symptoms, however, its efficacy has not been established in clinical studies. This study aimed to determine the feasibility, acceptability, and safety of two different medicinal cannabis interventions against placebo in people with endometriosis.

Materials and methods

A three-armed randomised controlled trial was conducted, comparing the effects of using both inhaled medicinal cannabis using dried flower containing 16 % delta-9-tetrahydrocannabinol (THC) via vaporisation and an oral oil containing 100mg cannabidiol (CBD) per mL together, versus an oral CBD oil alone, versus a taste- and colour-matched placebo oil. The trial aimed to recruit 63 participants (21 per intervention group). Outcome measures included safety and the occurrence of adverse events, and the acceptability and feasibility of recruitment and retention.

Results

Overall, 12 participants were randomised to one of three groups, of whom seven withdrew from the study; four completed the study and one was lost to follow-up. Therefore, acceptability and feasibility of recruitment and retention was considered low. There were 10 adverse events reported (two unrelated to cannabis and eight possibly related to cannabis) and two serious adverse events reported (both unrelated to the intervention).

Conclusion

Despite an urgent need for an evidence-based approach to using cannabis for endometriosis-related pain, our feasibility trial failed to recruit and retain the small intended sample. Failure of the trial was largely driven by two factors: the requirement to abstain from driving, and a high level of participant withdrawal.

背景和目的子宫内膜异位症患者报告使用大麻来控制其子宫内膜异位症症状，然而，其疗效尚未在临床研究中得到证实。本研究旨在确定子宫内膜异位症患者两种不同的药用大麻干预与安慰剂的可行性、可接受性和安全性。材料和方法进行了一项三手随机对照试验，比较了雾化吸入含有16% δ -9-四氢大麻酚（THC）的干花和每毫升含有100毫克大麻二酚（CBD）的口服油的效果，与单独口服CBD油相比，与口味和颜色匹配的安慰剂油相比。该试验旨在招募63名参与者（每个干预组21人）。结局指标包括安全性和不良事件的发生，以及招募和保留的可接受性和可行性。总体而言，12名参与者被随机分为三组，其中7人退出研究；其中4人完成了研究，1人失去了随访。因此，招聘和保留的可接受性和可行性被认为很低。报告了10起不良事件（2起与大麻无关，8起可能与大麻有关）和2起严重不良事件（均与干预措施无关）。结论：尽管迫切需要一种基于证据的方法来使用大麻治疗子宫内膜异位症相关的疼痛，但我们的可行性试验未能招募和保留预期的小样本。试验的失败主要是由两个因素驱动的：要求放弃驾驶，以及参与者的高度戒断。

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引用次数: 0

Comparative efficacy and safety of Chinese patent medicines as adjunctive therapies for glycolipid regulation in metabolic syndrome: A network meta-analysis 中成药作为代谢综合征糖脂调节辅助疗法的疗效和安全性比较：网络荟萃分析

IF 3 3区医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE

Complementary Therapies in Clinical Practice

Pub Date : 2025-09-23 DOI: 10.1016/j.ctcp.2025.102024

Zhilin Chen , Haoyue Shi , Juju Shang , Wenchu Kang , Yuhan Hao , Xuerui Zhao , Sinai Li , Yifeng Shen

Background and purpose

Effective management of glycolipid metabolism is key to reducing the risk of cardiovascular disease in patients with metabolic syndrome (MetS). Chinese patent medicines (CPMs), a type of standardized herbal formulation, are widely used in China. This study compared the efficacy, safety, and cost-effectiveness of CPMs as adjunctive therapies for glycolipid regulation in MetS via network meta-analysis (NMA), providing a reference for clinical decision-making.

Methods

By October 2024, we searched eight databases for randomized controlled trials (RCTs) investigating the use of CPMs in the treatment of MetS. The impact of CPMs on lipid profiles, blood glucose levels, and insulin resistance indicators was evaluated using methods including surface under the cumulative ranking curve (SUCRA). The cost-effectiveness analysis was conducted on the basis of the market price in China and SUCRA rankings.

Results

A total of 25 RCTs involving 17 CPMs were included. The results revealed that combining specific CPMs with conventional treatment had significant beneficial effects on lipid and glucose metabolism. Hedan tablet was revealed to be the most effective at regulating the levels of lipids, when both efficacy and cost were considered. Shenqi Jiangtang granule and Jiangzhi Jianfei capsule had the greatest beneficial effects on glucose metabolism and insulin resistance.

Conclusion

CPMs have the potential to serve as effective adjunctive therapies for glycolipid regulation in patients with MetS. However, given the limited number and quality of studies included in this NMA, these conclusions should be interpreted with caution. Further high-quality RCTs are warranted to validate and update the current evidence.

背景与目的有效管理糖脂代谢是降低代谢综合征（MetS）患者心血管疾病风险的关键。中成药是一种标准化的中草药制剂，在中国被广泛使用。本研究通过网络荟萃分析（network meta-analysis， NMA）比较了cpm作为代谢综合征糖脂调节辅助疗法的疗效、安全性和成本效益，为临床决策提供参考。方法截至2024年10月，我们检索了8个数据库，以调查cpm治疗MetS的随机对照试验（rct）。采用累积排名曲线下曲面（SUCRA）等方法评估CPMs对血脂、血糖水平和胰岛素抵抗指标的影响。成本效益分析是根据中国市场价格和SUCRA排名进行的。结果共纳入25个随机对照试验，涉及17个cpm。结果显示，特异性CPMs联合常规治疗对小鼠脂糖代谢有显著的改善作用。从疗效和成本两方面考虑，和丹片在调节血脂水平方面是最有效的。参芪降糖颗粒和降脂健肺胶囊对葡萄糖代谢和胰岛素抵抗的改善作用最大。结论cpms可作为代谢代谢综合征患者糖脂调节的有效辅助疗法。然而，鉴于本NMA中纳入的研究数量和质量有限，这些结论应谨慎解释。需要进一步的高质量随机对照试验来验证和更新现有证据。

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