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Biofield therapies: Guidelines for reporting clinical trials 生物场疗法:临床试验报告指南
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-02-01 DOI: 10.1016/j.ctim.2023.103011
Richard Hammerschlag , Meredith L. Sprengel , Ann L. Baldwin

A set of guidelines has been developed to help improve reporting of clinical trials of biofield therapies. The need for enhanced transparency when reporting trials of this family of integrative health practices, e.g., External Qigong, Healing Touch, Reiki and Therapeutic Touch, has been advocated in systematic reviews of these studies. The guidelines, called Biofield Therapies: Reporting Evidence Guidelines (BiFi REGs), supplement CONSORT 2010 by including details of the intervention protocols relevant to biofield therapy trials. BiFi REGs evolved through a draft document created by a core group, two rounds of a Delphi process with an international group of subject matter experts and two panels, meeting via Zoom, which included editors of complementary and integrative medicine journals. BiFi REGs comprises a 15-item Intervention checklist. Modifications of two other CONSORT topic areas are also proposed to enhance their relevance to trials of biofield therapies. Included for each item are an explanation, and exemplars of reporting from peer-reviewed published reports of biofield therapy trials. When used in conjunction with all other items from CONSORT 2010, we anticipate that BiFi REGs will expedite the peer review process for biofield therapy trials, facilitate attempts at trial replication and help to inform decision-making in the clinical practice of biofield therapies.

为帮助改进生物场疗法临床试验的报告工作,我们制定了一套指南。在对这些研究进行系统回顾时,人们一直主张在报告这一系列综合保健实践(如外气功、触疗、灵气疗法和治疗性触疗)的试验时需要提高透明度。该指南名为《生物场疗法:报告证据指南》(BiFi REGs)是对《CONSORT 2010》的补充,其中包括与生物场疗法试验相关的干预方案细节。BiFi REGs 是由一个核心小组编写的文件草案、两轮由国际主题专家组成的德尔菲流程以及两个通过 Zoom 会议的专家小组(其中包括补充医学和整合医学期刊的编辑)演变而成的。BiFi REGs 包括一个 15 个项目的干预检查表。此外,还建议对 CONSORT 的其他两个主题领域进行修改,以增强其与生物场疗法试验的相关性。每个项目都包含解释,以及经同行评审的生物场疗法试验报告范例。当与 CONSORT 2010 的所有其他项目结合使用时,我们预计 BiFi REGs 将加快生物场疗法试验的同行评审过程,促进试验复制的尝试,并有助于为生物场疗法临床实践中的决策提供信息。
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引用次数: 0
Effects of melatonin on blood pressure, arterial stiffness and quality of life in postmenopausal women: A randomized controlled trial 褪黑素对绝经后妇女血压、动脉僵化和生活质量的影响:随机对照试验。
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-20 DOI: 10.1016/j.ctim.2024.103026
Anne Kristine Amstrup, Lars Rejnmark

Objectives

Studies suggest that melatonin may promote cardiovascular protection. Previous trials have primarily been performed on co-morbid patients. Little information exist on the effect in postmenopausal women with general good health.

Design, participants and intervention

In a double-blinded placebo-controlled study, we randomized 41 postmenopausal women to either 10 mg melatonin per day or placebo for 3 months.

Outcome measures

Outcomes of the trial was changes in blood pressure, pulse wave velocity (PWV), and quality of sleep evaluated by Pittsburgh Sleep Quality Index (PSQI).

Results

Thirty-nine women completed the study. Mean age was 63 years (range 55–75 years). Over the 3 months of the trial, PWV did not differ between groups: Placebo 1.1% (IQR −2.1;9.9) vs. melatonin 0.0% (IQR-9.8;4.1), p = 0.43). The were no significant differences in blood pressure bewteen melatonin and placebo group. Both groups had a pour quality of sleep at baseline (placebo: PSQI 6.0 (IQR 3.3; 8.8) vs. melatonin PSQI 6.0 (IQR 3.0; 10.0), p = 0.94), which did not change in response to treatment.

Conclusion

In healthy postmenopausal women, supplementation with 10 mg melatonin was well-tolerated, but we did not observe any significant improvements in pulse wave velocity, blood pressure or quality of sleep compared with placebo.

目的研究表明,褪黑激素可促进心血管保护。以往的试验主要针对合并疾病的患者。在一项双盲安慰剂对照研究中,我们将 41 名绝经后妇女随机分组,每天服用 10 毫克褪黑素或安慰剂,为期 3 个月。结果测量试验结果为血压、脉搏波速度(PWV)和睡眠质量(由匹兹堡睡眠质量指数(PSQI)评估)的变化。平均年龄为 63 岁(55-75 岁不等)。治疗后,脉搏波速度的变化在各组之间没有差异:安慰剂 1.1% (IQR -2.1;9.9) vs. 褪黑激素 0.0% (IQR-9.8;4.1), p=0.43)。卧床血压(24 小时)无夜间变化:安慰剂组收缩压为-2.3%(IQR -9.6;11.5),褪黑素组收缩压为-1.9%(IQR-4.7;4.2),P=0.81。安慰剂组舒张压变化:-0.7% (IQR -13.2;6.6),褪黑素组舒张压变化:1.8% (IQR -13.2;6.6):1.8%(IQR -5.1;10.0),P=0.53。两组基线睡眠质量均较差(安慰剂组:PSQI 6.0(IQR -5.1;10.0结论 褪黑素的耐受性良好,但我们没有观察到心血管方面的改善。结论褪黑素的耐受性很好,但我们没有观察到对心血管的改善作用。对于总体健康状况良好的绝经后妇女,褪黑素对心血管的额外益处很少。
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引用次数: 0
Curcumin effects on glycaemic indices, lipid profile, blood pressure, inflammatory markers and anthropometric measurements of non-alcoholic fatty liver disease patients: A systematic review and meta-analysis of randomized clinical trials 姜黄素对非酒精性脂肪肝患者血糖指数、血脂状况、血压、炎症指标和人体测量的影响:随机临床试验的系统回顾和荟萃分析
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-15 DOI: 10.1016/j.ctim.2024.103025
Armin Ebrahimzadeh , Shokouh Mohseni , Mohammad Safargar , Abbas Mohtashamian , Sara Niknam , Mohammadreza Bakhoda , Sanaz Afshari , Amirhossein Jafari , Anahita Ebrahimzadeh , Sara Fooladshekan , Alireza Mohtashami , Gordon A. Ferns , Siavash Babajafari , Zahra Sohrabi

Objectives

Curcumin has antioxidant properties and has been proposed as a potential treatment for NAFLD. The aim of current systematic review and meta-analysis was to evaluate previous findings for the effect of curcumin supplementation on glycaemic indices, lipid profile, blood pressure, inflammatory markers, and anthropometric measurements of NAFLD patients.

Methods

Relevant studies published up to January 2024 were searched systematically using the following databases: PubMed, SCOPUS, WOS, Science Direct, Ovid and Cochrane. The systematic review and meta-analysis were conducted according to the 2020 PRISMA guidelines. The quality of the papers was assessed the using the Joanna Briggs Institute (JBI) Critical Appraisal Checklist. Pooled effect sizes were calculated using a random-effects model and reported as the WMD and 95% CI. Also, subgroup analyses were done to find probable sources of heterogeneity among studies.

Results

Out of 21010 records initially identified, 21 eligible RCTs were selected for inclusion in a meta-analysis. Overall, 1191 participants of both genders, 600 in the intervention and 591 in the control group with NAFLD were included. There are several limitations in the studies that were included, for instance, the results are weakened substantially by potential bias or failure to account for potential adulteration (with pharmaceuticals) or contamination (with other herbs) of the curcumin supplements that were tested. However, previous studies have reported curcumin to be a safe complementary therapy for several conditions. Our study indicated that curcumin supplementation in doses of 50−3000 mg/day was associated with significant change in FBG [WMD: −2.83; 95% CI: −4.61, −1.06), I2 = 51.3%], HOMA-IR [WMD: −0.52; 95% CI: −0.84, −0.20), I2= 82.8%], TG [WMD: −10.31; 95% CI: −20.00, −0.61), I2 = 84.5%], TC [WMD: −11.81; 95% CI: −19.65, −3.96), I2 = 94.6%], LDL [WMD: −8.01; 95% CI: −15.79, −0.24), I2 = 96.1%], weight [WMD: −0.81; 95% CI: −1.28, −0.35), I2= 0.0%] and BMI [WMD: −0.35; 95% CI: −0.57, −0.13), I2= 0.0%] in adults with NAFLD. There was no significant change in HbA1C, plasma insulin, QUICKI, HDL, SBP, DBP, CRP, TNF-α and WC after curcumin therapy. Subgroup analysis suggested a significant changes in serum FBG, TG, SBP, WC in RCTs for intervention durations of ≥ 8 weeks, and SBP, TG, LD

目的姜黄素具有抗氧化特性,被认为是治疗非酒精性脂肪肝的一种潜在方法。本系统综述和荟萃分析旨在评估姜黄素补充剂对非酒精性脂肪肝患者的血糖指数、血脂状况、血压、炎症指标和人体测量的影响:PubMed、SCOPUS、WOS、Science Direct、Ovid 和 Cochrane。系统综述和荟萃分析根据 2020 年 PRISMA 指南进行。论文质量采用乔安娜-布里格斯研究所(JBI)的批判性评估清单进行评估。汇总效应大小采用随机效应模型计算,并以 WMD 和 95% CI 的形式报告。此外,还进行了亚组分析,以找出研究间异质性的可能来源。结果在最初确定的 21010 条记录中,有 21 项符合条件的 RCT 被选中纳入荟萃分析。总共纳入了 1191 名非酒精性脂肪肝患者,其中干预组和对照组各占 600 人和 591 人。所纳入的研究存在一些局限性,例如,研究结果可能存在偏差,或未考虑所测试的姜黄素补充剂可能掺假(与药物混合)或污染(与其他草药混合)的情况,从而大大削弱了研究结果。不过,以往的研究报告表明,姜黄素是一种安全的辅助疗法,可治疗多种疾病。我们的研究表明,姜黄素补充剂的剂量为 50-3000 毫克/天与 FBG [WMD: - 2.83; 95% CI: - 4.61, - 1.06), I2 = 51.3%], HOMA-IR [WMD: -0.52; 95% CI: -0.84, -0.20), I2 = 82.8%], TG [WMD: - 10.31; 95% CI: - 20.00,- 0.61),I2=84.5%],TC[WMD:- 11.81;95% CI:- 19.65,- 3.96),I2=94.6%],LDL[WMD:- 8.01;95% CI:- 15.79,- 0.24),I2=96.1%]、非酒精性脂肪肝成人的体重[WMD:-0.81;95% CI:-1.28,-0.35),I2=0.0%]和BMI[WMD:-0.35;95% CI:-0.57,-0.13),I2=0.0%]。姜黄素治疗后,HbA1C、血浆胰岛素、QUICKI、HDL、SBP、DBP、CRP、TNF-α和WC均无明显变化。亚组分析表明,在干预时间≥8周的研究中,血清FBG、TG、SBP和WC发生了显著变化;在样本量为55人的研究中,SBP、TG、LDL、HDL、BMI和WC发生了显著变化。以往的研究表明,姜黄素是一种治疗多种疾病的安全辅助疗法。我们建议,如果姜黄素补充剂在临床上用于特定病症,应谨慎使用。此外,非酒精性脂肪肝等级的不同可能会影响评估结果,因此建议今后的研究根据非酒精性脂肪肝等级对亚组进行分析。此外,由于大多数研究未能对姜黄/姜黄素产品进行独立的生化评估,以及潜在的偏倚来源,因此在解释结果时应谨慎。
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引用次数: 0
Acupuncture for post-stroke spasticity: An overview of systematic reviews 针灸治疗中风后痉挛:系统综述
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-15 DOI: 10.1016/j.ctim.2024.103024
Lizhen Yi, Linxing Huang, Ruixue Chen, Sheng Zhan, Huiyuan Huang, Zenghui Yue

Background

Post-stroke spasticity (PSS) is the most common complication of stroke. Acupuncture is widely used in clinical practice for the treatment of PSS, and is therefore considered a common complementary treatment. Several systematic reviews (SRs) and meta-analyses (MAs) have demonstrated the efficacy and safety of acupuncture in the treatment of PSS; however, the quality of evidence of these studies has not been adequately assessed.

Objective

To evaluate and summarize the SRs/MAs and inform future research and clinical practice on the efficacy and safety of acupuncture for PSS.

Data sources and extracion

The following databases were searched from their dates of inception to March 26, 2023: PubMed, Embase, The Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, SinoMed, and Chinese Science and Technology Periodical Database (VIP), and grey literature were manually searched. Two reviewers independently completed literature retrieval, screening, and data extraction.

Review appraisal

Systematic evaluation tools to Assess Systematic Reviews (AMSTAR) 2, Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020 Checklist), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system were used to systematically evaluate the methodological, reporting, and evidence quality of the SRs/MAs.

Results

Overall, 226 papers were examined, and after careful consideration, 10 SRs/MAs were deemed eligible for inclusion. The AMSTAR 2 assessment revealed that one SR/MA had medium, one study had low, and the remaining eight studies had critically low methodological qualities. Additionally, four SRs/MAs completed more than 60 % of the PRISMA 2020 checklist. The GRADE system indicated that six outcomes were medium, 26 outcomes were low, and 24 outcomes were critically low.

Conclusion

Based on the evidence, acupuncture may be a promising complementary treatment to improve post-stroke spasticity and quality of life. Further high-quality RCTs are needed in future studies to support the broader application of acupuncture for the treatment of PSS.

背景中风后痉挛(PSS)是中风最常见的并发症。针灸在临床实践中被广泛用于治疗中风后痉挛,因此被认为是一种常见的辅助治疗方法。一些系统综述(SR)和荟萃分析(MA)证明了针灸治疗 PSS 的有效性和安全性;然而,这些研究的证据质量尚未得到充分评估:PubMed、Embase、The Cochrane Library、中国国家知识基础设施(CNKI)、万方数据库、SinoMed和中国科技期刊数据库(VIP),并人工检索了灰色文献。综述评估采用系统综述评估工具(AMSTAR)2、系统综述和荟萃分析首选报告项目(PRISMA 2020检查表)以及推荐评估、发展和评价分级(GRADE)系统对SR/MA的方法学、报告和证据质量进行了系统评估。AMSTAR 2 评估显示,一项 SR/MA 为中等,一项研究为低,其余八项研究的方法学质量为极低。此外,有四项 SR/MA 完成了 PRISMA 2020 核对表的 60% 以上。GRADE 系统显示,6 项结果为中等,26 项结果为低等,24 项结果为极低等。今后的研究需要进一步开展高质量的 RCT,以支持针灸在治疗 PSS 方面的更广泛应用。
{"title":"Acupuncture for post-stroke spasticity: An overview of systematic reviews","authors":"Lizhen Yi,&nbsp;Linxing Huang,&nbsp;Ruixue Chen,&nbsp;Sheng Zhan,&nbsp;Huiyuan Huang,&nbsp;Zenghui Yue","doi":"10.1016/j.ctim.2024.103024","DOIUrl":"10.1016/j.ctim.2024.103024","url":null,"abstract":"<div><h3>Background</h3><p>Post-stroke spasticity (PSS) is the most common complication of stroke. Acupuncture is widely used in clinical practice for the treatment of PSS, and is therefore considered a common complementary treatment. Several systematic reviews (SRs) and meta-analyses (MAs) have demonstrated the efficacy and safety of acupuncture in the treatment of PSS; however, the quality of evidence of these studies has not been adequately assessed.</p></div><div><h3>Objective</h3><p>To evaluate and summarize the SRs/MAs and inform future research and clinical practice on the efficacy and safety of acupuncture for PSS.</p></div><div><h3>Data sources and extracion</h3><p>The following databases were searched from their dates of inception to March 26, 2023: PubMed, Embase, The Cochrane Library, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, SinoMed, and Chinese Science and Technology Periodical Database (VIP), and grey literature were manually searched. Two reviewers independently completed literature retrieval, screening, and data extraction.</p></div><div><h3>Review appraisal</h3><p>Systematic evaluation tools to Assess Systematic Reviews (AMSTAR) 2, Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA 2020 Checklist), and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system were used to systematically evaluate the methodological, reporting, and evidence quality of the SRs/MAs.</p></div><div><h3>Results</h3><p>Overall, 226 papers were examined, and after careful consideration, 10 SRs/MAs were deemed eligible for inclusion. The AMSTAR 2 assessment revealed that one SR/MA had medium, one study had low, and the remaining eight studies had critically low methodological qualities. Additionally, four SRs/MAs completed more than 60 % of the PRISMA 2020 checklist. The GRADE system indicated that six outcomes were medium, 26 outcomes were low, and 24 outcomes were critically low.</p></div><div><h3>Conclusion</h3><p>Based on the evidence, acupuncture may be a promising complementary treatment to improve post-stroke spasticity and quality of life. Further high-quality RCTs are needed in future studies to support the broader application of acupuncture for the treatment of PSS.</p></div>","PeriodicalId":10545,"journal":{"name":"Complementary therapies in medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0965229924000128/pdfft?md5=6d54a5bfe7ce6cc8e5c4df6400e42f38&pid=1-s2.0-S0965229924000128-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139470703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effectiveness of animal-assisted therapy and pet-robot interventions in reducing depressive symptoms among older adults: A systematic review and meta-analysis 动物辅助治疗和宠物机器人干预对减轻老年人抑郁症状的效果:系统回顾与元分析
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-15 DOI: 10.1016/j.ctim.2024.103023
David Villarreal-Zegarra , Teodoro Yllescas-Panta , Sofía Malaquias-Obregon , Andrea Dámaso-Román , Nikol Mayo-Puchoc

Background

Systematic reviews suggest that animal-assisted therapy (AAT) and pet-robot interventions (PRI) achieve a reduction in mental health variables such as depressive symptoms. However, these systematic reviews include both randomised and non-randomised studies, which prevents an adequate assessment of the effect of confounding variables.

Objective

This systematic review and meta-analysis aimed to evaluate the comparative effectiveness of AAT and PRI through randomized controlled trials (RCTs) in reducing depression in older adults.

Methods

Our study is a systematic review. We searched three databases of scientific articles: SCOPUS, Web of Science and PubMed. We included studies that their population was older adults, aged 65 years or older, with or without a clinical condition, clinical diagnosis based on mental examination/test or documentation from medical records, accredited by the facilities' staff. We included trials in which the comparator was a passive intervention or an active intervention. We used the Cochrane risk-of-bias tool for randomised trials (RoB 2) to assess the risk of bias for each study. Our study was registered in PROSPERO (CRD42023393740).

Results

Twenty-three studies were included in this systematic review. However, only 19 trials were included in the meta-analysis. At the overall risk of bias level, 78.9% of the studies were at high risk of bias (n = 15). We found that AAT (g= −0.72; 95%CI −1.13 to −0.31; p = 0.001) has a moderate and statistically significant effect as an intervention to reduce depressive symptoms in older adults. However, the PRIs do not show a significant effect on reducing depressive symptoms in older adults. In addition, a sub-analysis based on dog-assisted therapy (g= −0.65; 95%CI −1.21 to −0.08; p = 0.025), a specific type of AAT, showed a modest effect on reducing depressive symptoms.

Conclusions

Our study concluded that AAT and DAT had a moderate and statistically significant effect as interventions to reduce depressive symptoms in older adults. On the other hand, PRI did not show a significant effect in reducing depressive symptoms.

背景系统综述表明,动物辅助疗法(AAT)和宠物机器人干预(PRI)可减少抑郁症状等心理健康变量。本系统综述和荟萃分析旨在通过随机对照试验(RCTs)评估动物辅助疗法和宠物机器人干预在减轻老年人抑郁方面的比较效果。我们检索了三个科学文章数据库:SCOPUS、Web of Science 和 PubMed。我们纳入的研究对象是 65 岁或 65 岁以上的老年人,无论有无临床症状,临床诊断是否基于精神检查/测试或医疗记录文件,并由医疗机构的工作人员认可。我们纳入了比较对象为被动干预或主动干预的试验。我们使用科克伦随机试验偏倚风险工具(RoB 2)来评估每项研究的偏倚风险。我们的研究已在 PROSPERO 注册(CRD42023393740)。然而,只有 19 项试验被纳入荟萃分析。在总体偏倚风险水平上,78.9%的研究存在高偏倚风险(n=15)。我们发现,AAT(g= -0.72; 95%CI -1.13 to -0.31;p=0.001)作为减少老年人抑郁症状的干预措施,具有中度和统计学意义上的显著效果。然而,PRIs 对减轻老年人抑郁症状的效果并不明显。此外,基于狗辅助疗法(g= -0.65;95%CI -1.21 至 -0.08;p=0.025)(一种特殊的 AAT)的子分析表明,狗辅助疗法对减轻老年人抑郁症状有一定的效果。另一方面,PRI 对减轻抑郁症状没有明显效果。
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引用次数: 0
Evidence of the interactions between immunosuppressive drugs used in autoimmune rheumatic diseases and Chinese herbal medicine: A scoping review 自身免疫性风湿病所用免疫抑制剂与中药相互作用的证据:范围综述
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-11 DOI: 10.1016/j.ctim.2024.103017
Ting Hui Woon , Melissa Jia Hui Tan , Yu Heng Kwan , Warren Fong

Objectives

Chinese herbal medicine (CHM) has been shown to be effective in autoimmune rheumatic diseases, but harmful herb-drug interactions might be inherent. We aim to review the evidence regarding herb-drug interactions between immunosuppressive drugs used in autoimmune rheumatic diseases and CHM.

Methods

We searched PubMed, EMBASE and CINAHL from inception till 30 April 2023 using keywords that encompassed ‘herb-drug interactions’, ‘herbs’ and ‘immunosuppressants’. Articles were included if they contained reports about interactions between immunosuppressive drugs used in the treatment of rheumatic diseases with CHM. Level of evidence for each pair of interaction was graded using the algorithm developed by Colalto.

Results

A total of 65 articles and 44 unique pairs of interactions were identified. HDIs were reported for cyclophosphamide, cyclosporine, tacrolimus, methotrexate, mycophenolic acid, glucocorticoids, sulfasalazine, tofacitinib and biologic disease-modifying antirheumatic drugs. Among these, cyclosporine (n = 27, 41.5%) and tacrolimus (n = 19, 29.2%) had the highest number of documented interactions. Hypericum perforatum had the highest level of evidence of interaction with cyclosporine and tacrolimus. Consumption reduced the bioavailability and therapeutic effects of the drugs. Schisandra sphenanthera had the highest level of evidence of interaction with tacrolimus and increased the bioavailability of the drug. Majority of the articles were animal studies.

Conclusion

Overall level of evidence for the included studies were low, though interactions between cyclosporine, tacrolimus, Hypericum perforatum and Schisandra sphenanthera were the most and well-documented. Healthcare professionals should actively enquire about the concurrent use of CHM in patients, especially when drugs with a narrow therapeutic index are consumed.

目的中草药(CHM)已被证明对自身免疫性风湿病有效,但可能存在有害的草药-药物相互作用。我们旨在回顾有关自身免疫性风湿病中使用的免疫抑制剂与中药之间的草药-药物相互作用的证据。方法我们检索了从开始到 2023 年 4 月 30 日的 PubMed、EMBASE 和 CINAHL,关键词包括 "草药-药物相互作用"、"草药 "和 "免疫抑制剂"。如果文章包含治疗风湿性疾病的免疫抑制剂与 CHM 之间相互作用的报告,则将其纳入。采用 Colalto 开发的算法对每对相互作用的证据水平进行了分级。结果共发现 65 篇文章和 44 对独特的相互作用。报告了环磷酰胺、环孢素、他克莫司、甲氨蝶呤、霉酚酸、糖皮质激素、柳氮磺吡啶、托法替尼和生物修饰抗风湿药的HDIs。其中,环孢素(27 例,41.5%)和他克莫司(19 例,29.2%)的相互作用记录最多。金丝桃与环孢素和他克莫司相互作用的证据水平最高。服用金丝桃会降低药物的生物利用度和治疗效果。五味子与他克莫司相互作用的证据水平最高,可增加药物的生物利用度。结论虽然环孢素、他克莫司、贯叶连翘和五味子之间的相互作用最多且证据充分,但所纳入研究的总体证据水平较低。医护人员应积极询问患者是否同时使用 CHM,尤其是在服用治疗指数较窄的药物时。
{"title":"Evidence of the interactions between immunosuppressive drugs used in autoimmune rheumatic diseases and Chinese herbal medicine: A scoping review","authors":"Ting Hui Woon ,&nbsp;Melissa Jia Hui Tan ,&nbsp;Yu Heng Kwan ,&nbsp;Warren Fong","doi":"10.1016/j.ctim.2024.103017","DOIUrl":"10.1016/j.ctim.2024.103017","url":null,"abstract":"<div><h3>Objectives</h3><p>Chinese herbal medicine (CHM) has been shown to be effective in autoimmune rheumatic diseases, but harmful herb-drug interactions might be inherent. We aim to review the evidence regarding herb-drug interactions between immunosuppressive drugs used in autoimmune rheumatic diseases and CHM.</p></div><div><h3>Methods</h3><p>We searched PubMed, EMBASE and CINAHL from inception till 30 April 2023 using keywords that encompassed ‘herb-drug interactions’, ‘herbs’ and ‘immunosuppressants’. Articles were included if they contained reports about interactions between immunosuppressive drugs used in the treatment of rheumatic diseases with CHM. Level of evidence for each pair of interaction was graded using the algorithm developed by Colalto.</p></div><div><h3>Results</h3><p>A total of 65 articles and 44 unique pairs of interactions were identified. HDIs were reported for cyclophosphamide, cyclosporine, tacrolimus, methotrexate, mycophenolic acid, glucocorticoids, sulfasalazine, tofacitinib and biologic disease-modifying antirheumatic drugs. Among these, cyclosporine (n = 27, 41.5%) and tacrolimus (n = 19, 29.2%) had the highest number of documented interactions. <em>Hypericum perforatum</em> had the highest level of evidence of interaction with cyclosporine and tacrolimus. Consumption reduced the bioavailability and therapeutic effects of the drugs. <em>Schisandra sphenanthera</em> had the highest level of evidence of interaction with tacrolimus and increased the bioavailability of the drug. Majority of the articles were animal studies.</p></div><div><h3>Conclusion</h3><p>Overall level of evidence for the included studies were low, though interactions between cyclosporine, tacrolimus, <em>Hypericum perforatum</em> and <em>Schisandra sphenanthera</em> were the most and well-documented. Healthcare professionals should actively enquire about the concurrent use of CHM in patients, especially when drugs with a narrow therapeutic index are consumed.</p></div>","PeriodicalId":10545,"journal":{"name":"Complementary therapies in medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0965229924000050/pdfft?md5=b3a2c19018ddcecc9cdd9577c02a29b8&pid=1-s2.0-S0965229924000050-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139457941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Effects of traditional Chinese exercises in fibromyalgia syndrome: A meta-analysis of randomized controlled trials 中医锻炼对纤维肌痛综合征的影响:随机对照试验的元分析》。
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-09 DOI: 10.1016/j.ctim.2024.103019
Hongshi Zhang , Xiaotu Zhang , Yidan Wang , Xuefeng Sun , Sixuan Li , Jindan Zhang , Jundong Jiao

Objectives

To explore the efficacy and safety of five traditional Chinese exercises (TCEs) in patients with fibromyalgia syndrome (FMS).

Methods

The PubMed, Embase, Scopus, ProQuest, Web of Science, Cochrane, CNKI, WanFang, and VIP databases were comprehensively searched for randomized controlled trials (RCTs) related to TCEs published from inception until February 2023. Standardized mean differences (SMD) and 95% confidence intervals (CI) were used to determine the combined effects of the intervention, and the Cochrane risk-of-bias assessment tool and Review 5.2 software were used to assess methodological quality. The data were extracted and analyzed by the Stata15.0 random effects model.

Results

Nineteen RCTs including 1315 participants were included in the analysis. The studies were found to be heterogeneous (I2 =86.2, P = 0.000), and thus a random effects model was used to combine the data. The results showed that traditional Chinese exercises had potentially beneficial effects on reducing pain (SMD =−0.66,95% CI [−1.08, −0.25], P = 0.002), improving sleep (SMD = −0.35,95% CI [−0.68,0. 01], P = 0.041) and relieving depression (SMD= −0.24,95% CI [−0.47, −0.02], P = 0.034) in FMS patients. However, no significant effects were found on improved quality of life (SMD =−0.20,95% CI [−0.48,0.09], P = 0.176).

Conclusions

TCEs can improve pain, sleep quality and depression in patients with FMS and are safe. However, they do not improve the quality of life significantly. Further large-scale, high-quality, and multi-center RCTs are required to verify the efficacy of TCEs.

目的:探讨五种传统中医运动对纤维肌痛综合征(FMS)患者的疗效和安全性:探讨五种传统中医运动对纤维肌痛综合征(FMS)患者的疗效和安全性:方法:在PubMed、Embase、Scopus、ProQuest、Web of Science、Cochrane、CNKI、WanFang和VIP数据库中全面检索了从开始到2023年2月发表的与TCE相关的随机对照试验(RCT)。采用标准化平均差(SMD)和95%置信区间(CI)确定干预的综合效果,并使用Cochrane偏倚风险评估工具和Review 5.2软件评估方法学质量。采用Stata15.0随机效应模型对数据进行提取和分析:结果:19 项 RCT(包括 1315 名参与者)被纳入分析。发现这些研究存在异质性(I2=86.2,P=0.000),因此采用随机效应模型对数据进行合并。结果显示,传统中医运动对FMS患者减轻疼痛(SMD=-0.66,95% CI [-1.08, -0.25],P=0.002)、改善睡眠(SMD=-0.35,95% CI [-0.68, 0.01],P=0.041)和缓解抑郁(SMD=-0.24,95% CI [-0.47, -0.02],P=0.034)有潜在的有益作用。然而,在改善生活质量方面没有发现明显效果(SMD=-0.20,95% CI [-0.48,0.09],n=16,P=0.176):TCEs可以改善FMS患者的疼痛、睡眠质量和抑郁,并且是安全的。结论:TCEs 可以改善 FMS 患者的疼痛、睡眠质量和抑郁,并且是安全的。需要进一步开展大规模、高质量和多中心的 RCT 研究,以验证 TCEs 的疗效。
{"title":"Effects of traditional Chinese exercises in fibromyalgia syndrome: A meta-analysis of randomized controlled trials","authors":"Hongshi Zhang ,&nbsp;Xiaotu Zhang ,&nbsp;Yidan Wang ,&nbsp;Xuefeng Sun ,&nbsp;Sixuan Li ,&nbsp;Jindan Zhang ,&nbsp;Jundong Jiao","doi":"10.1016/j.ctim.2024.103019","DOIUrl":"10.1016/j.ctim.2024.103019","url":null,"abstract":"<div><h3>Objectives</h3><p>To explore the efficacy and safety of five traditional Chinese exercises (TCEs) in patients with fibromyalgia syndrome (FMS).</p></div><div><h3>Methods</h3><p>The PubMed, Embase, Scopus, ProQuest, Web of Science, Cochrane, CNKI, WanFang, and VIP databases were comprehensively searched for randomized controlled trials (RCTs) related to TCEs published from inception until February 2023. Standardized mean differences (SMD) and 95% confidence intervals (CI) were used to determine the combined effects of the intervention, and the Cochrane risk-of-bias assessment tool and Review 5.2 software were used to assess methodological quality. The data were extracted and analyzed by the Stata15.0 random effects model.</p></div><div><h3>Results</h3><p>Nineteen RCTs including 1315 participants were included in the analysis. The studies were found to be heterogeneous (<em>I</em><sup>2</sup> =86.2, <em>P</em> = 0.000), and thus a random effects model was used to combine the data. The results showed that traditional Chinese exercises had potentially beneficial effects on reducing pain (SMD =−0.66,95% CI [−1.08, −0.25], <em>P</em> = 0.002), improving sleep (SMD = −0.35,95% CI [−0.68,0. 01], <em>P</em> = 0.041) and relieving depression (SMD= −0.24,95% CI [−0.47, −0.02], <em>P</em> = 0.034) in FMS patients. However, no significant effects were found on improved quality of life (SMD =−0.20,95% CI [−0.48,0.09], <em>P</em> = 0.176).</p></div><div><h3>Conclusions</h3><p>TCEs can improve pain, sleep quality and depression in patients with FMS and are safe. However, they do not improve the quality of life significantly. Further large-scale, high-quality, and multi-center RCTs are required to verify the efficacy of TCEs.</p></div>","PeriodicalId":10545,"journal":{"name":"Complementary therapies in medicine","volume":null,"pages":null},"PeriodicalIF":3.6,"publicationDate":"2024-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S0965229924000074/pdfft?md5=fe67e4b0716245b8affccef40a79af9e&pid=1-s2.0-S0965229924000074-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139424466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Bitter ginger (Zingiber zerumbet) for patients with solid tumors with no treatment options: A pilot clinical study 无任何治疗方案的实体瘤患者用苦参(Zingiber zerumbet)治疗:一项试验性临床研究。
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-08 DOI: 10.1016/j.ctim.2024.103021
Larissa Vieira de Queiroz , José Favoreto Neto , Fernando Luiz Affonso Fonseca , Carlos Cleomir Pinheiro , Auro del Giglio

Introduction

Zerumbone is a natural compound found in bitter ginger plants (Zingiber zerumbet) that shows antiproliferative, antioxidant, anti-inflammatory, and analgesic properties. We aimed to investigate the role of zerumbone in improving the quality of life and symptom control in cancer patients with no treatment options.

Methods

We conducted a pilot, non-randomized, single-center, open prospective, and systematic study on the use of 400 mg of zerumbone twice a day.

Results

The study included 35 patients (mean age, 68 years; 64% men), of which 16 completed the eight-week study. The intention-to-treat population showed no significant changes in weight or sleep quality over the eight-week study. Assessments performed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) showed significant improvements in the quality of life in the global (p = 0.072), activity (p = 0.0393), social (p = 0.0001), and emotional (p = 0.0023) dimensions. The Hospital Anxiety and Depression Scale (HADS) questionnaire scores showed significant improvement in anxiety (p = 0.032) and depression (p = 0.021), while the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire scores also indicated a significant improvement (p = 0.001). Bitter ginger showed low toxicity.

Conclusions

Bitter ginger showed promising results in improving the quality of life and reducing symptoms of anxiety and depression in the study population. A randomized placebo-controlled study is necessary to confirm these results.

This trial was registered under the number FMABC: CAAE – 93459418.00000082, at ISRCTN (BIOMED CENTRAL) NUMBER 4388 (03/07/23) and at Plataforma Brasil (https://plataformabrasil.saude.gov.br/login.jsf)

简介姜酮是一种存在于苦姜(Zingiber zerumbet)植物中的天然化合物,具有抗增殖、抗氧化、抗炎和镇痛特性。我们的目的是研究姜酮在改善无治疗方案的癌症患者的生活质量和症状控制方面的作用:我们进行了一项试验性、非随机、单中心、开放前瞻性和系统性研究,研究对象为使用400毫克泽润邦的患者,每天两次:该研究包括 35 名患者(平均年龄 68 岁;64% 为男性),其中 16 人完成了为期八周的研究。在为期八周的研究中,意向治疗人群的体重和睡眠质量没有发生显著变化。使用欧洲癌症研究和治疗组织生活质量问卷核心 30(EORTC QLQ-C30)进行的评估显示,总体(p = 0.072)、活动(p = 0.0393)、社交(p = 0.0001)和情感(p = 0.0023)方面的生活质量均有显著改善。医院焦虑和抑郁量表(HADS)问卷调查结果显示,焦虑(p = 0.032)和抑郁(p = 0.021)得到显著改善,而慢性疾病治疗功能评估-疲劳(FACIT-F)问卷调查结果也显示有显著改善(p = 0.001)。苦姜的毒性较低:结论:苦姜在改善研究对象的生活质量、减轻焦虑和抑郁症状方面显示出良好的效果。有必要进行随机安慰剂对照研究来证实这些结果。该试验的注册编号为 FMABC:CAAE - 93459418.00000082、ISRCTN (BIOMED CENTRAL) NUMBER 4388 (03/07/23) 和 Plataforma Brasil (https://plataformabrasil.saude.gov.br/login.jsf)。
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引用次数: 0
Effectiveness of mind-body medicine for Hwa-Byung (a Korean cultural diagnosis of suppressed anger): A systematic review of interventional studies 心身医学对 Hwa-Byung(韩国文化中的压抑愤怒诊断)的疗效:介入性研究的系统回顾。
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-06 DOI: 10.1016/j.ctim.2024.103016
Chan-Young Kwon , Boram Lee

Objective

This systematic review analysed the effectiveness of mind-body modalities (MBMs) in Hwa-byung (HB).

Methods

Ten electronic databases were searched. Intervention studies using MBMs for individuals with HB, published up to July 2023, were included. The methodological quality of the included studies was assessed using the Cochrane RoB and ROBINS-I tools. Meta-analysis of continuous variables was presented as mean differences (MDs) and their 95% confidence intervals (CIs).

Results

Nine studies including five randomized controlled clinical trials, were included. The MBM types were meditation, relaxation, biofield therapy, art therapy, and forest-based MBM, and comprehensive HB programs. Most studies used an MBM group, with 5–6 sessions delivered during an average of 4–5 weeks. As a result of the meta-analysis, art therapy showed a statistically significantly better effect on improving the Hwa-Byung Scale (HB-S) score compared to the waitlist control (MD = −7.74; 95% CI = −9.81 to −5.66). In the before-and-after comparison, MBMs were frequently reported to have significant benefits for improving the HB-S total score (7/7, 100%), depressive mood (4/5, 80%), and state anxiety (6/8, 75%). Some methodological flaws were identified in the included studies, including the reliability of diagnosis, non-implementation of assessor blinding, and inappropriate control groups.

Conclusions

This review identified potentially promising MBMs that were not previously recommended in the current HB clinical practice guidelines. In the future, high-quality clinical studies that include the use of standardized HB diagnostic criteria, homogeneous interventions, appropriate control groups, standard assessment tools such as the HB-S, and assessor blinding are needed.

目的本系统综述分析了身心模式(MBMs)在华-京(HB)中的有效性:方法:检索了十个电子数据库。方法:检索了 10 个电子数据库,纳入了截至 2023 年 7 月发表的针对 HB 患者使用身心模式的干预研究。使用 Cochrane RoB 和 ROBINS-I 工具评估了纳入研究的方法学质量。连续变量的元分析以平均差(MDs)及其95%置信区间(CIs)表示:结果:共纳入 9 项研究,包括 5 项随机对照临床试验。MBM类型包括冥想、放松、生物场疗法、艺术疗法、基于森林的MBM以及综合HB计划。大多数研究使用了甲基溴治疗小组,在平均 4-5 周的时间内进行了 5-6 次治疗。荟萃分析的结果表明,与候补对照组相比,艺术疗法对提高华-京量表(HB-S)评分的效果明显优于候补对照组(MD = -7.74;95% CI = -9.81至-5.66)。在前后对比中,MBMs经常被报告对改善HB-S总分(7/7,100%)、抑郁情绪(4/5,80%)和状态焦虑(6/8,75%)有显著效果。在纳入的研究中发现了一些方法上的缺陷,包括诊断的可靠性、未对评估者实施盲法以及不适当的对照组:本综述发现了一些具有潜在前景的多学科综合疗法,而这些疗法之前并未在现行的 HB 临床实践指南中得到推荐。今后,需要开展高质量的临床研究,包括使用标准化的 HB 诊断标准、同质干预、适当的对照组、标准评估工具(如 HB-S)和评估者盲法。
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引用次数: 0
What is the influence of policosanol supplementation on liver enzymes? A systematic review and dose-response meta-analysis of randomized controlled trials 补充肌醇对肝酶有什么影响?随机对照试验的系统回顾和剂量反应荟萃分析
IF 3.6 3区 医学 Q1 Health Professions Pub Date : 2024-01-06 DOI: 10.1016/j.ctim.2024.103018
Afsaneh Gholamrezayi , Mohammad Reza Amini , Niloufar Rasaei , Camellia Akhgarjand , Zahra Kalantar , Gholamreza Askari , Azita Hekmatdoost

Objective

Policosanol is a mixture of long chain alcohols refined from sugar cane. Significant reductions in liver enzymes have been observed in some studies. However, the impact of policosanol on liver enzymes remained controversial. The current meta-analysis aims to evaluate the effect of policosanol supplementation on the levels of alanine transaminase (ALT) and aspartate transaminase (AST).

Methods

The literature was systematically searched for studies published up to November 2023 in PubMed/Medline, Google Scholar, EMBASE, and Scopus. Randomized controlled trial (RCT) studies were included to evaluate the intervention effect of policosanol compared to placebo on ALT and AST. DerSimonian and Laird models were used to calculate effect sizes.

Results

Twenty-three trials including 2535 participants were included in the study. The combination of effect sizes, regarding the random-effects model, demonstrated significant changes in ALT serum levels after intervention (WMD: -1.48 U/L; 95% CI: -2.33 to -0.64; P = 0.001), and AST (WMD: -1.10 U/L; 95% CI: -1.70 to -0.51; P<0.001). Subgroup analysis of AST and ALT showed that this reduction effect was most often observed at the dose of 20 mg/d. The dose-response analysis represented a non-significant non-linear connection between the dosage and duration of policosanol intervention in ALT and AST serum reduction.

Conclusion

Policosanol supplementation exerts a beneficial effect on liver enzymes as well as ALT and AST concentrations in adults. However, further long-term and well-designed RCTs with better quality are needed to further assess and confirm these results.

目的泼立醇是从甘蔗中提炼出来的一种长链醇混合物。在一些研究中,观察到肝酶显著降低。然而,policosanol 对肝酶的影响仍存在争议。目前的荟萃分析旨在评估补充肌醇对丙氨酸转氨酶(ALT)和天冬氨酸转氨酶(AST)水平的影响。方法在 PubMed/Medline、Google Scholar、EMBASE 和 Scopus 中系统检索截至 2023 年 11 月发表的研究文献。纳入随机对照试验(RCT)研究,以评估与安慰剂相比,policosanol 对 ALT 和 AST 的干预效果。研究采用 DerSimonian 和 Laird 模型计算效应大小。随机效应模型的效应大小组合显示,干预后 ALT 血清水平(WMD:-1.48 U/L;95% CI:-2.33 至 -0.64;P = 0.001)和 AST(WMD:-1.10 U/L;95% CI:-1.70 至 -0.51;P<0.001)有显著变化。对谷草转氨酶和谷丙转氨酶的亚组分析表明,这种降低效果最常出现在 20 毫克/天的剂量上。剂量-反应分析表明,在降低谷丙转氨酶和谷草转氨酶血清浓度的过程中,policosanol 干预的剂量和持续时间之间存在非显著的非线性联系。然而,要进一步评估和证实这些结果,还需要进一步开展长期的、设计良好的、质量更高的 RCT 研究。
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引用次数: 0
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Complementary therapies in medicine
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