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The case for data sharing in traditional, complementary, and integrative medicine research. 在传统、补充和综合医学研究中共享数据的案例。
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2025-03-01 Epub Date: 2024-11-14 DOI: 10.1016/j.imr.2024.101101
Jeremy Y Ng

Traditional, complementary, and integrative medicine (TCIM) research encompasses a diverse range of health practices rooted in various cultural, philosophical, and historical frameworks. As global interest in conducting research in this field grows, the need for rigorous research to support the integration of evidence-based TCIM therapies into mainstream healthcare has become essential. Data sharing is critical to advancing TCIM research by enhancing reproducibility, fostering interdisciplinary collaboration, promoting ethical practices, and addressing global health challenges. Despite its benefits, numerous challenges are associated with data sharing in TCIM, including a lack of standardized practices, cultural sensitivity, intellectual property concerns, and technical barriers in resource-limited settings. This editorial explores the unique nature of TCIM research, emphasizing the importance of data sharing while acknowledging the complexities it entails. Implementing the CARE Principles for Indigenous Data Governance, which prioritize collective benefit, authority to control, responsibility, and ethics, offers a framework for ensuring that data sharing respects indigenous knowledge and cultural sensitivities. Strategies for overcoming barriers to data sharing include developing standardized protocols, investing in research infrastructure, and fostering a culture of openness and collaboration within the TCIM community and beyond. By advancing data sharing practices, TCIM research can contribute to evidence-based healthcare solutions and address global health disparities, ultimately improving health outcomes worldwide.

传统、补充和综合医学(TCIM)的研究包括植根于不同文化、哲学和历史框架的各种卫生实践。随着全球对开展该领域研究的兴趣日益浓厚,需要进行严格的研究,以支持将循证TCIM疗法整合到主流医疗保健中,这一点变得至关重要。通过加强可重复性、促进跨学科合作、促进伦理实践和应对全球卫生挑战,数据共享对于推进TCIM研究至关重要。尽管有诸多好处,但TCIM中的数据共享也面临许多挑战,包括缺乏标准化实践、文化敏感性、知识产权问题以及资源有限环境中的技术壁垒。这篇社论探讨了TCIM研究的独特性,强调了数据共享的重要性,同时承认其复杂性。落实CARE土著数据治理原则,优先考虑集体利益、控制权力、责任和道德,为确保数据共享尊重土著知识和文化敏感性提供了一个框架。克服数据共享障碍的战略包括制定标准化协议、投资于研究基础设施以及在TCIM社区内外培养开放与合作的文化。通过推进数据共享实践,TCIM研究可以为基于证据的医疗保健解决方案做出贡献,并解决全球健康差异,最终改善全球的健康结果。
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引用次数: 0
Acupuncture for acute ischemic stroke: A systematic review and meta-analysis of randomized controlled trials 针刺治疗急性缺血性脑卒中:随机对照试验的系统回顾和荟萃分析
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-12-01 DOI: 10.1016/j.imr.2024.101092
Shanshan Huang , Yuting Wang , Yifan Wu , Puchen Huang , Yu Dong , Qiao Zhang , Mengjiao Zhao , Jingchun Zeng , Liming Lu , Xinxia Liu

Objective

Assess the safety and effectiveness of acupuncture for acute ischemic stroke (AIS).

Methods

We conducted a comprehensive search across the PubMed, Cochrane Library, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), China Science and Technology Journal Database (VIP), Wanfang, and SinoMed databases from their inception until October 3, 2023. Two reviewers screened eligible randomized controlled trials (RCTs) according to criteria and extracted data using a pre-established form. Cochrane tool was used for risk of bias assessment, and Revman 5.3 was used for subsequent meta-analysis. The GRADE tool will be used to assess the quality of evidence.

Results

Thirty-one RCTs were included, involving 3604 patients. Meta-analysis showed that compared with conventional treatments (CTs), acupuncture combined with CTs could improve in National Institutes of Health Stroke Scale (NIHSS) and Efficiency (MD:1.70, 95 %CI [-2.27, -1.14], P < 0.00001;RR: 1.21, 95 %CI [1.12, 1.31], P < 0.00001,);On the Chinese Stroke Scale (CSS) and effectiveness based on CSS, acupuncture showed positive effects (MD:4.33, 95 %CI [-5.67, -2.98], P < 0.00001; RR: 1.26, 95 %CI [1.13, 1.41], P < 0.0001). Furthermore, ADL, Fugl-Meyer Assessment Scale (FMA), prognosis analyses also showed the effectiveness of acupuncture. (SMD: 0.98, 95 % CI [0.64, 1.31], P < 0.00001; MD: 16.46, 95 %CI [12.56, 20.35], P < 0.00001; RR: 0.38, 95 %CI [0.16, 0.89], P = 0.03). However, the certainty of evidence was low.

Conclusion

According to current evidence, Acupuncture may be effective and safe for AIS. The future still needs high-quality evidence to support this conclusion.
目的评价针刺治疗急性缺血性脑卒中(AIS)的安全性和有效性。方法我们对PubMed、Cochrane Library、Embase、Web of Science、中国知网(CNKI)、中国科技期刊库(VIP)、万方和中国医学信息数据库进行了全面检索,检索时间为2023年10月3日。两位审稿人根据标准筛选符合条件的随机对照试验(rct),并使用预先建立的表格提取数据。偏倚风险评估采用Cochrane工具,后续meta分析采用Revman 5.3。GRADE工具将用于评估证据的质量。结果纳入31项随机对照试验,共纳入3604例患者。meta分析显示,与常规治疗(CTs)相比,针刺联合CTs可改善美国国立卫生研究院卒中量表(NIHSS)和效率(MD:1.70, 95% CI [-2.27, -1.14], P <;0.00001;RR: 1.21, 95% CI [1.12, 1.31], P <;在中国脑卒中量表(CSS)和基于CSS的疗效上,针灸有积极的效果(MD:4.33, 95% CI [-5.67, -2.98], P <;0.00001;RR: 1.26, 95% CI [1.13, 1.41], P <;0.0001)。此外,ADL、Fugl-Meyer评估量表(FMA)、预后分析也显示了针刺的有效性。(SMD: 0.98, 95% CI [0.64, 1.31], P <;0.00001;MD: 16.46, 95% CI [12.56, 20.35], P <;0.00001;Rr: 0.38, 95% ci [0.16, 0.89], p = 0.03)。然而,证据的确定性很低。结论根据目前的证据,针灸治疗AIS可能是安全有效的。未来仍需要高质量的证据来支持这一结论。
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引用次数: 0
Effect of electroacupuncture on internal carotid artery blood flow in patients undergoing laparoscopic gallbladder surgery: A randomized clinical trial 电针对腹腔镜胆囊手术患者颈内动脉血流的影响:随机临床试验
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-11-02 DOI: 10.1016/j.imr.2024.101097
Lili Hu , Yongyan Zhang , Ying Li , Ruiping Wang , Hua Xu

Background

Little is known about the effect of electroacupuncture (EA) on cerebral blood flow. We investigated this question in patients undergoing laparoscopic cholecystectomy, hypothesizing that EA would increase cerebral blood flow during surgery.

Methods

Eighty-two patients undergoing laparoscopic cholecystectomy were randomly divided into receiving electroacupuncture and intravenous anesthesia (EA+IA) and receving intravenous anesthesia alone (IA). The patients in EA+IA were treated with EA at Baihui (GV 20), Shuigou (GV 26), unilateral Neiguan (PC 6) and unilateral Zusanli (ST 36) points 20 min before anesthesia until the end of the operation. The patients in IA received intravenous anesthesia alone. The internal carotid artery blood flow (Q), mean arterial pressure (MAP), end-tidal carbon dioxide pressure (PETCO2) and heart rate (HR) were recorded respectively before anesthesia induction (T1), 2 min after anesthesia induction (T2), 1 min after pneumoperitoneum (T3), 1 min after head-up tilt (T4) and after anesthesia resuscitation (T5).

Results

The internal carotid artery blood flow was significantly higher in EA+IA (mean [SD], T3, 294.0 [89.6] ml min-1; T4, 303.8 [90.6] ml min-1) than in IA (mean [SD], T3, 246.4 [80.9] ml min-1; T4, 253.5 [78.4] ml min-1) at T3 and T4 (P < 0.05). There was no difference in blood flow between the two groups at T2 and T5. As compared with baseline (T1), the internal carotid artery blood flow decreased at T2-T4 in two groups (P < 0.05). There were no differences in MAP, PETCO2, and HR between the two groups.

Conclusion

Electroacupuncture intervention could reduce the decline of internal carotid artery blood flow in patients undergoing laparoscopic cholecystectomy.

Trial registration

ChiCTR: 2,100,041,761.
背景人们对电针(EA)对脑血流的影响知之甚少。我们在接受腹腔镜胆囊切除术的患者中研究了这一问题,假设电针会增加手术中的脑血流量。方法将接受腹腔镜胆囊切除术的 82 名患者随机分为接受电针和静脉麻醉(EA+IA)和单独接受静脉麻醉(IA)。EA+IA患者在麻醉前20分钟在百会穴(GV 20)、水沟穴(GV 26)、单侧内关穴(PC 6)和单侧足三里穴(ST 36)进行电针治疗,直至手术结束。IA患者仅接受静脉麻醉。分别记录麻醉诱导前(T1)、麻醉诱导后2分钟(T2)、气腹后1分钟(T3)、仰头后1分钟(T4)和麻醉复苏后(T5)的颈内动脉血流(Q)、平均动脉压(MAP)、潮气末二氧化碳压力(PETCO2)和心率(HR)。结果 在T3和T4,EA+IA的颈内动脉血流(平均值[标度],T3,294.0 [89.6] ml min-1;T4,303.8 [90.6] ml min-1)明显高于IA(平均值[标度],T3,246.4 [80.9] ml min-1;T4,253.5 [78.4] ml min-1)(P <0.05)。两组在 T2 和 T5 时的血流量没有差异。与基线(T1)相比,两组颈内动脉血流在 T2-T4 均有所下降(P < 0.05)。结论电针干预可减少腹腔镜胆囊切除术患者颈内动脉血流的下降。
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引用次数: 0
Prevalence of and factors associated with trauma surgeons' referral and patients' willingness to acupuncture treatment after traumatic rib fractures: A single-center cross-sectional study 创伤性肋骨骨折后外科医生转诊及患者愿意接受针灸治疗的普遍性及相关因素:单中心横断面研究
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-10-29 DOI: 10.1016/j.imr.2024.101096
Min Ha Kim , Hyun Min Cho , Seon Hee Kim , Youngwoong Kim , Yu Kyung Shin , Kun Hyung Kim

Background

Pain after traumatic rib fractures (TRF) detrimentally affects the injured. Multidisciplinary pain management is crucial for patient care. There is little empirical evidence on acupuncture as a multidisciplinary treatment for patients with TRF. This study aimed to illustrate the characteristics of the patients referred for or received acupuncture and explore the associated factors.

Methods

We conducted a cross-sectional study of Korean Trauma Data Bank and electronic medical records of patients aged 19 or older with TRF from August 2016 to October 2021 in the regional trauma center of Pusan National University Hospital. The sociodemographic and clinical characteristics of patients referred for acupuncture by trauma surgeons and those who received acupuncture were analysed descriptively. In multivariable logistic regression analyses, associations between covariates and either surgeon referrals for or patient willingness to receive acupuncture were quantitatively estimated.

Results

Among 2,937 injured patients, trauma surgeons referred 178 (6.1 %) to acupuncture. Among the referred patients, 111 (72.1 %) underwent acupuncture. Patients with polytrauma (aOR 0.46; 0.30 to 0.68) were less likely to be referred to acupuncture, whereas female patients (aOR 3.92, 1.31 to 11.77) were most likely to receive acupuncture.

Conclusions

A small proportion of patients with TRF were referred for acupuncture, but the referred patients were more likely to receive acupuncture. Polytrauma may be an important criterion for referral to acupuncture services from the perspective of trauma surgeons, while the willingness to receive acupuncture may be associated with gender-related factors. Further studies are warranted to investigate the role of acupuncture in the postinjury care of patients with TRF.
背景创伤性肋骨骨折(TRF)后疼痛对伤者造成不利影响。多学科疼痛治疗对患者护理至关重要。关于针灸作为创伤性肋骨骨折患者多学科治疗方法的实证证据很少。本研究旨在说明转诊或接受针灸治疗的患者的特征,并探讨相关因素。方法我们对韩国创伤数据库和2016年8月至2021年10月釜山大学医院地区创伤中心19岁或以上TRF患者的电子病历进行了横断面研究。研究对创伤外科医生转诊针灸的患者和接受针灸的患者的社会人口学和临床特征进行了描述性分析。在多变量逻辑回归分析中,定量估计了协变量与外科医生转诊或患者接受针灸意愿之间的关系。在转诊患者中,111 人(72.1%)接受了针灸治疗。多发性创伤患者(aOR 0.46;0.30 至 0.68)转诊针灸的可能性较低,而女性患者(aOR 3.92,1.31 至 11.77)接受针灸的可能性最大。从创伤外科医生的角度来看,多发性创伤可能是转诊针灸服务的一个重要标准,而接受针灸的意愿可能与性别因素有关。针灸在TRF患者伤后护理中的作用值得进一步研究。
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引用次数: 0
Non-pharmacological interventions of traditional Chinese medicine in treating polycystic ovary syndrome: a group consensus 中医非药物干预治疗多囊卵巢综合征:小组共识
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-10-22 DOI: 10.1016/j.imr.2024.101093
Tianyi Zhou , Fangfang Wang , Xinfen Xu , Yuhang Zhu , Rong Zhang , Hye Won Lee , Xiao-Yang Mio Hu , Fan Qu , Minchen Dai , Yijing He , Xinyue Li , Zhichun Jin , Yan Yin , Ziming Huang , Kaiqing Lin , Bianba Zhuoma , Xiaoyong Chen , Mali Chen , Longlong Fan , Lanzhong Guo , Dan Pan

Background

To make a group consensus about non-pharmacological interventions of traditional Chinese medicine in treating polycystic ovary syndrome based on the previous guidelines, literature, and expert viewpoints.

Methods

Organized by Chinese Integrative Medicine & Traditional Chinese Medicine Academy, Chinese Maternal and Child Health Association, China, 29 experts from 18 Chinese provinces and 2 international experts, who specialize in gynecology, obstetrics, pediatrics, endocrinology, cardiovascular, psychology, reproductive genetics, nursing, acupuncture and tuina, traditional Chinese medicine, integrative medicine, and other disciplines, discussed and revised the recommendations one by one through in-person or online communication. Each recommendation was approved by ≥90% of the experts before it could be established. The main outcome measure is an optimal clinical regimen for addressing the requirements of women with PCOS and improving their quality of life.

Result(s)

The writing panel drafted the initial report, following a consensus process via adequate communication, which was then reviewed and revised by the consensus panel. This consensus provides 12 non-pharmacological interventions (including acupuncture, thumbtack needle, thread-embedding therapy, TEAS, AA, acupoint hot compress, cupping, acupressure, moxibustion, five elements music, aromatherapy, traditional Chinese exercises) for 8 phenotypes of PCOS, resulting in 34 items of clinical practice recommendations.

Conclusion(s)

The consensus provides 12 non-pharmacological interventions of traditional Chinese medicine for 8 phenotypes of PCOS, resulting in 34 items of clinical practice recommendations, which may be improved by more high-quality multicenter clinical trials.
背景基于既往指南、文献和专家观点,就中医药非药物干预治疗多囊卵巢综合征达成共识。方法在中国中西医结合学会、中国中医科学院、中国妇幼保健协会的组织下,来自中国18个省的29位专家和2位国际专家,分别来自妇科、产科、儿科、内分泌科、心血管科、心理学、生殖遗传学、护理学、针灸推拿学、中医学、中西医结合学等学科,通过面对面或在线交流的方式,逐条讨论并修改建议。每项建议都要经过≥90%的专家认可后才能确立。主要成果衡量标准是针对多囊卵巢综合征女性患者的要求和改善其生活质量的最佳临床方案。结果编写小组通过充分沟通达成共识后,起草了初步报告,然后由共识小组进行审查和修订。该共识针对多囊卵巢综合征的 8 种表型,提供了 12 种非药物干预方法(包括针灸、拇指针、埋线疗法、TEAS、AA、穴位热敷、拔罐、穴位贴敷、艾灸、五行音乐、芳香疗法、传统中医运动),形成了 34 项临床实践建议。结论:本共识针对多囊卵巢综合征的 8 种表型提供了 12 种中医非药物干预措施,形成了 34 项临床实践建议,这些建议可通过更多高质量的多中心临床试验加以完善。
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引用次数: 0
Acupuncture in the emergency department (ACUITY): Results from a BraveNet multi-center feasibility randomized controlled trial 急诊科针灸 (ACUITY):BraveNet 多中心可行性随机对照试验的结果
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-10-21 DOI: 10.1016/j.imr.2024.101095
Jeffery A. Dusek , Gene A. Kallenberg , Alan B. Storrow , Robert M. Hughes , Christopher J. Coyne , David R. Vago , Arya Nielsen , Alison Karasz , Ryung S. Kim , Jessica Surdam , Tracy Segall , Kiran A. Faryar , Natalie L. Dyer , Bruce A. Barton , M. Diane McKee

Background

Pain plays a significant role in emergency department (ED) visits, however safe and effective nonpharmacologic options are needed. Prior studies of acupuncture in the ED reported pain reduction with minimal side effects, but most were small and single site.

Methods

We conducted ACUITY, a prospectively designed multi-center feasibility RCT. Our goal was to recruit 165 adults with acute non-emergent pain ≥4 on a 0–10-point scale at three EDs affiliated with BraveNet Practice Based Research Network. At baseline and 45–60 min later (post), participants self-assessed their pain and anxiety using a 0–10 rating scale. The primary feasibility outcome was recruitment of participants, whereas secondary outcomes were retention, and participant/provider acceptability.

Results

From May 3, 2021, to September 24, 2022, 632 eligible individuals were approached and 165 enrolled (165/632: 26.1 %), meeting our recruitment goal. Notably, 42.4 % of enrollees were Black/African American, 42.4 % were White/Caucasian, and 13.9 % were Hispanic/Latino. Participants were randomized to Acupuncture (n = 83) or Usual care (n = 82), of which 151 (91.5 %) and 128 (77.6 %) provided pain and anxiety scores at post-treatment and 1-week respectively. Acupuncture was rated acceptable to participants and providers. Mean pain ratings (pre-to-post) were 7.4 (2.2) to 4.8 (2.8) for acupuncture and 7.1 (2.3) to 6.4 (2.5) for usual care. Mean anxiety ratings (pre-to-post) were 4.5 (3.4) to 2.5 (2.6) for acupuncture and 4.1 (3.4) to 3.5 (3.2) for usual care.

Conclusion

Successful completion of ACUITY indicates we have the expertise and preliminary data to conduct a future definitive, multi-center RCT.

Trial registration: Clinical trials.gov

NCT04880733.
背景疼痛在急诊科(ED)就诊中扮演着重要角色,但需要安全有效的非药物治疗方案。之前在急诊室进行的针灸研究报告称,针灸可减轻疼痛,且副作用极小,但大多数研究规模较小,且只在单一地点进行。方法我们进行了 ACUITY,这是一项前瞻性设计的多中心可行性 RCT。我们的目标是在 BraveNet 基于实践的研究网络下属的三家急诊室招募 165 名急性非急症疼痛≥4 级(0-10 分)的成人患者。在基线和 45-60 分钟后(后期),参与者使用 0-10 级评分表对疼痛和焦虑进行自我评估。结果从 2021 年 5 月 3 日到 2022 年 9 月 24 日,共接触了 632 名符合条件的人员,其中 165 人注册(165/632:26.1%),达到了我们的招募目标。值得注意的是,42.4%的注册者为黑人/非裔美国人,42.4%为白人/高加索人,13.9%为西班牙裔/拉丁美洲人。参与者被随机分配到针灸治疗(83 人)或常规治疗(82 人),其中 151 人(91.5%)和 128 人(77.6%)分别提供了治疗后和一周内的疼痛和焦虑评分。参与者和提供者均认为针灸是可接受的。针灸治疗的平均疼痛评分(治疗前至治疗后)为 7.4 (2.2) 至 4.8 (2.8),常规护理为 7.1 (2.3) 至 6.4 (2.5)。针灸的平均焦虑评分(前-后)为 4.5 (3.4) 到 2.5 (2.6),常规护理为 4.1 (3.4) 到 3.5 (3.2):试验注册:Clinical trials.govNCT04880733。
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引用次数: 0
Medical cannabis: From research breakthroughs to shifting public perceptions and ensuring safe use 医用大麻:从研究突破到转变公众观念并确保安全使用
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-10-20 DOI: 10.1016/j.imr.2024.101094
Muhammad Kamal Hossain , Han Jung Chae
The landscape of medical cannabis has evolved dramatically over the past few decades. Once stigmatized and illegal in most parts of the world, cannabis is now recognized for its potential therapeutic benefits, supported by an expanding body of scientific research. However, the transition from prohibition to medical recognition is shaped by complex interactions among scientific advancements, public perception and regulatory frameworks for its legalization. This review examines the recent breakthroughs in medical cannabis research, explores the shifting public perceptions and the stigma associated with its use and discusses strategies for enhancing the safety of medical cannabis. We also synthesize the connections between scientific research, public perception and safety considerations in the uses of medical cannabis, providing a comprehensive understanding of how these elements influence each other and shape the future of medical cannabis use for patient adherence.
过去几十年来,医用大麻的状况发生了巨大变化。在世界大部分地区,大麻曾一度被视为污名化的非法药物,但在不断扩大的科学研究的支持下,大麻现在因其潜在的治疗功效而得到认可。然而,从禁用到医学认可的转变是由科学进步、公众认知和大麻合法化监管框架之间复杂的相互作用决定的。本综述研究了医用大麻研究的最新突破,探讨了公众观念的转变以及与使用医用大麻相关的耻辱感,并讨论了提高医用大麻安全性的策略。我们还综合了医用大麻使用中的科学研究、公众认知和安全考虑之间的联系,让人们全面了解这些因素如何相互影响,并塑造医用大麻使用的未来,以促进患者坚持使用医用大麻。
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引用次数: 0
Symptom improvements and adverse effects with Reishi mushroom use: A Cross-Sectional survey of cancer patients 服用灵芝后的症状改善和不良反应:癌症患者横断面调查
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-30 DOI: 10.1016/j.imr.2024.101089
Xiaotong Li , Lingyun Sun , Susan Chimonas , Susan Q. Li , Peng Feng , Yufei Yang , Jun J. Mao

Background

Reishi, a medicinal mushroom, is increasingly used for symptom control by cancer patients worldwide. However, data around patients' experiences with Reishi in oncology are lacking, limiting safe, effective clinical applications. We thus sought to evaluate patient reported benefits and harms of using Reishi.

Methods

We conducted a cross-sectional survey among Chinese cancer patients using Reishi products, probing for symptom improvements and/or adverse events (AEs) after taking Reishi. Multivariable logistic regression models assessed whether socio-demographic or clinical factors, as well as duration of Reishi use or combination with other TCM herbs, were associated with being a “responder” – reporting “quite a bit” or “very much” symptom improvement.

Results

Among 1374 participants, more than half of participants reported that nausea (55 %), fatigue (52 %), poor appetite (51 %), and depression (50 %) improved quite a bit or very much after taking Reishi. In multivariate analyses, age <65 years (adjusted odds ratios [AOR] = 1.76, p = 0.001), diagnosis ≥ 10 years (AOR = 1.78, p = 0.018), and duration of Reishi use ≥ 1 year (1–3 years: AOR = 1.53, p = 0.045; 3–5 years: AOR = 2.04, p = 0.001; >5 years: AOR = 2.07, p < 0.001) were significantly associated with higher responder rates for symptom improvement. However, 125 (9.1 %) also reported a range of AEs, including dry mouth (5 %), constipation (4 %), insomnia (3 %), pruritus (3 %) and vertigo (3 %).

Conclusion

While majority of cancer patients using Reishi reported symptom improvements, some reported adverse effects. This information can assist clinicians in advising cancer patients on safe and effective use of Reishi and help identify specific outcomes for assessment in future prospective clinical trials.
背景灵芝是一种药用蘑菇,越来越多地被世界各地的癌症患者用于控制症状。然而,有关患者使用灵芝治疗肿瘤的经验的数据却很缺乏,这限制了灵芝安全、有效的临床应用。因此,我们试图评估患者报告的使用灵芝的益处和害处。方法 我们对使用灵芝产品的中国癌症患者进行了横断面调查,探究服用灵芝后症状改善情况和/或不良事件(AEs)。多变量逻辑回归模型评估了社会人口学或临床因素、服用灵芝的持续时间或与其他中草药合用是否与 "反应者"--症状改善 "相当多 "或 "非常多"--有关。结果在 1374 名参与者中,超过一半的人表示服用灵芝后恶心(55%)、疲劳(52%)、食欲不振(51%)和抑郁(50%)症状改善 "相当多 "或 "非常多"。在多变量分析中,年龄为 65 岁(调整后的几率比 [AOR] = 1.76,P = 0.001)、确诊时间≥ 10 年(AOR = 1.78,P = 0.018)、服用灵芝时间≥ 1 年(1-3 年,AOR = 1.53,P = 0.018):AOR=1.53,p=0.045;3-5 年:AOR=2.04,p=0.001;>5 年:AOR=2.07,p=0.001)与较高的症状改善应答率明显相关。然而,也有 125 人(9.1%)报告了一系列不良反应,包括口干(5%)、便秘(4%)、失眠(3%)、瘙痒(3%)和眩晕(3%)。这些信息有助于临床医生指导癌症患者安全有效地使用灵芝,并有助于确定未来前瞻性临床试验的具体评估结果。
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引用次数: 0
Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial 关于 Uchasingihwan 治疗腰椎间盘突出症引起的腰痛伴根性病变的有效性和安全性的临床研究:多中心、随机对照等效试验
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-30 DOI: 10.1016/j.imr.2024.101090
Bonhyuk Goo , Jung-Hyun Kim , Eun-Jung Kim , Dongwoo Nam , Hyun-Jong Lee , Jae-Soo Kim , Yeon-Cheol Park , Yong-Hyeon Baek , Sang-Soo Nam , Byung-Kwan Seo

Background

This study aimed to establish the clinical evidence regarding the effectiveness and safety of Uchasingihwan (UCSGH) in improving pain, function, and quality of life in patients with lumbar herniated intervertebral disc (LHIVD).

Methods

This was a multicenter, randomized, controlled, equivalence trial with two parallel arms. Seventy-four participants with LHIVD were recruited and randomly allocated to the experimental and control groups. The participants in each group took 2.5 g of UCSGH granule or loxoprofen 60 mg tablet three times a day for six weeks. Additionally, both groups received the same acupuncture treatment once a week for six weeks. Outcomes about effectiveness and safety were assessed at baseline and 3, 6, and 10 weeks after screening.

Results

As the primary outcome, the mean differences with a 95 % confidence interval (CI) of changes in low back pain between the two groups at weeks 6 (95 % CI:9.26, 8.37) and 10 (95 % CI:9.03, 9.62) from baseline were within the equivalence limit. Also, changes in radiating pain at weeks 6 (95 % CI:1.70, 15.69) and 10 (95 % CI:4.72, 13.75) were within the equivalence limit. Outcome measures for function and quality of life also showed no statistical difference. Regarding safety, the frequency of adverse events related to intervention was lower in UCSGH.

Conclusion

UCSGH showed the equivalent level of effectiveness as loxoprofen in reducing low back and radiating pain in LHIVD patients and showed sufficient safety to be used as a complementary treatment option.

Trial registration

ClinicalTrials.gov (NCT03386149), CRIS (KCT0002848).
背景本研究旨在建立有关Uchasingihwan(UCSGH)改善腰椎间盘突出症(LHIVD)患者疼痛、功能和生活质量的有效性和安全性的临床证据。招募了 74 名腰椎间盘突出症患者,并将他们随机分配到实验组和对照组。每组患者服用 2.5 克 UCSGH 颗粒剂或 60 毫克洛索洛芬片剂,每天三次,连续服用六周。此外,两组均接受每周一次的相同针灸治疗,为期六周。结果作为主要结果,两组患者在第6周(95 % CI:9.26,8.37)和第10周(95 % CI:9.03,9.62)时腰背痛的变化与基线的平均差异(95 % 置信区间)均在等效范围内。此外,放射痛在第 6 周(95 % CI:1.70, 15.69)和第 10 周(95 % CI:4.72, 13.75)的变化也在等效范围内。功能和生活质量方面的结果也没有统计学差异。结论UCSGH在减轻LHIVD患者腰背痛和放射痛方面的疗效与洛索洛芬相当,并显示出足够的安全性,可作为一种辅助治疗方案。
{"title":"Clinical research on the effectiveness and safety of Uchasingihwan for low back pain with radiculopathy caused by herniated intervertebral disc of the lumbar spine: A multicenter, randomized, controlled equivalence trial","authors":"Bonhyuk Goo ,&nbsp;Jung-Hyun Kim ,&nbsp;Eun-Jung Kim ,&nbsp;Dongwoo Nam ,&nbsp;Hyun-Jong Lee ,&nbsp;Jae-Soo Kim ,&nbsp;Yeon-Cheol Park ,&nbsp;Yong-Hyeon Baek ,&nbsp;Sang-Soo Nam ,&nbsp;Byung-Kwan Seo","doi":"10.1016/j.imr.2024.101090","DOIUrl":"10.1016/j.imr.2024.101090","url":null,"abstract":"<div><h3>Background</h3><div>This study aimed to establish the clinical evidence regarding the effectiveness and safety of Uchasingihwan (UCSGH) in improving pain, function, and quality of life in patients with lumbar herniated intervertebral disc (LHIVD).</div></div><div><h3>Methods</h3><div>This was a multicenter, randomized, controlled, equivalence trial with two parallel arms. Seventy-four participants with LHIVD were recruited and randomly allocated to the experimental and control groups. The participants in each group took 2.5 g of UCSGH granule or loxoprofen 60 mg tablet three times a day for six weeks. Additionally, both groups received the same acupuncture treatment once a week for six weeks. Outcomes about effectiveness and safety were assessed at baseline and 3, 6, and 10 weeks after screening.</div></div><div><h3>Results</h3><div>As the primary outcome, the mean differences with a 95 % confidence interval (CI) of changes in low back pain between the two groups at weeks 6 (95 % CI:9.26, 8.37) and 10 (95 % CI:9.03, 9.62) from baseline were within the equivalence limit. Also, changes in radiating pain at weeks 6 (95 % CI:1.70, 15.69) and 10 (95 % CI:4.72, 13.75) were within the equivalence limit. Outcome measures for function and quality of life also showed no statistical difference. Regarding safety, the frequency of adverse events related to intervention was lower in UCSGH.</div></div><div><h3>Conclusion</h3><div>UCSGH showed the equivalent level of effectiveness as loxoprofen in reducing low back and radiating pain in LHIVD patients and showed sufficient safety to be used as a complementary treatment option.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov (NCT03386149), CRIS (KCT0002848).</div></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 4","pages":"Article 101090"},"PeriodicalIF":2.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142705666","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
A deeper understanding of acupoints: Are superficial landmarks enough? 深入了解穴位:肤浅的标记是否足够?
IF 2.8 4区 医学 Q2 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-30 DOI: 10.1016/j.imr.2024.101091
In-Seon Lee , Seunghoon Lee , Heeyoung Moon , Da-Eun Yoon , Younbyoung Chae
{"title":"A deeper understanding of acupoints: Are superficial landmarks enough?","authors":"In-Seon Lee ,&nbsp;Seunghoon Lee ,&nbsp;Heeyoung Moon ,&nbsp;Da-Eun Yoon ,&nbsp;Younbyoung Chae","doi":"10.1016/j.imr.2024.101091","DOIUrl":"10.1016/j.imr.2024.101091","url":null,"abstract":"","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":"13 4","pages":"Article 101091"},"PeriodicalIF":2.8,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142705671","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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
期刊
Integrative Medicine Research
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