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Utilization of medicinal herbs among soccer athletes in the West Bank of Palestine 巴勒斯坦西岸足球运动员对药草的利用
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-01 DOI: 10.1016/j.eujim.2024.102398
Faten Amer , Mahmoud Alatrash

Introduction

Herbal supplements are popular among athletes, yet research on their types, purposes, and information sources is limited, particularly for Palestinian soccer players. This study aims to fill this gap by examining the types of herbal supplements used by young soccer athletes in the West Bank, their purposes, and the sources of information influencing their use. Understanding these aspects is crucial for safely and effectively integrating traditional remedies into modern sports nutrition.

Methods

In 2023, we conducted a cross-sectional study with young soccer athletes in the West Bank. We utilized a validated survey to collect data on the types of herbal supplements, their preparation methods, and information sources. We analyzed the data for frequencies and use values (UV).

Results

Out of 165 invited athletes, 155 participated, with 144 confirming their current use of herbal supplements. The participants, aged 18–25 (mean age 20.34), employed a variety of preparation and consumption methods. Information sources comprised traditional knowledge, advice from herbalists ("Attar" in Arabic), and online trends. Herbs that enhance physical endurance and stamina had the highest UV of 3.93, highlighting their critical importance. Herbs for joint and muscle pain and central nervous system stimulation had UV of 2.28 and 2.10, respectively, reflecting their significant roles. Antistress and anabolic herbs had UVs of 1.28 and 1.21, respectively. The total UV of 10.81 indicates a substantial use of herbal supplements. We recorded 1,675 recommendations, with the primary uses being: enhancing physical endurance and strength (36.36 %), reducing joint and muscle pain (21.13 %), acting as a CNS stimulant (19.46 %), alleviating stress (11.82 %), and providing testosterone-like effects (11.22 %). The top 10 herbs were ginseng (7.46 %), small nettle (6.99 %), olive (6.63 %), date (5.85 %), chili pepper (5.43 %), green tea (5.19 %), fenugreek (4.84 %), soy (4.24 %), coffee (4.24 %), and mate (4.12 %), collectively accounting for about 55 % of all recommendations.

Conclusion

This study identifies the top 10 herbs used by soccer athletes, as well as their role in modern sports nutrition. Future research should evaluate their effectiveness and safety, focusing on herbs like date and small nettle. Educating athletes on the proper use and risks of herbal supplements is essential.

引言草药补充剂在运动员中很受欢迎,但对其类型、目的和信息来源的研究却很有限,尤其是对巴勒斯坦足球运动员而言。本研究旨在通过考察约旦河西岸年轻足球运动员使用的草药补充剂的类型、目的以及影响其使用的信息来源来填补这一空白。了解这些方面对于安全有效地将传统疗法融入现代运动营养至关重要。方法 2023 年,我们对约旦河西岸的年轻足球运动员进行了一项横断面研究。我们利用有效调查收集了有关草药补充剂类型、配制方法和信息来源的数据。结果 在 165 名受邀运动员中,有 155 人参加了调查,其中 144 人确认他们目前使用草药补充剂。参与者的年龄在 18-25 岁之间(平均年龄为 20.34 岁),他们采用了多种配制和食用方法。信息来源包括传统知识、草药专家(阿拉伯语为 "Attar")的建议和网络趋势。增强身体耐力和体力的草药的 UV 值最高,为 3.93,凸显了其至关重要性。治疗关节和肌肉疼痛以及刺激中枢神经系统的草药的 UV 值分别为 2.28 和 2.10,反映了它们的重要作用。抗抑郁和合成代谢药材的 UV 值分别为 1.28 和 1.21。总 UV 值为 10.81,表明草药补充剂的使用量很大。我们记录了 1,675 项推荐,主要用途包括:增强身体耐力和力量(36.36%)、减轻关节和肌肉疼痛(21.13%)、作为中枢神经系统兴奋剂(19.46%)、缓解压力(11.82%)和提供类似睾酮的效果(11.22%)。排名前 10 位的草药分别是人参(7.46 %)、小荨麻(6.99 %)、橄榄(6.63 %)、大枣(5.85 %)、辣椒(5.43 %)、绿茶(5.19 %)、葫芦巴(4.84 %)、大豆(4.24 %)、咖啡(4.24 %)和马黛茶(4.本研究确定了足球运动员使用最多的 10 种草药,以及它们在现代运动营养中的作用。未来的研究应评估这些草药的有效性和安全性,重点关注红枣和小荨麻等草药。教育运动员正确使用草药补充剂及其风险至关重要。
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引用次数: 0
Effect of adlay seed extract on the level of neuroprotection gene expression in human nasal orbital mesenchymal stem cells 阿德雷籽提取物对人鼻眶间充质干细胞神经保护基因表达水平的影响
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-01 DOI: 10.1016/j.eujim.2024.102397
Fatemeh Sanie-Jahromi, Ali Azimi, Hamidreza Hassanipour, Pardis Bostanian, Behzad Khademi

Introduction

Stem cells have gained attention for their potential as a promising approach for generating neurotrophins and advancing cell-based therapies for retinal degenerative diseases such as glaucoma. This study aimed to explore how adlay seed extract impacts the gene expression of key components within the neuroprotection pathway (NGF, TRKB, MAPK, PI3K) in human nasal orbital adipocytes mesenchymal stem cells (OAMSCs).

Methods

Nasal OAMSCs, with a density of 106 cells/ 10 cm2, were subjected to a 24-hour exposure to adlay seed extracts (namely the methanolic (MeOH) and residual (Res) fractions at a concentration of 1 mg/ml). The control group received an identical medium without the extract at the same time and under the same circumstances. We measured the relative expression levels of nerve growth factor (NGF), tyrosine receptor kinase B (TRKB), mitogen-activated protein kinase (MAPK), and phosphoinositide 3-kinase (PI3K) in the treated cells versus the control group using real-time polymerase chain reaction (PCR).

Results

Our data revealed that both the MeOH and Res extracts of adlay seed led to a significant upregulation of NGF in nasal OAMSCs. MeOH extract also led to the overexpression of TRKB (the gene coding for BDNF receptor) in OAMSCs, while the other genes understudy, were not altered.

Conclusions

Our study highlighted initial documentation of the stimulating impact of adlay extract on the transcriptional level of neurotrophin NGF and the TRKB in nasal OAMSCs. We also showed that the extraction method could significantly affect the molecular-level properties of adlay. This preliminary study can pave the ground for future advancements in the treatment of retinal neurodegenerative disorders and glaucoma.

导言干细胞作为产生神经营养素和推进视网膜退行性疾病(如青光眼)细胞疗法的一种有前途的方法,其潜力已引起人们的关注。本研究旨在探讨阿德雷种子提取物如何影响人鼻眶脂肪细胞间充质干细胞(OAMSCs)神经保护通路关键成分(NGF、TRKB、MAPK、PI3K)的基因表达。方法将密度为106个细胞/ 10平方厘米的鼻眶脂肪细胞间充质干细胞置于阿德雷种子提取物(即甲醇(MeOH)和残留物(Res)馏分,浓度为1毫克/毫升)中24小时。对照组在相同的时间和环境下接受不含提取物的相同培养基。我们使用实时聚合酶链反应(PCR)测定了处理组与对照组细胞中神经生长因子(NGF)、酪氨酸受体激酶 B(TRKB)、丝裂原活化蛋白激酶(MAPK)和磷脂酰肌醇3-激酶(PI3K)的相对表达水平。结论我们的研究初步证明了阿德雷提取物对鼻腔 OAMSCs 中神经营养素 NGF 和 TRKB 转录水平的刺激作用。我们的研究还表明,提取方法会显著影响阿德雷的分子水平特性。这项初步研究为今后治疗视网膜神经退行性疾病和青光眼奠定了基础。
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引用次数: 0
Safety and effect of a new artificial saliva containing Zingiber officinale and Cuminum cyminum on stimulating saliva secretion: In vitro, in vivo and preliminary clinical study 含有姜黄和孜然的新型人工唾液对刺激唾液分泌的安全性和效果:体外、体内和初步临床研究
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-09-01 DOI: 10.1016/j.eujim.2024.102396
Supamas Napavichayanun , Sutima Luangdilok , Rungnapha Yamdech , Pornanong Aramwit

Introduction

Xerostomia is a symptom that affects quality of life and may lead to malnutrition. While artificial saliva is used as a lubricant for the oral cavity, it rarely stimulates saliva secretion. The objective of this study was to develop a herbal artificial saliva (HAS) that could stimulate saliva secretion and be safe for human consumption.

Methods

Three HAS formulations were prepared with 0.3 % Cuminum cyminum extract and 0.05 %, 0.10 %, and 0.15 % Zingiber officinale extract (HAS0.05, HAS 0.10, and HAS0.15, respectively). In vivo skin and oral mucosal irritation tests were used to evaluate the safety of HAS0.15. Additionally, the preliminary efficacy and safety of the three HAS formulations were investigated in 21 healthy volunteers. The sample was sprayed into the oral cavity under the left and right sides of the tongue. Thirty minutes after spraying, the amount of saliva was assessed using a visual analogue scale and a Schirmer strip. In addition, dry mouth symptoms, the saliva pH, and adverse reactions were assessed before and after testing.

Results

HAS0.15 caused minimal skin irritation and did not alter the epithelium or other structures of the oral mucosa. The saliva quantity after using HAS0.10 and HAS0.15 was significantly higher than prior to testing (p < 0.05). None of the formulations induced mucositis or adverse reactions.

Conclusion

This study was successful in the development of a new HAS that stimulated saliva secretion and was safe for humans. However, this study is preliminary: Further clinical investigation in patients with hyposalivation will confirm the efficacy of this novel HAS. This novel HAS may be an alternative treatment for the elderly and patients with hyposalivation.

导言:口腔异味是一种影响生活质量并可能导致营养不良的症状。虽然人工唾液可用作口腔润滑剂,但很少能刺激唾液分泌。本研究的目的是开发一种可刺激唾液分泌且可安全食用的草本人工唾液(HAS)。方法用 0.3 % 的小茴香提取物和 0.05 %、0.10 % 和 0.15 % 的细辛提取物(分别为 HAS0.05、HAS 0.10 和 HAS0.15)制备了三种人工唾液配方。体内皮肤和口腔粘膜刺激试验用于评估 HAS0.15 的安全性。此外,还在 21 名健康志愿者中对三种 HAS 配方的初步功效和安全性进行了调查。将样品喷洒在口腔中舌头的左右两侧下方。喷洒 30 分钟后,使用视觉模拟量表和施尔默试纸对唾液量进行评估。此外,还对测试前后的口干症状、唾液 pH 值和不良反应进行了评估。结果HAS0.15 对皮肤的刺激极小,不会改变口腔黏膜上皮或其他结构。使用 HAS0.10 和 HAS0.15 后的唾液量明显高于测试前(p < 0.05)。结论这项研究成功地开发出了一种新的 HAS,它能刺激唾液分泌,而且对人体安全。然而,这项研究还只是初步的:对唾液分泌过少患者的进一步临床研究将证实这种新型 HAS 的疗效。这种新型 HAS 可能是老年人和唾液分泌过少患者的另一种治疗方法。
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引用次数: 0
Parkinsonia praecox bark as a new source of antibacterial and anticancer compounds 作为抗菌和抗癌化合物新来源的朴树树皮
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-27 DOI: 10.1016/j.eujim.2024.102401
Armando Ordaz-Hernández , Beatriz Hernández-Carlos , Héctor Manuel Arreaga González , Lorena Hernández-Ramiro , Misael Corona Ramírez , Mayra Herrera-Martínez

Introduction

Parkinsonia praecox is used in traditional medicine to treat various diseases; however, the antibacterial and anticancer properties from its bark have not been reported. Thus, this study aimed to evaluate the antibacterial activity, cytotoxicity and chemical study of methanolic extract of Parkinsonia praecox bark (PpBM).

Methods

The PpBM antibacterial activity was determined against pathogen strains using the broth microdilution method, the cytotoxic effect was assessed on cancerous (HepG2, SKOV-3 and HeLa) and non-cancerous (J774A.1 and HaCaT) cells using the crystal violet assay, the in vitro hemotoxicity was evaluated using the hemolysis assay on human erythrocytes and the identification of major compounds derived from PpBM was performed by 1H and 13C NMR and 2D NMR experiments.

Results

PpBM (2000 µg/mL) demonstrated antibacterial activity against Listeria monocytogenes, a potential breakthrough in the fight against this pathogen. PpBM decreased cell viability of HepG2 liver cancer cells (IC50, 104.56 µg/mL) with a selectivity index of 1.38 regarding J774A.1 macrophages and 2.04 to HaCaT keratinocytes, suggesting a selective anticancer potential. On the other hand, PpBM did not cause hemolysis to high concentrations (1000 µg/mL) or alterations in the morphology of human erythrocytes at doses lower than 200 µg/mL. For the first time, lupenone, germanicone, 3-oxo-oleanane-18-en-28-ol, and combretol were identified in P. praecox. PpBM showed antibacterial, selective anticancer, and non-hemotoxic properties. These activities may be related to the major compounds, such as lupenone.

Conclusion

P. praecox bark is a new option for obtaining bioactive compounds, further in vitro and in vivo studies are required to confirm their efficacy and safety.

引言 朴树在传统医学中被用于治疗各种疾病,但其树皮的抗菌和抗癌特性尚未见报道。因此,本研究旨在评估朴树树皮甲醇提取物(PpBM)的抗菌活性、细胞毒性和化学研究。方法 采用肉汤微稀释法测定朴树树皮甲醇提取物对病原体菌株的抗菌活性,采用水晶紫法评估朴树树皮甲醇提取物对癌细胞(HepG2、SKOV-3 和 HeLa)和非癌细胞(J774A.1 和 HaCaT)的细胞毒性作用。结果 PpBM(2000 µg/mL)对单核细胞增生李斯特菌具有抗菌活性,这可能是抗击该病原体的一个突破。PpBM 可降低 HepG2 肝癌细胞的存活率(IC50,104.56 µg/mL),对 J774A.1 巨噬细胞的选择性指数为 1.38,对 HaCaT 角质细胞的选择性指数为 2.04,表明其具有选择性抗癌潜力。另一方面,PpBM 在高浓度(1000 微克/毫升)下不会引起溶血,在剂量低于 200 微克/毫升时也不会改变人类红细胞的形态。这是首次在P. praecox中发现羽扇豆酮、锗酮、3-oxo-oleanane-18-en-28-ol和combretol。PpBM 具有抗菌、选择性抗癌和无血液毒性的特性。这些活性可能与主要化合物(如羽扇豆酮)有关。结论:Praecox 树皮是获得生物活性化合物的新选择,需要进一步的体外和体内研究来确认其有效性和安全性。
{"title":"Parkinsonia praecox bark as a new source of antibacterial and anticancer compounds","authors":"Armando Ordaz-Hernández ,&nbsp;Beatriz Hernández-Carlos ,&nbsp;Héctor Manuel Arreaga González ,&nbsp;Lorena Hernández-Ramiro ,&nbsp;Misael Corona Ramírez ,&nbsp;Mayra Herrera-Martínez","doi":"10.1016/j.eujim.2024.102401","DOIUrl":"10.1016/j.eujim.2024.102401","url":null,"abstract":"<div><h3>Introduction</h3><p><em>Parkinsonia praecox</em> is used in traditional medicine to treat various diseases; however, the antibacterial and anticancer properties from its bark have not been reported. Thus, this study aimed to evaluate the antibacterial activity, cytotoxicity and chemical study of methanolic extract of <em>Parkinsonia praecox</em> bark (PpBM).</p></div><div><h3>Methods</h3><p>The PpBM antibacterial activity was determined against pathogen strains using the broth microdilution method, the cytotoxic effect was assessed on cancerous (HepG2, SKOV-3 and HeLa) and non-cancerous (J774A.1 and HaCaT) cells using the crystal violet assay, the <em>in vitro</em> hemotoxicity was evaluated using the hemolysis assay on human erythrocytes and the identification of major compounds derived from PpBM was performed by <sup>1</sup>H and <sup>13</sup>C NMR and 2D NMR experiments.</p></div><div><h3>Results</h3><p>PpBM (2000 µg/mL) demonstrated antibacterial activity against <em>Listeria monocytogenes</em>, a potential breakthrough in the fight against this pathogen. PpBM decreased cell viability of HepG2 liver cancer cells (IC<sub>50</sub>, 104.56 µg/mL) with a selectivity index of 1.38 regarding J774A.1 macrophages and 2.04 to HaCaT keratinocytes, suggesting a selective anticancer potential. On the other hand, PpBM did not cause hemolysis to high concentrations (1000 µg/mL) or alterations in the morphology of human erythrocytes at doses lower than 200 µg/mL. For the first time, lupenone, germanicone, 3-oxo-oleanane-18-en-28-ol, and combretol were identified in <em>P. praecox</em>. PpBM showed antibacterial, selective anticancer, and non-hemotoxic properties. These activities may be related to the major compounds, such as lupenone.</p></div><div><h3>Conclusion</h3><p><em>P. praecox</em> bark is a new option for obtaining bioactive compounds, further <em>in vitro</em> and <em>in vivo</em> studies are required to confirm their efficacy and safety.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"71 ","pages":"Article 102401"},"PeriodicalIF":1.9,"publicationDate":"2024-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142167160","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}
引用次数: 0
Revealing the anti-inflammatory mechanism and effective constituents of Hosta plantaginea flowers by a strategy integrating network pharmacology, molecular docking, and experimental verification 通过网络药理学、分子对接和实验验证相结合的策略,揭示玉簪花的抗炎机理和有效成分
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-10 DOI: 10.1016/j.eujim.2024.102400
Bowei Xia , Xiaomei Li , Qingcui Zhang , Zhongwei He , Jian Liang , Junwei He , Wanchun Wang , Degang Dong , Li Yang

Introduction

Inflammation is a common cause of illness among outpatients, but effective drugs are extremely scarce. Hosta plantaginea flower is an important herbal medicine in China that treats inflammation-related diseases, but its anti-inflammatory mechanism remains unclear.

Methods

Systematic network pharmacology was employed to decipher H. plantaginea flower's anti-inflammatory hub targets and candidate phytochemicals. Furthermore, molecular docking was used to elucidate the interaction of constituents and targets. Afterward, the anti-inflammatory activity of H. plantaginea flower and its mechanism were validated in RAW264.7 cells activated by lipopolysaccharide (LPS).

Results

H. plantaginea flower contains 153 phytochemicals, of which 85 were potential effective constituents. 949 H. plantaginea flower targets and 814 inflammation-related targets were predicted, of which 211 intersecting targets were acquired. Six major constituents, including corvitin, phytyldiol, agapanthagenin, 5,7-dimethoxy-8-methyl-4′-hydroxyflavan, (3R)-2,3-dihydro-7-hydroxy-3-[(4-methoxyphenyl)methyl]-4H-1-benzopyran-4-one, and phenol, 4-[(2S)-3,4-dihydro-5,7-dimethoxy-2H-1-benzopyran-2-yl] were picked out. Furthermore, 6 hub targets such as C-type lectin-like receptor 2 (CLEC1B), toll-like receptor (TLR), tumor necrosis factor (TNF), recombinant V-Rel reticuloendotheliosis viral oncogene homolog A (RELA), signal transducer and activator of transcription 3 (STAT3), and protein kinase B α (AKT1) were obtained using Gene Ontology and Kyoto Encyclopedia of Genes and Genomes functional analyses. Molecular docking indicated that these 6 constituents had strong binding abilities with these 6 hub targets. Finally, the anti-inflammatory effect of H. plantaginea flower and its mechanism were verified in LPS-induced RAW264.7 cells by the inhibition of CLEC1B, TLR-4, TNF-α, STAT3, and Akt1 proteins, thereby suppressing the overproduction of nitric oxide.

Conclusion

H. plantaginea flower exerted a significant anti-inflammatory activity by suppressing TLR-4 and CLEC1B signaling pathways, which was elucidated and validated by an integrated strategy based on network pharmacology, molecular docking, and experimental verification. Collectively, this study provides a novel insight into the pharmacodynamics and mechanisms of H. plantaginea flower as a promising agent in treating inflammation-related disease.
引言炎症是门诊病人的常见病因,但有效药物却极为缺乏。方法采用系统网络药理学方法破译了玉簪花的抗炎枢纽靶点和候选植物化学成分。此外,还采用分子对接法阐明了成分与靶点之间的相互作用。随后,在脂多糖(LPS)激活的 RAW264.7 细胞中验证了车前草花的抗炎活性及其机制。预测了 949 个车前草花靶标和 814 个炎症相关靶标,其中获得了 211 个交叉靶标。六种主要成分,包括柯维丁、phytyldiol、agapanthagenin、5,7-二甲氧基-8-甲基-4′-羟基黄烷、(3R)-2、(3R)-2,3-二氢-7-羟基-3-[(4-甲氧基苯基)甲基]-4H-1-苯并吡喃-4-酮,以及苯酚,4-[(2S)-3,4-二氢-5,7-二甲氧基-2H-1-苯并吡喃-2-基]。此外,通过基因本体论和《京都基因和基因组百科全书》的功能分析,还获得了 6 个枢纽靶标,如 C 型凝集素样受体 2(CLEC1B)、收费样受体(TLR)、肿瘤坏死因子(TNF)、重组 V-Rel 网状内皮病病毒癌基因同源物 A(RELA)、信号转导和激活转录 3(STAT3)以及蛋白激酶 B α(AKT1)。分子对接表明,这 6 种成分与这 6 个枢纽靶点有很强的结合能力。最后,在 LPS 诱导的 RAW264.7 细胞中,通过抑制 CLEC1B、TLR-4、TNF-α、STAT3 和 Akt1 蛋白,从而抑制一氧化氮的过度产生,验证了车前草花的抗炎作用及其机制。通过基于网络药理学、分子对接和实验验证的综合策略,阐明并验证了车前草花通过抑制 TLR-4 和 CLEC1B 信号通路发挥显著的抗炎活性。总之,这项研究为了解车前草花的药效学和机制提供了新的视角,使其成为治疗炎症相关疾病的一种有前途的药物。
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引用次数: 0
Methodological quality evaluation of animal experiments on traditional Chinese medicine formulas for glaucoma: A systematic review 中药配方治疗青光眼动物实验的方法学质量评价:系统综述
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-07 DOI: 10.1016/j.eujim.2024.102399
Jiaxian Li , Xuqi Bi , Chengzhi Hou , Yu Jin , Mengqiu Shang , Xiaoyu Wu , Lina Liang

Introduction

This review aimed to evaluate the methodology and reporting quality of preclinical studies on traditional Chinese medicine (TCM) intervention for glaucoma, and explore areas for improvement.

Methods

Eight Chinese and English databases were searched for animal experiment articles on TCM formulas for glaucoma. The risk of bias was evaluated using the SYRCLE's tool, the reporting quality using the ARRIVE 2.0 guidelines and the GSPC checklist.

Results

Seventy-two articles met the inclusion/exclusion criteria for full-text review. According to the SYRCLE's tool, 7 (70%) of the 10 items had a low-risk rate of less than 50%, high-risk items were focused on selectivity bias, implementation bias, and measurement bias. Results of the ARRIVE 2.0 guidelines showed that 20 (53%) of the 38 sub-items had a high-agreement rate of less than 50%. Using the GSPC checklist, it was determined that 10 (53%) of the 19 sub-items had high-agreement rates of less than 50%. Randomization, blinding, ethical statements, housing and husbandry, animal care and monitoring, and protocol registration were low-agreement rate aspects of study reporting.

Conclusion

The methodology and reporting quality of animal studies on TCM formulas for glaucoma is generally low. It is advised to further refer to the SYRCLE's tool and reporting guidelines, to enhance the design, performance, and reporting of animal experiments to ensure the reproducibility and reliability of results.
引言 本综述旨在评估中药干预青光眼临床前研究的方法学和报告质量,并探讨需要改进的地方。方法检索了八个中英文数据库中有关中药治疗青光眼配方的动物实验文章。结果72篇文章符合全文综述的纳入/排除标准。根据 SYRCLE 工具,10 个项目中有 7 个(70%)的低风险率低于 50%,高风险项目主要集中在选择性偏差、实施偏差和测量偏差上。ARRIVE 2.0 指南的结果显示,38 个子项目中有 20 个(53%)的高同意率低于 50%。使用 GSPC 核对表确定,19 个子项中有 10 个(53%)的高度一致率低于 50%。随机化、盲法、伦理声明、饲养和管理、动物护理和监测以及方案注册是研究报告中同意率较低的方面。建议进一步参考SYRCLE的工具和报告指南,加强动物实验的设计、执行和报告,以确保结果的可重复性和可靠性。
{"title":"Methodological quality evaluation of animal experiments on traditional Chinese medicine formulas for glaucoma: A systematic review","authors":"Jiaxian Li ,&nbsp;Xuqi Bi ,&nbsp;Chengzhi Hou ,&nbsp;Yu Jin ,&nbsp;Mengqiu Shang ,&nbsp;Xiaoyu Wu ,&nbsp;Lina Liang","doi":"10.1016/j.eujim.2024.102399","DOIUrl":"10.1016/j.eujim.2024.102399","url":null,"abstract":"<div><h3>Introduction</h3><div>This review aimed to evaluate the methodology and reporting quality of preclinical studies on traditional Chinese medicine (TCM) intervention for glaucoma, and explore areas for improvement.</div></div><div><h3>Methods</h3><div>Eight Chinese and English databases were searched for animal experiment articles on TCM formulas for glaucoma. The risk of bias was evaluated using the SYRCLE's tool, the reporting quality using the ARRIVE 2.0 guidelines and the GSPC checklist.</div></div><div><h3>Results</h3><div>Seventy-two articles met the inclusion/exclusion criteria for full-text review. According to the SYRCLE's tool, 7 (70%) of the 10 items had a low-risk rate of less than 50%, high-risk items were focused on selectivity bias, implementation bias, and measurement bias. Results of the ARRIVE 2.0 guidelines showed that 20 (53%) of the 38 sub-items had a high-agreement rate of less than 50%. Using the GSPC checklist, it was determined that 10 (53%) of the 19 sub-items had high-agreement rates of less than 50%. Randomization, blinding, ethical statements, housing and husbandry, animal care and monitoring, and protocol registration were low-agreement rate aspects of study reporting.</div></div><div><h3>Conclusion</h3><div>The methodology and reporting quality of animal studies on TCM formulas for glaucoma is generally low. It is advised to further refer to the SYRCLE's tool and reporting guidelines, to enhance the design, performance, and reporting of animal experiments to ensure the reproducibility and reliability of results.</div></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"71 ","pages":"Article 102399"},"PeriodicalIF":1.9,"publicationDate":"2024-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000684/pdfft?md5=590f7d812de03664a14a5a0669e3915f&pid=1-s2.0-S1876382024000684-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142314881","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
The efficacy of Chinese patent medicine Xiaojin capsule in the treatment of Hashimoto's thyroiditis: A systematic review and meta-analysis 中成药小金胶囊治疗桥本氏甲状腺炎的疗效:系统回顾与荟萃分析
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-03 DOI: 10.1016/j.eujim.2024.102395
Aijing Chu , Shouyao Liu , Ying Chen , Zhongyuan Xia

Introduction

Hashimoto's thyroiditis (HT) is a common autoimmune disease of the thyroid gland and the main cause of hypothyroidism. Currently, Chinese medicine is widely used in clinical treatment, and Chinese patent medicine is more convenient for application. We conducted a meta-analysis of previously published literature to evaluate the efficacy and safety of Xiaojin capsule combined with levothyroxine (LT4) or selenium yeast in the treatment of HT, which also provided evidence-based medical evidence for traditional Chinese medicine in HT treatment.

Methods

We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of Xiaojin capsule on HT. The study was funded by National Natural Science Foundation of China (No. 81973855), and registered on PROSPERO (CRD42023412656). We searched PubMed, Embase, Web of Science, Cochrane Library, Chinese Scientific Journal Database (VIP), WanFang Database, China National Knowledge Information Database (CNKI), and SinoMed from inception to August 15, 2023. Two independent authors reviewed and coded the identified literature. Data analysis was performed using RevMan 5.3 software. We synthesized the results as standardized mean differences (SMD), mean difference (MD) 95 % confidence interval (CI) or relative risk (RR) 95 % CI. The Cochrane Systematic Risk of Bias Assessment Tool was used to assess the quality of the included studies.

Results

Thirteen RCTs with 1414 participants were included. The meta-analysis showed that compared with LT4 or selenium yeast alone, oral Xiaojin capsule combined with LT4 significantly reduced serum antibody levels against thyroid peroxidase (TPOAb) (SMD= −3.4, 95 % CI: −4.52 to −2.27, P<0.00001), oral Xiaojin capsule combined with selenium yeast reduced serum TPOAb (MD= −39.13, 95 % CI: −49.97 to −28.3, P<0.00001); oral Xiaojin capsule combined with LT4 significantly reduced serum antibody levels against thyroglobulin (TGAb) (SMD= −3.06, 95 % CI: −4.12 to −1.99, P<0.00001); increased clinical efficiency rate (RR=1.16, 95 % CI: 1.10 to 1.21, P<0.00001) and serum free thyroxine (FT4; SMD=1.18, 95 % CI: 0.47 to 1.88, P <0.00001) levels, and reduced thyroid volume (SMD =−0.59, 95 % CI: −0.87 to −0.32, P<0.0001). The effect on serum free triiodothyronine levels in two groups was not significant, and Xiaojin capsules did not increase the incidence of adverse events.

Conclusion

Xiaojin capsule combined with LT4 for treating HT significantly reduced serum TPOAb and TGAb levels, increased serum FT4 levels, and improved goiter. However, the strength of the evidence needs to be improved because of the poor quality of the included studies, and further validation by multiple high-quality randomized controlled trials with comprehensive outcome reporting is needed in the future.

导言 桥本氏甲状腺炎(HT)是一种常见的甲状腺自身免疫性疾病,也是导致甲减的主要原因。目前,中医药在临床治疗中应用广泛,且中成药应用更为方便。我们对既往发表的文献进行了荟萃分析,评价了小金胶囊联合左甲状腺素(LT4)或硒酵母治疗甲减的疗效和安全性,这也为中药治疗甲减提供了循证医学证据。方法我们对随机对照试验(RCTs)进行了系统回顾和荟萃分析,以评价小金胶囊对甲减的疗效。该研究由国家自然科学基金资助(编号:81973855),并在 PROSPERO 上注册(CRD42023412656)。我们检索了PubMed、Embase、Web of Science、Cochrane Library、中文科技期刊数据库(VIP)、万方数据库、中国知网数据库(CNKI)和SinoMed(从开始到2023年8月15日)。两位独立作者对鉴定出的文献进行了审阅和编码。数据分析使用 RevMan 5.3 软件进行。我们以标准化平均差 (SMD)、平均差 (MD) 95 % 置信区间 (CI) 或相对风险 (RR) 95 % CI 的形式对结果进行了综合。我们使用 Cochrane 系统偏倚风险评估工具来评估纳入研究的质量。荟萃分析表明,与单独使用LT4或硒酵母相比,口服小金胶囊联合LT4能显著降低血清甲状腺过氧化物酶抗体水平(TPOAb)(SMD= -3.4,95 % CI:-4.52~-2.27,P<0.00001),口服小金胶囊联合硒酵母可降低血清TPOAb(MD= -39.13,95 % CI:-49.97~-28.3,P<0.00001);口服小金胶囊联合LT4可显著降低血清甲状腺球蛋白(TGAb)抗体水平(SMD= -3.06,95 % CI:-4.12~-1.99,P<0.00001);提高临床有效率(RR=1.16,95 % CI:1.10 至 1.21,P<0.00001)和血清游离甲状腺素(FT4;SMD=1.18,95 % CI:0.47 至 1.88,P<0.00001)水平,以及甲状腺体积减少(SMD=-0.59,95 % CI:-0.87 至 -0.32,P<0.0001)。结论 小金胶囊联合LT4治疗高血压可显著降低血清TPOAb和TGAb水平,提高血清FT4水平,改善甲状腺肿大。然而,由于纳入的研究质量不高,证据的强度有待提高,今后还需要通过多个高质量的随机对照试验和全面的结果报告来进一步验证。
{"title":"The efficacy of Chinese patent medicine Xiaojin capsule in the treatment of Hashimoto's thyroiditis: A systematic review and meta-analysis","authors":"Aijing Chu ,&nbsp;Shouyao Liu ,&nbsp;Ying Chen ,&nbsp;Zhongyuan Xia","doi":"10.1016/j.eujim.2024.102395","DOIUrl":"10.1016/j.eujim.2024.102395","url":null,"abstract":"<div><h3>Introduction</h3><p>Hashimoto's thyroiditis (HT) is a common autoimmune disease of the thyroid gland and the main cause of hypothyroidism. Currently, Chinese medicine is widely used in clinical treatment, and Chinese patent medicine is more convenient for application. We conducted a meta-analysis of previously published literature to evaluate the efficacy and safety of Xiaojin capsule combined with levothyroxine (LT4) or selenium yeast in the treatment of HT, which also provided evidence-based medical evidence for traditional Chinese medicine in HT treatment.</p></div><div><h3>Methods</h3><p>We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of Xiaojin capsule on HT. The study was funded by National Natural Science Foundation of China (No. 81973855), and registered on PROSPERO (CRD42023412656). We searched PubMed, Embase, Web of Science, Cochrane Library, Chinese Scientific Journal Database (VIP), WanFang Database, China National Knowledge Information Database (CNKI), and SinoMed from inception to August 15, 2023. Two independent authors reviewed and coded the identified literature. Data analysis was performed using RevMan 5.3 software. We synthesized the results as standardized mean differences (SMD), mean difference (MD) 95 % confidence interval (CI) or relative risk (RR) 95 % CI. The Cochrane Systematic Risk of Bias Assessment Tool was used to assess the quality of the included studies.</p></div><div><h3>Results</h3><p>Thirteen RCTs with 1414 participants were included. The meta-analysis showed that compared with LT4 or selenium yeast alone, oral Xiaojin capsule combined with LT4 significantly reduced serum antibody levels against thyroid peroxidase (TPOAb) (SMD= −3.4, 95 % CI: −4.52 to −2.27, P&lt;0.00001), oral Xiaojin capsule combined with selenium yeast reduced serum TPOAb (MD= −39.13, 95 % CI: −49.97 to −28.3, P&lt;0.00001); oral Xiaojin capsule combined with LT4 significantly reduced serum antibody levels against thyroglobulin (TGAb) (SMD= −3.06, 95 % CI: −4.12 to −1.99, P&lt;0.00001); increased clinical efficiency rate (RR=1.16, 95 % CI: 1.10 to 1.21, P&lt;0.00001) and serum free thyroxine (FT4; SMD=1.18, 95 % CI: 0.47 to 1.88, <em>P</em> &lt;0.00001) levels, and reduced thyroid volume (SMD =−0.59, 95 % CI: −0.87 to −0.32, P&lt;0.0001). The effect on serum free triiodothyronine levels in two groups was not significant, and Xiaojin capsules did not increase the incidence of adverse events.</p></div><div><h3>Conclusion</h3><p>Xiaojin capsule combined with LT4 for treating HT significantly reduced serum TPOAb and TGAb levels, increased serum FT4 levels, and improved goiter. However, the strength of the evidence needs to be improved because of the poor quality of the included studies, and further validation by multiple high-quality randomized controlled trials with comprehensive outcome reporting is needed in the future.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"70 ","pages":"Article 102395"},"PeriodicalIF":1.9,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000647/pdfft?md5=aa43ef532fbb53130259aea95ac251ce&pid=1-s2.0-S1876382024000647-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142088495","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
Thinking style preferences of Chinese and Western physicians: A mixed-methods study 中西医思维方式偏好:混合方法研究
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-08-01 DOI: 10.1016/j.eujim.2024.102383
Wenhui Zhu , Kangle Shi , Ying Hu , Ruikun Wang , Xiaocong Wang , Shiyao Wang , Xinping Yu , Fangyan Yang , Zhijun Wang , Juan Wang , Cong Lei , Yuefan Yu , Xiaoyu Liu , Qian Liu , Qinggang Meng

Introduction

Traditional Chinese medicine (TCM) and Western medicine (WM) stem from distinct cultural and regional contexts, with the primary difference in their approaches to clinical reasoning. This study aims to investigate the cognitive preferences of TCM and WM physicians in clinical diagnosis and treatment, providing valuable insights for the advancement of TCM.

Methods

We implemented a two-phase mixed methods approach comprising questionnaires and semi-structured interviews. The Thinking Style Inventory (TSI) was used to evaluate the thinking styles of physicians through convenience sampling. Additionally, a total of six physicians (three practicing TCM and three WM) were selected by purposive sampling and open-ended responses regarding self-cognition and influencing factors were analyzed using thematic analysis.

Results

A total of 150 surveys and six interviews consistently indicated a preference among both TCM and WM physicians for Legislative, Executive, Hierarchical, Liberal, and External styles. In contrast, TCM physicians exhibited a tendency towards Legislative and Liberal styles, whereas WM physicians leaned towards Executive and Judicial styles. Thematic analysis of the interviews revealed four themes: self-understanding, thinking characteristics, influencing factors, and style changes.

Conclusion

Our study identified that within TCM and WM, a blend of shared characteristics and distinct individuality in thinking styles existed, exhibiting variations in the growth processes of physicians. Both TCM and WM physicians attributed the formation of their thinking styles to factors such as education, internship experience, Chinese social culture and personal disposition. Furthermore, empirical research methods emerged as effective tools for studying clinical reasoning in healthcare contexts.

导言传统中医(TCM)和西医(WM)源于不同的文化和地域背景,其主要区别在于临床推理方法。本研究旨在调查中医和西医在临床诊断和治疗中的认知偏好,为中医的发展提供有价值的见解。通过便利抽样,使用思维风格量表(TSI)评估医生的思维风格。此外,我们还通过目的取样法选取了六名医生(三名中医和三名妇科医生),并采用主题分析法对他们关于自我认知和影响因素的开放式回答进行了分析。结果 150份调查问卷和六次访谈一致表明,中医和妇科医生都偏好立法型、行政型、等级型、自由型和外在型思维风格。相比之下,中医倾向于立法和自由风格,而西医则倾向于行政和司法风格。对访谈的主题分析显示了四个主题:自我理解、思维特点、影响因素和风格变化。结论我们的研究发现,在中医和西医中,思维风格既有共同的特点,也有鲜明的个性,表现出医生成长过程中的差异。中医师和西医师都将其思维风格的形成归因于教育、实习经历、中国社会文化和个人性格等因素。此外,实证研究方法成为研究医疗背景下临床推理的有效工具。
{"title":"Thinking style preferences of Chinese and Western physicians: A mixed-methods study","authors":"Wenhui Zhu ,&nbsp;Kangle Shi ,&nbsp;Ying Hu ,&nbsp;Ruikun Wang ,&nbsp;Xiaocong Wang ,&nbsp;Shiyao Wang ,&nbsp;Xinping Yu ,&nbsp;Fangyan Yang ,&nbsp;Zhijun Wang ,&nbsp;Juan Wang ,&nbsp;Cong Lei ,&nbsp;Yuefan Yu ,&nbsp;Xiaoyu Liu ,&nbsp;Qian Liu ,&nbsp;Qinggang Meng","doi":"10.1016/j.eujim.2024.102383","DOIUrl":"10.1016/j.eujim.2024.102383","url":null,"abstract":"<div><h3>Introduction</h3><p>Traditional Chinese medicine (TCM) and Western medicine (WM) stem from distinct cultural and regional contexts, with the primary difference in their approaches to clinical reasoning. This study aims to investigate the cognitive preferences of TCM and WM physicians in clinical diagnosis and treatment, providing valuable insights for the advancement of TCM.</p></div><div><h3>Methods</h3><p>We implemented a two-phase mixed methods approach comprising questionnaires and semi-structured interviews. The Thinking Style Inventory (TSI) was used to evaluate the thinking styles of physicians through convenience sampling. Additionally, a total of six physicians (three practicing TCM and three WM) were selected by purposive sampling and open-ended responses regarding self-cognition and influencing factors were analyzed using thematic analysis.</p></div><div><h3>Results</h3><p>A total of 150 surveys and six interviews consistently indicated a preference among both TCM and WM physicians for Legislative, Executive, Hierarchical, Liberal, and External styles. In contrast, TCM physicians exhibited a tendency towards Legislative and Liberal styles, whereas WM physicians leaned towards Executive and Judicial styles. Thematic analysis of the interviews revealed four themes: self-understanding, thinking characteristics, influencing factors, and style changes.</p></div><div><h3>Conclusion</h3><p>Our study identified that within TCM and WM, a blend of shared characteristics and distinct individuality in thinking styles existed, exhibiting variations in the growth processes of physicians. Both TCM and WM physicians attributed the formation of their thinking styles to factors such as education, internship experience, Chinese social culture and personal disposition. Furthermore, empirical research methods emerged as effective tools for studying clinical reasoning in healthcare contexts.</p></div>","PeriodicalId":11932,"journal":{"name":"European Journal of Integrative Medicine","volume":"69 ","pages":"Article 102383"},"PeriodicalIF":1.9,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1876382024000532/pdfft?md5=7d0fa68cd1bb7fbdcf71eb547c871c89&pid=1-s2.0-S1876382024000532-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141700698","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
Rationale and design of aromatic and warming-up management in coronary microvascular disease (AWARD): A study protocol for a multicenter, randomized, double-blind, placebo-controlled clinical trial 冠状动脉微血管疾病芳香和热身管理(AWARD)的原理和设计:多中心、随机、双盲、安慰剂对照临床试验的研究方案
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-31 DOI: 10.1016/j.eujim.2024.102393
Mingwang Liu , Yangfang Zhang , Beili Xie , Lulian Jiang , Haohao Li , Jianpeng Du , Dawu Zhang , Zikai Yu , Yuxin Yan , Keji Chen , Fuhai Zhao

Introduction

Current treatments for coronary microvascular disease (CMVD) have limited efficacy. Kuanxiong Aerosol (KXA), a representative preparation used for aromatic and warming-up management, is a typical Chinese proprietary medicine that relieves the symptoms of angina pectoris and contributes to improving coronary microcirculation disorders, which may provide an option for the treatment of CMVD.

Methods

This is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 120 eligible patients will be randomized 1:1 to KXA or placebo groups and receive 30-day interventions and follow-up. The primary outcome will be the Seattle Angina Scale score. Secondary outcomes will be the TCM (traditional Chinese medicine) syndrome score, self-rated anxiety scale score, self-rated depression scale, microcirculation function, and laboratory index for coronary microvascular.

Discussion

This trial will evaluate the clinical efficacy and safety of KXA in the treatment of CMVD. The results of this study may provide clinical evidence for the use of Chinese patent medicine in CMVD.

Trial registration

Chinese Clinical Trial Registry ChiCTR2200057494

导读:目前治疗冠状动脉微血管疾病(CMVD)的方法疗效有限。冠雄气雾剂(KXA)是芳香化湿、温经通络的代表性制剂,是一种典型的中成药,能缓解心绞痛症状,有助于改善冠状动脉微循环障碍,可为冠心病微血管病变的治疗提供一种选择。共有 120 名符合条件的患者将按 1:1 随机分配到 KXA 或安慰剂组,并接受 30 天的干预和随访。主要结果是西雅图心绞痛量表评分。次要结果为中医综合征评分、焦虑自评量表评分、抑郁自评量表评分、微循环功能和冠状动脉微血管实验室指标。 讨论本试验将评估 KXA 治疗 CMVD 的临床疗效和安全性。试验注册中国临床试验注册中心 ChiCTR2200057494
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引用次数: 0
A global comparative analysis of guidelines for herbal medicines Pharmacopoeia and Good Manufacturing Practice, with a case study of Panax ginseng C.A Meyer 草药药典和良好生产规范指南的全球比较分析,以人参为例 C.A. Meyer
IF 1.9 4区 医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE Pub Date : 2024-07-31 DOI: 10.1016/j.eujim.2024.102394
Minghui Xu , Dung Thuy Nguyen , Sujata Purja , Eunyoung Kim

Introduction

The use of herbal medicines is widespread, and ensuring their quality control, as guaranteed by pharmacopoeia and Good Manufacturing Practice (GMP) guidelines, has garnered significant attention. Discrepancies in quality standards across different regulatory agencies challenge the global marketing of herbal medicines and hinder public access to these products. Therefore, this research aims to compare pharmacopeia on Panax ginseng C.A. Meyer (P. ginseng) and GMP guidelines for herbal medicines to provide an evidence-based understanding of quality control standards.

Methods

Definitions of herbal medicines across regulatory authorities, including the World Health Organization (WHO), Pharmaceutical Inspection Co-operation Scheme (PIC/S), European Union (EU), China, Japan, South Korea, and Vietnam, were collected. Additionally, pharmacopeial standards on Panax ginseng case study were analysed, focusing on aspects such as origin, identification, testing methods, extractives, assay, purity, and drug information. The study also compared GMP requirements for herbal medicines, which included personnel, premises and equipment, documentation, production, quality control, contract manufacturing and analysis, complaints and product recall, and self-inspection.

Results

Definitions of herbal medicines are similar among the WHO, PIC/S, and the EU, while distinct definitions based on scientific evidence and traditional practices were presented in China, Japan, South Korea, and Vietnam. Pharmacopeia standards varied across regulatory agencies, as evidenced by the P. ginseng case study. However, testing methods closely resembled each other between China and Vietnam, as well as between Japan and South Korea. Among pharmacopoeias, the WHO monographs offered the most comprehensive drug information on P. ginseng. In contrast, the European Pharmacopoeia lists such details separately in a P. ginseng assessment report. Regarding GMP requirements, although examined components varied among regulatory agencies, significant resemblances exist between the GMP guidelines of PIC/S, the EU, and South Korea, and between those of the WHO and Vietnam.

Conclusions

Disparities in quality standards across jurisdictions highlight the necessity for international collaboration to achieve harmonization. Harmonizing these standards aims to promote the global availability of standardized herbal medicinal products, benefiting public health.

导言:草药的使用非常广泛,而确保其质量控制(如药典和《药品生产质量管理规范》(GMP)指南所保证的那样)已引起了人们的极大关注。不同监管机构在质量标准上的差异给草药的全球营销带来了挑战,也阻碍了公众对这些产品的使用。因此,本研究旨在比较有关人参(Panax ginseng C.A. Meyer)的药典和草药 GMP 指南,以提供对质量控制标准的循证理解。方法收集了世界卫生组织(WHO)、药品检查合作计划(PIC/S)、欧盟(EU)、中国、日本、韩国和越南等监管机构对草药的定义。此外,还分析了三七案例研究的药典标准,重点关注产地、鉴定、检测方法、提取物、化验、纯度和药物信息等方面。研究还比较了 GMP 对中药材的要求,包括人员、场所和设备、文件、生产、质量控制、合同生产和分析、投诉和产品召回以及自检。各监管机构的药典标准不尽相同,人参的案例研究就证明了这一点。不过,中国和越南以及日本和韩国的检测方法非常相似。在药典中,世界卫生组织的专著提供了最全面的人参药物信息。相比之下,《欧洲药典》在人参评估报告中单独列出了这些细节。关于 GMP 要求,尽管各监管机构审查的内容各不相同,但 PIC/S、欧盟和韩国的 GMP 准则之间以及世卫组织和越南的 GMP 准则之间存在着显著的相似性。统一这些标准旨在促进全球标准化草药产品的供应,从而造福公众健康。
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引用次数: 0
期刊
European Journal of Integrative Medicine
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