Pub Date : 2024-09-01DOI: 10.1016/j.joim.2024.06.005
Alexander L. Tournier , Leoni V. Bonamin , Susann Buchheim-Schmidt , Steven Cartwright , Christoph Dombrowsky , Paul Doesburg , Carla Holandino , Maria Olga Kokornaczyk , Everine B. van de Kraats , Jesús Antonio López-Carvallo , Papiya Nandy , José Manuel Mazón-Suástegui , Fateme Mirzajani , Bernard Poitevin , Claudia Scherr , Karin Thieves , Sandra Würtenberger , Stephan Baumgartner
Objective
Pharmacopoeias regulate the manufacture of potentised pharmaceutical preparations used in different branches of complementary and integrative medicine. The physicochemical properties and biological activity of these preparations are often investigated in preclinical research, yet no guidelines for experimental research currently exist in this area. The present PrePoP guidelines aim to provide recommendations to promote high-quality, statistically sound, and reproducible preclinical research on potentised preparations.
Methods
Input was gathered from researchers nominated by the relevant scientific societies using a simplified Delphi consensus approach covering the most relevant aspects of basic research methodology in the field including appropriate controls, sample preparation and handling, and statistics. After three rounds of feedback, a consensus was finally reached on the most important aspects and considerations for conducting high-quality research on potentised preparations.
Results
We present a series of recommendations on a range of topics including experimental controls, system stability, blinding and randomisation, environmental influences, and procedures for the preparation of potentised samples and controls, and we address some specific challenges of this research field.
Conclusion
This expert consensus process resulted in a robust set of methodological guidelines for research on potentised preparations and provides a valuable framework that will inform and improve the quality of subsequent research in this emerging field.
Please cite this article as
Tournier AL, Bonamin LV, Buchheim-Schmidt S, Cartwright S, Dombrowsky C, Doesburg P, Holandino C, Kokornaczyk MO, van de Kraats EB, López-Carvallo JA, Nandy P, Mazón-Suástegui JM, Mirzajani F, Poitevin B, Scherr C, Thieves K, Würtenberger S, Baumgartner S. Scientific guidelines for preclinical research on potentised preparations manufactured according to current pharmacopoeias—the PrePoP guidelines. J Integr Med. 2024; 22(5): 533–544.
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Pub Date : 2024-09-01DOI: 10.1016/j.joim.2024.07.003
Hui-zhi Zhu , Cheng-yi Li , Liang-ji Liu , Jia-bing Tong , Zhi-hui Lan , Shu-guang Tian , Qiao Li , Xiang-li Tong , Ji-feng Wu , Zhen-gang Zhu , Su-yun Li , Jian-sheng Li
<div><h3>Background</h3><div>Chronic obstructive pulmonary disease (COPD), a common respiratory disease, can be effectively treated by traditional Chinese medicine (TCM). Qingfei Huatan, a TCM formula, has been reported to effectively alleviate the clinical symptoms of COPD patients. However, there is a lack of multi-centre, randomised, double-blind, controlled clinical trials documenting the clinical efficacy and safety of this formula in the treatment of acute exacerbation of COPD (AECOPD).</div></div><div><h3>Objective</h3><div>This study evaluated the efficacy and safety of Qingfei Huatan formula in the treatment of AECOPD, thereby providing high-quality clinical evidence.</div></div><div><h3>Design, setting, participants and interventions</h3><div>A total of 276 patients with AECOPD were included in this multi-centre, randomised, double-blind, placebo-controlled trial and were randomised into treatment and control groups at a ratio of 1:1. Patients in the treatment and control groups took Qingfei Huatan granules or simulated Qingfei Huatan granules twice a day, for 14 days, in addition to Western medicine treatment. All patients were followed up for 3 months.</div></div><div><h3>Main outcome measures</h3><div>The primary outcome was time taken to symptom stabilisation. The secondary outcomes included duration of antibiotic use, clinical symptom and sign score, TCM syndrome score, dyspnoea score, and quality of life (QOL) score. Meanwhile, the safety of the formula was assessed through routine urine and stool tests, electrocardiograms, liver and kidney function tests, and the observation of adverse events throughout the trial.</div></div><div><h3>Results</h3><div>The time taken for effective stabilisation (<em>P</em> < 0.05) and obvious stabilisation (<em>P</em> < 0.01), and the duration of antibiotic use (<em>P</em> < 0.05) were significantly shorter in the treatment group than in the control group. On days 6, 9, 12 and 14 of treatment, clinical symptom and sign score decreased in both groups, particularly in the treatment group (<em>P</em> < 0.01). On days 9, 12 and 14 of treatment, the TCM syndrome scores of both groups were reduced (<em>P</em> < 0.01), with more significant reductions in the treatment group. At 3 months after the end of treatment, the treatment group continued to have lower clinical symptom and sign score and TCM syndrome score than the control group (<em>P</em> < 0.01). On days 6, 9, 12 and 14 of treatment, dyspnoea and QOL scores were markedly reduced in the two groups (<em>P</em> < 0.05 and <em>P</em> < 0.01, respectively), especially in the treatment group. At 3 months after the end of treatment, dyspnoea and QOL scores were lower in the treatment group than those in the control group (<em>P</em> < 0.01). No serious adverse events were observed in either group.</div></div><div><h3>Conclusion</h3><div>The Qingfei Huatan formula can effectively shorten the duration of AECOPD and antibiotic use
背景 慢性阻塞性肺疾病（COPD）是一种常见的呼吸系统疾病，中医药可有效治疗该病。据报道，中药配方清热化痰汤能有效缓解慢性阻塞性肺疾病患者的临床症状。然而，目前尚缺乏多中心、随机、双盲、对照临床试验记录该方剂在治疗慢性阻塞性肺疾病急性加重期（AECOPD）中的临床疗效和安全性。本研究评估了清热化痰方在治疗慢性阻塞性肺疾病急性加重期中的疗效和安全性，从而提供高质量的临床证据。这项多中心、随机、双盲、安慰剂对照试验共纳入了276名AECOPD患者，并按1:1的比例随机分为治疗组和对照组。治疗组和对照组患者在接受西药治疗的同时，服用清瘟化毒颗粒或模拟清瘟化毒颗粒，每天两次，共14天。主要结果测量主要结果是症状稳定所需时间。次要结果包括抗生素使用时间、临床症状和体征评分、中医综合征评分、呼吸困难评分和生活质量（QOL）评分。同时，在整个试验过程中，通过尿液和粪便常规检查、心电图、肝功能和肾功能检查以及不良事件观察来评估配方的安全性。在治疗的第 6、9、12 和 14 天，两组的临床症状和体征评分均有所下降，尤其是治疗组（P < 0.01）。在治疗的第 9、12 和 14 天，两组的中医综合征评分均有所下降（P < 0.01），其中治疗组的下降更为显著。治疗结束后 3 个月，治疗组的临床症状和体征评分及中医证候评分仍低于对照组（P < 0.01）。在治疗的第 6、9、12 和 14 天，两组患者的呼吸困难和 QOL 评分明显降低（分别为 P < 0.05 和 P < 0.01），尤其是治疗组。治疗结束 3 个月后，治疗组的呼吸困难和 QOL 评分低于对照组（P <0.01）。结论清热化痰方能有效缩短 AECOPD 病程和抗生素使用时间，显著缓解 AECOPD 患者的临床症状，提高 QOL，且安全性良好。这些结果表明，该配方可作为 AECOPD 患者的辅助治疗：该方案已在中国临床试验注册中心注册（ChiCTR1900026576）：Zhu HZ, Li CY, Liu LJ, Tong JB, Lan ZH, Tian SG, Li Q, Tong XL, Wu JF, Zhu ZG, Li SY, Li JS.清瘟化浊方治疗慢性阻塞性肺疾病急性加重期的有效性和安全性：多中心、随机、双盲、安慰剂对照试验。J Integr Med.2024; 22(5):561-569.
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Pub Date : 2024-09-01DOI: 10.1016/j.joim.2024.07.002
Yu Zhang , Xiao-bo Zhu , Yang Zhao , Gui-yun Cui , Wen-tao Li , Can-xing Yuan , Jian-ping Huang , Ying Wan , Na Wu , Lu Song , Jia-hao Zhao , Yan Liang , Chuan-ying Xu , Mei-juan Liu , Chen Gao , Xin-xin Chen , Zhen-guo Liu
Background
Patients with Parkinson’s disease (PD) undergoing long-term levodopa therapy are prone to develop levodopa-induced dyskinesia (LID). Amantadine is the main drug recommended for the treatment of LID by current guidelines, but it is far from meeting clinical needs. Tianqi Pingchan Granule (TPG), a compound Chinese herbal medicine, has been developed to relieve symptom of LID.
Objective
This randomized controlled trial evaluated the efficacy and safety of the combination of TPG and amantadine for LID.
Design, setting, participants and interventions
This is a randomized double-blind placebo-controlled trial, conducted from January 2020 to August 2021 at 6 sites in Jiangsu, Zhejiang and Shanghai, China. One hundred PD patients with ≥ 0.5 h of LID were randomly assigned to either the TPG plus amantadine group (TPG group) or the placebo plus amantadine group (placebo group), and treated for a period of 12 weeks. To ensure unbiased results, all study participants, investigators and sponsors were unaware of group allocations. Additionally, the data analysts remained blinded until the analysis was finalized.
Main outcome measures
The primary outcome was assessed using the Unified Dyskinesia Rating Scale (UDysRS) (Range 0–104). The key secondary end point was improvement of motor and non-motor symptoms. Safety analyses included all enrolled patients.
Results
One hundred patients were enrolled and randomized into the two treatment groups. The changes in UDysRS at week 12 were –11.02 for the TPG group and –4.19 for the placebo group (treatment difference –6.83 [–10.53 to –3.12]; P = 0.0004). Adverse events were reported for 2 of 50 patients (4.0%) in each of the groups.
Conclusion
This study indicated that a 12-week treatment of amantadine plus TPG effectively reduced UDysRS scores and was well tolerated, demonstrating the efficacy and safety of TPG for the treatment of LID in PD.
Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG. Efficacy and safety of Tianqi Pingchan Granule, a compound Chinese herbal medicine, for levodopa-induced dyskinesia in Parkinson’s disease: A randomized double-blind placebo-controlled trial. J Integr Med. 2024; 22(5): 545–551.
背景长期接受左旋多巴治疗的帕金森病（PD）患者容易出现左旋多巴诱发的运动障碍（LID）。金刚烷胺是目前指南推荐的治疗 LID 的主要药物，但远远不能满足临床需要。这项随机对照试验评估了天芪平消颗粒和金刚烷胺联合治疗LID的有效性和安全性。设计、地点、参与者和干预措施这是一项随机双盲安慰剂对照试验，于2020年1月至2021年8月在中国江苏、浙江和上海的6个地点进行。100名LID≥0.5 h的帕金森病患者被随机分配到TPG加金刚烷胺组（TPG组）或安慰剂加金刚烷胺组（安慰剂组），接受为期12周的治疗。为确保结果无偏见，所有研究参与者、调查人员和赞助商都不知道组别分配情况。主要结果测量主要结果采用统一运动障碍评定量表（UDysRS）（范围 0-104）进行评估。主要次要终点是运动和非运动症状的改善。安全性分析包括所有入组患者。第12周时，TPG组的UDysRS变化为-11.02，安慰剂组为-4.19（治疗差异为-6.83 [-10.53 to -3.12]；P = 0.0004）。结论本研究表明，金刚烷胺加TPG治疗12周可有效降低UDysRS评分，且耐受性良好，证明了TPG治疗PD患者LID的有效性和安全性：试验注册：ClinicalTrials.gov identifier：本文引用地址：Zhang Y, Zhu XB, Zhao Y, Cui GY, Li WT, Yuan CX, Huang JP, Wan Y, Wu N, Song L, Zhao JH, Liang Y, Xu CY, Liu MJ, Gao C, Chen XX, Liu ZG.复方中药天芪平消颗粒治疗左旋多巴所致帕金森病运动障碍的有效性和安全性：随机双盲安慰剂对照试验。J Integr Med.2024; 22(5):545-551.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.04.005
Phytosomes (phytophospholipid complex) are dosage forms that have recently been introduced to increase the stability and therapeutic effect of herbal medicine. Currently, bioactive herbs and the phytochemicals they contain are considered to be the best remedies for chronic diseases. One promising approach to increase the efficacy of plant-based therapies is to improve the stability and bioavailability of their bio-active ingredients. Phytosomes employ phospholipids as their active ingredients, and use their amphiphilic properties to solubilize and protect herbal extracts. The unique properties of phospholipids in drug delivery and their use in herbal medicines to improve bioavailability results in significantly enhanced health benefits. The introduction of phytosome nanotechnology can alter and revolutionize the current state of drug delivery. The goal of this review is to explain the application of phytosomes, their future prospects in drug delivery, and their advantages over conventional formulations.
Please cite this article as: Chauhan D, Yadav PK, Sultana N, Agarwal A, Verma S, Chourasia MK, Gayen JR. Advancements in nanotechnology for the delivery of phytochemicals. J Integr Med. 2024; 22(4): 385–398.
植物载体（植物磷脂复合物）是最近推出的一种剂型，可提高草药的稳定性和治疗效果。目前，生物活性草药及其所含的植物化学物质被认为是治疗慢性疾病的最佳疗法。提高植物疗法疗效的一个可行方法是提高其生物活性成分的稳定性和生物利用率。植物载体采用磷脂作为其活性成分，并利用其两亲特性来溶解和保护草药提取物。磷脂在给药方面具有独特的特性，在草药中使用磷脂可提高生物利用率，从而显著增强保健功效。植物胶体纳米技术的引入可以改变和革新当前的给药方式。本综述旨在解释植物体的应用、其在给药方面的未来前景以及与传统制剂相比的优势：Chauhan D, Yadav PK, Sultana N, Agarwal A, Verma S, Chourasia MK, Gayen JR.纳米技术在植物化学物质递送方面的进展。J Integr Med.2024; 22(4):385-398.
{"title":"Advancements in nanotechnology for the delivery of phytochemicals","authors":"","doi":"10.1016/j.joim.2024.04.005","DOIUrl":"10.1016/j.joim.2024.04.005","url":null,"abstract":"<div><p>Phytosomes (phytophospholipid complex) are dosage forms that have recently been introduced to increase the stability and therapeutic effect of herbal medicine. Currently, bioactive herbs and the phytochemicals they contain are considered to be the best remedies for chronic diseases. One promising approach to increase the efficacy of plant-based therapies is to improve the stability and bioavailability of their bio-active ingredients. Phytosomes employ phospholipids as their active ingredients, and use their amphiphilic properties to solubilize and protect herbal extracts. The unique properties of phospholipids in drug delivery and their use in herbal medicines to improve bioavailability results in significantly enhanced health benefits. The introduction of phytosome nanotechnology can alter and revolutionize the current state of drug delivery. The goal of this review is to explain the application of phytosomes, their future prospects in drug delivery, and their advantages over conventional formulations.</p><p>Please cite this article as: Chauhan D, Yadav PK, Sultana N, Agarwal A, Verma S, Chourasia MK, Gayen JR. Advancements in nanotechnology for the delivery of phytochemicals. <em>J Integr Med.</em> 2024; 22(4): 385–398.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 385-398"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140774358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.05.001
Visnagin is a furanochromone and one of the most important compound in the Ammi visnaga (L.) Lam (a synonym of Visnaga daucoides Gaertn.) plant, which is used to cure various ailments. Many investigations into the bioactive properties of visnagin have been studied to date. The literature on visnagin demonstrates its biological properties, including anti-inflammatory, anti-diabetic, and beneficial effects in cardiovascular and renal diseases. Moreover, visnagin improves sperm quality parameters, stimulates steroidogenesis, and increases serum gonadotropins and testosterone levels, while decreasing pro-inflammatory cytokines, oxidative damage, genomic instability, and it modulates apoptosis. Thus, visnagin has emerged as an exciting lead for further research, owing to its potential in various unmet clinical needs. The current review summarized its basic structure, pharmacokinetics, and pharmacological effects, focusing on its mechanisms of action. The review will help to understand the potential of visnagin as an alternative treatment strategy for several diseases and provide insight into research topics that need further exploration for visnagin’s safe clinical use.
Please cite this article as: Yadav P, Singh SK, Datta S, Verma S, Verma A, Rakshit A, Bali A, Bhatti JS, Khurana A, Navik U. Therapeutic potential and pharmacological mechanism of visnagin. J Integr Med. 2024; 22(4): 399–412.
Visnagin 是一种呋喃色素，是 Ammi visnaga (L.) Lam（Visnaga daucoides Gaertn.的异名）植物中最重要的化合物之一，可用于治疗各种疾病。迄今为止，人们已经对粘菌素的生物活性特性进行了许多研究。有关粘菌素的文献证明了它的生物特性，包括抗炎、抗糖尿病以及对心血管和肾脏疾病的有益作用。此外，粘蛋白还能改善精子质量参数，刺激类固醇生成，提高血清促性腺激素和睾酮水平，同时降低促炎细胞因子、氧化损伤、基因组不稳定性，并能调节细胞凋亡。因此，由于粘多糖在满足各种未满足的临床需求方面具有潜力，粘多糖已成为令人兴奋的进一步研究线索。本综述概述了它的基本结构、药代动力学和药理作用，重点关注其作用机制。这篇综述将有助于了解粘菌素作为多种疾病的替代治疗策略的潜力，并为粘菌素的安全临床应用提供需要进一步探索的研究课题：Yadav P, Singh SK, Datta S, Verma S, Verma A, Rakshit A, Bali A, Bhatti JS, Khurana A, Navik U. Therapeutic potential and pharmacological mechanism of visnagin.J Integr Med.2024; 22(4):399-412.
{"title":"Therapeutic potential and pharmacological mechanism of visnagin","authors":"","doi":"10.1016/j.joim.2024.05.001","DOIUrl":"10.1016/j.joim.2024.05.001","url":null,"abstract":"<div><p>Visnagin is a furanochromone and one of the most important compound in the <em>Ammi visnaga</em> (L.) Lam (a synonym of <em>Visnaga daucoides</em> Gaertn.) plant, which is used to cure various ailments. Many investigations into the bioactive properties of visnagin have been studied to date. The literature on visnagin demonstrates its biological properties, including anti-inflammatory, anti-diabetic, and beneficial effects in cardiovascular and renal diseases. Moreover, visnagin improves sperm quality parameters, stimulates steroidogenesis, and increases serum gonadotropins and testosterone levels, while decreasing pro-inflammatory cytokines, oxidative damage, genomic instability, and it modulates apoptosis. Thus, visnagin has emerged as an exciting lead for further research, owing to its potential in various unmet clinical needs. The current review summarized its basic structure, pharmacokinetics, and pharmacological effects, focusing on its mechanisms of action. The review will help to understand the potential of visnagin as an alternative treatment strategy for several diseases and provide insight into research topics that need further exploration for visnagin’s safe clinical use.</p><p>Please cite this article as: Yadav P, Singh SK, Datta S, Verma S, Verma A, Rakshit A, Bali A, Bhatti JS, Khurana A, Navik U. Therapeutic potential and pharmacological mechanism of visnagin. <em>J Integr Med</em>. 2024; 22(4): 399–412.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 399-412"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141053467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.06.004
The hypothalamic–pituitary–adrenal (HPA) axis is a critical component of the neuroendocrine system, playing a central role in regulating the body’s stress response and modulating various physiological processes. Dysregulation of HPA axis function disrupts the neuroendocrine equilibrium, resulting in impaired physiological functions. Acupuncture is recognized as a non-pharmacological type of therapy which has been confirmed to play an important role in modulating the HPA axis and thus favorably targets diseases with abnormal activation of the HPA axis. With numerous studies reporting the promising efficacy of acupuncture for neuroendocrine disorders, a comprehensive review in terms of the underlying molecular mechanism for acupuncture, especially in regulating the HPA axis, is currently in need. This review fills the need and summarizes recent breakthroughs, from the basic principles and the pathological changes of HPA axis dysfunction, to the molecular mechanisms by which acupuncture regulates the HPA axis. These mechanisms include the modulation of multiple neurotransmitters and their receptors, neuropeptides and their receptors, and microRNAs in the paraventricular nucleus, hippocampus, amygdala and pituitary gland, which alleviate the hyperfunctioning of the HPA axis. This review comprehensively summarizes the mechanism of acupuncture in regulating HPA axis dysfunction for the first time, providing new targets and prospects for further exploration of acupuncture.
Please cite this article as: Zheng JY, Zhu J, Wang Y, Tian ZZ. Effects of acupuncture on hypothalamic–pituitary–adrenal axis: Current status and future perspectives. J Integr Med. 2024; 22(4): 446–459.
下丘脑-垂体-肾上腺（HPA）轴是神经内分泌系统的重要组成部分，在调节机体的应激反应和调节各种生理过程中发挥着核心作用。HPA 轴功能失调会破坏神经内分泌平衡，导致生理功能受损。针灸被认为是一种非药物疗法，已被证实在调节 HPA 轴方面发挥重要作用，因此可用于治疗 HPA 轴异常激活的疾病。随着大量研究报道了针灸对神经内分泌疾病的良好疗效，目前需要对针灸的分子机制，尤其是调节 HPA 轴的分子机制进行全面综述。本综述从针灸调节 HPA 轴的基本原理、HPA 轴功能障碍的病理变化到针灸调节 HPA 轴的分子机制，总结了针灸治疗 HPA 轴的最新突破。这些机制包括调节室旁核、海马、杏仁核和垂体的多种神经递质及其受体、神经肽及其受体和微RNA，从而缓解HPA轴功能亢进。这篇综述首次全面总结了针灸调节HPA轴功能紊乱的机制，为针灸的进一步探索提供了新的靶点和前景。本文引用如前：Zheng JY, Zhu J, Wang Y, Tian ZZ.针灸对下丘脑-垂体-肾上腺轴的影响：针灸对下丘脑-垂体-肾上腺轴的影响：现状与展望。J Integr Med.2024; Epub ahead of print.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.05.003
Objective
Hepatolenticular degeneration (HLD) is an autosomal recessive disorder that manifests as multiorgan damage due to impaired copper (Cu) metabolism. Female patients with HLD often experience reproductive impairments. This study investigated the protective effect of berberine against ovarian damage in toxic-milk (TX) mice, a murine model for HLD.
Methods
Mice were categorized into control group, HLD TX group (HLD group), penicillamine (Cu chelator)-treated TX group and berberine-treated TX group. Body weight, ovary weight and the number of ovulated eggs were recorded. Follicular morphology and cellular ultrastructure were examined. Total iron, ferrous iron (Fe2+) and trivalent iron (Fe3+) levels, as well as malondialdehyde (MDA), glutathione (GSH) and oxidized glutathione (GSSG), were measured in the ovaries. Western blot analysis was used to analyze the expression of proteins related to ferroptosis and endoplasmic reticulum (ER) stress.
Results
Ovarian tissue damage was evident in the HLD group, with a significant increase in ferroptosis and ER stress compared to the control group. This damage was inhibited by treatment with penicillamine, a Cu chelator. Compared with the HLD group, berberine increased the number of ovulations, and improved ovarian morphology and ultrastructure. Further, we found that berberine reduced total iron, Fe2+, MDA and GSSG levels, elevated GSH levels, decreased the expression of the ferroptosis marker protein prostaglandin-endoperoxide synthase 2 (PTGS2), and increased glutathione peroxidase 4 (GPX4) expression. Furthermore, berberine inhibited the expression of ER stress-associated proteins mediated by the protein kinase RNA-like ER kinase (PERK) pathway.
Conclusion
Ferroptosis and ER stress are involved in Cu-induced ovarian damage in TX mice. Berberine ameliorates ovarian damage in HLD TX mice by inhibiting ferroptosis and ER stress.
Please cite this article as: Liu QZ, Han H, Fang XR, Wang LY, Zhao D, Yin MZ, Zhang N, Jiang PY, Ji ZH, Wu LM. Berberine alleviates ovarian tissue damage in mice with hepatolenticular degeneration by suppressing ferroptosis and endoplasmic reticulum stress. J Integr Med. 2024; 22(4): 494–503.
目的肝曲霉变性（HLD）是一种常染色体隐性遗传疾病，表现为铜（Cu）代谢障碍导致的多器官损害。HLD女性患者通常会出现生殖障碍。方法将小鼠分为对照组、HLD TX 组（HLD 组）、青霉胺（铜螯合剂）处理 TX 组和小檗碱处理 TX 组。记录体重、卵巢重量和排卵数量。检查卵泡形态和细胞超微结构。测量卵巢中的总铁、亚铁（Fe2+）和三价铁（Fe3+）水平，以及丙二醛（MDA）、谷胱甘肽（GSH）和氧化谷胱甘肽（GSSG）。结果HLD组卵巢组织损伤明显，与对照组相比，铁变态反应和内质网（ER）应激显著增加。使用铜螯合剂青霉胺治疗可抑制这种损伤。与 HLD 组相比，小檗碱增加了排卵数量，并改善了卵巢的形态和超微结构。此外，我们还发现小檗碱降低了总铁、Fe2+、MDA和GSSG水平，提高了GSH水平，减少了铁变态反应标志蛋白前列腺素内过氧化物合成酶2（PTGS2）的表达，并增加了谷胱甘肽过氧化物酶4（GPX4）的表达。此外，小檗碱还能抑制由蛋白激酶 RNA 样 ER 激酶（PERK）通路介导的 ER 应激相关蛋白的表达。小檗碱通过抑制铁变态反应和ER应激改善了HLD TX小鼠的卵巢损伤：Liu QZ, Han H, Fang XR, Wang LY, Zhao D, Yin MZ, Zhang N, Jiang PY, Ji ZH, Wu LM.小檗碱通过抑制铁突变和内质网应激减轻肝细胞变性小鼠的卵巢组织损伤J Integr Med.2024; 22(4):494-503.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.05.002
<div><h3>Background</h3><p>Hypertension, a prevalent disease, is a significant risk factor for coronary heart disease. Huoxue Qianyang Qutan Recipe (HQQR), a traditional Chinese herbal remedy, has been used for treating hypertension over several years.</p></div><div><h3>Objective</h3><p>This study assesses HQQR’s efficacy for controlling blood pressure among patients with hypertension related to blood stasis, yang hyperactivity and phlegm.</p></div><div><h3>Design, setting, participants and interventions</h3><p>A randomized controlled trial was conducted at the Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, China, from July 2020 to June 2022. Major components of HQQR were identified using thin-layer chromatography and high-performance liquid chromatography. Participants aged 18–80 years, exhibiting traditional Chinese medicine syndromes of blood stasis, yang hyperactivity or phlegm, along with grades 1 or 2 hypertension, were randomly categorized into two groups. The intervention group was given HQQR granules alongside conventional hypertension treatment, while the control group was given placebo granules in addition to conventional treatment for 12 weeks.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was clinic blood pressure, whereas secondary outcomes included metabolic indices (e.g., homeostasis model assessment of insulin resistance [HOMA-IR], total cholesterol [TC], low-density lipoprotein cholesterol and triglyceride), target organ damage indices (left ventricular mass index and urinary albumin creatinine ratio [UACR]) and inflammation indices (interleukin-6 [IL-6] and high-sensitivity C-reactive protein [hs-CRP]).</p></div><div><h3>Results</h3><p>HQQR’s primary components were identified as salvianolic acid B, emodin and ferulic acid. Of the 216 participants (108 in each group), compared to the control, the intervention group exhibited significant improvements (<em>P</em> < 0.001) in clinic systolic blood pressure ([136.24 ± 7.63] <em>vs</em> [130.06 ± 8.50] mmHg), clinic diastolic blood pressure ([84.34 ± 8.72] <em>vs</em> [80.46 ± 6.05] mmHg), home systolic blood pressure ([131.64 ± 8.74] <em>vs</em> [122.36 ± 8.45] mmHg) and home diastolic blood pressure ([78.47 ± 9.53] <em>vs</em> [71.79 ± 6.82] mmHg). HQQR demonstrated a reduction in ambulatory blood pressure (24-hour systolic blood pressure: [133.75 ± 10.49] <em>vs</em> [132.46 ± 8.84] mmHg and 24-hour diastolic blood pressure: [84.12 ± 8.01] <em>vs</em> [82.11 ± 7.45] mmHg) and an improvement in HOMA-IR ([4.09 ± 1.72] <em>vs</em> [3.98 ± 1.44]), TC ([4.66 ± 1.47] <em>vs</em> [3.75 ± 1.81] mmol/L) and UACR (75.94 [5.12, 401.12] <em>vs</em> 45.61 [4.26, 234.26]). Moreover, HQQR demonstrated a decrease in hs-CRP (1.46 [0.10, 10.53] <em>vs</em> 0.57 [0.12, 3.99] mg/L) and IL-6 (6.69 [2.00, 29.74] <em>vs</em> 5.27 [2.00, 9.73] pg/mL), with no reported side effects (<em>P</em> < 0.00
背景高血压是一种常见病，也是冠心病的重要危险因素。本研究评估了 HQQR 对血瘀、阳亢、痰浊型高血压患者控制血压的疗效。采用薄层色谱法和高效液相色谱法鉴定 HQQR 的主要成分。研究对象年龄在18-80岁之间，具有中医血瘀、阳亢、痰浊等证候，并伴有1或2级高血压，被随机分为两组。干预组在常规高血压治疗的基础上服用 HQQR 颗粒，对照组在常规治疗的基础上服用安慰剂颗粒，疗程 12 周、主要结果是临床血压，次要结果包括代谢指数（如胰岛素抵抗的稳态模型评估[HOMA-IR]、总胆固醇[TC]、低密度脂蛋白胆固醇和甘油三酯）、靶器官损伤指数（左心室质量指数和尿白蛋白肌酐比值[UACR]）和炎症指数（白细胞介素6[IL-6]和高敏C反应蛋白[hs-CRP]）。结果HQQR的主要成分被确定为丹参酚酸B、大黄素和阿魏酸。在 216 名参与者（每组 108 人）中，与对照组相比，干预组的临床收缩压（[136.24 ± 7.63] vs [130.06 ± 8.50] mmHg）、门诊舒张压（[84.34 ± 8.72] vs [80.46 ± 6.05] mmHg）、家庭收缩压（[131.64 ± 8.74] vs [122.36 ± 8.45] mmHg）和家庭舒张压（[78.47 ± 9.53] vs [71.79 ± 6.82] mmHg）均有明显改善（P < 0.001）。HQQR 可降低非卧床血压（24 小时收缩压：[133.75 ± 10.49] vs [132.46 ± 8.84] mmHg，24 小时舒张压：[84.12 ± 8.01] vs [82.11 ± 7.45] mmHg），HOMA-IR（[4.09 ± 1.72] vs [3.98 ± 1.44]）、TC（[4.66 ± 1.47] vs [3.75 ± 1.81] mmol/L）和 UACR（75.94 [5.12, 401.12] vs 45.61 [4.26, 234.26]）也有所改善。此外，HQQR 还降低了 hs-CRP（1.46 [0.10, 10.53] vs 0.57 [0.12, 3.99] mg/L）和 IL-6（6.69 [2.00, 29.74] vs 5.27 [2.00, 9.73] pg/mL），且未报告副作用（P < 0.001）。结论本研究强调了使用 HQQR 在改善高血压患者血压、糖脂代谢和炎症方面的治疗潜力。试验注册ChiCTR2000035092 (https://www.chictr.org.cn/)。本文引用如前：Xie J, Ma YL, Gui MT, Yao L, Li JH, Wang MZ, Zhou XJ, Wang YF, Zhao MY, Cao H, Lu B, Fu DY.藿雪前阳瞿潭方对高血压的疗效：随机、双盲、安慰剂对照试验J Integr Med 2024; 22(4)：485-493.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.05.005
Background
Electroacupuncture is often used to treat insomnia.
Objective
To evaluate the efficacy and safety of electroacupuncture for insomnia.
Search strategy
Databases including PubMed, Cochrane Library, Embase, Web of Science, Chinese Biomedical Literature Database, China National Knowledge Infrastructure, Wanfang Data and VIP Full-text e-Journals Database were searched up to January 15, 2023.
Inclusion criteria
Randomized clinical trials were included if they compared the clinical efficacy and safety of electroacupuncture with sham acupuncture, no treatment or usual care (UC) and general acupuncture.
Data extraction and analysis
The full texts of the studies were reviewed to remove ineligible literature. The extracted data included authors, publication year, diagnostic criteria, sample size, population characteristics, interventions and outcomes. The above steps were performed independently by two reviewers and the data were cross-checked. Stata15.0 software was used to analyze the extracted outcome data. For continuous data (Pittsburgh Sleep Quality Index [PSQI] score and Insomnia Severity Index score), weighted mean difference (WMD) was calculated and 95% confidence interval (CI) was reported when the same scale was applied. For dichotomous variables (clinical response rate and adverse events), a meta-analysis was performed using risk ratio (RR) as the effect indicator.
Results
Thirty-one trials with 2226 subjects were included. The meta-analysis suggested that electroacupuncture was more effective in improving insomnia compared with the control group (sham acupuncture, no treatment, UC and general acupuncture) (RR = 1.21; 95% CI: [1.16, 1.27]), significantly reducing the PSQI score in insomnia patients after treatment and at follow-up (WMD = −3.23; 95% CI: [−4.29, −2.17]; P < 0.001). There was no significant difference in the incidence of adverse events between the EA and control groups (sham acupuncture and no treatment or UC. RR = 1.48; 95% CI: [0.91, 2.40]; P = 0.117). In addition, the regression results revealed that receiving electroacupuncture for seven to nine weeks provided the best efficacy (P < 0.05).
Conclusion
Electroacupuncture can significantly promote better sleep quality in insomnia patients and is suitable for the treatment of various types of insomnia. However, the articles included were single-center trials with small sample sizes, and some articles were of poor quality. Therefore, further research is still needed to confirm these findings.
Please cite this article as: Xu HY, Wu LN, Zhang Y, Ba T, Zhao XF. Efficacy and safety of electroacupuncture for insomnia: A systematic review and meta-analysis. J Integr Med. 2024; 22(4): 460–473.
背景：电针是治疗失眠的常用方法：电针常被用于治疗失眠：评估电针治疗失眠的有效性和安全性：检索数据库包括PubMed、Cochrane Library、Embase、Web of Science、中国生物医学文献数据库、中国国家知识基础设施、万方数据和VIP全文电子期刊数据库，检索期截至2023年1月15日：数据提取和分析：对研究报告全文进行审查，删除不符合条件的文献。提取的数据包括作者、发表年份、诊断标准、样本大小、人群特征、干预措施和结果。上述步骤由两名审稿人独立完成，并对数据进行交叉核对。提取的结果数据使用Stata15.0软件进行分析。对于连续性数据（匹兹堡睡眠质量指数[PSQI]得分和失眠严重程度指数得分），计算加权平均差（WMD），并报告采用相同量表时的95%置信区间（CI）。对于二分变量（临床反应率和不良事件），采用风险比（RR）作为效应指标进行了荟萃分析：结果：共纳入 31 项试验，2226 名受试者。荟萃分析表明，与对照组（假针灸、不治疗、UC和普通针灸）相比，电针在改善失眠方面更有效（RR = 1.21；95% CI：[1.16, 1.27]），治疗后和随访时可显著降低失眠患者的PSQI评分（WMD = -3.23；95% CI：[-4.29, -2.17]；P 结论：电针可显著改善失眠患者的睡眠质量：电针能明显改善失眠患者的睡眠质量，适用于治疗各种类型的失眠。然而，纳入的文章均为单中心试验，样本量较小，且部分文章质量较差。因此，还需要进一步的研究来证实这些发现。本文引用如前：Xu HY, Wu LN, Zhang Y, Ba T, Zhao XF.电针治疗失眠的有效性和安全性：系统综述和荟萃分析。J Integr Med.2024; Epub ahead of print.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.06.003
Background
Sleep disturbance is commonly seen in fibromyalgia syndrome (FMS); however, high quality studies involving manual therapies that target FMS-linked poor sleep quality are lacking for the Indian population.
Objective
Craniosacral therapy (CST), Bowen therapy and exercises have been found to influence the autonomic nervous system, which plays a crucial role in sleep physiology. Given the paucity of evidence concerning these effects in individuals with FMS, our study tests the effectiveness of CST, Bowen therapy and a standard exercise program against static touch (the manual placebo group) on sleep quality in FMS.
Design, setting, participants and intervention
A placebo-controlled randomized trial was conducted on 132 FMS participants with poor sleep at a hospital in Bangalore. The participants were randomly allocated to one of the four study groups, including CST, Bowen therapy, standard exercise program, and a manual placebo control group that received static touch. CST, Bowen therapy and static touch treatments were administered in once-weekly 45-minute sessions for 12 weeks; the standard exercise group received weekly supervised exercises for 6 weeks with home exercises until 12 weeks. After 12 weeks, all study participants performed the standard exercises at home for another 12 weeks.
Main outcome measures
Sleep quality, pressure pain threshold (PPT), quality of life and fibromyalgia impact, physical function, fatigue, pain catastrophizing, kinesiophobia, and positive–negative affect were recorded at baseline, and at weeks 12 and 24 of the intervention.
Results
At the end of 12 weeks, the sleep quality improved significantly in the CST group (P = 0.037) and Bowen therapy group (P = 0.023), and the PPT improved significantly in the Bowen therapy group (P = 0.002) and the standard exercise group (P < 0.001), compared to the static touch group. These improvements were maintained at 24 weeks. No between-group differences were observed for other secondary outcomes.
Conclusion
CST and Bowen therapy improved sleep quality, and Bowen therapy and standard exercises improved pain threshold in the short term. These improvements were retained within the groups in the long term by adding exercises. CST and Bowen therapy are treatment options to improve sleep and reduce pain in FMS.
Trial registration number
Registered at Clinical Trials Registry of India with the number of CTRI/2020/04/024551.
Please cite this article as: Ughreja RA, Venkatesan P, Gopalakrishna DB, Singh YP, Lakshmi VR. Effectiveness of craniosacral therapy, Bowen therapy, static touch and standard exercise program on sleep quality in fibromyalgia syndrome: a randomized controlled trial. J Integr Med. 2024; 22(4): 474–484.
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