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.
{"title":"Efficacy and safety of electroacupuncture for insomnia: A systematic review and meta-analysis","authors":"","doi":"10.1016/j.joim.2024.05.005","DOIUrl":"10.1016/j.joim.2024.05.005","url":null,"abstract":"<div><h3>Background</h3><p>Electroacupuncture is often used to treat insomnia.</p></div><div><h3>Objective</h3><p>To evaluate the efficacy and safety of electroacupuncture for insomnia.</p></div><div><h3>Search strategy</h3><p>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.</p></div><div><h3>Inclusion criteria</h3><p>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.</p></div><div><h3>Data extraction and analysis</h3><p>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.</p></div><div><h3>Results</h3><p>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]; <em>P</em> < 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]; <em>P</em> = 0.117). In addition, the regression results revealed that receiving electroacupuncture for seven to nine weeks provided the best efficacy (<em>P</em> < 0.05).</p></div><div><h3>Conclusion</h3><p>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.</p><p>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.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 459-472"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141318642","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.2024.06.003
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.
{"title":"Effectiveness of craniosacral therapy, Bowen therapy, static touch and standard exercise program on sleep quality in fibromyalgia syndrome: A randomized controlled trial","authors":"","doi":"10.1016/j.joim.2024.06.003","DOIUrl":"10.1016/j.joim.2024.06.003","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Objective</h3><p>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.</p></div><div><h3>Design, setting, participants and intervention</h3><p>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.</p></div><div><h3>Main outcome measures</h3><p>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.</p></div><div><h3>Results</h3><p>At the end of 12 weeks, the sleep quality improved significantly in the CST group (<em>P</em> = 0.037) and Bowen therapy group (<em>P</em> = 0.023), and the PPT improved significantly in the Bowen therapy group (<em>P</em> = 0.002) and the standard exercise group (<em>P</em> < 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.</p></div><div><h3>Conclusion</h3><p>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.</p></div><div><h3>Trial registration number</h3><p>Registered at Clinical Trials Registry of India with the number of CTRI/2020/04/024551.</p><p>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. <em>J Integr Med.</em> 2024; 22(4): 474–484.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 473-483"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141494018","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.2024.06.001
The property theory of traditional Chinese medicine (TCM) has been practiced for thousands of years, playing a pivotal role in the clinical application of TCM. While advancements in energy metabolism, chemical composition analysis, machine learning, ion current modeling, and supercritical fluid technology have provided valuable insight into how aspects of TCM property theory may be measured, these studies only capture specific aspects of TCM property theory in isolation, overlooking the holistic perspective inherent in TCM. To systematically investigate the modern interpretation of the TCM property theory from multidimensional perspectives, we consulted the Chinese Pharmacopoeia (2020 edition) to compile a list of Chinese materia medica (CMM). Then, using the Latin names of each CMM and gut microbiota as keywords, we searched the PubMed database for relevant research on gut microbiota and CMM. The regulatory patterns of different herbs on gut microbiota were then summarized from the perspectives of the four natures, the five flavors and the meridian tropism. In terms of the four natures, we found that warm-natured medicines promoted the colonization of specific beneficial bacteria, while cold-natured medicines boosted populations of some beneficial bacteria while suppressing pathogenic bacteria. Analysis of the five flavors revealed that sweet-flavored and bitter-flavored CMMs positively influenced beneficial bacteria while inhibiting harmful bacteria. CMMs with different meridian tropism exhibited complex modulative patterns on gut microbiota, with Jueyin (Liver) and Taiyin (Lung) meridian CMMs generally exerting a stronger effect. The gut microbiota may be a biological indicator for characterizing the TCM property theory, which not only enhances our understanding of classic TCM theory but also contributes to its scientific advancement and application in healthcare.
Please cite this article as: Yang YN, Zhan JG, Cao Y, Wu CM. From ancient wisdom to modern science: Gut microbiota sheds light on property theory of traditional Chinese medicine. J Integr Med 2024; 22(4): 413–445.
传统中药(TCM)的药性理论已有数千年的历史,在中药的临床应用中发挥着举足轻重的作用。虽然能量代谢、化学成分分析、机器学习、离子流建模和超临界流体技术的进步为如何测量中药药性理论的各个方面提供了宝贵的见解,但这些研究只是孤立地捕捉中药药性理论的特定方面,忽略了中药固有的整体观。为了从多维角度系统地研究中药性理论的现代诠释,我们查阅了《中国药典》(2020 年版),编制了中药目录(CMM)。然后,我们以每种中药的拉丁文名称和肠道微生物群为关键词,在PubMed数据库中检索肠道微生物群和中药的相关研究。然后从四性、五味和经络滋补的角度总结了不同中草药对肠道微生物群的调控模式。在四性方面,我们发现温性药能促进特定有益菌的定植,而寒性药则在抑制致病菌的同时提高了某些有益菌的数量。对五味的分析表明,甜味和苦味的 CMM 对有益菌有积极影响,而对有害菌则有抑制作用。具有不同经络滋补功能的 CMM 对肠道微生物群表现出复杂的调节模式,其中足厥阴肝经和足太阴肺经的 CMM 一般具有更强的作用。肠道微生物群可能是表征中医属性理论的生物学指标,这不仅能加深我们对中医经典理论的理解,还有助于其在医疗保健领域的科学进步和应用:Yang YN, Zhan JG, Cao Y, Wu CM.从古代智慧到现代科学肠道微生物群揭示中药属性理论。J Integr Med 2024; 22(4):413-445.
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Pub Date : 2024-07-01DOI: 10.1016/j.joim.2024.06.002
This study was conducted to identify the number and density of active licensed acupuncturists (LAcs), as well as the number of accredited schools in acupuncture and Oriental medicine (AOM), as of January 1, 2023, in the United States (U.S.). The number of active LAcs as of January 1, 2023 was 34,524, potentially 33,364 after removing license duplication in multiple states, among which the largest three states were California (with 7317 LAcs [21.19% of the total]), New York (5024 [14.55%]) and Florida (2644 [7.66%]). The total number of LAcs decreased by 8.87% from 2018, and fell short of our projected number of LAcs in 2023 by 9037, or 20.75%. The overall LAc density in the U.S.—measured as the number of LAcs per 100,000 population—was 10.36, less than in 2018. There were 56 active, accredited AOM schools which offered a total of 147 programs (121 at the level necessary for licensing [entry-level], 12 for an advanced practicing degree [advanced-level], and 14 for certifications). Broken down further, offerings included 50 master’s degrees in acupuncture, 40 master’s degrees in Oriental medicine, 31 entry-level doctorate degrees (10 in acupuncture and 21 in acupuncture plus Chinese herbal medicine), and 12 advanced-level doctorate degrees in AOM. The certification programs included one in East-Asian Medical Bodywork and 13 in CHM. Among these schools in 2023, institutions in the West and East Coast states comprised 67.86% (decreased from 77.42% in 2018) of the national total. California, Florida and Illinois represented 39.29%. There were 48 jurisdictions with acupuncture practice laws in place. The data suggests that the acupuncture profession in the U.S. has been significantly impacted during the coronavirus disease 2019 pandemic.
Please cite this article as: Fan AY, He DG, Sangraula A, Alemi SF, Matecki A. Distribution of licensed acupuncturists and educational institutions in the United States at the start of 2023, during the late stage of the COVID-19 pandemic. J Integr Med. 2024; 22(4): 379–384.
{"title":"Distribution of licensed acupuncturists and educational institutions in the United States at the start of 2023, during the late stage of the COVID-19 pandemic","authors":"","doi":"10.1016/j.joim.2024.06.002","DOIUrl":"10.1016/j.joim.2024.06.002","url":null,"abstract":"<div><p>This study was conducted to identify the number and density of active licensed acupuncturists (LAcs), as well as the number of accredited schools in acupuncture and Oriental medicine (AOM), as of January 1, 2023, in the United States (U.S.). The number of active LAcs as of January 1, 2023 was 34,524, potentially 33,364 after removing license duplication in multiple states, among which the largest three states were California (with 7317 LAcs [21.19% of the total]), New York (5024 [14.55%]) and Florida (2644 [7.66%]). The total number of LAcs decreased by 8.87% from 2018, and fell short of our projected number of LAcs in 2023 by 9037, or 20.75%. The overall LAc density in the U.S.—measured as the number of LAcs per 100,000 population—was 10.36, less than in 2018. There were 56 active, accredited AOM schools which offered a total of 147 programs (121 at the level necessary for licensing [entry-level], 12 for an advanced practicing degree [advanced-level], and 14 for certifications). Broken down further, offerings included 50 master’s degrees in acupuncture, 40 master’s degrees in Oriental medicine, 31 entry-level doctorate degrees (10 in acupuncture and 21 in acupuncture plus Chinese herbal medicine), and 12 advanced-level doctorate degrees in AOM. The certification programs included one in East-Asian Medical Bodywork and 13 in CHM. Among these schools in 2023, institutions in the West and East Coast states comprised 67.86% (decreased from 77.42% in 2018) of the national total. California, Florida and Illinois represented 39.29%. There were 48 jurisdictions with acupuncture practice laws in place. The data suggests that the acupuncture profession in the U.S. has been significantly impacted during the coronavirus disease 2019 pandemic.</p><p>Please cite this article as: Fan AY, He DG, Sangraula A, Alemi SF, Matecki A. Distribution of licensed acupuncturists and educational institutions in the United States at the start of 2023, during the late stage of the COVID-19 pandemic. <em>J Integr Med</em>. 2024; 22(4): 379–384.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 379-384"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141471733","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.2024.05.004
Objective
Studies have demonstrated that cycloastragenol induces antitumor effects in prostate, colorectal and gastric cancers; however, its efficacy for inhibiting the proliferation of lung cancer cells is largely unexplored. This study explores the efficacy of cycloastragenol for inhibiting non-small cell lung cancer (NSCLC) and elucidates the underlying molecular mechanisms.
Methods
The effects of cycloastragenol on lung cancer cell proliferation were assessed using an adenosine triphosphate monitoring system based on firefly luciferase and clonogenic formation assays. Cycloastragenol-induced apoptosis in lung cancer cells was evaluated using dual staining flow cytometry with an annexin V-fluorescein isothiocyanate/propidium iodide kit. To elucidate the role of cycloastragenol in the induction of apoptosis, apoptosis-related proteins were examined using Western blots. Immunofluorescence and Western blotting were used to determine whether cycloastragenol could induce autophagy in lung cancer cells. Genetic techniques, including small interfering RNA technology, were used to investigate the underlying mechanisms. The effects against lung cancer and biosafety of cycloastragenol were evaluated using a mouse subcutaneous tumor model.
Results
Cycloastragenol triggered both autophagy and apoptosis. Specifically, cycloastragenol promoted apoptosis by facilitating the accumulation of phorbol-12-myristate-13-acetate-induced protein 1 (NOXA), a critical apoptosis-related protein. Moreover, cycloastragenol induced a protective autophagy response through modulation of the adenosine 5ʹ-monophosphate-activated protein kinase (AMPK)/unc-51-like autophagy-activating kinase (ULK1)/mammalian target of rapamycin (mTOR) pathway.
Conclusion
Our study sheds new light on the antitumor efficacy and mechanism of action of cycloastragenol in NSCLC. This insight provides a scientific basis for exploring combination therapies that use cycloastragenol and inhibiting the AMPK/ULK1/mTOR pathway as a promising approach to combating lung cancer.
Please cite this article as follows: Zhu LH, Liang YP, Yang L, Zhu F, Jia LJ, Li HG. Cycloastragenolinduces apoptosis and protective autophagy through AMPK/ULK1/mTOR axis in human non-small celllung cancer cell lines. J Integr Med. 2024; 22(4): 504–515.
目的研究表明,环黄芪醇可诱导前列腺癌、结直肠癌和胃癌的抗肿瘤作用,但其抑制肺癌细胞增殖的功效却尚未得到广泛探讨。本研究探讨了环黄芪醇抑制非小细胞肺癌(NSCLC)的功效,并阐明了其潜在的分子机制。方法使用基于萤火虫荧光素酶和克隆形成试验的三磷酸腺苷监测系统评估环黄芪醇对肺癌细胞增殖的影响。使用附件素 V-异硫氰酸荧光素/碘化丙啶试剂盒的双重染色流式细胞术评估了环黄芪醇诱导的肺癌细胞凋亡。为了阐明环黄芪醇在诱导细胞凋亡中的作用,使用 Western 印迹法检测了与细胞凋亡相关的蛋白质。免疫荧光和 Western 印迹技术用于确定环黄芪醇是否能诱导肺癌细胞自噬。基因技术,包括小干扰 RNA 技术,被用来研究其潜在机制。利用小鼠皮下肿瘤模型评估了环黄芪醇对肺癌的作用和生物安全性。具体来说,环黄芪醇通过促进光甘油-12-肉豆蔻酸-13-乙酸诱导蛋白1(NOXA)的积累来促进细胞凋亡,NOXA是一种关键的细胞凋亡相关蛋白。此外,环黄芪醇通过调节腺苷-5ʹ-单磷酸激活蛋白激酶(AMPK)/unc-51样自噬激活激酶(ULK1)/哺乳动物雷帕霉素靶标(mTOR)通路,诱导保护性自噬反应。这一发现为探索环黄芪醇与抑制AMPK/ULK1/mTOR通路的联合疗法提供了科学依据,是一种很有前景的抗击肺癌的方法:Zhu LH, Liang YP, Yang L, Zhu F, Jia LJ, Li HG.环黄芪醇通过AMPK/ULK1/mTOR轴在人非小细胞肺癌细胞系中诱导凋亡和保护性自噬。J Integr Med.2024; 22(4):504-515.
{"title":"Cycloastragenol induces apoptosis and protective autophagy through AMPK/ULK1/mTOR axis in human non-small cell lung cancer cell lines","authors":"","doi":"10.1016/j.joim.2024.05.004","DOIUrl":"10.1016/j.joim.2024.05.004","url":null,"abstract":"<div><h3>Objective</h3><p>Studies have demonstrated that cycloastragenol induces antitumor effects in prostate, colorectal and gastric cancers; however, its efficacy for inhibiting the proliferation of lung cancer cells is largely unexplored. This study explores the efficacy of cycloastragenol for inhibiting non-small cell lung cancer (NSCLC) and elucidates the underlying molecular mechanisms.</p></div><div><h3>Methods</h3><p>The effects of cycloastragenol on lung cancer cell proliferation were assessed using an adenosine triphosphate monitoring system based on firefly luciferase and clonogenic formation assays. Cycloastragenol-induced apoptosis in lung cancer cells was evaluated using dual staining flow cytometry with an annexin V-fluorescein isothiocyanate/propidium iodide kit. To elucidate the role of cycloastragenol in the induction of apoptosis, apoptosis-related proteins were examined using Western blots. Immunofluorescence and Western blotting were used to determine whether cycloastragenol could induce autophagy in lung cancer cells. Genetic techniques, including small interfering RNA technology, were used to investigate the underlying mechanisms. The effects against lung cancer and biosafety of cycloastragenol were evaluated using a mouse subcutaneous tumor model.</p></div><div><h3>Results</h3><p>Cycloastragenol triggered both autophagy and apoptosis. Specifically, cycloastragenol promoted apoptosis by facilitating the accumulation of phorbol-12-myristate-13-acetate-induced protein 1 (NOXA), a critical apoptosis-related protein. Moreover, cycloastragenol induced a protective autophagy response through modulation of the adenosine 5ʹ-monophosphate-activated protein kinase (AMPK)/unc-51-like autophagy-activating kinase (ULK1)/mammalian target of rapamycin (mTOR) pathway.</p></div><div><h3>Conclusion</h3><p>Our study sheds new light on the antitumor efficacy and mechanism of action of cycloastragenol in NSCLC. This insight provides a scientific basis for exploring combination therapies that use cycloastragenol and inhibiting the AMPK/ULK1/mTOR pathway as a promising approach to combating lung cancer.</p><p>Please cite this article as follows: Zhu LH, Liang YP, Yang L, Zhu F, Jia LJ, Li HG. Cycloastragenolinduces apoptosis and protective autophagy through AMPK/ULK1/mTOR axis in human non-small celllung cancer cell lines. <em>J Integr Med.</em> 2024; 22(4): 504–515.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 4","pages":"Pages 503-514"},"PeriodicalIF":4.2,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095496424003352/pdfft?md5=d921ddf3956ec8849ad90348c10155a0&pid=1-s2.0-S2095496424003352-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141141266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-01DOI: 10.1016/j.joim.2024.04.002
Chao Yang , Shan-ze Wang , Sheng Chen , Shuo Du , Guan-qun Wang , Wei Guo , Xiao-long Xie , Bi-hui Peng , Shi-hao Du , Ji-ping Zhao
Urinary incontinence (UI) is a common problem worldwide. It has a major impact on physical and social activities and interpersonal relationships. UI is common in women, but is under-reported and under-treated. It affects the quality of life of female patients severely. Acupuncture and moxibustion have been proposed as potentially effective interventions for female UI. Hence, for the benefit of acupuncture practitioners around the world, the World Federation of Acupuncture-moxibustion Societies initiated a project to develop a clinical practice guideline (CPG) for the use of acupuncture and moxibustion to treat female UI. This CPG was developed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, referring to the principles of the World Health Organization Handbook for Guideline Development. During the development of the CPG, the guideline development group (GDG) played an important role. The clinical questions, recommendations and therapeutic protocols were all formulated by GDG using the modified Delphi method. This CPG contains ten recommendations about the use of acupuncture and moxibustion interventions for ten clinical questions, which include nine conditional recommendations for the intervention and one conditional recommendation for either the intervention or the comparison. This CPG also provides one protocol for conventional filiform needle therapy, two therapy protocols for deep needling stimulation on lumbosacral acupoints, and four moxibustion therapy protocols, based on the protocols presented in randomized controlled trials reviewed by the GDG.
Please cite this article as: Yang C, Wang SZ, Chen S, Du S, Wang GQ, Guo W, Xie XL, Peng BH, Du SH, Zhao JP. Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence. J Integr Med. 2024; 22(3): 258–269.
尿失禁(UI)是全球普遍存在的问题。它对身体和社交活动以及人际关系都有重大影响。尿失禁在女性中很常见,但报告和治疗不足。它严重影响女性患者的生活质量。针灸被认为是治疗女性尿崩症的有效方法。因此,为了全世界针灸从业者的利益,世界针灸学会联合会发起了一个项目,以制定针灸治疗女性尿道炎的临床实践指南(CPG)。该临床实践指南是根据世界卫生组织《指南制定手册》的原则,按照 "建议评估、制定和评价分级"(GRADE)方法制定的。在制定 CPG 的过程中,指南制定小组(GDG)发挥了重要作用。临床问题、建议和治疗方案均由 GDG 采用改良德尔菲法制定。本指导原则针对十个临床问题提出了十项针灸干预建议,其中九项为有条件的干预建议,一项为有条件的干预或对比建议。该CPG还根据GDG审查的随机对照试验中提出的方案,提供了1个传统丝状针疗法方案、2个腰骶部穴位深刺刺激疗法方案和4个艾灸疗法方案:Yang C, Wang SZ, Chen S, Du S, Wang GQ, Guo W, Xie XL, Peng BH, Du SH, Zhao JP.针灸临床实践指南:女性尿失禁。J Integr Med.2024; 22(3):258-269.
{"title":"Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence","authors":"Chao Yang , Shan-ze Wang , Sheng Chen , Shuo Du , Guan-qun Wang , Wei Guo , Xiao-long Xie , Bi-hui Peng , Shi-hao Du , Ji-ping Zhao","doi":"10.1016/j.joim.2024.04.002","DOIUrl":"10.1016/j.joim.2024.04.002","url":null,"abstract":"<div><p>Urinary incontinence (UI) is a common problem worldwide. It has a major impact on physical and social activities and interpersonal relationships. UI is common in women, but is under-reported and under-treated. It affects the quality of life of female patients severely. Acupuncture and moxibustion have been proposed as potentially effective interventions for female UI. Hence, for the benefit of acupuncture practitioners around the world, the World Federation of Acupuncture-moxibustion Societies initiated a project to develop a clinical practice guideline (CPG) for the use of acupuncture and moxibustion to treat female UI. This CPG was developed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology, referring to the principles of the <em>World Health Organization Handbook for Guideline Development</em>. During the development of the CPG, the guideline development group (GDG) played an important role. The clinical questions, recommendations and therapeutic protocols were all formulated by GDG using the modified Delphi method. This CPG contains ten recommendations about the use of acupuncture and moxibustion interventions for ten clinical questions, which include nine conditional recommendations for the intervention and one conditional recommendation for either the intervention or the comparison. This CPG also provides one protocol for conventional filiform needle therapy, two therapy protocols for deep needling stimulation on lumbosacral acupoints, and four moxibustion therapy protocols, based on the protocols presented in randomized controlled trials reviewed by the GDG.</p><p>Please cite this article as: Yang C, Wang SZ, Chen S, Du S, Wang GQ, Guo W, Xie XL, Peng BH, Du SH, Zhao JP. Clinical practice guideline for acupuncture and moxibustion: Female urinary incontinence. <em>J Integr Med</em>. 2024; 22(3): 258–269.</p></div>","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 3","pages":"Pages 258-269"},"PeriodicalIF":4.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2095496424000499/pdfft?md5=2e23504c8c9ad1e8b5bf70d0a403a894&pid=1-s2.0-S2095496424000499-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140772609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-05-01DOI: 10.1016/j.joim.2024.04.004
Jia-jia Wu , Tian-yi Zhang , Ying-hui Qi , Min-yan Zhu , Yan Fang , Chao-jun Qi , Li-ou Cao , Ji-fang Lu , Bo-han Lu , Lu-min Tang , Jian-xiao Shen , Shan Mou
<div><h3>Background</h3><p>Yiqi Peiyuan (YQPY) prescription, a composite prescription of traditional Chinese medicine, has been used to prevent or delay the continued deterioration of renal function after acute kidney injury (AKI) in some institutions and has shown considerable efficacy.</p></div><div><h3>Objective</h3><p>This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI.</p></div><div><h3>Design, setting, participants and interventions</h3><p>This is a prospective, double-blind, multicenter, randomized, and placebo-controlled clinical trial. A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule. Participants, caregivers and investigators assessing the outcomes were blinded to group assignment. Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days. Patients in the placebo group received a placebo in the same dose as the YQPY granules.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was the change in the estimated glomerular filtration rate (eGFR) between baseline and after 4 and 24 weeks of treatment. The secondary outcomes were the change of serum creatinine (Scr) level between baseline and after treatment, and the incidence of endpoint events, defined as eGFR increasing by more than 25% above baseline, eGFR >75 mL/min per 1.73 m<sup>2</sup> or the composite endpoint, which was defined as the sum of patients meeting either of the above criteria.</p></div><div><h3>Results</h3><p>Data from a total of 114 patients (59 in the YQPY group and 55 in the control group) were analyzed. The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups. In further subgroup analysis (22 in the YQPY group and 31 in the control group), the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m<sup>2</sup> in the YQPY group and 5.78 mL/min per 1.73 m<sup>2</sup> in the placebo group, and the mean difference between groups was 21.61 mL/min per 1.73 m<sup>2</sup> (<em>P</em> < 0.001). Thirteen (59.1%) patients in the YQPY group and 5 (16.1%) in the placebo group reached the composite endpoints (<em>P</em> = 0.002). During the intervention, 2 and 4 severe adverse events were reported in the YQPY and placebo groups, respectively.</p></div><div><h3>Conclusion</h3><p>The YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI, indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI. The YQPY granules may be a promising therapy for adults with AKI.</p></div><div><h3>Trial Registration</h3><p>Chinese Clinical Trial Registry ChiCTR2100051723.</p><p>Please cite this article as: Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-t
背景益气培元方是一种中药复方制剂,在一些机构已被用于预防或延缓急性肾损伤(AKI)后肾功能的持续恶化,并显示出相当的疗效。共有 144 名参加者按照随机分配表被随机分配到两组。参试者、护理人员和评估结果的研究人员对组别分配进行盲测。YQPY组患者服用36克YQPY颗粒,每天两次,连续服用28天。主要结果测量主要结果是基线与治疗 4 周和 24 周后估计肾小球滤过率(eGFR)的变化。次要结果是基线与治疗后血清肌酐(Scr)水平的变化,以及终点事件的发生率,终点事件定义为 eGFR 比基线增加 25% 以上、eGFR >75 mL/min per 1.73 m2 或复合终点,复合终点定义为符合上述任一标准的患者总和。结果共分析了 114 名患者(YQPY 组 59 人,对照组 55 人)的数据。两组患者在第 4 周和第 24 周的 eGFR 和 Scr 平均值变化没有差异。在进一步的亚组分析中(YQPY 组 22 人,对照组 31 人),治疗 4 周后,YQPY 组的 eGFR 平均变化为 27.39 mL/min 每 1.73 m2,安慰剂组为 5.78 mL/min 每 1.73 m2,组间平均差异为 21.61 mL/min 每 1.73 m2(P < 0.001)。YQPY 组中有 13 名(59.1%)患者达到了综合终点,安慰剂组中有 5 名(16.1%)患者达到了综合终点(P = 0.002)。结论YQPY颗粒能在AKI发生4周后有效改善患者的肾功能,这表明它对改善AKI患者的短期肾脏预后具有良好的疗效。试验注册中国临床试验注册中心 ChiCTR2100051723.Please cite this article as:Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: a multicenter, double-blind, placebo-controlled, randomized trial.J Integr Med.2024; 22(3):279-285.
{"title":"Efficacy and safety of Yiqi Peiyuan granules for improving the short-term prognosis of patients with acute kidney injury: A multicenter, double-blind, placebo-controlled, randomized trial","authors":"Jia-jia Wu , Tian-yi Zhang , Ying-hui Qi , Min-yan Zhu , Yan Fang , Chao-jun Qi , Li-ou Cao , Ji-fang Lu , Bo-han Lu , Lu-min Tang , Jian-xiao Shen , Shan Mou","doi":"10.1016/j.joim.2024.04.004","DOIUrl":"10.1016/j.joim.2024.04.004","url":null,"abstract":"<div><h3>Background</h3><p>Yiqi Peiyuan (YQPY) prescription, a composite prescription of traditional Chinese medicine, has been used to prevent or delay the continued deterioration of renal function after acute kidney injury (AKI) in some institutions and has shown considerable efficacy.</p></div><div><h3>Objective</h3><p>This is the first randomized controlled trial to assess efficacy and safety of YQPY for improving short-term prognosis in adult patients with AKI.</p></div><div><h3>Design, setting, participants and interventions</h3><p>This is a prospective, double-blind, multicenter, randomized, and placebo-controlled clinical trial. A total of 144 enrolled participants were randomly allocated to two groups according to a randomization schedule. Participants, caregivers and investigators assessing the outcomes were blinded to group assignment. Patients in the YQPY group received 36 g YQPY granules twice a day for 28 days. Patients in the placebo group received a placebo in the same dose as the YQPY granules.</p></div><div><h3>Main outcome measures</h3><p>The primary outcome was the change in the estimated glomerular filtration rate (eGFR) between baseline and after 4 and 24 weeks of treatment. The secondary outcomes were the change of serum creatinine (Scr) level between baseline and after treatment, and the incidence of endpoint events, defined as eGFR increasing by more than 25% above baseline, eGFR >75 mL/min per 1.73 m<sup>2</sup> or the composite endpoint, which was defined as the sum of patients meeting either of the above criteria.</p></div><div><h3>Results</h3><p>Data from a total of 114 patients (59 in the YQPY group and 55 in the control group) were analyzed. The mean changes in eGFR and Scr in weeks 4 and 24 had no difference between the two groups. In further subgroup analysis (22 in the YQPY group and 31 in the control group), the mean change in eGFR after treatment for 4 weeks was 27.39 mL/min per 1.73 m<sup>2</sup> in the YQPY group and 5.78 mL/min per 1.73 m<sup>2</sup> in the placebo group, and the mean difference between groups was 21.61 mL/min per 1.73 m<sup>2</sup> (<em>P</em> < 0.001). Thirteen (59.1%) patients in the YQPY group and 5 (16.1%) in the placebo group reached the composite endpoints (<em>P</em> = 0.002). During the intervention, 2 and 4 severe adverse events were reported in the YQPY and placebo groups, respectively.</p></div><div><h3>Conclusion</h3><p>The YQPY granules can effectively improve the renal function of patients 4 weeks after the onset of AKI, indicating that it has good efficacy for improving short-term renal outcomes in patients with AKI. The YQPY granules may be a promising therapy for adults with AKI.</p></div><div><h3>Trial Registration</h3><p>Chinese Clinical Trial Registry ChiCTR2100051723.</p><p>Please cite this article as: Wu JJ, Zhang TY, Qi YH, Zhu MY, Fang Y, Qi CJ, Cao LO, Lu JF, Lu BH, Tang LM, Shen JX, Mou S. Efficacy and safety of Yiqi Peiyuan granules for improving the short-t","PeriodicalId":48599,"journal":{"name":"Journal of Integrative Medicine-Jim","volume":"22 3","pages":"Pages 279-285"},"PeriodicalIF":4.8,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140766916","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}