PDF(Pubmed)
Abstract：
BACKGROUND: Chronic spontaneous urticaria (CSU) is a common chronic inflammatory skin disease that manifests as itching and wheals, seriously affecting quality of life. Clinical observations and previous research trials have shown that acupuncture is safe and effective for the treatment of CSU. However, there are problems, such as a short duration of action and frequent treatment. Compared with traditional acupuncture, acupoint catgut embedding (ACE) has the advantages of a longer effect and higher compliance. Clinical trials are needed to prove its efficacy and mechanism of action.
OBJECTIVE: This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE.
METHODS: This is a randomized, double-blind, placebo-controlled trial. In this trial, 108 participants aged 18-60 years with a diagnosis of CSU and no history of ACE will be randomly assigned to 2 groups (1:1 ratio) using the Statistical Analysis System: treatment (ACE) and control (sham ACE). The participants and efficacy evaluators will be blinded to the grouping. Both the ACE and sham ACE groups will undergo acupuncture, but the sham ACE group will not receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period. Twenty patients will be randomly selected to undergo functional magnetic resonance imaging before and after the treatment period. The primary outcome will be the urticaria activity score over 7 days (UAS7). We will use R (version 4.0.1; R Project for Statistical Computing) to perform ANOVA and independent samples t tests to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of .05.
RESULTS: The study protocol has been approved by the Ethics Committee of Guang\'anmen Hospital on September 7, 2022, and has been registered on November 30, 2022. Recruitment began on March 1, 2023. A total of 4-6 participants are expected to be recruited each month. The recruitment is planned to be completed on March 1, 2025, and we expect to publish our results by the winter of 2025. As of November 1, 2023, we have enrolled 25 participants with CSU.
CONCLUSIONS: This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching will show greater improvement in participants receiving active therapy than in those receiving sham treatment. The limitations of this study include its single-center trial design, small sample size, and short treatment duration, which may have certain impacts on the research results.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2200066274; https://www.chictr.org.cn/showprojEN.html?proj=179056.
UNASSIGNED: DERR1-10.2196/54376.
OBJECTIVE: This trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE.
METHODS: This is a randomized, double-blind, placebo-controlled trial. In this trial, 108 participants aged 18-60 years with a diagnosis of CSU and no history of ACE will be randomly assigned to 2 groups (1:1 ratio) using the Statistical Analysis System: treatment (ACE) and control (sham ACE). The participants and efficacy evaluators will be blinded to the grouping. Both the ACE and sham ACE groups will undergo acupuncture, but the sham ACE group will not receive catgut sutures. Treatment will be performed twice weekly for 8 weeks, with a 1-week run-in period and a 16-week follow-up period. Twenty patients will be randomly selected to undergo functional magnetic resonance imaging before and after the treatment period. The primary outcome will be the urticaria activity score over 7 days (UAS7). We will use R (version 4.0.1; R Project for Statistical Computing) to perform ANOVA and independent samples t tests to compare the differences within and between groups before and after treatment by judging the rejection range based on a significance level of .05.
RESULTS: The study protocol has been approved by the Ethics Committee of Guang\'anmen Hospital on September 7, 2022, and has been registered on November 30, 2022. Recruitment began on March 1, 2023. A total of 4-6 participants are expected to be recruited each month. The recruitment is planned to be completed on March 1, 2025, and we expect to publish our results by the winter of 2025. As of November 1, 2023, we have enrolled 25 participants with CSU.
CONCLUSIONS: This randomized, double-blind, placebo-controlled trial aims to provide definitive evidence for the treatment of CSU with ACE and explore the mechanism of ACE. We hypothesize that wheals and itching will show greater improvement in participants receiving active therapy than in those receiving sham treatment. The limitations of this study include its single-center trial design, small sample size, and short treatment duration, which may have certain impacts on the research results.
BACKGROUND: Chinese Clinical Trial Registry ChiCTR2200066274; https://www.chictr.org.cn/showprojEN.html?proj=179056.
UNASSIGNED: DERR1-10.2196/54376.
摘要：
背景：慢性自发性荨麻疹（CSU）是一种常见的慢性炎症性皮肤病，表现为瘙痒和风团，严重影响生活质量。临床观察和先前的研究试验表明，针灸治疗CSU是安全有效的。然而,有问题,例如短时间的作用和频繁的治疗。与传统针灸相比,穴位埋线(ACE)具有作用时间长、依从性高等优点。需要临床试验来证明其功效和作用机制。
目的：本试验旨在为ACE治疗CSU提供明确的证据，并探讨ACE的作用机制。
方法：这是一个随机的，双盲,安慰剂对照试验。在这次审判中,108名年龄在18-60岁之间，诊断为CSU且无ACE病史的参与者将使用统计分析系统随机分为2组（1：1比例）：治疗（ACE）和对照（假ACE）。参与者和疗效评估者将对分组视而不见。ACE和假ACE组都将接受针灸治疗，但假ACE组将不接受羊肠线缝合。治疗将每周两次，持续8周，1周磨合期和16周随访期。将随机选择20名患者在治疗前后进行功能磁共振成像。主要结果将是超过7天的荨麻疹活动评分(UAS7)。我们将使用R（4.0.1版；用于统计计算的R项目）进行方差分析和独立样本t检验，通过基于0.05的显著性水平判断排斥范围，比较治疗前后组间和组间的差异。
结果：本研究方案已于2022年9月7日获得广安门医院伦理委员会批准，并于2022年11月30日注册。招聘开始于2023年3月1日。预计每月总共招募4-6名参与者。此次招聘计划于2025年3月1日完成，我们预计将于2025年冬季公布业绩。截至2023年11月1日，我们已经招募了25名CSU参与者。
结论：这是随机的，双盲,安慰剂对照试验旨在为ACE治疗CSU提供明确的证据，并探讨ACE的作用机制。我们假设，接受积极治疗的参与者比接受假治疗的参与者的风团和瘙痒将显示出更大的改善。这项研究的局限性包括其单中心试验设计，小样本量，治疗时间短，这可能会对研究结果产生一定的影响。
背景：中国临床试验注册中心ChiCTR2200066274;https://www.chictr.org.cn/showprojEN.html?proj=179056。
■DERR1-10.2196/54376。
目的：本试验旨在为ACE治疗CSU提供明确的证据，并探讨ACE的作用机制。
方法：这是一个随机的，双盲,安慰剂对照试验。在这次审判中,108名年龄在18-60岁之间，诊断为CSU且无ACE病史的参与者将使用统计分析系统随机分为2组（1：1比例）：治疗（ACE）和对照（假ACE）。参与者和疗效评估者将对分组视而不见。ACE和假ACE组都将接受针灸治疗，但假ACE组将不接受羊肠线缝合。治疗将每周两次，持续8周，1周磨合期和16周随访期。将随机选择20名患者在治疗前后进行功能磁共振成像。主要结果将是超过7天的荨麻疹活动评分(UAS7)。我们将使用R（4.0.1版；用于统计计算的R项目）进行方差分析和独立样本t检验，通过基于0.05的显著性水平判断排斥范围，比较治疗前后组间和组间的差异。
结果：本研究方案已于2022年9月7日获得广安门医院伦理委员会批准，并于2022年11月30日注册。招聘开始于2023年3月1日。预计每月总共招募4-6名参与者。此次招聘计划于2025年3月1日完成，我们预计将于2025年冬季公布业绩。截至2023年11月1日，我们已经招募了25名CSU参与者。
结论：这是随机的，双盲,安慰剂对照试验旨在为ACE治疗CSU提供明确的证据，并探讨ACE的作用机制。我们假设，接受积极治疗的参与者比接受假治疗的参与者的风团和瘙痒将显示出更大的改善。这项研究的局限性包括其单中心试验设计，小样本量，治疗时间短，这可能会对研究结果产生一定的影响。
背景：中国临床试验注册中心ChiCTR2200066274;https://www.chictr.org.cn/showprojEN.html?proj=179056。
■DERR1-10.2196/54376。
