Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-02-12 DOI:10.1016/j.conctc.2025.101454

He Chen , Sixing Liu , Shuai Gao , Jiamin Yi , Hangyu Shi , Jiufei Fang , Weiming Wang , Huan Chen , Zhishun Liu

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引用次数: 0

Abstract

Background

Senile pruritus (SP), characterized by idiopathic itch in individuals aged 60 years and older without primary skin lesions, significantly impacts sleep and quality of life. Effective alternative treatments are needed. Acupuncture has been suggested as a potential intervention to alleviate pruritus; however, its role in managing SP remains uncertain. This study aims to evaluate the efficacy and safety of acupuncture for SP.

Methods

This single-center, parallel, two-arm, randomized, sham-controlled trial will enroll 200 patients diagnosed with SP in a 1:1 ratio to either the acupuncture or sham acupuncture group, receiving acupuncture or sham acupuncture three sessions weekly for six weeks. Participants, outcome assessors, and the statisticians will be blinded. The primary outcome is the change from baseline in the Average Pruritus Numerical Rating Scale (AP-NRS) score at week 6. Secondary outcomes include changes in AP-NRS (at other timepoints), Peak Pruritus Numerical Rating Scale (PP-NRS), number of scratch episodes, itchy area of body surface, overall dry skin score (ODS), the Dermatology Life Quality Index (DLQI), the Pittsburgh Sleep Quality Index (PSQI), the Hospital Anxiety and Depression Scale (HADS), and Patient Global Impression of Change (PGIC). Long-term effects of acupuncture will also be explored. Adverse events and additional treatments will be monitored throughout the study period. The modified intention-to-treat (mITT) population which includes participants who complete baseline assessments and receive at least one treatment session will be analyzed.

Discussion

This trial represents the first rigorously designed, single-center, randomized, sham-controlled study assessing the effects and safety of acupuncture for senile pruritus. We used valid outcome measurements which can provide valuable insights into the patient's symptoms and facilitate tracking symptoms over time and evaluate treatment effectiveness. This study may provide valuable insights into the research topic and inform future research.

Ethics and dissemination

This study has received ethical approval from the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (2024-087-KY).

Trial registration

Registered with ClinicalTrials.gov (NCT06506240) on July 11, 2024.

查看原文本刊更多论文

针灸与非穿透性假针灸治疗老年性瘙痒的疗效和安全性：随机对照试验的基本原理和设计

背景：老年性瘙痒症（老年性瘙痒症，SP）以特发性瘙痒为特征，发生于60岁及以上无原发皮肤病变的个体，显著影响睡眠和生活质量。需要有效的替代疗法。针灸已被认为是一种潜在的干预措施，以减轻瘙痒；然而，它在管理SP方面的作用仍不确定。本研究旨在评估针灸治疗SP的有效性和安全性。方法本研究为单中心、平行、双臂、随机、假对照试验，将200例确诊为SP的患者按1:1的比例分为针灸组和假针灸组，每周接受针灸或假针灸治疗3次，持续6周。参与者、结果评估者和统计学家将采用盲法。主要结果是第6周平均瘙痒数值评定量表（AP-NRS）评分较基线的变化。次要结局包括AP-NRS（在其他时间点）、峰值瘙痒数值评定量表（PP-NRS）、抓痕发作次数、体表瘙痒面积、总体皮肤干燥评分（ODS）、皮肤病生活质量指数（DLQI）、匹兹堡睡眠质量指数（PSQI）、医院焦虑和抑郁量表（HADS）和患者整体变化印象（PGIC）的变化。针灸的长期效果也将被探讨。不良事件和额外的治疗将在整个研究期间进行监测。修改意向治疗（mITT）人群，包括完成基线评估并接受至少一次治疗的参与者将被分析。本试验是首个严格设计、单中心、随机、假对照的研究，旨在评估针灸治疗老年性瘙痒的疗效和安全性。我们使用了有效的结果测量，可以提供对患者症状的有价值的见解，并便于跟踪症状并评估治疗效果。本研究可为研究课题提供有价值的见解，并为未来的研究提供参考。伦理与传播本研究已获得中国中医科学院广安门医院伦理委员会（2024-087-KY）的伦理批准。试验注册于2024年7月11日在ClinicalTrials.gov （NCT06506240）注册。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.