急性高山症患者使用电拇指针的安全性和有效性:随机、单盲和安慰剂对照研究方案。

IF 3.3 2区 医学 Q1 INTEGRATIVE & COMPLEMENTARY MEDICINE
Xin Wang, GuangJun Wang, ShuYong Jia, Labasangzhu Labasangzhu, Zirong Wang, Jia Liu
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引用次数: 0

摘要

背景:急性高山反应(AMS)被认为是最常见的高原病。急性高山反应会损害快速攀登高山的游客的健康,也会影响到到高原工作或求学的人的表现。针灸作为一种简单、安全、有效的非药物治疗方法,已被证明可以改善高山反应。目前还没有研究证实电拇趾针能有效改善 AMS 患者的症状。在本研究中,我们将进行一项随机对照试验,以评估电拇趾针对 AMS 患者的临床疗效和安全性。我们的假设是,电拇趾针治疗急性髓系白血病患者是安全有效的:本研究是一项单中心、随机、单盲和安慰剂对照研究,至少有 114 名确诊为急性髓系阻塞症的患者参与。参与者按 1:1 的比例随机分配到电拇趾针组和假针灸组。治疗方案包括刺激七个预定义的穴位,包括中脘(RN12)、双侧内关(PC6)、双侧合谷(LI4)和双侧太阳穴(EX-HN5),每个穴位刺激约一分钟,持续施针 48 小时。主要结果是治疗 48 小时后 2018 年路易斯湖评分(LLS)的改善情况。次要结果指标包括中重度AMS(AMS>5)和AMS参与者的发生率、LLS、头痛视觉模拟量表、临床功能评分、格罗宁根睡眠质量调查、斯坦福昏睡量表、血压、血氧饱和度和心率,此外还记录了与治疗相关的不良事件:本试验旨在确定ETN在缓解高海拔地区急性呼吸系统综合征症状方面的疗效,从而为传统医学,尤其是针灸在高海拔地区的应用提供证据基础:试验注册:中国临床试验注册中心:ChiCTR2300073882。注册日期:2023年7月24日。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Safety and efficacy of electro-thumbtack needle for acute mountain sickness patients: a protocol of a randomized, single-blinded, and placebo-controlled study.

Background: Acute mountain sickness (AMS) is considered the most common altitude sickness. It can be detrimental to the health of tourists who rapidly ascend high mountains, and can also impair the performance of individuals who move to the plateau for work or education. Acupuncture has been shown to improve AMS as a simple, safe, and effective nonpharmacological method, in case electro-thumbtack needle (ETN) is a more convenient form of acupuncture for both doctor and patient. There are no studies validating the effectiveness of electro-thumbtack needle in improving symptoms in participants with AMS. In this study, we will conduct a randomized controlled trial to evaluate the clinical efficacy and safety of electro-thumbtack needle in participants with AMS. Our hypothesis is that electro-thumbtack needle is safe and effective in treating participants with AMS.

Methods: This study is a single-center, randomized, single-blinded, and placebo-controlled study involving at least 114 participants who were diagnosed with AMS. The participants randomly assigned in a 1:1 ratio to the electro-thumbtack needle group and the sham acupuncture group. The treatment protocol involved stimulation of seven predefined acupuncture points, including Zhong Wan (RN12), bilateral Nei Guan (PC6), bilateral He Gu (LI4), and bilateral Tai Yang (EX-HN5), for approximately one minute each, with continuous application over 48 h. The primary outcome was improvement in 2018 Lake Louise score (LLS) after 48 h of treatment. Secondary outcome indicators included the incidence of participants with moderate-to-severe AMS (AMS > 5)and AMS, the LLS, visual analogue scale of headache, clinical functioning scores, the Groningen Sleep Quality Survey, the Stanford Somnolence Scale, blood pressure, oxygen saturation, and heart rate, in addition to treatment-related adverse events were also captured.

Discussion: This trial aims to ascertain the therapeutic benefits of ETN in mitigating AMS symptoms, thereby contributing to the evidence base for traditional medical practices, particularly acupuncture, in high-altitude medicine.

Trial registration: Chinese Clinical Trials Registry: ChiCTR2300073882. Registered on 24 July 2023.

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来源期刊
BMC Complementary Medicine and Therapies
BMC Complementary Medicine and Therapies INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
6.10
自引率
2.60%
发文量
300
审稿时长
19 weeks
期刊介绍:
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