Acupuncture for Residual Dizziness After Successful Repositioning Maneuvers in Patients with Benign Paroxysmal Positional Vertigo: Study Protocol for a Randomized Noninferiority Trial.

IF 0.8 Q4 INTEGRATIVE & COMPLEMENTARY MEDICINE
Medical Acupuncture Pub Date : 2024-08-21 eCollection Date: 2024-08-01 DOI:10.1089/acu.2023.0135
Yu Xia, Jingchao Sun, Kun Dai, Fuqiang Sun, Zhe Ren, Bin Cheng
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引用次数: 0

Abstract

Introduction: Benign paroxysmal positional vertigo (BPPV) is the most common cause of peripheral vertigo among adults. Successful treatment often requires an appropriate canalith repositioning procedure (CRP), which has proven effective in the treatment of BPPV. However, some patients experience residual dizziness (RD) after CRP, affecting their daily activities and quality of life. Although oral betahistine is a common clinical treatment for RD, some patients may discontinue this medication due to adverse effects. Conversely, acupuncture has demonstrated efficacy in treating dizziness with minimal adverse effects. However, to date, no trials have directly compared the efficacy of acupuncture and betahistine in treating RD. Our goal was to assess the noninferiority of acupuncture in treating RD compared with the commonly used oral betahistine treatment.

Methods and analysis: A randomized, controlled, non-inferiority trial was conducted to compare the effectiveness of acupuncture and betahistine in patients with BPPV who experience RD after a successful CRP. Eighty-four participants were randomly assigned to two treatment groups, each receiving either acupuncture or betahistine. The assessors and statisticians were blinded to treatment allocation. The primary outcomes were the response rate and change in vertigo level, and secondary outcomes included Visual Analog Scores and the presence and change in depressive symptoms among patients. Scale measures were recorded at baseline, 2, 4, and 12 weeks after randomization. This trial aims to provide causal evidence supporting the non-inferiority of acupuncture therapy relative to oral betahistine, offering an alternative treatment avenue for patients intolerant to betahistine.

Ethics and dissemination: Ethics approval was obtained from the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, with permission number 2023-095-KY. Written informed consent was obtained from the enrolled patients.

针灸治疗良性阵发性位置性眩晕患者成功复位后的残余眩晕:随机非劣效试验的研究方案。
简介良性阵发性位置性眩晕(BPPV)是成人周围性眩晕最常见的原因。成功的治疗通常需要进行适当的椎管复位术(CRP),该疗法已被证明对治疗良性阵发性位置性眩晕有效。然而,一些患者在接受椎管复位术后会出现残余眩晕(RD),影响其日常活动和生活质量。虽然口服倍他司汀是治疗 RD 的常用临床方法,但一些患者可能会因不良反应而停止用药。相反,针灸在治疗头晕方面疗效显著,且不良反应极小。然而,迄今为止,还没有试验直接比较过针灸和倍他司汀治疗 RD 的疗效。我们的目标是评估针灸治疗 RD 与常用的口服倍他司汀治疗相比的非劣效性:我们进行了一项随机对照非劣效性试验,比较针灸和倍他司汀对成功接受 CRP 后出现 RD 的 BPPV 患者的疗效。84名参与者被随机分配到两个治疗组,每组接受针灸或倍他司汀治疗。评估人员和统计人员对治疗分配双盲。主要结果是反应率和眩晕程度的变化,次要结果包括视觉模拟评分和患者抑郁症状的存在和变化。量表测量在基线、随机分配后 2 周、4 周和 12 周进行记录。该试验旨在提供支持针灸疗法相对于口服倍他司汀无劣效的因果证据,为不能耐受倍他司汀的患者提供另一种治疗途径:本研究获得了山东中医药大学附属医院的伦理批准,批准号为2023-095-KY。已获得入组患者的书面知情同意。
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
Medical Acupuncture
Medical Acupuncture INTEGRATIVE & COMPLEMENTARY MEDICINE-
CiteScore
1.80
自引率
18.20%
发文量
73
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