Department of Global Public Health and Korean Medicine Management, Graduate School.
Department of Preventive Medicine, College of Korean Medicine, Kyung Hee University, Seoul, Republic of Korea.
Medicine (Baltimore). 2021 Mar 19;100(11):e25107. doi: 10.1097/MD.0000000000025107.
Pharmacopuncture is a combination of acupuncture and herbal medicine, which involves the injection of herbal extracts into acupuncture points (acupoints). Pharmacopuncture has become one of the major therapeutic tools used in Korea; however, safety is one of the major concerns associated with it. We aim to systematically review clinical studies on the adverse events of pharmacopuncture in Korea.
To collect data on the incidence and characteristics of adverse events (AEs) and to evaluate pharmacopuncture safety, 2 or more researchers will conduct a comprehensive search of pertinent English and Korean databases using the keywords "pharmacopuncture" and "adverse events." Regardless of the participants' conditions or treatment types, we will include clinical studies on the AEs of pharmacopuncture. Studies that were not conducted in Korea, and acupoint injections containing Western medications, vitamins, or autologous serum will be excluded from this study. The severity of AEs will be classified using the common terminology criteria for adverse events, and the causality between pharmacopuncture and AEs will be assessed using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality scale. The quality of identifying and reporting the AEs will be assessed using the McHarm scale. The risk of selection bias will be assessed using the Cochrane risk of bias and the risk of bias for non-randomized studies tools. Studies will be assessed for heterogeneity utilizing Higgins's I2 statistics, and the risk of publication bias will be assessed and expressed in the form of a contour-enhanced funnel plot.
Comprehensive investigation of all types of clinical studies in Korea will provide clearer evidence of the safety of pharmacopuncture. The results of this study will be useful for traditional medical doctors and patients who use such treatments and interventions.Systematic Review Registration: Open Science Foundation (osf.io/umhyz).
穴位药物注射疗法是将草药提取物注射到穴位（穴位）中，将针灸和草药结合在一起的一种疗法。穴位药物注射疗法已成为韩国主要的治疗工具之一，但安全性是其主要关注点之一。我们旨在系统地审查韩国穴位药物注射疗法不良事件的临床研究。
为了收集有关不良事件（AE）发生率和特征的数据，并评估穴位药物注射疗法的安全性，将由 2 名或更多研究人员使用“穴位药物注射”和“不良事件”等关键词对相关的英文和韩文数据库进行全面搜索。无论参与者的病情或治疗类型如何，我们都将包括穴位药物注射疗法不良事件的临床研究。本研究将排除不在韩国进行的研究，以及含有西药、维生素或自体血清的穴位注射。AE 的严重程度将使用不良事件常用术语标准进行分类，穴位药物注射疗法与 AE 之间的因果关系将使用世界卫生组织-乌普萨拉监测中心（WHO-UMC）因果关系量表进行评估。AE 的识别和报告质量将使用 McHarm 量表进行评估。选择偏倚的风险将使用 Cochrane 偏倚风险和非随机研究工具进行评估。将使用 Higgins 的 I2 统计量评估研究之间的异质性，并以轮廓增强漏斗图的形式评估发表偏倚的风险并表示。
对韩国所有类型的临床研究进行全面调查，将为穴位药物注射疗法的安全性提供更清晰的证据。本研究的结果将对使用此类治疗和干预措施的传统医学医生和患者有用。系统评价注册：开放科学基金会（osf.io/umhyz）。
