James Brian Lee, Welch John, Williamson Clint
Department of Pain Management, Pain Clinic, Chillicothe Veterans Affairs Medical Center, Chillicothe, OH, USA, and the Heritage College of Osteopathic Medicine, Ohio University, Athens, OH, USA.
Medical-Surgical Care Line, Pain Clinic, Chillicothe Veterans Affairs Medical Center, Chillicothe, OH, USA, and the Heritage College of Osteopathic Medicine, Ohio University, Athens, OH, USA.
Med Acupunct. 2021 Oct 1;33(5):349-352. doi: 10.1089/acu.2021.0007. Epub 2021 Oct 18.
issues an pertaining to a published article in the October 2021 issue of the journal entitled, "Self-Administration of Auricular Acupuncture in Rural Veterans with Chronic Pain: A Pilot Project," by Brian Lee James, John Welch, and Clint Williamson. (Med Acupunct 33(5):2021.349-352; doi: 10.1089/acu.2021.0007) The journal has received communications from several sources raising significant concerns regarding the claims made in this article as they pertain to the self-administration of Battlefield Acupuncture and patient self-use of acupuncture needles. Each communication states that acupuncture needles are considered FDA-approved medical equipment and are not intended for patient self-administration. An official inquiry with the authors' institution has been launched by the editors and publisher of the journal. Such an inquiry may be a protracted process but the journal will update this notice once a resolution has been reached. There has been little research on self-administration of auricular acupuncture by patients. This study was conducted to assess the safety and feasibility of self-administration of Battlefield Acupuncture (BFA) with semipermanent needles at intervals of 2 weeks over a timeperiod of 6 months. This study was conducted at the Chillicothe Veterans Affairs Medical Center, Chillicothe, OH, USA, and its satellite Community-Based Outpatient Clinics in Ohio. The participants were 12 healthy veteran volunteers (10 males and 2 females) who previously had repeated good responses to BFA administration by a provider. Outcomes of treatment-emergent adverse events and subjective perception of pain relief, compared with provider-administered BFA, were collected telephonically every 2 weeks for 6 months. No treatment-emergent adverse events were reported by any participant over a 6-month time period. Of 12 participants,10 (83%) were able to perform BFA on themselves reliably after a didactic session. Pain relief from self-administration experienced by participants was comparable to that experienced when administered by a provider. In this small pilot study, self-administration of BFA was safe and effective for individuals who had previously received repeated benefit from provider-administered BFA. The contents do not represent the views of the U.S. Department of Veterans Affairs or the United States Government. This research is registered at ClinicalTrials.gov as NCT #: NCT04208659.
针对布莱恩·李·詹姆斯、约翰·韦尔奇和克林特·威廉姆森发表在2021年10月《医学针灸》杂志上的一篇题为《农村慢性疼痛退伍军人耳针自我管理：一项试点项目》的文章（《医学针灸》33(5):2021.349 - 352；doi: 10.1089/acu.2021.0007）所引发的问题。该杂志收到了来自多个渠道的来信，对本文中关于战场针灸自我管理以及患者自行使用针灸针的说法提出了重大关切。每封来信都指出，针灸针被视为美国食品药品监督管理局（FDA）批准的医疗设备，并非供患者自行使用。该杂志的编辑和出版商已对作者所在机构展开正式调查。这样的调查可能是一个漫长的过程，但一旦达成解决方案，杂志将更新此通知。关于患者耳针自我管理的研究很少。本研究旨在评估每隔2周使用半永久性针进行战场针灸（BFA）自我管理6个月的安全性和可行性。本研究在美国俄亥俄州奇利科西市的奇利科西退伍军人事务医疗中心及其在俄亥俄州的卫星社区门诊诊所进行。参与者为12名健康的退伍军人志愿者（10名男性和2名女性），他们之前接受提供者进行的BFA治疗时反应良好。与提供者实施的BFA相比，在6个月内每2周通过电话收集治疗中出现的不良事件结果以及疼痛缓解的主观感受。在6个月的时间段内，没有参与者报告治疗中出现的不良事件。12名参与者中，10名（83%）在经过培训课程后能够可靠地自行进行BFA。参与者自行进行BFA所体验到的疼痛缓解与由提供者实施时相当。在这项小型试点研究中，对于之前从提供者实施的BFA中反复受益的个体，BFA自我管理是安全有效的。本文内容不代表美国退伍军人事务部或美国政府的观点。本研究已在ClinicalTrials.gov注册，编号为NCT #: NCT04208659。
