Brian Lee James1, John Welch2, Clint Williamson1,2. 1. 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. 2. 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.
Abstract
Expression of Concern: Medical Acupuncture issues an Expression of Concern 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. Objective: 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. Materials and Methods: 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. Results: 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. Conclusions: 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. Copyright 2021, Mary Ann Liebert, Inc., publishers.
Expression of Concern: Medical Acupuncture issues an Expression of Concern 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. Objective: 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. Materials and Methods: 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. Results: 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. Conclusions: 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. Copyright 2021, Mary Ann Liebert, Inc., publishers.
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