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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study.

ABSTRACT: Objective: The purpose of this study was to integrate acupuncture within the standard of care during outpatient opioid tapering and assess impact of this treatment on cumulative withdrawal symptoms, psychologic distress, and pain. Methods: This prospective randomized controlled pilot study administered the National Acupuncture Detoxification Association protocol following monthly opioid tapering. A total of 9 participants were randomized into the intervention group and compared with 6 participants who underwent the standard of care for outpatient opioid tapering. All providers prescribing medication management to both groups were blinded. Psychologic distress was evaluated using the hospital anxiety and depression scale (HADS). The clinical institute narcotic assessment (CINA) measured subjective withdrawal symptoms and pain was assessed using the numerical rating scale (NRS). Results: Overall anxiety appeared slightly higher in the acupuncture group (HADS 7.0 compared with 6.5), however, depression was lower when compared with the standard of care group (HADS 4.0 compared with 6.5). The standard of care group reported more intense withdrawal symptoms (CINA 9.0 compared with 3.5) as well as higher pain scores (NRS 6.5 compared with 5.0). There were no statistically significant differences among the standard of care and acupuncture groups. Conclusions: This study suggests that auricular acupuncture may be implemented within the standard of care for patients undergoing outpatient opioid weaning regimens. Although results were not statistically significant, they support future research and reveal a promising expansion of treatment options for patients physically dependent on opioid medication. Clinical Trials.gov ID: NCT02882048.

SUBMITTER: Jackson HJ

PROVIDER: S-EPMC8064932 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study.

Jackson Heather J HJ Walters Jenna J Raman Rameela R

Medical acupuncture 20210419 2

<b>Objective:</b> The purpose of this study was to integrate acupuncture within the standard of care during outpatient opioid tapering and assess impact of this treatment on cumulative withdrawal symptoms, psychologic distress, and pain. <b>Methods:</b> This prospective randomized controlled pilot study administered the National Acupuncture Detoxification Association protocol following monthly opioid tapering. A total of 9 participants were randomized into the intervention group and compared wit ...[more]

PMID: 33912273

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Project description:ImportanceThe overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain.ObjectiveTo investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery.Design, setting, and participantsThis parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged ≥18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization.InterventionsPatients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge.Main outcomes and measuresMain outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle.ResultsA total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription. Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventy-three patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled.Conclusions and relevanceThe findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery.Trial registrationClinicalTrials.gov Identifier: NCT04254679.

Project description: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.

Project description:BackgroundMany Gulf War (GW) Veterans report chronic symptoms including pain, fatigue, and cognitive impairment, commonly defined as Gulf War Illness (GWI). Complementary and integrative health (CIH) therapies may potentially improve multiple symptoms of GWI.ObjectiveTo examine the effectiveness of combining 2 commonly available CIH therapies, mindfulness meditation and auricular acupuncture, in improving health-related functioning and multiple symptom domains of GWI (e.g., pain, fatigue).MethodsThis study was a randomized controlled trial in which Veterans with GWI were randomly assigned to either the intervention group (n = 75), wherein they received 2 distinct CIH therapies - mindfulness meditation and auricular acupuncture, or the active control group, wherein they received a GW Health Education (GWHE) program (n = 74), each lasting 8 weeks. Self-report health measures were assessed at baseline, endpoint, and 3 month follow-up.ResultsIn the intention-to-treat analyses, there were significant between-group differences for mental-health related functioning, fatigue, depression symptoms, and Kansas total severity scores for symptoms in which the CIH group had improved scores for these outcomes at endpoint compared to the GWHE group (all P ≤ .05). The CIH group also had significant reductions in pain interference at endpoint and follow-up compared to baseline (estimated marginal mean difference: -2.52 and -2.22, respectively; all P = .01), whereas no significant changes were observed in the GWHE group. For pain characteristics, the GWHE group had a worsening of pain at endpoint compared to baseline (estimated marginal mean difference: +2.83; P = .01), while no change was observed in the CIH group.ConclusionFindings suggest a possible beneficial effect of combining 2 CIH therapies, mindfulness meditation and auricular acupuncture, in reducing overall symptom severity and individual symptom domains of fatigue, musculoskeletal, and mood/cognition in Veterans with GWI.Trial registrationClinical Trials identifier NCT02180243.

Project description:BackgroundObesity is an increasingly prevalent chronic condition that is associated with serious morbidity and mortality. Excess body weight is a risk factor contributing to diseases such as hypertension, heart disease, hypercholesterolaemia, diabetes mellitus, cerebrovascular disease, gall bladder disease, and some types of cancer. Almost all the Western anti-obesity drugs have adverse effects or body weight is regained upon cessation of therapy. Recent studies have found that acupuncture had a similar efficacy as the Western anti-obesity drugs with fewer reported adverse effects. However, these conclusions were limited due to the small sample size and low quality of methodologies of these studies. Therefore, we design this study to explore the effectiveness and safety of acupuncture on weight control.Methods/designThis is a pilot single-blinded, randomized, sham-controlled trial on acupuncture for body weight control. Seventy-two participants are randomly assigned to the acupuncture group or the control group. Tianshu (ST-25), Daheng (SP-15), Daimai (GB-26), Qihai (CV-6), Zhongwan (CV-12), Zusanli (ST-36), Fenglong (ST-40), and Sanyinjiao (SP-6) are selected as acupuncture points. For the acupuncture group, disposable acupuncture needles will be inserted at a depth of 10-25 mm into the points and electrical stimulation with dense-disperse waves at 50 Hz and 10 V will be applied on the abdominal points. The bodily needles will be retained for 30 minutes. For subjects assigned to the control group, Streitberger's non-invasive acupuncture needles will be applied to serve as the sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin instead of inserted. The duration of the treatment is 8 weeks with two sessions per week, and the follow-up period is 8 weeks. The primary outcome is the change in body weight before and after treatment. The secondary outcomes include changes in body mass index, waist circumference, hip circumference, and body fat percentage during the treatment and follow-up period.DiscussionThe study will compare the efficacy and safety of acupuncture with sham acupuncture on weight control, in the hope of obtaining evidence for utilizing acupuncture for body weight control.Trial registrationNCT02516878 . Registered on 30 July 2015.

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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study.

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Auricular Acupuncture to Facilitate Outpatient Opioid Weaning: A Randomized Pilot Study.

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