Holli A DeVon1, Glorieuse Uwizeye2, Hui Yan Cai3, Adhir R Shroff4, Joan E Briller4, Amer Ardati4, Debra Hoppensteadt5, Lauren Rountree1, Judith M Schlaeger6. 1. School of Nursing, University of California, Los Angeles, Los Angeles, CA, USA. 2. Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois Chicago, Chicago, IL, USA. 3. Department of Acupuncture and Oriental Medicine, National University of Health Sciences, Lombard, IL, USA. 4. Department of Cardiology, College of Medicine, University of Illinois Chicago, Chicago, IL, USA. 5. Department of Pathology and Pharmacology, Loyola University Medical Center, Maywood, IL, USA. 6. Department of Human Development Nursing Science, College of Nursing, University of Illinois Chicago, Chicago, IL, USA.
Abstract
PURPOSE: Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL). METHODS: Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis. RESULTS: The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p < 0.001; and HRQoL, b = 38.8 (11.9), p = 0.001). CONCLUSIONS AND IMPLICATIONS: Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT. TRIAL REGISTRATION NUMBER: NCT02914834 (ClinicalTrials.gov).
PURPOSE: Stable angina is ischemic chest pain on exertion or with emotional stress. Despite guideline-directed therapy, up to 30% of patients have suboptimal pain relief. The aims of this study were to: (1) determine the feasibility and acceptability of a randomized controlled trial (RCT) of acupuncture; and (2) evaluate preliminary efficacy of acupuncture with respect to reduction of pain and increased functional status and health-related quality of life (HRQoL). METHODS: Participants with stable angina for ⩾1 month received either a standardized acupuncture protocol, twice per week for 5 weeks, or an attention control protocol. Measures included the McGill Pain Questionnaire (average pain intensity (API), pain now) and the Seattle Angina Questionnaire-7 (functional status, symptoms, and HRQoL). Feasibility was defined as ⩾80% recruitment, ⩾75% retention following enrollment, and ⩾80% completion. Descriptive statistics and mixed-effects linear regression were used for analysis. RESULTS: The sample (n = 24) had a mean age of 59 ± 12 years, was predominantly female (63%), and represented minority groups (8% White, 52% Black, 33% Hispanic, and 8% Other). Feasibility was supported by 79% retention and 89% completion rates. The recruitment rate (68%) was slightly lower than expected. Acceptability scores were 87.9% for the acupuncture group and 51.7% for the control group. Outcomes were significantly better for the acupuncture versus control groups (API, b = -2.1 (1.1), p = 0.047; functional status, b = 27.6 (7.2), p < 0.001; and HRQoL, b = 38.8 (11.9), p = 0.001). CONCLUSIONS AND IMPLICATIONS: Acupuncture was feasible and acceptable in our diverse sample. We were slightly under the recruitment target of 80%, but participants who started the study had a high likelihood of completing it. Acupuncture shows promise for stable angina, but its effectiveness needs to be confirmed by a larger, adequately powered RCT. TRIAL REGISTRATION NUMBER: NCT02914834 (ClinicalTrials.gov).
Authors: J A Spertus; J A Winder; T A Dewhurst; R A Deyo; J Prodzinski; M McDonell; S D Fihn Journal: J Am Coll Cardiol Date: 1995-02 Impact factor: 24.094
Authors: Richard E Harris; Jon-Kar Zubieta; David J Scott; Vitaly Napadow; Richard H Gracely; Daniel J Clauw Journal: Neuroimage Date: 2009-06-06 Impact factor: 6.556
Authors: Hui Yan Cai; Alana D Steffen; Veronica Angulo; Adhir R Shroff; Joan E Briller; Debra Hoppensteadt; Heather A Pauls; Miho Takayama; Hiroyoshi Yajima; Nobuari Takakura; Judith Schlaeger; Glorieuse Uwizeye; Holli A DeVon Journal: JMIR Res Protoc Date: 2019-07-29