在服务不足的多样化人群中进行针灸治疗心绞痛的可行性和初步疗效。
Feasibility and preliminary efficacy of acupuncture for angina in an underserved diverse population.
机构信息
School of Nursing, University of California, Los Angeles, Los Angeles, CA, USA.
Department of Biobehavioral Nursing Science, College of Nursing, University of Illinois Chicago, Chicago, IL, USA.
出版信息
Acupunct Med. 2022 Apr;40(2):152-159. doi: 10.1177/09645284211055754. Epub 2021 Dec 2.
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).
目的
稳定型心绞痛是指体力活动或情绪应激时出现的缺血性胸痛。尽管采用了指南指导的治疗，但多达 30%的患者疼痛缓解效果不佳。本研究的目的是：（1）确定针刺随机对照试验（RCT）的可行性和可接受性；（2）评估针刺在减轻疼痛、提高功能状态和健康相关生活质量（HRQoL）方面的初步疗效。
方法
稳定型心绞痛患者（≥1 个月）接受标准化针刺方案（每周 2 次，共 5 周）或对照方案（注意力控制）。测量指标包括麦吉尔疼痛问卷（平均疼痛强度（API）、现在疼痛）和西雅图心绞痛问卷-7（功能状态、症状和 HRQoL）。可行性定义为≥80%的招募率、≥75%的入组后保留率和≥80%的完成率。采用描述性统计和混合效应线性回归进行分析。
结果
样本（n=24）平均年龄为 59±12 岁，主要为女性（63%），代表少数族裔（8%白人、52%黑人、33%西班牙裔和 8%其他）。保留率为 79%，完成率为 89%，支持可行性。招募率（68%）略低于预期。针刺组的可接受性评分为 87.9%，对照组为 51.7%。针刺组与对照组相比，结果明显更好（API，b=-2.1（1.1），p=0.047；功能状态，b=27.6（7.2），p<0.001；HRQoL，b=38.8（11.9），p=0.001）。
结论和意义
针刺在我们的多样化样本中是可行和可接受的。我们略低于 80%的招募目标，但开始研究的参与者完成研究的可能性很高。针刺对稳定型心绞痛有一定疗效，但需要更大、充分有力的 RCT 来证实。
试验注册
NCT02914834（ClinicalTrials.gov）。
Zotero 插件