乳腺癌相关淋巴水肿的针灸治疗:一项随机试点研究。
Acupuncture Treatment for Breast Cancer-Related Lymphedema: A Randomized Pilot Study.
发表日期:2023 Apr 20
作者:
Rosie Friedman, Anna Rose Johnson, Kathy Shillue, Aaron Fleishman, Chris Mistretta, Leo Magrini, Bao Ngoc N Tran, Stanley G Rockson, Weidong Lu, Gloria Y Yeh, Dhruv Singhal
来源:
CYTOKINE & GROWTH FACTOR REVIEWS
摘要:
背景:对于与乳腺癌相关的淋巴水肿(BCRL),保守治疗方法在时间、费用和方便性方面都很费力。此外,许多患者不适合进行手术治疗。初步结果显示,针灸可能对BCRL患者有益。在这个小型试点研究中,我们检验了使用一系列标准化临床和患者中心性结果测量,对这种患者群进行针灸随机对照试验(RCT)的安全性和可行性。方法和结果:BCRL患者被随机分为针灸组(n=10)和对照组(n=4)。患者每两周在未受影响的肢体上接受一次针灸治疗,治疗持续6周。可行性定义为招募≥80%的人员,每人完成≥9次12次针灸会议,完成三次三次测量访问的≥75%。为了为未来的足够动力的RCT提供信息,我们描述了患者中心结果的组内变化,包括周长测量、生物阻抗谱、周长测量仪、细胞因子水平和患者生活质量。不断跟踪不良事件。14名患者完成了研究。其中接受针灸治疗的人数为10人,其中8人完成了所有12次针灸会议,2人完成了11次会议。93%的所有参与者完成了所有三次测量访问。手臂体积没有一致的改善。炎性标志物水平在两组中波动不一。所有接受针灸治疗的患者都显示出功能生活质量评分的改善。没有发生严重不良事件。结论:BCRL的针灸随机对照研究是可行的。这种针灸干预对这种人群是可接受的,在小样本中没有安全问题,值得进一步研究。
Background: Methods of conservative management for breast cancer-related lymphedema (BCRL) are burdensome in terms of time, cost, and convenience. In addition, many patients are not candidates for surgical treatment. Preliminary results have demonstrated possible beneficial effects of acupuncture for patients with BCRL. In this small pilot study, we examined the safety and feasibility of an acupuncture randomized control trial (RCT) in this patient cohort, utilizing a battery of standardized clinical and patient-centered outcome measures. Methods and Results: Patients with BCRL were randomized 2:1 to the acupuncture (n = 10) or the control (n = 4) group. Patients received acupuncture to the unaffected extremity biweekly for 6 weeks. Feasibility was defined as enrollment ≥80%, completion of ≥9 of 12 acupuncture sessions per person, and ≥75% completion of three of three measurement visits. To inform a future adequately powered RCT, we describe within-group changes in patient-centered outcomes, including circumferential measurements, bioimpedance spectroscopy, perometry, cytokine levels, and patient quality of life. Adverse events were systematically tracked. Fourteen patients completed the study. Of those who received acupuncture (n = 10), 8 completed all 12 acupuncture sessions, and 2 patients completed 11 sessions. Ninety-three percent of all participants completed all three measurement visits. There was no consistent improvement in arm volumes. Inflammatory marker levels had inconclusive fluctuations among both groups. All patients receiving acupuncture demonstrated an improvement in their functional quality-of-life score. No severe adverse events occurred. Conclusions: A randomized controlled study of acupuncture for BCRL is feasible. The acupuncture intervention is acceptable in this population, without safety concerns in a small sample and warrants further investigation.