Division of Plastic and Reconstructive Surgery, Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.
Stanford Center for Lymphatic and Venous Disorders, Stanford University School of Medicine, Stanford, California, USA.
Lymphat Res Biol. 2023 Oct;21(5):488-494. doi: 10.1089/lrb.2022.0001. Epub 2023 Apr 20.
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. Patients with BCRL were randomized 2:1 to the acupuncture ( = 10) or the control ( = 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 ( = 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. 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.
方法的保守治疗乳腺癌相关淋巴水肿( BCRL )是负担沉重的时间,成本和方便。此外,许多患者不适合手术治疗。初步结果表明可能有益的影响针灸治疗患者的 BCRL 。在这个小的初步研究中,我们研究了安全性和可行性的针灸随机对照试验( RCT )在这一组患者,利用电池的标准化临床和以患者为中心的结果的措施。
患者的 BCRL 被随机分为 2 : 1 ,针灸( = 10 )或对照组( = 4 )组。患者接受针灸治疗的非影响肢双周 6 周。可行性被定义为登记≥ 80 % ,完成≥ 9的 12 次针灸会议,每个人和≥ 75 %完成三次三测量访问。为了通知一个未来的充分有力的 RCT ,我们描述的组内变化,以患者为中心的结果,包括圆周测量,生物阻抗光谱,围度,细胞因子水平和患者的生活质量。不良事件进行了系统的跟踪。 14 例患者完成了这项研究。那些接受针灸( = 10 ) , 8 完成所有 12 次针灸会议,和 2 名患者完成 11 次会议。 93 %的所有参与者完成所有三次测量访问。没有一致的改善手臂的体积。炎性标志物水平有不一致的波动,在两组。所有接受针灸治疗的患者表现出改善他们的功能生活质量评分。没有严重的不良事件发生。
一个随机对照研究针灸治疗 BCRL 是可行的。针灸干预是可以接受的,在这一人群中,没有安全问题,在一个小样本,并值得进一步研究。