早期乳腺癌化疗女性患者中，颅微电流刺激对抑郁、焦虑、疼痛、疲劳和睡眠障碍症状影响的随机假对照试验
Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer.
作者信息
Lyon Debra, Kelly Debra, Walter Jeanne, Bear Harry, Thacker Leroy, Elswick Ronald K
机构信息
Kirbo Endowed Chair, University of Florida College of Nursing, Gainesville, FL 32601 USA.
Virginia Commonwealth University School of Nursing, Richmond, Virginia USA.
出版信息
Springerplus. 2015 Jul 23;4:369. doi: 10.1186/s40064-015-1151-z. eCollection 2015.
PURPOSE
Women with breast cancer may experience symptoms of depression, anxiety, pain, fatigue and sleep disturbances during chemotherapy. However, there are few modalities that address multiple, commonly occurring symptoms that may occur in individuals receiving cancer treatment. Cranial electrical stimulation (CES) is a treatment that is FDA cleared for depression, anxiety and insomnia. CES is applied via electrodes placed on the ear that deliver pulsed, low amplitude electrical current to the head.
METHODS
This phase III randomized, sham-controlled study aimed to examine the effects of cranial microcurrent stimulation on symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Patients were randomly assigned to either an actual or sham device and used the device daily for 1 h. The study was registered at clinicaltrials.gov, NCT00902330.
RESULTS
The sample included N = 167 women with early-stage breast cancer. Symptom severity of depression, anxiety, and fatigue and sleep disturbances were generally mild to moderate. Levels of pain were low. Anxiety was highest prior to the initial chemotherapy and decreased over time. The primary outcome assessment (symptoms of depression, anxiety, fatigue, pain, sleep disturbances) revealed no statistically significant differences between the two groups, actual CES vs. sham.
CONCLUSION
In this study, women receiving chemotherapy for breast cancer experienced multiple symptoms in the mild to moderate range. Although there is no evidence for the routine use of CES during the chemotherapy period for symptom management in women with breast cancer, further symptom management modalities should be evaluated to mitigate symptoms of depression, anxiety, fatigue, pain and sleep disturbances over the course of chemotherapy.
目的
乳腺癌女性在化疗期间可能会出现抑郁、焦虑、疼痛、疲劳和睡眠障碍等症状。然而，针对癌症治疗患者中多种常见症状的治疗方法却很少。颅电刺激（CES）是一种经美国食品药品监督管理局（FDA）批准用于治疗抑郁、焦虑和失眠的疗法。CES通过置于耳部的电极进行，电极向头部传递脉冲式低幅电流。
方法
本III期随机、假对照研究旨在探讨颅微电流刺激对早期乳腺癌化疗女性抑郁、焦虑、疼痛、疲劳和睡眠障碍症状的影响。患者被随机分配至实际治疗设备组或假设备组，每天使用该设备1小时。该研究已在clinicaltrials.gov注册，注册号为NCT00902330。
结果
样本包括167名早期乳腺癌女性。抑郁、焦虑、疲劳和睡眠障碍的症状严重程度一般为轻度至中度。疼痛程度较低。初始化疗前焦虑程度最高，且随时间下降。主要结局评估（抑郁、焦虑、疲劳、疼痛、睡眠障碍症状）显示，实际CES组与假治疗组之间无统计学显著差异。
结论
在本研究中，接受乳腺癌化疗的女性出现了轻度至中度的多种症状。尽管没有证据表明在乳腺癌女性化疗期间常规使用CES来管理症状，但应评估进一步的症状管理方法，以减轻化疗过程中抑郁、焦虑、疲劳、疼痛和睡眠障碍的症状。
Zotero 插件