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.
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.
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DOI：
10.1186/s40064-015-1151-z
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发表时间：
2015
期刊：
影响因子：
--
通讯作者：
Elswick RK
中科院分区：
文献类型：
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作者：
Lyon D;Kelly D;Walter J;Bear H;Thacker L;Elswick RK
患有乳腺癌的女性在化疗期间可能会出现抑郁、焦虑、疼痛、疲劳和睡眠障碍的症状。然而，很少有方法可以解决接受癌症治疗的个体可能出现的多种常见症状。颅脑电刺激 (CES) 是 FDA 批准的一种治疗抑郁、焦虑和失眠的疗法。 CES 通过放置在耳朵上的电极来施加，该电极向头部传送脉冲、低幅度电流。这项 III 期随机、假对照研究旨在检查颅微电流刺激对接受早期乳腺癌化疗的女性抑郁、焦虑、疼痛、疲劳和睡眠障碍症状的影响。患者被随机分配使用真实设备或假设备，并每天使用该设备 1 小时。该研究已在 ClinicalTrials.gov 注册，NCT00902330。该样本包括 167 名患有早期乳腺癌的女性。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。焦虑在初始化疗前最高，并随着时间的推移而减少。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 与假手术组之间没有统计学上的显着差异。在这项研究中，接受乳腺癌化疗的女性出现了多种轻度至中度症状。尽管没有证据表明在乳腺癌女性化疗期间常规使用CES进行症状管理，但应评估进一步的症状管理方式，以减轻化疗过程中的抑郁、焦虑、疲劳、疼痛和睡眠障碍症状。本文的在线版本 (doi:10.1186/s40064-015-1151-z) 包含补充材料，可供授权用户使用。
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. 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. 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. 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. The online version of this article (doi:10.1186/s40064-015-1151-z) contains supplementary material, which is available to authorized users.