Department of Family Medicine, University of Michigan, Ann Arbor2Department of Nutritional Sciences, University of Michigan, Ann Arbor.
Department of Family Medicine, University of Michigan, Ann Arbor3Department of Biostatistics, University of Michigan, Ann Arbor.
JAMA Oncol. 2016 Nov 1;2(11):1470-1476. doi: 10.1001/jamaoncol.2016.1867.
Fatigue is a common and debilitating late-term effect of breast cancer that is associated with poor sleep and decreased quality of life, yet therapies remain limited. Acupressure has reduced fatigue in previous small studies, but rigorous clinical trials are needed.
To investigate if 6 weeks of 2 types of self-administered acupressure improved fatigue, sleep, and quality of life vs usual care in breast cancer survivors and to determine if changes were sustained during a 4-week washout period.
DESIGN, SETTING, AND PARTICIPANTS: Phase 3 randomized, single-blind, clinical trial conducted from March 1, 2011, through October 31, 2014. Women were recruited from the Michigan Tumor Registry.
Randomization (1:1:1) to 6 weeks of daily self-administered relaxing acupressure, stimulating acupressure, or usual care.
The primary outcome was change in the Brief Fatigue Inventory score from baseline to weeks 6 and 10. Secondary analyses were sleep (Pittsburgh Sleep Quality Index) and quality of life (Long-Term Quality of Life Instrument).
A total of 424 survivors of stages 0 to III breast cancer who had completed cancer treatments at least 12 months previously were screened, and 288 were randomized, with 270 receiving relaxing acupressure (n = 94), stimulating acupressure (n = 90), or usual care (n = 86). One woman withdrew owing to bruising at the acupoints. At week 6, the percentages of participants who achieved normal fatigue levels (Brief Fatigue Inventory score <4) were 66.2% (49 of 74) in relaxing acupressure, 60.9% (42 of 70) in stimulating acupressure, and 31.3% (26 of 84) in usual care. At week 10, a total of 56.3% (40 of 71) in relaxing acupressure, 60.9% (42 of 69) in stimulating acupressure, and 30.1% (25 of 83) in usual care continued to have normal fatigue. At neither time point were the 2 acupressure groups significantly different. Relaxing acupressure, but not stimulating acupressure, showed significant improvements in sleep quality compared with usual care at week 6, but not at week 10. Only relaxing acupressure significantly improved quality of life vs usual care at weeks 6 and 10.
Both acupressure arms significantly reduced persistent fatigue compared with usual care, but only relaxing acupressure had significant effects on sleep quality and quality of life. Relaxing acupressure offers a possible low-cost option for managing symptoms.
clinicaltrials.gov Identifier: NCT01281904.
疲劳是乳腺癌晚期常见且使人虚弱的一种影响，与睡眠质量差和生活质量下降有关，但目前的治疗方法仍然有限。在之前的小型研究中，穴位按压已减轻了疲劳，但仍需要严格的临床试验。
探究 6 周的 2 种自我实施的穴位按压（放松型和刺激型）是否比常规护理更能改善乳腺癌幸存者的疲劳、睡眠和生活质量，并确定在 4 周的洗脱期内这些变化是否能持续。
设计、地点和参与者：2011 年 3 月 1 日至 2014 年 10 月 31 日进行的 3 期随机、单盲、临床试验。从密歇根肿瘤登记处招募了女性参与者。
随机（1:1:1）接受 6 周的日常自我实施的放松型穴位按压、刺激型穴位按压或常规护理。
主要结局是从基线到第 6 周和第 10 周时简要疲劳量表评分的变化。次要分析包括睡眠（匹兹堡睡眠质量指数）和生活质量（长期生活质量量表）。
共有 424 名处于 0 至 III 期的乳腺癌幸存者接受了筛查，这些幸存者在之前至少完成了 12 个月的癌症治疗，其中 288 名被随机分组，270 名接受了放松型穴位按压（n=94）、刺激型穴位按压（n=90）或常规护理（n=86）。1 名女性因穴位处瘀伤而退出。在第 6 周时，达到正常疲劳水平（简要疲劳量表评分<4）的参与者百分比分别为：放松型穴位按压组 66.2%（74 名中的 49 名）、刺激型穴位按压组 60.9%（70 名中的 42 名）和常规护理组 31.3%（84 名中的 26 名）。在第 10 周时，放松型穴位按压组的总共有 56.3%（71 名中的 40 名）、刺激型穴位按压组的 60.9%（69 名中的 42 名）和常规护理组的 30.1%（83 名中的 25 名）继续保持正常的疲劳水平。在任何时间点，2 个穴位按压组之间均无显著差异。与常规护理相比，放松型穴位按压而非刺激型穴位按压在第 6 周时显著改善了睡眠质量，但在第 10 周时则没有。只有放松型穴位按压在第 6 周和第 10 周时显著改善了生活质量。
与常规护理相比，两种穴位按压组都显著减轻了持续性疲劳，但只有放松型穴位按压对睡眠质量和生活质量有显著影响。放松型穴位按压为管理这些症状提供了一种可能的低成本选择。
clinicaltrials.gov 标识符：NCT01281904。
