两种自我指压用于乳腺癌患者癌症相关持续疲劳的随机临床试验
疲劳是乳腺癌常见并令人虚弱的晚期反应,与失眠和生活质量下降相关,疗法仍然有限。在既往小型研究中,指压可以减轻疲劳,但是还需严格临床试验。
指压(中医又称指针疗法、穴位按压)是以指代针对腧穴进行按压以治疗疾病的方法。
2016年7月7日,《美国医学会杂志肿瘤学分册》在线发表密歇根大学安娜堡分校、密歇根州立大学、安娜堡老年医学研究教育临床中心的随机临床试验报告,调查了6周2种自我指压对比常规治疗能否改善乳腺癌患者的疲劳、睡眠、生活质量,并确定停止指压4周期间的疗效是否持续。
该Ⅲ期随机单盲临床试验于2011年3月1日~2014年10月31日从密歇根肿瘤登记数据库入组女性,随机分组(1∶1∶1)进行6周每天自我放松指压、刺激指压或常规治疗。主要结局指标为第0、6、10周简易疲劳量表评分的变化,次要分析睡眠(匹兹堡睡眠质量指数)和生活质量(长期生活质量工具)。
结果从424例已经完成癌症治疗至少12个月的0~III期乳腺癌患者中,筛选出288例进行随机分组,其中270例进行放松指压(94例)、刺激指压(90例)或常规治疗(86例)。1例女性由于腧穴青肿而退出。
当第6周结束治疗时,放松指压、刺激指压、常规治疗的恢复正常疲劳水平者(简易疲劳量表评分<4)分别占66.2%(49/74)、60.9%(42/70)、31.3%(26/84)。
停止治疗4周,到第10周时,放松指压、刺激指压、常规治疗的保持正常疲劳水平者分别占56.3%(40/71)、60.9%(42/69)、30.1%(25/83)。2种指压在任一时间点均无显著差异。
与常规治疗相比,放松指压(而非刺激指压)第6周(而非第10周)显著改善睡眠质量,第6周和第10周显著改善生活质量。
因此,与常规治疗相比,2种自我指压均显著减轻持续疲劳,但是仅有放松指压对睡眠质量和生活质量有显著影响。放松指压为控制症状提供了一种可能的低成本选择。
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JAMA Oncol. 2016 Jul 7. [Epub ahead of print]
Investigation of 2 Types of Self-administered Acupressure for Persistent Cancer-Related Fatigue in Breast Cancer Survivors: A Randomized Clinical Trial.
Suzanna M. Zick, Ananda Sen, Gwen K. Wyatt, Susan L. Murphy, J. Todd Arnedt, Richard E. Harris.
University of Michigan, Ann Arbor; Michigan State University, East Lansing; Geriatric Research, Education and Clinical Center, Ann Arbor, Michigan.
IMPORTANCE: 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.
OBJECTIVES: 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.
INTERVENTIONS: Randomization (1:1:1) to 6 weeks of daily self-administered relaxing acupressure, stimulating acupressure, or usual care.
MAIN OUTCOMES AND MEASURES: 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).
RESULTS: 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.
CONCLUSIONS AND RELEVANCE: 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.
Trial Registration: clinicaltrials.gov Identifier: NCT01281904
DOI: 10.1001/jamaoncol.2016.1867