Li Xue, Wang Xueqian, Song Lijun, Tian Jiayue, Ma Xuejiao, Mao Qiyuan, Lin Hongsheng, Zhang Ying
Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences.
School of Graduates, Beijing University of Chinese Medicine, Beijing, China.
Medicine (Baltimore). 2020 Nov 6;99(45):e23016. doi: 10.1097/MD.0000000000023016.
Cancer-related fatigue (CRF) is one of the most common and disabling outcomes in patients with breast cancer (BC). Traditional Chinese medicine (TCM) nonpharmacological interventions are becoming increasingly popular for cancer treatment and rehabilitation interventions. However, their efficacy and safety remain unclear and there is no systematic review or meta-analysis focusing fully on this issue. We aim to evaluate the effects of representative TCM nonpharmacological interventions, including Qigong, Tai Chi, acupuncture, and Tuina, on CRF in BC patients.
Published randomized controlled trials (RCTs) that assessed the efficacy of these interventions on CRF for BC patients will be included. We will search from the following electronic databases: PubMed, Cochrane Library, EMBASE, MEDLINE, Web of Science, Scopus, PsycINFO, PSYINDEX, CINAHL, China National Knowledge Infrastructure (CNKI), WanFang Database, and Chinese Biomedical Literature Database (CBM). The primary outcomes are the improvement of CRF, which will be evaluated by the Piper Fatigue Scale (PFS), the Functional Assessment of Cancer Therapy (FACT)-Fatigue Scale, Schwartz Cancer Fatigue Scale (SCFS), the Multidimensional Fatigue Inventory (MFI). The secondary outcomes are quality of life and safety. The meta-analysis will be performed using RevMan ver 5.3(Cochrane) statistical software.
We will provide more practical results investigating the efficacy of Qigong, Tai Chi, acupuncture, Tuina for BC patients with CRF from several respects including the improvement of fatigue, quality of life, and safety.
This review will generate more stronger evidence in BC patients for TCM nonpharmacological interventions, including Qigong, Tai Chi, acupuncture, Tuina, in the treatment of CRF and help to inform clinicians and policymakers.
Ethical approval is not necessary because all of the study base in our review will be based on published research. We will submit our results to a peer-reviewed journal.
The study is priorly registered through International Platform of Registered Systematic Review and Meta-analysis Protocol on October 2, 2020 (INPLASY 2020100003).
癌症相关疲劳(CRF)是乳腺癌(BC)患者最常见且致残的后果之一。中医非药物干预在癌症治疗和康复干预中越来越受欢迎。然而,其疗效和安全性仍不明确,且尚无全面聚焦于此问题的系统评价或荟萃分析。我们旨在评估包括气功、太极拳、针灸和推拿在内的代表性中医非药物干预对BC患者CRF的影响。
将纳入已发表的评估这些干预对BC患者CRF疗效的随机对照试验(RCT)。我们将从以下电子数据库进行检索:PubMed、Cochrane图书馆、EMBASE、MEDLINE、科学引文索引、Scopus、PsycINFO、PSYINDEX、护理学与健康照护领域数据库、中国知网、万方数据库和中国生物医学文献数据库(CBM)。主要结局是CRF的改善情况,将通过派珀疲劳量表(PFS)、癌症治疗功能评估(FACT)-疲劳量表、施瓦茨癌症疲劳量表(SCFS)、多维疲劳量表(MFI)进行评估。次要结局是生活质量和安全性。将使用RevMan 5.3版(Cochrane)统计软件进行荟萃分析。
我们将从多个方面,包括疲劳改善、生活质量和安全性等,提供更具实用性的结果,以研究气功、太极拳、针灸、推拿对BC合并CRF患者的疗效。
本综述将为中医非药物干预(包括气功、太极拳、针灸、推拿)治疗BC患者的CRF提供更有力的证据,并有助于为临床医生和政策制定者提供参考。
无需伦理批准,因为我们综述中的所有研究基础均基于已发表的研究。我们将把研究结果提交给同行评审期刊。
本研究于2020年10月2日通过国际注册系统评价和荟萃分析方案平台进行了预注册(INPLASY 2020100003)。