摘要
目的:评价气功治疗纤维肌痛综合征的疗效及安全性。方法:纳入气功治疗纤维肌痛综合征的随机对照试验(RCT)。检索中国生物医学文献数据库(SinoMed)、国家知识基础设施数据库(CNKI)、中文科技期刊数据库(CCCD)、中国学术期刊数据库(CSPD)、PubMed、EMBASE、Cochrane Library、中国临床试验注册库。检索时间从建库至2019年7月10日,无语种限制。使用Cochrane风险评估工具进行文献质量评价并使用RevMan 5.3软件进行Meta分析,二分类变量采用相对危险度(RR)分析,连续性变量采用均差(MD)或标准化均差(SMD),均给出95%置信区间(CI)。根据GRADE证据分级标准进行证据级别评价。结果:共纳入10项RCT涉及542名受试者。有3项中文和7项英文研究。10项研究的方法学偏倚风险较高,且方法学质量整体较低。在疼痛改善方面,气功组优于假气功(假气功:其肢体动作与气功一样,但没有冥想和口诀,并且在运动过程中自我呼吸不需要与肢体动作协调一致)组(SMD=-1.44,95%CI=-2.77,-0.11)和有氧运动组(SMD=0.96,95%CI=0.10,1.81),气功联合药物组(包括中药和西药)的疗效优于药物组(MD=-8.94,95%CI=-15.69,-2.19);在生命质量改善方面,气功组优于假气功组(SMD=-1.83,95%CI=-3.27,-0.39)和有氧运动组(SMD=0.98,95%CI=0.13,1.84),气功联合药物组与药物组疗效相当(MD=-3.98,95%CI=-10.93,2.97)。生命质量采用FIQ、SF-36、CHAQ、QOML、WHOQOL-BREF量表测评。仅1项研究报告了习练气功相关的不良事件(右肩疼痛1例,足底筋膜炎1例)。GRADE分析显示为低确定性证据。结论:气功在改善纤维肌痛综合征患者的疼痛和生命质量方面可能具有潜在疗效,且比较安全。但研究设计的方法学质量较差、研究数目较少,未来仍需更多设计严谨、多中心、大样本的RCT来进一步验证气功的疗效。
Objective:To evaluate the effects and safety of Qigong for fibromyalgia syndrome.Methods:Randomized controlled trial of Qigong for fibromyalgia syndrome was included.Chinese Biomedical Literature Database,China National Knowledge Infrastructure,Chinese Scientific Journal Database,Chinese Academic Conference Papers Database and Chinese Dissertation Database,PubMed,the Cochrane Library,Clinical Trials and Clinical trials in China.All databases were searched from inception to 10,July 2019 without language restrictions.The Cochrane risk assessment(risk of bias,ROB)tools were used for quality evaluation of the studies and Rev Man 5.3 software was used for meta-analysis,Binary variables were analyzed by relative risk(RR),and continuous variables were analyzed by mean difference(MD)or standardized mean difference(SMD),with 95%confidence intervals(CI).We evaluated the quality of evidence according to the GRADE(“grades of recommendations assessment,development and evaluation”)evidence grading standards.Results:A total of 10 RCT with 542 participants were included.There are 3 Chinese and 7 English studies.The risk of methodological bias in the 10 studies is high,and the methodological quality was low.In terms of pain improvement,Qigong group was better than sham Qigong(sham Qigong:The body movements are the same as Qigong,but there is no meditation and formula,and self-breathing do not need to be coordinated with body movements during exercise)and aerobic exercise(SMD=-1.44,95%CI=-2.77 to-0.11])and(SMD=0.96,95%CI=0.10 to 1.81]),Qigong combined with drug group(including Chinese medicine and western medicine)was more effective than the drug group(MD=-8.94,95%CI=-15.69 to-2.19]);In terms of quality of life improvement,Qigong group was superior to sham Qigong and aerobic exercise(SMD=-1.83,95%CI=-3.27 to-0.39])and(SMD=0.98,95%CI=0.13 to 1.84]);Qigong combination drug group had the same effect as the drug group(MD=-3.98,95%CI=-10.93 to 2.97]);FIQ,SF-36,CHAQ,QOML,WHOQOL-BREF scale were used to evaluate the quality of life.Only one study reported adverse event related to practicing Qigong(one right shoulder pain and a patient′s foot fasciitis).GRADE analysis showed low-level evidence for Qigong for fibromyalgia syndrome.Conclusion:This evidence suggests that Qigong may have potential efficacy in reducing pain and improving quality of life in patients with fibromyalgia,and it is relatively safe.However,its methodological quality was low,and the number of studies was small.In the future,more RCT with strict design and large samples are needed to further verify the efficacy and safety of Qigong for fibromyalgia syndrome.
作者
张亚鹏
来保勇
胡瑞学
梁士兵
刘建平
ZHANG Yapeng;LAI Baoyong;HU Ruixue;LIANG Shibing;LIU Jianping(Centre for Evidence-Based Chinese Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;The 3nd Affiliated Hospital of Beijing Universality of Chinese Medicine,Beijing 100029,China;Center of Evidence Based Traditional Chinese Medicine,Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《世界中医药》
CAS
2021年第24期3615-3623,共9页
World Chinese Medicine
基金
国家自然科学基金项目(81830115)——基于整体观和辨证论治复杂干预的中医疗效评价关键技术和结局指标研究。
