近十年针刺治疗腰痛的国内外指南与临床研究现状分析
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摘要
目的了解针刺治疗腰痛在国内外相关指南中的推荐情况及临床研究现状,为开展针刺临床研究和积累临床证据提供思路与方法。方法检索Medline、EMBASE、Cochrane library、中国知网、Sinomed、维普、万方及中国临床指南文库、英国国家临床优化研究所(NICE)、美国国家指南库(NGC)、苏格兰校际指南网络(SIGN)、新西兰指南研究组(NZGG)、加拿大医学会临床指南库(CMACPG)、国际指南网络(GIN),分析2008年10月至2018年10月间发表的腰痛的指南中针刺的推荐情况和针刺治疗腰痛的临床试验的研究目的、主要对照干预措施和临床结局指标选取情况,并对纳入分析的指南及临床研究的实用性及差异进行分析。结果共纳入国外指南13份,临床研究文献92篇;国内指南4份,临床研究文献379篇。国外腰痛指南仅做了针刺推荐,较少有推荐级别和具体针刺方案,临床指导意义欠缺;国内指南针对不同腰痛类别给出了详细针刺推荐级别和具体的针刺选穴、操作、疗程方案等,更加实用。国内外针刺治疗腰痛的临床试验在研究目的、方法学、报告的规范性等层面差异较大,目前的临床研究存在样本量少、随访时间短等不足,积累的临床证据与临床实际存在差距的问题。结论目前针刺治疗腰痛临床证据和指南推荐与临床实际存在一定偏差,亟需高质量的RCT证据和真实世界的临床研究证据来促进实用性指南的建立。
Objective To understand the recommendation and clinical research status of acupuncture in the guidelines of low back pain at home and abroad,and provide ideas and methods for conducting clinical research and accumulating clinical evidence for acupuncture.Methods The Medline,EMBASE,the Cochrane library,China National Knowledge Infrastructure(CNKI),Sinomed,VIP database,Wanfang Data and China Guideline Clearinghouse,National Institute for Clinical excellence(NICE),National Guideline Clearinghouse(NGC),Scottish Intercollegiate Guidelines Network(SIGN),New Zealand Guideline Group(NZGG),Canadian Medical Association Clinical Practice Guidelines Database(CMACPG),Guidelines International Network(GIN) were retrieved,and the recommendations of acupuncture in the guidelines for low back pain published from October 2008 to October 2018 and the clinical purpose of acupuncture treatment for low back pain,the main control interventions and the selection of clinical outcome indicators were analyzed,and the practicality and differences of the guidelines and clinical researches for inclusion were analyzed.Results A total of 13 foreign guidelines and 4 domestic guidelines were obtained,and92 foreign clinical studies and 379 domestic clinical studies were included.Foreign guidelines on lumbago only recommend acupuncture,but few recommend levels and specific acupuncture programs,which lack clinical significance.The domestic guidelines are more practical and provide detailed recommendation levels and specific acupuncture point selection,operation and treatment programs for different types of lumbago.The clinical trials of acupuncture for the treatment of low back pain at home and abroad vary greatly in aspects of research objectives,selection of outcome indicators,and standardization of clinical research reports.The current clinical research had shortcomings such as small sample size and short follow-up time,and the accumulated clinical evidence and clinical reality are different.Conclusion At present,the clinical evidence and guidelines for acupuncture in the treatment of lumbago are deviated from the actual clinical practice to some degree,and high-quality RCT and real-world clinical research evidence are urgently needed in the treatment of lumbago,to facilitate the establishment of practical guidelines.
Objective To understand the recommendation and clinical research status of acupuncture in the guidelines of low back pain at home and abroad,and provide ideas and methods for conducting clinical research and accumulating clinical evidence for acupuncture.Methods The Medline,EMBASE,the Cochrane library,China National Knowledge Infrastructure(CNKI),Sinomed,VIP database,Wanfang Data and China Guideline Clearinghouse,National Institute for Clinical excellence(NICE),National Guideline Clearinghouse(NGC),Scottish Intercollegiate Guidelines Network(SIGN),New Zealand Guideline Group(NZGG),Canadian Medical Association Clinical Practice Guidelines Database(CMACPG),Guidelines International Network(GIN) were retrieved,and the recommendations of acupuncture in the guidelines for low back pain published from October 2008 to October 2018 and the clinical purpose of acupuncture treatment for low back pain,the main control interventions and the selection of clinical outcome indicators were analyzed,and the practicality and differences of the guidelines and clinical researches for inclusion were analyzed.Results A total of 13 foreign guidelines and 4 domestic guidelines were obtained,and92 foreign clinical studies and 379 domestic clinical studies were included.Foreign guidelines on lumbago only recommend acupuncture,but few recommend levels and specific acupuncture programs,which lack clinical significance.The domestic guidelines are more practical and provide detailed recommendation levels and specific acupuncture point selection,operation and treatment programs for different types of lumbago.The clinical trials of acupuncture for the treatment of low back pain at home and abroad vary greatly in aspects of research objectives,selection of outcome indicators,and standardization of clinical research reports.The current clinical research had shortcomings such as small sample size and short follow-up time,and the accumulated clinical evidence and clinical reality are different.Conclusion At present,the clinical evidence and guidelines for acupuncture in the treatment of lumbago are deviated from the actual clinical practice to some degree,and high-quality RCT and real-world clinical research evidence are urgently needed in the treatment of lumbago,to facilitate the establishment of practical guidelines.
引文
[1]WEISS J,QUANTE S,XUE F,et al.Effectiveness and acceptance of acupuncture in patients with chronic low back pain:results of a prospective,randomized,controlled trial[J].J Altern Complement Med,2013,19(12):935-941.
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[3]SHERMAN KJ,CHERKIN DC,CONNELLY MT,et al.Complementary and alternative medical therapies for chronic low back pain:What treatments are patients willing to try?[J].BMC Complement Altern Med,2004,4:9.doi:10.1186/1472-6882-4-9.
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[6]冯大刚,郑爽,陈玉.SCI统计源期刊针灸治疗腰痛的临床RCT设计特点分析[J].山东中医杂志,2018,37(7):571-575.
[7]LANGEVIN HM,HAMMERSCHLAG R,LAO L,et al.Controversies in acupuncture research:selection of controls and outcome measures in acupuncture clinical trials[J].JAltern Complement Med,2006,12(10):943-953.
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[21]QASEEM A,WILT TJ,MCLEAN RM,et al.Noninvasive treatments for acute,subacute,and chronic low back pain:a clinical practice guideline from the American College of Physicians[J].Ann Intern Med,2017,166(7):514-530.
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[23]FOSTER NE,BISHOP A,BARTLAM B,et al.Evaluating Acupuncture and Standard carE for pregnant women with Back pain(EASE Back):a feasibility study and pilot randomised trial[J].Health Technol Assess,2016,20(33):1-236.
[24]VAS J,ARANDA-REGULES JM,MODESTO M,et al.Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy:study protocol for a multicentre randomised placebo-controlled trial[J].Trials,2014,15:288.doi:10.1186/1745-6215-15-288.
[25]LEEM J,KIM H,JO HG,et al.Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain:A study protocol for a randomized,controlled,assessor-blinded,multicenter clinical trial[J].Medicine,2018,97(21):e10790.doi:10.1097/MD.0000000000010790.
[26]AYATI MH,TOROSKI M,NIKFAR S,et al.Comparison of the Cost-utility Analysis of Electroacupuncture and Nonsteroidal Anti-inflammatory Drugs in the Treatment of Chronic Low Back Pain[J].J Acupunct Meridian Stud,2018,11(4):182-183.
[27]SHERMAN KJ,CHERKIN DC,ICHIKAWA L,et al.Characteristics of patients with chronic back pain who benefit from acupuncture[J].BMC Musculoskelet Disord,2009,10:114.doi:10.1186/1471-2474-10-114.
[28]HOPTON AK,THOMAS KJ,MACPHERSON H.Willingness to try acupuncture again:reports from patients on their treatment reactions in a low back pain trial[J].Acupunct Med,2010,28(4):185-188.
[29]VAS J,PEREA-MILLA E,MENDEZ C,et al.Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain:a randomised controlled multicentre trial protocol[J].BMC Complement Altern Med,2006,6:14.doi:10.1186/1472-6882-6-14.
[30]COMACHIO J,MAGALHES MO,BURKE TN,et al.Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain:study protocol for a randomized controlled trial[J].Trials,2015,16:469.doi:10.1186/s13063-015-0850-7.
[31]DI CESARE A,GIOMBINI A,DI CESARE M,et al.Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain:a short term randomized controlled trial[J].Complement Ther Med,2011,19(1):19-26.
[32]CECCHERELLI F,RIGONI MT,GAGLIARDI G,et al.Comparison of superficial and deep acupuncture in the treatment of lumbar myofascial pain:a double-blind randomized controlled study[J].Clin J Pain,2002,18(3):149-153.
[33]王雪强,郑依莉,胡浩宇,等.常用腰痛功能障碍评估量表的研究进展[J].中国康复理论与实践,2017,23(6):672-676.
[34]中国针灸学会.循证针灸临床实践指南:腰痛[M].北京:中国中医药出版社,2014.
[35]中国骨科相关专家小组(统称).安徽省腰椎间盘突出症分级诊疗指南(2015年版)[J].安徽医学,2016,37(1):14-20.
[36]中国康复医学会脊柱脊髓专业委员会专家组.中国急/慢性非特异性腰背痛诊疗专家共识[J].中国脊柱脊髓杂志,2016,26(12):1134-1138.
[37]周谋望,岳寿伟,何成奇,等.“腰椎间盘突出症的康复治疗”中国专家共识[J].中国康复医学杂志,2017,32(2):129-135.
[38]朱远,赵宏,李思诺,等.运用《腰痛循证针灸临床实践指南》推荐方案治疗慢性非特异性腰痛临床观察[J].安徽中医药大学学报,2016,35(6):65-69.
[39]时宗庭,刘恒平,于栋,等.肌骨超声引导下精准针刀治疗腰椎关节突关节源性腰痛35例[J].中国中医骨伤科杂志,2018,26(4):69-72.
[40]刘丽莎,袁秀丽,段莹,等.针灸治疗腰痛国内外研究现状分析[J].中华中医药杂志,2018,33(7):3082-3084.
[41]陈飞宇刘小平,徐福,等.2014-2016年国内针刺治疗腰痛临床观察指标的组合定量分析[J].中华全科医学,2018,16(7):1183-1187.
[42]吕中茜,郭义,陈泽林,等.针灸临床实践指南制订中证据体的评估方法探索:分层证据评分法[J].中国针灸,2018,38(10):1115-1118.
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[2]EAVES ER,SHERMAN KJ,RITENBAUGH C,et al.Aqualitative study of changes in expectations over time among patients with chronic low back pain seeking four CAM therapies[J].BMC Complement Altern Med,2015,15:12.doi:10.1186/s12906-015-0531-9.
[3]SHERMAN KJ,CHERKIN DC,CONNELLY MT,et al.Complementary and alternative medical therapies for chronic low back pain:What treatments are patients willing to try?[J].BMC Complement Altern Med,2004,4:9.doi:10.1186/1472-6882-4-9.
[4]WANG H,YANG G,WANG S,et al.The most commonly treated acupuncture indications in the United States:a cross-sectional study[J].Am J Chin Med,2018,46(7):1387-1419.
[5]LAM M,GALVIN R,CURRY P.Effectiveness of acupuncture for nonspecific chronic low back pain:a systematic review and meta-analysis.[J].Spine(Phila Pa 1976),2013,38(24):2124-2138.
[6]冯大刚,郑爽,陈玉.SCI统计源期刊针灸治疗腰痛的临床RCT设计特点分析[J].山东中医杂志,2018,37(7):571-575.
[7]LANGEVIN HM,HAMMERSCHLAG R,LAO L,et al.Controversies in acupuncture research:selection of controls and outcome measures in acupuncture clinical trials[J].JAltern Complement Med,2006,12(10):943-953.
[8]YUAN J,PUREPONG N,KERR DP,et al.Effectiveness of acupuncture for low back pain:a systematic review[J].J Spine,2008,33(23):E887-E900.
[9]National Institute for Health and Care Excellence.Low Back Pain and Sciatica in Over 16s:Assessment and Management.National Institute for Health and Care Excellence[EB/OL].(2016-11-30)[2018-10-21].https://www.nice.org.uk/guidance/ng59/resources/low-backpain-and-sciatica-in-over-16s-assessment-and-management-1837521693637.
[10]GREENFIELD S,AUERBACH A,AVORN J,et al.Clinical practice guidelines we can trust[M].Washington DC:National Academies Press,2011:266.
[11]SAVIGNY P,KUNTZE S,WATSON P,et al.Low back pain:early management of persistent non-specific low back pain[EB/OL].(2009-06-04)[2018-02-27].https://ci.nii.ac.jp/naid/10030903466.
[12]Low Back Pain Guideline Team.Acute Low Back Pain[EB/OL].(2010-01-01)[2018-10-21].http://www.med.umich.edu/1info/FHP/practiceguides/back/back.pdf.
[13]National Guideline Clearinghouse.Toward Optimized Practice.Guideline for the evidence-informed primary care management of low back pain[EB/OL].(2011-11-01)[2019-02-27].https://www.guidelinecentral.com/share/summary/52d56565e39b7#section-society.
[14]Philippine Academy of Rehabilitation Medicine.Low back pain management guideline:Low back pain management guideline[EB/OL].(2011-04-01)[2018-10-21].https://docplayer.net/5250044-Low-back-painmanagement-guideline.html.
[15]GOERTZ M,THORSON D,BONSELL J,et al.Adult acute and subacute low back pain.Bloomington(MN):Institute for Clinical Systems Improvement(ICSI)[EB/OL].(2012-12-01)[2018-10-21].https://www.icsi.org/_asset/bjvqrj/LBP.pdf.
[16]KREINER DS,HWANG SW,EASA JE,et al.An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy[J].Spine J,2014,14(1):180-191.
[17]Colorado Division of Workers'Compensation.Low back pain medical treatment guidelines[EB/OL].(2014-02-03)[2018-10-21].http://content.guidelinecentral.com/guideline/get/pdf/2653.
[18]National Health Committee.Low Back Pain:a pathway to prioritisation-Consultation[EB/OL].(2015-11-11)[2019-02-27].https://www.health.govt.nz/publication/low-back-pain-pathway-prioritisation-consultation.
[19]National Guideline Clearinghouse.Guideline summary:Low back disorders[EB/OL].(2016-01-01)[2018-10-21].https://www.ahrq.gov/gam/index.html.
[20]National Guideline Clearinghouse.Guideline for the evidence-informed primary care management of low back pain[EB/OL].(2017-03-01)[2018-10-21].http://www.topalbertadoctors.org/download/1885/LB-Pguideline.pdf.
[21]QASEEM A,WILT TJ,MCLEAN RM,et al.Noninvasive treatments for acute,subacute,and chronic low back pain:a clinical practice guideline from the American College of Physicians[J].Ann Intern Med,2017,166(7):514-530.
[22]STOCHKENDAHL MJ,KJAER P,HARTVIGSEN J,et al.National Clinical Guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy[J].Eur Spine J,2018,27(1):60-75.
[23]FOSTER NE,BISHOP A,BARTLAM B,et al.Evaluating Acupuncture and Standard carE for pregnant women with Back pain(EASE Back):a feasibility study and pilot randomised trial[J].Health Technol Assess,2016,20(33):1-236.
[24]VAS J,ARANDA-REGULES JM,MODESTO M,et al.Auricular acupuncture for primary care treatment of low back pain and posterior pelvic pain in pregnancy:study protocol for a multicentre randomised placebo-controlled trial[J].Trials,2014,15:288.doi:10.1186/1745-6215-15-288.
[25]LEEM J,KIM H,JO HG,et al.Efficacy and safety of thread embedding acupuncture combined with conventional acupuncture for chronic low back pain:A study protocol for a randomized,controlled,assessor-blinded,multicenter clinical trial[J].Medicine,2018,97(21):e10790.doi:10.1097/MD.0000000000010790.
[26]AYATI MH,TOROSKI M,NIKFAR S,et al.Comparison of the Cost-utility Analysis of Electroacupuncture and Nonsteroidal Anti-inflammatory Drugs in the Treatment of Chronic Low Back Pain[J].J Acupunct Meridian Stud,2018,11(4):182-183.
[27]SHERMAN KJ,CHERKIN DC,ICHIKAWA L,et al.Characteristics of patients with chronic back pain who benefit from acupuncture[J].BMC Musculoskelet Disord,2009,10:114.doi:10.1186/1471-2474-10-114.
[28]HOPTON AK,THOMAS KJ,MACPHERSON H.Willingness to try acupuncture again:reports from patients on their treatment reactions in a low back pain trial[J].Acupunct Med,2010,28(4):185-188.
[29]VAS J,PEREA-MILLA E,MENDEZ C,et al.Efficacy and safety of acupuncture for the treatment of non-specific acute low back pain:a randomised controlled multicentre trial protocol[J].BMC Complement Altern Med,2006,6:14.doi:10.1186/1472-6882-6-14.
[30]COMACHIO J,MAGALHES MO,BURKE TN,et al.Efficacy of acupuncture and electroacupuncture in patients with nonspecific low back pain:study protocol for a randomized controlled trial[J].Trials,2015,16:469.doi:10.1186/s13063-015-0850-7.
[31]DI CESARE A,GIOMBINI A,DI CESARE M,et al.Comparison between the effects of trigger point mesotherapy versus acupuncture points mesotherapy in the treatment of chronic low back pain:a short term randomized controlled trial[J].Complement Ther Med,2011,19(1):19-26.
[32]CECCHERELLI F,RIGONI MT,GAGLIARDI G,et al.Comparison of superficial and deep acupuncture in the treatment of lumbar myofascial pain:a double-blind randomized controlled study[J].Clin J Pain,2002,18(3):149-153.
[33]王雪强,郑依莉,胡浩宇,等.常用腰痛功能障碍评估量表的研究进展[J].中国康复理论与实践,2017,23(6):672-676.
[34]中国针灸学会.循证针灸临床实践指南:腰痛[M].北京:中国中医药出版社,2014.
[35]中国骨科相关专家小组(统称).安徽省腰椎间盘突出症分级诊疗指南(2015年版)[J].安徽医学,2016,37(1):14-20.
[36]中国康复医学会脊柱脊髓专业委员会专家组.中国急/慢性非特异性腰背痛诊疗专家共识[J].中国脊柱脊髓杂志,2016,26(12):1134-1138.
[37]周谋望,岳寿伟,何成奇,等.“腰椎间盘突出症的康复治疗”中国专家共识[J].中国康复医学杂志,2017,32(2):129-135.
[38]朱远,赵宏,李思诺,等.运用《腰痛循证针灸临床实践指南》推荐方案治疗慢性非特异性腰痛临床观察[J].安徽中医药大学学报,2016,35(6):65-69.
[39]时宗庭,刘恒平,于栋,等.肌骨超声引导下精准针刀治疗腰椎关节突关节源性腰痛35例[J].中国中医骨伤科杂志,2018,26(4):69-72.
[40]刘丽莎,袁秀丽,段莹,等.针灸治疗腰痛国内外研究现状分析[J].中华中医药杂志,2018,33(7):3082-3084.
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