规范中医药临床研究方案内容2018声明:建议、说明与详述
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摘要
中医学是古老的医学体系之一,但临床试验质量的参差不一限制了其被广泛接受。2013年出版的规范临床研究方案内容声明(Standard Protocol Items:Recommendations for Interventional Trials SPIRIT 2013声明)确立了运作临床试验的规范,从而保证结果准确可靠。由于中医药特殊的理论体系和干预措施特征,中医临床研究直接应用SPIRIT 2013声明存在诸多问题。因此,本文对原始SPIRIT 2013声明进行了中医药扩展。由于中药复方、针刺和灸法是中医药临床实践中最常用且最具代表性的三项干预措施,执行工作组决定SPIRIT-TCM扩展声明应基于此三项干预措施开发。邀请中医药领域的专家,开展三轮Delphi共识调研。执行工作组鼓励所有参与专家提出针对预设条目的意见,并建议新的扩展条目。SPIRIT-TCM扩展声明的条目清单基于共识调研的反馈进行了修改,最终经由一次共识会议定稿了SPIRIT-TCM扩展声明的内容。工作组修订了SPIRIT 2013原始条目中的7项条目,即"题目"、"背景和理念"、"目的"、"合格标准"、"干预措施"、"结局指标"和"数据收集方法"。扩展内容引入了中医学中证候的概念和三项主要的中医药干预措施,同时匹配了实例及说明。SPIRIT-TCM扩展声明为研究者设计高质量的临床试验提供了依据。其原则的广泛传播和应用将有助于持续推进中医药在医疗健康实践的国际化应用。
Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestions for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
Traditional Chinese Medicine(TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials(SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestions for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
引文
[1] World Health Organization.WHO traditional medicine strategy:2014-2023 [OL].2013 [cited 2017 Sep 9].Available from:http://apps.who.int/iris/bitstream/10665/92455/1/9789241506090_eng.pdf?ua=1.
[2] Chen KJ,Qian ZH,Zhang WQ,et al.Effectiveness analysis for double blinded treatment with refined coronary tablets on angina pectoris leaded by coronary heart disease in 112 cases[J].J Med Res,1982,11(11):24-25.
[3] Wieland LS,Manheimer E,Sampson M,et al.Bibliometric and content analysis of the Cochrane complementary medicine field specialized register of controlled trials[J].Syst Rev,2013,2:51.
[4] Turner L,Shamseer L,Altman DG,et al.Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals?[J].Syst Rev,2012,1:60.
[5] MacPherson H,Altman DG,Hammerschlag R,et al.Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA):extending the CONSORT statement[J].J Evid Based Med,2010,3(3):140-155.
[6] Cheng CW,Fu SF,Zhou QH,et al.Extending the CONSORT Statement to moxibustion[J].J Integr Med,2013,11(1):54-63.
[7] Cheng CW,Wu TX,Shang HC,et al.CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration[J].Ann Intern Med,Epub 2017 Jun 27.
[8] Chan AW,Tetzlaff JM,Altman DG,et al.SPIRIT 2013 statement:defining standard protocol items for clinical trials[J].Ann Intern Med,2013,158(3):200-207.
[9] 2013 SPIRIT Statement.About SPIRIT:Endorsement[OL].2013 [cited 2017 Sep 9].Available from:http://www.spirit-statement.org/about-spirit/spirit-endorsement/.
[10] Zhong LD,Cheng CW,Wu TX,et al.SPIRIT 2013 statement:define standard protocol items for clinical trials[J].Chin J Integr Tradit West Med,2014,34(1):115-122.
[11] Han M,Yang GY,Wang YY,et al.Design and report specification of clinical trials of traditional Chinese medicine[J].Chin J Integr Tradit West Med,2014,34(8):907-910.
[12] Shen WJ,Wu XK,Wang GY,et al.Common problems and solving strategy of clinical trial protocols of traditional Chinese medicine[J].Acta Chin Med Pharmacol,2015,43(4):1-4.
[13] Doctor Society of Integrative Medicine of Chinese Medical Doctor Association,Evidence-based Medicine Professional Committee of Chinese Association of Integrative Medicine.Guideline for traditional Chinese medicine and integrative medicine clinical research methods[J].Chin J Integr Tradit West Med,2016,35(8):901-932.
[14] Liu YX.Randomization of clinical trials[J].J Med Postgraduate,2015,28(2):113-117.
[15] Tan Y,Zhao Y,He T,et al.Efficacy and safety of auricular point acupressure treatment of gastrointestinal dysfunction after laparoscopic cholecystectomy:study protocol for a randomized controlled trials[J].Trials,2016,17(1):280.
[16] Wang S,Jiang H,Yu Q,et al.Efficacy and safety of Lian-Ju-Gan-Mao Capsules for treating the common cold with wind-heat syndrome:study protocol for a randomized controlled trial[J].Trials 2017,18(1):2.
[17] Bian ZX,Chang YH.Revised STRICTA as an extension of the CONSORT statement:more items should be involved in the checklist[J].J Altern Complement Med,2011,17(2):97-98.
[18] Scheid V.Convergent lines of descent:Symptoms,patterns,constellations,and the emergent interface of systems biology and Chinese medicine[J].East Asian Sci Technol Soc,2014,8(1):107-139.
[19] World Health Organization.WHO international standard terminologies on traditional medicine in the western pacific region[OL].2007 [cited 2017 Sep 9].Available from:http://www.wpro.who.int/publications/who_istrm_file.pdf.
[20] Lu AP,Jiang M,Zhang C,et al.An integrative approach of linking traditional Chinese medicine pattern classification and biomedicine diagnosis[J].J Ethnopharmacol,2012,141(2):549-556.
[21] Tang Q.Syndrome diagnosis criteria and therapeutic schedule for depression[J].J Beijing Univ Tradit Chin Med,2011,34(12):810-811.
[22] Li J,Wang Z,Li S,et al.Syndrome diagnosis criteria for common cold (2013 version)[J].J Tradit Chin Med,2014,55(4):350-351.
[23] Bian ZX,Moher D,Dagenais S,et al.Improving the quality of randomized controlled trials in Chinese herbal medicine,part II:control group design[J].J Chin Integr Med,2006,4(2):130-136.
[24] Zhang YC,Li G,Jiang C,et al.Tissue-specific distribution of ginsenosides in different aged ginseng and antioxidant activity of ginseng leaf[J].Molecules,2014,19(11):17381-17399.
[25] Li YH,Chen F,Wang J,et al.Analysis of nine compounds from Alpinia oxyphylla fruit at different harvest time using UFLC-MS/MS and an extraction method optimized by orthogonal design[J].Chem Cent J,2013,7:134.
[26] Su T,Yu H,Kwan HY,et al.Comparisons of the chemical profiles,cytotoxicities and anti-inflammatory effects of raw and rice wine-processed Herba Siegesbeckiae[J].J Ethnopharmacol,2014,156(1):365-369.
[27] Zhang Z,Tian D,Xing J,et al.Quality comparison on Farfarae Flos from various origins by UPLC based on multi-components content determination method[J].Chin Tradit Herb Drugs,2015,46(15):2296-2302.
[28] Zhang S,Mu W,Xiao L,et al.Is deqi an indicator of clinical efficacy of acupuncture?A systematic review[J].Evid Based Complement Alternat Med,2013:750140.
[29] Luo J,Xu H,Liu B.Real world research:a complementary method to establish the effectiveness of acupuncture[J].BMC Complementary Alternat Med,2015,15:153.
[30] Deng H,Shen X.The mechanism of moxibustion:ancient theory and modern research[J].Evid Based Complement Alternat Med,2013:379291.
[31] Streitberger K,Kleinhenz J.Introducing a placebo needle into acupuncture research[J].Lancet,1998,352(9125):364-365.
[32] Zhao B,Wang X,Lin Z,et al.A novel sham moxibustion device:a randomized,placebo-controlled trial[J].Complement Ther Med,2006,14(1):53-60.
[33] Bian ZX,Moher D,Li Y,et al.Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine[J].J Chin Integr Med,2008,6(8):771-775.
[34] Zhang L,Zhang J,Chen J,et al.Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets[J].Evid Based Complement Alternat Med,2013:202703.
[35] China Food and Drug Administration.Announcement of self-examination and inspection of drug clinical trial data[OL].2015 [cited 2017 Sep 9].Available from:http://www.sda.gov.cn/WS01/CL0087/124800.html.
[2] Chen KJ,Qian ZH,Zhang WQ,et al.Effectiveness analysis for double blinded treatment with refined coronary tablets on angina pectoris leaded by coronary heart disease in 112 cases[J].J Med Res,1982,11(11):24-25.
[3] Wieland LS,Manheimer E,Sampson M,et al.Bibliometric and content analysis of the Cochrane complementary medicine field specialized register of controlled trials[J].Syst Rev,2013,2:51.
[4] Turner L,Shamseer L,Altman DG,et al.Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals?[J].Syst Rev,2012,1:60.
[5] MacPherson H,Altman DG,Hammerschlag R,et al.Revised standards for reporting interventions in clinical trials of acupuncture (STRICTA):extending the CONSORT statement[J].J Evid Based Med,2010,3(3):140-155.
[6] Cheng CW,Fu SF,Zhou QH,et al.Extending the CONSORT Statement to moxibustion[J].J Integr Med,2013,11(1):54-63.
[7] Cheng CW,Wu TX,Shang HC,et al.CONSORT Extension for Chinese Herbal Medicine Formulas 2017:Recommendations,Explanation,and Elaboration[J].Ann Intern Med,Epub 2017 Jun 27.
[8] Chan AW,Tetzlaff JM,Altman DG,et al.SPIRIT 2013 statement:defining standard protocol items for clinical trials[J].Ann Intern Med,2013,158(3):200-207.
[9] 2013 SPIRIT Statement.About SPIRIT:Endorsement[OL].2013 [cited 2017 Sep 9].Available from:http://www.spirit-statement.org/about-spirit/spirit-endorsement/.
[10] Zhong LD,Cheng CW,Wu TX,et al.SPIRIT 2013 statement:define standard protocol items for clinical trials[J].Chin J Integr Tradit West Med,2014,34(1):115-122.
[11] Han M,Yang GY,Wang YY,et al.Design and report specification of clinical trials of traditional Chinese medicine[J].Chin J Integr Tradit West Med,2014,34(8):907-910.
[12] Shen WJ,Wu XK,Wang GY,et al.Common problems and solving strategy of clinical trial protocols of traditional Chinese medicine[J].Acta Chin Med Pharmacol,2015,43(4):1-4.
[13] Doctor Society of Integrative Medicine of Chinese Medical Doctor Association,Evidence-based Medicine Professional Committee of Chinese Association of Integrative Medicine.Guideline for traditional Chinese medicine and integrative medicine clinical research methods[J].Chin J Integr Tradit West Med,2016,35(8):901-932.
[14] Liu YX.Randomization of clinical trials[J].J Med Postgraduate,2015,28(2):113-117.
[15] Tan Y,Zhao Y,He T,et al.Efficacy and safety of auricular point acupressure treatment of gastrointestinal dysfunction after laparoscopic cholecystectomy:study protocol for a randomized controlled trials[J].Trials,2016,17(1):280.
[16] Wang S,Jiang H,Yu Q,et al.Efficacy and safety of Lian-Ju-Gan-Mao Capsules for treating the common cold with wind-heat syndrome:study protocol for a randomized controlled trial[J].Trials 2017,18(1):2.
[17] Bian ZX,Chang YH.Revised STRICTA as an extension of the CONSORT statement:more items should be involved in the checklist[J].J Altern Complement Med,2011,17(2):97-98.
[18] Scheid V.Convergent lines of descent:Symptoms,patterns,constellations,and the emergent interface of systems biology and Chinese medicine[J].East Asian Sci Technol Soc,2014,8(1):107-139.
[19] World Health Organization.WHO international standard terminologies on traditional medicine in the western pacific region[OL].2007 [cited 2017 Sep 9].Available from:http://www.wpro.who.int/publications/who_istrm_file.pdf.
[20] Lu AP,Jiang M,Zhang C,et al.An integrative approach of linking traditional Chinese medicine pattern classification and biomedicine diagnosis[J].J Ethnopharmacol,2012,141(2):549-556.
[21] Tang Q.Syndrome diagnosis criteria and therapeutic schedule for depression[J].J Beijing Univ Tradit Chin Med,2011,34(12):810-811.
[22] Li J,Wang Z,Li S,et al.Syndrome diagnosis criteria for common cold (2013 version)[J].J Tradit Chin Med,2014,55(4):350-351.
[23] Bian ZX,Moher D,Dagenais S,et al.Improving the quality of randomized controlled trials in Chinese herbal medicine,part II:control group design[J].J Chin Integr Med,2006,4(2):130-136.
[24] Zhang YC,Li G,Jiang C,et al.Tissue-specific distribution of ginsenosides in different aged ginseng and antioxidant activity of ginseng leaf[J].Molecules,2014,19(11):17381-17399.
[25] Li YH,Chen F,Wang J,et al.Analysis of nine compounds from Alpinia oxyphylla fruit at different harvest time using UFLC-MS/MS and an extraction method optimized by orthogonal design[J].Chem Cent J,2013,7:134.
[26] Su T,Yu H,Kwan HY,et al.Comparisons of the chemical profiles,cytotoxicities and anti-inflammatory effects of raw and rice wine-processed Herba Siegesbeckiae[J].J Ethnopharmacol,2014,156(1):365-369.
[27] Zhang Z,Tian D,Xing J,et al.Quality comparison on Farfarae Flos from various origins by UPLC based on multi-components content determination method[J].Chin Tradit Herb Drugs,2015,46(15):2296-2302.
[28] Zhang S,Mu W,Xiao L,et al.Is deqi an indicator of clinical efficacy of acupuncture?A systematic review[J].Evid Based Complement Alternat Med,2013:750140.
[29] Luo J,Xu H,Liu B.Real world research:a complementary method to establish the effectiveness of acupuncture[J].BMC Complementary Alternat Med,2015,15:153.
[30] Deng H,Shen X.The mechanism of moxibustion:ancient theory and modern research[J].Evid Based Complement Alternat Med,2013:379291.
[31] Streitberger K,Kleinhenz J.Introducing a placebo needle into acupuncture research[J].Lancet,1998,352(9125):364-365.
[32] Zhao B,Wang X,Lin Z,et al.A novel sham moxibustion device:a randomized,placebo-controlled trial[J].Complement Ther Med,2006,14(1):53-60.
[33] Bian ZX,Moher D,Li Y,et al.Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine[J].J Chin Integr Med,2008,6(8):771-775.
[34] Zhang L,Zhang J,Chen J,et al.Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets[J].Evid Based Complement Alternat Med,2013:202703.
[35] China Food and Drug Administration.Announcement of self-examination and inspection of drug clinical trial data[OL].2015 [cited 2017 Sep 9].Available from:http://www.sda.gov.cn/WS01/CL0087/124800.html.