Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration(SPIRIT-TCM Extension 2018)
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摘要
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 suggestion 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 suggestion 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 suggestion 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
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2.Chen KJ,Qian ZH,Zhang WQ,Guan WR,Wu XG,Chen XJ,et al.Effectiveness analysis for double blinded treatment with refined coronary tablets on angina pectoris leaded by coronary heart disease in 112 cases.J Med Res(Chin)1982;11:24-25.
3.Wieland LS,Manheimer E,Sampson M,Barnabas JP,Bouter LM,Cho K,et al.Bibliometric and content analysis of the Cochrane complementary medicine field specialized register of controlled trials.Syst Rev 2013;2:51.
4.Turner L,Shamseer L,Altman DG,Schulz KF,Moher D.Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals?A Cochrane review.Syst Rev 2012;1:60.
5.Mac Pherson H,Altman DG,Hammerschlag R,Li Y,Wu T,White A,et al.Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement.Acupunct Med 2010;28:83-93.
6.Cheng CW,Fu SF,Zhou QH,Wu TX,Shang HC,Tang XD,et al.Extending the CONSORT Statement to moxibustion.J Integr Med 2013;11:54-63.
7.Cheng CW,Wu TX,Shang HC,Li YP,Altman DG,Moher D,et al.CONSORT extension for Chinese herbal medicine formulae2017:recommendations,explanation and elaboration.Ann Intern Med 2017 Jun 27.doi:10.7326/M16-2977.
8.Chan AW,Tetzlaff JM,G?tzsche PC,Altman DG,Mann H,Berlin JA,et al.SPIRIT 2013 explanation and elaboration:guidance for protocols of clinical trials.BMJ 2013;346:e7586.
9.The SPIRIT Statement.Endorsement.Accessed 20 Dec2017.Available at:http://www.spirit-statement.org/aboutspirit/spirit-endorsement.
10.Zhong LD,Cheng CW,Wu TX,Li YP,Shang HC,Zhang BL,et al.SPIRIT 2013 statement:define standard protocol items for clinical trials.Chin J Integr Tradit West Med(Chin)2014;34:115-122.
11.Han M,Yang GY,Wang YY,Liu JP.Chinese medicine clinical trial protocol design and report specifications.Chin J Integr Tradit West Med(Chin)2014;34:907-910.
12.Shen WJ,Wu XK,Wang GY,Liu JP.Common problems and solving strategy of clinical trial protocols of traditional Chinese medicine.Acta Chin Med Pharmacol(Chin)2015;43:1-4.
13.Integrative Traditional and Western Medicine Branch of Chinese Medical Doctor Association,Evidence-based Medicine Professional Committee of Chinese Integrative Medicine Association.Methodology guideline for clinical studies investigating traditional Chinese medicine and integrative medicine.Chin J Integr Tradit West Med(Chin)2015;35:901-932.
14.Liu YX.Randomization of clinical trials.J Med Postgrad(Chin)2015;28:113-117.
15.Tan Y,Zhao Y,He T,Ma Y,Cai W,Wang Y.Efficacy and safety of auricular point acupressure treatment of gastrointestinal dysfunction after laparoscopic cholecystectomy:study protocol for a randomized control ed trials.Trials 2016;17:280.
16.Wang S,Jiang H,Yu Q,She B,Mao B.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.Trials 2017;18:2.
17.Bian ZX,Chang YH.Revised STRICTA as an extension of the CONSORT statement:more items should be involved in the checklist.J Altern Complement Med 2011;17:97-98.
18.Scheid V.Convergent lines of descent:symptoms,patterns,constellations,and the emergent interface of systems biology and Chinese medicine.East Asian Sci Technol Soc2014;8:107-139.
19.World Health Organization.WHO international standard terminologies on traditional medicine in the western pacific region.2007.Accessed 20 Dec 2017.Available at:http://www.wpro.who.int/publications/who_istrm_file.pdf.
20.L u A,J i a n g M,Z h a n g C,C h a n K.A n i n t e g r a t i v e approach of linking traditional Chinese medicine pattern classification and biomedicine diagnosis.J Ethnopharmacol2012;141:549-556.
21.Tang Q.Syndrome diagnosis criteria and therapeutic schedule for depression.J Beijing Univ Tradit Chin Med(Chin)2011;34:810-811.
22.Li J,Wang Z,Li S,Li Y,Zhang HC,Chao E,et al.Syndrome diagnosis criteria for common cold(2013version).J Tradit Chin Med(Chin)2014;55:350-351.
23.Bian ZX,Moher D,Dagenais S,Li YP,Liu L,Wu TX,et al.Improving the quality of randomized controlled trials in Chinese herbal medicine,partⅡ:control group design.JChin Integr Med(Chin)2006;4:130-136.
24.Zhang YC,Li G,Jiang C,Yang B,Yang HJ,Xu HY,et al.Tissue-specific distribution of ginsenosides in different aged ginseng and antioxidant activity of ginseng leaf.Molecules2014;19:17381-17399.
25.Li YH,Chen F,Wang JF,Wang Y,Zhang JQ,Guo T.Analysis of nine compounds from Alpinia oxyphylla fruit at different harvest time using UFLC-MS/MS and an extraction method optimized by orthogonal design.Chem Cent J 2013;7:134.
26.Su T,Yu H,Kwan HY,Ma XQ,Cao HH,Cheng CY,et al.Comparisons of the chemical profiles,cytotoxicities and antiinflammatory effects of raw and rice wine-processed Herba Siegesbeckiae.J Ethnopharmacol 2014;156:365-369.
27.Zhang ZZ,Tian D,Xing J,Li ZY,Qin XM.Quality comparison on Farfarae Flos from various origins by UPLCbased on multi-components content determination method.Chin Tradit Herb Drugs(Chin)2015;46:2296-2302.
28.Zhang S,Mu W,Xiao L,Zheng WK,Liu CX,Zhang L,et al.Is deqi an indicator of clinical efficacy of acupuncture?Asystematic review.Evid Based Complement Alternat Med2013;2013:750140.
29.Luo J,Xu H,Liu B.Real world research:a complementary method to establish the effectiveness of acupuncture.BMCComplement Altern Med 2015;15:153.
30.Deng H,Shen X.The mechanism of moxibustion:ancient theory and modern research.Evid Based Complement Alternat Med 2013;2013:379291.
31.Streitberger K,Kleinhenz J.Introducing a placebo needle into acupuncture research.Lancet 1998;352:364-365.
32.Zhao B,Wang X,Lin Z,Liu R,Lao L.A novel sham moxibustion device:a randomized,placebo-controlled trial.Complement Ther Med 2006;14:53-60.
33.Bian ZX,Moher D,Li YP,Wu TX,Dagenais S,Cheng CW,et al.Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine.J Chin Integr Med(Chin)2008;6:771-775.
34.Zhang L,Zhang J,Chen J,Xing D,Mu W,Wang J,et al.Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets.Evid Based Complement Alternat Med 2013;2013:202703.
35.Administration CFDA.Announcement of self-examination and inspection of drug clinical trial data.2015.Accessed20 Dec 2017.Available at:http://www.sda.gov.cn/WS01/CL0087/124800.html.
2.Chen KJ,Qian ZH,Zhang WQ,Guan WR,Wu XG,Chen XJ,et al.Effectiveness analysis for double blinded treatment with refined coronary tablets on angina pectoris leaded by coronary heart disease in 112 cases.J Med Res(Chin)1982;11:24-25.
3.Wieland LS,Manheimer E,Sampson M,Barnabas JP,Bouter LM,Cho K,et al.Bibliometric and content analysis of the Cochrane complementary medicine field specialized register of controlled trials.Syst Rev 2013;2:51.
4.Turner L,Shamseer L,Altman DG,Schulz KF,Moher D.Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals?A Cochrane review.Syst Rev 2012;1:60.
5.Mac Pherson H,Altman DG,Hammerschlag R,Li Y,Wu T,White A,et al.Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA):extending the CONSORT statement.Acupunct Med 2010;28:83-93.
6.Cheng CW,Fu SF,Zhou QH,Wu TX,Shang HC,Tang XD,et al.Extending the CONSORT Statement to moxibustion.J Integr Med 2013;11:54-63.
7.Cheng CW,Wu TX,Shang HC,Li YP,Altman DG,Moher D,et al.CONSORT extension for Chinese herbal medicine formulae2017:recommendations,explanation and elaboration.Ann Intern Med 2017 Jun 27.doi:10.7326/M16-2977.
8.Chan AW,Tetzlaff JM,G?tzsche PC,Altman DG,Mann H,Berlin JA,et al.SPIRIT 2013 explanation and elaboration:guidance for protocols of clinical trials.BMJ 2013;346:e7586.
9.The SPIRIT Statement.Endorsement.Accessed 20 Dec2017.Available at:http://www.spirit-statement.org/aboutspirit/spirit-endorsement.
10.Zhong LD,Cheng CW,Wu TX,Li YP,Shang HC,Zhang BL,et al.SPIRIT 2013 statement:define standard protocol items for clinical trials.Chin J Integr Tradit West Med(Chin)2014;34:115-122.
11.Han M,Yang GY,Wang YY,Liu JP.Chinese medicine clinical trial protocol design and report specifications.Chin J Integr Tradit West Med(Chin)2014;34:907-910.
12.Shen WJ,Wu XK,Wang GY,Liu JP.Common problems and solving strategy of clinical trial protocols of traditional Chinese medicine.Acta Chin Med Pharmacol(Chin)2015;43:1-4.
13.Integrative Traditional and Western Medicine Branch of Chinese Medical Doctor Association,Evidence-based Medicine Professional Committee of Chinese Integrative Medicine Association.Methodology guideline for clinical studies investigating traditional Chinese medicine and integrative medicine.Chin J Integr Tradit West Med(Chin)2015;35:901-932.
14.Liu YX.Randomization of clinical trials.J Med Postgrad(Chin)2015;28:113-117.
15.Tan Y,Zhao Y,He T,Ma Y,Cai W,Wang Y.Efficacy and safety of auricular point acupressure treatment of gastrointestinal dysfunction after laparoscopic cholecystectomy:study protocol for a randomized control ed trials.Trials 2016;17:280.
16.Wang S,Jiang H,Yu Q,She B,Mao B.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.Trials 2017;18:2.
17.Bian ZX,Chang YH.Revised STRICTA as an extension of the CONSORT statement:more items should be involved in the checklist.J Altern Complement Med 2011;17:97-98.
18.Scheid V.Convergent lines of descent:symptoms,patterns,constellations,and the emergent interface of systems biology and Chinese medicine.East Asian Sci Technol Soc2014;8:107-139.
19.World Health Organization.WHO international standard terminologies on traditional medicine in the western pacific region.2007.Accessed 20 Dec 2017.Available at:http://www.wpro.who.int/publications/who_istrm_file.pdf.
20.L u A,J i a n g M,Z h a n g C,C h a n K.A n i n t e g r a t i v e approach of linking traditional Chinese medicine pattern classification and biomedicine diagnosis.J Ethnopharmacol2012;141:549-556.
21.Tang Q.Syndrome diagnosis criteria and therapeutic schedule for depression.J Beijing Univ Tradit Chin Med(Chin)2011;34:810-811.
22.Li J,Wang Z,Li S,Li Y,Zhang HC,Chao E,et al.Syndrome diagnosis criteria for common cold(2013version).J Tradit Chin Med(Chin)2014;55:350-351.
23.Bian ZX,Moher D,Dagenais S,Li YP,Liu L,Wu TX,et al.Improving the quality of randomized controlled trials in Chinese herbal medicine,partⅡ:control group design.JChin Integr Med(Chin)2006;4:130-136.
24.Zhang YC,Li G,Jiang C,Yang B,Yang HJ,Xu HY,et al.Tissue-specific distribution of ginsenosides in different aged ginseng and antioxidant activity of ginseng leaf.Molecules2014;19:17381-17399.
25.Li YH,Chen F,Wang JF,Wang Y,Zhang JQ,Guo T.Analysis of nine compounds from Alpinia oxyphylla fruit at different harvest time using UFLC-MS/MS and an extraction method optimized by orthogonal design.Chem Cent J 2013;7:134.
26.Su T,Yu H,Kwan HY,Ma XQ,Cao HH,Cheng CY,et al.Comparisons of the chemical profiles,cytotoxicities and antiinflammatory effects of raw and rice wine-processed Herba Siegesbeckiae.J Ethnopharmacol 2014;156:365-369.
27.Zhang ZZ,Tian D,Xing J,Li ZY,Qin XM.Quality comparison on Farfarae Flos from various origins by UPLCbased on multi-components content determination method.Chin Tradit Herb Drugs(Chin)2015;46:2296-2302.
28.Zhang S,Mu W,Xiao L,Zheng WK,Liu CX,Zhang L,et al.Is deqi an indicator of clinical efficacy of acupuncture?Asystematic review.Evid Based Complement Alternat Med2013;2013:750140.
29.Luo J,Xu H,Liu B.Real world research:a complementary method to establish the effectiveness of acupuncture.BMCComplement Altern Med 2015;15:153.
30.Deng H,Shen X.The mechanism of moxibustion:ancient theory and modern research.Evid Based Complement Alternat Med 2013;2013:379291.
31.Streitberger K,Kleinhenz J.Introducing a placebo needle into acupuncture research.Lancet 1998;352:364-365.
32.Zhao B,Wang X,Lin Z,Liu R,Lao L.A novel sham moxibustion device:a randomized,placebo-controlled trial.Complement Ther Med 2006;14:53-60.
33.Bian ZX,Moher D,Li YP,Wu TX,Dagenais S,Cheng CW,et al.Appropriately selecting and concisely reporting the outcome measures of randomized controlled trials of traditional Chinese medicine.J Chin Integr Med(Chin)2008;6:771-775.
34.Zhang L,Zhang J,Chen J,Xing D,Mu W,Wang J,et al.Clinical research of traditional Chinese medicine needs to develop its own system of core outcome sets.Evid Based Complement Alternat Med 2013;2013:202703.
35.Administration CFDA.Announcement of self-examination and inspection of drug clinical trial data.2015.Accessed20 Dec 2017.Available at:http://www.sda.gov.cn/WS01/CL0087/124800.html.