Chin J Integr Med
•1•
PERSPECTIVE Improving Clinical Practice Guideline Development in Integration of Traditional Chinese Medicine and Western Medicine LU Ai-ping (吕爱平)1 and CHEN Ke-ji (陈可冀)2 Integration of traditional Chinese medicine (TCM) and Western medicine (WM), or called as integrative medicine (IM) in China, came into being in 1950s as a new form of medicine. IM emphasizes the combination of both conventional WM and TCM alternative approaches to address all aspects of health and illness.(1) The major practice in IM includes the integration of disease diagnosis in WM and pattern classification (or syndrome differentiation) in TCM, and the integration of WM interventions and TCM interventions. Up to now, there are about 300 IM hospitals, 30 IM departments in medical universities, and more than 100 IM-specific institutes in China. In the United States, 80% of family practice physicians expressed an interest in receiving training in alternative therapies, including acupuncture, hypnotherapy, and massage therapy, (2) and the hospitals set up about 60 IM clinics.(3) As more clinical practitioners use IM diagnosis and intervention, and more patients accept IM therapy, the urgent need is to develop the clinical practice guideline (CPG) to make sure of the high efficacy and safety in the clinical practice. However, the majority of clinical practices in IM are mainly based on the individual experiences and lack of guidelines based on the strong clinical evidence or expert consensus. CPG is commonly defined as "systematically developed statements to assist the practitioner and patient decision about appropriate health care for specific clinical circumstances." (4) CPG could be categorized as Evidence Based (EB) guidelines, Consensus Based with no explicit consideration of Evidence Based (CB-EB) guidelines and Consensus Based (CB) guidelines, according to the development method.(5) CB is developed by the agreement with a group of experts. EB is developed after the systematic retrieval and appraisal of information from the literature. It usually includes strategies for describing the strength of the evidence, and try to clearly separate opinions from evidence they make statements not just about
which of two treatment options is 'better', but quantify the absolute differences in outcome, including both benefits and harms. (6) CB-EB is developed by combining a consensus of experts and a not enough formal literature analysis to create evidence. EB guideline is the mainstream and trend of guideline development, because guidelines based on a consensus of expert opinion or on unsystematic literature survey have been criticized as not reflecting current medical knowledge and being liable to bias.(7,8) Two international specific public databases for CPG, National Guideline Clearinghouse (NGC, http://www.guideline.gov/), Guidelines International Network (G-I-N, http://www. g-i-n.net/), were the major databases of EB guidelines on WM. Because of the complexity of TCM diagnosis and intervention and lack of high quality of clinical trials, CB and CB-EB guidelines are the mainstream in TCM CPG development.(9) The first batch of CB-EB guidelines in TCM CPG development were issued in 2011.(10) In those CPGs, both WM and TCM diagnosis and TCM interventions are basically included, however the CPGs specifically focused on IM are few.(1) Though more clinical studies were conducted in IM and more IM practices were used worldwide, the CPG development in IM would still be based on CB-EB at present because there are still lack of strong and enough evidence. Similar to all CB-EB CPGs development process,(11-13) the major points for IM CPG development should also include the technical guidance and quality control, literature review (evidence accumulation), Delphi survey, the consensus conference, CPG
©The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag Berlin Heidelberg 2014 1. School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong SAR, China; 2. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100070), China Correspondence to: Prof. LU Ai-ping, Tel: 852-34112457, E-mail: [email protected] DOI: 10.1007/s11655-014-1961-9
Chin J Integr Med
•2•
Clinical evidences
Expert consensus
Combination of WM disease diagnosis and TCM Zheng classification
Data mining based on literatures
TCM herbs-WM drug interaction
Combination of WM interventions and TCM interventions
Synthesis of multi-resources
IM CPG report
Figure 1.
The Key Approaches Related to IM CPG Development
Notes: The different resources of information, including clinical evidence, expert consensus, data mining outcome and potential herb-drug interaction, need to be analyzed in order to get the major contents of IM CPG both in diagnosis and intervention.
drafting and edit. Based on the specificity of IM clinical practice, major contents in IM CPG should contain the diagnosis referring to "combination of WM disease diagnosis and TCM pattern classification," and the intervention referring to "combination of WM interventions and TCM interventions accordingly." Regarding to the integration of diagnostic approaches, more data are needed to support the TCM pattern classification under a specific disease with specially focusing on the indexes including TCM related symptoms and signs. Regarding to the integration of TCM and WM interventions, the herb-drug interaction would be another important content in the development of IM CPG.
major pharmacological activity, associate activity and sideline activity (potential side effect) of the combination therapeutics, when the pharmacological networks of the combination therapy are mapped onto the molecular networks of the disease. No doubt, IM CPG development would foster much more effective and safe IM clinical practice, when more IM CPGs are used in clinical practice.
REFERENCES 1.
2008;14:234-240. 2.
Comparing to general CPG development, some issues in the process and contents of IM CPG development could be taken into consideration (Figure 1). As to TCM pattern classification under a disease, an integrated approach could be adopted, including clinical study evidence search, expert consensus, and clinical data mining. Evidence search could find out the existed solid data though it is not enough at present, and the expert consensus would give much clear picture about TCM pattern classification in the disease, (14) and clinical data mining results would give much help for expert to develop the items in the questionnaire for Delphi survey.(15-17) As to the combination of WM and TCM intervention in IM CPG development, evidence search, expert consensus and data mining could be also used to find out the best therapeutic combination, but more importantly in IM practice, the TCM herb and WM drug interaction should be discussed or predicted in the IM CPG development. Modern bioinformatics approaches, with big and solid data support, can be used to predict the
Lu AP, Ding XR, Chen KJ. Current situation and progress in integrative medicine in China. Chin J Integr Med Lesley R, Andrew W. Integrated medicine: Imbues orthodox medicine with the values of complementary medicine. BMJ 2001;322:119-120.
3.
Snyderman R, Weil AT. Integrative medicine: bringing medicine back to its roots. Arch Intern Med 2002;162:395-397.
4.
Field M, Lohr K. Clinical practice guidelines: directions for a new program. Washington (DC): National Academy Press; 1990:3.
5.
Cruse H, Winiarek M, Marshburn J, Clark O, Djulbegovic B. Quality and methods of developing practice guidelines. BMC Health Serv Res 2002;2:1-73.
6.
New Zealand Guidelines Group. Handbook for the preparation of explicit evidence-based clinical practice guidelines. New Zealand Guidelines Group; 2001:1-57.
7.
Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized controlled trials and recommendations of clinical experts: treatments for myocardial infarction. JAMA 1992;268:240-248.
8.
Mulrow CD. Systematic reviews: rationale for systematic reviews. BMJ 1994;309:597-599 .
9.
Yuwen Y, Shi NN, Wang LY, Xie YM, Han XJ, Lu AP. Development of clinical practice guidelines in 11 common
Chin J Integr Med
•3•
diseases with Chinese medicine interventions in China.
Hamel C, et al. Development of AMSTAR: a measurement
Chin J Integr Med 2012;12:112-119.
tool to assess the methodological quality of systematic
10. Yuwen Y, Xu JL, Shi NN, Wang LY, Han XJ, Wang YY, Lu
reviews. BMC Med Res Methodol 2007;15(7):10.
AP. Assessing the quality of the first batch of evidence-
14. Min HX, Qi YD, Chuan WS, Wang J. Application of Delphi
based clinical practice guidelines in traditional Chinese
method in Chinese medicine diagnosing and treating
medicine. Chin J Tradit Chin Med 2011;31:376-381. 11. Qaseem A, Forland F, Macbetch F, Ollenschläger G, Phillips S, van der Wees P, et al. Guidelines international network: toward intenational standards for clinical practice guidelines. Ann Intern Med 2012;156:525-531. 12. Saag KG, Teng GG, Patkar NM, Finney C, Curtis JR,
guideline. J Pediatrics of TCM (Chin) 2010;6(4):50-51. 15. Hand DJ. Principles of data mining. Drug Safety 2007;30:621-622. 16. Zhang Y, Yang J, Liu JP. The data picking applied in the research of traditional Chinese medicine. J Liaoning Univ Tradit Chin Med (Chin) 2008;10:153-154.
Paulus HE, et al. American college of rheumatology 2008
17. Zhou X, Peng Y, Liu B. Text mining for traditional Chinese
recommendations for the use of nonbiological and biologic
medical knowledge discovery: a survey. J Biomed Inform
disease--modifying antirheumatic drugs in rheumatoid
2010;43:650-660.
arthritis. Arthritis Rheum 2008;59:762-784. 13. Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N,
(Received December 18, 2014) Edited by ZHANG Wen
•1•
PERSPECTIVE Improving Clinical Practice Guideline Development in Integration of Traditional Chinese Medicine and Western Medicine LU Ai-ping (吕爱平)1 and CHEN Ke-ji (陈可冀)2 Integration of traditional Chinese medicine (TCM) and Western medicine (WM), or called as integrative medicine (IM) in China, came into being in 1950s as a new form of medicine. IM emphasizes the combination of both conventional WM and TCM alternative approaches to address all aspects of health and illness.(1) The major practice in IM includes the integration of disease diagnosis in WM and pattern classification (or syndrome differentiation) in TCM, and the integration of WM interventions and TCM interventions. Up to now, there are about 300 IM hospitals, 30 IM departments in medical universities, and more than 100 IM-specific institutes in China. In the United States, 80% of family practice physicians expressed an interest in receiving training in alternative therapies, including acupuncture, hypnotherapy, and massage therapy, (2) and the hospitals set up about 60 IM clinics.(3) As more clinical practitioners use IM diagnosis and intervention, and more patients accept IM therapy, the urgent need is to develop the clinical practice guideline (CPG) to make sure of the high efficacy and safety in the clinical practice. However, the majority of clinical practices in IM are mainly based on the individual experiences and lack of guidelines based on the strong clinical evidence or expert consensus. CPG is commonly defined as "systematically developed statements to assist the practitioner and patient decision about appropriate health care for specific clinical circumstances." (4) CPG could be categorized as Evidence Based (EB) guidelines, Consensus Based with no explicit consideration of Evidence Based (CB-EB) guidelines and Consensus Based (CB) guidelines, according to the development method.(5) CB is developed by the agreement with a group of experts. EB is developed after the systematic retrieval and appraisal of information from the literature. It usually includes strategies for describing the strength of the evidence, and try to clearly separate opinions from evidence they make statements not just about
which of two treatment options is 'better', but quantify the absolute differences in outcome, including both benefits and harms. (6) CB-EB is developed by combining a consensus of experts and a not enough formal literature analysis to create evidence. EB guideline is the mainstream and trend of guideline development, because guidelines based on a consensus of expert opinion or on unsystematic literature survey have been criticized as not reflecting current medical knowledge and being liable to bias.(7,8) Two international specific public databases for CPG, National Guideline Clearinghouse (NGC, http://www.guideline.gov/), Guidelines International Network (G-I-N, http://www. g-i-n.net/), were the major databases of EB guidelines on WM. Because of the complexity of TCM diagnosis and intervention and lack of high quality of clinical trials, CB and CB-EB guidelines are the mainstream in TCM CPG development.(9) The first batch of CB-EB guidelines in TCM CPG development were issued in 2011.(10) In those CPGs, both WM and TCM diagnosis and TCM interventions are basically included, however the CPGs specifically focused on IM are few.(1) Though more clinical studies were conducted in IM and more IM practices were used worldwide, the CPG development in IM would still be based on CB-EB at present because there are still lack of strong and enough evidence. Similar to all CB-EB CPGs development process,(11-13) the major points for IM CPG development should also include the technical guidance and quality control, literature review (evidence accumulation), Delphi survey, the consensus conference, CPG
©The Chinese Journal of Integrated Traditional and Western Medicine Press and Springer-Verlag Berlin Heidelberg 2014 1. School of Chinese Medicine, Hong Kong Baptist University, Kowloon, Hong Kong SAR, China; 2. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing (100070), China Correspondence to: Prof. LU Ai-ping, Tel: 852-34112457, E-mail: [email protected] DOI: 10.1007/s11655-014-1961-9
Chin J Integr Med
•2•
Clinical evidences
Expert consensus
Combination of WM disease diagnosis and TCM Zheng classification
Data mining based on literatures
TCM herbs-WM drug interaction
Combination of WM interventions and TCM interventions
Synthesis of multi-resources
IM CPG report
Figure 1.
The Key Approaches Related to IM CPG Development
Notes: The different resources of information, including clinical evidence, expert consensus, data mining outcome and potential herb-drug interaction, need to be analyzed in order to get the major contents of IM CPG both in diagnosis and intervention.
drafting and edit. Based on the specificity of IM clinical practice, major contents in IM CPG should contain the diagnosis referring to "combination of WM disease diagnosis and TCM pattern classification," and the intervention referring to "combination of WM interventions and TCM interventions accordingly." Regarding to the integration of diagnostic approaches, more data are needed to support the TCM pattern classification under a specific disease with specially focusing on the indexes including TCM related symptoms and signs. Regarding to the integration of TCM and WM interventions, the herb-drug interaction would be another important content in the development of IM CPG.
major pharmacological activity, associate activity and sideline activity (potential side effect) of the combination therapeutics, when the pharmacological networks of the combination therapy are mapped onto the molecular networks of the disease. No doubt, IM CPG development would foster much more effective and safe IM clinical practice, when more IM CPGs are used in clinical practice.
REFERENCES 1.
2008;14:234-240. 2.
Comparing to general CPG development, some issues in the process and contents of IM CPG development could be taken into consideration (Figure 1). As to TCM pattern classification under a disease, an integrated approach could be adopted, including clinical study evidence search, expert consensus, and clinical data mining. Evidence search could find out the existed solid data though it is not enough at present, and the expert consensus would give much clear picture about TCM pattern classification in the disease, (14) and clinical data mining results would give much help for expert to develop the items in the questionnaire for Delphi survey.(15-17) As to the combination of WM and TCM intervention in IM CPG development, evidence search, expert consensus and data mining could be also used to find out the best therapeutic combination, but more importantly in IM practice, the TCM herb and WM drug interaction should be discussed or predicted in the IM CPG development. Modern bioinformatics approaches, with big and solid data support, can be used to predict the
Lu AP, Ding XR, Chen KJ. Current situation and progress in integrative medicine in China. Chin J Integr Med Lesley R, Andrew W. Integrated medicine: Imbues orthodox medicine with the values of complementary medicine. BMJ 2001;322:119-120.
3.
Snyderman R, Weil AT. Integrative medicine: bringing medicine back to its roots. Arch Intern Med 2002;162:395-397.
4.
Field M, Lohr K. Clinical practice guidelines: directions for a new program. Washington (DC): National Academy Press; 1990:3.
5.
Cruse H, Winiarek M, Marshburn J, Clark O, Djulbegovic B. Quality and methods of developing practice guidelines. BMC Health Serv Res 2002;2:1-73.
6.
New Zealand Guidelines Group. Handbook for the preparation of explicit evidence-based clinical practice guidelines. New Zealand Guidelines Group; 2001:1-57.
7.
Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analyses of randomized controlled trials and recommendations of clinical experts: treatments for myocardial infarction. JAMA 1992;268:240-248.
8.
Mulrow CD. Systematic reviews: rationale for systematic reviews. BMJ 1994;309:597-599 .
9.
Yuwen Y, Shi NN, Wang LY, Xie YM, Han XJ, Lu AP. Development of clinical practice guidelines in 11 common
Chin J Integr Med
•3•
diseases with Chinese medicine interventions in China.
Hamel C, et al. Development of AMSTAR: a measurement
Chin J Integr Med 2012;12:112-119.
tool to assess the methodological quality of systematic
10. Yuwen Y, Xu JL, Shi NN, Wang LY, Han XJ, Wang YY, Lu
reviews. BMC Med Res Methodol 2007;15(7):10.
AP. Assessing the quality of the first batch of evidence-
14. Min HX, Qi YD, Chuan WS, Wang J. Application of Delphi
based clinical practice guidelines in traditional Chinese
method in Chinese medicine diagnosing and treating
medicine. Chin J Tradit Chin Med 2011;31:376-381. 11. Qaseem A, Forland F, Macbetch F, Ollenschläger G, Phillips S, van der Wees P, et al. Guidelines international network: toward intenational standards for clinical practice guidelines. Ann Intern Med 2012;156:525-531. 12. Saag KG, Teng GG, Patkar NM, Finney C, Curtis JR,
guideline. J Pediatrics of TCM (Chin) 2010;6(4):50-51. 15. Hand DJ. Principles of data mining. Drug Safety 2007;30:621-622. 16. Zhang Y, Yang J, Liu JP. The data picking applied in the research of traditional Chinese medicine. J Liaoning Univ Tradit Chin Med (Chin) 2008;10:153-154.
Paulus HE, et al. American college of rheumatology 2008
17. Zhou X, Peng Y, Liu B. Text mining for traditional Chinese
recommendations for the use of nonbiological and biologic
medical knowledge discovery: a survey. J Biomed Inform
disease--modifying antirheumatic drugs in rheumatoid
2010;43:650-660.
arthritis. Arthritis Rheum 2008;59:762-784. 13. Shea BJ, Grimshaw JM, Wells GA, Boers M, Andersson N,
(Received December 18, 2014) Edited by ZHANG Wen
