An Overview on Evidence-Based Medicine and Medical Informatics in Traditional Chinese Medicine Practice
Abstract
This chapter describes how best to look at the evidence-base of the rich experience-based disciplines of traditional Chinese medicine in this era of highly advance of biomedicine, science-orientated development and information technology. It is emphasized that there is a need in using modified modalities that can focus on the inclusion of holistic TCM diagnosis and treatment outcomes of individual patients in randomized clinical trial for TCM products studies and that in practice individual patients’ reported outcomes linked with biomedical parameters may provide evidence-base treatment efficacy. Using TCM formulae for treatment of female infertility as an example for IT contribution to data analysis, it is suggested that continuing feedback between practitioners in each field will help refining IT analysis of TCM informatics in general.
Keywords
Traditional Chinese Medicine Chinese Herbal Medicine Conventional Medicine Synergy Index Traditional Chinese Medicine TheoryReferences
- C. Acquadro, R. Berzon, D. Dubois, N.K. Leidy, P. Marquis, D. Revicki, M. Rothman, Incorporating the patient’s perspective into drug development and communication: an ad hoc task force report of the Patient-Reported Outcomes (PRO) Harmonization Group meeting at the Food and Drug Administration, February 16, 2001. Value Health 6, 522–531 (2003)CrossRefGoogle Scholar
- E. Ainy, P. Mirmiran, S. Zahedi Asl, F. Azizi, Prevalence of metabolic syndrome during menopausal transition Tehranian women: Tehran Lipid and Glucose Study (TLGS). Maturitas 58, 150–155 (2007)CrossRefGoogle Scholar
- Z.X. Bian, D. Moher, S. Dagenais, Y.P. Li, L. Liu, T.X. Wu, J.X. Miao, Improving the quality of randomized controlled trials in Chinese herbal medicine, part II: control group design. Zhong xi yi jie he xue bao (J. Chin. Integr. Med.) 4, 130–136 (2006)CrossRefGoogle Scholar
- S. Campbell, M. Whitehead, Oestrogen therapy and the menopausal syndrome. Clin. Obstet. Gynaecol. 4, 31–47 (1977)Google Scholar
- K. Chan, Chinese medicinal materials and their interface with Western medical concepts. J. Ethnopharmacol. 96, 1–18 (2005)CrossRefGoogle Scholar
- K. Chan, L. Cheung, Interactions between Chinese Herbal Medicinal Products and Orthodox Drugs, Taylor & Francis Group, September 11, 2000 by CRC Press ISBN 9789057024139 Ca#TF3184Google Scholar
- M. Deng, X.Q. Sui, S.B. Zhu, W. Ma, Y. Xu, Z.M. Chen, Clinical observation on the treatment of atrial fibrillation with amiodarone combined with Shenmai injection (). Chin. J. Integr. Med. 16, 453–456 (2010)CrossRefGoogle Scholar
- L. Donald, Patient-Reported Outcomes (PROs): an organizing tool for concepts, measures, and applications. Qol Newslett. 31, 1–5 (2003)Google Scholar
- F.Y. Edgeworth, Mathematical Psychics: An Essay on the Application of Mathematics to the Moral Sciences (C.K. Paul & co., London, 1881)Google Scholar
- E. Ernst, Methodological aspects of Traditional Chinese Medicine (TCM). Ann. Acad. Med. Singapore 35, 773–774 (2006)Google Scholar
- E. Ernst, M.H. Pittler, Alternative therapy bias. Nature 385, 480 (1997)CrossRefGoogle Scholar
- A.Y. Fan, L. Lao, R.X. Zhang, A.N. Zhou, B.M. Berman, Preclinical safety evaluation of the aqueous acetone extract of Chinese herbal formula modified Huo Luo Xiao Ling Dan. Zhong Xi Yi Jie He Xue Bao 8, 438–447 (2010)CrossRefGoogle Scholar
- B. Flaws, The Treatment of Modern Western Diseases with Chinese Medicine (Blue Poppy Press, Boulder, 2005)Google Scholar
- Q. Geng, B.D. Lu, X.J. Huang, Effect of modified tianxiong powder in treating oligospermia and asthenospermia. Zhongguo Zhong Xi Yi Jie He Za Zhi 30, 496–498 (2010)Google Scholar
- Y. Gong, Q. Zha, L. Li, Y. Liu, B. Yang, L. Liu, A. Lu, Y. Lin, M. Jiang, Efficacy and safety of Fufangkushen colon-coated capsule in the treatment of ulcerative colitis compared with mesalazine: a double-blinded and randomized study. J. Ethnopharmacol. 141, 592–598 (2012)CrossRefGoogle Scholar
- F.L. Guo, C. Han, Q.P. Liu, L.J. Liu, Clinical observation on the effect of Tongbi Heji plus syndrome differentiation treatment for 90 rheumatoid arthritis patients. J. Tradit. Chin. Med. 10, 34–37 (2008)Google Scholar
- Y. He, A. Lu, Y. Zha, X. Yan, Y. Song, S. Zeng, W. Liu, W. Zhu, L. Su, X. Feng, X. Qian, C. Lu, Correlations between symptoms as assessed in traditional Chinese medicine (TCM) and ACR20 efficacy response: a comparison study in 396 patients with rheumatoid arthritis treated with TCM or Western medicine. J. Clin. Rheumatol. 13, 317–321 (2007)CrossRefGoogle Scholar
- S.C. Hsieh, J.N. Lai, P.C. Chen, C.C. Chen, H.J. Chen, J.D. Wang, Is Duhuo Jisheng Tang containing Xixin safe? A four-week safety study. Chin. Med. 5, 6 (2010)CrossRefGoogle Scholar
- A.R. Jadad, D. Rennie, The randomized controlled trial gets a middle-aged checkup. JAMA 279, 319–320 (1998)CrossRefGoogle Scholar
- G. Jia, M.B. Meng, Z.W. Huang, X. Qing, W. Lei, X.N. Yang, S.S. Liu, J.C. Diao, S.Y. Hu, B.H. Lin, R.M. Zhang, Treatment of functional constipation with the Yun-chang capsule: a double-blind, randomized, placebo-controlled, dose-escalation trial. J. Gastroenterol. Hepatol. 25, 487–493 (2010)CrossRefGoogle Scholar
- M. Jiang, J. Zhao, A. Lu, Q. Zha, Y. He, Does gastrointestinal adverse drug reaction influence therapeutic effect in the treatment of rheumatoid arthritis? J. Altern. Complement. Med. 16, 143–144 (2010)CrossRefGoogle Scholar
- M. Jiang, C. Lu, G. Chen, C. Xiao, Q. Zha, X. Niu, S. Chen, A. Lu, Understanding the molecular mechanism of interventions in treating rheumatoid arthritis patients with corresponding traditional Chinese medicine patterns based on bioinformatics approach. Evid. Based Complement. Alternat. Med.: eCAM 2012, 129452 (2012a)Google Scholar
- M. Jiang, C. Lu, C. Zhang, J. Yang, Y. Tan, A. Lu, K. Chan, Syndrome differentiation in modern research of traditional Chinese medicine. J. Ethnopharmacol. 140, 634–642 (2012b)CrossRefGoogle Scholar
- M. Jiang, C. Zhang, G. Zheng, H. Guo, L. Li, J. Yang, C. Lu, W. Jia, A. Lu, Traditional Chinese medicine Zheng in the era of evidence-based medicine: a literature analysis. Evid. Based Complement. Alternat. Med.: eCAM 2012, 409568 (2012c)Google Scholar
- M. Jun, C. Foote, J. Lv, B. Neal, A. Patel, S.J. Nicholls, D.E. Grobbee, A. Cass, J. Chalmers, V. Perkovic, Effects of fibrates on cardiovascular outcomes: a systematic review and meta-analysis. Lancet 375, 1875–1884 (2010)CrossRefGoogle Scholar
- R. Ko, Adverse reactions to watch for in patients using herbal remedies. West. J. Med. 171, 181–186 (1999)Google Scholar
- K.F. Leung, F.B. Liu, L. Zhao, J.Q. Fang, K. Chan, L.Z. Lin, Development and validation of the Chinese quality of life instrument. Health Qual. Life Outcomes 3, 26 (2005)CrossRefGoogle Scholar
- X. Li, C. Zhang, Q. Shi, T. Yang, Q. Zhu, Y. Tian, C. Lu, Z. Zhang, Z. Jiang, H. Zhou, X. Wen, H. Yang, X. Ding, L. Liang, Y. Liu, Y. Wang, A. Lu, Improving the efficacy of conventional therapy by adding andrographolide sulfonate in the treatment of severe hand, foot, and mouth disease: a randomized controlled trial. Evid. Based Complement. Alternat. Med.: eCAM 2013, 316250 (2013)Google Scholar
- J.P. Liu, M. Zhang, W.Y. Wang, S. Grimsgaard, Chinese herbal medicines for type 2 diabetes mellitus. Cochrane Database Syst. Rev. 3, CD003642 (2004)Google Scholar
- T. Liu, C. Liu, P.X. Gao, C.P. Yu, Clinical study on method of “tonifying the lung to check the liver” for treatment of chronic cholecystitis. Chin. Acupunct. Moxib. 12, 29–30 (2005)MATHGoogle Scholar
- D. Liu, H. Lin, X. Wang, W. Zhou, G. Chen, W. Guo, J. Ye, Z. Xu, H. Chen, X.M. Chen, Z. Lai, C. Xiang, Influence of removing blood stasis and tonifying liver and kidney method on quality of life in patients with essential hypertension: randomized controlled observation. Chin. J. Clin. Rehabil. 23, 9–12 (2006a)Google Scholar
- J.P. Liu, M. Yang, Y.X. Liu, M.L. Wei, S. Grimsgaard, Herbal medicines for treatment of irritable bowel syndrome. Cochrane Database Syst. Rev. 25(1), CD004116 (2006b)Google Scholar
- A.P. Lu, K.J. Chen, Integrative medicine in clinical practice: from pattern differentiation in traditional Chinese medicine to disease treatment. Chin. J. Integr. Med. 15, 152 (2009)CrossRefGoogle Scholar
- A.P. Lu, H.W. Jia, C. Xiao, Q.P. Lu, Theory of traditional Chinese medicine and therapeutic method of diseases. World J. Gastroenterol. 10, 1854–1856 (2004)Google Scholar
- A.P. Lu, S.S. Zhang, Q.L. Zha, D.H. Ju, H. Wu, H.W. Jia, C. Xiao, S. Li, H. Jian, Correlation between CD4, CD8 cell infiltration in gastric mucosa, Helicobacter pylori infection and symptoms in patients with chronic gastritis. World J. Gastroenterol. 11, 2486–2490 (2005)Google Scholar
- A.P. Lu, X.R. Ding, K.J. Chen, Current situation and progress in integrative medicine in China. Chin. J. Integr. Med. 14, 234–240 (2008)CrossRefGoogle Scholar
- C. Lu, X. Niu, C. Xiao, G. Chen, Q. Zha, H. Guo, M. Jiang, A. Lu, Network-based gene expression biomarkers for cold and heat patterns of rheumatoid arthritis in traditional Chinese medicine. Evid. Based Complement. Alternat. Med.: eCAM 2012, 203043 (2012a)Google Scholar
- C. Lu, C. Xiao, G. Chen, M. Jiang, Q. Zha, X. Yan, W. Kong, A. Lu, Cold and heat pattern of rheumatoid arthritis in traditional Chinese medicine: distinct molecular signatures indentified by microarray expression profiles in CD4-positive T cell. Rheumatol. Int. 32, 61–68 (2012b)CrossRefGoogle Scholar
- K.S. Poon, J. Poon, M. McGrane, X. Zhou, P. Kwan, R. Zhang, B. Liu, J. Gao, C. Loy, K. Chan, D. and Sze, A Novel Approach in Discovering Significant Interactions from TCM Patient Prescription Data, International Journal of Data Mining and Bioinformatics, 5(4), 353–367 (2011)Google Scholar
- V.R. Mesch, L.E. Boero, N.O. Siseles, M. Royer, M. Prada, F. Sayegh, L. Schreier, H.J. Benencia, G.A. Berg, Metabolic syndrome throughout the menopausal transition: influence of age and menopausal status. Climacteric 9, 40–48 (2006)CrossRefGoogle Scholar
- U.A. Meyer, Pharmacogenetics and adverse drug reactions. Lancet 356, 1667–1671 (2000)CrossRefGoogle Scholar
- G. Nestler, Traditional Chinese medicine. Med. Clin. North Am. 86, 63–73 (2002)CrossRefGoogle Scholar
- K.A. Phillips, D.L. Veenstra, E. Oren, J.K. Lee, W. Sadee, Potential role of pharmacogenomics in reducing adverse drug reactions: a systematic review. JAMA 286, 2270–2279 (2001)CrossRefGoogle Scholar
- X.Y. Qin, X.X. Li, S. Suteanu, Comparative study on Chinese medicine and western medicine for treatment of prolapse of lumbar intervertebral disc. Chin. Acupunct. Moxib. 5, 53–56 (2007)Google Scholar
- H. Qing, S.F. Wang, J.M. Fan, I.L.H. Zha, J.Y. Mao, L.J. Sun, R.L. Zhang, Multi-center clinical study of Rhadiola extract injection on the treatment of stable angina pectoris of coronary heart disease with cardiac blood stasis syndrome. Chin. Tradit. Pat. Med. 3, 20–33 (2009)Google Scholar
- K. Rothman, The estimation of synergy or antagonism. Am. J. Epidemiol. 103, 506–511 (1976)Google Scholar
- K.F. Schulz, I. Chalmers, R.J. Hayes, D.G. Altman, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 273, 408–412 (1995)CrossRefGoogle Scholar
- Y.H. Shen, R. Nahas, Complementary and alternative medicine for treatment of irritable bowel syndrome. Can. Fam. Physician Medecin de famille canadien 55, 143–148 (2009)Google Scholar
- C. Stevinson, M.H. Pittler, E. Ernst, Garlic for treating hypercholesterolemia. A meta-analysis of randomized clinical trials. Ann. Intern. Med. 133, 420–429 (2000)CrossRefGoogle Scholar
- S.C. Sze, K.L. Wong, W.K. Liu, T.B. Ng, J.H. Wong, H.P. Cheung, C.M. Yow, E.S. Chu, Q. Liu, Y.M. Hu, K.W. Tsang, W.S. Lee, Y. Tong, Regulation of p21, MMP-1, and MDR-1 expression in human colon carcinoma HT29 by Tian Xian Liquid, a Chinese medicine formula. In vitro and in vivo. Integr. Cancer Ther. 10, 58–69 (2011)Google Scholar
- J.L. Tang, S.Y. Zhan, E. Ernst, Review of randomised controlled trials of traditional Chinese medicine. BMJ (Clinical research ed) 319, 160–161 (1999)CrossRefGoogle Scholar
- X.L. Tong, Q. Ni, F.M. Lian, J.Q. Hu, F.H. Yu, Y. Ou, Q. Xue, Z. Jiang, S.T. Wu, H. Jiang, T.S. Gao, (2009)Google Scholar
- D. Topkis, Supermodularity and Complementarity (Princeton University Press, Princeton, 1998)Google Scholar
- M.R. Trusheim, E.R. Berndt, F.L. Douglas, Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nat. Rev. Drug Discov. 6, 287–293 (2007)CrossRefGoogle Scholar
- J.P. Vader, Randomised controlled trials: a user’s guide. BMJ (Clinical research ed) 317, 1258 (1998)CrossRefGoogle Scholar
- H. van Wietmarschen, K. Yuan, C. Lu, P. Gao, J. Wang, C. Xiao, X. Yan, M. Wang, J. Schroen, A. Lu, G. Xu, J. van der Greef, Systems biology guided by Chinese medicine reveals new markers for sub-typing rheumatoid arthritis patients. J. Clin. Rheumatol. 15, 330–337 (2009)CrossRefGoogle Scholar
- N. Vipond, Intervertebral disc replacement (2007), http://www.acc.co.nz/PRD_EXT_CSMP/groups/external_communications/documents/reports_results/prd_ctrb091239.pdf. Accessed 28 Sep 2010
- J.A. Walters, E.H. Walters, R. Wood-Baker, Oral corticosteroids for stable chronic obstructive pulmonary disease. Cochrane Database Syst. Rev., CD005374 (2005)Google Scholar
- H. Wang, H.C. Shang, J.H. Zhang, J. Chen, B.Z. Sun, D.D. Shang, Y.Z. Xiang, H.B. Cao, M. Ren, L.P. Cuo, B.L. Zhang, Niuhuang Jiangya preparation for treatment of essential hypertension: a systematic review. Liaoning J. Tradit. Chin. Med. 35, 649–652 (2008) [in Chinese]Google Scholar
- S.Z. Wang, H.L. Lin, H.M. Song, W.H. Zhong, T.X. Wu, G.J. Liu, S.Q. Chen, Conservative in the treatment of protrusion of cervical vertebra intervertebral disc: a systematic review. Chin. J. Evid. Based Med. 9, 331–336 (2009) [in Chinese]Google Scholar
- L. Wang, R.M. Zhang, G.Y. Liu, B.L. Wei, Y. Wang, H.Y. Cai, F.S. Li, Y.L. Xu, S.P. Zheng, G. Wang, Chinese herbs in treatment of influenza: a randomized, double-blind, placebo-controlled trial. Respir. Med. 104, 1362–1369 (2010)CrossRefGoogle Scholar
- C. Wang, B. Cao, Q.Q. Liu, Z.Q. Zou, Z.A. Liang, L. Gu, J.P. Dong, L.R. Liang, X.W. Li, K. Hu, X.S. He, Y.H. Sun, Y. An, T. Yang, Z.X. Cao, Y.M. Guo, X.M. Wen, Y.G. Wang, Y.L. Liu, L.D. Jiang, Oseltamivir compared with the Chinese traditional therapy maxingshigan-yinqiaosan in the treatment of H1N1 influenza: a randomized trial. Ann. Intern. Med. 155, 217–225 (2011)CrossRefGoogle Scholar
- Y.G. Wang, M. Jiang, R.B. Wang, Q.L. Zha, S.J. Zhang, G.Q. Zhou, X.W. Li, Y.Y. Wang, A.P. Lv, Duration of viral shedding of influenza A (H1N1) virus infection treated with oseltamivir and/or traditional Chinese medicine in China: a retrospective analysis. J. Tradit. Chin. Med. (Chung i tsa chih ying wen pan)//sponsored by All-China Association of Traditional Chinese Medicine, Academy of Traditional Chinese Medicine 32, 148–155 (2012)Google Scholar
- L.S. Wei Jinqi, H. Weining, Compared with Tagamet in treating chronic gastric ulcer. Chin. J. Integr. Tradit. West. Med. S1, 29–30 (1994)Google Scholar
- J.A. Wessels, S.M. van der Kooij, S. le Cessie, W. Kievit, P. Barerra, C.F. Allaart, T.W. Huizinga, H.J. Guchelaar, A clinical pharmacogenetic model to predict the efficacy of methotrexate monotherapy in recent-onset rheumatoid arthritis. Arthritis Rheum. 56, 1765–1775 (2007)CrossRefGoogle Scholar
- B. Wu, M. Liu, S. Zhang, Dan Shen agents for acute ischaemic stroke. Cochrane Database Syst. Rev. 18(2), CD004295 (2007)Google Scholar
- T. Wu, Y. Li, Z. Bian, G. Liu, D. Moher, Randomized trials published in some Chinese journals: how many are randomized? Trials 10, 46 (2009)CrossRefGoogle Scholar
- J.X. Xie, H.T. Hu, D.N. Xiao, H.Z. Xie, C.B. Zhu, W.T. Yang, X.X. Huang, X.J. He, G.R. Liang, Z.G. Wang, Safety and efficacy of Qianliean Suppository for chronic prostatitis of damp-heat and blood-stasis syndrome: a randomized, single-blind, parallel controlled, multi-centered phase III clinical trial. Zhonghua Nan Ke Xue 15, 1049–1052 (2009)Google Scholar
- D.Y. Xu, J. Shu, Q.Y. Huang, L. Liu, S.P. Zhao, A comparative study of the efficacy and safety Zhibitai and atorvastatin. Zhonghua Nei Ke Za Zhi 49, 392–395 (2010a)Google Scholar
- D.Y. Xu, J. Shu, Q.Y. Huang, B. Wasti, C. Chen, L. Liu, S.P. Zhao, Evaluation of the lipid lowering ability, anti-inflammatory effects and clinical safety of intensive therapy with Zhibitai, a Chinese traditional medicine. Atherosclerosis 211, 237–241 (2010b)CrossRefGoogle Scholar
- Y.H. Xu, J.H. Wang, F.X. Yang, X.Z. He, 8. The effects of respiratory rehabilitation training on pulmonary function and quality of life of patients with COPD. Chin. J. Rehabil. 2, 42–44 (2010c)Google Scholar
- H. Yang, J. Yang, Z. Wen, Q. Zha, G. Nie, X. Huang, C. Zhang, A. Lu, M. Jiang, X. Wang, Effect of combining therapy with traditional Chinese medicine-based psychotherapy and herbal medicines in women with menopausal syndrome: a randomized controlled clinical trial. Evid. Based Complement. Alternat. Med.: eCAM 2012, 354145 (2012)Google Scholar
- H.G. Yi, G.Z. Huang, G.J. Liu, Efficacy and safety of Levoamlodipine Besylate for essential hypertension: a systematic review. Chin. J. Evid. Based Med. 8, 543–550 (2008) [in Chinese]Google Scholar
- Z. Yu, G. Wang, G.Y. Chen, J. Chang, Y. Zhang, R.M. Zhang, Muo-luo-dan. Concentrated pill in treatment of chronic atrophic gastritis (the stomach-yin of deficiency and stagnated blood of stomach meridian): a prospective, randomized, controlled trial. West China Med. J. 2, 287–289 (2007)Google Scholar
- Q. Zha, S. Lin, C. Zhang, C. Chang, H. Xue, C. Lu, M. Jiang, Y. Liu, Z. Xiao, W. Liu, Y. Shang, J. Chen, M. Wen, A. Lu, Xiaoqinglong granules as add-on therapy for asthma: latent class analysis of symptom predictors of response. Evid. Based Complement. Alternat. Med.: eCAM 2013, 759476 (2013)Google Scholar
- L. Zhao, K. Chan, Building a bridge for integrating Chinese medicine into conventional healthcare: observations drawn from the development of the Chinese quality of life instrument. Am. J. Chin. Med. 33, 897–902 (2005)CrossRefGoogle Scholar
- L. Zhao, A.Y. Li, H. Lv, F.Y. Liu, F.H. Qi, Traditional Chinese medicine Ningdong granule: the beneficial effects in Tourette’s disorder. J. Int. Med. Res. 38, 169–175 (2010)CrossRefGoogle Scholar
- W. Zhou, Y.Q. Zhong, H.M. Yang, H.L. Jiang, J.J. Fu, W.B. Zhang, B. Mao, Traditional Chinese medicine in the treatment of chronic obstructive pulmonary disease in stable stage: a systematic review of randomized controlled trials. Chin. J. Evid. Based Med. 9, 311–318 (2009) [in Chinese]Google Scholar
- C.X. Zhou, X. Cui, X.Q. Li, H.L. Zeng, H.H. Ni, C.S. Huang, J. Wu, J.C. Shi, M.L. Feng, Y.G. Wu, Clinical research on combined herbal medicine and acupuncture in treating poststroke depression. Shanghai J. Tradit. Chin. Med. 5, 52–54 (2010a)Google Scholar
- C.Y. Zhou, J.Y. Tang, D.Y. Fang, Clinical study on active rheumatoid arthritis treated with simiao xiaobi decoction. Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi (Chinese journal of integrated traditional and Western medicine//Zhongguo Zhong xi yi jie he xue hui, Zhongguo Zhong yi yan jiu yuan zhu ban) 30, 275–279 (2010b)Google Scholar
- J. Zhu, X. Wan, Y. Zhu, X. Ma, Y. Zheng, T. Zhang, Evaluation of salidroside in vitro and in vivo genotoxicity. Drug Chem. Toxicol. 33, 220–226 (2010)CrossRefGoogle Scholar