Method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials_Chinese Journal of Evidence-Based Medicine

Authors：

 ZHAI Jingbo ¹ , SHANG Hongcai ²

1. School of Public Health, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P. R. China;
2. Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine, Beijing 100700, P. R. China;

Corresponding author：

ZHAI Jingbo, Email: zhaijingbo@foxmail.com

Keywords：

Traditional Chinese medicine; Individual efficacy; Evaluation method; N-of-1 trial; Bayesian model

DOI：

10.7507/1672-2531.202304087

Video：

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Abstract Full text Figures/Tables Video References Cited by

The method of evaluating clinical efficacy of traditional Chinese medicine is one of the hotspots in the field of traditional Chinese medicine in recent years. How to dynamically evaluate individual efficacy is one of the key scientific problems to explain the clinical efficacy of traditional Chinese medicine. At present, there are no recognized methods of evaluating individual efficacy of traditional Chinese medicine. In this study, we provided a method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials after analyzing the current status of researches on methods of evaluating individual efficacy of traditional Chinese medicine. This method has the advantages of both N-of-1 trials and Bayesian multilevel models. It is feasible to evaluate individual efficacy of traditional Chinese medicine from the perspective of the design and analysis method. This study can provide an important basis for enriching and improving the methodology of evaluating individual efficacy of traditional Chinese medicine.

Citation： ZHAI Jingbo, SHANG Hongcai. Method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials. Chinese Journal of Evidence-Based Medicine, 2023, 23(11): 1334-1339. doi: 10.7507/1672-2531.202304087 Copy

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2.	翟静波, 任明, 曹红波, 等. 中医药辅助治疗肿瘤疗效评价新方法—二维一体(TIO)法. 中国循证医学杂志, 2013, 13(11): 1280-1282.
3.	赵晨, 刘智, 商洪才. 中医临床疗效评价差异化策略的提出—个体化研究方法学元素初探. 世界中医药, 2017, 12(6): 1221-1225.
4.	阚红星, 金力, 杨艳, 等. 基于信息平台的中医个体化疗效评价指标体系构建. 世界科学技术-中医药现代化, 2013, 15(2): 192-195.
5.	何易, 刘恩顺. 基于个体化临床信息利用的中医疗效评价模型构建思路. 中医杂志, 2017, 58(7): 562-564.
6.	王俊文, 赵英凯, 王琦, 等. 中医个体化诊疗疗效评价现状、方法与思路. 世界科学技术-中医药现代化, 2016, 18(1): 7-10.
7.	王洋, 李书楠, 王昌恩, 等. 基于整体、动态、个性化的中医疗效评价框架的构建. 中华中医药杂志, 2017, 32(6): 2350-2352.
8.	陈锦团, 骆云丰, 李灿东. 基于时空观中医疗效的动态评价分析. 中华中医药杂志, 2017, 32(5): 1930-1932.
9.	刘玉, 黄彬, 陈生, 等. 六味地黄胶囊治疗肝肾阴虚证疗效评价的例随机对照双盲试验. 中医杂志, 2018, 59(11): 947-951.
10.	皇玲玲, 赵晓峰, 郭立中. 凉血化瘀方加减治疗原发性血小板增多症单病例随机对照研究. 中医杂志, 2019, 60(8): 680-683.
11.	蹇文渊, 路雪婧, 段俊国. 单病例随机对照设计研究现状与中医辨证论治的思考. 西部中医药, 2015(5): 47-49.
12.	张大铮, 蹇文渊, 路雪婧, 等. 单病例随机对照试验与中医药个体化疗效评价思考. 北京中医药, 2016, 35(6): 597-598.
13.	薛晶晶, 杨佩兰, 王洁等. 评价中医个体化治疗: 单病例随机对照试验的初步研究. 循证医学, 2016, 16(2): 103-108.
14.	井含光, 孟庆刚. 单病例随机对照试验在中医药临床疗效评价中的应用与思考. 北京中医药大学学报, 2018, 41(10): 842-847.
15.	翟静波, 商洪才, 李江, 等. 单病例随机对照试验的统计分析方法. 中国循证医学杂志, 2017, 17(4): 494-496.
16.	Zhai J, Cao H, Ren M, et al. Reporting of core items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects is suboptimal. J Clin Epidemiol, 2016, 76: 99-107.
17.	翟静波, 李江, 商洪才, 等. 贝叶斯单病例随机对照试验简介. 中国循证医学杂志, 2017, 17(7): 848-851.
18.	Zhai JB, Li J, Chen J. The applications of Bayesian models in real-world studies of traditional Chinese medicine: a primer. Tradit Med Res, 2017, 2(2): 88-93.
19.	Porcino AJ, Shamseer L, Chan AW, et al. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ, 2020, 368: m122.
20.	Schluter PJ, Ware RS. Single patient (n-of-1) trials with binary treatment preference. Stat Med, 2005, 24(17): 2625-2636.
21.	Huber AM, Tomlinson GA, Koren G, et al. Amitriptyline to relieve pain in juvenile idiopathic arthritis: a pilot study using Bayesian metaanalysis of multiple N-of-1 clinical trials. J Rheumatol, 2007, 34(5): 1125-1132.
22.	Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
23.	Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
24.	Stunnenberg BC, Raaphorst J, Groenewoud HM, et al. Effect of mexiletine on muscle stiffness in patients with nondystrophic myotonia evaluated using aggregated N-of-1 trials. JAMA, 2018, 320(22): 2344-2353.
25.	Senarathne SGJ, Overstall AM, McGree JM. Bayesian adaptive N-of-1 trials for estimating population and individual treatment effects. Stat Med, 2020, 39(29): 4499-4518.
26.	Shrestha S, Jain S. A Bayesian-bandit adaptive design for N-of-1 clinical trials. Stat Med, 2021, 40(7): 1825-1844.
27.	Prosperi M, Min JS, Bian J, et al. Big data hurdles in precision medicine and precision public health. BMC Med Inform Decis Mak, 2018, 18(1): 139.
28.	Schork NJ. Personalized medicine: Time for one-person trials. Nature, 2015, 520(7549): 609-611.
29.	Percha B, Baskerville EB, Johnson M, et al. Designing robust N-of-1 studies for precision medicine: simulation study and design recommendations. J Med Internet Res, 2019, 21(4): e12641.
30.	Davidson KW, Cheung YK. Envisioning a future for precision health psychology: innovative applied statistical approaches to N-of-1 studies. Health Psychol Rev, 2017, 11(3): 292-294.
31.	王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究: 更新与展望. 中国循证医学杂志, 2020, 20(11): 1241-1246.
32.	符宇, 邵明义, 燕树勋, 等. 真实世界研究与中医临床疗效评价. 中医杂志, 2019, 60(7): 546-550.
33.	Nikles J, Onghena P, Vlaeyen JWS, et al. Establishment of an international collaborative network for N-of-1 trials and single-case designs. Contemp Clin Trials Commun, 2021, 23: 100826.
34.	牟玮, 黄宇虹, 李艳芬, 等. 基于叙事医学、循证医学的中西医临床共同决策模式构建初探. 中医杂志, 2020, 61(18): 1598-1603.
35.	王红迁, 汪鹏, 王飞, 等. 多元数据融合的临床辅助决策系统的研究与应用. 中国数字医学, 2019, 14(11): 18-20.
36.	Samuel J, Holder T, Molony D. N-of-1 trials as a decision support tool in clinical practice: a protocol for a systematic literature review and narrative synthesis. Healthcare (Basel), 2019, 7(4): 136.
37.	Nikles CJ, Clavarino AM, Del Mar CB. Using n-of-1 trials as a clinical tool to improve prescribing. Br J Gen Pract, 2005, 55(512): 175-180.

1. 国务院16部门联合发布实施. 中医药创新发展规划纲要(2006-2020年). 中医药管理杂志, 2007, 15(4): 225-230.
2. 翟静波, 任明, 曹红波, 等. 中医药辅助治疗肿瘤疗效评价新方法—二维一体(TIO)法. 中国循证医学杂志, 2013, 13(11): 1280-1282.
3. 赵晨, 刘智, 商洪才. 中医临床疗效评价差异化策略的提出—个体化研究方法学元素初探. 世界中医药, 2017, 12(6): 1221-1225.
4. 阚红星, 金力, 杨艳, 等. 基于信息平台的中医个体化疗效评价指标体系构建. 世界科学技术-中医药现代化, 2013, 15(2): 192-195.
5. 何易, 刘恩顺. 基于个体化临床信息利用的中医疗效评价模型构建思路. 中医杂志, 2017, 58(7): 562-564.
6. 王俊文, 赵英凯, 王琦, 等. 中医个体化诊疗疗效评价现状、方法与思路. 世界科学技术-中医药现代化, 2016, 18(1): 7-10.
7. 王洋, 李书楠, 王昌恩, 等. 基于整体、动态、个性化的中医疗效评价框架的构建. 中华中医药杂志, 2017, 32(6): 2350-2352.
8. 陈锦团, 骆云丰, 李灿东. 基于时空观中医疗效的动态评价分析. 中华中医药杂志, 2017, 32(5): 1930-1932.
9. 刘玉, 黄彬, 陈生, 等. 六味地黄胶囊治疗肝肾阴虚证疗效评价的例随机对照双盲试验. 中医杂志, 2018, 59(11): 947-951.
10. 皇玲玲, 赵晓峰, 郭立中. 凉血化瘀方加减治疗原发性血小板增多症单病例随机对照研究. 中医杂志, 2019, 60(8): 680-683.
11. 蹇文渊, 路雪婧, 段俊国. 单病例随机对照设计研究现状与中医辨证论治的思考. 西部中医药, 2015(5): 47-49.
12. 张大铮, 蹇文渊, 路雪婧, 等. 单病例随机对照试验与中医药个体化疗效评价思考. 北京中医药, 2016, 35(6): 597-598.
13. 薛晶晶, 杨佩兰, 王洁等. 评价中医个体化治疗: 单病例随机对照试验的初步研究. 循证医学, 2016, 16(2): 103-108.
14. 井含光, 孟庆刚. 单病例随机对照试验在中医药临床疗效评价中的应用与思考. 北京中医药大学学报, 2018, 41(10): 842-847.
15. 翟静波, 商洪才, 李江, 等. 单病例随机对照试验的统计分析方法. 中国循证医学杂志, 2017, 17(4): 494-496.
16. Zhai J, Cao H, Ren M, et al. Reporting of core items in hierarchical Bayesian analysis for aggregating N-of-1 trials to estimate population treatment effects is suboptimal. J Clin Epidemiol, 2016, 76: 99-107.
17. 翟静波, 李江, 商洪才, 等. 贝叶斯单病例随机对照试验简介. 中国循证医学杂志, 2017, 17(7): 848-851.
18. Zhai JB, Li J, Chen J. The applications of Bayesian models in real-world studies of traditional Chinese medicine: a primer. Tradit Med Res, 2017, 2(2): 88-93.
19. Porcino AJ, Shamseer L, Chan AW, et al. SPIRIT extension and elaboration for n-of-1 trials: SPENT 2019 checklist. BMJ, 2020, 368: m122.
20. Schluter PJ, Ware RS. Single patient (n-of-1) trials with binary treatment preference. Stat Med, 2005, 24(17): 2625-2636.
21. Huber AM, Tomlinson GA, Koren G, et al. Amitriptyline to relieve pain in juvenile idiopathic arthritis: a pilot study using Bayesian metaanalysis of multiple N-of-1 clinical trials. J Rheumatol, 2007, 34(5): 1125-1132.
22. Vohra S, Shamseer L, Sampson M, et al. CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. BMJ, 2015, 350: h1738.
23. Li J, Hu JY, Zhai JB, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : recommendations, explanation and elaboration. Complement Ther Med, 2019, 46: 180-188.
24. Stunnenberg BC, Raaphorst J, Groenewoud HM, et al. Effect of mexiletine on muscle stiffness in patients with nondystrophic myotonia evaluated using aggregated N-of-1 trials. JAMA, 2018, 320(22): 2344-2353.
25. Senarathne SGJ, Overstall AM, McGree JM. Bayesian adaptive N-of-1 trials for estimating population and individual treatment effects. Stat Med, 2020, 39(29): 4499-4518.
26. Shrestha S, Jain S. A Bayesian-bandit adaptive design for N-of-1 clinical trials. Stat Med, 2021, 40(7): 1825-1844.
27. Prosperi M, Min JS, Bian J, et al. Big data hurdles in precision medicine and precision public health. BMC Med Inform Decis Mak, 2018, 18(1): 139.
28. Schork NJ. Personalized medicine: Time for one-person trials. Nature, 2015, 520(7549): 609-611.
29. Percha B, Baskerville EB, Johnson M, et al. Designing robust N-of-1 studies for precision medicine: simulation study and design recommendations. J Med Internet Res, 2019, 21(4): e12641.
30. Davidson KW, Cheung YK. Envisioning a future for precision health psychology: innovative applied statistical approaches to N-of-1 studies. Health Psychol Rev, 2017, 11(3): 292-294.
31. 王雯, 谭婧, 任燕, 等. 重新认识真实世界数据研究: 更新与展望. 中国循证医学杂志, 2020, 20(11): 1241-1246.
32. 符宇, 邵明义, 燕树勋, 等. 真实世界研究与中医临床疗效评价. 中医杂志, 2019, 60(7): 546-550.
33. Nikles J, Onghena P, Vlaeyen JWS, et al. Establishment of an international collaborative network for N-of-1 trials and single-case designs. Contemp Clin Trials Commun, 2021, 23: 100826.
34. 牟玮, 黄宇虹, 李艳芬, 等. 基于叙事医学、循证医学的中西医临床共同决策模式构建初探. 中医杂志, 2020, 61(18): 1598-1603.
35. 王红迁, 汪鹏, 王飞, 等. 多元数据融合的临床辅助决策系统的研究与应用. 中国数字医学, 2019, 14(11): 18-20.
36. Samuel J, Holder T, Molony D. N-of-1 trials as a decision support tool in clinical practice: a protocol for a systematic literature review and narrative synthesis. Healthcare (Basel), 2019, 7(4): 136.
37. Nikles CJ, Clavarino AM, Del Mar CB. Using n-of-1 trials as a clinical tool to improve prescribing. Br J Gen Pract, 2005, 55(512): 175-180.

Chinese Journal of Evidence-Based Medicine

Method of dynamically evaluating individual efficacy of traditional Chinese medicine based on Bayesian N-of-1 trials

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