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

1.	國務院16部門聯合發布實施. 中醫藥創新發展規劃綱要(2006-2020年). 中醫藥管理雜志, 2007, 15(4): 225-230.
2.	翟靜波, 任明, 曹紅波, 等. 中醫藥輔助治療腫瘤療效評價新方法—二維一體(TIO)法. 中國循證醫學雜志, 2013, 13(11): 1280-1282.
3.	趙晨, 劉智, 商洪才. 中醫臨床療效評價差異化策略的提出—個體化研究方法學元素初探. 世界中醫藥, 2017, 12(6): 1221-1225.
4.	闞紅星, 金力, 楊艷, 等. 基于信息平臺的中醫個體化療效評價指標體系構建. 世界科學技術-中醫藥現代化, 2013, 15(2): 192-195.
5.	何易, 劉恩順. 基于個體化臨床信息利用的中醫療效評價模型構建思路. 中醫雜志, 2017, 58(7): 562-564.
6.	王俊文, 趙英凱, 王琦, 等. 中醫個體化診療療效評價現狀、方法與思路. 世界科學技術-中醫藥現代化, 2016, 18(1): 7-10.
7.	王洋, 李書楠, 王昌恩, 等. 基于整體、動態、個性化的中醫療效評價框架的構建. 中華中醫藥雜志, 2017, 32(6): 2350-2352.
8.	陳錦團, 駱云豐, 李燦東. 基于時空觀中醫療效的動態評價分析. 中華中醫藥雜志, 2017, 32(5): 1930-1932.
9.	劉玉, 黃彬, 陳生, 等. 六味地黃膠囊治療肝腎陰虛證療效評價的例隨機對照雙盲試驗. 中醫雜志, 2018, 59(11): 947-951.
10.	皇玲玲, 趙曉峰, 郭立中. 涼血化瘀方加減治療原發性血小板增多癥單病例隨機對照研究. 中醫雜志, 2019, 60(8): 680-683.
11.	蹇文淵, 路雪婧, 段俊國. 單病例隨機對照設計研究現狀與中醫辨證論治的思考. 西部中醫藥, 2015(5): 47-49.
12.	張大錚, 蹇文淵, 路雪婧, 等. 單病例隨機對照試驗與中醫藥個體化療效評價思考. 北京中醫藥, 2016, 35(6): 597-598.
13.	薛晶晶, 楊佩蘭, 王潔等. 評價中醫個體化治療: 單病例隨機對照試驗的初步研究. 循證醫學, 2016, 16(2): 103-108.
14.	井含光, 孟慶剛. 單病例隨機對照試驗在中醫藥臨床療效評價中的應用與思考. 北京中醫藥大學學報, 2018, 41(10): 842-847.
15.	翟靜波, 商洪才, 李江, 等. 單病例隨機對照試驗的統計分析方法. 中國循證醫學雜志, 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.	翟靜波, 李江, 商洪才, 等. 貝葉斯單病例隨機對照試驗簡介. 中國循證醫學雜志, 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, 譚婧, 任燕, 等. 重新認識真實世界數據研究: 更新與展望. 中國循證醫學雜志, 2020, 20(11): 1241-1246.
32.	符宇, 邵明義, 燕樹勛, 等. 真實世界研究與中醫臨床療效評價. 中醫雜志, 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.	牟瑋, 黃宇虹, 李艷芬, 等. 基于敘事醫學、循證醫學的中西醫臨床共同決策模式構建初探. 中醫雜志, 2020, 61(18): 1598-1603.
35.	王紅遷, 汪鵬, 王飛, 等. 多元數據融合的臨床輔助決策系統的研究與應用. 中國數字醫學, 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. 國務院16部門聯合發布實施. 中醫藥創新發展規劃綱要(2006-2020年). 中醫藥管理雜志, 2007, 15(4): 225-230.
2. 翟靜波, 任明, 曹紅波, 等. 中醫藥輔助治療腫瘤療效評價新方法—二維一體(TIO)法. 中國循證醫學雜志, 2013, 13(11): 1280-1282.
3. 趙晨, 劉智, 商洪才. 中醫臨床療效評價差異化策略的提出—個體化研究方法學元素初探. 世界中醫藥, 2017, 12(6): 1221-1225.
4. 闞紅星, 金力, 楊艷, 等. 基于信息平臺的中醫個體化療效評價指標體系構建. 世界科學技術-中醫藥現代化, 2013, 15(2): 192-195.
5. 何易, 劉恩順. 基于個體化臨床信息利用的中醫療效評價模型構建思路. 中醫雜志, 2017, 58(7): 562-564.
6. 王俊文, 趙英凱, 王琦, 等. 中醫個體化診療療效評價現狀、方法與思路. 世界科學技術-中醫藥現代化, 2016, 18(1): 7-10.
7. 王洋, 李書楠, 王昌恩, 等. 基于整體、動態、個性化的中醫療效評價框架的構建. 中華中醫藥雜志, 2017, 32(6): 2350-2352.
8. 陳錦團, 駱云豐, 李燦東. 基于時空觀中醫療效的動態評價分析. 中華中醫藥雜志, 2017, 32(5): 1930-1932.
9. 劉玉, 黃彬, 陳生, 等. 六味地黃膠囊治療肝腎陰虛證療效評價的例隨機對照雙盲試驗. 中醫雜志, 2018, 59(11): 947-951.
10. 皇玲玲, 趙曉峰, 郭立中. 涼血化瘀方加減治療原發性血小板增多癥單病例隨機對照研究. 中醫雜志, 2019, 60(8): 680-683.
11. 蹇文淵, 路雪婧, 段俊國. 單病例隨機對照設計研究現狀與中醫辨證論治的思考. 西部中醫藥, 2015(5): 47-49.
12. 張大錚, 蹇文淵, 路雪婧, 等. 單病例隨機對照試驗與中醫藥個體化療效評價思考. 北京中醫藥, 2016, 35(6): 597-598.
13. 薛晶晶, 楊佩蘭, 王潔等. 評價中醫個體化治療: 單病例隨機對照試驗的初步研究. 循證醫學, 2016, 16(2): 103-108.
14. 井含光, 孟慶剛. 單病例隨機對照試驗在中醫藥臨床療效評價中的應用與思考. 北京中醫藥大學學報, 2018, 41(10): 842-847.
15. 翟靜波, 商洪才, 李江, 等. 單病例隨機對照試驗的統計分析方法. 中國循證醫學雜志, 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. 翟靜波, 李江, 商洪才, 等. 貝葉斯單病例隨機對照試驗簡介. 中國循證醫學雜志, 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, 譚婧, 任燕, 等. 重新認識真實世界數據研究: 更新與展望. 中國循證醫學雜志, 2020, 20(11): 1241-1246.
32. 符宇, 邵明義, 燕樹勛, 等. 真實世界研究與中醫臨床療效評價. 中醫雜志, 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. 牟瑋, 黃宇虹, 李艷芬, 等. 基于敘事醫學、循證醫學的中西醫臨床共同決策模式構建初探. 中醫雜志, 2020, 61(18): 1598-1603.
35. 王紅遷, 汪鵬, 王飛, 等. 多元數據融合的臨床輔助決策系統的研究與應用. 中國數字醫學, 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

Abstract Full text Figures/Tables Video References Cited by

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