AbstractObjectivesTo overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine.
MethodsA systematic literature review was conducted based on the pubmed database. The search term were ‘N-of-1 Trial’, ‘Chinese Medicine’, ‘Herbal Medicine’, ‘Kampo’. There was no restriction in year.
ResultsFour clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication.
참고문헌1. Akobeng, AK. Understanding randomised controlled trials. Archives of Disease in Childhood, (2005). 90(8), 840-844.
![]() 2. Spieth, PM, Kubasch, AS, Penzlin, AI, Illigens, BM, Barlinn, K, & Siepmann, T. Randomized controlled trials - a matter of design. Neuropsychiatric Disease and Treatment, (2016). 12, 1341-9.
![]() ![]() 3. Suresh, K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. Journal of Human Reproductive Sciences, (2011). 4(1), 8-11.
![]() ![]() ![]() 4. Jones, DS, & Podolsky, SH. The history and fate of the gold standard. Lancet, (2015). 385(9977), 1502-3.
![]() ![]() 5. Chao, J, Dai, Y, Verpoorte, R, Lam, W, Cheng, YC, & Pao, LH, et al. Major achievements of evidence-based traditional Chinese medicine in treating major diseases. Biochemical Pharmacology, (2017). 139, 94-104.
![]() ![]() 6. Sackett, DL, Rosenberg, WM, & Gray, JA, et al. Evidence based medicine: what it is and what it isn’t. BMJ, (1996). 312(7023), 71-2.
![]() ![]() ![]() 7. Guyatt, G, Sackett, D, Taylor, DW, Chong, J, Roberts, R, & Pugsley, S. Determining optimal therapy--randomized trials in individual patients. The New England Journal of Medicine, (1986). 314(14), 889-92.
![]() ![]() 8. Guyatt, GH, Keller, JL, Jaeschke, R, Rosenbloom, D, Adachi, JD, & Newhouse, MT. The n-of-1 randomized controlled trial: clinical usefulness. Our three-year experience. Annals of Internal Medicine, (1990). 112(4), 293-9.
![]() ![]() 9. Shaffer, JA, Kronish, IM, Falzon, L, Cheung, YK, & Davidson, KW. N-of-1 Randomized Intervention Trials in Health Psychology: A Systematic Review and Methodology Critique. Annals of Behavioral Medicine, (2018). 52(9), 731-742.
![]() ![]() ![]() 10. Mirza, RD, Punja, S, Vohra, S, & Guyatt, G. The history and development of N-of-1 trials. Journal of the Royal Society of Medicine, (2017). 110(8), 330-340.
![]() ![]() 11. Lillie, EO, Patay, B, Diamant, J, Issell, B, Topol, EJ, & Schork, NJ. The n-of-1 clinical trial: the ultimate strategy for individualizing medicine? Personalized Medicine, (2011). 8(2), 161-173.
![]() ![]() ![]() 12. Schork, NJ. Personalized medicine: Time for one-person trials. Nature, (2015). 520(7549), 609-11.
![]() ![]() 13. Terasawa, K. Evidence-based Reconstruction of Kampo Medicine: Part-III-How Should Kampo be Evaluated? Evidence-Based Complementary and Alternative Medicine, (2004). 1(3), 219-222.
![]() ![]() ![]() 14. Li, J, Tian, J, Ma, B, & Yang, K. N-of-1 trials in China. Complementary Therapies in Medicine, (2013). 21(3), 190-4.
![]() ![]() 15. Yoshinaga, R, Goto, Y, Inoue, H, Yano, H, Nabeshima, S, & Tahara, E. A Case of Lower Back with Extremity Pain Successfully Treated with Kanzobushito. Kampo Medicine, (2019). 70(2), 146-150.
![]() 16. Tsubo, T, Unita, A, Furuta, T, Suzuki, M, Ueno, T, & Suzuki, T, et al. A Patient with Diffuse Panbronchiolitis Treated with a Combination of Keishikyoshakuyakukasokyoto and Acupuncture. Kampo Medicine, (2019). 70(2), 99-105.
![]() 17. Jeung, CW, Jeon, SW, & Kim, HK. Reduction of Adverse Effects from Jayeumganghwa-tang for Pegylated Liposomal Doxorubicin and Carboplatin in Recurrent Ovarian Cancer. The Journal of Internal Korean Medicine, (2019). 40(6), 1278-1287.
![]() 18. Yuhong, H, Qian, L, Yu, L, Yingqiang, Z, Yanfen, L, & Shujing, Y, et al. An n-of-1 Trial Service in Clinical Practice: Testing the Effectiveness of Liuwei Dihuang Decoction for Kidney-Yin Deficiency Syndrome. Evidence-Based Complementary and Alternative Medicine, (2013). 2013, 827915.
![]() ![]() ![]() 19. Huang, H, Yang, P, Xue, J, Tang, J, Ding, L, & Ma, Y, et al. Evaluating the Individualized Treatment of Traditional Chinese Medicine: A Pilot Study of N-of-1 Trials. Evidence-Based Complementary and Alternative Medicine, (2014). 2014, 148730.
![]() ![]() ![]() 20. Huang, H, Yang, P, Wang, J, Wu, Y, Zi, S, & Tang, J, et al. Investigation into the Individualized Treatment of Traditional Chinese Medicine through a Series of N-of-1 Trials. Evidence-Based Complementary and Alternative Medicine, (2018). 2018, 5813767.
![]() ![]() ![]() 21. Li, J, Niu, J, Yang, M, Ye, P, Zhai, J, & Yuan, W, et al. Using single-patient (n-of-1) trials to determine effectiveness of traditional Chinese medicine on chemotherapy-induced leukopenia in gastric cancer: a feasibility study. Annals of Translational Medicine, (2019). 7(6), 124.
![]() ![]() ![]() 22. Li, J, Wei, D, Niu, J, Yang, M, Ge, L, & Wang, X, et al. Potential Facilitators and Barriers to Awareness of N-of-1 Trials for Physicians in Traditional Chinese Medicine. Alternative Therapies In Health And Medicine, (2018). 24(2), 44-49.
![]() 23. Xie, T, & Yu, Z. N-of-1 Design and Its Applications to Personalized Treatment Studies. Statistics in Biosciences, (2017). 9(2), 662-675.
![]() ![]() ![]() 24. Li, J, Hu, JY, Zhai, JB, Niu, JQ, Kwong, JSW, & Ge, L, et al. CONSORT extension for reporting N-of-1 trials for traditional Chinese medicine (CENT for TCM) : Recommendations, explanation and elaboration. Complementary Therapies in Medicine, (2019). 46, 180-188.
![]() ![]() 25. Chen, J, Huang, J, Li, JV, Lv, Y, He, Y, & Zheng, Q. The Characteristics of TCM Clinical Trials: A Systematic Review of ClinicalTrials.gov. Evidence-Based Complementary and Alternative Medicine, (2017). 2017, 9461415.
![]() 26. Kravitz, RL, Schmid, CH, Marois, M, Wilsey, B, Ward, D, & Hays, RD, et al. Effect of Mobile Device-Supported Single-Patient Multi-crossover Trials on Treatment of Chronic Musculoskeletal Pain: A Randomized Clinical Trial. JAMA Internal Medicine, (2018). 178(10), 1368-1377.
![]() ![]() ![]() 27. Mirza, RD, & Guyatt, GH. A Randomized Clinical Trial of n-of-1 Trials-Tribulations of a Trial. JAMA Internal Medicine, (2018). 178(10), 1378-1379.
![]() ![]() 28. Kravitz, RL, Sim, I, & Duan, N. A Case for n-of-1 Trials-Reply. JAMA Internal Medicine, (2019). 179(3), 453.
![]() ![]() 29. Terasawa, K. Evidence-based Reconstruction of Kampo Medicine: Part II-The Concept of Sho. Evidence-Based Complementary and Alternative Medicine, (2004). 1(2), 119-123.
![]() ![]() ![]() 30. Duan, N, Kravitz, RL, & Schmid, CH. Single-patient (n-of-1) trials: a pragmatic clinical decision methodology for patient-centered comparative effectiveness research. Journal of Clinical Epidemiology, (2013). 66(8 Suppl), S21-8.
![]() ![]() ![]() 31. Zucker, DR, Ruthazer, R, & Schmid, CH. Individual (N-of-1) trials can be combined to give population comparative treatment effect estimates: methodologic considerations. Journal of Clinical Epidemiology, (2010). 63(12), 1312-1323.
![]() 32. Takahashi, K, Yoshino, T, Maki, Y, Ishiuchi, K, Namiki, T, & Ogawa-Ochiai, K, et al. Identification of glycyrrhizin metabolites in humans and of a potential biomarker of liquorice-induced pseudoaldosteronism: a multi-centre cross-sectional study. Archives of Toxicology, (2019). 93(11), 3111-3119.
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