The Journal of Korean Medicine (대한한의학회지)

The Society of Korean Medicine (대한한의학회)
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Analysis of Existing Guidelines and Controlled Clinical Trials for Development of [Guideline of Clinical Trials with Herbal Medicinal Products for Colorectal Cancer]

결장직장암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 대조군 임상시험 고찰

  • Park, Eunjoo (Soram Hospital of Korean Medicine) ;
  • Seong, Sin (Soram Hospital of Korean Medicine) ;
  • Kim, Sungsu (Soram Hospital of Korean Medicine) ;
  • Kim, Jinsung (Department of Gastroenterology, College of Korean Medicine, Kyung Hee University) ;
  • Park, Jae-Woo (Department of Gastroenterology, College of Korean Medicine, Kyung Hee University) ;
  • Ko, Seok-Jae (Department of Gastroenterology, College of Korean Medicine, Kyung Hee University) ;
  • Han, Gajin (Soram Hospital of Korean Medicine)
  • Received : 2019.02.26
  • Accepted : 2019.03.14
  • Published : 2019.03.31
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Abstract

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

Keywords

References

  1. National Center Information Cancer[Internet]. Goyang-si, Republic of Korea: Ministry of Health and Welfare; [cited 2019 Jan 25]. Available from : https://www.cancer.go.kr
  2. Arnold M, Sierra MS, Laversanne M, et al. Global patterns and trends in colorectal cancer incidence and mortality. Gut 2017;66:683-691. https://doi.org/10.1136/gutjnl-2015-310912
  3. Global Cancer Observatory[Internet]. Lyon, France: International Agency for Research on Cancer;[cited 2019 Jan 25]. Available from: http://gco.iarc.fr/today/home.
  4. Committee of Korean Clinical Practice Guideline for Colon and Rectal Cancer. Korean Clilnical Practice Guideline for Colon and Rectal Cancer v1.0. Seoul: Korean Academy of Medical Sciences. 2012: 21-47.
  5. National Comprehensive Cancer Network[internet]. Plymouth Meeting, USA: National Comprehensive Cancer Network;[cited 2019 Jan 25]. Available from: https://www.nccn.org/professionals/physician
  6. Lee YJ. Management Behavior for Symptoms and Quality of Life on the Side Effects of Chemotherapy in Gastrointestinal Cancer Patients [master's thesis]. Suwon-si, Republic of Korea: Ajou university; 2012.
  7. American cancer society[Internet]. Atlanta, Georgia, USA: (C) 2019 American Cancer Society, Inc; [cited 2019 Jan 25]. Available from: https://www.cancer.org/cancer/colon-rectal-cancer.html
  8. Lim SJ. Study on cancer patients presenting to the emergency department due to chemotherapy induced side effects [master's thesis]. Seoul, Republic of Korea: Seoul National University; 2013.
  9. Lee SS, Park YJ, Han SH, Park JS. The Adverse Effects of Radiotherapy and Its Management in the Hospice and Palliative Care Patients. Korean journal of hospice and palliative care. 2011;14(2):61-70. https://doi.org/10.14475/kjhpc.2011.14.2.61
  10. Kim EH, Suh SR. A longitudinal path analysis of symptom, fatigue and quality of life in patients with colorectal cancer during chemotherapy. J Health Info Stat 2018;43(3):200-207. https://doi.org/10.21032/jhis.2018.43.3.200
  11. Takegawa Y, Ikushima H, Ozaki K, Furutani S, Kawanaka T, Kudoh T. et al. Can Kampo therapy prolong the life of cancer patients? J Med Invest 2008; 55(1-2):99-105. https://doi.org/10.2152/jmi.55.99
  12. Zhuang SR, Chen SL, Tsai JH, Huang CC, Wu TC, Liu WS, et al. Effec of citronellol and the Chinese medical herb complex on cellular immunity of cancer patients receiving chemotherapy/radiotherapy. Phytother Res 2009;23(6):785-790. https://doi.org/10.1002/ptr.2623
  13. Kang YH, Hong MN, Han CW, Choi JY, Park SH, Kim SY. Review on Clinical Studies of Traditional Herbal Medicine and Acupuncture Treatments for Colorectal Cancer Patients. J Physiol & Pathol Korean Med. 2016;30(4):219-28. https://doi.org/10.15188/kjopp.2016.08.30.4.219
  14. Han GJ, Seong S, Kim SS, Kim JS, Park JW. Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for gastric cancer]. J Korean Med. 2017;38(3):124-142. https://doi.org/10.13048/jkm.17031
  15. Luo Q, Asher GN. Complementary and alternative medicine use at a comprehensive cancer center. Integr Cancer Ther. 2017;16:104-109. https://doi.org/10.1177/1534735416643384
  16. Park BK, Wang JH, Cho JH, Son CG. Review of Randomized Controlled Trials using Herbal Remedies on Cancer Patients. J Korean Oriental Med. 2010;31(5):12-32.
  17. Oh HK, Lee JY, Ryu HS, Yoon SW. Review of Clinical cancer Research Methodology of Botanical Agents. J of Kor. Traditional Oncology. 2015;20(1):11-21. https://doi.org/10.15432/JKTO.2015.20.1.011
  18. Lee YM. Introduction to Evidence Based Medicine. Vascular Specialist International. 2003;19(2):212-9.
  19. Kim JY, Yoo HS, Cho JH. A Preliminary Study for Development of Clinical Practice Guidelines of Korean Medicine in Colorectal Cancer. Journal of Haehwa Medicine. 2016;24(2):65-82.
  20. Shin SG. Clinical trial status and prospect of domestic drug. Seoul: Korea Health Industry Development Institute. 2006:7-14.
  21. Shin HG, Lee KG, Bae SH. A study on the clinical trial guidelines of herbal medicinal drug. Seoul:Ministry of Food and Drug Safety. 2005:1-174.
  22. Shin HK, Kang JS, Kim YC, Lee KG, Yu YB, Bae SH. A Study on the clinical trial guideline of herbal medical drug(II). Seoul:Ministry of Food and Drug Safety. 2005:1-538.
  23. Ko SG, Jeong SK, Kwon DR, Seon SH, Ko HY, Jang BH, et al. Research on outcome indicators for clinical trials of herbal medicinal products. Seoul:Ministry of Food and Drug Safety. 2006:16-132.
  24. Kim SH, Namgung MA, Chang YS, Jeong SK, Kim JS, Yoon SW, et al. Study on Development of Assessment Guideline and Endpoints for Clinical Trial with Antitumor Natural Products. Korean J Oriental Physiology & Pathology. 2006;20(6):1678-1727.
  25. Chung MA. Guideline on evaluation of clinical trial of anticancer drugs. Seoul: The Pharmaceutical Society of Korea. 2006:145.
  26. Ministry of Food and Drug Safety. General considerations in clinical trials of herbal medicine preparations. Seoul:Ministry of Food and Drug Safety. 2007.
  27. Drug Evaluation Department Oncology and Antimicrobial Products Division. Guidelines for clinical testing of anti-cancer drugs and non-clinical test data for approval of items. Cheongju: Korea Food & Drug Administration. 2010:1-13.
  28. Lee SH, Han ES, Kim SH, Yun KE, Eom JE, Park SR, et al. Guidelines for clinical trial of anti-cancer drugs. Cheongju: National Institute of Food and Drug Safety Evaluation. 2015:1-31.
  29. Lee SH, Han ES, Kim SH, Yun KE, Eom JE, Park SR, et al. Guidelines for non-clinical trial of anti-cancer drugs. Cheongju: National Institute of Food and Drug Safety Evaluation. 2015:1-13.
  30. Lee SH, Han ES, Kim SH, Yun KE, Park SR, Kim DH, et al. National Institute of Food and Drug Safety Evaluation. Guidelines for Exemption of Anticancer Drug Data in Bridging Study. Cheongju: National Institute of Food and Drug Safety Evaluation. 2016:1-26.
  31. Kim DC, Park JY, Moon HJ, Kang IH, Kim JY, Kim HM, et al. Quality guidelines of herbal medicine for clinical trial. Cheongju: National Institute of Food and Drug Safety Evaluation. 2017:1-27.
  32. Lee NH, Lee SD, Kim HS, Kim BS, Kang MS, Lee IS, et al. Guideline for the use of clinical trial medicines for therapeutic purposes. Cheongju: Ministry of Food and Drug Safety.2018:1-47.
  33. Lee BI, Hong SP, Kim SE, Kim SH, Kim HS, Hong SN et al. Korean Guidelines for Colorectal Cancer Screening and Polyp Detection. Korean J Gastroenterol. 2012;59(2):65-84. https://doi.org/10.4166/kjg.2012.59.2.65
  34. Kummar S, Copur MS, Rose M, Wadler S, Stephenson J, O'Rourke M, Brenckman W, Tilton R, Liu SH, Jiang Z, Su T, Cheng YC, Chu E. A phase I study of the chinese herbal medicine PHY906 as a modulator of irinotecan-based chemotherapy in patients with advanced colorectal cancer. Clin Colorectal Cancer. 2011;10(2):85-96. https://doi.org/10.1016/j.clcc.2011.03.003
  35. Cao B, Li ST, Li Z, Deng WL. Yiqi zhuyu decoction combined with FOLFOX-4 as first-line therapy in metastatic colorectal cancer. Chin J Integr Med. 2011;17(8):593-9. https://doi.org/10.1007/s11655-011-0822-z
  36. Nishioka M, Shimada M, Kurita N, Iwata T, Morimoto S, Yoshikawa K, Higashijima J, Miyatani T, Kono T. The Kampo medicine, Goshajinkigan, prevents neuropathy in patients treated by FOLFOX regimen. Int J Clin Oncol. 2011;16(4):322-7. https://doi.org/10.1007/s10147-010-0183-1
  37. Yoshikawa K, Shimada M, Nishioka M, Kurita N, Iwata T, Morimoto S, et al. The effects of the Kampo medicine (Japanese herbal medicine) "Daikenchuto" on the surgical inflammatory response following laparoscopic colorectal resection. Surg Today. 2012;42(7):646-51. https://doi.org/10.1007/s00595-011-0094-4
  38. Chen WT, Yang TS, Chen HC, Chen HH, Chiang HC, Lin TC, et al. Effectiveness of a novel herbal agent MB-6 as a potential adjunct to 5-fluoracil-based chemotherapy in colorectal cancer. Nutr Res. 2014;34(7):585-94. https://doi.org/10.1016/j.nutres.2014.06.010
  39. Matsuda C, Munemoto Y, Mishima H, Nagata N, Oshiro M, Kataoka M, et al. Double-blind, placebo-controlled, randomized phase II study of TJ-14 (Hangeshashinto) for infusional fluorinated-pyrimidine-based colorectal cancer chemotherapy-induced oral mucositis. Cancer Chemother Pharmacol. 2015;76(1):97-103. https://doi.org/10.1007/s00280-015-2767-y
  40. Oki E, Emi Y, Kojima H, Higashijima J, Kato T, Miyake Y, et al. Preventive effect of Goshajinkigan on peripheral neurotoxicity of FOLFOX therapy (GENIUS trial): a placebo-controlled, double-blind, randomized phase III study. Int J Clin Oncol. 2015;20(4):767-75. https://doi.org/10.1007/s10147-015-0784-9
  41. Katsuno H, Maeda K, Kaiho T, Kunieda K, Funahashi K, Sakamoto J, et al. Clinical efficacy of Daikenchuto for gastrointestinal dysfunction following colon surgery: a randomized, double-blind, multicenter, placebo-controlled study. Jpn J Clin Oncol. 2015;45(7):650-6. https://doi.org/10.1093/jjco/hyv056
  42. Fei B, Dai W, Zhao S. Efficacy, Safety, and Cost of Therapy of the Traditional Chinese Medicine, Catalpol, in Patients Following Surgical Resection for Locally Advanced Colon Cancer. Med Sci Monit. 2018;24:3184-92. https://doi.org/10.12659/MSM.907569
  43. Zhou LY, Shan ZZ, You JL. Clinical observation on treatment of colonic cancer with combined treatment of chemotherapy and Chinese herbal medicine. Chin J Integr Med. 2009;15(2):107-11. https://doi.org/10.1007/s11655-009-0107-y
  44. Xu HX, Huang XE, Li Y, Li CG, Tang JH. A clinical study on safety and efficacy of Aidi injection combined with chemotherapy. Asian Pac J Cancer Prev. 2011;12(9):2233-6.
  45. Chien TJ, Liu CY, Lu RH, Kuo CW, Lin YC, Hsu CH. Therapeutic efficacy of Traditional Chinese medicine, "Kuan-Sin-Yin", in patients undergoing chemotherapy for advanced colon cancer - A controlled trial. Complement Ther Med. 2016;29:204-12. https://doi.org/10.1016/j.ctim.2016.10.001
  46. Cheon CH, Park SJ, Jang BH, Shin YC, Ko SG. The Analysis of usage of Symptom Differentiation in Clinical Trials in Korean Medicine for Cancer Patients. spkom. 2015:19(1):61-70.
  47. Lyseng-Williamson KA, Fenton C. Docetaxel: a review of its use in metastatic breast cancer. Drugs. 2005;65(17):2513-31. https://doi.org/10.2165/00003495-200565170-00007
  48. Jeong TY, Lee YW, Cho JG, Yoo HS. Analysis of Clinical Characteristics for 899 Cancer Patients Treated at an Oriental Hospital. Korean J Orient Int Med. 2010;31(1):102-12.
  49. Yoshikawa K, Shimada M, Wakabayashi G, Ishida K, Kaiho T, Kitagawa Y,et al. Effect of Daikenchuto, a Traditional Japanese Herbal Medicine, after Total Gastrectomy for Gastric Cancer: A Multicenter, Randomized, Double -Blind, Placebo-Controlled, Phase II Trial. J Am Coll Surg. 2015;221(2):571-8. https://doi.org/10.1016/j.jamcollsurg.2015.03.004
  50. Krishnan AV, Goldstein D, Friedlander M, Kiernan MC. Oxaliplatin-induced neurotoxicity and the development of neuropathy. Muscle Nerve. 2015;32:51-60.
  51. Rubenstein EB, Peterson DE, Schubert M, Keefe D, McGuire D, Epstein J et al. Mucositis study section of the multinational association for supportive care in cancer; international society for oral oncology. Clinical practice guidelines for the prevention and treatment of cancer therapy-induced oral and gastrointestinal mucositis. Cancer. 2004;100:2026-46. https://doi.org/10.1002/cncr.20163
  52. Brierley J, Gospodarowicz M, O'Sullivan B. The principles of cancer staging. E cancer medical science. 2016;10:ed61.
  53. Kim JB, An KS. A Comparative Study between East and West Medicine on the Colorectal Cancer. Journal of physiology & pathology in Korean medicine. 1995;10:89-127.
  54. Montazeri A, Milroy R, Hole D, McEwen J, Gillis CR. How quality of life data contribute to our understanding of cancer patients' experiences? A study of patients with lung cancer. Quality of Life Research. 2003;12:157-166. https://doi.org/10.1023/A:1022232624891
  55. Montazeri A, Milroy R, Hole D, McEwen J, Gillis CR. Quality of life in patients with lung cancer: as an important prognostic factor. Lung Cancer. 2001;31:233-40. https://doi.org/10.1016/S0169-5002(00)00179-3
  56. Lee NH, Cho JH, Son CG, Yoo HS, Lee YW, Yoon DH, et al. Analysis of Studies on Quality of Life according to Cancer Types and Symptoms. Korean J Orient Int Med. 2006:27(3):555-60.
  57. Lee EH, Park HB, Kim MW, Kang SH, Lee HJ, Lee WH, et al. Analyses of the Studies on Cancer-Related Quality of Life Published in Korea. Radiat Oncol J. 2002.29(4):359-66.
  58. Kim HY. Tumor response evaluation(WHO vs. RECIST) and problems. J Clin Cancer Res. 2007:1(1):1-6.
  59. Therasse P1, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada., J Natl Cancer Inst. 2000;92(3):205-16. https://doi.org/10.1093/jnci/92.3.205
  60. Kim HY. Tumor response assessment (WHO vs. RECIST) and problems. J Clin Cancer Res. 2007:1(2):1-6.
  61. Ministry of Food and Drug Safety. Evaluation of the safety information of the client requesting pharmaceutical clinical trials and considerations for reporting. 2017.8