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Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer]

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰

  • Han, Gajin (Soram Hospital of Korean Medicine) ;
  • Cho, Minji (Soram Hospital of Korean Medicine) ;
  • Park, Eunjoo (Soram Hospital of Korean Medicine) ;
  • Seong, Sin (Soram Hospital of Korean Medicine) ;
  • Kim, Sungsu (Soram Hospital of Korean Medicine) ;
  • Kim, Kwan-Il (Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Jung, Hee-Jae (Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Lee, Beom-Joon (Division of Allergy, Immune and Respiratory System, Department of Internal Medicine, College of Korean Medicine, Kyung Hee University) ;
  • Leem, Jungtae (Chung-Yeon Central Institute)
  • Received : 2019.03.04
  • Accepted : 2019.03.13
  • Published : 2019.03.31

Abstract

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. 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 guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

Keywords

References

  1. National Center Information Cancer. 2018. Republic of Korea: Ministry of Health and Welfare;Available from : https://www.cancer.go.kr. Accessed Feb 13, 2019
  2. American cancer society. Available from: https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/cancer-facts-figures-2018.html. Accessed Feb 14, 2019
  3. National Comprehensive Cancer Network. Available from: https://www.nccn.org/professionals/physician_gls/pdf/sclc.pdf. Accessed Jan 25, 2019
  4. National Comprehensive Cancer Network. Available from: https://www.nccn.org/professionals/physician_gls/pdf/nscl_blocks.pdf. Accessed Jan 25, 2019
  5. Kim YH, Kim YT, Kim HK, Park IG, Wu HG, Song SY, et al. Lung cancer clinical practice guideline. Seoul: Korean Association for the Study of Lung Cancer. 2011:1-141.
  6. The Korea Academy of Tuberculosis and Respiratory Disease. Pneumology. Seoul: Koonja. 2007: 597-634.
  7. Korean Oncology Nursing Society. Oncology Nursing : Treatment and Care. 2nd ed. Seoul: FOR NURSE. 2014: 50-70.
  8. Baek SM. Related Factors on Quality of life in Patients with Lung cancer [master's thesis]. Gwangju: Chonnam National University; 2011.
  9. Hong MN, Shim SH, Yoon SH, Choi JY, Kim YS. Development and Validity Test on Preliminary Critical Pathway of Integrative Medicine for Lung Cancer Patients Treated with Chemotherapy. J. Int. Korean Med. 2017;38(6):917-929. https://doi.org/10.22246/jikm.2017.38.6.917
  10. Jung HJ, Kim JD. The role of Korean Medicine for Treatment and Management gor Lung cancer. J of Kor. Traditional Oncology. 2015;20(1);45-54. https://doi.org/10.15432/JKTO.2015.20.1.045
  11. Chang SB, Lee TW, Kim S, Yoo IY, Kim IS, Kang KH, et al. A study of complementary and aiternative medicine used by cancer patients in Korea. J Korean Acad Adult Nurs.2006:18;92-101.
  12. Kim KS, Kim SH, Eo WK, Cheon SH, Eo SK, Jo HJ. Clinical research methodology for traditional Korean medicine treatment of lung cancer : Evidence based approach. J. Oriental Medical Classics. 2010:23(4);39-62.
  13. Korean Asociation for the Study of Lung Cancer. Korean clinical practice guidelines for lung cancer. Seoul: Korean Asociation for the Study of Lung Cancer. 2010: 1-134.
  14. 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.
  15. Chung MA. Guideline on evaluation of clinical trial of anticancer drugs. Seoul: The Pharmaceutical Society of Korea. 2006:145.
  16. 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.
  17. 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.
  18. 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.
  19. 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.
  20. 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.
  21. Lee HJ, Kim JH, Kim YK, Park CM, Chin AY, Jeong YJ. Korean Society of Thoracic Radiology Guideline for Lung Cancer Screening with Low-Dose CT. J Korean Soc Radiol 2012;67(5):349-365 https://doi.org/10.3348/jksr.2012.67.5.349
  22. Shin SG. Clinical trial status and prospect of domestic drug. Seoul: Korea Health Industry Development Institute. 2006:7-14.
  23. 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.
  24. 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.
  25. Jang SY, Cho JH, Oh MH, Kim GE, Baek JH, Lee JP, et al. General considerations in clinical trials of herbal medicine preparations. Seoul:Ministry of Food and Drug Safety. 2007:1-173.
  26. 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.
  27. Du QC, Yang KZ, Sun XF. Efficacy of auxiliary therapy with Danggui Buxue Decoction No.1 in treating patients of non-small cell lung cancer at peri-operational stage. Chin J Integr Med. 2009 ;15(3):184-188 https://doi.org/10.1007/s11655-009-0184-y
  28. Dou YQ, Yang MH, Wei ZM, Xiao C, Yang XH. The study of early application with Dixiong Decoction(地芎汤) for non- small cell lung cancer to decrease the incidence and severity of radiation pneumonitis: A prospective, randomized clinical trial. Chin J Integr Med. 2010;16(5):411-416. https://doi.org/10.1007/s11655-010-9998-x
  29. Guo L, Bai SP, Zhao L, Wang XH. Astragalus polysaccharide injection integrated with vinorelbine and cisplatin for patients with advanced non-small cell lung cancer: effects on quality of life and survival. Med Oncol. 2012;29:1656-62. https://doi.org/10.1007/s12032-011-0068-9
  30. Jiang Y, Liu LS, Shen LP, Han ZF, Jian H, Liu JX, Xu L, Li HG, Tian JH, Mao ZJ. Traditional Chinese Medicine treatment as maintenance therapy in advanced non-small-cell lung cancer: A randomized controlled trial. Complement Ther Med. 2016;24:55-62. https://doi.org/10.1016/j.ctim.2015.12.006
  31. Xue D, Han S, Jiang S, Sun H, Chen Y, Li Y, et al. Comprehensive geriatric assessment and traditional Chinese medicine intervention benefit symptom control in elderly patients with advanced non-small cell lung cancer. Med Oncol. 2015;32:114 https://doi.org/10.1007/s12032-015-0563-5
  32. Xu ZY, Jin CJ, Zhou CC, Wang ZQ, Zhou WD, Deng HB, et al. Treatment of advanced non-small-cell lung cancer with Chinese herbal medicine by stages combined with chemotherapy. J Cancer Res Clin Oncol. 2011; 137:1117-22. https://doi.org/10.1007/s00432-011-0975-3
  33. Wu WY, Yang XB, Deng H, Long SQ, Sun LS, He WF, et al. Treatment of advanced non-small cell lung cancer with extracorporeal high frequency thermotherapy combined with Chinese medicine. Chin J Integr Med. 2010;16(5):406-410. https://doi.org/10.1007/s11655-010-0535-8
  34. Benveniste MF, Welsh J, Viswanathan C, Shroff GS, Betancourt Cuellar SL, Carter BW, et al. Lung Cancer: Posttreatment Imaging: Radiation Therapy and Imaging Findings. Radiol Clin North Am. 2018;56(3):471-483. https://doi.org/10.1016/j.rcl.2018.01.011
  35. Joshi SS, Maron SB, Catenacci DV. Pembrolizumab for treatment of advanced gastric and gastroesophageal junction adenocarcinoma. Future Oncol. 2018;14(5):417-430. https://doi.org/10.2217/fon-2017-0436
  36. Ji NF, Yao LS, Li Y, He W, Yi KS, Huang M. Polysaccharide of Cordyceps sinensis enhances cisplatin cytotoxicity in non-small cell lung cancer H157 cell line. Integr Cancer Ther. 2011;10(4):359-367. https://doi.org/10.1177/1534735410392573
  37. 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):102-112.
  38. The Evidence-Based Medicine Working Group. User's Guides to the Medical Literature: Essentials of Evidence-Based Clinical Practice. second edition. AMA Press. 2002:5-15.
  39. Lee YM. Introduction to Evidence Based Medicine. Vascular Specialist International. 2003;19(2):212-219.
  40. Soda M, Choi YL, Enomoto M, Takada S, Yamashita Y, Ishikawa S, et al. Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature 2007;448(7153):561-566. https://doi.org/10.1038/nature05945
  41. Bledsoe TJ, Nath SK, Decker RH. Radiation Pneumonitis. Clin Chest Med. 2017;38(2):201-208. https://doi.org/10.1016/j.ccm.2016.12.004
  42. McDonald S, Rubin P, Phillips TL, et al. Injury to the lung from cancer therapy: clinical syndromes, measurable endpoints, and potential scoring systems. Int J Radiat Oncol Biol Phys 1995;31(5):1187-1203. https://doi.org/10.1016/0360-3016(94)00429-O
  43. Eom SK. Disease recognition of tumor, bump or mass until Han Dynasty. The Journal Of Korean Medical Classics. 2008;21(2):39-48.
  44. Brierley J, Gospodarowicz M, O'Sullivan B. The principles of cancer staging. Ecancermedicalscience. 2016;10:ed61.
  45. 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.
  46. 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(2):157-166. https://doi.org/10.1023/A:1022232624891
  47. Cho JH, Son CG, Lee YW, Yoo HS, Seong JH, Kim SY. Current Status of Studies on Cancer-Related Quality of Life Instruments. Korean J Orient Int Med. 2006;27(1):84-91.
  48. Kim HY. Tumor response assessment (WHO vs. RECIST) and problems. J Clin Cancer Res. 2007:1(2):1-6.
  49. Caillet P, Canoui-Poitrine F, Vouriot J, Berle M, Reinald N, Krypciak S, et al. Comprehensive geriatric assessment in the decision-making process in elderly patients with cancer. ELCAPA study. J Clin Oncol. 2011;29(27):3636-3642. https://doi.org/10.1200/JCO.2010.31.0664
  50. 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):555-560.
  51. Jeon BM, Lee NH. Evaluation of the safety information of the client requesting pharmaceutical clinical trials and considerations for reporting. Seoul:Ministry of Food and Drug Safety.2017:1-14.

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