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The Journal of Internal Korean Medicine > Volume 40(1); 2019 > Article
The Journal of Internal Korean Medicine 2019;40(1): 89-116.
doi: https://doi.org/10.22246/jikm.2019.40.1.89
간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰
한가진1,2, 김동훈1, 박은주1,2, 성 신1, 김성수1, 임정태3,4
1소람한방병원
2소람한의약연구소
3청연중앙연구소
4동신한방병원
Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer]
Ga-jin Han1,2, Dong-hun Kim1, Eun-joo Park1,2, Sin Seong1, Sung-su Kim1, Jung-tae Leem3,4
1Soram Hospital of Korean Medicine
2Soram Korean Medicine Research Institute
3Chung-Yeon Central Institute
4Dongshin Korean Medicine Hospital
Correspondence  Ga-jin Han ,Tel: +82-70-4803-6648, Fax: +82-70-8282-7001, Email: kmdhgj@soram.kr
Received: March 9, 2019,   Accepted: March 28, 2019,   Published online: March 30, 2019.
ABSTRACT
Objective:
This study aimed to ascertain what should be considered in the “Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer,” by analyzing existing guidelines and clinical trials.

Methods:
Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the “Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer.” Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: “liver neoplasms”; “herbal medicine”; “medicine, Korean traditional”; and “medicine, Chinese Traditional.”.

Results:
Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated.

Conclusion:
Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the “Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer.”
Key words: liver neoplasms, hepatocellular carcinoma, herbal medicinal product, clinical trial, guideline
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