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논문 기본 정보

자료유형
학술저널
저자정보
박은주 (소람한방병원) 성신 (소람한방병원) 김성수 (소람한방병원) 김진성 (경희대학교) 박재우 (경희대학교) 고석재 (경희대학교) 한가진 (소람한방병원)
저널정보
대한한의학회 대한한의학회지 대한한의학회지 제40권 제1호
발행연도
2019.3
수록면
124 - 152 (29page)

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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”.

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UCI(KEPA) : I410-ECN-0101-2019-519-000766577