대한한방내과학회지 제4 0 권 1 호( 2 0 1 9 년 3 월) J .I n t .K o r e a nMe d .2 0 1 9 ; 4 0 ( 1 ) : 8 9 -1 1 6 h t t p : / / d x . d o i . o r g / 1 0 . 2 2 2 4 6 / j i k m. 2 0 1 9 . 4 0 . 1 . 8 9 8 9 ․투고일:2 0 1 9 . 0 3 . 0 9 ,심사일:2 0 1 9 . 0 3 . 2 5 ,게재확정일:2 0 1 9 . 0 3 . 2 8 ․교신저자:한가진 서울 강남구 봉은사로 4 6 2 소람한의약연구소 TEL:+8 2 -7 0 -4 8 0 3 -6 6 4 8 FAX:+8 2 -7 0 -8 2 8 2 -7 0 0 1 E-ma i l :k md h g j @s o r a m. k r ,Do n g -h u nKi m R e s u l t s : Te na r t i c l e sw e r eo b t a i n e df r o m p u b me da n dE mb a s e .Th e r ew a sn og u i d e l i n ef o rc l i n i c a lt r i a l so nu s i n gh e r b a l me d i c i n ef o rt r e a t i n gl i v e rc a n c e r .Al lt h ep a r t i c i p a n t si n t h er e v i e we d a r t i c l e sh a dp r i ma r y l i v e rc a n c e r ,a n d t h et y p eo f i n t e r v e n t i o nv a r i e d( e . g . , d e c o c t i o n , p a t c h e s , a n dc a p s u l e s . T h ec o mp a r a t o r si n c l u d e dp l a c e b o sa n dc o n v e n t i o n a lt r e a t me n t ss u c h a sc h e mo t h e r a p y . T h eo u t c o mea s s e s s me n tme t h o d sw e r et u mo rr e s p o n s e , q u a l i t yo fl i f e , s u r v i v a l , a n dl i v e rf u n c t i o nt e s t s . A d v e r s e e v e n t so c c u r i n gd u r i n gt h et r i a lwe r ea l s oe v a l u a t e d .
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".
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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