• The Journal of Korean Medicine
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• v.40 no.1
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• pp.124-152
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• 2019

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".

• Journal of the Korean Society of Food Science and Nutrition
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• v.34 no.2
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• pp.167-175
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• 2005

Houttuynia cordata THNUB (He; Uh-Sung-Cho) is a medicinal plant which has been widely used as a component of blood-building decoctions. This study was performed to investigate the immunomodulative effect of He in mice. In vitro experiment, the mice splenocytes proliferation and three kinds of cytokines (IL-1$\beta$, IL-6, TNF- $\alpha$) production by mice peritoneal macrophages cultured with six (methanol, hexane, chloroform, ethylacetate, butanol and water) fractions of He were used to indicate the immunomodulative effect. Ex vivo experiment, the different concentrations of He water extract was orally administrated every other day for two weeks. The production of cytokines IL-1$\beta$, IL-6, TNF- $\alpha$) secreted by activated macrophages and the mice splenocytes proliferation were used as an index for the immunocompetence. The supplementation of all six fractions of He enhanced the splenocytes proliferation at the level of 6.58$\pm$1.23∼47.82$\pm$5.48 compared to that of control in the range of 1∼50 $\mu\textrm{g}$/mL. IL-1$\beta$ production was significantly increased with the supplementation of chloroform and water extract of He. Higher level of IL-6 production was detected by the supplementation of ethylacetate, butanol and water extract. TNF - $\alpha$ production was enhanced by the supplementation of all six fractions of He. From the ex vivo study, the highest proliferation of splenocytes was seen from the mice orally administrated with the He water extract at the concentration of 500 mg/kg bw In case of cytokines production, IL-1$\beta$, IL-6, and TNF- $\alpha$ release by activated peritoneal macrophages were augmented by the oral administration of He water extract. These results indicated that He may enhance the immune function by regulating the splenocytes proliferation and cytokines production capacity in mice.