• 한국한의학연구원논문집
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• 제12권1호
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• pp.13-22
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• 2006

Background and Aims: Herbal drugs and traditional medicines have lately attracted considerable attention by global pharmaceutical corporations because the conventional chemical drugs didn't work well for many chronic diseases or intractable diseases. The government of Korea is also supporting to develop the new drug which is high value added product, and the natural medicine including herbal medicine(or Traditional Korean Medicine) have a significant presence in this field. non-clinical pharmacology/toxicology study and clinical trial are the two major criteria which estimate efficacy and safety for registration of new drugs. All of the pharmaceutical companies producing herbal medicine and the academic and the academic world of Tradition Korean Medicine have the will to develop new herbal drugs, but there are obstacles that they have neither experience nor guideline about clinical trial. Therefore for developing new herbal drugs, it is necessary to research the present conditions and comprehensive systems about clinical trial in Northeast Asian countries China, Taiwan and Japan because they have the common background with Korea in traditional medicine fields. Methods : The present state of clinical trial for herbal medicine in Korea was investigated. And then, those in China, Taiwan, Japan was also investigated. Results and conclusions : There are significant differences among 4 Southeast Asian countries Korea, China, Taiwan and Japan each in present condition, purpose, involved comprehensive system including legislation, and actual operation of clinical trial for traditional medicine.

• 대한예방한의학회지
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• 제5권1호
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• pp.31-40
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• 2001

Legal permissible limit of herbal drugs metal level in Korea is define 'less 30.0ppm in total(except mineral drugs)' including Pb Hg Cd As Cr Ni etc. This limit has a lot of problems in several factors, that is, not divide hazard and essential elements, not consider high and low toxic effect in each metal, not calculate dose-response relationship and average health behavior in Korean etc. As a that result, It has strong limits and weakness in the basic toxicology and Oriental medicine. To improve and correct these factors, We need to several new approach as like below. It must be radical study following problems in short and middle-long period in the future, toxic metal and essential element must be divide to basic toxicology and also be diverse toxic effect. But mineral drugs that included a amount of severe toxic metals is being used as active prescription drug until now. If toxic, safety and side-effect of metals will be considered, mineral drugs must prohibit instantly or use at least after examined toxic effect. But one of the most important things about herbal drugs contamination, all people and department (government, farmer and trader, oriental medicine doctors and association) will be participate cooperative and collection for preventive or the least contamination in herbal drugs.

• 대한한방소아과학회지
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• 제36권3호
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• pp.35-48
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• 2022

Objectives The purpose of this study is to review relevant clinical studies to investigate the effectiveness of herbal medicines for IgA (Immunoglobulin A) nephropathy in children. Methods Studies on herbal treatment for IgA nephropathy were searched and analyzed through electronic databases such as PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang, CiNii, J-STAGE, Oriental Medicine Advanced Searching Integrated System and Science ON. Studies included Randomized controlled trials and case series. Results We selected nine studies and analyzed the findings. In most studies, improvement of IgA nephropathy was observed after treatment, and was evaluated using factors as 24 hour urine protein, hematuria, Scr (serum creatinine) and BUN (blood urea nitrogen). The most commonly used herbs for IgA nephropathy were Poria cocos (茯苓), Astragalus membranaceus (黃芪), and Rehmannia glutinosa (生地黃). Conclusions Based on the results of the clinical studies, we identified that herbal medicine is an effective treatment for IgA nephropathy. However, additional systematic clinical studies are necessary to prove its effect and safety.

• 대한본초학회지
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• 제25권3호
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• pp.117-121
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• 2010

Objective：The Herbal Remedy for Diabetes Mellitus-01 (HRDM-01) is composed of 11 species of medicinal plants. HRDM-01 is used as anti-hyperglycaemic agent. Anti-hyperglycaemic agents in western medicine often have hepatotoxicities. Therefore, we investigated safety of HRDM-01, especially in liver functions. Methods：We investigated the effects of HRDM-01 on liver function measuring serum AST, ALT and LDH levels and histopathological changes of liver tissue using photomicroscope. In addition, we also investigated the effects on serum lipid levels such as total cholesterol, HDL-cholesterol and triglyceride. Results：In our experiment, single injection of streptozotocin elevated levels of AST and ALT in serum. But LDH level was not affected. In addition, our animal model showed elevated levels of total cholesterol and triglyceride in serum. 30 days treatment with HRDM-01 lowered serum AST level. Serum levels of ALT and LDH did not affected. In addition, HRDM-01 lowered serum triglyceride level significantly. In histopathological observation, we did not find any abnormal changes in all experimental groups. Conclusions：Briefly, HRDM-01 did not elevate serum levels of ALT, LDH, total cholesterol and did not affect histopathological changes in liver tissues. Moreover, HRDM-01 lowered serum AST, triglyceride, which are elevated by induction of diabetes mellitus. These results suggest the safety of HRDM-01 in diabetic treatment.

• 대한한방소아과학회지
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• 제35권3호
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• pp.67-88
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• 2021

Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.

• 동의생리병리학회지
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• 제20권2호
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• pp.494-497
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• 2006

A child with five delay, five ankylosis, five weakening needs to take herbal medicine for a long term. So safety, efficacy inspection for the long term usage of herbal medicine and mixed dose is needed because other medication or functional health foods, etc could be taken during this process. Operated liver function test before and after dosing herbal medicine to one hundred and sixty children who aided private oriental medicine located in Seoul, and measured the efficacy by comparing sleeping hours, morbidity, stamina, sanguineness, personality, digestion with the state before taking herbal medicine based on questionnaire done by the parents. Every children were under the limits, and there were no differences between boys and girls, and no notable differences according to family histories. There were positive results in efficacy inspection ordered as improvement in personality, stamina, sanguineness, decrease in morbidity, increase in appetite, digestion. No signs of disorder in liver function has been found during the dose of herbal medicine or simultaneous medicine, and shown promotion of health.

• 대한한방소아과학회지
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• 제35권4호
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• pp.56-74
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• 2021

Objectives The purpose of this study is to analyze the trend of herbal medicine treatment, treatment's effect and stability for Crohn's disease by reviewing clinical studies published over the past 5 years. Methods 22 articles which were published from 2017 to August, 2021 were obtained from the ScienceON, Research information sharing service (RISS), Koreanstudies Information Service System (KISS), Oriental medicine advanced searching integrated system (OASIS), China national knowledge infrastructure (CNKI), Pubmed. We analyzed the literature in regards to the treatment methods and results. Results There were 6 case reports, 1 controlled clinical trial, and 15 randomized controlled trial and in most cases, herbal medicines and Western medicines were administered in combination. The pathology of damp-heat due to spleen deficiency was the most common, and Sijunzi-tang and Shenling Baishu san were the most commonly used. As a result of the treatment, it was found that the combined administration of the herbal medicine and the Western medicine was more effective than the administration of the Western medicine alone. Conclusions Herbal treatment of Crohn's disease induced high cure rate safely than when only western treatment was applied. Future studies on safety and studies that can suggest specific guidelines for the combined administration of western and herbal medicines are needed.

• 동의신경정신과학회지
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• 제33권1호
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• pp.79-111
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• 2022

Major depressive disorder (MDD) causes a persistent feeling of sadness and loss of interest. It can lead to emotional and physical problems. Treatments such as antidepressant and cognitive behavioral therapy for MDD have many limitations. Traditional East Asian Herbal Medicine (TEAM) is a representative modality of Complementary and Integrative Medicine (CIM) which can be used for MDD. However, no study has systematically reviewed the efficacy or safety of TEAM for MDD so far. Therefore, we performed a systematic review and meta-analysis to evaluate effectiveness and safety of TEAM as a monotherapy for MDD. We only included TEAM that could be used in context of clinical setting in Korean Medicine. Outcomes were the Hamilton Depression Rating Scale (HAMD) and total effective rate (TER). After comprehensive electronic search of 11 databases, we included 28 randomized controlled trials (RCTs) that compared HM as monotherapy with antidepressant for MDD. Meta-analysis showed that TEAM had significant benefits in reducing HAMD (MD=-0.40, 95% CI: -0.67 to -0.13, p=0.003, I²=85%) and improving TER (RR=1.06, 95% CI: 1.02 to 1.10, p=0.003, I²=0%). It also appeared to be safer than antidepressant in terms of adverse effects. Methods used for RCTs were poor and the quality of evidence was graded 'low' or 'moderate'. These findings indicate that the use of HM as a monotherapy might have potential benefits in MDD treatment as an alternative to antidepressant. However, considering the methodological quality of included RCTs, the clinical evidence is uncertain. Further well-designed RCTs are required to confirm these findings.

• 대한한방소아과학회지
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• 제32권2호
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• pp.43-63
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• 2018

Objectives The purpose of this study is to evaluate the efficacy and safety of herbal medication for the treatment of nocturnal enuresis in children by analyzing randomized controlled trials conducted in China. Methods We searched literatures from China National Knowledge Infrastructure published up to 19 January, 2018. Selected literatures were collected and analyzed in order of publication year, and then demographic information, treatment method, duration of illness, duration of treatment, follow-up period, outcome measurement and adverse events. Results A total of 34 studies were selected for the analysis. In most studies, the total efficacy of the treatment group was reported to be higher than that of the control group, and the recurrence rate and complete cure rate were also found to be more effective in the herbal medicine treatment group. The most frequently used medical herb was Alpiniae Fructus (益智仁), and the use of medical herbs belong to tonifying yang (補陽藥), tonifying qi (補氣藥), and astringing essence strengthening collapse medicine (澁精縮尿止帶藥) were relatively high. The adverse events rate for the herbal medicine treatment group were significantly lower than those in the Western medicine treatment group. Conclusions This study showed that a herbal medicine treatment can be effective and safe option for treating pediatric nocturnal enuresis. However, additional well-designed clinical studies need to be performed to establish a basis.

• 한방안이비인후피부과학회지
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• 제37권3호
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• pp.1-16
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• 2024

Objectives : The purpose of this study is to investigate the effectiveness and safety of herbal medicine treatment for acute pharyngitis. Methods : 2 databases(Wangfang Med Online, CNKI) were used to search Randomized Controlled Trials(RCTs) that used herbal medicine treatment for acute pharyngitis, which were published from January 2007 until April 2024. Results : 9 RCTs were selected in this study, and all studies compared herbal medicine alone treatment with western medicine alone treatment. The most frequently used medicine was Toxin-removing medicinal(淸熱解毒藥). Platycodonis Radix(桔梗) was the most frequently used herb. Meta-analysis of nine studies showed that the Total Effective Rate(TER) of treatment group was statistically higher than that of control group(RR:1.12, 95% CI:1.06 to 1.19, p<0.00001, I²=22%). Meta-analysis of 3 studies showed that the total symptom score of treatment group statistically improved than that of control group(MD: -1.00, 95% CI: -1.30 to -0.71, p<0.00001, I²=0%). Mild adverse events such as anorexia were identified in 4 RCTs, but no serious adverse events were reported. Conclusion : Using herbal medicine alone can be more effective and safe in improving acute pharyngitis than using western medicine. But further well-designed studies are needed because heterogeneity between studies existed and the quality of the reports needs to be improved.