• 동의생리병리학회지
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• 제35권6호
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• pp.219-227
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• 2021

The purpose of this study is to analyze the side effects (ADR) of Traditional Chinese Medicine (TCM) injections by age, injection type, symptoms, and causes, and to find preventive solutions for ADR. For the ADR of TCM injection data collected during the search period from January 1, 2010 to December 31, 2020, the correlation between each section was analyzed by subdividing it into age, injection type, symptoms and causes. CNKI, PubMed, and EMBASE were used to collect the clinical data. 'Chinese herbal injection', 'Traditional Chinese Medicine injection', 'Chinese herbal injection side effect', 'Chinese herbal injection adverse drug reaction' were used for the keyword from the database. All data were collected mainly for TCM injection and the causes of ADR due to TCM injection. However, data not related to the relevant study or TCM injection were excluded from this study. Among a total of 941 studies collected during the search period from January 1, 2010 to December 31, 2020, a total of 10 studies were selected for final analysis. In 1462 clinical data sets, ADR by gender was higher in males than females. By age, 41 to 60 years were the most common. The incidence of ADR by injection type was highest in the blood regulating injection type. Data analysis showed Xueshuantong injection had the highest ADR. Among the symptoms of ADR, skin diseases were the most common. The most common cause of ADR was the unreasonable use of drugs. In China, for ADR management, the use of TCM injections is recommended according to the basic principles for the clinical use of TCM injections established by the Chinese government. In this study, we analyzed the current status and causes of ADR in TCM injections, and found a preventive solution. It is expected that it can be used as basic data to increase the usability of pharmacopuncture and herbal medicines in Korea in the future.

• 대한한방소아과학회지
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• 제36권3호
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• pp.75-86
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• 2022

Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.

• 한국환경농학회지
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• 제39권2호
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• pp.142-169
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• 2020

BACKGROUND: A new analytical method has been developed to determine 261 pesticide residues in herbal medicines. METHODS AND RESULTS: The extraction of pesticides was carried out by modified method of the Korea Food Standards Codex sample extraction and determination was performed using GC-MS/MS and LC-MS/MS. During the pre-treatment process of the test method, Solid-liquid separation was changed to centrifugation. The method was validated by the precision and accuracy results. 261 pesticides spiked at three level 20, 50, 100 ug/kg in herbal medicines. The limit of quantification of method were 4-40 ug/kg for GC-MS/MS and 2-45 ug/kg for LC-MS/MS, respectively. Among the pesticides analysed by GC-MS/MS and LC-MS/MS, 244 pesticides (94% of total number) in chinese matrimony vine and 224 pesticides (86% of total number) in korean angelica root and 231 pesticides (89% of total number) in jujube and 214 (82% of total number) in cnidium showed recoveries in the range of 70-120% with RSD⪯20%. CONCLUSION: These results indicated that GC-MS/MS and LC-MS/MS analysis with the sample extraction in this study can be applied to multi-residue analysis of pesticides in herbal medicines.

• 대한한방소아과학회지
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• 제38권3호
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• pp.29-52
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• 2024

Objective This study aimed to evaluate the effect of herbal medicines on alopecia areata (AA). Methods We searched 10 Korean, English, Japanese, and Chinese databases for studies published until April 3, 2024. Randomized controlled trials (RCTs) assessing the effect of herbal medicines on AA were included. The Cochrane risk of bias tool was used to evaluate the quality of the studies. A meta-analysis was conducted according to outcome measurements, such as total effective rate (TER), full recovery rate, and recurrence rate, using the Review Manager software. Results Seventeen RCTs were included in this study, and the TER in the treatment group was 1.48 times higher than that in the control group [Risk ratio (RR): 1.48, 95% confidence interval (CI): 1.40~1.55, I² = 43%]. The full recovery rate was 2.25 times higher in the treatment group [RR: 2.25, 95% CI: 1.62~3.12, I² = 53%], and the recurrence rate was 0.22 times lower, than that of the control group [RR: 0.22, 95% CI: 0.070~0.68, I² = 0%]. Four studies reported that there were no adverse events. Four studies reported mild gastric discomfort, a mild increase in alanine aminotransferase (ALT), and constipation in the treatment group. Conclusions Our meta-analysis showed that herbal medicines are significantly effective in treating AA. However, owing to the low quality of the included studies, future clinical studies are required to determine their potential for clinical applications.

• 대한한의학회지
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• 제41권1호
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• pp.107-116
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• 2020

Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

• 한방재활의학과학회지
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• 제26권4호
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• pp.23-35
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• 2016

Objectives This systematic review is to support the effectiveness of herbal medicine for the treatment of simple obesity in adults. Methods A total of 8 electronic databases were searched in English, Chinese and Korean. Standard methodologies for the systematic review were used to search, analyze and synthesize data based on NECA's guideline for undertaking systematic review and meta-analyses for intervention. Results After screening 1781 potential articles, we identified 13 randomized controlled trials (RCTs). We conducted a meta-analysis for the study using Bangpungtongsung-san and Taeeumjowi-tang to evaluate the effectiveness of herbal medicines on weight loss compared to placebo control. Both herbs showed positive effect in weight, body mass index and waist circumference. In an analysis comparing herbal effects considering constitutions showed that proper treatment can lower adverse events. Conclusions Our results provide evidence that herbal medicine can be an effective treatment for the obesity compare to placebo or to conventional medicine without serious adverse events. Further study is needed to evaluate effectiveness of herbal medicines considering personalized treatment and its safety.

• 동의신경정신과학회지
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• 제35권1호
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• pp.69-99
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• 2024

Objectives: This study aimed to systematically review the effectiveness and safety of traditional herbal medicine treatments for metabolic syndrome (MS) in patients receiving antipsychotic drugs (APs). Methods: We searched 11 domestic and foreign databases for randomized controlled trials (RCTs) using traditional herbal medicines for MS in patients receiving APs. Results: Twenty RCTs conducted in China were included in the analysis. The most common disease among the participants was schizophrenia. Most studies used the 2004 Chinese Diabetes Society (CDS) standards as the diagnostic criteria for MS. The most used prescription was Yukultang (Liuyu-tang). The most used herbal material was Pinelliae Rhizoma, followed by Poria, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma. Traditional herbal medicines were mostly reported to improve the symptoms of MS. Conclusions: Traditional herbal medicines may be effective in improving the symptoms of MS in patients receiving APs. However, the quality of the included studies was low, and the studies were heterogeneous. Methodologically rigorous clinical studies on traditional herbal medicine treatments for MS in patients receiving APs are needed.

• 동의신경정신과학회지
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• 제20권4호
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• pp.79-89
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• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• 대한한방소아과학회지
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• 제26권4호
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• pp.61-70
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• 2012

Objectives: Literature Study of clinical cases with Traditional Chinese Medicine (TCM) as reference for Korean medicine based treatment of juvenile patients with Down's syndrome. Methods: 4 TCM journals with the highest impact factors were searched and selected among the journals listed in www.cnki.net. The search keywords were "蒙古症", "唐氏症(産生唐氏症)", "唐氏症候群", "先天愚型", "伸舌樣痴呆", "21三体綜合徵", "三染色体症", "Down's syndrome", and "Mongolism". Accordingly, searched papers were analyzed. Results: Total 6 studies were selected: RCT(5), case report(1). Among the RCT related studies, 2 studies tested the effect of Electroacupuncture (電鍼), 1 study tested the effect of Electroacupuncture and Pharmacopuncture (藥鍼) treatment together, and 2 studies tested the effect of Electroacupuncture and Herbal Medicines (藥物) co-treatment. In all the studies, the study groups showed significantly improved intelligence quotient (IQ) in comparison with the control groups. The case report showed improvement of cognitive ability and other clinical parameters as a result of Acupuncture (鍼) and Herbal Medicines co-treatment in juvenile patients with Down's syndrome. Conclusions: Clinical studies testing the effect of TCM for the treatment of Down's syndrome have been conducted in small scales, and all the studies showed a certain level of brain function improvement of the patients in the study groups. These results implicate that the methods in Korean medicine can be highly potential treatment options for the treatment of Down's syndrome. Conduction of accurate and well-controlled studies in large scale would be required to prove the effect of Korean medicine for the treatment of patients with Down's syndrome.

• 대한한의학방제학회지
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• 제20권2호
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• pp.187-197
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• 2012

Objectives : The purpose of this study is to find a reasonable solution to a current status of drug classification between the drugs of western conventional (allopathic) medicine and Korean medicine. A clear and distinct concept on the drugs of allopathic medicine and Korean medicine based on reasonable concepts and broad consensus is a pressing issue in Korea, and will facilitate the development of herbal medicinal products and pharmaceutical industry. Methods : Considering the issue of drug classification from domestic and international regulations, we reviewed the current Drug Law of Korea and China, Guidance for Industry, Botanical Drug Products of USA, Directive 2004/24/EC of the European parliament and of the council. Results : In Korea, the drug classification of allopathic medicine and Korean medicine is quite vague even though differential licensure system is enforced for the clinicians of allopathic medicine and Korean medicine field. According to the definition in the Drug Law, the scope of Korean medicine drug is so broad that even a drug made of single-compound material, as well as herbal extract of crude mixture, is regarded as a drug of Korean medicine, as long as the material may be separated from medicinal herbs, animal tissues, or mineral resources. Only new compound not found in natural resources are outside of the scope of Korean medicine drug. In USA and EU, medicinal products manufactured from herbs are approved by separate regulations for the herbs with special waivers. In China, the category of new medicine and the definition of allopathic medicine and traditional chinese medicine are clearly specified and classified. Conclusions : As medicines are validated therapeutic materials for efficacy and toxicity, we suggest that generally the concept of conventional medicines is based on a single compound that has been synthesized and individually validated and that of Korean medicines is based on a compound extracted from natural materials or a complex of compounds that has been validated as a whole in its totality.