• 제목/요약/키워드: Herbal medicine safety

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현행 한국의 한약재 중금속기준개정 필요성 고찰 (Problems of Legal Permissible Limit in Metal Level of Herbal Drugs Using Current Korea)

  • 이선동;박경식
    • 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.

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소아 IgA 신병증의 한약 치료에 대한 임상연구 동향 (Trend of Clinical Studies on Herbal Medicine Treatment for IgA Nephropathy in Children)

  • 정지은;정민정
    • 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.

당뇨한약복합처방(Herbal Remedy for Diabetes Mellitus-01, HRDM-01)이 당뇨병성 흰쥐의 간 및 혈중 지질에 미치는 영향 (Effects of Herbal Remedy for Diabetes Mellitus-01 (HRDM-01) on Liver and Serum Lipid Level in Diabetic Rats)

  • 김형우;하태훈;조명래;조수인
    • 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.

소아 기능성 위장 장애의 한약 치료에 대한 임상연구 동향 - 중의학 무작위 대조군 임상시험을 중심으로 (Trends in Clinical Research of Herbal Medicine Treatment for Functional Gastrointestinal Disorders in Children - Focused on Randomized Controlled Trials in traditional Chinese medicine)

  • 이지홍;이선행;장규태
    • 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.

한약 장기복용이 발달장애아동의 간기능과 건강증진에 미치는 영향 (Influence of Taking Medicine for a Period of Time on the Liver Function and Improvement of the Developmental Disordered Children)

  • 박재형;박재현;윤영주;정슬기;이현정;임자성;반건호;문진수;백은경
    • 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.

주요우울장애에 대한 한약 단독치료의 효과와 안전성: 체계적 문헌고찰 및 메타분석 (Effectiveness and Safety of Traditional East Asian Herbal Medicine as Monotherapy for Major Depressive Disorder: A Systematic Review and Meta-Analysis)

  • 승혜빈;권희주;김상호
    • 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.

크론병의 한약 치료에 대한 최근 국내외 임상연구 동향 (Recent Domestic and International Trends in Clinical Research of Herbal Medicine Treatment for Crohn's disease)

  • 이신희;허유진;조연수
    • 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.

소아 야뇨의 한약치료에 대한 임상연구 동향 -중의학 논문을 중심으로- (Review of Clinical Researches for Herbal Medicine Treatment on Nocturnal Enuresis in Children)

  • 신혜진;이보람;이지홍;장규태
    • 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.

기능성 자궁출혈에 대한 한약치료 : 체계적 문헌 고찰 (Traditional Herbal Medicine for Dysfunctional Uterine Bleeding versus Western Medicine: A Systematic Review of Randomized Controlled Trials)

  • 박어진;조희근;최지현
    • 대한한방부인과학회지
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    • 제31권4호
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    • pp.110-127
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    • 2018
  • Objectives: To evaluate the effectiveness and safety of traditional herbal medicine (THM) in the treatment of dysfunctional uterine bleeding (DUB) versus conventional western medicine. Methods: Randomized Controlled Trials (RCTs) comparing THM vs. conventional western medicine for DUB, were obtained from PubMed, Cochrane Library, Embase, CNKI, RISS, NDSL, KISS and OASIS. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 16 RCTs with 1,659 patients were identified and reviewed. 10 RCTs reported THM was statistically effective than control group in effective rate. Also recurrent rate was estimated in 6 RCTs and was lower than control group. 7 studies observed adverse events (AEs) and severe AEs were not reported. Conclusions: Despite several limitations, this review suggested that THM was safe and effective in the treatment of DUB. THM may also decrease the recurrence rate. However, this could not be proven conclusively. To ensure evidence-based clinical practice, more sternly designed trials are warranted.

소아 틱장애의 한약치료에 대한 최신 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 - (Recent Trends in Clinical Research of Herbal Medicine for Tic Disorder in Children - Focused on Chinese Randomized Controlled Trials -)

  • 김재현;박용석;정윤경;장규태
    • 대한한방소아과학회지
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    • 제36권1호
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    • pp.38-56
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    • 2022
  • Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.