• Title/Summary/Keyword: Herbal medicine safety

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Herbal Medicine for Sarcopenia: A Systematic Review of Randomized Controlled Trials (근감소증에 대한 한약 치료 : 체계적 문헌 고찰)

  • Se-eun Chun;Soo-hyung Lee;Yong-jeen Shin;Sun-ho Shin
    • The Journal of Internal Korean Medicine
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    • v.44 no.6
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    • pp.1118-1138
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    • 2023
  • Objectives: Sarcopenia is an age-associated skeletal muscle disorder that can profoundly impact the health of elderly people. However, the efficacy of herbal medicine in sarcopenia is uncertain. This review aims to investigate evidence of the effect of herbal medicine on sarcopenia. Methods: We systematically searched 12 electronic databases for relevant randomized controlled trials (RCTs). Only trials that met the inclusion criteria were selected, and the characteristics of the included studies were extracted and synthesized in a narrative manner. The quality of the included studies was assessed using Cochrane's Risk of Bias (RoB) 2.0 tool. Results: 7 RCTs involving 672 participants with sarcopenia met the inclusion criteria. The intervention combining herbal medicine and conventional treatment (i.e., exercise, nutritional support) had a significant therapeutic effect compared with the conventional treatment, showing improvement in muscle strength (i.e., grip strength), muscle mass (i.e., appendicular skeletal muscle mass index), and physical function (i.e., gait speed, short physical performance battery, and timed up and go test). However, the methodological quality of the included RCTs was relatively low due to their high RoB, making it difficult to evaluate the efficacy of herbal medicine in sarcopenia. In terms of safety, several adverse events were reported. Conclusion: This review suggests that herbal medicine has a positive effect on muscle strength, muscle mass, and physical performance in elderly patients with sarcopenia, but there is a clear need for further research in this area.

Analysis of Studies on Yukmijihwang-tang for Establishment of Evidence Based Medicine (EBM 구축을 위한 육미지황탕 문헌 분석 연구)

  • Lee, Jun-Kyoung;Lee, Nam-Hun;Ha, Hye-Kyoung;Lee, Ho-Young;Jung, Da-Young;Choi, Ji-Yoon;Seo, Chang-Sub;Shin, Hyun-Kyu
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.23 no.1
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    • pp.15-26
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    • 2009
  • The purpose of this report was to provide the information about activity and safety of Yukmijihwang-tang by analyzing domestic/international papers and theses about Yukmijihwang-tang. Domestic/international papers and theses related to Yukmijihwang-tang were reviewed and analyzed. These papers were then classified by year, experimental method, and activity subject. The following results were obtained in this study. The study of Yukmijihwang-tang started from 1978 and was rapidly increased after 1990s. The study of Yukmijihwang-tang was continuously increased now and was mainly forcused on experimental model rather than clinical study. The paper of SCI journal or non-SCI journal was 27 volume and the other domestic paper was 64 volume. The total papers of Yukmijihwang-tang, 91 volume was analysed in this study. Allatoin, gallic acid, loganin, morroniside, paeoniflorin, paenol, urosolic acid were determined in Yukmijihwang-tang by using HPLC and HPLC-MS-MS. In classified Yukmijihwang-tang paper by experimental method and animal, more than a half study was in vivo experiment used rat. Furthermore clinical experiments were performed variously. As these studies were classified by subject, papers related to renal function were most abundant by 16 papers. Besides there were several papers related to cognitive vitality, anti-diabetic effect, immuno-regulation, reproductive activity, anti-oxidant effect, liver function, anti-cancer and blood pressure depress. According to basic research and clinic research data, it is supported that Yukmijihwang-tang was useful prescription in renal function, cognitive vitality, anti-diabetic effect and reproductive activity. Many study of basic and clinic research were performed and reported variously on Yukmijihwang-tang in domestic/international journal. According to basic research and clinic research data, it is supported that Yukmijihwang-tang was useful prescription in renal function, cognitive vitality, anti-diabetic effect and reproductive activity. However, studies on efficacy and mechanism of Yukmijihwang-tang should be conducted at the molecular biology level and studies on safety of Yukmijihwang-tang need to be completed at the clinical level.

Good Laboratory Practice Requirements in Oriental Pharmacy

  • Seo, Min-Jun;Lee, Jae-Jun;Park, Jin-Han
    • Journal of Evidence-Based Herbal Medicine
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    • v.1 no.1
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    • pp.29-34
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    • 2008
  • Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

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A Survey on General Public's Experience and Perception of Korean Medicine Treatment for Developing Clinical Practice Guideline of Nausea and Vomiting of Pregnancy (임신오조 한의표준임상진료지침 개발을 위한 일반인 대상 의료 이용 경험 및 인식도 조사)

  • Hyo-Jeong Jung;Su-Ji Choi;Dong-Il Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.2
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    • pp.69-84
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    • 2023
  • Objectives: This study was conducted to reflect the public's perspective when developing Korean Medicine (KM) Clinical Practice Guideline (CPG) for nausea and vomiting of pregnancy (NVP). Methods: 317 respondents who had experienced nausea and vomiting during current or past pregnancy completed the questionnaire online, and we analyzed their answers. Results: 1. 24% of all respondents had received KM treatment. The most common reason for choosing KM treatment was "it would be relatively safe for pregnant women and fetuses", and the reason for not choosing KM treatment was "they did not know much about it". 2. Respondents who had experienced KM treatment for NVP had felt the effects of KM treatment (79%), and chose herbal medicine as the most effective and preferred treatment. 3. 64.1% of respondents who had not experienced KM treatment for NVP preferred cooperative treatment with Western medicine. They answered that herbal medicine would be the most effective treatment, but preferred acupuncture. 4. The most important factor when treating NVP was "the safety of treatments". 59% of all respondents perceived KM treatment is safe for NVP. The treatments perceived as safest were herbal medicine and acupuncture, while the treatments with the least safety information were pharmacopuncture and electro-acupuncture. 5. Treatments that medical consumers were comprehensively interested in were acupuncture, KM treatment & Fluid, herbal medicine, moxibustion, and acupressure, in order. Conclusions: This study revealed the public's experience of using medical care, preference and perception of KM treatment for NVP. Therefore we would reflect the patients' clinical needs in the CPG.

Establishment of Pre-Harvest Residue Limit(PHRL) of the Fungicide Amisulbrom during Cultivation of Winter-Grown Cabbage (엇갈이배추 재배기간 중 살균제 Amisulbrom의 생산단계 잔류허용기준 설정)

  • Ahn, Kyung-Geun;Kim, Gyeong-Ha;Kim, Gi-Ppeum;Kim, Min-Ji;Hong, Seung-Beom;Hwang, Young-Sun;Kwon, Chan-Hyeok;Son, Young Wook;Lee, Young Deuk;Choung, Myoung-Gun
    • Korean Journal of Environmental Agriculture
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    • v.34 no.2
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    • pp.120-127
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    • 2015
  • BACKGROUND: Supervised residue trials were conducted to establish pre-harvest residue limit(PHRL), a criterion to ensure the safety of the pesticide residue in the crop harvest, of amisulbrom for winter-grown cabbage in two fields. Following to application of amisulbrom on the crop, time-course study was carried out to obtain the amisulbrom dissipation of statistical significance which enabled to calculate the predicted values of PHRL. METHOD AND RESULTS: During cultivation under greenhouse condition, samples of winter-grown cabbage were collected at 0, 1, 3, 5, 7 and 10 days after amisulbrom application, and subjected to residue analysis. Analytical method was validated by recoveries ranging 93.7~100.0% as well as limit of quantitation(LOQ) of 0.04 mg/kg. Amisulbrom residues in winter-grown cabbage gradually decreased as time elapsed. The dissipation rate of the residue would be affected by intrinsic degradation along with dilution by the cabbage growth. The decay pattern was well fitted by the simple first-order kinetics. CONCLUSION: Biological half-lives of amisulbrom in winter-grown cabbage ranged 3.7~4.1 days in two field conditions. Based on the regression of amisulbrom dissipation, PHRLs of amisulbrom in winter-grown cabbage were recommended as 8.86~9.47 and 4.21~4.35 mg/kg for 10 and 5 days before harvest, respectively.

World research trends and problems in papers relating metal contamination level of herbal medicines (한약 금속오염과 관련된 세계적인 인식경향 -발표된 논문을 중심으로-)

  • Lee Sun-Dong;Lee Jung-Seok;Park Kyung-Sik
    • Journal of Society of Preventive Korean Medicine
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    • v.6 no.1
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    • pp.117-128
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    • 2002
  • Metal problems in herbal medicine are not regulate properly by law and public management around world country until this time. General people belief as safety about herbal since natural material. And almost all persons can also purchase by their-self and use by self-prescription in reality. As this result herbal medicines can always occur acute and chronic toxicity by not proper use problems, side-effect and overdose. Heavy metal toxic diseases in historical view point was big accidents that didnot forget including minamata and itai-itai in Japan. These accident's teach to us must not use toxic metal level and not include or at least Pb Hg As Cd in all kind material use and intake by people, especially herbal. Herbal contamination research is beginner state that had not many papers until nowadays. Even if this pan had some papers, it had negative result and bigger and larger than problems level because of one way research trend of not many sample case-report and screening test of dried herbal form in chiefly. Many persons have afraid and risk thinking about herbal, animal and minerals since these cause. Further research related this subject will be needed at fact of epidemiology including case-control and cohort study for more precision research affecting in short and long term intake of oriental medicines

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A Study on the Processing Standard of REALGAR

  • Kwak, Hwa-Sun;Byun, Young-Ho;Lee, Soo-Chan;Lee, Hyo-Jeong;Park, Seong-Cheol;Kim, Hye-Sung;Kwon, Dong-Yeul
    • Journal of Evidence-Based Herbal Medicine
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    • v.3 no.1
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    • pp.1-7
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    • 2010
  • While herbal medicine including mineral herbal medicine mostly provides microelements to the human body thanks to abundant metallic elements, its harmfulness has been raised due to elements of heavy metals. Harmfulness of mineral herbal medicine needs to be analyzed quantitatively as well as qualitatively so that specificity of herbal medicine including mineral herbal medicine can be reflected. Consequently, the following aims should be set up to mineral herbal medicine, REALGAR, standard processing of REALGAR and the standards of processed drugs should be secured. On the basis of the results of this study, the reasonable measures to develop the processing method and the test method for heavy metals were presented. Such measures are expected to give the following results. First, consumers may take food and medicine without anxiety, and food and medicine may be effectively managed, and the national service may be improved, and also safety against heavy metals may be publicized. Second, as the principal ingredients and microelements of mineral herbal medicine are qualitatively analyzed, such results are expected to contribute to the advance of national analytics for herbal medicine.

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An Investigation about the Present States of Clinical Trial for Traditional Medicine in Korea, China, Taiwan and Japan (한국과 중국, 대만, 일본의 전통약 임상시험 현황에 대한 연구)

  • Lee, Kyun-Goo;Bae, Sun-Hee;Shin, Hyeon-Kyoo
    • Korean Journal of Oriental Medicine
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    • v.12 no.1
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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.

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Review of Clinical Studies of Herbal Medicine Retention Enema for Pediatric Diarrhea in Chinese Medicine (중의학에서 소아 설사에 적용하는 한약 보류관장요법에 대한 문헌 고찰)

  • Park, Beom Chan;Kim, Hee Yeon;Kim, Kibong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.33 no.4
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    • pp.47-59
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    • 2019
  • Objectives The purpose of this study is to analyze recent Chinese randomized controlled trials on efficacy and safety of the retention enema with herbal medicine in pediatric diarrhea. Methods We searched the recent Chinese randomized controlled trials from the China National Knowledge Infrastructure (CNKI) by using key words; '保留灌腸', '小兒', '腹瀉' and '泄瀉' with data range from January $1^{st}$, 2010 to March $2^{nd}$, 2019. Year of the publication, demographic information, disease, intervention, outcome measure, results, adverse events and composition of herbal medicine were analyzed for this study. Results 19 out of 32 studies were selected and analyzed. The most commonly used herbal medicine was Galgeungeumlyeon-tang modification (葛根芩連湯加減), and the most widely used retention enema method was to retain for 15 minutes and administer twice a day for 3 days. In most of the studies, retention enema with herbal medicine in pediatric diarrhea showed significant efficacies. No adverse effects were reported from the studies. Conclusions The results of these studies from China showed that the retention enema with herbal medicine in pediatric diarrhea may be effective and safe.

Korean Herbal Medicine on Liver Function : A Systematic Review in Korean Literature (한약 복용이 간기능에 미치는 영향 : 국내 문헌에 대한 체계적 고찰)

  • Yun, Young-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Cho, Sung-Il;Shin, Woo-Jin;Park, Hi-Joon;Lee, Hye-Jung
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.153-172
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    • 2009
  • Background : The safety of Korean herbal Medicine (KHM: prescribed herbal medicine by doctors of traditional Korean medicine) is an important issue in Korea. Although both fields. western medicine and traditional Korean medicine. have been studied on the safety of herbs and KHM, their results were not concordance with each other. Objectives : This study aims to review the influence of KHM on liver function in Korean literature systematically. Additionally, we tried to estimate the change of data of liver function test (LFT) and the incidence of liver injury (LI) after the use of KHM. Methods : Systematic literature searches were performed on 4 major databases of Korea from their inception to May 2008. Screening and selection of the studies and the extraction of data were performed independently by two authors. There were no restrictions on the types of publication including grey literatures. Results : Forty studies were included. Only sixteen studies were performed prospectively and fifteen studies collected data from outpatients. Only 8 studies reported the occurrence of LI after the use of KHM. Nineteen cases of LI showed no or mild symptoms and the elevation of LFT was not high. All of LI patients used conventional western drug and KHM concomitantly. and causality of LI was not assessed properly. The incidence of LI related to the use of KHM was estimated as 0.59%-0.76% from all data of these studies. The conflicting results were shown on the change of alanine aminotransferase (ALT) and total bilirubin (TB) after the use of KHM. Conclusions : KHM might be a minor cause of LI in Korea. However the results are not strongly supported as enough to make the safety issue clear because of the limitations of original studies. More rigorous studies are required for answering the safety issue of KHM with the cooperative investigation of both fields of Korean traditional medicine and western medicine.

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