• Title/Summary/Keyword: safety of herbal medicine

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Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer] (폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Gajin;Cho, Minji;Park, Eunjoo;Seong, Sin;Kim, Sungsu;Kim, Kwan-Il;Jung, Hee-Jae;Lee, Beom-Joon;Leem, Jungtae
    • The Journal of Korean Medicine
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    • v.40 no.1
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    • pp.153-173
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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 Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. 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 guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

Preference of Herbal Medicine Packagings for Caregivers (환아 보호자 대상으로 실시한 한약 용기 선호도 조사)

  • Jeong, A Ram;Lee, Hye Yoon;Cheon, Jin Hong;Kim, Ki Bong
    • The Journal of Pediatrics of Korean Medicine
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    • v.28 no.4
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    • pp.71-84
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    • 2014
  • Objectives The aim of this study is to investigate preferred herbal medicine packaging. Methods The study used questionnaires for the caregivers, who have administered their children herbal and western medicine. 106 of them were visited the Department of Pediatrics, the Oriental Medicine Hospital of ${\bigcirc}{\bigcirc}$ University, during the period between in 2014. We used PASW Stastics 18.0 to analyze different dosing methods, and preferred packaging and drug formulations. Results 1. 77.4% answered that they use cups to administer medications, 9.4% transferred it to other plastic bottles, 8.5% used straw to drink from the pouch, 4.7% drank as it is inside the pouch. Method of taking it was not very significant depending on the age. 2. Compare to pills and capsules, 48 responders answered that pills and capsules are easier to take, 11 answered herbal medication is easier to take. 32 answered that there were no significant difference. 3. 45.3% reported vinyl pouch was preferable, 44.3% answered spout pouch was preferred, 5.7% answered bottles are convenient, and another 5.7% responders thought cup was fine. Others include syrup bottles had 1 person. These varying preferences were not depending on the age variations. 4. 56.3% answered that price was the main reason why they prefer one over the other. Others 29.2% stated convenience, 12.5% reported safety, and 10.4% people answered ease of administration as their main reason for their preferences. Conclusions Based on this study, numbers of parents felt inconvenient administering herbal medicine as a vinyl pouch, and felt necessary to improve this. However, price and other reasons made vinyl pouch still more preferable option. Vinyl pouch that we are using today didn't show any safety issues. Therefore, it is recommended to still use vinyl pouch, but with caps on top to improve administration and distinguishing issues.

A Study on the Results of the Incheon Metropolitan City Korean Medicine Infertility Support Program in 2021 (2021년도 인천광역시 한의약 난임 지원 사업에 관한 결과 연구)

  • Kwon, Na-Yoen;Lee, Dong-Nyung;Sung, Hyun-Kyung;Park, Jang-Kyung
    • The Journal of Korean Obstetrics and Gynecology
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    • v.35 no.4
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    • pp.143-160
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    • 2022
  • Objectives: This study aimed to lay the foundation for the Korean medicine infertility treatment support program to be implemented in the future by analyzing the results of the Korean medicine infertility treatment support program implemented by Incheon metropolitan city. Methods: 224 patients applied for the Korean medicine infertility treatment support program conducted by Incheon metropolitan city and had three months of herbal medicine treatment and three months of follow-up time. Information on general, demographic, and infertility-related characteristics of patients before treatment was collected. Information on treatment contents performed by Korean medical doctors during treatment, and information on results and satisfaction after treatment was collected. In order to evaluate the safety of treatment, blood tests were performed before and after treatment, and abnormal reactions were monitored. Results: Of 224 patients, 211 ended treatment, of which 45 (21.33%) succeeded in pregnancy. The characteristics of the successful and failure groups of pregnancy were found to be statistically significant differences in age, therapeutic history, parity, anti-müllerian hormone test results, and type of infertility of the patients and spouses. The most common pattern identification was kidney deficiency, and the most widely used prescription was Jogyeongjongok-tang. Patients were highly satisfied with the treatment of Korean medicine infertility. As a result of the safety evaluation, herbal medicine treatment was confirmed to be a safe treatment. Conclusions: In this study, clinical information on the Incheon metropolitan city Korean medicine infertility treatment support program was obtained. Based on this study, it is expected that the Korean medicine infertility treatment program in the future will guarantee more extensive treatments such as extending the treatment period or supporting korean herbal medicine to spouses.

Anti-obesity Activity of Extract from Saussurea lappa (목향 추출물의 항비만 활성 효과)

  • Yoon, Tae-Sook;Sung, Yoon-Young;Jang, Ja-Young;Yang, Won-Kyung;Ji, Yun-Ui;Kim, Ho-Kyoung
    • Korean Journal of Medicinal Crop Science
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    • v.18 no.3
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    • pp.151-156
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    • 2010
  • Obesity has become one of the main public health problems. Saussurea lappa (Asteraceae), syn Aucklandia lappa and Saussurea costus, is a well-known herbal medicine that has been used for treating various ailments, such as inflammatory and gastrointestinal diseases. The present study examined the anti-obesity effect of S. lappa extract (SLE) in 3T3-L1 adipocytes and high fat diet (HFD)-induced obese mouse model. SLE significantly inhibited the differentiation from preadipocytes to adipocytes of cultured 3T3-L1 in dose-dependent manner. In addition, SLE significantly decreased the body weight gain and the food efficiency ratio of mice fed HFD during 9 weeks. Further study must be performed for the pharmacological mechanism and safety of SLE as well as the identification of active compound in SLE. Our results revealed that S. lappa suppresses the adipogenesis in cultured cells and the obesity in rodent models. Therefore, S. lappa may be useful toward the development of new potent anti-obesity drugs.

hERG Channel-Related Cardiotoxicity Assessment of 13 Herbal Medicines (한약재 13종의 hERG 채널 관련 심장독성 평가)

  • Ha, Hyekyung;Lee, Sion;Kim, Dong-Hyun;Seo, Chang-Seob;Shin, Hyeun-kyoo
    • The Journal of Korean Medicine
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    • v.42 no.3
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    • pp.44-55
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    • 2021
  • Objectives: As the use of herbal medicinal products (HMPs) increases worldwide, systematic verification of the safety of HMPs is required. The induction of cardiotoxicity is one of the major factors in post-approval withdrawal of medicinal products, and drug-induced cardiotoxicity assessment is emerging as an important step in drug development. In the present study, we evaluated human ether-à-go-go-related gene (hERG) potassium channel-related cardiotoxicity to predict the risk of cardiac arrhythmia in thirteen herbal medicines known to have cardiac toxicity. Methods: We measured the inhibition rate of hERG potassium channel activity of 13 medicinal herbal extracts in hERG-expressing HEK 293 cells using an automated patch-clamping system. Quinidine was used as a positive control for inhibition of hERG activity. Results: Extracts of Evodiae Fructus, Strychni Semen, and Corydalis Tuber potently inhibited the activity of hERG, and IC50 values were 3.158, 19.87, and 41.26 ㎍/mL, respectively. Cnidi Fructus, Ephedra Herba, Lithospermi Radix, Polygoni Multiflori Radix, Visci Ramulus et Folium, Asiasari Radix et Rhizoma, and Scolopendra weakly inhibited hERG activity, and the IC50 value for each herbal medicine was more than 400 ㎍/mL. Aconiti Kusnezoffii Tuber and two types of Aconiti Lateralis Radix Preparata (Po and Yeom) had weak inhibitory activity against hERG, and the IC50 values were more than 700 ㎍/mL. The IC50 value of quinidine against hERG was 1.021 𝜇M. Conclusion: Evodiae Fructus, Strychni Semen, and Corydalis Tuber acted as potent inhibitors against hERG. These herbal medicines may cause cardiac arrhythmia through QT prolongation, so care should be taken when taking them.

Single Oral Dose Toxicity Study of Modified Samjung-Hwan in Sprague-Dawley Rats (삼정환의 랫드를 이용한 단회 경구투여 독성시험)

  • Kim, Min-Jee;Lee, Myeong-Jong;Kim, Hojun
    • Journal of Korean Medicine for Obesity Research
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    • v.17 no.2
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    • pp.96-100
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    • 2017
  • Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

Attitude and Recognition of Medical School Students on Korean Traditional Medicine Diagnosis and Treatment (의대생들의 한의학 진단 및 치료에 대한 인식 조사)

  • Huh, Nam-Woo;Jeong, Seung-A;Kim, Sun-Jae;Mok, Na-Rae;Park, Hae-Won;Shin, Hyeun-Kyoo
    • Journal of Society of Preventive Korean Medicine
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    • v.17 no.1
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    • pp.107-116
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    • 2013
  • Objectives : This study was aimed to facilitate mutual comprehension between Western and Traditional Korean Medicine (TKM) by analyzing recognition of medical school students on traditional medical prescription and treatment such as herbal medicines and acupuncture. Methods : We conducted a survey targeting medical school students of four medical schools from April through May 2009, and analyzed 208 cases responded. Results : Survey results revealed that medical school students took knowledge of traditional medicine from TV programs and on the Web in general. They thought they had considerable traditional medical knowledge but did not almost understand for professional contents. Regardless of some positive recognition for traditional herbal medicine, negative perspectives were more common and its safety and efficacy on the drug reference were considered as a major reason. On the other hand, recognition on acupuncture was comparatively positive. Scientific data for both herbal medicine and acupuncture are lacking in reality but the attitude only for acupuncture was different. Of the survey respondents, 57.8% had negative attitude against diagnostic methods of TKM and 59.1% opposed to the usage of modern medical equipments by TKM doctors. With regard to the future position of TKM, they tacitly approved that TKM would be absorbed into the complementary and alternative medicine (CAM) and importance of TKM objectification, followed by Government's support. Conclusions : Medical school students neither affirm nor deny TKM as a whole but the state of awareness for each item was similar to the physician. In terms of TKM its internal and external innovation would be required to continuously establish objectification of TKM prescription and scientific research on treatment technology.

Investigation of Micromorphological Characteristics of Herbal Acupuncture Needle Tip According to the Number of Injection (자침 횟수에 따른 약침용 주사침첨의 미세 형태 관찰)

  • Lee, Jong-Young;Hwang, Jung-Soo;Kim, Kwang-Ho;Kwon, Ki-Rok;Won, Seung-Hwan
    • Journal of Acupuncture Research
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    • v.22 no.5
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    • pp.49-55
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    • 2005
  • Objectives : In order to ensure safe Herbal Acupuncture treatment, the quality of needle tip is much important. Therefore we investigated micromorphological characteristics of Herbal Acupuncture needle tip according to the number of injection. Methods : We have selected the 26 Gage syringes & 29 Gage syringes that using currently in Herbal Acupuncture treatment. And we evaluated the change of shape of Herbal Acupuncture needle tip after several times of injection by Inverted System Microscope(x 200). Results & Conclusion : We found at Herbal Acupuncture needle tips had several defects such as hooked, scuffed, lump and irregular, stubbed or malformed shape in spite of new syringes. And we found at Herbal Acupuncture needle tips had several defects that is harmful to body such as mild pain, possibility of damage of tissue after several times of injection. Therefore it is necessary to pay attention to use Herbal Acupuncture needle tips.

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Herbal Medicine for The Treatment of Pityriasis rosea: A Systematic Review and Meta-analysis (장미색 비강진의 한방 탕약 치료에 대한 연구 : 체계적 문헌 고찰)

  • Jin, Han-Sol;Lim, Hui-Yeong;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.117-133
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    • 2021
  • Objectives : Pityriasis rosea is an acute and subacute papular scaly disease, and is a disease that mainly resolves spontaneously. However, since the outbreak of COVID-19, the possibility that the disease may occur as a sequelae of the disease and side effects of vaccination has been announced. Methods : We searched articles related to oriental treatment of pityriasis rosea at organized in domestic and foreign DBs. Articles were searched for RCT. The results were summarized in tables and graphs, and meta-analysis was performed. Also, we assessed the risk or bias. Results : As a result of setting the herbal medicine alone treatment as an intervention for pityriasis rosea and Western medicine alone as the control group, total 9 articles were searched. We analyzed them and got the results. The efficient rate of the treatment group was statistically significantly higher than that of the control group. In addition, adverse events were significantly less in the treatment group than in the control group. Conclusions : Herbal medicine treatment can be more effective than Western therapy(mainly anti-histamines and glycyrrhizin injection) for pityriasis rosea. In addition, herbal medicine treatment can be superior to Western treatment for safety. However, the limitations of this study include the small number of articles, no other evaluation indicators other than the efficient rate, and insufficient data such as pathological examination.

INHIBITORY ACTION OF PROCESSED HERBAL MEDICINES ON THE PRODUCTION OF ADVANCED GLYCATION ENDPRODUCTS(AGEs)

  • Kim, Jin-Sook;Ko, Jin-Hee;Kim, Hyung-Jeong;Ma, Jin-Yeul
    • Proceedings of the PSK Conference
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    • 2002.10a
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    • pp.383.2-383.2
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    • 2002
  • Diabetic nephropathy is major chronic complication of diabetes mellitus. Advanced glycation endproducts(AGEs) are largely involved in the pathogenesis of diabetic nephropathy. The irreversibly formed AGEs do not return to normal even if hyperglycemia is corrected and continue to accumulate over the lifetime of protein. The AGEs inhibitor. aminoguanidine(AG), is the only protein glycation inhibitor currently under development. its safety however is desirable. To find possible AGEs inhibitor in herbal medicines, bovine serum albumin was added to a mixture of sugars and some of processed. unprocessed herbal medicines or AG. Cyperi rhizoma was processed in four different methods according to chinese pharmacopoeia and traditional literatures. In comparision to the negative control with no inhibitor and positive control with AG. alcoholic extracts of these processed cyperi rhizoma proved to have more potent inhibitory activities than that of unprocessed cyperi rhizoma. These results revealed that some processed herbal medicines have a more potent in vitro inhibitory action on AGEs formation than AG. suggesting the possible candidate for diabetic nephropathy from the processed herbal medicines.

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