• Title/Summary/Keyword: safety of herbal medicine

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Adverse Effects of Ephedra According to Sasang Typology in Healthy Adults : A Double-Blind Randomized Controlled Trial (마황복용 후 사상체질별 이상반응에 관한 임상연구 : 무작위배정 이중맹검시험)

  • Lee, Tae-Ho;Hsing, Li-Chang;Yang, Chang-Sop;Kim, Lak-Hyung;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.144-152
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    • 2009
  • Background : Ephedra (Ephedra sinica) has been widely used to treat respiratory disease in traditional medicine of East Asia for over a hundred years. Despite safety concerns raised by some, the use of ephedra in traditional medicine is documented over more than 1,800 years. It is well established that ephedra is one of the central medicines in Korean 'Seseng constitution' medicine. In Sasang constitution medicine, all humans can be divided into one of four types: Soeumin, Soyangin, Taeumin or Taeyangin, and each constitution type has their own typical characteristics. Accordingly, it is hypothesized that the adverse effects of ephedra differ depending on the Sasang constitution classification. Objectives : The aim of this study was to determine adverse effects of ephedra which is classified as a Taeumin herb, and to observe whether the response differs or not. according to Sasang constitution classification. Methods : The study design was a double-blind randomized controlled trial. The subjects were healthy adults 20 - 50 years old who agreed to participate in this study. They were allocated through randomization to either ephedra group (N=55) or placebo group (N=24). where ephedra extract (6 g of dried ephedra) and placebo with similar opaque capsules were given twice for one day. To compare the adverse events of ephedra according to Sasang constitution classification, we analyzed blood pressure (systolic and diastolic), pulse rate, the morning questionnaire, and patient's global assessment scale score for well known adverse events: palpitation, headache, sweating, tiredness, dyspepsia, and dry mouth. Results : After ingestion of ephedra, the pulse rate had a significant increase in all constitution types. The changes of diastolic pressure in Soeumin and the changes of pulse rate in Soeumin, Soyangin and Taeumin had a significant increase in the ephedra over the control group. In the ephedra group, the palpitation and dyspepsia score of the patients' global assessment scale had a significant increase in Soeumin, with palpitation and sweating score increasing in Soyangin. Others observations were insignificant results. Conclusion : The results of this study may confirm that the physical responses or adverse effects of herbs differ for each type of Sasang constitution. Future studies using other herbs will be required to ascertain the herbal drug reaction of Sasang constitutions.

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Study on Development of Assessment Guideline and Endpoints for Clinical Trial with Antitumor Natural Products (천연물 항암제제 임상시험 평가지표 개발연구)

  • Namgung, Mi-Ae;Chang, Yoo-Sung;Jeong, Seung-Gi;Kim, Jin-Seung;Yoon, Sung-Woo;Jang, Ki-Young;Yoo, Hwa-Seung;Jung, Myeon-Woo;Lee, Sung-Ho;Kim, Sung-Hoon
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.20 no.6
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    • pp.1678-1727
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    • 2006
  • This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

Utilization Patterns and Determinants of Oriental Medical Services : Focused on the Residents of Taegu City (한방의료의 이용행태 및 이용결정요인 분석 - 일부 대도시 지역주민을 중심으로 -)

  • Yoo Wang-Keun;Ryu Kyung-A
    • Journal of Society of Preventive Korean Medicine
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    • v.4 no.2
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    • pp.1-24
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    • 2000
  • This study was conducted to examine utilization patterns and determinants of oriental medical services. Data were collected from 545 residents in Taegu city The results of this study are summarized as follows 1) 37.8% of subjects used oriental medical services in the past year. Especially, the female, the ages of 50 and 60 over, the single. low-educated. high-income class, white-collar class, medical insured tended to use more oriental medical services than another groups. 2) 46.7% of users of oriental medical services reported that number of visits in the past year was 2 - 5 times 37 1% of them was 1 times, and 4.5% over 10 times. 3) According to the reasons to choose the oriental medical facilities, most was 'on their own judgement'(48.8%) and 'by the advice of relatives and friends'(42.0%) Regarding to the objectives of using oriental medicine, 68.3% was 'treatment', 31.7% 'health counselling and promotion'. And among diseases of users, diseases of musculo-skeletal system was the highest(54.5%). 4) 57.9% of oriental medical services users had experience of utilizing western medicine on the same diseases. Among peoples with experiencing western medicine on the same diseases. 54.4% received oriental medical services 'in addition to western medicine', 45.6%'in place of western medicine 'And 41.2% of using both services reported that they had difficulty in deciding to choose the type of services -oriental medical services or western medicine-for their diseases. 37.3% of them answered that 'providing relevant information' was the most desirable measure to solve this problem, 27.3% 'establishment of effective referral system between oriental and western medical facilities '23.6% 'cooperative medical treatment systems in the same facilities', 11.8%'integration of oriental medicine into western medicine 5) According to the satisfaction level with each items of oriental medical services, the respondents had positive views on efficacy, kindness, and side-effects. They, however, had negative view on the cost of oriental medical services. 6) In regarding to the priority of improvement of oriental medical system,'expansion of insurance benefit package 'ranked first. 'expansion of insurance benefit Package 'ranked second, 'improvement of scientific methods and diagnostic technique 'third, and 'safety of herbal medicine' fourth in order. 7) The significant factors influencing the utilization of oriental medical services were kindness of oriental medical practitioners, efficacy , travel time, age To be brief, utilization rate of oriental medical services in urban area generally tends to be high. There, however, have been various barriers to limit oriental medical services, such as incomplete benefit package of oriental medical insurance and lack of coordination and referral system between oriental and western medical services, lack of scientific diagnostic procedures, high price etc . For the development of oriental medical services, Much attention to remove these limiting factors should be placed. In addition, kindness of oriental medical practitioners , which is expected to be more important factor in the consumer - focused health care environment than ever, should be kept high consistently. Since this study was conducted for specific residents of an urban city. further research including more sampling in different urban areas should be required to generalize the results of the study.

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Anti-Cancer and Anti-Allergy Activities of Mycelia Extracts of Lentinus edodes Mushroom-Cultured Glycyrrhiza radix (감초로 배양한 표고버섯 균사체 추출물이 항암 효과 및 알레르기 억제 효과 검증)

  • Bae, Man-Jong;Yee, Sung-Tae;Ye, Eun-Ju
    • Journal of the East Asian Society of Dietary Life
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    • v.17 no.1
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    • pp.43-50
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    • 2007
  • This study investigated the effects of mycelia of Lentinus edodes mushroom-cultured Glycyrrihiza radix(LMG) on cancer cell lines and sarcoma 180(S-180), as well as on human mast cells. In an anti-cancer tests using Hep3B(hepatic cancer cell), MCF-7(breast cancer), and HeLa(uterine cancer) cells, LMG extract exhibited greater anti-proliferation effects than Glycyrrihiza glabra(GG) extract. LMG extract multiplication restraining effects were 60% that of ethanol at 3 mg/mL extract also displayed tumor suppressive effects in mice injected with S-180 cells. The growth-inhibition rates against tumor cells were 56% for LMG and 37% for GG. When LMG was added to human mast cells, the Intensity of RT-PCR products using primers($FC{\varepsilon}RI\;c-kit$) decreased. significantly compared with that of control. These results suggest that Lentinus edodes Mushroom-Cultured Glycyrrhiza glabra has an anti-proliferation effects against cancer cell lines(Hep3B, MCF-7 and HeLa) and S-180 tumors and will be also beneficial in treating allergic reactions.

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Ginsenoside Rg3 ameliorates allergic airway inflammation and oxidative stress in mice

  • Huang, Wen-Chung;Huang, Tse-Hung;Yeh, Kuo-Wei;Chen, Ya-Ling;Shen, Szu-Chuan;Liou, Chian-Jiun
    • Journal of Ginseng Research
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    • v.45 no.6
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    • pp.654-664
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    • 2021
  • Background: Ginsenoside Rg3, isolated from Panax ginseng, has anti-inflammatory and anti-tumor activities. It is known to reduce inflammation in acute lung injury in mice, and to reduce the expression of inflammatory cytokines and COX-2 in human asthmatic airway epithelium. In this study, we attempted to determine whether ginsenoside Rg3 inhibits airway inflammation, oxidative stress, and airway hyperresponsiveness (AHR) in the lungs of asthmatic mice. We also investigated its effects on oxidative stress and the inflammatory response in tracheal epithelial cells. Methods: Asthma symptoms were induced in female BALB/c mice sensitized with ovalbumin (OVA). Mice were divided into five groups: normal controls, OVA-induced asthmatic controls, and asthmatic mice treated with ginsenoside Rg3 or prednisolone by intraperitoneal injection. Inflammatory BEAS-2B cells (human tracheal epithelial cells) treated with ginsenoside Rg3 to investigate its effects on inflammatory cytokines and oxidative responses. Results: Ginsenoside Rg3 treatment significantly reduced eosinophil infiltration, oxidative responses, airway inflammation, and AHR in the lungs of asthmatic mice. Ginsenoside Rg3 reduced Th2 cytokine and chemokine levels in bronchoalveolar lavage fluids and lung. Inflammatory BEAS-2B cells treated with ginsenoside Rg3 reduced the eotaxin and pro-inflammatory cytokine expressions, and monocyte adherence to BEAS-2B cells was significantly reduced as a result of decreased ICAM-1 expression. Furthermore, ginsenoside Rg3 reduced the expression of reactive oxygen species in inflammatory BEAS-2B cells. Conclusion: Ginsenoside Rg3 is a potential immunomodulator that can ameliorate pathological features of asthma by decreasing oxidative stress and inflammation

Effects of Hataedock with Douchi on 2,4-dinitrofluorobenzene-induced Atopic Dermatitis-like Skin Lesion in NC/Nga Mice (두시를 이용한 하태독법의 NC/Nga 생쥐에서 DNFB로 유발된 피부손상 완화 효과)

  • Song, Ji-hoon;Ahn, Sang-Hyun;Cheon, Jin-Hong;Park, Sun-young;Kim, Ho-Hyun;Kim, Ki-Bong
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.30 no.2
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    • pp.109-115
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    • 2016
  • Hataedock is a Korean medical treatment that administers herbal extracts orally to newborn infants. This method is used for alleviating harmful heat and excreting fetal wastes by meconium. The purpose of this study was to evaluate anti-inflammatory effect of Hataedock method with Douchi on 2,4-dinitrofluorobenzene (DNFB)-induced atopic dermatitis (AD). The 3-week-old NC/Nga mice were divided into 3 groups: the control group (Ctrl), the AD-induced group (AE), and the Hataedock-treated group (GT). Only the GT group was treated with Hataedock at the 3rd week. After 28 days from Hataedock treatment, we induced AD-like dermatitis to the AE and GT group by DNFB. The effects of Hataedock were evaluated by immunohistochemical method. In the epithelium, PKC-positive reaction of the GT group was decreased by 57%. In the dermal papillae, IL-4-positive reaction was decreased by 34%. In the dermis, the distribution of degranulated mast cells was decreased and substance P-positive reaction was decreased by 49%. In the skin tissue, edema was decreased and MMP-9-positive reaction was decreased by 71%. Tissue damage such as epithelial cell hyperplasia, infiltration of granulocyte and lymphocyte, and capillary distribution were also decreased. The Hataedock method with Douchi maintained skin barrier and inhibited skin-damaging factors via regulating Th2 differentiation. In conclusion, Hataedock has a potential for preventative treatment of AD. Further studies are necessary to investigate the immune-regulating mechanism and verify the safety and efficacy of the Hataedock method.

A Case Study on Effect of Oriental Medical Treatment to an Aged Female Obese Patient (한방비만치료의 여성노인환자 치험1례)

  • Kim, Eu-Gene;Cha, Yun-Yeop;Kim, Dong-Gun;Heo, Seong-Kyu;Heo, Young-Jin;Han, Seok-Hun;Kong, In-Pyo
    • Journal of Korean Medicine for Obesity Research
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    • v.7 no.1
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    • pp.87-96
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    • 2007
  • Objectives : This study was performed to evaluate the effect of oriental medical treatment on aged female obese patient. Methods : We experienced an aged female obese patient. We applied herbal medication(Choweseuncheng-tang), electrolipolysis, auricular acupuncture to her from 26th, March. 2007 to 25th, May. 2007. And we examined the changes of her weight, body composition, body size, skin resistance variability, visual analogue scale of knee pain. Results : 1. Her weight decreased from 73.5kg to 71.1kg and body mass index(BMI) decreased from $29.46kg/m^2$ to $28.11kg/m^2$. 2. Body fat mass(BFM) decreased from 25.7kg to 21.6kg but body muscle mass(BMM) increased from 45.1kg to 46.7kg. 3. Waist-hip ratio(WHR) decreased from 0.96 to 0.92. 4. Basal metabolic rate(BMR) increased from 1,273kcal to 1,314kcal. 5. The circumference of upper extremity decreased 1.03cm and lower extremity decreased 1.30cm but the circumference of the muscle of upper extremity increased 0.41cm and lower extremity increased 0.63cm. 6. The circumference of chest and hip are decreased. In addition to the circumference and fat of abdomen are decreased. 7. The visual analogue scale of knee pain is improved. Conclusions : According to above results, oriental medical treatment could be used safety to aged obese patients without loss of fat free mass. The study is more required to aged obese patient from now on.

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Antimicrobial Activity of Sodium chlorate and Korean Herbal Extracts against Mice infected with Escherichia coli O157:H7 (Escherichia coli O157:H7에 감염된 마우스에 대한 염소산나트륨과 한약재 복합추출물 합제의 항균효과)

  • Cha, Chun-Nam;Lee, Yeo-Eun;Son, Song-Ee;Park, Eun-Kee;Choi, Hyun-Ju;Kim, Suk;Lee, Hu-Jang
    • Journal of Food Hygiene and Safety
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    • v.27 no.1
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    • pp.81-86
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    • 2012
  • The present study was evaluated the antibacterial effect of the combination of $Coptidis$ $rhizoma$, $Glycyrrhiza$ $uralensis$ Fischet, $Schizandra$ $chinensis$ and $Corni$ $Fructus$(1:1:1) extracts(CGSC10). Furthermore, the effectiveness of CGSC10, sodium chlorate, and the combination of CGSC10 and sodium chlorate(CGSCS10) against $E.$ $coli$ O157:H7 infection was studied using ICR female mice. During the incubation period, the dose of 5, 10, and 20% CGSC10 was inhibited the growth of $E.$ $coli$ O157:H7 by 34.7, 60.2, and 76.4%, respectively. For 7 days after single challenge with $E.$ $coli$ O157:H7, forty female ICR mice were divided into four experimental groups which were administered in drinking water with saline, 10% CGSC10, 15 mM sodium chlorate, and CGSCS10, respectively. On the 3rd day, the number of $E.$ $coli$ O157:H7 in mouse feces was significantly decreased by administration of CGSC10, 15 mM sodium chlorate, and CGSCS10 ($p$ < 0.001). On the 7th day-after administration, CGSC10, sodium chlorate, and CGSCS10 were decreased the number of $E.$ $coli$ O157:H7 by 27.1, 67.7, and 83.3%, respectively. According to the results of the present study, administration of CGSCS10 to mice can reduce the severity of $E.$ $coli$ O157:H7 infection. In addition, it is suggested that CGSCS10 represents a good candidate for the treatment of enteric infections in domestic animals.

A Study on Standardization of Shinbaro Pharmacopuncture Using Herbal Medicines Identification Test and HPLC-DAD (신바로 약침의 한약재 확인시험 및 HPLC-DAD를 통한 표준화 연구)

  • Lee, Jin Ho;Kim, Min Jeong;Lee, Jae Woong;Kim, Me Riong;Lee, In Hee;Kim, Eun Jee
    • Journal of Acupuncture Research
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    • v.32 no.2
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    • pp.1-9
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    • 2015
  • Objectives : The present study was an evaluation and standardization of herbal components in order to establish the efficacy and safety of Shinbaro pharmacopuncture. Methods : Among the raw materials of Shinbaro pharmacopuncture, the components Cibotii Rhizoma, Eucommiae Cortex, and Ledebouriellae Radix were assessed through ingredient verification experiments using thin-layer chromatography(TLC) and ultraviolet rays(UV) lamps. In addition, we standardized Acanthopanacis Cortex and Achyranthis Radix through validation using high performance liquid chromatograph-diode array detector(HPLC-DAD). Results : As result appeared a blue-white fluorescence under ultraviolet rays; changed to dark green after adding 1 % ferric chloride solution(due to Cibotii Rhizoma), and presented a yellow-green fluorescence when mixed with an ethyl ether under UV lamps by way of the ethyl ether layer, confirming Eucommiae Cortex. Ledebouriellae Radix was confirmed as dark brown spots at Rf values of 0.56 and 0.71 using TLC. Additionally, Acanthopanacis Cortex and Achyranthis Radix HPLC test results showed that linearity was $R^2{\geq}0.99$, and detection limit and quantitation limit were 0.23 to $1.29{\mu}g/mL$, and 0.71 to $3.90{\mu}g/mL$, respectively. Furthermore, precision and accuracy were confirmed to have relative standard deviation(RSD) values of 0.10 to 1.89 % and 96.19 to 103.72 %, respectively. Shinbaro pharmacopuncture did not have any overlapping or interference from other peaks in detection under the abovementioned analysis conditions. Conclusions : In conclusion, we confirmed that maintenance of Shinbaro pharmacopuncture validity was possible by means of quality control of Cibotii Rhizoma, Eucommiae Cortex, and Ledebouriellae Radix through ingredient identification and Acanthopanacis Cortex and Achyranthis Radix through high performance liquid chromatograph(HPLC) analysis. Further, we hope to contribute to the development strategy of herbal industry acupuncture.

The Content and Risk Assessment of Heavy Metals in Herbal Pills (유통 환제의 유해 중금속 함량 및 위해도 평가)

  • Lee, Sung-Deuk;Lee, Young-Ki;Kim, Moo-Sang;Park, Seok-Ki;Kim, Yeon-Sun;Chae, Young-Zoo
    • Journal of Food Hygiene and Safety
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    • v.27 no.4
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    • pp.375-387
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    • 2012
  • The objective of this study is investigation of contamination levels and assessment of health risk effects of heavy metals in herbal pills. 31 Items and 93 samples were obtained for this investigation from major herbal medicine producing areas, herbal markets and on-line supermarkets from Jan to Jun in 2010. Inductively coupled plasma mass spectrometer method was conducted for the quantitative analysis of Pb, Cd and As. In addition, the mercury analyzer system was conducted for that of Hg without sample digestion. The average contents of heavy metals in samples were as follows : 0.87 mg/kg for Pb, 0.08 mg/kg for Cd, 2.87 mg/kg for As and 0.16 mg/kg for Hg, respectively. In addition, the average contents of heavy metals in different parts of plants, including cortex, fructus, herba, radix, seed, algae and others were 0.63 mg/kg, 3.94 mg/kg, 1.42 mg/kg, 1.05 mg/kg, 0.16 mg/kg, 22.31 mg/kg and 10.17 mg/kg, respectively. After the estimations of dietary exposure, the acceptable daily intake (ADI), the average daily dose (ADD), the provisional tolerable weekly intake (PTWI) and the relative hazard of heavy metals were evaluated. As the results, the relative hazards compared to PTWI in samples were below the recommended standard of JECFA as Pb 3.1%, Cd 0.9%, Hg 0.5%. Cancer risks through slope factor (SF) by Ministry of Environment Republic Korea and Environmental Protection Agency was $4.24{\times}10^{-7}$ for Pb and $3.38{\times}10^{-4}$ for As (assuming that the total arsenic content was equal to the inorganic arsenic). Based on our results, possible Pb-induced cancer risks in herbal pills according to parts used including cortex, fructus, herba, radix, seed, algae and others were $1.95{\times}10^{-7}$, $1.45{\times}10^{-6}$, $2.14{\times}10^{-7}$, $6.27{\times}10^{-7}$, $1.99{\times}10^{-8}$, $3.61{\times}10^{-7}$ and $9.64{\times}10^{-8}$, respectively. Possible As-induced cancer risks in herbal pills by parts used including cortex, fructus, herba, radix, seed, algae and others were $1.54{\times}10^{-5}$, $7.24{\times}10^{-5}$, $1.23{\times}10^{-4}$, $2.02{\times}10^{-5}$, $3.25{\times}10^{-6}$, $2.18{\times}10^{-3}$ and $5.67{\times}10^{-6}$ respectively. Taken together, these results indicate that the majority of samples except for some samples with relative high contents of heavy metals were safe.