• Title/Summary/Keyword: Herbal medicine safety

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Korean research project on the integrated exposure assessment of hazardous substances for food safety

  • Lim, Ji-Ae;Kwon, Ho-Jang;Ha, Mina;Kim, Ho;Oh, Se Young;Kim, Jeong Seon;Lee, Sang-Ah;Park, Jung-Duck;Hong, Young-Seoub;Sohn, Seok-Joon;Pyo, Heesoo;Park, Kyung Su;Lee, Kwang-Geun;Kim, Yong Dae;Jun, Sangil;Hwang, Myung Sil
    • Environmental Analysis Health and Toxicology
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    • v.30
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    • pp.4.1-4.11
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    • 2015
  • Objectives: This survey was designed to conduct the first nationwide dietary exposure assessment on hazardous substances including the intakes of functional food and herbal medicine. In this paper, we introduced the survey design and the results of the dietary exposure status and internal exposure levels of lead (Pb), cadmium (Cd), and mercury (Hg). Methods: We selected 4867 subjects of all ages throughout Korea. We conducted a food survey, dietary survey, biomonitoring, and health survey. Results: Pb and Cd were the highest (median value) in the seaweed ($94.2{\mu}g/kg$ for Pb; $594{\mu}g/kg$ for Cd), and Hg was the highest in the fish ($46.4{\mu}g/kg$). The dietary exposure level (median value) of Pb was $0.14{\mu}g/kg$ body weight (bw)/d, $0.18{\mu}g/kg$ bw/d for Cd, and $0.07{\mu}g/kg$ bw/d for Hg. Those with a blood Pb level of less than $5.00{\mu}g/dL$ (US Centers for Disease Control and Prevention, reference value for those 1 to 5 years of age) were 99.0% of all the subjects. Those with a blood Cd level with less than $0.30{\mu}g/L$ (German Federal Environmental Agency, reference value for non-smoking children) were 24.5%. For those with a blood Hg level with less than $5.00{\mu}g/L$ (human biomonitoring I, references value for children and adults, German Federal Environmental Agency) was 81.0 % of all the subjects. Conclusions: The main dietary exposure of heavy metals occurs through food consumed in a large quantity and high frequency. The blood Hg level and dietary exposure level of Hg were both higher than those in the European Union.

Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol

  • Kim, Jihye;Kim, Hyunho;Kim, Keun Ho
    • Integrative Medicine Research
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    • v.6 no.3
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    • pp.317-324
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    • 2017
  • Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

The Effect of Bojungikgi-tang on Stress Urinary Incontinence: A Systematic Review and Meta-Analysis (복압성 요실금에 대한 보중익기탕의 효과 : 체계적 문헌고찰과 메타분석)

  • Nam, Hyun-seo;Baek, Tae-hyun
    • The Journal of Internal Korean Medicine
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    • v.42 no.3
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    • pp.293-307
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    • 2021
  • Objectives: This study investigates the effects and safety of Bojungikgi-tang for stress urinary incontinence by systemic review and meta-analysis of randomized controlled trials (RCTs). Methods: RCTs were selected from articles published until December 2019 in seven domestic and foreign databases. The quality of the literature was evaluated using Cochrane's risk of bias (RoB) tool, and RevMan 5.3 was used to synthesize the results. Results: A total of 694 patients with stress urinary incontinence participated in eight RCTs. Meta-analysis showed that the total effective rate of treatment that combines pelvic floor muscle training (PFMT) and Bojungikgi-tang was significantly higher than that of PFMT alone. The volume of urine leakage per hour after the combined treatment was significantly lower than that of PFMT alone. The International Consultation on Insurance Questionnaire-Short Form (ICIQ-SF) scores from combining PFMT and Bojungikgi-tang were significantly lower than those for PFMT alone. Conclusion: This study suggests that Western medical treatment combined with Bojungikgi-tang for urinary incontinence from stress might be more effective in improving symptoms than conventional Western medical treatment alone. However, the number of studies included in the meta-analysis was insufficient, and the quality of the selected literature was generally low. Therefore, high-quality clinical studies on herbal medicine treatment for urinary incontinence would be required in the future.

Case Series of Low Back Pain and Pelvic Pain Caused by Traffic Accident during Pregnancy (임신 중 교통사고로 인한 요통 및 골반통으로 입원한 환자 증례 보고)

  • O, Kwang-Woo;Ryu, Ik-Han;Kim, Ji-Ryang;Kim, Hae-Jung;Kang, Jung-Ah;Lee, Su-Jeong;Choi, Chang-Min
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.4
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    • pp.194-204
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    • 2009
  • Purpose: When pregnant women get symptom like pain, because of fear of using analgesic drugs and X-ray test during pregnancy, pain is nevertheless often left. This study was to report the clinical application and safety of oriental treatment to low back pain and pelvic pain caused by traffic accident during pregnancy. Methods: We experienced seven patients who suffered from low back pain and pelvic pain caused by traffic accident during pregnancy. During their admission, we treated with acupuncture, cupping therapy and herbal medicine. We checked the symptoms during admission at progress note, and follow up by phone call. Results: The degree of low back pain and pelvic pain were decreased or resolved. After treatment, no serious adverse effects were found on the patients, and there were no adverse effects at all on the infants. Conclusion: The results indicate that oriental treatment can be effective for the management of low back pain and pelvic pain caused by traffic accident during pregnancy. And these treatments are safe to both patients and infants.

Review of Clinical and Experimental Studies on External Application Treatment for Atopic Dermatitis in the Korean Literature (아토피 피부염 외용제에 관련된 국내 임상 및 실험 논문 고찰)

  • Min, Deul Le;Park, Eun Jung;Kang, Kyung Ha
    • The Journal of Pediatrics of Korean Medicine
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    • v.27 no.1
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    • pp.36-49
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    • 2013
  • Objectives The goal of this review is to investigate clinical and experimental studies on external application treatment for atopic dermatitis in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Methods Electronic researches were performed with KTKP, OASIS, National Assembly Library, Korean Medicine Database, KISS, DBpia, and KISTI. Results and Conclusions In Twenty six studies, the numbers of clinical and experimental studies are respectively 10 (38.46%) and 16 (61.54%). The numbers of studies that used herbal complex were 20 (76.92%), and out of that, 6 studies had used a single herbal medicine (23.08%). The external application with oriental medicine for the atopic dermatitis used with Phellodendri Cortex (7), Sophorae Radix (6), Scutellariae Radix (6), Lonicerae Flos (5), Coptidis Rhizoma (5) and so on. Among the clinical studies, the 5 studies were double-blind and randomized-controlled study (50%). The numbers of studies that used Hanifin and Rajka Diagnostic Criteria (1980) were 6 (60%), and that used the Diagnostic Criteria in Korean Atopic Dermatitis (2005) were 4 (40%). Among the clinical studies, categories to evaluate of atopic dermatitis are respectively SCORAD Index (80%), Total IgE (80%), Eosinophil count (70%) and so on. All of the clinical studies (100%) showed a statistically significant decline in atopic dermatitis according to the SCORAD Index, Modified SCORAD Index, the Clinic index score. Among the experimental studies, the numbers of studies that used NC/Nga mice were 9 (56.25%), and out of that 5 studies used BALB/c mice (31.25%). Most of the studies (68.75%) used DNCB as allergy inducing materials. The scales for evaluation of atopic dermatitis were Clinical skin severity score, Histopathologic examination, Immunohematologic examination, safety test and so on. In 12 cases (75%) of experimental studies, the IgE level of experimental group showed a statistically significant decline after using external application. In 8 study cases (50%), Clinical skin severity score of experimental group showed a statistically significant decline after using external application.

Clinical study of Bangpoongtongsungsan on body weight change in subjects with obesity (방풍통성산이 비만인에 미치는 영향에 대한 임상적 연구)

  • Shin, Dae-Hee;Cho, Guk-Hyun;Lee, Hyuck;Moon, Mi-Kyung;Kang, Dae-Gill;Yun, Young-Gab;Park, Do-Shim;Juhng, Seon-Kwan;Lee, Ho-Sub
    • Herbal Formula Science
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    • v.16 no.2
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    • pp.133-144
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    • 2008
  • Recently, people are becoming fatter in most parts of the world. Obesity is regarded as an important risk factor to adversely affect the health of humans, associated with hypertension, hyperlipidemia, diabetes, and cardiovascular diseases. In the present study, therefore, we tested the short time efficiency and safety of Bangpoongtongsungsan as a drug to decrease body weight in subjects with obesity. A total 48 volunteers (24 man, 24 woman) with body mass index (BMI : weight in kg divided by square of height in meters) of $23㎏/m^2$ participated in clinical study for 12 weeks, from 2008, March 01 to 2008, Jun 30. The subjects was received a dietary supplement of 12 pieces hard capsules per day (4 pieces in one, 3 times in a day) during the clinical study. At the end of clinical study, body weight of subjects was significantly decreased from $72.21{\pm}11.44\;kg$ to $70.53{\pm}11.67\;kg$ (p<0.05). Waist circumferences of subjects were reduced $91.58{\pm}6.43\;cm$ to $85.25{\pm}7.70\;cm$ (p<0.05). Also, a BMI of subjects was significantly decreased $26.07{\pm}2.35\;kg/m^2$ to $25.63{\pm}2.63\;kg/m^2$ (p<0.05). Particularly, a decrease in body weight, waist circumferences, and BMI was more significant in woman than man. But, other biochemical levels including lipid and glucose in plasma had no changes at the end of clinical study. In conclusion, administration of Bangpoongtongsungsan in subjects with high body weight fat could inhibit obesity associated with a decrease in body weight, waist circumferences, and BMI.

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Comparisons of Effects of Biman-tang according to Administration Period in Childhood Obesity (비만환아에서 복약기간에 따른 비만탕의 치료효과 비교연구)

  • Lim, Youngkwern;Min, Seorim;Kim, Heeman;Hur, Kwang-Wook;Lee, Hoon;Lee, Jinsoo;Kim, Hocheol;Park, Jae-Woo;Park, Hi-Joon
    • The Journal of Pediatrics of Korean Medicine
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    • v.27 no.4
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    • pp.57-67
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    • 2013
  • Objectives The purpose of this study is to investigate the safety and effect of Biman-tang (BMT) on two different administration periods in the treatment of childhood overweight and obesity. Methods In retrospective study, 39 overweight and obese ($85^{th}$ percentile ${\leq}$ Body Mass Index (BMI)) children were treated with BMT from January 2006 to April 2013 at Korean Medical Clinic in Suwon, Korea. The primary outcomes were the changes in BMI and Obesity Index (OI) from baseline to the treatment groups. Secondary outcomes included the changes in height, weight and safety of the medicine. Comparisons of BMI, OI, height and weight between the short-period (SP) treatment group and the long-period (LP) treatment group were done by using ANCOVA. Results The change of the mean of BMI ($-0.5{\pm}0.6kg/m^2$ vs $-1.4{\pm}0.8kg/m^2$, respectively; p=0.003) and OI ($-3.6{\pm}3.9%$ vs $-9.7{\pm}4.7%$, respectively; p<0.001) showed significant reduction both in SP (n=16) and LP treatment group (n=23). The mean height showed no significant difference in both groups. The mean weight of LP treatment group showed significant reduction compared to SP treatment group ($-0.2{\pm}1.3kg$ vs $-1.6{\pm}1.6kg$, respectively; p=0.006). Most of the children were compliant to the medication and no serious adverse events were found in two groups. Conclusions These findings emphasize that BMT is effective in the treatment of childhood obesity and it requires at least 45 days of treatment for the best result.

The Study of Effect and Safety related to Dong-gi Acupuncture(DGA) and Complex therapy on Lumbago due to blood stasis and sprain (좌섬(挫閃)·어혈(瘀血) 요통(腰痛)에 동기침법(動氣鍼法) 및 복합치료(複合治療)의 유효성(有效性) 및 안정성(安定性) 연구(硏究))

  • Kim, Kee-Hyun;Lim, Hyung-Ho;Hwang, Hyeon-Seo;Song, Ho-Sueb;Song, Young-Sang;Kwon, Soon-Jung;Kim, Kyung-Nam;Ahn, Koang-Hyun;Lee, Seong-No;Kang, Mi-Suk;Gyun, Im-Jung
    • Journal of Acupuncture Research
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    • v.19 no.3
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    • pp.107-114
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    • 2002
  • Objective : This study was designed to find the most effective and safest way to overcome Lumbago due to blood stasis and sprain involved in a few Meridian Tendino-musculatures by evaluating the effect of two kinds of Dong-gi(Dong-qi) Acupuncture(DGA) and by reporting their side effects. Material : 97 patients of out and admission patients were selected, who were diagnosed with lumbar sprain caused by repetitive bending, heavy weight lifting, unsuitable posture, concussion and falling down and whose Lumbago due to blood stasis and sprain in the concept of oriental medicine. Methods : 97 patients were divided into three groups. One is exclusive DGA group to which DGA and the method retaining needles on the acupoints for about 20 minutes were applied, the other is DGA combined active exercise group in which patients stretched their Meridian Tendino-muscuIatures with their hips moving up and downward repeatedly during DGA, the third is DGA combined passive exercise group in which patients were made to flex or extend their bodies on the auto flexion-distraction table in a prone position, from 10 to 20 degree, during DGA. In each group, bed rest, physical therapy and herbal medicine were used according to symptoms, in addition to DGA. In DGA method, "Su(Shu)" points of the meridian related to the involved Meridian Tendino-musculature were mainly chosen, that is, Sokkol(Shugu, B65), Hugye(Houxi, SI3), ChungJo(Zhongzhu, TE3) were used, for most LBP belonged to Bladder and Gallbladder Meridian Tendino-musculature disorders. Pyong-Bo-Pyong-Sa(Ping-Bu-Ping-Xie) such as Dong-Gi and Yeom-Jeon(Nian-Zhuan) was applied as Bo-Sa method. For evaluation of effectiveness, new score system was devised by severity of pain and range of movement. the score was given twice at patients' first and last visit and the difference between first and last score was regarded as a evaluation scale, the effectiveness was classified into four grade by evaluation scale.(scale : 12-15; excellent, 8-11; good, 4-7; fair, 0-3; bad) Results : 1. Exclusive DGA, DGA combined active exercise and DGA combined passive exercise group showed 97, 87 and 89% in effectiveness. 2. Exclusive DGA, DGA combined active exercise and DGA combined passive exercise group showed no aggravation of pain, range of movement. 3. In blood test of 34 patients, only one patient showed abnormal rise of sGOT, sGPT and $\gamma$-GTP at his first visit and the others didn't show any detrimental change. DGA had no bad influence upon BUN and creatinine of patients. Conclusion : For complex theraphy combining DGA, exercise, physical therapy and Herbal medicine proved to be highly effective on treating lumbago due to blood stasis and sprain, this is expected to be available for clinical use.

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Systemic Review of Clinical Studies about Oriental Medical Treatment of Cancer in Korea (국내에 보고된 한국 한의학의 암치료 임상연구에 대한 계통적 고찰)

  • Park, Bong-Ky;Lee, Jong-Hoon;Cho, Chong-Kwan;Shin, Hyun-Kyu;Eom, Seok-Ki;Yoo, Hwa-Seung
    • The Journal of Internal Korean Medicine
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    • v.29 no.4
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    • pp.1061-1074
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    • 2008
  • Objectives : Recently, the number of cancer patients who use complementary and alternative medicine (CAM), including oriental medicine, are increasing. Also, evidence for efficacy and safety of cancer CAM is reported continuously. This study was designed to evaluate the quality of the published papers for clinical studies about oriental medical cancer treatment in Korea. Methods : We searched for clinical research papers on the websites of the Korean oriental medical society and subsidiary academies, Korean traditional knowledge portal. Koreanstudies information service system (KISS), etc. We used the reference words 'cancer', 'malignant tumor', 'leukemia', 'lymphoma', 'multiple myeloma', 'melanoma', etc, We then chose studies that had been presented between 1991 and 2008 and analyzed them by publication year, design, cancer type, intervention, subject and journal. Results : There were 86 clinical research papers that were published between 1991 and 2008. The number of clinical studies has increased in a time-dependent manner. Case reports and case series studies account for 78% of total clinical research. Studies of lung cancer account for 17%. Studies of cancer-related symptoms of cancer patients account for 38%. Studies of Hang-Am-Dan account for 33%. Studies published in the journal of the Korean Society of Oriental Internal Medicine account for 35%. Conclusion : The clinical research papers about oriental medicine are increasing over time, but most of the studies are retrospective case reports or case series. Well-designed and prospective clinical trials would be recommended to provide more reliable evidence.

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Synergistic combination effect of anti-obesity in the extracts of Phyllostachys pubescence Mael and Scutellaria baicalensis Georgi (죽엽(竹葉)과 황금(黃芩) 복합물의 항비만 효과)

  • Kang, Young Min;Kim, Seung-Hyung;Lee, Young-Cheol;Kim, Ho Kyoung;Kim, Dong-Seon
    • The Korea Journal of Herbology
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    • v.29 no.6
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    • pp.7-13
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    • 2014
  • Objectives : Anti-obesity drugs that have been developed so far have limited efficacies and considerable adverse effects affecting tolerability and safety. Therefore, most anti-obesity durgs have been withdrawn. We tried to develop anti-obesity agent by combinations from herbs that are used in food ingredients as well as in traditional medicines. Methods : The 80% (v/v) ethanol extracts from Bamboo (Phyllostachys pubescence) leaf (BL) and Scutellaria baicalensis (SB) and their 1:1 combination (BLSB) was evaluated on high fat diet induced obese mice compared to Omega-3 as a positive control. The mice were divided into six groups (n=5), one group fed a normal diet (ND), and the others fed a high fat diets for eight weeks. Two weeks after starting feeding the diets, the high fat diet groups were orally administered vehicle and Omega-3, BL, SB, and BLSB at dosage of 200 mg/kg/day for six weeks. All groups were assayed for body weights, food efficiency ratio, blood biochemistry parameters, and organic tissue weights. Results : BLSB group showed significant reductions in body weight gain and fat weights of liver and epididymal adipose tissue compared to BL or SB alone as well as control. Total-cholesterol and LDL-cholesterol levels significantly decreased, and HDL-cholesterol level increased. In liver tissue, macrovesicular steaotisis was remarkably improved and its fat cell size was also significantly decreased. Conclusions : These results suggested that a combination preparation of bamboo leaf and S. baicalensis has anti-obesity effect and have synergistic effect compared to bamboo leaf or S. baicalesis.