• Title/Summary/Keyword: Herbal medicine safety

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Safety Evaluation from Aflatoxin risk of Korean Angelicae Gigantis Radix Based on Critical Control Points (중점관리기준에 기초한 국내생산 당귀의 산지 수확 후 아플라톡신의 안전성 평가 연구)

  • Choi, Hye-Jin;An, Tae-Jin;Ahn, Young-Sup;Park, Chung-Berm;Kim, Ju-Il;Park, Seong-Hwan;Yang, Hyun;Do, Kee-Hun;Moon, Yu-Seok
    • Korean Journal of Medicinal Crop Science
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    • v.19 no.1
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    • pp.47-53
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    • 2011
  • HACCP methodology was applied in the post-harvest processing and storage of domestic medicinal produces. Particularly in terms of mold and mycotoxin contamination, candidate critical control points (CCP) in the conventional practice in Korean farms were selected and monitored by comparing with on the standard guided processing and storage. When each processing of Angelicae Gigantis Radix were assessed for their safety, the drying steps such as the sun drying or the thermal drying depending on each farm made differences in mold contamination. Moreover, the storage conditions before or after the processing were another critical determinant in the fungal contamination. In other words, storage under $4{\circ}C$ rather than at room temperature was favorable for reducing mold growth in the harvested crops. Occurrence rate of Aflatoxin $B_1 \;(AFB_1)$ in Angelicae Gigantis Radix were 12.8%, but amount of $AFB_1$ in all the collected samples were below 10 ppb regulatory limit allowed in Korea. However, for a few samples of Angelicae Gigantis Radix, still relatively high levels of total amount of the major aflatoxins (aflatoxin $B_1\; +\; B_2\; +\; G_1\; +\; G_2$) were observed around 0.18~49.94 ppb, which is not regulated presently in Korea. It thus can be suggested that post-harvest processing and storage of Korean medicinal crops need further investigation and monitoring to establish the Good Agricultural Practice (GAP), particularly to minimize microbial risk including mold and mycotoxin contamination under the changing climate. Additionally, it is also warranted for new enacting of regulatory limits for total aflatoxins in the medicinal crops.

The Bibilographic studies on Aconiti Ciliare Tuber and Radix Aconiti (초오(草烏), 천오(川烏)에 대한 문헌적(文獻的) 고찰(考察))

  • Yoo, Chang-Kil;Kwon, Gi-Rok
    • Journal of Pharmacopuncture
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    • v.4 no.2
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    • pp.87-93
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    • 2001
  • Objectives : Through the literature on the effect of Aconiti Cliare Tuber, Radix Aconiti, we are finding out the clinical posibility and revealing the more effective to intractable disease. Methods : We inverstigated the literatures of Oriental Medicine and experimental reports about Aconiti Cliare Tuber, Radix Aconiti. Results : 1. The taste of Aconiti Cliare Tuber, Radix Aconiti is hot, sweet, bitter, warm and hot, and the effect is dehumidification, warm up and relieve the pain, so it can be used for arthritis, hemiplegia, carpopedal spasm, sciatica, cancer, numbness. 2. A toxic constituent of Aconiti Cliare Tuber, Radix Aconitiis is induced by aconitine alkaloid, develope toxic symptoms and result in death. So it needs suitabe treatment for safety. 3. It is known that the toxicopathy due to Radix Aconiti was 3-30g(dosage for adult) and Aconiti Ciliare Tuber was 1-9g. But only using aconitine alkaloid to oral feeding, the toxicopathy due to 0.2mg/kg and lethal dose is 3-4mg. So we using this for treating, we must be careful and need more varialble study about toxicopathy, lethal dose. 4. On clinical treatment, we thought Aconiti Cliare Tuber, Radix Aconiti is so effective to intractable disease after control the toxicity, it may be need variable study on toxicity and clinical effects.

Review of Clinical Studies on Oriental Medicine Treatment for Obesity in the Korean Literature (비만의 한방 치료에 대한 국내 임상 논문 고찰)

  • Moon, Su-Jeong;Kong, Jae-Cheol;Kwon, Young-Dal;Song, Yong-Sun;Han, A-Lum;Kwon, Young-Mi;Lee, Su-Kyung
    • Korean Journal of Oriental Medicine
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    • v.16 no.3
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    • pp.85-93
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    • 2010
  • The aim of this review is to investigate clinical studies on oriental medicine treatment for obesity in Korean literature and to propose for the better method of clinical studies in order to seek more effective treatment. Electric searches were performed with NDSL, National assembly library, RISS4U, DBPIA, KISS, KMBASE, KoreaMed, Korean traditional knowledge portal and Oasis. Also, 21 major journals associated with oriental medicine in Korea were searched manually. Eighty three studies were included and analyzed in terms of study design, subjects, interventions, results and evaluation of safety. The numbers of controlled, non-controlled and case studies are respectively 26(31%), 43(52%) and 14(17%). Studies using sample size less than 30 accounts for 49% and studies using subjects diagnosed as obese or overweight by specific criteria were 35(42%). Studies which used more than 2 interventions or co-interventions were 76%. Clinical studies which used single herbal medicine were few and clinically studied single herbal medicine were limited to ephedra. More than half of 83 studies were studied for 8 weeks and less. 12% of 69 studies(except case studies) were not statistically analyzed and studies which evaluated safety of intervention were 22(27%) and reported adverse events were 9(11%). To improve the quality of clinical studies on oriental medicine treatment for obesity, studies need to use restricted number of interventions and subjects need to specifically diagnosed as overweight or obese. In addition, various kinds of single herbs need to be clinically studied based on experimental studies and herbalogy.

A Case Report of Primary Peritoneal Carcinoma Patient Treated with Paclitaxel/Carboplain Regimen Combined with Traditional Korean Medicine on the Improvement of Quality of Life (Paclitaxel/Carboplain과 한의 치료를 병행한 원발성 복막암종 환자의 삶의 질 개선에 대한 증례보고)

  • Song, Si-yeon;Ha, Su-jeong;Park, So-jung;Jeon, Hyung-joon;Lee, Yeon-weol;Cho, Chong-kwan;Yoo, Hwa-seung
    • Journal of Korean Traditional Oncology
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    • v.23 no.2
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    • pp.27-33
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    • 2018
  • Objective: The purpose of this study is to report the therapeutic possibility of a primary peritoneal carcinoma (PPC) patient with Traditional Korean Medicine (TKM). Methods: A 37 years old female patient diagnosed with PPC suffered from operation site pain, neck pain, nausea, headache and fatigue after undergoing operation and chemotherapy (Paclitaxel/Carboplain). The patient was treated with acupuncture, pharmacoacupuncture, moxibution and herbal medicine. Laboratory study and National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0 were used to evaluate the safety and adverse events of treatments. The performance status was measured by Eastern Cooperative Oncology Group (ECOG) scale. Results: After treatments, cancer did not show any progression. Related symptoms such as postoperative pain, nausea, fatigue and quality of life have improved. Conclusion: This case study implies that TKM may have therapeutic possibility in treating PPC patient.

Integrated Rehabilitation for Children with Cerebral palsy: A Prospective Observational Study

  • Lee, Hye-Yoon;Yun, Young-Ju;Shin, Yong-Beom;Kim, Soo-Yeon;Han, Jun-hee;Yu, Sun-ae
    • The Journal of Korean Medicine
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    • v.42 no.4
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    • pp.61-74
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    • 2021
  • Objectives: This study aimed to analyse: 1) the clinical effectiveness and safety of traditional Korean Medicine (TKM) and frequency of TKM therapies used and their relationship with conventional treatments. Methods: This prospective observational study enrolled children with cerebral palsy (CP) aged 6-78 months (n=126). The children who used herbal medication for >30 days or acupuncture treatment >12 sessions within 6 months were defined as the integrated rehabilitation (IR) group; the remaining participants were included in the conventional rehabilitation (CR) group. Results: Changes in the Gross Motor Function Measure-66 (GMFM-66) were greater in the IR group (6.4±6.1) than in the CR group (4.6±5.8). The reduction in the number of other health problems was greater in the IR group than in the CR group. The GMFM-66 improvement was greatest in gross motor function classification system level 1. There was no between-group difference in the frequency of rehabilitation therapy (10.9±6.6 and 12.0±9.9 in the IR and CR groups, respectively). Conclusion: TKM may offer additional benefits in terms of the GMFM-66 score and other health problems. However, there is a need for further randomized controlled trials involving a restricted CP type and a controlled treatment type and intensity to confirm these findings.

Clinical Assessment of Usefulness, Effectiveness and Safety of Kyejibokryung-hwan on Various Neuropathies

  • Park, Seong-Uk;Jung, Woo-Sang;Kim, Yun-Kyung;Moon, Sang-Kwan;Kim, Young-Suk;Bae, Hyung-Sup;Cho, Ki-Ho;Ko, Chang-Nam
    • The Journal of Korean Medicine
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    • v.27 no.4
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    • pp.135-141
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    • 2006
  • We were to assess clinical effectiveness, safety and usefulness of Kyejibokryung-hwan (KBH), which has been used for Er-hyul similar with vascular or neurologic disorders causing sensory or motor abnormalities. This study is a retrospective single case series. Two hundred ninety five patients were treated with KBH for various neuropathies in our hospital. Of them, 120 cases were excluded because of insufficient medical records or failure to follow up; the remaining 175 were included in the analysis. There were 18 patients with sensory abnormalities and 28 with motor abnormalities after stroke. Of peripheral type, there were 14 with diabetic neuropathy, 12 with carpal tunnel syndrome, 41 with spinal radiculopathies, and 62 with idiopathic neuropathies, for which the effectiveness was assessed as 55.6%, 21.4%, 64.3%, 83.3%, 45.0%, and 56.5%, respectively. Adverse effects including indigestion or diarrhea were seen in 3.4% of the total patients. Taking the effectiveness and the safety together into consideration, the usefulness was assessed as 55.6%, 21.4%, 64.3%, 83.3%, 45.0%, and 54.8% for treating post-stroke sensory and motor abnormalities, diabetic neuropathy, carpal tunnel syndrome, spinal radiculopathies, and idiopathic neuropathies, respectively. In conclusion, we suggest that KBH is a useful herbal medicine for various neuropathies, especially of sensory type.

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Review of the Large-Scale Clinical Researches on Acupuncture in Germany: ASH, ART, ARC, and GERAC (2000년부터 독일에서 수행된 대규모 침 임상연구들에 대한 고찰: ASH, ART, ARC, GERAC)

  • Yoon, Juyeon;Han, Kuk-In;Jeong, Jinsu;Lee, Seungho;Jang, Insoo
    • Korean Journal of Acupuncture
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    • v.30 no.1
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    • pp.21-26
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    • 2013
  • Objectives : The purpose is to introduce the recent large-scale clinical researches for safety, efficacy and effectiveness of acupuncture in Germany. Results : In 2000, the German Federal Committee of Physicians and Health insurer proposed that large research initiatives on acupuncture, Acupuncture Model Projects(Modellvorhaben Akupunktur), could be conducted by health insurance companies for several pain that acupuncture is syndromes to justify the insurance-based reimbursement. Accordingly, 4 clinical researches were carried out; the Acupuncture Safety and Health economics studies(ASH), the Acupuncture Randomised Trial(ART), the Acupuncture in Routine Care studies(ARC), and the German Acupuncture trial(GERAC). Meanwhile, ASH is a prospective observational study for safety and costs. ART and GERAC are composed of RCTs for efficacy. ARC includes 6 pragmatic RCTs with additional non-randomized cohort study for effectiveness. We investigated the papers related to them and discussed about the outcomes. The researches showed that acupuncture is effective in practice for several chronic conditions such as migraine, tension-type headache, chronic low back pain, osteoarthritis of knee, dysmenorrhea, and allergic rhinitis. Based in part on them, the German health authorities decided that acupuncture would be included into routine reimbursement by social health insurance funds for chronic low back pain and chronic osteoarthritis of the knee in 2006. Conclusions : The German clinical researches may suggest the clues for establishing the evidence of acupuncture treatment.

The Monitoring of some heavy metals in oriental herbal medicines and their intake rates (한약재 중 중금속의 모니터링 및 가용 섭취율 분석 연구)

  • Yim, Okkyoung;Han, Eunjung;Chung, Jaeyeon;Park, Kyungsu;Kang, Inho;Kang, Sinjung;Kim, Yunje
    • Analytical Science and Technology
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    • v.22 no.2
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    • pp.128-135
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    • 2009
  • This paper is the monitoring results of some heavy metals (lead, cadmium, arsenic, mercury) in herbal medicines and their intake rates. The monitoring of lead, cadmium, arsenic and mercury was carried out on 600 samples with 60 kinds of herbal medicines. And the transfer ratio of heavy metals in the water-boiled drinks w as calculated. The results show that lead was detected over the Maximum Residue Limits (MRL) in 10 samples (7 species). Cadmium was detected over the MRM in 69 samples (19 species). Arsenic was detected over the MRM in 3 samples (3 species). Mercury was detected over the MRM in 13 samples (10 species). We need continuously monitoring to ensure confidence and safety for these herbal medicines. In case of the water-boiled drink, average intake rates of lead, cadmium, arsenic and mercury are 9.77%, 6.72%, 26.1% and 6.79%, respectively.

A Comparative Clinical Study on the Effect of Hwangryunhaedok-tang in Gastritis Treatment (황련해독탕의 위염 치료 효과에 대한 단일비교 임상연구)

  • Park, Beom-Chan;Kim, Hee-Yeon;Kim, Kwang-Youn;Yang, Ju-Hye;Kim, Kyungho;Do, Hyun Ju;Jee, Seon young;Choi, Jun-Yong;Kim, Young Woo;Park, Kwang Il;Kim, Kibong
    • Herbal Formula Science
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    • v.28 no.2
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    • pp.157-167
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    • 2020
  • Objectives : The purpose of this clinical study was to investigate the efficacy and safety of Hwangryunhaedok-tang on the gastritis treatment. Methods : A total of 20 subjects who visited Pusan National University Hospital from April 2nd, 2019 to September 2nd, 2019 were included. In this study, we evaluated the individual symptoms through questionnaires, laboratory test, BIA (Bioelectrical Impedance Analysis), and adverse reaction according to medication. Statistical analysis was performed with paired t-test and Wilcoxon Signed Rank test. Statistical significance was achieved if the probability was less than 5% (p < 0.05). Results : After medications, the total score of individual symptoms, primary outcome, was significantly decreased. In particular, individual symptoms such as upper abdominal pain, bloating, heartburn and trim showed significant improvement. However, no statistically significant differences were found in nausea/vomiting and anorexia. In additions, the laboratory test showed a statistically significant decrease in total cholesterol, but no statistically significant differences in results of BIA. In the safety evaluation, adverse reactions were not reported. Conclusions : Considering this results, we have confirmed the possibility of Hwangryunhaedok-tang to the gastritis treatment.

Effects of the Combination Herbal Extract on Working Memory and White Matter Integrity in Healthy Individuals with Subjective Memory Complaints : A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

  • Kwon, Oran;Lee, Sunho;Ban, Soonhyun;Im, Jooyeon J.;Lee, Doo Suk;Lee, Eun Hee;Kim, Joohee;Lim, Soo Mee;Lee, Sang Gon;Kang, Ilhyang;Kim, Kyung-Hee;Yoon, Sujung;Lee, Sun Hea
    • Korean Journal of Biological Psychiatry
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    • v.22 no.2
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    • pp.63-77
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    • 2015
  • Objectives The combination extract of four kinds of herbs, Gastrodia elata, Liriope platyphylla, Dimocarpus longan, and Salvia miltiorrhiza, has shown to have memory improving effects in mice. The aim of this study was to investigate the efficacy and safety of the herbal mixture for improving working memory as well as microstructural changes in white matter integrity in individuals with subjective memory complaints. Methods Seventy-five individuals with subjective memory complaints were assigned to receive either placebo (n = 15) or herbal mixture (low-dose group, n = 30 and high-dose group, n = 30) supplementation in an 8-week, randomized, double-blind, placebo-controlled clinical trial. Changes in working memory performance and fractional anisotropy (FA) values reflecting white matter integrity from baseline to 8-week endpoint were assessed. Results The herbal mixture group showed an increase in working memory performance compared to the placebo group (p for interaction = 0.001). In addition, the herbal mixture group showed an increase in FA values in the temporo-parietal regions (corrected p < 0.05), which are crucially involved in working memory function and are among the most affected regions in patients with cognitive impairments. Conclusions Findings from this study indicate that the herbal mixture may be a promising therapeutic option for individuals with subjective memory complaints.