• The Journal of Korean Medicine
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• v.44 no.3
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• pp.189-200
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• 2023

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

• The Journal of Korean Medicine
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• v.43 no.1
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• pp.33-41
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• 2022

Objectives: Drug-induced blockade of the human ether-à-go-go related gene (hERG) potassium ion channel causes acquired long QT syndrome, which is known to cause cardiac arrhythmias and be fatal. To establish safety evidence of herbal formulae, we evaluated the effects of 31 herbal formulae on hERG channel activity. Methods: The current through hERG channel was measured by changing the membrane voltage before and after treatment with 31 herbal formulae in HEK 293 cell overexpressing hERG channel using a whole-cell patch clamp system. The current-voltage curves and the activity curves were fitted, and the hERG activity and 50% inhibitory concentration (IC₅₀) according to each herbal formula were calculated. Results: Chokyungjongok-tang, Oncheong-eum, and Cheongsangbangpung-tang strongly inhibited the hERG activity, with IC₅₀ values of 67.67, 141.2, and 296.3 ㎍/mL, respectively. Yeonkyopaedok-san, Eunkyo-san, Ukgan-san gajinphibanha, Daegunjoong-tang (except Oryzae gluten), Insamyangyoung-tang, Banhahubak-tang, SokyungHwalhyul-tang, Jodeung-san, Hyeonggaeyeongyo-tang, and Bangkeehwangkee-tang weakly inhibited hERG activity, with IC₅₀ values ranging from 400 to 1000 ㎍/mL. The other 18 herbal formulae showed very weak hERG activity inhibition of less than 50% at the highest concentration (1000 ㎍/mL). Conclusion: This study provided safety information on cardiotoxicity by cardiac arrhythmia risk assessment of herbal formulae, and is expected to be a reference data for predicting the safety and risk of herbal formulae.

• Journal of Korean Medicine Rehabilitation
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• v.32 no.2
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• pp.1-17
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• 2022

Objectives This study was conducted to investigate the beta-glucan & ginsenoside content, antioxidant activity, anti-inflammatory effect and safety of herbal medicine mix. Methods The marker compounds contents, antioxidant activity and safety of herbal medicine mix were tested. The contents of beta-glucan and ginsenoside Rg3 were measured, the antioxidant activity was measured using 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radical scavenging activity, anti-inflammatory and a safety test was conducted via single dose toxicity assessment. Results Analyzing the contents of marker compounds showed 362.3 mg/g of beta-glucan, and 0.4184 mg/g of ginsenoside Rg3. In the DPPH free radical scavenging activity, the IC50 of herbal medicine mix, was 0.146%. The scavenging activity of herbal medicine mix was 88.28% activity at 0.5% concentration, and 90.61% activity at 5% concentration. In the lipopolysaccharides (LPS) anti-inflammatory test, the herbal remix showed a significant decrease in tumor necrosis factor-alpha (TNF-𝛼) and interleukin-6 (IL-6) compared to the LPS-induced group. In the single dose toxicity test of herbal medicine mix, a dose of 2,000 mg/kg body weight (BW) was set at its highest capacity and observed after oral administration to female and male rats. No toxicological findings were recognized. It was observed that the resulting lethal dose can be set to 2,000 mg/kg BW or higher for both females and males. Conclusions The results of the experiment on herbal medicine mix showed that the marker compounds contents were beta-glucan and ginsenoside Rg3, that antioxidant activity was observed through the DPPH free radical scavenging activity, anti-inflammatory effect was observed through TNF-𝛼 and IL-6 measurement, and safety was confirmed through the single dose toxicity assessment.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.4
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• pp.133-142
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• 2020

Objectives Studies on Chinese herbal injections are increasing. But, its safety are still not well reported. We have reviewed the literature related to the safety of Chinese herbal injection, especially those related to anaphylaxis. Methods The PubMed database was used to select the literatures related to anaphylaxis in China and to study the quality control and safety of Chinese herbal injection. Results Chinese herbal injection is a major traditional medical treatment in China, but it is the cause of adverse drug reactions including anaphylaxis. In order to solve this problem, various proposals have been made to identify the pharmacological and chemical causes of major side effects and to use them safely clinically. In addition, various researches have been conducted from preclinical to postmarketing surveillance to secure the safety of Chinese herbal injection. Based on this, it was found that various efforts are needed to secure the safety of bee sting needles. Conclusion In order to secure the safety of chinese herbal injections, it is necessary to identify the main mechanism of action and the pharmacological components contributing to it, and to develop a standardized formulation based on this. In addition, institutional pharmacovigilance is required.

• Journal of Korean Medicine Rehabilitation
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• v.19 no.3
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• pp.33-46
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• 2009

Objectives : The objective of the study was to summarize randomized clinical trials(RCTs) that have assessed the effectiveness of herbal medicine on treatment of obesity and to propose better process of study. Methods : NLM Medline(pubmed), EMBASE, the Cochrane library, Science Direct, EBSCO, 4 Korean medical databases were systematically searched and 4 Korean medical journals were manually searched for clinical trials investigating the efficacy of herbal medicines on treatment of overweight or obese people from 1998 to 2008. The methodological quality was assessed using a Jadad score and validity was assessed using Oxford Pain Validity Scale(OPVS). Results : 14 RCTs met all the inclusion criteria. The methodological and ethical quality of the trials was generally low. The mean score by Jadad was 2.6 and the mean score of validity was 11.2. Complex herbal medicine was used in 8 RCTs and single herbal medicine was used in 6 RCTs. Except 1 RCT, the other RCTs reported positive effects of herbal medicine on treatment of obesity. Herbal medicines didn't seem to affect toxicity. In general adverse events relevant with the therapy were minor, but more than half of RCTs did not report about the safety or adverse events of herbal medicine, questioning their reliability. Conclusions : Although most RCTs concluded the efficacy and safety of herbal medicines on treatment of obesity, the quality of trials was low in general. Further rigorous clinical trials using complex herbal medicine should be performed.

• The Journal of Korean Medicine
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• v.37 no.1
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• pp.34-40
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• 2016

Objectives: To observe safety and efficacy of herbal medicine for psoriasis patients. Methods: We did retrospective chart review for 107 psoriasis patients who had been treated by herbal medicine for 2 months, and we analyzed the liver function test (LFT) results and Psoriasis Area and Severity Index (PASI) scores of before and after the treatment. Results: The mean LFT and the number of patients with abnormal LFT decreased after the treatments. More than 95% of patients with normal LFT maintained normal results at after the treatment, and only 2.1% and 4.6% patients with normal LFT showed abnormal Glutamic Oxaloacetic Transaminase (GOT) and Glutamic Pyruvic Transaminase (GPT) results at after the treatment. Also, both mean PASI scores for all patients and patients with abnormal LFT before the treatment decreased significantly. Conclusions: This study suggest that herbal medicine may be safe and effective treatment for psoriasis.

• Journal of Physiology & Pathology in Korean Medicine
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• v.32 no.5
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• pp.347-353
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• 2018

There are some controversies about the safety of herbal medicine. In order to examine the safety of herbal medicine, this study investigated the level of liver function test(AST/ALT) in patients taking herbal medicine for more than 6 months We checked liver function in 121 patients who took herbal medicine for more than 6 months. AST/ALT were measured before treatment and every 3 months (from 3 month to 9 month). In 121 patients taking herbal medicine for more than 6 months, mean AST level after 6 months was lower than before treatment and mean ALT level after 6 months was lower than before treatment. In 20 patients with abnormal AST/ALT before herbal treatment, 18 patients's AST/ALT changed to normal after 6 month herbal treatment. 2 patients's AST/ALT was slightly higher than normal. One woman patient met the criteria for herb-induced liver injury(HILI) with RUCAM scores 4 after taking herbal medicine for 6 months. Although her RUCAM score decreased to zero after taking herbal medicine for 9 months. This study suggests that long-term herbal medicine for 6 months or longer is very unlikely to injury liver function. Individual-specific liver damage may occur, it can be recovered.

• The Journal of Korean Medicine
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• v.33 no.3
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• pp.95-104
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• 2012

Objectives: There are some controversies over the safety of herbal medication in relation to liver function. This report, therefore, aimed to analyze the safety issue of herbal medications by scrutinizing the liver function tests (LFT) results of 82 psoriasis patients on herbal medications for 3 months at an oriental medical clinic. Methods: We tested psoriasis patients' liver function periodically with Reflotron Plus of Roche during the herbal medication. Then we statistically analyzed the LFT results to see if there was any negative change. Results: Statistical analysis on the LFT results of 82 psoriasis patients showed no meaningful change caused by herbal medication over 3 months. Conclusions: From this result we conclude that herbal medication for 3 months does no harm to patients' liver function.

• Herbal Formula Science
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• v.31 no.2
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• pp.81-98
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• 2023

Objectives : This study aimed to analyze the trends in research and development projects related to herbal medicine and natural products in the field of traditional Korean medicine (TKM) over the past 20 years. Methods : Research projects were identified using "Korean medicine" as the subject heading in the National Science and Technology Information Service. The included projects investigated Korean medicine, natural products, or were related to the TKM industry. Data pre-processing and network analysis were performed using Python and Networkx package, and the network was visualized using the ForceAtlas2 visualization algorithm. Results : 1. Over the study period, 4,020 projects were conducted with a research budget of KRW 835.2 billion. Seven institutions performed over 100 projects each, accounting for 2.4% of all participating institutions, and the top 10 institutions accounted for 58.9% of total projects. 2. Obesity was the most frequently mentioned disease-related keyword. Chronic or age-related diseases such as diabetes, osteoporosis, dementia, parkinson's disease, cancer, inflammation, and asthma were also frequent research topics. Clinical research, safety, and standardization were also frequently mentioned. 3. Centrality analysis found that obesity was the only disease-related keyword identified, alongside TKM-related keywords. Standardization, safety, and clinical trials were identified as central keywords. Conclusions : The study found that research projects in TKM have focused on standardizing and ensuring the safety of herbal medicine, as well as on chronic and age-related diseases. Clinical studies aimed at verifying the effectiveness of herbal medicine were also frequent. These findings can guide future research and development in herbal medicine.

• Herbal Formula Science
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• v.30 no.3
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• pp.191-203
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• 2022

Purpose : In 『Herbal Formula Science in Korean Medicine (HFSKM)』, the weight unit of Shanghanlun '1 Liǎng (一兩)' is mostly converted to 3 g. We tried to confirm whether the usages of the Shanghanlun prescriptions of HFSKM are valid in the view of safety and efficacy. Method : The toxicity of herbs in Shanghanlun were summarized. The prescriptions of HFSKM including herbs recorded by weight in Shanghanlun were compared with the pharmacopoeia usage. Domestic clinical case studies were analyzed to confirm the clinical evidence for safety and efficacy. Results : Glycyrrhizae Radix, Rhei Radix et Rhizoma, Persicae Semen, Ephedrae Herba, Pinelliae Tuber, Aconiti Lateralis Radix Preparata, Asiasari Radix et Rhizoma, Armeniacae Semen and Scutellariae Radix have been reported to have toxicity. As a result of analyzing the 39 Shanghanlun prescriptions of HFSKM, 26 prescriptions were identified when they were within the pharmacopoeia usage, and 13 prescriptions were found in excess. As a result of analyzing the domestic clinical research papers, symptoms considered to be side effects were not mentioned, and improvement of the diseases was confirmed. As a result of measuring the actual weight, it was confirmed that the usage greatly exceeded the pharmacopoeia usage, such as 57.23 g for Pinelliae Tuber and 45.77 g for Armeniacae Semen. Conclusion : The composition of the prescription for Shanghanlun proposed in HFSKM is considered to be a reasonable dose, but continuous review and standard supplementation are necessary.