• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.31 no.2
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• pp.40-59
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• 2018

Objectives : We report on the contents and reviews of the guidelines for clinical trials of herbal medicine for psoriasis. Methods : After reviewing the existing reports, the guidelines were drafted by the writing committee on guidelines for Korean medicine clinical trial center in Kyung Hee university Korean medicine hospital. Since then, the guidelines have been consulted by the experts in diseases, clinical trials and pharmaceuticals. In addition, the guidelines have been certified by the Korean medicine clinical trial center association and Korean Medicine Ophthalmology & Otolaryngology & Dermatology Society. Results : The guidelines for clinical trials are divided into 8 categories: (1) general contents, (2) evaluation standards of effectiveness, (3) outcome valuables, (4) selection of study participants, (5) designs of clinical trials, (6) safety evaluations, (7) combination therapies in psoriasis treatment and (8) Korean medical considerations. Conclusions : There are 3 major contents for discussion: (1) obscurity of Korean medical considerations to differentiate from existing guidelines, (2) the absence of Korean version of PASI and DLQI, which are validity parameters and (3) realistic institutional problem using the herbal medicine.

• The Journal of Korean Obstetrics and Gynecology
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• v.29 no.4
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• pp.24-33
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• 2016

Objectives: The aim of this study was to demonstrate the benefit of Traditional Korean Medicine as an adjuvant therapy in management of early uterine contractions and the prevention of Preterm Birth (PTB). Methods: It is a case report of a 38 year-old-woman hospitalized for irregular uterine contractions and cervical change at 33^+3/7weeks of gestation. After 7 trials of IVF and artificial insemination, conception was successful via IVF with help of traditional Korean medicines. 2 TKMs were prescribed: Gami-danggui-san, and Antae-eum. 120 ml of Gami-danggui-san was given twice a day morning and evening along with same amount of Antae-eum once a day from 31 August 2013 to 28 November 2013. Tocolytics (Ritodrine) was administered as a first aid for maintenance of pregnancy. Information regarding progress until the delivery was collected during the patient’s visit. Results: As of 34^+2/7 weeks of gestation, intermittent uterine contractions appeared (5-12 min) on cardiotocography and vaginal bleeding was also smeared at 34^+3/7 weeks. However, enhanced tocolytics and continuous administration of herbal medicine sustained the pregnancy to term. At 37^+2/7 weeks, no sign of labor with restored cervical length was confirmed. The woman gave a term birth to a healthy infant via vaginal delivery at 39^+3/7 gestational weeks. Conclusions: Our report implies the potential of herbal medicine as a adjuvant therapy for preterm labor treatment. Further studies are needed to assess the safety and efficacy of TKM herbal medicine as a therapeutic alternative for curing preterm birth.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.1
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• pp.74-86
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• 2017

Objectives : This study aimed to assess the scientific evidence for the use of Hwanglyeonhaedok-tang, a traditional herbal formula, in the treatment of rhinitis, and prepare the basis for the investigational new drug application by analyzing the experimental studies. Methods : Ten electronic databases were searched up to December, 2016 without language limitation. Experimental studies on the anti-inflammatory and anti-allergic effects of Hwanglyeonhaedok-tang against rhinitis were included. We extracted data about study design, characteristics of intervention, outcomes, and pharmacological effects from the included studies and summarized them. Results : Eight hundred and thirty-three potentially relevant studies were identified, of which 18 experimental studies met our inclusion criteria. Of 18 included studies, 5 had conducted cell viability test, and all studies had reported that Hwanglyeonhaedok-tang was non-cytotoxic. Hwanglyeonhaedok-tang exhibits anti-inflammatory effect by regulating the inflammation-related cytokines including nitric oxide(NO), prostaglandin $E_2(PGE_2)$, interleukin-6(IL-6), and tumor necrosis $factor-{\alpha}(TNF-{\alpha})$ in vitro and in vivo. Hwanglyeonhaedok-tang exhibits anti-allergic effect by suppressing eosinophil, and histamine levels. Hwanglyeonhaedok-tang helps in the recovery of nasal mucous membrane by supressing goblet cells, heat shock protein 70, and substance P. Conclusions : This study suggests that Hwanglyeonhaedok-tang has the potential to be developed as therapeutic agent for rhinitis. Further experimental and clinical studies needed to be performed to prove the safety and efficacy.

• Journal of Korean Medicine Rehabilitation
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• v.32 no.3
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• pp.131-140
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• 2022

Objectives This study aimed to investigate whether the concurrent use of conventional and herbal medications affects liver and kidney function, by examining blood test data. Methods We retrospectively reviewed the electronic medical records of 590 inpatients with musculoskeletal diseases between 2013 and 2017. We investigated cases of drug-induced liver injury (DILI) according to the Roussel Uclaf Causality Assessment Method criteria and cases of drug-induced kidney injury (DIKI) based on the Kidney Disease Improving Global Outcomes definition. Results One case (0.17%) of DILI and one case (0.17%) of DIKI were identified. Significant improvements in serum laboratory data were observed after the concurrent use of both types of medications (p<0.05). The kappa coefficients ranged from 0.26 to 0.72, indicating that the values after the concurrent use of conventional and herbal medications showed a fair similarity to the baseline values of the patients. The linear regression test showed that female sex and high body mass index (BMI) were risk factors for an increase in the serum blood levels of liver function parameters. Conclusions The concurrent use of conventional and herbal medications for musculoskeletal disorders is relatively safe; however, clinicians should exercise caution when prescribing these medications to female patients and patients with a high BMI because of their potential effect on hepatic function.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.3
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• pp.91-102
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• 2015

Objective : The purpose of this study is to find out the possibility of application to herbal medicine's report form for adverse drug reaction (ADR) by reviewing and analyzing Asian countries's ADR report forms. Method : We investigated, compared, and analyzed ADR report forms (ADR-RF) of Asian countries's ADR institutions (ACAI), such as, Korea institute of drug safety & risk management and Dongguk university Ilsan oriental hospital (DUIOH) in Korea, national center for ADR monintoring (NCAM) in China, pharmaceuticals and medical devices agency (PMDA) in Japan, Ministry of Health and Welfare (MOHW) in Taiwan, and drug office, department of health, the government of the Hong Kong special administrative region (GHKSAR) in Hong Kong. Results : ADR-RF for ACAI included common contents, such as, patients information (name(initial), gender, age, weight), adverse event (AE)'s report information (Recognition and report for AE occurrence, first or follow up report, Severe AE), the detailed information of AE (the title of AE, onset & closing date of AE symptoms, the progress & results detailed test of AE), the information of AE's medicine (the types of medicine, product name, ingredient name, suspected or combination drug, single dose & frequency, dosage form, administration route, dealing for AE-suspected medicine), and AE reporter's information (reporter's information, institution's information). Taiwan had ADR-RF and the department exclusively for herbal medicine (HM), but others (except DUIOH) had not only no ADR report form but also contents for HM. Conclusion : ADR-RF for HM have to include the common contents of ACAI at least, as well as HM information related to ADR, such as the title, composition and types of HM, history related to HM's ADR, and the contents of drug-induced liver injury and so on. In addition, the main department of government for HM's ADR will be needed.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.31 no.2
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• pp.104-112
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• 2018

Objectives : The purpose of this study is to examine whether the topical preparations containing 12 herbal extracts is effective for patients with atopic dermatitis. Methods : We retrospectively reviewed the medical records of 11 patients who were prescribed topical preparations containing 12 herbal extracts on the outpatient clinic of 4 hospitals; Noble Korean Medicine Clinic, Amar Korean Medicine Clinic, Chung-Yeon Korean Medical Hospital, Donggwangju Chung-Yeon Korean Medical Hospital. Results and Conclusions : A total of 11 patients were included in the selection and exclusion criteria. The OSI mean value before treatment and at the last treatment day decreased significantly from $37.03{\pm}16.75$ to $13.32{\pm}9.83$, and the mean value of EASI decreased from $13.33{\pm}12.85$ to $2.78{\pm}5.00$, which was statistically significant. No safety concerns were reported. The results of this study confirmed the possibility that the topical preparations can be effective in moderate to severe infants, adolescents, and adult atopic dermatitis patients.

• The Journal of Internal Korean Medicine
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• v.43 no.6
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• pp.1105-1121
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• 2022

Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

• Journal of Acupuncture Research
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• v.37 no.2
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• pp.102-109
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• 2020

Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

• The Korean Society of Law and Medicine
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• v.11 no.1
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• pp.271-296
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• 2010

Objective: Poisonous Medicinal herbs can be considered as a risk factor to public health unless they are prescribed by Doctor of traditional Korean medicine. The proper method to manage them should be prepared to prevent risk factors caused by misuse and abuse of the poisonous medicinal herbs and enhance public health. Methods: In this dissertation (paper), the definition, scope, management status, data about pharmacology and toxicity and media release regarding adverse reaction were understood after organizing documents, laws and regulations concerning poisonous medicinal herbs. Also, management methods are suggested by analyzing related examples and regulations in China, Japan and Hong Kong, where the use of herbal medicine is general. Results: Methods for items for poisonous medicinal herbs, safety information management, management based on standardization of traditional processing methodology and reorganization and revision of related laws and regulations are established. Conclusion: Proper laws and regulations are not yet established to manage poisonous medicinal herbs in Korea. In this regard, it is urgent to establish laws and regulations which can apply independently. The purpose of the laws and regulations should be to enhance management of poisonous medicinal herbs and prevent incidence of addiction and death, improving the public health.

• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.4
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• pp.1134-1139
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• 2004

This study was conducted to investigate the application possibility of leaf and stem extract(LSE) from the mixture of leaf and stem of ginseng radix(Panax Ginseng CA Meyer). This study measured antifatigue effects by rota-rod test and swimming test. Also we examined the cell toxicity in normal liver and kidney cells, and acute toxicity in mice. Dropping times of LSE treated group decreased about 39-83% compared to the control group according to supplementation intake levels. Swimming time in LSE treated group increased compared to the control group at short and long supplementation. Negative effects were not found from the results of the cell toxicity. Also acute toxicity not shown. These results imply that the leaf and stem of ginseng radix could be used as possible food resources and functional food material and feed stuff.