• The Journal of Korean Obstetrics and Gynecology
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• v.27 no.3
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• pp.79-93
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• 2014

Objectives: This study was to establish safety and efficacy of using herbal medicine during pregnancy and to investigate patient's satisfaction. Methods: We investigated general pregnancy outcome, birth history, newborn infant's physical condition and patient's satisfaction. Survey respondents were 54 gynecological outpatients who visited Daejeon University Dunsan Oriental hospital from January 1, 2011 through February 28, 2013. Results: A total of fifty one cases maintained pregnancy and 3 cases had miscarriages. Forty seven cases delivered normally, 4 cases gave birth prematurely. There was no congenital malformation due to using herbal medicine and most of newborn babies had on the average weight and height and were healthy condition. The average score of patient's satisfaction was 3.44 point (Excellent=5). Conclusions: This study presents safety and efficacy of using herbal medicine during pregnancy.

• The Journal of Korean Medicine
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• v.28 no.3 s.71
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• pp.144-155
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• 2007

Background : In western medicine, there has been much interest in medication teaching since the separation of dispensary from medical practice in 2000. On the other hand, few investigations have been carried out about medication teaching for herbal medicine. Objectives : The purpose of this study wasto investigate the current status of medication teaching of herbal medicine and develop a better guide. Methods : Pharmaceutical affairs law in Korea was searched and some medication teaching guides were compared and analyzed to develop a better guide suitable for herbal medicine. Results and Conclusions : The future guide should be based on scientific evidence and include the following: (1)the origin of each herbal formula (2)the constitution of each herbal formula and proportion of each herb included (3)the chief virtue of each herbal formula (4)the efficacy of each herbal formula (5)the safety of each herbal formula (6)combined treatment with herbal formulas and western drugs (7)the way of decocting each herbal formula (8)the way of safekeeping and period of circulation of each herbal formula (9)a summary and evaluation for each herbal formula (10)references of each herbal formula.

• Korean Journal of Medicinal Crop Science
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• v.20 no.6
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• pp.434-439
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• 2012

This study was conducted to determine the contents of heavy metal in commercial herbal medicines. The monitoring of lead, arsenic, cadmium and mercury was carried out on 100 samples with 10 kinds of herbal medicines. The contents of heavy metal were measured by inductively coupled plasma atomic emission spectrometry (ICP-AES) and mercury analyzer. The mean values of heavy metal contents for herbal medicines were Pb 1.87 mg/kg, As 0.39 mg/kg, Cd 0.26 mg/kg and Hg 0.021 mg/kg. Of the total samples, 19 samples (19%, 4 types) were violated the KFDA regulatory guidance of heavy metal in herbal medicines (9 samples on Pb, 10 samples on Cd). Among these 19 unsuitable samples, 16 samples were domestic and 3 samples were imported. Therefore, we need continuously monitoring to ensure confidence and safety for these herbal medicines.

• Journal of Society of Preventive Korean Medicine
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• v.14 no.1
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• pp.49-58
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• 2010

Objective : The purpose of this study is to examine safety of herbal medicine on liver function and compare with western medicine. Method : 303 subjects of skin disease(vitiligo and psoriasis) were chosen at a local oriental medical clinic, and tested with a spot liver function test from Sept 1, 2006 to Dec 31, 2006. Subjects were grouped into untreated, herbal medicine, western medicine, and combination group by treatment record. Total bilirubin, AST, ALT and LDH was compared in each group, odds ratio and regression coefficient was calculated. Results : Subjects comprised of 116 individuals receiving western medication(38.28%), 54 receiving herbal medication(17.82%), 107 receiving combined forms of medication(35.31%), and 26 individuals without any types of medication(8.58%). With the mean age of 37.0 yr. 204 were male(67.3%), 99 were female(32.7%). Comparing variables of liver functions, there was no significant difference between the control and experiment groups. After adjusting potential confounders, monthly $\beta$(SE) of multiple regression -0.009~0.000 for the herbal group, -0.005~0.000 for the western group, and -0.001~0.001 for the combination group. No significant difference between the groups. OR of T-bilirubin were 1.02, 1.05, and 1.04. AST were 0.92, 0.94, and 0.98. ALT were 0.85, 0.99, and 0.97. LDH were 0.96, 1.06, 1.00 for the herbal, western, and combination group, respectively. Conclusion : Comparing with western medication, herbal medication did not cause special ill-effect on the liver function based on liver function tests.

• Herbal Formula Science
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• v.19 no.2
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• pp.73-82
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• 2011

Objectives : This study aims to investigate the acute oral toxicity and safety of Samsoeum (Shensuyin) extracts and fermented Samsoeum extracts. Methods : For that objective, we used ICR mice. ICR mice were administerd orally with dosage of 1250mg/kg, 2500mg/kg and 5000mg/kg of Samsoeum extracts and fermented Samsoeum extracts. Results : We daily examined number of deaths, clinical signs, body weights and gross findings for 2 weeks. 1. The results of acute oral toxicity using ICR mice showed that LD50 of value over 5000 mg/kg. 2. Samsoeum extracts and fermented Samsoeum extracts not affect on bodyweight gross findings of ICR mice. 3. The results of Serum chemistry analysis and Complete Blood Count(CBC) through the autopsy were showed normal range values. Conclusions : Samsoeum extracts and fermented Samsoeum extracts did not show any toxic effects in ICR mice. And oral LD50 value was over 5000mg/kg in ICR mice and it is very safe for ICR mice.

• Journal of Korean Medical classics
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• v.20 no.1
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• pp.103-111
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• 2007

1. "Regulation for about kind of formularies of Korean traditional herbaland preparation method"(Ministry of Health and Welfare No. 1995-15, 95. 3. 15) and "Regulation for review safety and efficacy of drugs. Article 2. 1 Clause 10." should revise "Sasanguihak(四象醫學)" by "Donguisusebowon(東醫壽世保元)" that is the name of book. 2. "Regulation for review safety and efficacy of drugs. Article 2. 1 Clause 10." was defining 'The 11 established formularies of Korean traditional herbal medicine volumes' "Donguisusebowon" that is defined as "The 11 established formularies of Korean traditional herbal medicine volumes" is "Susebowon(壽世保元)" that the Ming period Gong jung-hyun writes. Otherwise, mistake that "Donguisusebowon" of Lee Jema(李濟馬) was recorded 2 times occurs. Therefore, "Susebowon" of "The 11 established formularies of Korean traditional herbal medicine volumes" is that "Susebowon" of the Ming period Gong Jung-hyun writes 3. "yaksungga(藥性歌)" is nonbook in "The 11 established formularies of Korean traditional herbal medicine volumes" and should be erase. Because basis is ambiguous. 4. "The 11 established formularies of Korean traditional herbal medicine volumes" must revise by 10 kinds in "Regulation for about kind of formularies of Korean traditional herbaland preparation method" and "Regulation for review safety and efficacy of drugs. Article 2." The kinds should be revised by "Donguibogam(東醫寶鑑)", "jejungsinpyeon(濟衆新編)", "Euihakipmoon(醫學入門)", "kyungakjeonse(景岳全書)", "Susebowon", "Bonchogangmok(本草鋼目)", "Bangyakhappyeon(方樂合編)", "Hyangyakjipseongbang(鄕樂集成方)", "Gwangjebigeup" and "Donguisusebowon".

• Korean Journal of Pharmacognosy
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• v.35 no.2 s.137
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• pp.122-127
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• 2004

This study was conducted to investigate the safety and efficacy of an oriental herbal composition, Kamihonghwatang(KH-19), for the reduction of the side effects of chemotherapeutic drug. KH-19 prevented the reduction of white blood cells including lymphocytes, monocytes and eosinophiles in C57BL/6 mice injected with fluorouracil, a commonly used anticancer drug. KH-19 also prevented the reduction of cell densities in bone marrow and spleen of fluorouracil-injected mice. To evaluate the safety of KH-19, single-dose toxicity test was conducted using SD rats. No dead animal was found and the minimum lethal dose of KH-19 was more than 5000 mg/kg.

• The Journal of Korean Medicine
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• v.21 no.3
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• pp.99-112
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• 2000

Objective: This study was conducted to suggest a proper administration system of the quality of herbal medicine. Methods: Related literature was carefully inspected and discussions among specialists in the field of herbal medicine's growth, production, circulation and administration were conducted. Results: 1. The administration of herbal medicine's quality should be done in each stage of its circulation; growing stage, harvesting stage, importing stage, production stage, quality examination stage, wrapping stage, circulating stage, and administration stage. 2. A safety standard should be established for items, parts and origins of each medicinal herb. A standard for the identification of forged products and objective standards for quality discrimination should also be established. 3. A national system for the training of herbal medicine quality administration personnel and herbal medicine discrimination personnel should be established. A data base of standardized product specimens should be established and a pharmacopoeia of herbal medicine should be published as a standard of quality administration in herbal medicine. 4. Research into the following preliminary areas should be conducted to investigate quality adminstration of herbal medicine: research related to herbal medicine's raw materials and herbal medicinal drugs; quality estimation of raw materials and drugs; quality administration in oriental medical hospitals; herbal medicine administration law; herbal medicine administration organization; herbal medicinal pharmacology; and policy-related research for the quality improvement of domestically grown medicinal herbs. Conclusion: For the proper administration of herbal medicine's quality, governmental support and intensive research among specialists should be done for the supply of good quality medicinal herbs and the improvement of the efficacy of herbal medicine.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.1
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• pp.45-57
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• 2023

Objectives This study aimed to provide a basis for the research on the trend and safety of Korean herbal medicines among children and adolescents. Methods Patients aged <19 years who received outpatient treatment at the Korean pediatrics department of Kyung Hee University Hospital from January 1, 2017 to October 31, 2022 were included. The current state of annual visits and herbal medicine prescriptions was analyzed. A retrospective chart review was conducted by examining the medical records of subjects who received herbal medicines, including deer antler. Adverse drug reactions in patients who received herbal medicine were also investigated. Results A total of 57,457 people visited the Korean pediatrics department, and 51,768 people (90.1%) were prescribed herbal medicine. Among these, 21,826 patients (42.2%) were prescribed with deer antler. A total of 117 adverse drug reactions were reported among the patients who received herbal medicines. Conclusions This study aimed to determine the trends and safety of herbal medicine treatment, particularly deer antlers, in children and adolescents. Well-designed, long-term, multi-institutional follow-up studies are required to expand the field of Korean pediatrics.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.2
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• pp.90-111
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• 2020

Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.