• Title/Summary/Keyword: Herbal medicine safety

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Review of Recent Clinical Research for Oral Herbal Medicine Treatment on Primary Hyperhidrosis in Children - Focused on Chinese Randomized Controlled Trials - (소아 일차성 다한증의 경구 한약치료에 대한 중의학 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Choil, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.75-86
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    • 2022
  • Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.

The Implementation of Korean Medicine Prescription Information System (한약처방 정보 검색 시스템 구축)

  • Yea, Sang-Jun;Shin, Hyeun-Kyoo;Kim, Chul
    • Herbal Formula Science
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    • v.20 no.2
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    • pp.47-54
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    • 2012
  • Objectives : This study aimed to build up information system for the 25 cases of Korean Medicine (KM) prescriptions which are used mostly often in clinic and aimed to offer information about its effect and safety to public and researcher. Methods : We used KM prescription data-bank which came from 'The Bio-informatics for herbal formula' and 'The evidence based medicine for herbal formula' projects of Korean Institute of Oriental Medicine (KIOM) Results : First, we analyzed prescription data and categorized 7 classes, then we built up prescription database based on it. Second, we designed and developed user functions of prescription information system, then we link it to OASIS. Third, we developed adminstration system to manage the prescription data. Conclusions : From this study we hope that KM prescription information system will be used for fusion research based on KM. Because the implemented system is linked to OASIS, we expect it will be widely used.

Acute toxicity study of 77 herbal formulas according to GLP guidelines in rats (흰쥐에서 GLP 기준에 의한 한약처방 77종의 단회 투여 급성 독성 연구)

  • Hyeun-kyoo Shin;Woo-Young Jeon;Chang-Seob Seo;Mee-Young Lee
    • The Journal of Korean Medicine
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    • v.44 no.3
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    • pp.29-38
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    • 2023
  • Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

Panax ginseng: An Overview of the Clinical Evidence

  • Ernst, Edzard
    • Journal of Ginseng Research
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    • v.34 no.4
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    • pp.259-263
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    • 2010
  • This overview is focused on Panax ginseng, one of the most commonly used herbal remedies. The currently available data regarding its clinical efficacy is somewhat confusing, despite the fact that many clinical trials and systematic reviews have been published. The risks of Panax ginseng seem to be only minor. Numerous mechanisms of action have been described. Future studies of this fascinating herbal remedy seem warranted but they should overcome the methodological limitations of the previous research.

Recent Trends in Clinical Research of Herbal Medicine Treatment for Pediatric Constipation - Focused on Chinese Randomized Controlled Trials - (소아 변비의 한약 치료에 대한 최신 임상연구 동향 - 중국 RCT 연구를 중심으로 -)

  • Kim, Jae Hyun;Park, Yong Seok;Lee, Jihong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.4
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    • pp.59-76
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    • 2020
  • Objectives The purpose of this study is to analyze the trends of recent clinical studies on the effect of herbal medicine for pediatric constipation in China, and to evaluate the efficacy and safety of herbal medication treatment for pediatric constipation. Methods The authors searched the clinical studies using China National Knowledge Infrastructure (CNKI) published from January 2016 to June 2020. We analyzed the literature in regards to focusing on the treatment methods and results. Results A total of 29 randomized controlled trials were selected and analyzed. In all the those studies, the total effective rate of herbal medicine treatment group in pediatric constipation was significantly higher than those of the control group. The most commonly used herbs for pediatric constipation were Atractylodis Rhizoma Alba (白朮) followed by Aurantii Immaturus Fructus (枳實), Glycyrrhizae Radix (甘草), Semen Cannabis (火麻仁), Raphani Semen (萊菔子). The recurrence rate of the herbal medicine treatment group was significantly lower than those of control group. In most studies, the adverse events from the herbal medicine treatment group were significantly less than those of the control group. Conclusions Based on the results of the analyzed clinical studies, herbal medicine treatment has been shown to be safe and effective in the treatment of pediatric constipation. Additional clinical studies are needed to solidify these findings.

A Systematic Review of Traditional Herbal Medicine Treatments for Metabolic Syndrome in Patients Receiving Antipsychotic Drugs (항정신병약물 복용 환자의 대사증후군에 대한 한약치료의 체계적 문헌고찰)

  • Sun-Woo Lim;O-Reun Park;So-Hyeon Park;Sung-Youl Choi;Bo-Kyung Kim;Jung-Hwa Lim
    • Journal of Oriental Neuropsychiatry
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    • v.35 no.1
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    • pp.69-99
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    • 2024
  • Objectives: This study aimed to systematically review the effectiveness and safety of traditional herbal medicine treatments for metabolic syndrome (MS) in patients receiving antipsychotic drugs (APs). Methods: We searched 11 domestic and foreign databases for randomized controlled trials (RCTs) using traditional herbal medicines for MS in patients receiving APs. Results: Twenty RCTs conducted in China were included in the analysis. The most common disease among the participants was schizophrenia. Most studies used the 2004 Chinese Diabetes Society (CDS) standards as the diagnostic criteria for MS. The most used prescription was Yukultang (Liuyu-tang). The most used herbal material was Pinelliae Rhizoma, followed by Poria, Citri Reticulatae Pericarpium, and Glycyrrhizae Radix et Rhizoma. Traditional herbal medicines were mostly reported to improve the symptoms of MS. Conclusions: Traditional herbal medicines may be effective in improving the symptoms of MS in patients receiving APs. However, the quality of the included studies was low, and the studies were heterogeneous. Methodologically rigorous clinical studies on traditional herbal medicine treatments for MS in patients receiving APs are needed.

Review of Clinical Studies for Korean Medicine Treatment on Nocturnal Enuresis in Children (소아 야뇨의 한의학적 치료에 대한 국내외 임상연구 동향 - 2000년 이후 발표된 연구를 중심으로 -)

  • Lee, Yoo Been;Jeong, Aram
    • The Journal of Pediatrics of Korean Medicine
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    • v.34 no.1
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    • pp.1-25
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    • 2020
  • Objectives The purpose of this study is to identify the research trends and to evaluate the effectiveness and safety of Korean medicine treatment by analyzing the recently published clinical studies of Korean medicine treatment on nocturnal enuresis in children. Methods The literatures were searched from OASIS, KISS, NDSL, RISS, Cochrane, CINAHL, Embase, Pubmed, and only clinical studies published from 2000 to October 2019 were included. The publication year, study type, type of enuresis, demographic information of participants, duration of illness, intervention type and details, follow-up period, outcome measurements and adverse events of selected literatures were analyzed. Results A total of 38 studies were selected. In the selected studies, acupuncture was the most frequently used treatment for nocturnal enuresis, followed by herbal medicine, electrical stimulation treatment, moxibustion, acupressure and plaster therapy. The most commonly used acupoints for acupuncture were SP6 and CV4, and the most used herbal medicine was Chukcheonwhan, while Alpiniae Fructus (益智仁) and Dioscoreae Rhizoma (山藥) were the most used herbal materials. Most of the studies showed that the total effective rate of Korean medicine treatment was high. All the adverse events occurred in the Korean medicine treatment group were caused by acupuncture or puncture. Conclusions This study analyzed clinical studies of Korean medicine treatment on nocturnal enuresis in children, identified the research trends and evaluated the effectiveness and safety of the Korean medicine treatment.

Effect of Herbal Medicine on Transient Synovitis of Hip in Children: A Systemic Review and Meta-analysis (소아 일과성 고관절 활액막염에 대한 한약의 효과: 체계적 문헌 고찰 및 메타분석)

  • Hong Ye Na;Lee Young Hun;Yu Sun Ae
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.4
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    • pp.34-52
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    • 2023
  • Objective This study aimed to evaluate the effect of herbal medicines on transient hip synovitis (TSH) in children. Methods We searched 10 Korean, English, Japanese, and Chinese databases for studies published up to September 19, 2023. Randomized controlled trials (RCTs) evaluating the effect of herbal medicines on TSH levels in children were included. The Cochrane risk of bias was used to evaluate the quality of the studies. A meta-analysis was conducted according to outcome measurements, such as total effective rate (TER), visual analog score (VAS), time to pain relief, and hip joint mobility disorder disappearance time, using the Review Manager website. Results Eleven RCTs were included in this study. TER in the treatment group was significantly higher than in the control group. The duration of pain relief was significantly shorter in the treatment group than in the control group. The VAS score of the treatment group was significantly lower than that of the control group, although the statistical heterogeneity was substantial. The hip joint mobility disorder disappeared in the treatment group treated with external therapy, which was significantly shorter than in the control group. Regarding safety, two of the 11 studies reported that there were no adverse events. Conclusions Herbal medicines are effective in the treatment of TSH in children. However, the safety of herbal medicines should be carefully considered due to the lack of data.

Quality Control of Pharmacopuncture: A Comparative Study of Good Manufacturing Practice and External Herbal Dispensary Standards

  • Han, Ji-Eun;Park, Minjung;An, Tteul-E-Bom;Park, Jong-Hyun;Oh, Danny;Kim, Kyeong Han;Sung, Soo-Hyun
    • Journal of Pharmacopuncture
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    • v.24 no.2
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    • pp.59-67
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    • 2021
  • Objectives: We aimed to compare the external herbal dispensary (EHD) evaluation criteria for pharmacopuncture and the Korea Good Manufacturing Practice (KGMP) sterile medicine standards to contribute to the establishment of quality control criteria for pharmacopuncture. Methods: We obtained the KGMP standards from the Ministry of Food and Drug Safety and the pharmacopuncture certification criteria from the Ministry of Health and Welfare of South Korea. The EHD evaluation items were classified into three categories: facilities, quality control, and validation. The evaluation items were compared with the KGMP sterile medicine criteria to determine their conformance with each other, followed by a discussion among the committee of six experts and their consensus to suggest the items to complement the EHD evaluation criteria. Results: Among the KGMP sterile medicine criteria, 44 were related to the management of the facilities, and 32 pharmacopuncture evaluation items corresponded to these KGMP items (66.7%). Fifty-eight KGMP criteria were related to quality management, and 42 pharmacopuncture evaluation items corresponded to these KGMP items (72.4%). Twentyfive KGMP sterile medicine criteria were related to validation, and 11 pharmacopuncture evaluation items corresponded to these KGMP items (44.0%). Sixteen items under the pharmacopuncture EHD criteria corresponded to the KGMP sterile medicine criteria based on the consent of the experts. Among these, 4 were related to facility management, 6 were related to quality control, and 6 were related to validation. Conclusion: For the safety and quality control of pharmacopuncture, there is a need to select the criteria for the mandatory items among the proposed pharmacopuncture-EHD criteria laws and systems to ensure that the pharmacopuncture materials are produced under the pharmacopuncture-EHD in compliance with the relevant requirements. More studies are needed to secure the safety level of pharmacopuncture materials corresponding to that of conventional medicine.

Systematic Studies on Galgeun-tang(gegen-tang, kakkon-to) for Establishment of Evidence Based Medicine (표준한방처방의 EBM 구축을 위한 갈근탕(葛根湯) 문헌 분석 연구)

  • Lee, Jun-Kyoung;Kim, Jung-Hoon;Shin, Hyeun-Kyoo
    • Herbal Formula Science
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    • v.19 no.1
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    • pp.103-111
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    • 2011
  • Objectives : The purpose of this report was to provide the information of activity and safety of galgeun-tang by analyzing domestic/international papers and theses about galgeun-tang. Methods : Domestic/international papers and theses related to galgeun-tang were reviewed and analyzed. These papers were then classified by efficacy, or clinical trials. Results : The basic pharmacological experiment showed antipyretic, analgesic and anti-virus and anti-oxidant efficacy of galgeun-tang. In the case report of galgeun-tang, it showed therapeutic effect for patient with chronic rhinitis. But administration of galgeun-tang induced pruritic eruption in the two case report as a side effects of galgeun-tang. Conclutions : galgeun-tang showed tantipyretic, analgesic and anti-virus and anti-oxidant efficacy in the basic pharmacological experiment. Also, galgeun-tang showed therapeutic effect for patient with chronic rhinitis. But it was reported that galgeun-tang induced pruritic eruption in two case report, so physicians should be aware of the potential side effects.