• The Journal of Korean Medicine
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• v.30 no.6
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• pp.80-85
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• 2009

Objective: This study aimed to build an overview of randomized clinical controlled trials (RCTs) for chronic fatigue-related symptoms to extract the useful data for management of patients and development of therapeutics using Korean traditional medicine in the future. Methods: All RCT-derived papers for chronic fatigue-related symptoms were collected via PubMed Database. We surveyed elementary information of RCTs such as clinical question, study design, and its quality and results. Results: A total of fifty-three RCTs met these review criteria. Most of the RCTs were performed in Western countries, particularly the UK and USA. The major portion of RCTs focused on chronic fatigue syndrome using immune modulators, psychotherapeutic and anti-depressants. Five RCTs using complementary and alternative medicine, including herbal remedies, showed positive results. Conclusions: Fatigue-related symptoms are a main target of Oriental medicine. This study provides helpful information for planning clinical study of chronic fatigue-related symptoms using traditional Korean medicine.

• Korean Journal of Acupuncture
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• v.30 no.1
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• pp.16-20
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• 2013

Objectives : The objective of this study is to report the efficacy of acupuncture and moxibustion for the treatment of fetal breech presentation. Methods : We searched papers in PubMed, using the keywords "breech and moxibustion" and "breech and acupuncture". Search range includes randomized clinical trials(RCTs), controlled clinical trials(CCTs), case reports, and case series. Each original article must have an abstract in English. Finally, 7 RCTs from 102 were included in this review. Results : As a result of analyzing the 7 RCTs, five trials hold that moxibustion or acupuncture at BL67 has been shown to produce a positive effect for the correction of breech presentation and the other two trials indicated no beneficial effect. However, one of the latter could not come to a conclusion owing to the unsatisfactory compliance record of the participants. Conclusions : Acupuncture and moxibustion may be effective to correct fetal breech presentation. In this regard, the related clinical researches are worth to be conducted.

• The Journal of Internal Korean Medicine
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• v.43 no.6
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• pp.1149-1161
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• 2022

Purpose: This systematic review was conducted to evaluate the clinical effects of Injinho-tang on hyperbilirubinemia in hepatobiliary disorders. Methods: We searched for randomized controlled clinical trials that had administered Injinho-tang as an intervention in the following medical databases: Public/Publisher MEDLINE (PubMed), Excerpta Medica dataBASE (EMBASE), Cochrane library, Research Information Sharing Service (RISS), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), and China National Knowledge Infrastructure (CNKI). Among the retrieved studies, only trials that met the inclusion criteria were selected, and serum total bilirubin values were extracted and analyzed from the finally selected trials. Results: The serum total bilirubin values of 1,302 patients with various hepatobiliary diseases were synthesized through a meta-analysis, which confirmed a decrease in serum total bilirubin of 21.03 𝜇mol/L (95% CI -29.58~-12.49, p<0.01) in the group administered with Injinho-tang compared with the control group. Conclusions: Injinho-tang is effective in alleviating hyperbilirubinemia in hepatobiliary diseases when administered with conventional treatment. However, the potential risk of bias, high heterogeneity among the included trials, and differences in herbal composition are limitations of the results of this meta-analysis.

• Translational and Clinical Pharmacology
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• v.26 no.4
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• pp.155-159
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• 2018

For regulatory approval of a new drug, the most preferred and reliable source of evidence would be randomized controlled trials (RCT). However, a great number of drugs, being developed as well as already marketed and being used, usually lack proper indications for children. It is imperative to develop properly evaluated drugs for children. And expanding the use of already approved drugs for other indications will benefit patients and the society. Nevertheless, to get an approval for expansion of indications, most often with off-label experiences, for drugs that have been approved or for the development of pediatric indications, either during or after completing the main drug development, conducting RCTs may not be the only, if not right, way to take. Extrapolation strategies and modelling & simulation for pediatric drug development are paving the road to the better approval scheme. Making the use of data sources other than RCT such as EHR and claims data in ways that improve the efficiency and validity of the results (e.g., randomized pragmatic trial and randomized registry trial) has been the topic of great interest all around the world. Regulatory authorities should adopt new methodologies for regulatory approval processes to adapt to the changes brought by increasing availability of big and real world data utilizing new tools of technological advancement.

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.153-173
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

• Journal of Pharmacopuncture
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• v.20 no.3
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• pp.179-193
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• 2017

Objectives: Nigella sativa (black seed or black cumin), which belongs to the Ranunculacea family, is an annual herb with many pharmacological properties. Among its many active constituents, thymoquinone (TQ) is the most abundant constituent of the volatile oil of Nigella sativa (N. sativa) seeds, and it is the constituent to which most properties of this herb are attributed. Methods: PubMed-Medline, Scopus, and Web of Science databases were searched to identify randomized control trials (RCTs) investigating the therapeutic effects of N. sativa and/or TQ. In this review, we investigated the clinical uses of N. sativa and TQ in the prevention and the treatment of different diseases and morbidity conditions in humans. Results: Black seed and TQ are shown to possess multiple useful effects for the treatment of patients with several diseases, such as inflammatory and auto-immune disorders, as well as metabolic syndrome. Also, other advantages, including antimicrobial, anti-nociceptive and anti-epileptic properties, have been documented. The side effects of this herbal medicine appear not to be serious, so it can be applied in clinical trials because of its many advantages. Conclusion: Some effects of N. sativa, such as its hypoglycemic, hypolipidemic and bronchodilatory effects, have been sufficiently studied and are sufficiently understood to allow for the next phase of clinical trials or drug developments. However, most of its other effects and applications require further clinical and animal studies.

• Phonetics and Speech Sciences
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• v.2 no.1
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• pp.99-112
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• 2010

This study attempted to review the recent, high-quality evidence-based practical research related to the treatment effectiveness of voice disorders which focus on randomized controlled trials (RCTs) and translational research of vocal fold tissue engineering for vocal fold regeneration. Methodology including PICO (P; Populations or Patients, I; Interventions, C; Comparison group (control, placebo, gold standard), O; Outcomes or measures made) information for RCTs and animal models (species), regenerative therapy method, and outcomes of translational research for clinical application was summarized and discussed for future voice disorder research.

• The Academic Congress of Korean Shoulder and Elbow Society
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• 2009.03a
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• pp.7-7
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• 2009

• Journal of Physiology & Pathology in Korean Medicine
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• v.29 no.6
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• pp.458-466
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• 2015

The purpose of this study was to review the research on treating depression in Traditional Chinese Medicine(TCM) over the last 5 years to set the foundation for further studies. We searched for and analyzed articles about depression in CNKI(China National Knowledge Infrastructure) from January 2010 to December 2014. The results were as follows : The most frequently used diagnostic criteria was CCMD-3(The Chinese Classification of Mental Disorders-3), and the most used evaluation criteria was HAMD(Hamilton Depression Rating Scale). Prescription of decoction of medical herbs was most frequently used as a therapeutic method. Acupuncture, traditional Chinese psychotherapy, and music therapy were also used for some studies. The most frequent TCM Syndrome Differentiation Type was stagnation of liver-QI. For decoction of Chinese herbs, Soyo-san(Xiaoyao-san) and Sihosogan-san(Chaihushugan-san) were most often prescribed, and Bupleuri Radix, Paeoniae Radix Alba, Curcumae Radix, Poria cocos wolf, Angelicae Gigantis Radix, Atractylodis Rhizoma Alba were mainly used for medical herbs. BaekHoi(GV20) and Yindang(Ex-HN3) were often used as acupuncture sites. Post-Stroke Depression was the most common case of intercurrent or secondary depression. According to the Jadad Quality Assessment Scale, the quality of the reports was not high as most of the reports had a score of 3 or below. Most systematic reviews on depression were conducted by Chinese researchers. The problem with Clinical research on depression, according to those reviews, was that there were no standardized criteria for the diagnosis and treatment and the trials were usually not randomized nor controlled. We found out there are various clinical methods for treating depression in TCM, and hope that this research could provide the preliminary data for designing and conducting clinical trials for depression.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.6
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• pp.698-704
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• 2013

The purpose of this study is to figure out which acupoints are selected to treat nuchal pain and attempt to analyze the meaning of those acupoints in current clinical trials. We searched ten electronic databases and manually checked related Korean journals and references. We included randomized controlled trials(RCT), clinical controlled trials(CCT), case reports/series, and literature reviews using acupojnts to treat nuchal pain. We investigated the frequency of selected acupoints. We included 31 articles in this study. The most frequently adopted acupoints were GB20(77.41%), followed by GB21(61.29%). In distribution according to meridian system, BL was the most(25.60%), followed by Extra points of Dong-Shi(12.19%). Selected acupoints for treat nuchal pain were considered to be affected by flow of meridian system. It is necessary for more studies to provide clinical guideline of acupoint selection.