• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.20 no.3
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• pp.138-146
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• 2007

Objective : To observe the trend in clinical study on atopic dermatitis(AD) over the last 3 years in order to develop a study methodology of AD in Oriental Medicine. Methods : Using the Pub med on line site; search terms: atopic dermatitis, field as title/abstract, limitation as published in the last 3 years, only items with links to full text, Humans, Clinical Trial, English. I observed the study contents of all this research and focused on the classification of treatments. I also observed of AD clinical trials registered on a clinical trial site(www.clinicaltrial.gov) on 23rd of June, 2007: study contents, localization and study designs. Results : Through the Pub Med site, I found 169 articles. Classified according to study subject, the studies related to treatment were 114(67.5%); physiology, pathology and prevention 12(7.1%); Diagnosis and Evaluation(7.1%); psychological aspects including quality of life 10(5.9%); diet and management 10(5.9%); epidemiology 7(4.1%); and others 7(4.1%). However, the treatment study of herb-medicine as intervention showed only 1 article. Futhermore, it wasn't based on Oriental Medicine philosophy. In the clinical trial site, there were 31 studies in which patients were recruited or planned for the future. The study on efficacy and safety of the medicine produced 14 trials, 5 comparative trials, 2 phototherapy, 2 diagnosis, 6 physiology and pathology, and 2 epidemiology. The trial institutions were concentrated in U.S.A. Conclusion : I suggest we'd better try to make a good clinical guideline and standardization of diagnosis and herb-medicine in order to develop a clinical study methodology of AD as soon as possible in the future. Even though it 's very hard to find the study methodology, we should aim to achieve positive results and show the evidence of the efficacy and safety of herb-medicine treatment for AD using Oriental Medicine.

• Journal of dental hygiene science
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• v.14 no.3
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• pp.269-275
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• 2014

Recently, there are lots methodologies to improve the quality of research in medical and public health fields. One of them is to checking a process of research with a reporting guideline before reporting paper. Especially, reporting guideline for randomized controlled trials (RCTs) is the consolidated standards of reporting trials (CONSORT). Therefore, this review describes the latest version of the CONSORT statement, CONSORT 2010, including intent, background, and contents of this. The CONSORT statement comprises a checklist of essential items that should be included in reports of RCTs and a diagram for documenting the flow of participants through a trial. This report guideline aims at providing guidance to authors about how to improve the reporting of their trials. As consulting the CONSORT, authors could be strictly reported about research methods and results. From this review, we expect to elevate the quality of such research about dental hygiene and to establish the foundation for evidence-based dental hygiene.

• Quality Improvement in Health Care
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• v.2 no.1
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• pp.86-109
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• 1995

Clinical trials of drugs on humans is the final and most important stage in evaluating the safety and efficacy of the drugs. Good Clinical Practice(GCP) standards were announced in 1987 to protect testees' rights as well as to ensure validity of the clinical trial results, but its implementation has been delayed until now. The purpose of this study is to evaluate the preparedness of the designated institutions to abide by GCP standards during clinical trials, and thereby to determine GCP implementability at the institutions. Survey on the status of clinical trials was conducted for the designated 83 clinical trial hospitals. Response rate was 95.2%. Donabedian's quality assessment model was applied as the basic framework for the study. And the relative - weights for the evaluation items were determined by expert's evaluation. Among the designated 83 hospitals, 39 conducted clinical trials to obtain drug manufacturing approval from 1990 to 1994. Only 19 institutions are found to be able to meet the requirements of KGCP. Structure variables - manpower, organization, and facility -, which are the basic elements for GCP, are evaluated as unsatisfied in many hospitals. Institutions which established IRB accounted for 41 or 51.9%, but those who have a protocol evaluation guideline, or Adverse Drug Reaction(ADR) reporting system were only 12 and 21 institutions, respectively. Also, the institutions providing educational programs on conducting clinical trials are few - 20. The study results indicates that the level of conducting KGCP is unsatisfactory. However, more institutions are expected to be able to meet the standards soon because GCP standards does not require so much regulation on facilities, but stress importance on research methodology and human right. At present as the institutions for clinical trials are primarily training hospitals with residency programs, such efforts as education will accelerate the implementability of GCP in Korea. Institutions must build the appropriate infrastructure and government must prepare to strongly enforce KGCP before it can successfully take place.

• Journal of Sasang Constitutional Medicine
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• v.27 no.1
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• pp.71-81
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• 2015

Objectives This research was proposed to present clinical practice guideline (CPG) for Taeyangin Disease of Sasang Constitutional Medicine (SCM). This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods This guideline was performed that search and collection of literature related SCM such as "Dongeuisusebowon", textbook of SCM, clinical guidebook of SCM and fundamental research to standardize diagnosis of Sasang Constitutional Medicine. Journal search related clinical trial or human complementary medicine of SCM was performed domestic and overseas. Finally, 1 article was selected and included in CPG for Taeyangin disease. Results & Conclusions The CPG of Taeyangin disease include classification, definition and standard symptoms of each pattern. Taeyangin disease is classified into exterior-origin lower back (EOLB) disease and interior-origin small intestine (IOSI) disease by region of symptom. EOLB can be replaced with Oegam-yocheok and IOSI can be replaced with Naechok-sojang that is Korean pronuncation. EOLB disease is classified into lower back favorable symptomatology (LBFS) and lower back unfavorable symptomatology (LBUS). Lower back is to say Yocheok, so LBFS can be called Yocheok favorable symptomatology and LBUS can be called Yocheok unfavorable symptomatology. LBUS is to say paraparesis symptomatology or Haeyeok, that is Korean pronunciation, symptomatology. IOSI disease is classified into small intestine favorable symptomatology (SIFS) and small intestine unfavorable symptomatology (SIUS). Small intestine is to say Sojang, so SIFS can be called Sojang favorable symptomatology and SIUS can be called Sojang unfavorable symptomatology. SIUS is to say regurgitation symptomatology or Yeolgeok, that is Korean pronunciation, symptomatology.

• Korean Journal of Clinical Pharmacy
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• v.33 no.3
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• pp.178-185
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• 2023

Objective: Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease. Both tralokinumab and dupilumab have been recommended in the European Guideline for the treatment of adult patients with severe AD. In Korea, dupilumab has been approved for patients with moderate to severe AD, and reimbursed for those with severe AD. Since there is no clinical trial directly comparing tralokinumab and dupilumab, we conducted indirect comparison to assess the clinical usefulness in patients with AD. Methods: We selected clinical trials for indirect comparison through a systematic literature review. Individual patient data were available for the tralokinumab clinical trial, and aggregated data were available for the dupilumab clinical trial. Therefore, we employed the Matching-Adjusted Indirect Comparison (MAIC) method. The treatment efficacy was assessed based on whether patients achieved a 75% reduction on the Eczema Area and Severity Index (EASI 75) after drug administration. Results: The difference in the proportion of patients achieving EASI 75 between tralokinumab and dupilumab was 4.7% (95% CI: -7.9 to 17.3). Considering the non-inferiority margin for the EASI 75 achievement rate is -10%, tralokinumab is deemed non-inferior to dupilumab as the lower bound of the CI for the difference in the EASI 75 achievement rate between tralokinumab and dupilumab was within -10%. Conclusion: We conducted a MAIC analysis comparing tralokinumab and dupilumab based on EASI 75 achievement. The findings of this study show that tralokinumab is non-inferior to dupilumab and can be implemented in Korean clinical settings with a therapeutic position comparable to dupilumab.

• Journal of Society of Preventive Korean Medicine
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• v.27 no.2
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• pp.85-107
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• 2023

Objective : To investigate the usage of Korean herbal medicine (KHM) for climacteric symptoms, this study reviewed clinical studies conducted in Korea. Method : Literature search was performed on three Korean database; OASIS, RISS and NDSL. Studies published before July 2023 were categorized and analyzed according to the study type and herbal prescriptions. Results : Fifty-eight studies including 7 controlled trial, 27 case series and 24 single case reports were included in our review and the total number of case patients was 420. 52 prescriptions based on syndrome identifications and 11 prescriptions of Sasang constitutions were used and the most frequently used prescriptions were Soyosan(逍遙散) and Guibitang(歸脾湯). Thirty-two prescriptions were also mentioned in previous delphi research or clinical practice guideline, and the rest were not. Thirty-five studies used acupuncture combined with KHM and 10 studies used pharmacopuncture and 5 studies used herbal hipbath. Conclusion : To increase the therapeutic effect of KHM and establish KHM as an alternative to hormone treatment, various prescriptions should be used according to syndrome identifications in the clinical field. High-quality RCTs on frequently used prescriptions and the development of various type of KHM are also necessary.

• Journal of Sasang Constitutional Medicine
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• v.27 no.1
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• pp.42-56
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• 2015

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Taeeumin Disease of Sasang Constitutional Medicine(SCM): Esophagus Cold-based Exterior Cold (Wiwansuhan-pyohan) disease. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, collection and organization of literature related to SCM such as Donguisusebowon, Text book of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine was performed. Secondly, journals related to clinical trial or Human complementary medicine of SCM were searched. Finally, 7 articles were selected and included in CPG for Esophagus Cold-based Exterior Cold (Wiwansuhan-pyohan) disease. Results & Conclusions The CPG of Esophagus Cold-based Exterior Cold (Wiwansuhan-pyohan) disease in Taeeumin Disease include classification, definition and standard symptoms of each pattern. Esophagus Cold-based Exterior Cold (Wiwansuhan-pyohan) disease consists of two aspects : Esophagus-Cold (Wiwanhan) and Esophagus-Cold Lung-Dry (Wiwanhan-paejo) symptomatology. Esophagus-Cold (Wiwanhan) symptomatology is classified into mild and moderate pattern by severity. Mild pattern of Esophagus-Cold (Wiwanhan) symptomatology is classified into Supraspinal Exterior (Baechu-pyo) initial and Wheezing-Dyspnea (Hyocheon) pattern. Moderate pattern of Esophagus-Cold (Wiwanhan) symptomatology is classified into Cold-reversal (Hanguel) and Cold-reversal (Hanguel) advanced pattern. And Esophagus-Cold Lung-Dry (Wiwanhan-paejo) symptomatology is classified into severe and critical pattern by severity. Severe pattern of Esophagus-Cold Lung-Dry (Wiwanhan-paejo) is classified into Dry-Cold (Johan) pattern and Dry-Cold (Johan) advanced pattern. Critical pattern of Esophagus-Cold Lung-Dry (Wiwanhan-paejo) symptomatology consists of Dry-Cold (Johan) intense pattern (Eumhyeol-mogal handa pattern).

• Journal of Sasang Constitutional Medicine
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• v.26 no.3
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• pp.262-271
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soyangin Disease of Sasang Constitutional Medicine (SCM) ; Chest-Heat congested(Hyunggyeok-yeol) Symptomatology. Methods This CPG was developed by the national-wide experts committee consisting of SCM professors. First, collection and organization of literature related to SCM such as Donguisusebowon, Text book of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine was performed. Secondly, journals related to clinical trial or Human complementary medicine of SCM were searched. Finally, 4 articles were selected and included in CPG for Chest-Heat congested(Hyunggyeok-yeol) Symptomatology of Stomach Heat-based Interior Heat disease in Soyangin disease. Results & Conclusions CPG of Chest-Heat congested(Hyunggyeok-yeol) symptomatology in Soyangin disease includes classification, definition and standard symptoms of each pattern. Chest-Heat congested(Hyunggyeok-yeol) symptomatology is classified into mild and moderate pattern by severity. Chest-Heat(Hyunggyeok-yeol) symptomatology Mild pattern is classified into Chest-Heat congested(Hyunggyeok-yeol) initial pattern and Chest-Heat congested(Hyunggyeok-yeol) advanced pattern. And Chest-Heat congested (Hyunggyeok-yeol) moderate pattern is classified into Clear Yang Failure of Stomach(Weguck-cheongyang Bulsagnseung) pattern (Upper wasting-thirst(Sangso) pattern), Clear Yang Failure of Large Intestine (Daejang-cheongyang Bulsangseung) pattern (Middle wasting-thirst (Jungso) pattern).

• Journal of Sasang Constitutional Medicine
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• v.26 no.3
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• pp.241-250
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• 2014

Objectives This research was proposed to present Clinical Practice Guideline(CPG) for Soyangin Disease of Sasang Constitutional Medicine(SCM): Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology. This CPG was developed by the national-wide experts committee consisting of SCM professors. Methods First, it was performed that search and collection of literature related SCM such as "Dongeuisusebowon", Textbook of SCM, Clinical Guidebook of SCM and Fundamental research to standardize diagnosis of Sasang Constitutional Medicine. And journal search related to clinical trial or Human complementary medicine of SCM was performed domestic and overseas. Finally, 1 articles were selected and included in CPG for Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology of Spleen Cold-based Exterior Cold (Bisuhan-pyohan) disease in Soyangin Disease. Results & Conclusions The CPG of Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology in Soyangin Disease include classification, definition and standard symptoms of each pattern. Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology is classified into mild and moderate pattern by severity. Lessor-Yang Wind-Injury (Soyang-sangpung) Symptomatology mild pattern is classified into initial pattern and advanced pattern. Lesser-Yang Wind-Injury (Soyang-sangpung) symptomatology moderate pattern is classified into Chest-binding (Gyeolhyoong) pattern and Chest-binding (Gyeolhyoong) advanced pattern.

• Bulletin of the Korean Chemical Society
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• v.33 no.2
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• pp.433-442
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• 2012

The promise of stem cell therapy for various clinical applications seems getting realistic. An increasing number of researchers, from virtually every discipline of natural sciences, are flocking into this new world. Only ten years ago, gene therapy was the medicine for the 21st century. The possibility was endless. Although the science itself underlying gene therapy was very young, the field was exploding under the optimism that this new medicine would revolutionize both the basic and clinical sciences. For many reasons, the initial target was cancer. Here, we will focus on the results of cancer gene therapy clinical trials using liposome or nonviral gene carrier, hoping that the lesson from here will be a guideline for the new generation of cell-based therapies.