• Korean Journal of Acupuncture
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• v.30 no.4
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• pp.201-211
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• 2013

Objectives : The aim of this study is to summarize and compare acupuncture points used for dental disorder in the classics with those used in recent clinical trials. Methods : We searched the data for acupuncture points used and rationale of acupuncture in dentistry. Following two sources were searched: 1) seven Classics of traditional medicine and 2) clinical trials through Pubmed from January 2000 to March 2013 with no language restriction. Results : Dental pain was the most common disorder in the dentistry section of the Classics of traditional medicine. We found many similarities of acupuncture points used between literatures and clinical trials. From the meridian perspective, large intestine meridian(LI), stomach meridian(ST), triple energizer meridian(TE), and gallbladder meridian(GB) were frequently used in the Classics of traditional medicine and the clinical trials. From the acupuncture point perspective, acupuncture points were selected according to syndrome. The specific points such as five transport points, source points, and connecting points were also used. In the clinical trials, combination of acupuncture points usually consisted adjacent points and distant points. Among them, LI4 was used in all of the studies included in this review. Conclusions : For well-designed clinical trial, appropriate intervention is essential. To establish appropriate acupuncture treatment, we have to suggest reasoning for treatment based on literature and/or expert consensus. Our review only focused on pain relief in dentistry and had many limitations. Further studies based on the literatures such as the Classics of traditional medicine are required to ensure the rationale of acupuncture treatments in various dental disorders.

• Korean Journal of Acupuncture
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• v.38 no.4
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• pp.222-234
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• 2021

Objectives : The purpose of this study is to examine the efficacy of fire needling and warm needling for De Quervain Syndrome by reviewing clinical studies for recent 10 years. Methods : Randomized controlled trials, non-randomized controlled trials, and case series containing more than 20 cases about fire needling and warm needling for De Quervain Syndrome published since 2011 were searched through four foreign online databases (CNKI, Pubmed, EMBASE, Cochrane Library) and five Korean online databases (OASIS, Science ON, DBPIA, KISS, RISS). The number and characteristics of participants, treatment points and main treatment methods involving other combination treatments, treatment cycle or total periods of treatments, evaluation indices, efficacy, and adverse events were analyzed. Risk of bias of included randomized clinical trials was assessed using a revised tool for assessing risk of bias in randomized trials (RoB 2). Results : A total of 6 randomized clinical trials and 2 case series involving 471 participants were included. Tender point or 'Ashi point' was the most commonly used treatment point, followed by LU4. Treatment frequency ranged from once a day to once a week. One to three outcome measures were used to evaluate the results of the studies, with the efficacy rate the most frequently used, followed by visual analogue scale. Overall risk of bias of all included randomized clinical trials was judged to have some concerns. Conclusions : All selected studies showed that fire needling and warm needling treatments for De Quervain syndrome were more effective than other clinical methods or acupuncture treatments. However, as the number of clinical studies is still too small and the risk of bias of the studies is not low, it is believed that more systematic and objective studies should be conducted.

• The Journal of Pediatrics of Korean Medicine
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• v.38 no.1
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• pp.55-77
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• 2024

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

• The Korean Journal of Physiology and Pharmacology
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• v.18 no.6
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• pp.447-456
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• 2014

Until now, a disease-modifying therapy (DMT) that has an ability to slow or arrest Alzheimer's disease (AD) progression has not been developed, and all clinical trials involving AD patients enrolled by clinical assessment alone also have not been successful. Given the growing consensus that the DMT is likely to require treatment initiation well before full-blown dementia emerges, the early detection of AD will provide opportunities to successfully identify new drugs that slow the course of AD pathology. Recent advances in early detection of AD and prediction of progression of the disease using various biomarkers, including cerebrospinal fluid (CSF) $A{\beta}_{1-42}$, total tau and p-tau181 levels, and imagining biomarkers, are now being actively integrated into the designs of AD clinical trials. In terms of therapeutic mechanisms, monitoring these markers may be helpful for go/no-go decision making as well as surrogate markers for disease severity or progression. Furthermore, CSF biomarkers can be used as a tool to enrich patients for clinical trials with prospect of increasing statistical power and reducing costs in drug development. However, the standardization of technical aspects of analysis of these biomarkers is an essential prerequisite to the clinical uses. To accomplish this, global efforts are underway to standardize CSF biomarker measurements and a quality control program supported by the Alzheimer's Association. The current review summarizes therapeutic targets of developing drugs in AD pathophysiology, and provides the most recent advances in the clinical utility of CSF biomarkers and the integration of CSF biomarkers in current clinical trials.

• The Korean Journal of Applied Statistics
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• v.22 no.2
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• pp.317-327
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• 2009

In adaptive designs important components of clinical trials may be changed based on the results of interim analysis. Several international guidelines point out that such interim analysis should be performed by independent experts who do not participate in clinical trials when adaptive designs are used in therapeutic confirmatory clinical trials, and if not, it may cause bias. The international guidelines recommend the establishment of independent data monitoring committee for conducting interim analysis independently.

• Journal of Hospice and Palliative Care
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• v.13 no.1
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• pp.1-6
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• 2010

The purpose of clinical trials is to find evidences for the effects of experimental new drugs or treatments on human. For the successful clinical trials, it is not sufficient to use statistics only for the analyses of collected data, but it is necessary to extend the usage of statistics in various ways. At the beginning of the study, one needs to use statistics for systematically and concretly planning the study. For this, we discussed the usage of statistics in defining the effect, determining the sample size, statistical analyses, and so on.

• Journal of Oriental Neuropsychiatry
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• v.28 no.3
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• pp.165-182
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• 2017

Objectives: The purpose of this systematic review was to understand clinical usefulness of Emotional Freedom Techniques (EFT) on students' mental health. Methods: Ten databases were included to extract clinical studies on effects of EFT intervention with students. Characteristics of selected studies were described, and biases were assessed with Risk of Bias (RoB) or Risk of Bias Assessment for Non-Randomized Studies (RoBANS). Results: A total of 14 clinical trials were extracted for analysis. There were 8 randomized-controlled trials (RCTs), 2 non-randomized-controlled trials (nRCTs), and 4 before-after studies. EFT have significant clinical usefulness in public speaking anxiety, test anxiety, stress, depression, learning related emotions, adolescent anxiety, and eating issues. The risk of selection bias in most studies was high or uncertain. Conclusions: EFT is an effective clinical technique for managing students' mental health issues. However, the included studies have been conducted with relatively poor quality and small sample size. Clinical trials with high quality study design and well-designed EFT education programs are needed to generalize clinical usefulness.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of Acupuncture Research
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• v.30 no.3
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

• The Journal of Korean Obstetrics and Gynecology
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• v.22 no.1
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• pp.279-302
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• 2009

Purpose: The aim of this study was to review systemically clinical trials on the trends of studies for Complementary Alternative Medicine in the treatment of dysmenorrhea. Methods: Through medical websites, foreign clinical literatures about complementary and alternative medicines of dysmenorrhea were searched. And domestic clinical literatures about dysmenorrhea, complementary and alternative treatment and oriental medicine treatment were searched using internet websites or hand-searching in National digital library, National assembly library, KISS, RISS. And then they were assessed by the assessment standard of Jadad scale and Classifying Recommendations. Results: 1. 15 foreign literatures and 36 domestic literatures were selected. 2. 4 foreign and 4 domestic clinical literatures were enough to satisfy over 2 points in Jadad score and recommendation level in Classifying Recommendations. 3. Some clinical trials were rated low in Jadad score since it was not easy to set control groups and keep blinding in clinical trials. 4. Some clinical trials were rated low in Classifying Recommendations since they did not carry out enough study about stability, side effect and follow-ups. Conclusion: To put clinical trials to practical use of Complementary Alternative Medicine in the treatment of dysmenorrhea, scientific and objective-based studies should be needed.