• Korean Journal of Oriental Medicine
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• v.8 no.2 s.9
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• pp.37-46
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• 2002

Clinical trials are experimental studies with human subjects in which various limitations and variables exist by their nature. As a preparatory stage for designing clinical trials in Oriental medicine, this study considers a virtual protocol to show guideline regarding tasks necessary when writing a trials protocol. Clinical trials have many difficulties in planning, procedure, and interpretation of results, and these may be influenced by various biases that are difficult to predict and eliminate. To deal with these issues, clinical trials need a collaboration between medical experts and biostatisticians from the beginning, through the entire trial, until the final analysis. Therefore, the first stage of clinical trials is to write out a trial plan among the experts in each field to derive the best design for the trial.

• Korean Journal of Acupuncture
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• v.36 no.4
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• pp.281-291
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• 2019

Objectives : As acupuncture treatment has been widely practiced in many countries around the world, clinical trials of acupuncture treatments also have become popular. The objective of the study was to explore the trends of research investigating the effect of acupuncture treatment in clinical trials using a bibliometric approach, a quantitative analytical methods. Methods : Publications related to clinical trials using acupuncture from 2000 to 2019 were retrieved from the Web of Science database. Extracted articles were analyzed in terms of publication year, country, journal, research area, organizations and authors. Trends in research on acupuncture in clinical trials were visualized using the VOSviewer program. Results : A total of 3,166 articles of acupuncture clinical trials published from 2000 to 2019 were identified and analyzed. The country producing the most articles in this field was USA followed by China, England, South Korea, and Germany. A network analysis based on the co-occurrence of keywords showed following three clusters: clinical studies, pain management studies, and methodology studies. Conclusions : This study provided a macroscopic overview of research in acupuncture clinical trials. These findings provide an expansive strategy for researchers in this field to cooperate with other researchers or organizations.

• Journal of Korean Medicine for Obesity Research
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• v.19 no.1
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• pp.56-67
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• 2019

Objectives: The purpose of this study is to review clinical studies of herb medicine and acupuncture treatment on obesity in menopausal women. Methods: Key words "Obesity", "Menopause", "Herb medicine", "Acupuncture", "Moxibustion", "Catgut embedding" were searched on 9 database systems (PubMed Central, Cochrane Controlled Register of Trials, Embase, China Academic Journals, Korean Traditional Knowledge Portal, Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Library, DBpia) on April 30th 2019. Results: 1 case report and 17 clinical trials were collected in accordance with the selection and exclusion criteria. Among the 17 trials, 6 were randomized controlled trials, 1 was controlled clinical trial, and 10 were single-arm trials. The types of intervention were herb medicine, electroacupuncture, acupuncture, auricular acupuncture, warm needle acupuncture, moxibustion, laser acupuncture, and catgut embedding. The study design, study results and method of intervention were analyzed. Conclusions: 1 case report described the effectiveness of pharmacopuncture, 4 trials described the effectiveness of herbal medicine, 2 of electroacupuncture, 1 of laser acupuncture, and 2 of catgut embedding. Among the 17 trials, 2 studies showed that herbal medicine treatment was more effective than no treatment or selective serotonin reuptake inhibitors, and 1 study showed that electroacupuncture was more effective than hormone therapy. All of 18 selected studies reported the effectiveness of weight reduction and abdominal obesity reduction after the traditional Korean medicine treatment for obesity in menopausal women.

• Journal of Society of Preventive Korean Medicine
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• v.20 no.3
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• pp.93-113
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• 2016

Objectives : The focus of the review was laid on differences in research pertaining to thread embedding acupuncture between domestic and foreign journals. Methods : We collected 53 Korean articles on thread embedding acupuncture study from 4 Korean article searching sites, and 80 foreign articles from Pubmed. We analyzed the number of the theses according to the publication year, study method, journal, and subject. Results : A total number of 134 thread embedding acupuncture articles were categorized as 100 clinical trials, 14 experimental papers, and 19 literature reviews. Of the collected clinical trials, 55 were case studies, 6 were CCTs and 39 were RCTs. The domestic clinical trials were comprised of 36 case studies, 1 CCT, and 2 RCTs, and foreign clinical trials were comprised of 19 case studies, 5 CCTs, and 37 RCTs. Although only 12 of the 39 domestic clinical trials exclusively treated thread embedding acupuncture to the experimental group, 38 out of 61 foreign clinical trials undertook thread embedding acupuncture as the sole treatment. While the 2 domestic RCTs research had no significant evidence that the experimental group was different from the control group, the experimental group demonstrated better responses than the control group in 31 of the 37 foreign RCT studies. Conclusions : Studies on thread embedding acupuncture are more intensively studied in the foreign field in comparison to the domestic field. Referring to the results from the foreign thread embedding acupuncture studies, domestic use of thread embedding acupuncture should be expanded. Also, more refined research needs to be conducted in the domestic field in order for the Koran medicine to lead the thread embedding acupuncture. This study is limited in that the literature search in the foreign journals were restricted.

• Journal of Acupuncture Research
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• v.28 no.5
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• pp.87-96
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• 2011

Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.

• Korean Journal of Fisheries and Aquatic Sciences
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• v.46 no.3
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• pp.287-295
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• 2013

The growth, respiration, ingestion, and ecological efficiencies of Hexagrammos otakii larvae and juveniles reared on different diets and temperatures were estimated. A factorial experiment using two diets [non-enriched hatched Artemia nauplii (NEA) and enriched Artemia nauplii (EA)] crossed with two temperatures [natural seawater temperature (NT, $5.1-8.5^{\circ}C$) and heated seawater (HT, $13{\pm}0.5^{\circ}C$)] was conducted to investigate growth and energy budgets of Hexagrammos otakii larvae and juveniles. The energy used by larvae and juveniles for 6 weeks was calculated using data on ingestion, growth, respiration, excretion, and egestion. In the NT trials, the energy used for growth by larvae and juveniles was 0.121 and 0.129 Kcal in the NEA and EA treatments, respectively. Assimilation efficiency at NT were 78.0% and 80.2% in the NEA and EA trials, respectively. Gross growth efficiency ($K_1$) were 60.5% and 62.3% and net growth efficiency ($K_2$) was 77.56% and 77.71% in the NEA and EA trials, respectively. In the HT trials, the energy used for growth by juveniles was 0.189 and 0.212 Kcal in the NEA and EA trials, respectively. Assimilation efficiency at HT was 86.4% and 95.1% in the NEA and EA trials, respectively. Values of $K_1$ and $K_2$ at HT were 69.5% and 80.43%, respectively, in the NEA trials, and 73.9% and 77.66%, respectively, in the EA trials. These results suggest that enriched Artemia nauplii and higher temperatures ($13{\pm}0.5^{\circ}C$) are effective for rearing larvae and juveniles of H. otakii.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.30 no.2
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• pp.1-18
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• 2017

Objectives : This review aims to evaluate a risk of bias by risk of bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of Korean medicines to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methods : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmed, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medicine assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trial, 13 non-randomized controlled trials and 3 case reports. This study evaluate the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusions : Korean medicine intervention can be an effective for treatment in alopecia. It was evaluated by hair density, thickness and expert panel assessment of photographs and all results are statistically significant. But enhancing levels of evidence, we must try to reduce bias in researches and report a safety, protocol and IRB.

• Journal of the Ergonomics Society of Korea
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• v.30 no.3
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• pp.381-387
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• 2011

Objective: The aim of this study was to investigate the maximal grip strength for the combinations of resting time and trial and to provide guideline of resting time for the maximum gripping task associated with the number of trials. Background: Despite many previous researches for the maximal grip strength, few studies have considered the effect of both trials and rest time on the maximum grip strength. Methods: A total of thirty subjects participated in the study. The average of maximum grip strength was measured using JAMAR hydraulic hand dynamometer. The testing position was same as the position recommended by the American Society of Hand Therapists. The between-subject experimental design has been conducted in this study. Trials(1~20 trials) and rest time(2, 3, and 4min) were considered as independent variables, and the maximum grip strength was considered as dependent variable, respectively, in this study. Results: According to the result of the number of trials, the maximal grip strength decreased gradually as the number of trials increased. The ANOVA result showed that the main effect was significant for both resting time(p<.0001) and trial(p<.0001), and the interaction was significant(p<0.0086). Conclusions: The maximal grip strength decreased gradually as the number of trials increased. Thus, basic guideline of resting time was suggested for the number of trials of maximal grip strength tests in this study.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.4
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• pp.11-20
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• 2018

Objectives To systematically explore the effects of acupuncture treatment for rotator cuff disorders and review the clinical trials. Methods We searched 9 electronic databases (PubMed, Cochrane central, Embase, China National Knowledge Infrastructure [CNKI], Korea Institute of Science and Technology Information [KISTI], National Digital Science Library [NDSL], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]) to find randomized controlled trials that used acupunture treatment for rotator cuff disorders. We assessed the designs of the randomized controlled trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). The methodological quality of randomized controlled trials were assessed using the Cochrane Risk of Bias (RoB) tool. Results Total 5 trials were reviewed. 4 out of 5 randomized clinical trials reported meaningful effects of acupuncture treatments compared to control group. However risk of bias seemed high. Conclusions Although the results suggest that acupuncture treatment has favorable effects for rotator cuff disorders, most of the studies included methodologically high risk of bias. Thus, well designed randomized clinical trials which evaluate the effects of acupuncture treatment for rotator cuff disorders should be encouraged.