• The Journal of Korean Medicine
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• v.38 no.1
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• pp.93-111
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• 2017

Objectives: The aim of this study is to make evidence-based data for developing a traditional Korean medicine clinical practice guideline for acute bronchitis. Methods: We searched 3 international databases(PubMed, EMBASE, CENTRAL) and 7 domestic databases (KoreaMed, Kmbase, NDSL, KISS, KISTI, OASIS, KoreaTK) to identify randomized controlled trials (RCTs) of acute bronchitis using medicine in recent 10 years. The chosen trials were analyzed by their study design, age range, intervention group, control group, primary and second outcome measure, inclusion and exclusion of participants and adverse events. Results: 15 RCTs are finally included in this study and most of their medications are herbal medicine. For diagnosis and outcome measure of acute bronchitis, Bronchitis Severity Score(BSS) was mostly used. Other measurements eligible are coughing fits, quality of life scale, sputum viscosity, change of individual symptoms and patient's satisfaction. Test duration was for average 7days and safety assessment was held by recording adverse events. Except for anti-inflammatory and antibiotic trials, all medications are found to be effective and well-tolerated. General risk of bias of chosen trials is evaluated low. Conclusions: A well designed clinical trials for traditional Korean medicine of acute bronchitis is needed and this study is expected to make it available.

• The Journal of Korean Medicine
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• v.36 no.3
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• pp.84-97
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• 2015

Objectives: The purpose of this study was to investigate and analyze the demands for educational programs on clinical trials of Korean medicine devices, and develop training programs based on the needs of Korean medicine. Methods: This research was conducted targeting 26 volunteer applicants who had participated in clinical trials of Korean medicine devices within the last five years (2010-2015). The survey was carried out between May 1, 2015 and May 26, 2015 via e-mail. After receiving questionnaire replies, the material was established. Using obtained data, frequency analyses were performed using SPSS 20.0 version. Results: 92% of the researchers who participated in the survey expected introduction of educational programs on clinical trials and anticipated that programs contain information that can meet the needs of each researcher. In addition, according to the analysis, introducing expert certification for clinical trials of Korean medicine devices is necessary, and offering related graduate courses are also needed. Conclusions: As a result of this study, researchers had difficulties during clinical trials of Korean medicine devices. If the educational programs were to be developed and institutional frameworks support them effectively, it would prove to be helpful to researchers in clinical trials.

• Journal of Acupuncture Research
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• v.27 no.1
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• pp.21-29
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• 2010

Objectives : This study aims to evaluate current clinical evidence of acupuncture treatment for rehabilitation in patients with traffic accident in South Korea. Methods : Seven Korean databases were searched for prospective clinical trials for acupuncture on rehabilitation in patients with traffic accident from their inception to June, 2009. Only studies conducted in Korean language were searched. Risk of bias in included randomized controlled trials were assessed by Cochrane Handbook procedure. Results : Fifteen clinical trials were included among 31 studies searched. Eight were observational studies, five were non-randomizedcontrolled trials, and two were randomized controlled trials. In all of included studies, acupuncture were conducted with other concomitant treatment. Included studies dealt with such conditions as neck pain, low back pain tinnitus after traffic accident, post-traumatic stress, oculomotor nerve palsy, diplopia and insomnia. All of included studies reported favorable effects of acupuncture group compared to baseline or control group. All of included studies lacked the occurrence of adverse events. High risk of bias were observed in two randomized controlled trials. Conclusions : There is no evidence that acupuncture is effective for rehabilitation of traffic accident. All of included studies lacked appropriate methodological qualities and internal validity. Future welldesigned clinical trials that evaluate the effects and safety of acupuncture treatment for rehabilitation in patients with traffic accident is needed.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.27 no.1
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• pp.31-38
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• 2016

Pharmacotherapy is considered the first line therapy in attention-deficit hyperactivity disorder (ADHD). Many patients also choose complementary medicine such as dietary supplements. Omega-3 has shown some efficacy for improving ADHD symptoms in several studies. The goal of this review is to integrate the previous research findings on omega-3 and understand the issues worth considering in the treatment of ADHD. The terms "attention deficit disorder with hyperactivity", "omega-3", and "dietary supplements" were searched on PubMed, Cochrane, and Google scholar. The search was further limited to clinical trials, reviews, and meta-analyses. Trials that examined treatments for ADHD, used randomized design, and placebo-controlled trials were included. Eighteen clinical trials with a total of 1,141 participants were included in this review. Fifteen trials had parallel designs, comparing an omega-3/6 polyunsaturated fatty acid (PUFAs) or a combination of both to a placebo and three compared omega-3/6 PUFAs to a placebo and psycho-stimulants. Seven of the included trials showed significant improvements in groups receiving omega-3/6 PUFAs compared to placebo groups, however, 11 trials showed no significant differences. Evidence that PUFAs supplementation provides benefits for ADHD was yet limited. Mixed results were due to selection variability criteria, variability of supplementation, and short follow-up intervals.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.2
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• pp.73-82
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• 2018

Objectives The purpose of this study is to systematically explore the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury and to review the methodology of clinical trials. Methods We searched 9 electronic databases(3 international, 1 Chinese, 5 Korean) including English, Korean and Chinese, up to December 2017 for randomized controlled trials which evaluated the effects of the acupuncture in patients with upper extremity peripheral nerve injury. We abstracted the designs of the randomized clinical trials and the method of acupuncture treatment according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA). Results A total of 8 papers were reviewed. All randomized clinical trials were conducted in China. Of them, five studies(62.5%) were electro-acupuncture as intervention. All randomized clinical trials reported favorable effects of acupuncture treatments compared to baseline or control group with outcomes of efficacy rate. However risk of bias seemed high. LI4, LI11, SI3, PC3, PC6 were most frequently used for acupoints to treat upper extremity peripheral nerve injury. Conclusions These results suggest that it is recommended to develop more detailed reporting standards for acupuncture treatment method. In the future, well designed randomized clinical trials which evaluate the effects and safety of acupuncture treatment for upper extremity peripheral nerve injury is highly needed.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.27 no.4
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• pp.45-57
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• 2014

Objective : This study aims to provide fundamental data for new directions(the improvement directions) from searching research papers of randomized controlled trials among thesis of Atopic Dermatitis related to oriental medicine in Korea from 2004 to 2014 and identifying the problem and level of a clinical study through an assessment of the quality, CONSORT statement. Methods : Data was collected through the Koreanstudies Information Service System(KISS). Two experts in Oriental Medicine reviewed the title and abstract in thesis, the results of searching the title, "Atopic dermatitis" and topic, "oriental medicine" at KISS, and then they handsearched Randomized Controlled Trials related to oriental medicine in Korea. According to guidelines defined by CONSORT statement, they assessed whether 37 items were followed by guidelines at yes or no answers in order to evaluate the quality as well. They assessed the definition of each item independently. After comparing, they made a decision on the item of different outcomes through an agreement with a third party. Results : Total number of randomized controlled trials in Atopic Dermatitis related to oriental medicine is eleven. A randomized controlled trial was first published in 2007. One or two papers associated it were released every year except 2013. 9 papers of them were approved by Institutional Review Board and were received written consent. The study included between 20 to 40 subjects for 2-arm parallel study design. The effect of treatment was observed for 4 to 8 weeks. On average, the number followed guidelines was 18.64 among those of 37 CONSORT statement and 50.38% of them was followed overall. Conclusion : As an interest about randomized controlled trials was increased, it was needed to care the standard providing information of CONSORT statement on randomized controlled trials related to oriental medicine in Korea. It is suggested to provide more clear information about it, so that it can be a motive for improving quality of the journal in oriental medicine.

• The Journal of Pediatrics of Korean Medicine
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• v.35 no.3
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• pp.67-88
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• 2021

Objectives The purpose of this study is to analyze randomized clinical trials (RCTs) on traditional Chinese medicine to summarize its efficacy and safety for the treatment of functional gastrointestinal disorders (FGIDs) in children. Methods We searched literatures published up to March 19, 2021 using two Chinese electronic databases. Data regarding patients, interventions, results, and adverse events were extracted from RCTs of herbal medicine for children with FGIDs. Results A total of 34 RCTs were included: 16 trials on functional dyspepsia, 7 trials on functional constipation, 6 trials on functional abdominal pain, 4 trials on irritable bowel syndrome, and 1 trial on functional diarrhea. 26 of 29 trials that reported total effective rate, the treatment group showed a significant improvement compared to the control group. Most of other evaluation indicators, such as symptom score, symptom disappearance time, and recurrence rate also demonstrated statistically significant improvement. Of the 16 studies which reported safety, 5 studies reported no adverse reactions in either group, and 4 studies reported no statistically significant differences in the incidence of adverse events between two groups. Also, reported adverse events were mostly mild. Conclusions Herbal medicine may help improve symptoms of FGIDs in children. However, due to limited types of studies on sub-diseases of FGIDs and small sample sizes in each study, additional large scale clinical studies on various other FGIDs are necessary.

• Korean Journal of Exercise Nutrition
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• v.24 no.3
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• pp.7-12
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• 2020

[Purpose] This study was performed to investigate the acid-base and ion balance at rest and after exercise in healthy males under normoxia, moderate hypoxia, and severe hypoxia. [Methods] Ten healthy Korean males completed three different trials on different days, comprising exercise under normoxia (F_iO₂ = 20.9%, N trial), moderate hypoxia (F_iO₂ = 16.5%, MH trial), and severe hypoxia (F_iO₂ = 12.8%, SH trial). They undertook endurance exercise for 30 min on a cycle ergometer at the same relative exercise intensity equivalent to 80% maximal heart rate under all conditions. Capillary blood samples were obtained to determine acid-base and ion balance at rest and after exercise. [Results] Exercise-induced blood lactate elevations were significantly increased as hypoxic conditions became more severe; SH > MH > N trials (P = 0.003). After exercise, blood glucose levels were significantly higher in the SH trial than in the N and MH trials (P = 0.001). Capillary oxygen saturation (S_CO₂) levels were significantly lowered as hypoxic conditions became more severe; SH > MH > N trials (P < 0.001). The pH levels were significantly lower in the MH trial than that in the N trial (P = 0.010). Moreover, H_CO_3^- levels were significantly lower in the SH trial than in the N trial, with significant interaction (P = 0.003). There were no significant differences in blood Na⁺, K⁺, and Ca²⁺ levels between the trials. [Conclusion] MH and SH trials induced greater differences in glucose, lactate, S_CO₂, pH, and HCO_3^- levels in capillary blood compared to the N trial. Additionally, lactate, S_CO₂, and HCO_3^- levels showed greater changes in the SH trial than in the MH trial. However, there were no significant differences in Na⁺, K⁺, and Ca²⁺ levels in MH and SH trials compared to the N trial.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.4
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• pp.79-93
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• 2023

Objectives The purpose of this study is to investigate therapeutic exercise and to provide the evidence of daoyin exercise for shoulder pain. Methods Electronic databases including PubMed, EMBASE, China National Knowledge Infrastructure, Science ON, Oriental Medicine Advanced Searching Integrated System were searched up to October 2022. We selected randomized controlled trials. The quality of studies was assessed by Cochrane risk of bias tool. Meta-analysis were perfomed by Review Manager software. Results Eighteen randomized controlled trials were collected in accordance with the selection and exclusion criteria. Among the 18 trials, 7 trials used strengthening exercise, 4 trials used stablilization exercise, 5 trials used both types of intervention, and 2 trials used daoyin exercise. The study characteristics, results and method of intervention were analyzed. Meta-analysis showed that therapeutic exercise appeared to more effective than no treatment group for shoulder pain (standardized mean difference=-1.18, 95% confidence interval=-1.44 to 0.91, Z=8.82, p<0.00001; chi²=2.71, p=0.61; I²=0%). Conclusions All of 18 selected studies reported the effectiveness of therapeutic exercise for shoulder pain. Combining strengthening and stablilization exercise is considered the most efficient way for shoulder pain. Based on this study, well-designed studies should be performed to be evidence of the use of daoyin exercise for shoulder pain.