• Journal of Oriental Neuropsychiatry
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• v.34 no.3
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• pp.213-234
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• 2023

Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

• 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.

• The Journal of Pediatrics of Korean Medicine
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• v.38 no.3
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• pp.13-28
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• 2024

Objectives This study aimed to analyze registrations in the World Health Organization International Clinical Trials Registry Platform for children and adolescents with tension-type headaches. Methods We collected and analyzed information on the basic and clinical characteristics of patients who participated in related clinical trials. All relevant clinical trials registered on or before July 2, 2024 were included in this study. Results Twenty clinical trials were selected for the analysis. Behavioral therapy was the most common intervention (60%), followed by drug, device, and manual therapies. The type of headache was the most frequently mentioned inclusion criteria, noted in 70% of the patients. Outcome indicators included headache frequency and intensity, quality of life, daily functioning, and mood. Conclusions Further clinical trials should require informed consent, an appropriate research design, suitable controls, and clear presentation of diagnostic criteria for more accurate and ethical studies.

• 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 Journal of Pediatrics of Korean Medicine
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• v.36 no.3
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• pp.1-18
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• 2022

Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

• The Journal of Internal Korean Medicine
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• v.41 no.3
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• pp.350-361
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• 2020

Objective: This study aimed to report the therapeutic effect of acupuncture on chemotherapy-induced peripheral neuropathy (CIPN). Methods: The articles were sourced from databases including PubMed, EMBASE, Cochrane Library, CNKI, CiNii, WHO ICTRP, JSOM, KMBASE, KISS, NDSL, and OASIS as of July 2019. The main search keywords were peripheral neuropathy and acupuncture, and only randomized controlled trials using acupuncture for therapeutic purposes were included. Cochrane's risk of bias was used to assess the risk of bias, and the Review Manager 5.3 program was used for meta-analysis. Results: Six studies with a total 394 participants were included. When combined treatment of acupuncture and usual care was compared with usual care alone, quality of life improved more significantly in the combination treatment group (SMD=-2.71, 95% CI: -5.01 to -0.41, P=0.02, I²=97%). The CIPN pain score was lower among the combination treatment group, but not to a significant degree (SMD=-2.55, 95% CI: -5.14 to 0.04, P<0.05, I²=98%). There were no severe side effects in any studies. Conclusion: Acupuncture combined with usual care may be considered to safely relieve CIPN pain and improve quality of life for cancer patients. However, as there are few randomized controlled trials studying the effect of acupuncture on CIPN, further well-designed research is needed.