• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.765-771
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• 2022

Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

• Journal of Periodontal and Implant Science
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• v.53 no.4
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• pp.306-317
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• 2023

Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ² test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

• 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.

• Journal of Oriental Neuropsychiatry
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• v.31 no.3
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• pp.135-147
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• 2020

Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

• Journal of Acupuncture Research
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• v.37 no.2
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• pp.102-109
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• 2020

Background: Due to the aging population in Korea, knee osteoarthritis (KOA) has become an increasingly common condition. Many patients with KOA prefer analgesics, herbal medicines, acupuncture, or exercise, rather than arthroscopic surgery or a knee replacement. Gyebutang (GB) granules are a herbal extract widely used to treat KOA in traditional Korean medicine, but there is insufficient evidence of its efficacy and safety. Methods: A multicenter, randomized, assessor-blinded, 2-armed parallel, controlled clinical trial has been designed to investigate the efficacy and safety of GB combined with acupuncture for the treatment of KOA. There will be 100 patients with KOA enrolled in the study from 3 traditional Korean medicine hospitals. The participants will be randomly allocated to an experimental group (GB and acupuncture) or a control group (celecoxib and acupuncture) in a 1:1 ratio. Both groups will receive acupuncture treatment once a week for 6 weeks; one group will receive GB and the other will receive celecoxib for the same duration. Results: The primary outcome will be the change of knee osteoarthritic pain, based on scores on a 100 mm visual analog scale. The secondary outcomes will be scores on a numeric rating scale, the Western Ontario and McMaster Universities osteoarthritis index, patient global assessment, European quality of life 5-dimension 5-level scale, and adverse events. Conclusion: The results of this study will provide evidence of efficacy and safety of GB as a treatment for patients with KOA.

• The Journal of Internal Korean Medicine
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• v.22 no.4
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• pp.633-638
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• 2001

Objective : Stroke is the most frequent cause of death in Korea. Because it remains severe disablities disturbing normal life, it is important to carry out intervention preventing from progression of condition in patients with acute ischemic stroke within therapeutic time window. Thus early thrombolysis is beneficial for patients with acute ischemic stroke. However its therapeutic efficacy is not known in combination with oriental medical therapy. In this study, we investigated the safety and the clinical effect of continous intravenous urokinase therapy and oriental medical therapy. Methods : Twenty eight patients with acute onset of ischemic stroke no later than three days received continous infusion of urokinase and oriental medical therapy. We estimated the subjects's neurological deficit and functional status with National institute of Neurologic Disorders and Stroke Scale(NIHSS) and Europian Stroke Scale (ESS) prior to therapy, on day 3, 7, 14 after the starting urokinase therapy and on day at discharge. Results: After day 7, the scores of NIHSS and ESS were improved significantly. There are no differences in therapeutic effects of the interval between onset of stroke and initiation of therapy. Complication were noted in four(14%) patients, but these are not fatal complication and make no neurological deficiency. Conclusion : The results of these investment suggest that continuous intravenous urokinase with oriental medical therapy could be a safe and effective intervention to prevent from progression in acute ischemic stroke. But this findings should be confirmed in multicenter double blind controlled trial.

• Journal of Periodontal and Implant Science
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• v.44 no.3
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• pp.134-140
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• 2014

Purpose: Triphala is a combination of three medicinal plants, extensively used in Ayurveda since ancient times. Triphala mouthwash is used in the treatment of periodontal diseases because of its antimicrobial and antioxidant properties. The aim of this study is to compare the efficacy of triphala mouthwash with 0.2% chlorhexidine in hospitalized periodontal disease patients. Methods: In this double-blind, randomized, multicenter clinical trial, 120 patients were equally divided into three groups. Patients in group A were advised to rinse their mouths with 10 mL of distilled water, group B with 0.2% chlorhexidine, and group C with triphala mouthwash for 1 minute twice daily for two weeks. The plaque index (PI) and the gingival index (GI) were recorded on the first and the fifteenth day. Results: There was no significant difference when the efficacy of triphala was compared with 0.2% chlorhexidine in hospitalized patients with periodontal disease. However, a statistically significant difference was observed in PI and GI when both group B and group C were compared with group A and also within groups B and C, after 15 days (P<0.05). Conclusions: The triphala mouthwash (herbal) is an effective antiplaque agent like 0.2% chlorhexidine. It is significantly useful in reducing plaque accumulation and gingival inflammation, thereby controlling periodontal diseases in every patient. It is also cost effective, easily available, and well tolerable with no reported side effects.

• Nutrition Research and Practice
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• v.8 no.1
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• pp.103-111
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• 2014

This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis (HD) patients: and thus demonstrate a viable developing country model. This paper describes the study protocol and baseline data. The study was a multicenter randomized controlled trial with parallel-group design involving 12 HD units: assigned to cluster A (n = 6) or B (n = 6). A total of 570 patients met the inclusion criteria. Patients in cluster A were randomly assigned as per dialysis shift to the following: Dedicated Dietitian (DD) (n = 133) and Existing Practice (EP) (n = 138) protocols. Cluster B patients (n = 299) received Trained Hospital Dietitian (THD) protocol. Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines. DD protocol included: individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change. EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study. The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities, with no set educational protocol or tools. Baseline data revealed that 40% of patients were hyperphosphatemics (> 5.5 mg/dl) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ($58.86%{\pm}33.87%$ of needs) yet adequate dietary P intake ($795.52{\pm}366.94$ mg/day). Quality of life (QOL) ranged from 48-75% of full health. Baseline differences between the 3 groups revealed significant differences in serum P, malnutrition status, adherence to diet and P chelators and in 2 factors of the QOL: physical and social functioning. The data show room for improvement in the nutritional status of the patients. The NEMO trial may be able to demonstrate a better nutritional management of HD patients.

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.772-778
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• 2022

Objective : Endovascular treatment of large, wide-necked intracranial aneurysms by coil embolization is often complicated by low rates of complete occlusion and high rates of recurrence. A flow diverter device has been shown to be safe and effective for the treatment of not only large and giant unruptured aneurysms, but small and medium aneurysms. However, in Korea, its use has only recently been approved for aneurysms <10 mm. This study aims to compare the safety and efficacy of flow diversion and coil embolization for the treatment of unruptured aneurysms ≥7 mm. Methods : The participants will include patients aged between 19 and 75 years to be treated for unruptured cerebral aneurysms ≥7 mm for the first time or for recurrent aneurysms after initial endovascular coil embolization. Participants assigned to a flow diversion cohort will be treated using any of the following devices : Pipeline Flex Embolization Device with Shield Technology (Medtronic, Minneapolis, MN, USA), Surpass Evolve (Stryker Neurovascular, Fremont, CA, USA), and FRED or FRED Jr. (MicroVention, Tustin, CA, USA). Participants assigned to a coil embolization cohort will undergo traditional endovascular coiling. The primary endpoint will be complete occlusion confirmed by cerebral angiography at 12 months after treatment. Secondary safety outcomes will evaluate periprocedural and post-procedural complications for up to 12 months. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes the aim and design of a multi-center, randomized, open-label trial to compare the safety and efficacy of flow diversion versus traditional endovascular treatment for unruptured cerebral aneurysms ≥7 mm.

• 대한예방의학회:학술대회논문집
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• 1994.02b
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• pp.313-319
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• 1994

Phase I of the Trials of Hypertension Prevention was a multicenter, randomized, controlled trial designed to determine the efficacy of seven nonpharmacologic interventions in reducing blood pressure among persons with high-normal diastolic blood pressure. the initial goal for recruitment was to enroll 2,100 participants over a nine-month period. The yield from the first screening visit to randomization was 13% overall, with clinic-specific yields ranging from 4.5% to 31.7%. After five months of recruitment, approximately 60% of the goal for that point in the recruitment timetable had been randomized. Clinical centers falling short of their goals at that time altered their recruitment strategies and intensified their efforts, and centers that had exceeded their goals recruited additional participants. As a result, 2,182 participants, or 104\% of the goal for recruitment, were randomized over a 13-month period. Those clinics using a cohort, or wave, type of enrollment were most successful in achieving their recruitment goals within the prescribed timetable.