• Journal of Oriental Neuropsychiatry
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• v.21 no.4
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• pp.151-161
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• 2010

Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.14-22
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• 2010

Objectives: This study aimed to evaluate any clinical research regarding asthma published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to asthma was initially obtained from journals in the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual search. Journals were limited to those registered by the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately into predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 99 articles initially obtained, 19 were finally analyzed. 14 were prospective whereas 5 were retrospective. Among the prospective articles, there were no randomized controlled trials and the non-randomized studies had no control groups, with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described asthma diagnosis objectively and outcome measures were either non-relevant to asthma or non-validated. Conclusions: Well-designed randomized controlled studies for asthma are needed and more rigorous non-randomized controlled studies should be conducted.

• 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.

• The Academic Congress of Korean Shoulder and Elbow Society
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• 2008.03a
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• pp.15-15
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• 2008

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.853-860
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• 2022

Objective : This prospective, randomized, double-blinded trial aimed to evaluate the efficacy and safety of prophylactic ramosetron administration against postoperative nausea and vomiting (PONV) in patients undergoing microvascular decompression (MVD). Methods : In this study, 100 patients undergoing MVD were randomly allocated to the control (normal saline, 2 mL) or ramosetron (ramosetron, 0.3 mg) groups at the end of surgery. The incidence and severity of PONV, need for rescue antiemetics, patient satisfaction score, duration of hospital stay, and the occurrence of adverse events were evaluated 48 hours post-surgery. Results : Data obtained from 97 patients were included in the final analysis. The incidence of PONV was significantly lower in the ramosetron group than in the control group throughout the 48-hour postoperative period (29.2% vs. 51.0%, p=0.028). A similar trend was observed with regard to PONV severity (p=0.041). The need for rescue antiemetics, satisfaction score, duration of hospital stays, and the occurrence of adverse events did not significantly differ between the groups. Conclusion : Prophylactic ramosetron administration reduced the incidence and severity of PONV in patients undergoing MVD without causing serious adverse events. Thus, ramosetron use may improve patient recovery following MVD.

• The korean journal of orthodontics
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• v.35 no.5 s.112
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• pp.381-387
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• 2005

The aim of this study was to compare the clinical performance of 4 types of orthodontic wires, indicated for initial tooth alignment: stainless steel, multistranded steel, superelastic and thermoactivated nickel-titanium. A prospective randomized clinical trial was conducted on a sample of 45 patients, at the Dental School of the State University of Rio do Janeiro, Brazil. Fixed appliances were fitted and study casts were obtained from each patient. Randomly, the wires were allocated as follows: 26 dental arches for superelastic NiTi wires, 22 for stainless steel, 22 for multistranded and 20 for thermoactivated archwires. After 8 weeks, the archwires were removed and impressions for study casts were taken again. Using a 3D digitization technique of defined anatomical points on the study cast crowns, a Dental Irregularity Index (DII) was created for each study cast. The difference between DII before and after the archwire insertion expressed the aligning effect of the wires. ANOVA tests were employed to evaluate the anatomical point approximation (positive DII) and separation (negative DII), for each area of the dental arches: upper and lower whole arch and anterior arch. Results showed no significant difference between the different archwires.

• Journal of Pharmacopuncture
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• v.11 no.2
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• pp.21-31
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• 2008

Objective This study was performed to investigate whether Bee Venom Pharmacopuncture(BVP) could be a more effective modality than Warm Needling(WN) in relieving pain and symptoms of knee osteoarthritis(OA). Design Prospective, randomized and controlled clinical trial. Setting Single center trial in Korea Patients 49 volunteers with knee OA participated in the study. All the participants were screened through an inclusion and exclusion criteria. 33 participants were completed the clinical trial. Intervention The subjects were randomly assigned to one of two groups. One group received BVP(n=18), while the other group received WN(n=15). Sixteen sessions of BVP or WN were given at the pain region of the problematic knee for 8 weeks. Primary outcome measure is the Korean translation of Western Ontario and McMaster Universities Osteoarthritis Index scores(Korean WOMAC, KWOMAC). Secondary outcome measure is the physical health scores based on the 36-Item Short-Form Health Survey(SF-36) and Patient Global Assessment(PGA). KWOMAC and SF-36 were measured third (baseline, 4 and 8 weeks). PGA was measured twice(4 and 8 weeks). Results BVP group showed significant decrease compared to WN group in pain, function and total scores of KWOMAC according to the Mann-Whitney U-test. In the PGA, BVP group, compared to WN group, showed a significant increase. Conclusions BVP was more effective in relieving pain of knee OA than WN. These findings suggest that BVP is a promising alternative for treating knee OA.

• Journal of Gastric Cancer
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• v.12 no.4
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• pp.205-209
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• 2012

In gastric adenocarcinoma, high rates of loco-regional recurrences have been reported even after complete resection, and various studies have been tried to find the role of postoperative adjuvant therapy. Among them, Intergroup 0116 trial was a landmark trial, and demonstrated the definite survival benefit in adjuvant chemoradiotherapy, compared with surgery alone. However, the INT 0116 trial had major limitation for global acceptance of the INT 0116 regimen as an adjuvant treatment modality because of the limited lymph node dissection. Lately, several randomized studies that were performed to patients with D2-dissected gastric cancer were published. This review summarizes the data about patterns of failure after surgical resection and the earlier prospective studies, including INT 0116 study. Author will introduce the latest studies, including ARTIST trial and discuss whether external beam radiotherapy should be applied to patients receiving extended lymph node dissection and adjuvant chemotherapy.

• Journal of Trauma and Injury
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• v.31 no.3
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• pp.143-150
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• 2018

Purpose: We have implemented a multi-disciplinary Screening, Brief Intervention and Referral to Treatment (SBIRT) protocol to prevent individuals who sustained alcohol-related traumatic injuries. We therefore conducted this single-center, prospective, randomized, controlled trial (RCT) to assess its efficacy. Methods: All the enrolled patients (n=30) were randomized to either the SBIRT group or the control group. In the current RCT, the proportion of the patients who reduced the amount of alcohol consumption and those who received a specialized treatment served as primary outcome measures. Moreover, changes in a 3-item version of the Alcohol Use Disorders Identification Test Consumption (AUDIT-C), Severity of Dependence Scale (SDS) and Kessler Psychological Distress Scale (K-6) scores at 3 months from baseline served as secondary outcome measures. Results: At 3 months, the proportion of the patients who reduced the amount of alcohol consumption was significantly higher in the SBIRT group as compared with the control group (86.7% vs. 57.1%, p=0.02). Moreover, the proportion of the patients who received a specialized treatment was also significantly higher as compared with the control group (26.7% vs. 1.4%, p=0.01). Furthermore, there were significant differences in changes in the AUDIT, SDS and K-6 scores at 3 months from baseline between the two groups (p<0.05). Conclusions: In conclusion, our results indicate that the SBIRT is effective in reducing hazardous and harmful levels of drinking, the degree of alcohol dependence and that of psychological distress in at-risk drinkers.

• Journal of Gastric Cancer
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• v.16 no.2
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• pp.93-97
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• 2016

Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.