• Journal of Dental Rehabilitation and Applied Science
• /
• v.38 no.4
• /
• pp.204-212
• /
• 2022

Purpose: The aim of this study was to compare changes of bite force, occlusal contact area, and dynamic functional occlusion analysis after occlusal stabilization splint therapy during sleep for one month in a patient with bruxism. Materials and Methods: From October 2021 to July 2022, sleep bruxism of 30 patients who visited the Department of Oral Medicine at Yonsei University College of Dentistry Hospital were recruited. The participants were divided into two groups: using an occlusal stabilization splint during sleep (treatment; n = 15) and not using an occlusal stabilization splint (control; n = 15). Before using the occlusal stabilization splint and one month after, bite force, occlusal contact area and dynamic functional occlusion analysis (ratio of left/right bite forces, average bite forces, maximum bite forces, and maximum contact areas during lateral and anterior and posterior mandibular movements) were performed. Results: There was no difference in bite force and occlusal contact area between the treatment group using the occlusal stabilization splint and the control group not using the occlusal stabilization splint during sleep for one month. However, there were significant differences in the average bite force and maximum bite force in the lateral and anterior and posterior mandibular movements and the maximum contact areas in the anterior and posterior mandibular movements. Conclusion: The occlusal stabilization splint is helpful for sleep bruxism patients who lateral and anterior and posterior mandibular movements. In addition, further studies are needed a double-blind study with a large population.

• Dementia and Neurocognitive Disorders
• /
• v.22 no.3
• /
• pp.100-108
• /
• 2023

Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

• The Journal of Korean Medicine
• /
• v.44 no.4
• /
• pp.104-120
• /
• 2023

Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

• Journal of Dental Anesthesia and Pain Medicine
• /
• v.24 no.5
• /
• pp.351-360
• /
• 2024

Background: This study aimed to evaluate and compare the efficacy of oral premedication with ibuprofen on the anesthetic efficacy of inferior alveolar nerve block (IANB) using 2% lignocaine and 1:100000 epinephrine in tobacco-chewing (TC) and non-tobacco-chewing (NTC) patients with symptomatic irreversible pulpitis (SIP) during nonsurgical endodontic intervention (NEI). Methods: This multicenter, prospective, double-blind, two-arm parallel-group randomized controlled trial involving 160 patients was conducted for a period of 9 months. The patients were classified into the study (TC patients) and control (NTC patients) groups, which were subdivided into two subgroups 1 hour before the procedure based on oral premedication with tab ibuprofen 600 mg. Nicotine dependence was assessed using the Modified Fagerstrom Tolerance Nicotine Scale. Patients were administered an IANB injection of 2% lignocaine containing epinephrine 1:100000 after premedication. Pulpal anesthesia before NEI was confirmed using electric pulp testing and cold spraying. Patients rated their pain on the 10-point visual analog scale (VAS) during NEI thrice at the dentin, pulp, and instrumentation levels. No pain at each level indicated the success of anesthesia. Results: The success and failure rates did not differ between the premedication and non-premedication subgroups in the TC or NTC groups (P > 0.05). However, the success rate was higher in the premedication subgroup of the NTC group (52.5%) than in the TC group (45%). Most patients with premedication experienced failure at the instrumentation level, whereas patients in the non-premedication group experienced pain at the dentin level. Failure rates of IANB did not differ significantly at different levels between the groups (P > 0.05). The mean VAS scores differed significantly at the dentin level in both groups, with lower values in the premedication group (P < 0.05). Conclusions: The efficacy of ibuprofen premedication with IANB during NEI did not differ significantly between the TC and NTC patients with SIP. The effect of premedication was more significant in the NTC group than in the TC group. A causal relationship between nicotine consumption and the success of premedication could not be established, and further studies are required to validate the results of the present study.

• The Journal of Korean Medicine
• /
• v.26 no.2 s.62
• /
• pp.95-104
• /
• 2005

Objectives: This was a double blinded, randomized, placebo-controlled clinical study for evaluation of safety and effective dose finding of Cardiotonic Pills$^{(R)}$ in patients with chest pain and discomfort. Cardiotonic Pills$^{(R)}$ are composed of Salviae Miltiorrhizae Radix (丹蔘), Notoginseng Radix (三七根) and Borneolum (龍腦). Major effects of Salviae Miltiorrhizae Radix and Notoginseng Radix are vasodilatation, sedation and analgesic action. Borneolum has an antibacterial effect, and can stimulate the central nervous system. All of these substances are oriental herbs that have been used for a long time in east Asia. Cardiotonic Pills fi received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) in the USA and 40 million people in the world take this pill. We performed a phase IV clinical study to confirm its efficacy and safety in patients who have probable cardiogenic or psychogenic chest pain or chest stifling. Methods: This study was planned for a multi-center clinical trial including four university hospitals of oriental medicine in Korea. This was the first time to evaluate the 'planning treatment according to diagnosis (辨證施治)' of chest pain or chest discomfort according to oriental medical guidelines. The patients who were included in this trial were adult volunteers from 20 to 70 years old who had chest pain or chest discomfort more than twice during a recent month, and we received written consent to participate in this study from all of them. After administration of Cardiotonic Pills$^{(R)}$ for 8 weeks, number of occurrences, duration, appearance and degree of chest pain or chest discomfort was observed and degree of symptoms (severity of illness, global improvement) were measured using a patient's global assessment composite scale. Results: In the patient's global assessment scale, the severity of illness of the Cardiotonic Pills$^{(R)}$ group (n=25) was 14/25=0.56 but of the placebo group (n=25) was 7/25=0.28 (p-value=0.0449). This result indicates Cardiotonic Pills$^{(R)}$have a positive effect on the symptoms of chest pain and discomfort. However, the global improvement of the Cardiotonic Pills$^{(R)}$group was 23/25=0.92, and of the placebo group was 22/25=0.88 (p-value=0.6374). The total symptom score of the Cardiotonic Pills$^{(R)}$ group was $1.68\pm20.06$, and of the placebo group was $16.76\pm72.l4$(p-value=0.2285). The number of symptom events of the Cardiotonic Pills$^{(R)}$ group was $72\pm29.78$, and of the placebo group (n=25) was $10.80\pm38.42$ (p­value=0.3660). We could not find any effects on the other factors examined besides the severity of illness, beyond the difference of standard deviations. Conclusions: Cardiotonic Pills$^{(R)}$ significantly reduced chest pain and chest discomfort in patients. Therefore, we expect that Cardiotonic Pills$^{(R)}$ will be helpful for patients with chest pain and chest discomfort not only caused by heart disease but also by other diseases.

• Tuberculosis and Respiratory Diseases
• /
• v.55 no.1
• /
• pp.69-87
• /
• 2003

Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.

• Tuberculosis and Respiratory Diseases
• /
• v.57 no.4
• /
• pp.320-328
• /
• 2004

Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

• Journal of Physiology & Pathology in Korean Medicine
• /
• v.32 no.4
• /
• pp.232-246
• /
• 2018

The purpose of this research is to contribute to clinical researches on neck pain and cervical spondylosis by reviewing the latest research trends and evaluation tools through the analyses of clinical studies on neck pain and cervical spondylosis over the last 5 years. 70 papers satisfying the selection conditions among the RCT papers that had been searched as "neck pain" or "cervical spondylosis" at Pubmed(https://www.ncbi.nlm.nih.gov/pubmed) from March 2011 to February 2016 were targeted. Papers were numbered in order of their publication dates and analyzed by classifying their contents into 1) pain classification, 2) treatment type, 3) treatment duration, 4) treatment time, 5) number of participants, 6) evaluation tools and methods of research, and 7) evaluation duration. 55 papers targeted chronic neck pain, 6 papers acute and subacute neck pain, and 2 papers subacute and chronic neck pain. In comparison by intervention, 43 papers corresponded to physical therapy, 3 papers to acupuncture, 1 to herbal fomentation, 5 to medication, and 18 papers corresponded to multilateral comparisons comparing the efficacy by various interventions. In research period, there were 50 papers based on treatment period, 16 papers based on the number of treatments, and 4 papers based on different periods depending on each group. In treatment duration, the cases from 1 month or more to less than 3 months were most, followed by the cases of less than 1 month, and the cases from 3 months or more to less than 6 months. In treatment frequency, the number of treatments of the treatment group was the same as that of the control group in 51 papers, and many treatments were conducted by the methods of acupuncture, manual therapy, and injection therapy in cases of once or twice of treatments, and physical therapy and electroacupuncture corresponded mainly to the cases from 3 times or more to less than 10 times of treatments, and retrospective observation and exercise programs corresponded mainly to the cases of more than 30 times of treatments. In the number of subjects of the researches, the cases from 50 or more to less than 100 were most, followed by the cases from 20 or more to less than 50. There were 7 evaluation tools cited 10 times or more: VAS, NRS, PPT, NDI, NPQ, CROM, and SF-36. In evaluation period, 37 papers evaluated only during the treatment period, and 33 papers conducted follow-up. In follow-up period, the cases of less than 3 months were most, followed by the cases from 6 months or more to less than 1 year, and the cases from 3 months or more to less than 6 months. When planning clinical researches on cervical pain in the future, appropriate intervention methods, frequency and duration of treatment, period of follow-up, appropriate number of subjects and selection of evaluation tools for objective validity will have to be considered. In addition, randomization, double-blind, etc. will have to be considered for researches with high basis level.

• Journal of the Korean Society of Food Science and Nutrition
• /
• v.36 no.11
• /
• pp.1391-1398
• /
• 2007

We performed a randomized double-blind placebo-controlled trial to determine whether Laminaria japonica extract (LJE) supplement modulates blood glucose, serum lipids and antioxidant systems in type II diabetic patients. We also measured critical parameters assessing safety in liver and kidney functions after LJE supplement. A total of 37 patients (18 males and 19 females) were randomized to either LJE group or placebo group. The treatment group received four 350 mg of LJE capsules (1.4 g, total) per day for 12 weeks. The placebo group received the same dose of cellulose capsules. Baseline characteristics regarding general life style and dietary intake pattern were similar between the two groups. There were no significant influences of LJE supplement except for waist circumference on anthropometric parameters. As the whole, 12 weeks of LJE supplement resulted in a little decrease in fasting blood glucose (FBG) and glycated hemoglobin (HbA1c), but a significant decrease was not observed. Total cholesterol, LDL-cholesterol and triglyceride concentrations were significantly (p<0.05) lowered in LJE group. The antioxidant enzymes, glutathion peroxidase (GSH-px) and superoxide dismutase (SOD) levels were elevated in the LJE group (p<0.05) compared to the placebo. The increase of these enzymes was associated significantly with the decrease of MDA concentration (p<0.05). Furthermore, LJE supplement showed no adverse effects on the functions of liver and kidney. Findings from this study suggest that LJE supplement can help improve serum lipid status in type II diabetic subjects without adverse effects.

• Journal of the Korea Academia-Industrial cooperation Society
• /
• v.19 no.10
• /
• pp.243-253
• /
• 2018

This study aimed to investigate the effects of DCI on glucose control, quality of life(SF-36 Version 2.0, Korean) and SDSCA(Summary of Diabetes Self-Care Activities) in patients with type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled study was performed on 46 patients with HbA1c 7.0% taking triple anti-diabetic drug regimen who visited the department of Endocrinology and Metabolism in Chungnam National University Hospital between March 2015 and May 2016. As a result, DCI treatment in the intervention group resulted in significantly reduced HbA1c levels $8.75{\pm}0.79%$(baseline), $8.36{\pm}1.03%$(after 12weeks), and $8.65{\pm}0.81%$(after 24weeks). However, patients in the control group did not show any significant change. Interestingly, both DCI treatment group and the control group significantly showed improvements in SDSCA. Participants in the intervention group showed a small yet significant improvement in their only fasting blood glucose test in SDSCA and revealed significant increase in the quantitative levels of quality of life, from $73.05{\pm}16.85$ to $82.74{\pm}10.68$. By using pathway analysis, improvement of SDSCA scores(${\beta}=-0.505$, t=-2.743) was the most influential factor to the fasting blood glucose. The quality of life of patients with type 2 diabetes mellitus was affected by changes of SDSCA scores(${\beta}=0.411$, t=2.024) and fasting c-peptide(${\beta}=-0.445$, t=-2.668) in DCI treatment group. In conclusion, treatment of DCI effectively improved glucose control in patients with type 2 DM(HbA1c level>7.0%) after 12 weeks of treatment, although it had no impact on glucose control after 24 weeks of treatment. Improved glucose control may encourage diabetic patients to conduct self-care activities and improve the quality of life. Based on the present study, we suggest that diabetes self-management, as well as consideration of comprehensive laboratory findings, may be important factor in regulating the quality of life in type 2 DM patients.