• Title/Summary/Keyword: Randomized Trial

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Comparison of Acute Cardiovascular Effects of Using Heated Tobacco Productsand Cigarette Smoking (가열담배 사용과 연소담배 흡연의 급성 심혈관 효과 검증)

  • Dong Kyu Kim;Maeng Kyu Kim
    • Journal of Life Science
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    • v.34 no.5
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    • pp.320-332
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    • 2024
  • The aims of this study were to compare the differences in hemodynamics between cigarette smoking and using heated tobacco products (HTPs) and to determine the acute effects of using HTPs on cardiac autonomic regulation. Another goal was to examine the acute cardiac autonomic responses when using different tobacco sticks in HTPs. Sixteen healthy male smokers completed an open-label, randomized, crossover trial consisting of non-smoking (NS), cigarette smoking, and the use of two different HTPs (IQOS with HEETS; lil SOLID with Fiit). Sub-trials, which included NS, lil SOLID with Fiit, and lil SOLID with HEET, were performed on eight smokers among the total subjects. Hemodynamic variables, such as systolic blood pressure (SBP) and diastolic blood pressure (DBP), and heart rate variability were measured before, during, and 30 minutes after using each tobacco product. Using HTPs resulted in a significant increase in both SBP and DBP, comparable to smoking cigarettes. Cardiac sympathetic activity significantly increased, and cardiac vagal tone (CVT) significantly decreased after acute exposure to HTP aerosol, similar to the effects of cigarette smoke exposure. Furthermore, differences in the withdrawal of CVT were observed when using different tobacco sticks in the same HTPs. The findings of this study indicate that acute exposure to HTP aerosol increases the hemodynamic burden and disrupts cardiac autonomic balance, similar to exposure to cigarette smoke. Moreover, depending on the type of tobacco stick inserted into the HTP device, acute withdrawal of CVT may have been enhanced.

Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
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    • v.44 no.4
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    • pp.104-120
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    • 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.

Effect of cryoanesthesia and sweet tasting solution in reducing injection pain in pediatric patients aged 7-10 years: a randomized controlled trial

  • Shital Kiran Davangere Padmanabh;Vishakha Bhausaheb Gangurde;Vikram Jhamb;Nasrin Gori
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.37-45
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    • 2024
  • Background: The delivery of profound local anesthetics helps children receive successful treatment by reducing fear, anxiety, and discomfort during dental procedures. Local anesthetic injections are the most anticipated stimuli in dental surgery. Children's perceptions of pain can be altered by applying cryotherapy to precool the oral mucosa or by diverting their minds through taste distractions before administering local anesthetic injections. This study aimed to evaluate the efficacy of cryoanesthesia and xylitol sweet-tasting solution at the injection site in 7-10-year-old children. Methods: A total of 42 participants, aged 7-10 years, who underwent dental treatment requiring local anesthesia, were enrolled in the study. The children were randomly divided into three groups. In group I, sterile water was held in the mouth for 2 minutes before anesthetic administration, similar to group II, and in group III, a xylitol sweet-tasting solution was used for 2 minutes before needle insertion. The analysis of pain perception was carried out based on the Visual Analog Scale (VAS) and the Sound, Eyes, and Motor (SEM) scale. For VAS analysis, a one-way analysis of variance (ANOVA) was performed for intergroup comparison, and a post hoc Tukey test was performed for subgroup analysis. For the categorical SEM scale, the Kruskal-Wallis test followed by the post hoc test was performed for intergroup comparison. Where a P value of <0.05 was considered statistically significant at 95% confidence intervals. Results: Cryoanesthesia significantly reduced pain scores on VAS (4.21 ± 1.42) when compared to those on VAS with xylitol sweet-tasting solution (5.50 ± 1.40) and that with sterile water (6.14 ± 2.47). Intergroup comparison of the VAS scores among the three groups was performed using one-way ANOVA, which demonstrated statistically significant differences (P value <0.026) on the VAS scale. Intergroup comparison of the SEM scale was performed using the Kruskal-Wallis test, followed by post hoc comparison, which exhibited statistically significant differences (P < 0.007) among the three groups for the SEM scale. Conclusion: Cryoanesthesia demonstrated higher efficacy in reducing injection pain than that exhibited by the xylitol sweet-tasting solution.

Identification of an effective and safe bolus dose and lockout time for patient-controlled sedation (PCS) using dexmedetomidine in dental treatments: a randomized clinical trial

  • Seung-Hyun Rhee;Young-Seok Kweon;Dong-Ok Won;Seong-Whan Lee;Kwang-Suk Seo
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.24 no.1
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    • pp.19-35
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    • 2024
  • Background: This study investigated a safe and effective bolus dose and lockout time for patient-controlled sedation (PCS) with dexmedetomidine for dental treatments. The depth of sedation, vital signs, and patient satisfaction were investigated to demonstrate safety. Methods: Thirty patients requiring dental scaling were enrolled and randomly divided into three groups based on bolus doses and lockout times: group 1 (low dose group, bolus dose 0.05 ㎍/kg, 1-minute lockout time), group 2 (middle dose group, 0.1 ㎍/kg, 1-minute), and group 3 (high dose group, 0.2 ㎍/kg, 3-minute) (n = 10 each). ECG, pulse, oxygen saturation, blood pressure, end-tidal CO2, respiratory rate, and bispectral index scores (BIS) were measured and recorded. The study was conducted in two stages: the first involved sedation without dental treatment and the second included sedation with dental scaling. Patients were instructed to press the drug demand button every 10 s, and the process of falling asleep and waking up was repeated 1-5 times. In the second stage, during dental scaling, patients were instructed to press the drug demand button. Loss of responsiveness (LOR) was defined as failure to respond to auditory stimuli six times, determining sleep onset. Patient and dentist satisfaction were assessed before and after experimentation. Results: Thirty patients (22 males) participated in the study. Scaling was performed in 29 patients after excluding one who experienced dizziness during the first stage. The average number of drug administrations until first LOR was significantly lower in group 3 (2.8 times) than groups 1 and 2 (8.0 and 6.5 times, respectively). The time taken to reach the LOR showed no difference between groups. During the second stage, the average time required to reach the LOR during scaling was 583.4 seconds. The effect site concentrations (Ce) was significantly lower in group 1 than groups 2 and 3. In the participant survey on PCS, 8/10 in group 3 reported partial memory loss, whereas 17/20 in groups 1 and 2 recalled the procedure fully or partially. Conclusion: PCS with dexmedetomidine can provide a rapid onset of sedation, safe vital sign management, and minimal side effects, thus facilitating smooth dental sedation.

Prasugrel-based De-Escalation of Dual Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients With STEMI

  • You-Jeong Ki;Bong Ki Lee;Kyung Woo Park;Jang-Whan Bae;Doyeon Hwang;Jeehoon Kang;Jung-Kyu Han;Han-Mo Yang;Hyun-Jae Kang;Bon-Kwon Koo;Dong-Bin Kim;In-Ho Chae;Keon-Woong Moon;Hyun Woong Park;Ki-Bum Won;Dong Woon Jeon;Kyoo-Rok Han;Si Wan Choi;Jae Kean Ryu;Myung Ho Jeong;Kwang Soo Cha;Hyo-Soo Kim;HOST-RP-ACS investigators
    • Korean Circulation Journal
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    • v.52 no.4
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    • pp.304-319
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    • 2022
  • Background and Objectives: De-escalation of dual-antiplatelet therapy through dose reduction of prasugrel improved net adverse clinical events (NACEs) after acute coronary syndrome (ACS), mainly through the reduction of bleeding without an increase in ischemic outcomes. Whether the benefits of de-escalation are sustained in highly thrombotic conditions such as ST-elevation myocardial infarction (STEMI) is unknown. We aimed to assess the efficacy and safety of de-escalation therapy in patients with STEMI or non-ST-segment elevation ACS (NSTE-ACS). Methods: This is a pre-specified subgroup analysis of the HOST-REDUCE-POLYTECH-ACS trial. ACS patients were randomized to prasugrel de-escalation (5 mg daily) or conventional dose (10 mg daily) at 1-month post-percutaneous coronary intervention. The primary endpoint was a NACE, defined as a composite of all-cause death, non-fatal myocardial infarction, stent thrombosis, clinically driven revascularization, stroke, and bleeding events of grade ≥2 Bleeding Academic Research Consortium (BARC) criteria at 1 year. Results: Among 2,338 patients included in the randomization, 326 patients were diagnosed with STEMI. In patients with NSTE-ACS, the risk of the primary endpoint was significantly reduced with de-escalation (hazard ratio [HR], 0.65; 95% confidence interval [CI], 0.48-0.89; p=0.006 for de-escalation vs. conventional), mainly driven by a reduced bleeding. However, in those with STEMI, there was no difference in the occurrence of the primary outcome (HR, 1.04; 95% CI, 0.48-2.26; p=0.915; p for interaction=0.271). Conclusions: Prasugrel dose de-escalation reduced the rate of NACE and bleeding, without increasing the rate of ischemic events in NSTE-ACS patients but not in STEMI patients.

A Review of Clinical Research Trends on Korean Medicine Treatment for Bell's Palsy during Pregnancy (임신 중 벨 마비 한방치료에 대한 국내외 증례 연구 고찰)

  • Hyo-Jeong Kim;Young-Tae Ahn;Ji-Soo Hyun;So-Youn Choi;Back-Jun Kim;Yoon-Jae Lee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.3
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    • pp.1-19
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    • 2024
  • Objectives: The purpose of this study is to analysis the clinical study trends on Korean Medicine treatment for Bell's palsy during pregnancy. Methods: Key words such as 'facial palsy', 'Bell's palsy, 'Korean medicine', 'herbal medicine', 'acupuncture', 'pregnancy' were searched through the 'RISS', 'OASIS', 'KISS', 'PubMed' and 'CNKI' databases. Results: Ten clinical studies with 107 patients were selected, and 1 randomized controlled trial and 9 case reports were included as the target studies. In the 9 case reports, the gestational age at the onset of facial palsy was most common in the third trimester (29-42 weeks) in 38 cases (56.7%). The most commonly used Korean medicine interventions were acupuncture, with the most frequently used acupoints being ST4, ST2, ST6, BL2, TE23, LI20, GB1, GB14, SI18, and CV24. The herbal medicine treatment most commonly utilized was Geumgwedanggwi-san (金匱當歸散), which is related to the principles of clearing heat, nourishing blood, and stabilizing the fetus (淸熱養血安胎). Among the 65 participants evaluated using the House-Brackmann facial nerve grading system, 81.5% showed complete recovery to grade 1, while 6% remained at grade 4 with no effect, indicating the efficacy of Korean medicine treatment for facial palsy during pregnancy. All the selected studies reported no abnormalities in the mothers or fetal growth, and all participants who had the reported delivery had full-term childbirth. Conclusions: The effect on Korean Medicine treatment for Bell's palsy during pregnancy had mostly positive results. However, further large, well-designed clinical trials are needed to establish the foundation of Korean Medicine treatment for Bell's palsy during pregnancy.

Effects of Laminaria Japonica Extract Supplement on Blood Glucose, Serum Lipids and Antioxidant Systems in Type ll Diabetic Patients (다시마추출물이 제2형 당뇨병 환자의 혈당, 지질 및 항산화 체계에 미치는 영향)

  • Park, Min-Jung;Ryu, Ho-Kyung;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.36 no.11
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    • pp.1391-1398
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    • 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.

Effect of Acupuncture on Nasal Obstruction in Patients with Persistent Allergic Rhinitis: A Randomized Controlled Trial (지속성 알레르기비염의 비폐색에 대한 침치료의 효과: 무작위배정 대조군 연구)

  • Jo, Jeong-Hyo;Hong, Kweon-Eey;Kang, Wee-Chang;Choi, Sun-Mi;Park, Yang-Chun
    • Journal of Acupuncture Research
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    • v.22 no.6
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    • pp.229-239
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    • 2005
  • Objectives : Allergic rhinitis is a prevalent disease. Nasal obstruction is one of the main symptom in allergic rhinitis. It induces sleep disturbances, depression, attention deficit, memory impairments. Acupuncture treatment for rhinitis was mentioned in literature, but there is not enough report that provide evidence by well designed clinical study. The purpose of this research is to examine the effect of acupuncture treatment for nasal obstruction of allergic rhinitis. Methods : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with minimal acupuncture for the treatment of nasal obstruction owing to persistent allergic rhinitis. Acupoints used in active acupuncture group were I120($Y{\hat{o}}nghyang$), GV23($Sangs{\hat{o}}ng$), IL4(Hapkok). Volunteers who satisfied the requirements were enrolled in study. Total nasal volume(NV) and total nasal minimum cross-sectional area(MCA) were measured by acoustic rhinometry before and after treatments(0min, 7.5min, 15min). Results : 101 subjects finished study. There were not difference between two groups on age, sex, weight, height, blood pressure, pulse, respiratory rate, severity of persistent allergic rhinitis, number of positive antigen. After treatment(0min) total NV were significantly increased compared with before treatment in active acupuncture group(p=0.0007) and minimal acupuncture group(p=0.0175). After treatment(15min) total NV of minimal acupuncture group was decreased compared with before treatment(p=0.2560), but total NV of active acupuncture group was maintained increasing in degree of borderline significance(p=0.0871). After treatment(0min) total NV were significantly increased compared with before treatment in active acupuncture group(0.0007) and minimal acupuncture group(p=0.0175). After treatment(Omin) total MCA were significantly increased compared with before treatment in active acupuncture group(p<0.000l) and minimal acupuncture group(p=0.0005). After treatment(15min) total MCA of minimal acupuncture group was decreased compared with before treatment(p=0.6082), but total NV of active acupuncture group was maintained increasing in degree of borderline significance(p=0.0929). Conclusion : Acupuncture treatment reduced nasal obstruction in persistent allergic rhinitis. Further study in the form of long term is needed.

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Prospective Randomized Trial for Postoperative Adjuvant Chemotherapy in Gastric Cancer without Serosal Invasion -Final Report- (장막침윤이 없는 위암환자에서 수술 후 보조적 화학 요법에 대한 전향적 연구 -최종보고-)

  • Kim Yong Jin;Kim Byung Sik;Kim Yong Ho;Yook Jung Hwan;Oh Sung Tae;Park Kun Choon
    • Journal of Gastric Cancer
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    • v.4 no.4
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    • pp.257-262
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    • 2004
  • Purpose: We reported our preliminary result in 2001. At that time, the follow-up period was too short to evaluate the survival benefit of adjuvant chemotherapy in gastric cancer without serosal invasion. Therefore, we followed those patients for 66 months to determine the long-term effects of adjuvant chemotherapy. Materials and Methods: We analyzed the recurrence pattern, the survival rate, and the disease-specific survival of 135 patients by reviewing their medical records and calling the patients or their relatives. All enrolled patients were included in the intention-to-treat analysis of efficacy. Results: The follow-up rate was $89.6\%$ (121/135), and the median follow-up duration was 66 months. Among the 135 patients, 4 relapsed in group 1 (5-FU+cisplatin), 7 in group 2 (mitomycin C+oral 5-FU), and 6 in group 3 (oral 5-FU only). The overall survival rate was $89\%$ in group 1, $84\%$ in group 2, and $82\%$ in group 3. There were no differences in the overall survival rates and the disease-specific survival rates among the three groups. Conclusion: Oral chemotherapeutic agents have an acceptable effect for adjuvant chemotherapy compared with intravenous agent. However, a large-scale, prospective, randomized study, including a control group, is needed for an exact evaluation.

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