• Title/Summary/Keyword: Randomized controlled study

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Effect of Supplementation of Fermented Milk Containing Active Peptides(IPP, VPP) in Accordance with Medical Nutrition Therapy in Pre- and Hypertension Subjects (고혈압 전단계 및 고혈압 환자에서 의학영양치료와 병행한 생리활성 펩티드 함유 유산균 발효유 섭취가 혈압에 미치는 영향)

  • Kim, Ji-Young;Kim, Yun-Young;Kim, Hye-Rang;Yun, Sung-Seob;Kim, Wan-Sik;Yea, Hyun-Soo;Chung, Jin-Young;Lee, In-Hoe;Choue, Ryo-Won
    • Journal of the East Asian Society of Dietary Life
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    • v.18 no.6
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    • pp.918-926
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    • 2008
  • It is well known non-drug therapy for hypertension patients can reduce blood pressure. These types of therapy include maintaining ones ideal body weight, quitting smoking, consuming large amounts of fruits and vegetables consuming low levels of saturated fat and salt and regular exercise. Fermented milk protein derived biologically active peptides such as isoleucine-proline-proline_(IPP) or valine-proline-proline_(VPP) have been shown to lower blood pressure in hypertensive subjects. This study was conducted to investigate the antihypertensive effects of medical nutritional therapy _(MNT) in accordance with the consumption of fermented milk enriched with IPP and VPP. To accomplish this, we conducted a randomized case-controlled study of 43 subjects who had blood pressure levels greater than 120/80 mmHg. The subjects in the study group were randomly allocated into two groups, an MNT + fermented milk (100mL/day) group (n=21) and an MNT+L. helveticus fermented milk with tripeptides (IPP=2.2mg, VPP=2.6mg/100mL) group (n=22). The MNT included weight management, reduction of sodium, total fat and saturated fat intake, increased intake of fruits and vegetables, and increased intake of low fat dairy products. The treatments were administered for 12 weeks during which time no drug interventions were conducted. The daily intakes of total calories, fats, cholesterol and Na decreased significantly after 12 weeks of MNT in the control and the experimental groups. In addition, the systolic blood pressure de creased significantly in the control and experimental groups; however, the diastolic blood pressure only decreased significantly in the experimental group. Overall, the results of this study indicate that the intake of fermented milk containing IPP and VPP in conjunction with MNT exerted positive effects on the blood pressure of pre- and hypertensive subjects.

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The effect of Type 2 diabetes management using a smartphone-based blood glucose management training program (모바일 자가혈당관리 교육프로그램을 이용한 2형 당뇨병 관리 효과 분석)

  • Lee, Jung-Hwa;Jung, Jin-Hee;Sim, Kang-Hee;Choi, Hee-Sun;Lee, Jeong-Rim;Kang, Yang-Gyo;Song, Bok-Rye
    • Journal of Industrial Convergence
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    • v.20 no.9
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    • pp.59-70
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    • 2022
  • Background: Diabetes education is an important factor in blood glucose control. Reinforced education is necessary for effective diabetes education. However, it is difficult to provide reinforced diabetes education within Korea's medical environment. Therefore, we want to analyze the effect of continuous diabetes education using mobile health care that can effectively provide repeated education without having to face the patient. Methods: This study is a multicenter, randomized, controlled, pre-post design study conducted to analyze the effect of a continuous diabetes education method. A total of 109 people were registered at five hospitals in south Korea, and they were randomly assigned to the app group (34 people) who received real-time coaching and repetitive training, the logbook group (37 people) who received face-to-face training after writing a blood glucose logbook, and the general group (38 people) who received a one-time diabetes education. The study was conducted for a total of 24 weeks. Twenty-one patients withdrew their consent and failed to perform an HbA1c. A final 88 patients were analyzed. The difference in HbA1c, Self-management behavior, and Quality of life before and after education was analyzed. Results: The study involved 51 (58%) male subjects, mean age was 55.8 years and mean duration of diabetes was 7.6 years. After 24 weeks of intervention, there was no significant difference in self-care behavior and quality of life between the three groups, but the HbA1c of the app group significantly decreased after education compared to the logbook group and the general group (F=4.62, p=.013). Conclusion: It can be seen through the app group that receiving real-time education is more effective in improving blood glucose management and continuous diabetes education is important.

Effects of Administration of Oxytocin Antagonist on Implantation and Pregnancy Rates in Patients with Repeated Failure of IVF/ICSI Treatment (체외수정시술의 반복적인 실패 환자에서 옥시토신 길항제 주입이 착상 및 임신에 미치는 영향)

  • Ahn, Jun-Woo;Kim, Chung-Hoon;Kim, So-Ra;Jeon, Gyun-Ho;Kim, Sung-Hoon;Chae, Hee-Dong;Kang, Byung-Moon
    • Clinical and Experimental Reproductive Medicine
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    • v.36 no.4
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    • pp.275-281
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    • 2009
  • Objective: This study was performed to evaluate the effect of oxytocin antagonist on the outcome of IVF/ICSI cycles in infertile patients with repeated failure of IVF/ICSI treatment. Method: Forty patients who had experienced two or more failures of IVF/ICSI treatment without low ovarian reserve, were recruited for this prospective randomized study. All patients received controlled ovarian stimulation (COS) using GnRH antagonist multidose protocol (MDP). For the intervention group, intravenous administration of atosiban (mixed vasopressin $V_{1A}$/oxytocin antagonist) started with a bolus dose 6.75 mg one hour before embryo transfer (ET) and continued at an infusion rate of 18 mg/hour. After ET, administered atosiban was reduced to 6 mg/hour and continued for 2 hours. The main efficacy endpoints were clinical pregnancy rate and implantation rate. Results: Patients' characteristics were comparable in the intervention and control groups. COS parameters and IVF results were also similar. The number of uterine contractions for 3 minutes measured just before ET was significantly lower in the intervention group than control group ($3.5{\pm}1.4$ vs $8.7{\pm}2.2$, p<0.001). While there was no statistically significant difference in the clinical pregnancy rate between control group and intervention group (20.0% and 40.0%, p=0.168), the implantation rate was significantly higher in the intervention group, with 16.9% (11/65) compared with 6.0% (4/67) in the control group (p=0.047). There were no differences in ectopic pregnancy rate and miscarriage rate between the two groups. Conclusion: This study demonstrates that administration of oxytocin antagonist during ET can improve the implantation rate probably by decreasing the frequency of uterine contractions in infertile patients undergoing IVF/ICSI treatment.

Effect of Glucose Control, SDSCA and Quality of Life of D-chiro-inositol(DCI) in patients with type 2 diabetes: A Path Analysis (제2형 당뇨병 환자의 D-chiro-inositol의 혈당강하 효과와 당뇨 자가관리 및 삶의 질: 경로분석)

  • Kang, Young Mi;Kim, Hyun Jin;Lee, Tae-Yong;Ku, Bon-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.243-253
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    • 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.

Pain reducing effect of vapocoolant spray during injection and heelstick procedure in neonates (신생아에서 근육 주사 및 발뒤꿈치 천자 시 냉각 분사의 통증감소효과: 냉각 분사와 30% 경구 포도당액의 비교)

  • Choi, Eun Kyong;Jung, Ji Mi;Sin, Jong Beom
    • Clinical and Experimental Pediatrics
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    • v.51 no.5
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    • pp.481-486
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    • 2008
  • Purpose : The aims of this study were to test the efficacy of vapocoolant spray to decrease the symptoms associated with pain in newborns undergoing heel stick and intramuscular injection and compare the pain relief effect of oral glucose. Methods : Randomized, controlled study including sixty newborns undergoing heel stick and intramuscular injection. Group 1 was heelsticked, Group 2 was intramuscular injected, Group A did not recieve any treatment, Group B recieved 30% glucose solution orally, Group C was applied vapocoolant spray symptoms and signs associated with pain at heel stick and intramuscular injection were measured with the premature Infant Pain Profile (PIPP) scale. Results : There was no significant difference in the PIPP score between intramuscular injected group control and heel stick group control (P=0.07). The mean PIPP score of Group 1A (control) $10.6{\pm}2.4$, Group 1B $5.5{\pm}2.0$, Group 1C $5.2{\pm}1.8$. The mean PIPP score 1B and 1C were significantly lower than control (1B P<0.001, 1C P<0.001). The mean PIPP score of Group 2A (control) $12.5{\pm}1.4$, Group 2B $7.0{\pm}1.7$, Group 2C $6.4{\pm}1.6$. The mean PIPP score 2B and 2C were significantly lower than control (2B P<0.001, 2C P<0.001). Conclusion : The antinociceptive effect of vapocoolant sparay is as effective as 30% oral glucose solution for pain control. So this study support the use of vapocoolant spray for reducing pain during painful procedure in the neonatal intensive care units.

Comparative efficacy of 5% EMLA cream and 20% Benzocaine gel during topical anesthesia (5% EMLA cream과 20% Benzocaine gel의 도포마취 효능 비교)

  • Lee, Dae-Woo;Baik, Byeong-Ju;Kim, Jae-Gon;Yang, Yeon-Mi;So, Yu-Ryeo
    • Journal of the korean academy of Pediatric Dentistry
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    • v.38 no.1
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    • pp.1-8
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    • 2011
  • The objective of this study was to determine the effectiveness of topical 5% EMLA cream versus 20% Benzocaine gel in reducing pain from intra oral needle insertion alone as well as injection of anesthetic. The 2 topical anesthetics were tested against each other bilaterally using a randomized, controlled, single blinded, split mouth design. Phase I was conducted to find out the rapidity of onset action of the two agents on anterior/posterior vestibules and anterior/posterior palatal mucosa. Phase II was conducted to evaluate the efficacy of the two topical anaesthetic agents in reducing the pain of intraoral injections. The agents were left in anterior/posterior vestibules and anterior/posterior palatal mucosa for the amount of time recorded in phase I. Subjects recorded pain on a 100-mm modified visual analog scale(VAS). A pulse oximeter was used to recorded the preoperative and postoperative pulse rates. In phase I of the study, two topical agents showed the longer onset of action at anterior part and vestibules than posterior part and palatal mucosa. EMLA cream showed the rapidest onset of action compared to benzocaine gel except on anterior palatal mucosa. In phase II of the study, the VAS grading of the pain for anesthetic administration showed EMLA cream was significantly(P<.05) better in elimination or reducing the pain on the anterior/posterior palatal mucosa. In conclusion, EMLA cream showed the rapidest onset of action compared to benzocaine gel except on anterior palatal mucosa. EMLA cream was found to be superior to Benzocaine gel with regards to pain reduction for anesthetic administration especially on anterior and posterior palatal mucosa.

The Effect of Argon Laser on Periodontal Disease (치주질환에 대한 Argon 레이저의 효과)

  • Ahn, Hyung-Joon;Ryu, Ji-Won;Kim, Jae-Hong;Kim, Chong-Youl
    • Journal of Oral Medicine and Pain
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    • v.30 no.2
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    • pp.277-285
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    • 2005
  • The purpose of this study was to evaluate photothermal effect of laser, which eliminates and reduces bacteria causing periodontal disease, on treatment of periodontal disease. This study included subjects with moderate periodontitis who visited the Department of Oral Medicine, College of dentistry, Yonsei University. The subjects were divided into experimental group, where Argon laser treatment was used, and control group, where conventional subgingival curettage was used. Gingival fluids from each subject were collected prior and after 1 week of the treatment, and changes in number of bacterial colonies cultured from aerobic as well as anaerobic bacteria responsible for the periodontal disease, and changes in clinical indices related to the periodontal disease, such as plaque index, gingival index, sulcus bleeding index, were analysed. As a result, the number of bacterial colonies of aerobic and anaerobic bacteria reduced after 1 week of the treatment in both groups, especially the bacterial colonies of anaerobic bacteria which showed statistically significant reduction(p<0.1). However, there was no significant difference between the experimental group and the control group. Clinical indices including plaque index, gingival index, sulcus bleeding index were reduced after 1 week of the treatment in both groups. In the experimental group, gingival index(p<0.1) and sulcus bleeding index(p<0.01) showed significant reduction, and, in the control group, sulcus bleeding index(p<0.01) showed significant reduction. However, there were no significant differences in each indices between the two groups. The above results suggest that Argon laser could be used as a substitute of conventional subgingival curettage, or in combination with subgingival curettage which would increase the effect of the treatment. Although the possibility of clinical application of Argon laser was observed in this study, more randomized-controlled research, including acquirement of sufficient samples as well as long-termed follow up, would be necessary before clinically effective application of Argon laser.

Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.4
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    • pp.320-328
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    • 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.

The Effects of Aroma Self Massage in Hands on Pain, Depressive Mood and Anxiety in Breast Cancer Patients (유방암 환자의 통증, 우울 및 불안 증상 조절에 아로마 자가 치료의 효과)

  • Sohn, Keun-Joo;Kim, Myung-Ja;Lee, June-Young;Lee, Jae-Bok;Kim, Su-Hyun;Kim, Jong-A;Jung, Hoe-Hyun;Choi, Seung-Wan;Choi, Youn-Seon
    • Journal of Hospice and Palliative Care
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    • v.8 no.1
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    • pp.18-29
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    • 2005
  • Purpose: Aroma therapy is one modality of alternative medicine. It was well known to have an analgesic, antidepressive and anxiolytic effects. This study is designed to investigate the effect of aroma self hand massage on vital signs, pain, depression, anxiety and stress in breast cancer patients. Methods: 32 female patient over 20 years old were divided into two groups by a non-blinded randomized controlled method. Patient in the aroma group (n=15) massaged their hands twice a day using aroma oil by themselves in their home for 2 weeks. However, those in control group (n=17) had not received my intervention during the study periods. Pain intensity, state anxiety, depression and stress of subjects were evaluated three times (0, 1, 3 weeks) using Visual Analogue Scale (VAS, $0{\sim}10cm$), State Trait Anxiety Inventory (STAI), Beck Depression Inventory Scales (BDIS), Brief Encounter Psychosocial Instrument (BEPSI revised edition). Also the change of patients' accompanying symptoms after aroma massage were analyzed using a structured questionnaire. Results: Pain Intensity decreased in the aroma group compared with control group (VAS changes $-0.83{\pm}1.01\;vs\;0.38{\pm}0.86$, P=0.005). The numbers of accompanying symptoms (P=0.044), depression score (P=0.001) and anxiety score (P=0.008) were significantly decreased in the aroma group, while in control group they increased after 2 weeks. However, the stress score showed no significant changes in both groups ($0.05{\pm}0.85\;vs\;0.04{\pm}0.20$, P=0.1519). The depression, anxiety and stress score showed negative correlation with compliance of aroma massage, but statistically no significant. The systolic blood pressure was a little increased in aroma group ($4.53{\pm}14.43\;vs\;0.0{\pm}7.22$, P=0.026), but was not significant clinically. Patients in the aroma group complained of several symptoms such as headache (20%), paresthesia (6.75%) and nausea (6.7%). However, there were no drop-out patients for those side effects. Conclusion: Aroma self massage during two weeks in breast cancer patients alleviates the pain intensity, depression and anxiety significantly.

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Analgesic Effect of Sugar Solution in Infantile Colic (설탕물이 영아 산통의 통증 감소에 미치는 영향)

  • Kim, Jong Seok;Kwon, Kyung Ho;Lee, Young A;Kim, Hyeon Jeong;Lee, Kyun Woo
    • Clinical and Experimental Pediatrics
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    • v.45 no.6
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    • pp.712-718
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    • 2002
  • Purpose : Infantile colic is one of the most commonly encountered problems, characterized by excessive crying in apparently healthy young infants within the first 3 months of life. It is commonly assumed that the infant with colic has distress and possible pain. In recent investigations, it has been found that sucrose has an analgesic effect in newborn infants. The purpose of this study is to examine if sugar solution as sucrose also has an analgesic effect on infant colic. Methods : This prospective randomized, double-blind placebo controlled study examined healthy term infants aged 4 to 12 weeks with colic. A total of 40 infants were randomly assigned into two groups who visited Daedong Hospital from June 1999 to June 2001. Each group received sugar solution or sterile water. All data from parental diaries and interviews were recorded and analysed blindly. Results : The daily crying time and the colic improvement score were significantly better in sugar solution group as compared with the control(P=0.019, 0.045). No significant differences were noted between groups regarding the number of night wakenings(P=0.173). Conclusion : We conclude that sugar solution has an analgesic effect on infantile colic.