• Title/Summary/Keyword: Controlled trial

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Diet intervention to improve cardiovascular risk factors among Iranian postmenopausal women

  • Abedi, Parvin;Lee, Mary Huang-Soo;Kandiah, Mirnalini;Yassin, Zaitun;Shojaeezade, Davood;Hosseini, Mostafa;MSc, Reza Malihi
    • Nutrition Research and Practice
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    • v.4 no.6
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    • pp.522-527
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    • 2010
  • Cardiovascular disease is a leading cause of death and disability and remains so in the future. The aim of this study was to detect the impact of a 6-month diet intervention on cardiovascular risk factors in postmenopausal Iranian women. It was a randomized controlled trial that carried out in the East Health Clinic in Ahvaz-Iran. This study started on June 2007 and was completed on May 2008. A total 64 healthy postmenopausal women recruited and randomly assigned to the intervention group (35) and control (29). Over the six months follow-up, the intervention group received five educational sessions (two face to face and three lecture discussion classes with slide demonstration) at the first month. These sessions were about menopause, cardiovascular disease and healthy diet. Every participant in the intervention group received one face to face education session at the $3^{rd}$ month, and also received a telephone call at the end of each month starting with the second month to remain on the diet. Pre-intervention and post-intervention anthropometric measurements, blood pressure, blood lipids and dietary intake were assessed. Data analyzed using the SPSS version 15. Descriptive (means and SD), univariate (paired-t test, Chi-Square and Independent T-test) and multivariate (GLM Repeated Measure) statistics were used. Participants in the diet group had significantly lower weight (-0.9 kg), body mass index (-0.4 $kg/m^2$), and fasting blood sugar (-4.5 mg/dl). The diet group significantly increased their daily intake of fiber (+2.3 g, P=0.05), decreased their intake of sodium (-28 mg, P=0.04), and consumption of fruit and vegetable ${\geq}$ 5 serving a day (80%, P=0.03) compared to the control group. Post menopausal women are at a greater risk for cardiovascular disease. Healthy diet using educational intervention can be an effective means of reducing cardiovascular risk in postmenopausal women.

Effects of Electroacupuncture on Parameters Related to Obesity in Adults with Abdominal Obesity:Three arm Randomized Single Blind Pilot Study (전침이 복부비만 성인의 비만관련 지표에 미치는 영향-무작위배정 단일 맹검 예비연구-)

  • Chung, Jie-Youn;Kim, Jong-In;Lee, Sang-Hoon;Kang, Sung-Keel
    • Journal of Acupuncture Research
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    • v.27 no.6
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    • pp.43-57
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    • 2010
  • Objectives : To investigate the effects of electroacupuncture on parameters related to obesity in adults with abdominal obesity. Methods : A three arm randomized single blind pilot study was conducted from Jan 4 to March 25, 2010 in Kyung Hee Oriental Medical Hospital. The subjects were 39 adults with abdominal obesity and were randomly divided by computer generated random table into 3 groups; EA(electroacupuncture), sham EA(sham electroacupuncture) and waitlist groups. Acupuncture points located at abdomen($CV_{12}$, $CV_6$, $ST_{25}$, $SP_{15}$, $SP_{14}$) and extremities($LI_4$, $LI_{11}$, $ST_{36}$, $ST_{44}$) were inserted by disposable stainless steel needles and were stimulated 30 minutes with 24Hz, 0.27~1.3mA(tolerable strength), asymmetric biphasic continuous pulse wave form by STN-111 Stratek device in EA group. Two treatment sessions per week for 5 weeks(10 sessions in total) were done in EA and sham EA groups. The primary outcome measurement was WC(waist circumference), and the secondary outcome measurements included WHR(waist hip ratio), ASF(thickness of abdominal subcutaneous fat), and inbody measurements of BW(body weight), BMI(body mass index), BFR(body fat ratio) and VFA(visceral fat area), and also scores of BULIT-R(bulimia test revised), KoQoL(Korean obesity of QoL) and BSQ(body shape questionnaire). Results : All of 39 subjects were included in ITT(intention-to-treat) analysis. There were significant reductions in WC, WHR and ASF after 5-week electroacupuncture treatments and the percentage reductions were significantly greater than sham EA or waitlist group. There were no significant differences between groups in percentage reductions of other parameters(BW, BMI, BFR, VFA, BULIT-R, KoQoL and BSQ). But, there were continuous reductions in BW, BMI, BFR and VFA at 3 weeks after the end of treatment and there was significant reduction in BW compared with the baseline value in EA group. No seriously adverse effects were reported during the period. Conclusions : Electroacupuncture was more effective than sham electroacupuncture or no intervention on the reduction of WC, WHR and ASF in adults with abdominal obesity.

Effect of xylooligosaccharide-sugar mixture on defecation frequency and symptoms in young women with constipation: a randomized, double-blind, placebo-controlled trial (자일로올리고당을 함유한 설탕이 20대 여성의 변비 개선에 미치는 효과: 이중맹검 연구)

  • Jeon, Jin Ho;Kyung, Myungok;Jung, Sangwon;Jo, SungEun;Chang, Moon-Jeong
    • Journal of Nutrition and Health
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    • v.48 no.1
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    • pp.19-29
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    • 2015
  • Purpose: To investigate the effects of the intake of xylooligosaccharide-sugar mixture (XOS) on defecation frequency and symptoms in 56 young women (mean age of 22.1 years old) with constipation. Methods: Two experiments were conducted. In experiment 1, a randomized double-blind study was performed to evaluate the effect of 6 weeks' intake of 10 g sucrose containing 7% xylooligosaccharide or 10 g sucrose on constipation. In experiment 2, 24 g coffee mixture containing 12.8 g plant cream and 11.2 g xylooligosaccharide-sugar mixture was consumed by the subjects. During the study, the clinical efficacy was assessed by using a daily diary. The subjects indicated the number of frequencies they defecated in a day and the clinical symptom scores. Results: In experiment 1, the mean frequency of defecations was 2.07 in the pretreatment week and increased significantly to 4.05, 4.42, 4.84, 4.84, and 4.05 in weeks 2 to 6 of XOS intake, in comparison with the 3-3.67 with sucrose intake (sucrose, SUC). In experiment 2, the mean frequency of defecations significantly increased from 2.47 in the pretreatment week to 4.11-5.67 in weeks 1-6 of XOS intake. The occurrence of very loose or loose stools in the XOS group was significantly increased in weeks 5 and 6, compared with the pretreatment week and SUC group. XOS intake significantly alleviated the abdominal displeasure and feeling of residual stool leftness in weeks 2, 3, 5, and 6, while SUC did so in weeks 4 and 6 (p < 0.05). The coffee mixture containing xylooligosaccharide-sugar mixture reduced the abdominal displeasure and feeling of residual stool leftness from week 3 until the end of the experiment (p < 0.05). Conclusion: Our results suggest that xylooligosaccharide-sugar mixture intake was effective, without adverse effects, for the alleviation of constipation in the young women in this study.

A Literature Review of the East-West Medical Combined Treatment (한양방 병용치료에 대한 문헌고찰)

  • Kim, Chang-Seok;Kim, Sang-Kyun;Kim, Young-Eun;Kim, Chul;Yea, Sang-Jun;Jang, Hyun-Chul;Song, Mi-Young
    • Korean Journal of Oriental Medicine
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    • v.18 no.2
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    • pp.101-116
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    • 2012
  • Objectives : This study aims to analyze the papers of the east-west medical combined treatment and suggest the research direction. Methods : 183 research papers were collected by using 25 keywords including combination(in korean words, 병용), collaborative practice(in korean words, 협진) in Korean Medical Database(KMbase) and Oriental Medicine Advanced Searching Integrated System(OASIS). We analysed the type of studies, the kind of diseases, the treatment method, the kind of herbs and drugs in frequent use, and the result of research. Results : Among the analysed 183 papers, clinical studies are 89 cases and experimental studies are 94. 5 cases of clinical studies are Randomized Controlled Trial(RCT). The cancer(50 papers) and diseases of the circulatory system(25 papers) occupied mostly in treatment studies. Because Combined treatment was actively progressed in oriental medicine, treatment was mainly applied the combined oriental medical treatment with herbs and western drugs. In herbal medicine, Mahwangyounpae-tang(麻黃潤肺湯) and Eunkyo-San(銀翹散) were frequently used in the papers. In western drugs, Cyclophosphamide, Cisplatin, and Mitomycin C were frequently used in the papers. 154 papers introduced the treatment effect, 14 papers announced the safety, and 4 papers mentioned the side effect. Conclusions : We suggested several future research direction as follows. Clinical studies based on experiment studies must be more activated and many RCT shoud be shown. Experimental group in clinical studies should be clearly separated to confirm the treatment method is effective or isn't effective. Studies about the side effect must be expanded, and every study should be confirmed both the treatment effect and safety.

Chunghyul-dan for the Prevention of Stroke Progression in Silent Brain Infarction (무증후성 뇌경색 환자에 대한 청혈단(淸血丹)의 중풍예방효과)

  • Cho Ki-Ho;Ji Nam-Gue;Jung Woo-Sang;Park Seong-Uk;Moon Sang-Kwan;Ko Chang-Nam;Kim Young-Suk;Bae Hyung-Sup
    • The Journal of Korean Medicine
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    • v.26 no.2 s.62
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    • pp.77-84
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    • 2005
  • Objectives: Chunghyul-dan is a combinatorial herbal medicine, and previous studies reported it had therapeutic effects for microangiopathy, which is a major part. in the progression of stroke, as well as having anti-hypertensive, anti-hyperlipidemic, anti-apoptotic, anti-oxidative, and anti-inflammatory activities, Therefore, we examined the inhibitory effect of Chunghyul-dan on stroke occurrence in patients with silent brain infarction. Methods: We prescribed Chunghyul-dan at 600 mg a day to patients with silent brain infarction confirmed by brain MRI, and monitored stroke occurrence, drug compliances, and adverse effects for 1 year, We then performed follow-up brain MRI to detect new vascular lesions after 1 year of Chunghyul-dan medication. As for the subjects lost to follow-up, we assessed their prognosis after 1 year by telephone. Results: There were twenty-one subjects who were treated with Chunghyul-dan for more than 1 year, None of them experienced new clinical syndromes characterized by rapidly developing clinical symptoms and signs of focal and at times global loss of brain function, which could be accompanied with evidence of stroke occurrence, or any adverse effects during the Chunghyul-dan medication period. These results might be explained by various biochemical effects of Chunghyul-dan on microangiopathy, which is closely related with cell cycle progression, hypertension, hyperlipidemia, vascular inflammation, and oxidative damage. Of the 10 subjects lost to follow-up, six were reached; two of them had stroke occurrence. Conclusions: We suggest Chunghyul-dan could be useful for prevention of stroke occurrence in patients with silent brain infarction by preventing the progression of microangiopathy. Further study with a randomized controlled trial is needed to confirm this suggestion.

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A Crossover Clinical Trial to Determine the Effect of Siguan(Four Gates) Points on Gastrointestinal Motility Suppressed by Loperamide Administration (Loperamide로 억제된 위장관 운동에 대한 사관혈의 자침효과: 무작위배정, 단일눈가림, 교차설계, 대조 임상시험)

  • Oh, Dal-Seok;Jung, So-Young;Kim, Ae-Ran;Kang, Wee-Chang;Park, Ji-Eun;Koo, Chang-Mo;Choi, Jun-Yong;Jung, Hee-Jung;Choi, Sun-Mi;Son, Chang-Gue
    • The Journal of Korean Medicine
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    • v.29 no.1
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    • pp.1-6
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    • 2008
  • Objective : To investigate the therapeutic effect of manual acupuncture at Siguan (four gates, bilateral LI4 and LR3) on suppression of gastrointestinal motility. Methods : A single blind, randomized, sham-acupuncture controlled, crossover study was conducted. Twenty healthy male subjects were admitted at hospital, and gastrointestinal motility suppression was induced by loperamide administration. Just after intake of 20 radio-markers, four gates or sham acupoint treatments were administered every 12 hours, 4 times over 48 hours. Gastrointestinal motility was evaluated by radiographic distribution of the radiomarkers at stomach or ileum, ascending, transverse, descending colon, sigmoid/rectum, and outside body at serial time points (0, 6, 12, 24, and 48 h). Results : Four gates acupuncture activated gastrointestinal movement as evidenced by significantly changed distributionof radio-makers at 6, 12, and 48 hours (P < 0.0001, P = 0.001, and P = 0.03, respectively) in Cochran-Mantel-Haenszel statistics. No serious adverse events occurred in either group. Conclusions : This study showed a scientific clinical relevance of four gates acupuncture to gastrointestinal disorders.

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Current Trends in Intervention Studies of Hwabyung in Korean Medicine (화병의 한의학적 치료에 대한 연구동향)

  • Suh, Hyo-Weon;Choi, Eun-Ji;Kim, Sang-Ho;Kim, Dong Hee;Kim, Lak-Hyung;Kim, Jong-Woo;Lee, Jae-Hyok;Lim, Jae-Hwan;Choi, Woo-Jin;Chung, Sun-Yong
    • Journal of Oriental Neuropsychiatry
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    • v.27 no.4
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

The Effect of Unstable Support Surface Plank Exercise on Flexibility, Abdominal Muscle Thickness and Pain in Chronic Low Back Pain (불안정한 지지면 위에서의 플랭크 운동이 만성허리통증환자의 유연성, 배 근육 두께 및 통증에 미치는 영향)

  • Han, Woo Jeong;Son, Kyung Hyun
    • Journal of Korean Physical Therapy Science
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    • v.26 no.3
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    • pp.23-36
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    • 2019
  • Background: The purpose of this study was to investigate the effect of Plank exercise on unstable support surfaces on flexibility, abdominal muscle thickness and pain in patients with chronic back pain. Design: Randomized controlled trial. Methods: This study was performed on 16 patients with chronic back pain of ◯◯ military unit. Sixteen subjects were randomly assigned into two groups, an upper extremity trainer group (group I, n=8) and a lower extremity trainer group (group II, n=8). The subjects in group I carried out Flank exercise applying the stability trainer to their upper extremities and ones in group II carried out the same exercise applying the stability trainer to their lower extremities for 4 weeks. In order to ascertain the difference between two groups, flexibility, abdominal muscle thickness and pain were measured before and after the exercise. The flexibility was measured by sit and reach test, the thickness of the abdominal muscle was measured by using ultrasonic imaging equipment, and the pain was measured by the visual analogue scale. A paired t-test was utilized to compare changes in pain, abdominal muscle thickness and flexibility before and after flank exercise on unstable support surfaces. Analysis of Covariance (ANCOVA) was performed for ascertaining the significant differences between groups. The significance level was set by α=.05. Results: 1) The flexibilities of two groups were increased after the exercise (p<0.05). 2) In both groups, the thicknesses of rectus abdominis, external oblique abdominis, internal oblique abdominis, and transverse abdominis were all increased after the exercise (p<0.05). 3) The pains in both groups were decreased after the exercise (p<0.05). 4) In the comparisons of two groups, there were no differences in the flexibility, thickness of external oblique abdominis, internal oblique abdominis and transverse abdominis and pain (p>0.05). Whereas only thickness of Rectus abdominis was larger in the group I than in the group II (p<0.05). Conclusion: Plank exercise on the unstable support surface for 4 weeks resulted in increased flexibility, abdominal muscle thickness and pain reduction in patients with chronic back pain. Therefore, it is considered that performing flank exercise on the unstable supporting surface is suitable for the reduction of the pain in patients with chronic back pain. However, in this study, it is considered that continuous and diverse studies are needed because there was not a large difference between the groups when the upper or lower limbs are provided unstable support surfaces.

Study of Instruments for Assessment and Clinical Research Trends in Common Cold (감기 임상연구의 최신 동향 및 평가도구에 관한 연구)

  • Yang, Su-Young;Byun, Jun-Seop;Hwang, Ji-Ho;An, Joung-Jo;Hong, Kweon-Eey;Kang, Wee-Chang;Lee, Yong-Koo;Park, Yang-Chun
    • The Journal of Korean Medicine
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    • v.29 no.2
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    • pp.165-181
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    • 2008
  • Objectives: This study was conducted to help clinical studies for treating the common cold with Oriental medicine. We inspected tendencies of clinical studies of the common cold in western medicine and analyzed the assessing instruments for it by scrutinizing PubMed publications for the last five years. Materials and Methods: We inspected 32 theses and scrutinized their objectives, periods, participants, materials and methods, the instrument of assessment for the studies, and validity, reliability, criteria and symptom score for questionnaires, results and JADAD score. Results: 1. The median for total period of study was 7 months, the median for days of treatment was 7.5, and most studies were carried out during the winter/spring period, because of the enhanced risk of cold infections. 2. The studies focused on unorthodox medicines or new drug products, such as antipyretic analgesics (e.g. paracetamol), decongestant and bronchodilator (e.g. ephedrine), echinacea, antioxidants (e.g. zinc), probiotic bacteria and so on. 3. All theses except one had subjectscomposed of cold patients who were infected naturally. The median number of subjects for final analysis was 187. 4. 27 studies used survey as the instrument of assessment. Among these, only one thesis was verified for validity. 5. The mean of JADAD score was 4.41, suggesting most of theses of worth. 7 studies were assessed as ineffective. Conclusion: Recent studies of the common cold are focused on unorthodox medicines or new drug products, and it is necessary to provide an objective instrument for assessing common cold treatments.

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The Effect of Alcohol-related Harm Preventing Intervention on Drinking Frequency and Problem Behaviors of Adolescent: A Meta-analysis (청소년의 음주폐해 예방 중재가 음주 빈도와 문제행동에 미치는 효과: 메타분석)

  • Song, A-Young;Song, Ye-Won;Lee, Jae-Shin
    • The Journal of the Korea Contents Association
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    • v.17 no.2
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    • pp.687-695
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    • 2017
  • This study tried to confirm the effective intervention to reduce drinking frequency and problem behaviors among the three interventions; school based, feedback, and behavior change. Meta-analysis was conducted targeting at 16 studies of randomized controlled trial in which alcohol intervention has been applied to adolescent. The drinking frequency and problem behaviors were analyzed by follow up period. There was a significant difference in the feedback intervention to reduce the frequency of drinking under 3 months of follow up period. Also, there was a significant difference in the feedback intervention to reduce the problematic behaviors of drinking between 4 and 12 months of follow up period(p<.05). The study confirmed that feedback intervention is effective in reducing the frequency of drinking during the follow up period under 3 months, and it is effective in reducing the problem behaviors of drinking during the 4~12 months of follow up period. Also, the study confirmed that school-based intervention and feedback intervention were useful in reducing and preventing harmful effects of drinking by adolescents.