• Title/Summary/Keyword: random clinical trial

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Health Blief Model-based intervention to improve nutritional behavior among elderly women

  • Iranagh, Jamileh Amirzadeh;Rahman, Hejar Abdul;Motalebi, Seyedeh Ameneh
    • Nutrition Research and Practice
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    • v.10 no.3
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    • pp.352-358
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    • 2016
  • BACKGROUND/OBJECTIVES: Nutrition is a determinant factor of health in elderly people. Independent living in elderly people can be maintained or enhanced by improvement of nutritional behavior. Hence, the present study was conducted to determine the impact of Health Belief Model (HBM)-based intervention on the nutritional behavior of elderly women. SUBJECTS/METHODS: Cluster-random sampling was used to assess the sample of this clinical trial study. The participants of this study attended a 12-week nutrition education program consisting of two (2) sessions per week. There was also a follow-up for another three (3) months. Smart PLS 3.5 and SPSS 19 were used for structural equation modeling, determination of model fitness, and hypotheses testing. RESULTS: The findings indicate that intervention had a significant effect on knowledge improvement as well as the behavior of elderly women. The model explained 5 to 70% of the variance in nutritional behavior. In addition, nutritional behavior was positively affected by the HBM constructs comprised of perceived susceptibility, self-efficacy, perceived benefits, and barriers after the intervention program. CONCLUSION: The results of this study show that HBM-based educational intervention has a significant effect in improving nutritional knowledge and behavior among elderly women.

Study of the Efficacy and Safety of "adenophorae radix extract" in the Obese Patients or Overweight (비만 및 과체중 환자에 대한 사삼추출물의 유효성 및 안전성 평가)

  • Kim, Gi-Tae;Go, Heung;Shin, Seon-Mi;Kim, Hyung-Jun
    • The Journal of Korean Obstetrics and Gynecology
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    • v.25 no.2
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    • pp.131-141
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    • 2012
  • Objectives: The purpose of this study is to evaluate the efficacy and biosafety of Adenophorae Radix(AR) extract in obesity or overweight patient. Methods: This study is double-blind, randomized, placebo-controlled intervention Study. 30 patients with BMI $25{\leq}$ and 30> were allotted into two groups at random. In 0, $6^{th}$, $12^{th}$ week, we had checked body weight, waist line, hip line, body fat and abdominal CT scan. In 0, $12^{th}$ week, we also had checked lipid metabolism and biosafety with blood test. Results: AR treatment had a significant effect on suppressing body wight gain (p<0.01) and BMI index(p<0.01). AR treatment reduced plasma TG level but we couldn't find statistical significance. AR treatment had produced no adverse reactions. Conclusions: This study shows that Adenophorae Radix(AR) extract can reduce the weight, BMI. Adenophorae Radix(AR) extract can be used in obesity or overweight patient.

The Assessment of Risk of Bias on Clinical Trials of Korean Medicine for Alopecia (탈모증의 한약제제 임상연구에 대한 비뚤림 위험 평가)

  • Ryu, Deok-hyun;Roh, Seok-sun
    • Journal of Haehwa Medicine
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    • v.24 no.1
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    • pp.25-36
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    • 2015
  • Objective : This study aims to evaluate a risk of bias by Risk of Bias tool and RoBANS(Risk of Bias Assessment tool for Non-randomized Study) tool for clinical trial papers proving treatment effect of herbs to alopecia and provides the newest reason of effectiveness of herbs to alopecia. Methos : Data were collected through electronic database including NDSL, KISS, KMBASE, Koreantk, OASIS, KoreaMed, KISTI, Pubmd, Cochrane CENTRAL and CINAHL. Two experts in Oriental Medince assessed risk of bias of randomized controlled trials by Cochrane group's Risk of Bias tool and non-randomized controlled trials by RoBANS tool after searching, reviewing and selecting papers. Results : Total number of selected trials is 20 including 4 randomized controlled trials, 13 non-randomized controlled trials and 3 case reports. This study evaluates the risk of bias of 17 papers including 4 randomized controlled trials and 13 non-randomized controlled trials except 3 case reports by risk of bias tool and RoBANS tool. All papers of randomized controlled trials are evaluated unclear for random sequence generation and allocation concealment as there are no word on them. And all papers of non-randomized controlled trials are evaluated unclear for blinding of outcome assessments and relatively low for others. Conclusion : We must try to specify concretely methods of allocation concealment after planning and practicing it for reducing a selection bias in randomized controlled trials. Also report a reason of missing value and blinding outcome assessments. And we have to agonize and mention methods of blinding of researchers for reducing a detection bias in non-randomized controlled trials.

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The Clinical Study on the Effect of the Sulguanjul-bang No.1 According to Formulation (퇴행성 슬관절염 환자에 대한 슬관절방(膝關節方) 1호(號)의 제형변화 유효성 임상연구)

  • Park, Min-Jung;Seo, Jin-Woo;Sung, In-Hyung;Kim, Nam-Ok;Sung, Su-Min;Chung, Ae-Kyung;Shin, Dae-Hee;Park, Koae-Hwan
    • Herbal Formula Science
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    • v.13 no.2
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    • pp.193-206
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    • 2005
  • Objective: This study is designed to compare the effects of Sulguanjul-Bang No.1 on osteoarthritis in knee joint according to formulation. Methods: 47 patients with symptomatic osteoarthritis of the knee joint were enrolled in a open clinical trial. The 47 patients were devided into two groups at random and taken Sulguanjul-bang No.1 with decoction type, suspension type respectively for8 weeks. After 8-week treatment period, the following parameters were analyzed ; Visual analogue Scale(VAS), Lysholm index score, patients' global assessment. Results: Sulguanjul-bang No.1 treatment led to significant improvement in the pain and symptoms of osteoarthritis as determined by all efficacy measures. After 8 weeks of therapy, there was significant improvement in VAS, Lysholm index and patients' global assessment. But there is no significant difference between two groups. Conclusions: Sulguanjul-bang No.1 was very beneficial pain relief effect and functional improvement irrespect of formulation, decoction type or suspension type.

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The Effect of Sweet Bee Venom Pharmacopuncture(SBVP) on Cancer-Related Pain : A Randomized Controlled Trial and Double Blinded - Pilot study (암성통증에 대한 SBVP 효과 - 무작위대조시험, 이중맹검)

  • Yoo, Hwa-Seung;Kim, Jung-Sun
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.21-29
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    • 2008
  • Objectives : To investigate the therapeutic effects of SBVP in the treatment of patients with cancer-related pain. Design : A prospective randomized, double-blind, placebo-controlled study of SBVP. Setting : The study was conducted at the East West Cancer Center of Daejeon University Dunsan Oriental Hospital from March 1, 2007 to June 20, 2007. Patients : 11 patients diagnosed with cancer-related pain of over 3rd degree on the Numeric Rating Scale(NRS)(0, no pain at all, 10, worst pain imaginable) were entered into a double-blind, placebo-controlled trial of SBVP. They were randomized into Groups A and B(SBVP and control group, respectively) using the table of random sampling numbers and never informed of their affiliation by the coordinator. 5 of 6 patients in Group A and 4 of 5 patients in Group B completed the clinical trial. Intervention : SBVP(1ml/day) for group A and Normal Saline Placebo(1ml/day) for group B was injected into the abdomen acupoint, Zhong Wan(CV 12). The treatment was administered daily for five days. Outcome Measures : Degree of cancer-related pain was measured using the Numeric Rating Scale(NRS) before and after each treatment for "Pain right now" and "Average pain in last 24 hours". Statistical Analysis : Analysis regarding variations in NRS was carried out by applying t-tests(independent sample t-test and paired sample t-test) and Wilcoxon signed rank test with level of significance at 5%. Results : Differences in NRS of "Pain right now" for the two groups were statistically significant. The mean improvement point of SBVP was significantly higher than the control group($2.48^{\circ}{\pm}1.52$ vs $0.97^{\circ}{\pm}1.88$, p<0.05). Differences in average pain score before and after treatment in SBVP group were also significant($5.13^{\circ}{\pm}1.77$ vs $2.65^{\circ}{\pm}0.67$, p<0.05) compared with control group. The two groups showed no significant differences for long term effects in "Average pain in last 24 hours." Conclusion : Although further study will be needed on the large scale, SBVP shows potential as an effective treatment for immediate relief of cancer-related pain.

Improvement of FK506 Production in the High-Yielding Strain Streptomyces sp. RM7011 by Engineering the Supply of Allylmalonyl-CoA Through a Combination of Genetic and Chemical Approach

  • Mo, SangJoon;Lee, Sung-Kwon;Jin, Ying-Yu;Suh, Joo-Won
    • Journal of Microbiology and Biotechnology
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    • v.26 no.2
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    • pp.233-240
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    • 2016
  • FK506, a widely used immunosuppressant, is a 23-membered polyketide macrolide that is produced by several Streptomyces species. FK506 high-yielding strain Streptomyces sp. RM7011 was developed from the discovered Streptomyces sp. KCCM 11116P by random mutagenesis in our previous study. The results of transcript expression analysis showed that the transcription levels of tcsA, B, C, and D were increased in Streptomyces sp. RM7011 by 2.1-, 3.1-, 3.3-, and 4.1-fold, respectively, compared with Streptomyces sp. KCCM 11116P. The overexpression of tcsABCD g enes in Streptomyces sp. RM7011 gave rise to approximately 2.5-fold (238.1 μg/ml) increase in the level of FK506 production compared with that of Streptomyces sp. RM7011. When vinyl pentanoate was added into the culture broth of Streptomyces sp. RM7011, the level of FK506 production was approximately 2.2-fold (207.7 μg/ml) higher than that of the unsupplemented fermentation. Furthermore, supplementing the culture broth of Streptomyces sp. RM7011 expressing tcsABCD genes with vinyl pentanoate resulted in an additional 1.7-fold improvement in the FK506 titer (498.1 μg/ml) compared with that observed under non-supplemented condition. Overall, the level of FK506 production was increased approximately 5.2-fold by engineering the supply of allylmalonyl-CoA in the high-yielding strain Streptomyces sp. RM7011, using a combination of overexpressing tcsABCD genes and adding vinyl pentanoate, as compared with Streptomyces sp. RM7011 (95.3 μg/ml). Moreover, among the three precursors analyzed, pentanoate was the most effective precursor, supporting the highest titer of FK506 in the FK506 high-yielding strain Streptomyces sp. RM7011.

Effects of Communication Ability Enhancement Program for Nursing Students in Korea: A Systematic Review and Meta-analysis (간호대학생을 위한 의사소통 능력 증진 프로그램의 효과: 체계적 문헌고찰 및 메타분석)

  • Han, Mihwa;Lee, Kyunghee
    • The Journal of Korean Academic Society of Nursing Education
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    • v.23 no.1
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    • pp.15-26
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    • 2017
  • Purpose: This study evaluated the efficacy of a communication ability enhancement program for nursing students in Korea through a systematic review of literature and meta-analysis. Methods: The researchers searched data-bases, including the Data Base Periodical Information Academic, Research Information Sharing Service, National Digital Science Library and National Assembly Library. The key words used included 'communication' and 'nursing student'. The researchers evaluated articles published up to July 2016. Out of 381 selected articles, 20 clinical trial studies were meta-analyzed. Each article was evaluated in accordance with the Checklist of Scottish Intercollegiate Guideline Network. The effect size of communication ability, self-efficacy and interpersonal relations were synthesized by a random effects model from analysis software (R 3.2.3). The heterogeneity of effect size was analyzed by exploratory and confirmatory moderator analysis. Results: The overall effect size of the program was of a moderate level (SMD=0.78, 95% CI: 0.49~1.07) along with each outcome of self-efficacy (SMD=0.80, 95% CI: 0.23~1.37), and interpersonal relations (SMD=0.47, 95% CI: 0.14~0.80). For heterogeneity, moderator analysis was performed, by grade, and a statistically significant moderator was found. Conclusion: It is evident that a communication ability enhancement program for nursing students is moderately effective in improving communication ability, self-efficacy and interpersonal relations.

Preventive Effects of Fluoride Gel Application on Dental Caries in the Permanent Tooth: A Systematic Review of Randomized Controlled Trials

  • Do, Kyung-Yi;Lee, Eun-Sun
    • Journal of dental hygiene science
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    • v.19 no.1
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    • pp.9-22
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    • 2019
  • Background: The purpose of this systematic review was to investigate the effects of topical fluoride gel application on dental caries prevention in the permanent teeth of children and adolescents. Methods: We searched the EMBASE, PubMed, and Cochrane Library databases for randomized controlled trials (RCTs) assessing the effects of self-applied or professionally applied topical fluoride gels in patients <18 years of age; the search was completed on April 1, 2018. All included trials involved an experimental group (fluoride gel application) and a control group (placebo or no treatment). The outcome measures were the D(M)FS and D(M)FT indices, which were compared between the two groups. Review Manager software was used for quantitative synthesis of the final selected articles, and a forest plot was generated via a meta-analysis conducted using a random effects model. Results: The results showed that the D(M)FS and D(M)FT indices were lower in the fluoride application group than in the control group, thus indicating that fluoride gel application was effective in dental caries prevention. We also performed a subgroup analysis to determine whether the effects of fluoride application differed if patients received oral prophylaxis (self or professional) before fluoride gel application. Therefore, the two groups showed slightly larger differences when studies without oral prophylaxis before fluoride gel application were considered; however, the difference was not statistically significant. Conclusion: These findings should be utilized to raise awareness about the caries-prevention effects of topical fluoride application among patients and guardians. Further RCTs should evaluate the effects of fluoride application with or without preceding oral prophylaxis, and appropriate fluoride application guidelines should be developed to maximize the effects of fluoride application in clinical practice.

Effects of Microcurrent on Inflammatory Musculoskeletal Diseases: A Meta-Analysis (염증성 근육뼈대계 질환에 대한 미세전류의 효과: 메타분석)

  • Lee, Jeongwoo;Ko, Un;Doo, Yeongtaek
    • Journal of The Korean Society of Integrative Medicine
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    • v.8 no.4
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    • pp.1-11
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    • 2020
  • Purpose : The purpose of this meta-analysis was to examine the effects of microcurrent on inflammatory musculoskeletal diseases. Methods : Domestic databases (RISS, NDSL, KISS, DBpia, and Kmbase) were searched for studies that conducted clinical trials associated with microcurrent and its impact on inflammatory musculoskeletal diseases. A total of 606 studies published between 2002 and 2019 were identified, with 8 studies satisfying the inclusion data. The studies were classified according to patient, intervention, comparison, and outcome (PICO). The search outcomes were items associated with blood component, pain, and function. The 8 studies that were included in the study were evaluated using R meta-analysis (version 4.0). The quality of 7 randomized control trials was evaluated using Cochrane risk of bias (ROB). The quality of 1 non-randomized control trial was evaluated using risk of bias assessment tool for non-randomized studies (RoBANS). Effect sizes were computed as the corrected standard mean difference (SMD). A random-effect model was used to analyze the effect size because of the high heterogeneity among the studies. Egger's regression test was carried out to analyze the publishing bias. Results : The following factors had a large effect size involving microcurrent on inflammatory musculoskeletal diseases: blood component (Hedges's g=-2.46, 95 % CI=-4.20~-0.73), pain (Hedges's g=3.51, 95 % CI=2.44~4.77), and function (Hedges's g=3.06, 95 % CI: 1.53~4.58). Except for function (t=1.572, p=.191), Egger's regression test showed that the publishing bias had statistically significant differences. Conclusion : This study provides evidence for the effectiveness of microcurrent on inflammatory musculoskeletal diseases in terms of blood component, pain, and function. However, due to the small sample sizes used in the included studies, the results of our study should be interpreted cautiously, especially considering the publishing bias.

Effects of Non-Contact Complex Exercise Program on the Older over 65 Years of Age on Muscle Strength, Falling Efficacy and Balance Ability

  • Sam Ho Park;Youn Jung Oh;Myung Mo Lee
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.167-176
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    • 2023
  • Objective: The purpose of this study was to investigate the effects of anon-contact complex exercise program on muscle strength, fall efficacy, quality of life, and balance ability in older over 65 years of age. Design: A randomized controlled trial Methods: A total of 37 people in older over 65 years of age participated in the study. Random program was conducted and assigned to the experimental group (n=19) and the control group (n=18). Both groups performed the older people welfare center program. In addition, in the experimental group, a non-contact complex exercise program for muscle and balance exercise was performed. All interventions were performed 2 times a week, for a total of 6 weeks. chair stand test (CST), fall efficacy scale (FES), Euro quality of life 5 dimension (EQ-5D), Berg balance scale (BBS), timed up and go test (TUG), Fullerton advanced balance scale (FAB) were measured before and after the intervention to compare their effectiveness. Results: Both groups showed significant differences in CST, FES, EQ-5D, BBS, and TUG before and after intervention (p<0.05). FAB showed significant differences before and after intervention in all items except for FAB 8 and 9 items in the experimental group. In addition, the experimental group showed significant differences in CST, FES, BBS, TUG, FAB (except 1, 7, 8, 9) compared to the control group (p<0.05). Conclusions: The non-contact complex exercise program is an effective intervention method that has clinical significance in improving muscle strength, fall efficacy and static and dynamic balance abilities for the older over 65 years of age.