• Title/Summary/Keyword: randomized clinical trial

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Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) for Insomnia Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (불면장애에 대한 천왕보심단의 체계적 문헌 고찰 및 메타분석 연구)

  • Sakong, Jong-Won;Kim, Dong-Hee;Ha, Ji-Won;Cho, Yun-Song;Kim, Bo-Kyung
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.4
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    • pp.267-280
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    • 2018
  • Objectives: The objective of this study was to provide clinical evidence to support the use of a herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet (TWBXP)) for insomnia. Methods: Randomized controlled trials that verified effects of Herbal Medicine (Cheonwangbosim-Dan, Tianwangbuxin-Pellet) treating primary insomnia were carried out. A literature search of English, Chinese, Korean databases was also performed. The selected literature were assessed by Risk of Bias (RoB). Results: The total number of selected trials was 13 RCTs. Among the 13 RCTs, 10 were meta-analyzed. The Chinese Classification of Mental Disorders-3 (CCMD-3) was frequently used as the diagnostic criteria for interventions during the analysis of the use of herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) for management of primary insomnia. As for outcome measurement, the effective rate was used. From the Meta-analysis of the studies, it was established that the insomnia cure effective rate in the TWBXP group was higher than that in the Western Medicine (WM) group (RR: 1.15, 95% CI: 1.07 to 1.24, p<0.0001, $I^2=33%$). Also, the effective rate in the TWBXP+ACU group was significantly different compared to the WM group (RR: 1.32, 95% CI: 1.13 to 1.54, p=0.0004, $I^2=0%$). The quality of the selected RCTs was low. Conclusions: Herbal medicine (Cheonwangbosim-Dan/Tianwangbuxin-Pellet) is effective for treating primary insomnia. It is worth noting that this studies were of relatively poor quality. The sample sizes were also small. Therefore, further investigations into the diagnosis and treatment of insomnia are warranted.

Efficacy and safety of equine cartilage for rhinoplasty: a multicenter double-blind non-inferiority randomized confirmatory clinical trial

  • Chang, Yongjoon;Yun, Hyunjong;Choi, Jong Woo;Suh, Joong Min;Jeong, Woo Shik;Park, Hojin;Kang, Min Kyu;Shin, Yongho;Kim, Kuylhee;Chung, Chul Hoon
    • Archives of Craniofacial Surgery
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    • v.23 no.4
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    • pp.152-162
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    • 2022
  • Background: The efficacy and safety of equine cartilage as a competent xenograft material for rhinoplasty were evaluated and compared to the outcomes of rhinoplasty using silicone implants. Methods: We performed a multicenter, double-blind, non-inferiority, and randomized confirmatory study. Fifty-six patients were randomized 1:1 to the study group (using MegaCartilage-E) and control group (using silicone implants). The Rhinoplasty Outcome Evaluation (ROE) score, photo documentation, Global Aesthetic Improvement Scale (GAIS), and adverse event data were obtained until 12 months after surgery. The primary efficacy, which is the change in ROE score 6 months after surgery, was assessed in the modified intention-to-treat set. The secondary efficacy was evaluated in the per-protocol set by assessing the change in ROE score 6 and 12 months after surgery and nasofrontal angle, the height of the nasion, and GAIS 1, 6, and 12 months after surgery. Results: The change in ROE score of the study group was non-inferior to that of the control group; it increased by 24.26±17.24 in the study group and 18.27±17.60 in the control group (p= 0.213). In both groups, all secondary outcome measures increased, but there was no statistical difference. In the safety set, treatment-emergent adverse events occurred in 10 patients (35.71%) in the study group and six patients (21.43%) in the control group (p= 0.237). There were 13 adverse device events in the study group and six adverse device events in the control group (p= 0.515). Conclusion: Processed equine cartilage can be used effectively and safely as xenograft material for rhinoplasty.

Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Success and failure of endodontic microsurgery (미세 치근단 수술의 성공과 실패)

  • Song, Min-Ju;Kim, Eui-Seong
    • Restorative Dentistry and Endodontics
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    • v.36 no.6
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    • pp.465-476
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    • 2011
  • In current endodontic practice, introduction of operating microscope, ultrasonic instruments, and microinstruments has induced a big change in the field of surgical retreatment. In this study, we aimed to offer key steps of endodontic microsurgery procedure compared with traditional root-end surgery, and to evaluate factors influencing success and failure based on published articles. Endodontic microsurgery is a surgical procedure performed with the aid of a microscope, ultrasonic instruments and modern microsurgical instruments. The microscope provides magnification and illumination - essential for identifying minute details of the apical anatomy. Ultrasonic instruments facilitate the precise root-end preparation that is within the anatomical space of the canal. Modern endodontics can therefore be performed with precision and predictability, thus eliminating the disadvantages inherent in traditional periapical surgery such as large osteotomy, beveled apicoectomy, inaccurate root-end preparation and the inability to observe isthmus. Factors influencing the outcomes of endodontic microsurgery may be diverse, but standardization of procedures can minimize its range. Among patient and tooth-related factors, periodontal status and tooth position are known to be prognostic, but there are only few articles concerning this matter. High-evidence randomized clinical trials or prospective cohort studies are needed to confirm these findings.

Interim Report about The Effect of Bunsimgi-eum(Fenxinqiyin) on the Chest Discomfort of Hwa-byung's Major Symptom (화병 핵심증상 중 흉민에 대한 분심기음의 효능 : 무작위배정, 이중맹검, 위약대조군연구의 중간보고 - 피험자 특성을 중심으로)

  • Yim, Hyeon-Ju;Kim, Seok-Hwan;Lee, Sang-Ryong;Kang, Wee-Chang;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.20 no.3
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    • pp.169-188
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    • 2009
  • Objectives : The purpose of this research is to examine the effect of Bunsimgi-eum on the chest discomfort of Hwa-byung's major symptom. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Bunsimgi-eum or controlled medication for major symptoms of Hwa-byung. As preparatory research, 100 mm Visual Analogue Scale(VAS) for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, Korean State-Trait Anger Expression Inventory(STAXI-K), Korean State-Trait Anxiety Inventory(STAI-K), Korean Beck's Depression Inventory(BDI-K) and Heart Rate Variability(HRV) were also measured as the 2nd evaluative instrument at the before treatment. Results : Clinical characteristics-vital signs & demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, etc, also showed no significant difference between both groups. There were almost no Coincidence between pattern identification & weight of Hwa-byung's major symptoms. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; 100 mm Visual Analogue Scale for chest discomfort, the Hwa-byung' major symptom was measured as the 1st evaluative instrument, and Likert scale for major symptom of Hwa-byung, STAXI-K, STAI-K, BDI-K and HRV. Conclusions : We considered that establishment of experimental group and controlled group was objective and worth conducting this research. And this methodology is expected to be applied to the subsequent research. And also, we hope to make up for this study through various study and discussion.

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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.

Interim Report about The Effect of Sihogayonggolmoryeo-tang on the Anxiety of Hwa-byung (화병의 불안 증상에 대한 시호가용골모려탕의 효능 임상연구 중간보고)

  • Choi, Woo-Chang;Park, Dae-Myung;Kang, Wee-Chang;Lee, Sang-Ryong;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
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    • v.23 no.4
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    • pp.133-152
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    • 2012
  • Objectives : The purpose of this study is to investigate the effect of Sihogayonggolmoryeo-tang on the anxiety of Hwa-byung. Methods : In this randomized, double blinded, placebo-controlled study, we planned to give Sihogayonggolmoryeo-tang or controlled medication for anxiety of Hwa-byung. Hamilton Anxiety Scale (HAM-A) was measured as the 1st evaluative instrument, and Korean State-Trait Anxiety Inventory (STAI-K), Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, Korean Beck's Depression Inventory (BDI-K), Korean State-Trait Anger Expression Inventory (STAXI-K), Insomnia severity Index (ISI), Instrument of Oriental Medical Evaluation for Hwa-Byung, WHO Quality of Life Avvreviated (WHOQOL-BREF), genral self-Efficacy Scale (GSES), Rosenberg Self-Esteem Inventory (SRE) and Heart Rate Variability (HRV) were also measured as the 2nd evaluative instrument before treatment. Results : Clinical characteristics-vital signs and demographic characteristics showed no significant difference between both groups. The characteristics of disease-chief complaint, pattern Identification, period, etiological factor, and etc, also showed similarity of distribution in both groups. The results of Chest PA, EKG and clinicopathologic examination showed no significant difference between both groups. There were no significant difference between both groups in all valuation scales; HAM-A was measured as the first evaluative instrument, and STAI-K, Likert scale for major symptom of Hwa-byung, Hwa-Byung Scale Score, BDI-K, STAXI-K, ISI, Instrument of Oriental Medical Evaluation for Hwa-Byung, WHOQOL-BREF, GSES, SRE and HRV. Conclusions : We considered that establishment of the experimental group and controlled group was objective and worth conducting this research. In addition, this methodology is expected to be applied to the subsequent research. Further, we hope to make up for this study through various study and discussion.

The Study on the Effectiveness of Acupuncture in Stroke Rehabilitation (중풍(中風) 재활(再活)의 침치료(鍼治療) 효과(效果)에 대한 고찰(考察) -최근 RCT(Randomized controlled trial) 논문을 중심으로-)

  • Kim, Eun-jung;Lee, Jae-dong;Kang, Sung-keel
    • Journal of Acupuncture Research
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    • v.22 no.1
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    • pp.211-221
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    • 2005
  • Objective : The aim of this study is to review clinical trials on the effectiveness of acupuncture in stroke rehabilitation. Methods : Computerized literature searches was carried out on three electronic databases, and hand-searching on some chinese medical journals in library of Kyung Hee Medical Center. Results : 1) Sixteen articles of clinical trials were collected and reviewed. Among these articles, randomized controlled trials were achieved in nine articles. 2) In three articles, statically significant results in improvement of mobile abilities, activities of daily life and Quality of life were reported after acupuncture treatment applied as a part of stroke rehabilitation. In three articles no statically significant changes were reported. 3) Among two articles about spasticity, One about the upper limbs and the results showed statically significant improvement of the spasticity after acupuncture treatment as stroke rehabilitation, and the other was about the lower limbs and the results showed no statically significant changes. 4) One article about acupuncture and postural control showed statically significant results suggesting that acupuncture promotes normalization of postural control after stroke.

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A Meta-analysis of the effects of Academic-related Satisfaction Intervention Programs for Nursing Students in Korea (메타분석을 이용한 간호 대학생의 학업 관련 만족도 중재프로그램의 효과)

  • Kim, Mina;Kim, Young A
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.10
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    • pp.218-228
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    • 2019
  • This study was conducted to review and analyze the academic-related satisfaction intervention programs for Korean nursing students and to provide evidence-based data. The data included in the meta-analysis were 25 studies published from 2001 to July 2018, and the design of the study consisted of 1 randomized controlled trial and 24 non-randomized controlled trials. The study subjects were nursing students from 1st to 4th grade, and the intervention program was conducted in theoretical and practical classes. The sample size was 1182 (mean: 47.3) in the experimental group and 1137 in the control group (mean: 45.5). The intervention program consisted of 1~16 weeks/1~16 sessions/7~240 minutes per session. Dependent variables were as follows: major satisfaction, learning satisfaction, satisfaction with the classroom practice, and satisfaction with the clinical practice. Satisfaction with the classroom practice (Hedges' g=0.876[95% CI: 0.405, 1.346]), satisfaction with the clinical practice (Hedges' g=0.515[95% CI: 0.312, 0.718]), and overall academic-related satisfaction (Hedges' g=0.630[95% CI: 0.371, 0.889]) were statistically significant and above intermediate levels in the meta-analysis. The study results are significant in that the objective results were confirmed by integrating the previous studies dealing with the academic-related satisfaction intervention program of nursing students.

Effect of Acupuncture Treatment on the Primary Dysmenorrhea;A Study of Single Blind, Sham Acupuncture, Randomized, Controlled Clinical Trial (원발성 월경곤란증의 침치료 효과에 대한 임상시험)

  • Youn, Hyoun-Min;Kim, Cheol-Hong;Park, Jae-Heung;Han, Min-Seok;Lee, In-Sun;Choi, Sun-Mi;Park, Ji-Eun;Kim, Kyu-kon
    • Journal of Acupuncture Research
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    • v.25 no.3
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    • pp.139-162
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    • 2008
  • Objectives : Korean tradithional acupuncture Theory, Sa-am's 5 phases acupuncture method was originated in 1644-1742, in the middle of the Cho Sun dynasty. This study was to vertify the effect of Sa-am Acupuncture Treatment on Primary dysmenorrhea of Women. Methods : The subjects were 80 volunteers who was suffering for dysmenorrhea, employed using Measure of Menstrual Pain (MMP) questionnaire. Subjects were divided into two groups including Sa-am acupuncture treatment group(n=25), minimal acupuncture treatment group(n=22). They had agreed to take part in this experiment, with didn't take any anodyne drugs. In the acupuncture group, subjects were stimulated at G41, $SI_3$, B66, $SI_2$(Small intestine jung-guk), $SP_6$, $CV_6$ and one points were inserted additionally depending the symptoms among $ST_{36}$ or $LI_2$. In the control group, subjects were needled at 5 non-acupuncture points have any effect on Dysmenorrhea. A total of 8 acupuncture sessions were performed for each patient depending on the individual menstruation cycle The MMP score by using 7 questions and the Menstrual Symptom Severity List(MSSL-D) was measured before and after menstruation cycle. Collected data were analyzed as frequency, percentage, paired t-test, independent t-test using SPSS 10.0 WIN Program. Results : Acupuncture treatment produced a significant decreasing the symptom of Primary dysmenorrhea in two groups, but a statistically significant difference was not shown in the acupuncture group compare to control group. Conclusions : Based on the above results, it was verified that Acupuncture Treatment was effective in decreasing the symptom of Primary Dysmenorrhea.

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