• 제목/요약/키워드: non-randomized controlled trial

검색결과 171건 처리시간 0.019초

Effect of coadministration of enriched Korean Red Ginseng (Panax ginseng) and American ginseng (Panax quinquefolius L) on cardiometabolic outcomes in type-2 diabetes: A randomized controlled trial

  • Jovanovski, Elena;Smircic-Duvnjak, Lea;Komishon, Allison;Au-Yeung, Fei (Rodney);Sievenpiper, John L.;Zurbau, Andreea;Jenkins, Alexandra L.;Sung, Mi-Kyung;Josse, Robert;Li, Dandan;Vuksan, Vladimir
    • Journal of Ginseng Research
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    • 제45권5호
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    • pp.546-554
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    • 2021
  • Background: Diabetes mellitus and hypertension often occur together, amplifying cardiovascular disease (CVD) risk and emphasizing the need for a multitargeted treatment approach. American ginseng (AG) and Korean Red Ginseng (KRG) species could improve glycemic control via complementary mechanisms. Additionally, a KRG-inherent component, ginsenoside Rg3, may moderate blood pressure (BP). Our objective was to investigate the therapeutic potential of coadministration of Rg3-enriched Korean Red Ginseng (Rg3-KRG) and AG, added to standard of care therapy, in the management of hypertension and cardiometabolic risk factors in type-2 diabetes. Methods: Within a randomized controlled, parallel design of 80 participants with type-2 diabetes (HbA1c: 6.5-8%) and hypertension (systolic BP: 140-160 mmHg or treated), supplementation with either 2.25 g/day of combined Rg3-KRG + AG or wheat-bran control was assessed over a 12-wk intervention period. The primary endpoint was ambulatory 24-h systolic BP. Additional endpoints included further hemodynamic assessment, glycemic control, plasma lipids and safety monitoring. Results: Combined ginseng intervention generated a mean ± SE decrease in primary endpoint of 24-h systolic BP (-3.98 ± 2.0 mmHg, p = 0.04). Additionally, there was a greater reduction in HbA1c (-0.35 ± 0.1% [-3.8 ± 1.1 mmol/mol], p = 0.02), and change in blood lipids: total cholesterol (-0.50 ± 0.2 mmol/l, p = 0.01), non-HDL-C (-0.54 ± 0.2 mmol/l, p = 0.01), triglycerides (-0.40 ± 0.2 mmol/l, p = 0.02) and LDL-C (-0.35 ± 0.2 mmol/l, p = 0.06) at 12 wks, relative to control. No adverse safety outcomes were observed. Conclusion: Coadministration of Rg3-KRG + AG is an effective addon for improving BP along with attaining favorable cardiometabolic outcomes in individuals with type 2 diabetes. Ginseng derivatives may offer clinical utility when included in the polypharmacy and lifestyle treatment of diabetes. Clinical trial registration: Clinicaltrials.gov identifier, NCT01578837;

Electroacupuncture Treatment for Women with Primary Obesity: A Review of Randomized Controlled Trials

  • Lee, Soo Jin;Oh, Da Yoon;Park, Jae Eun;Lee, Min Cheol;Jeon, Myung Kyu;Jang, Yeong Suk;Kim, Hyeon Jin;Ahn, Jae Young;Hong, Noo ri;Kim, Woo Young
    • Journal of Acupuncture Research
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    • 제37권2호
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    • pp.79-87
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    • 2020
  • The purpose of this review was to evaluate the effectiveness of electroacupuncture treatment for women with "primary obesity." Primary obesity is caused by an imbalance in energy intake and consumption due to abnormal eating and living habits in the absence of specific diseases causing the obesity. A literature review (up to December 2019) of randomized controlled trials (RCT) of electroacupuncture treatment for women with "primary obesity" was performed. Relevant clinical studies were retrieved from several databases, and interventions and results were analyzed. There were 6 RCT that fitted the inclusion criteria for this review. The intervention for the treatment group of the selected 6 RCT was electrical stimulation applied to acupoints. Interventions for the control groups included non-treatment, general acupuncture, and so on. Indicators for assessing treatment effects varied from study to study. Four out of 5 studies used body mass index (BMI) as an assessment tool and showed a significant decrease in BMI following electroacupuncture treatment. There were 4 studies using waist circumference as an indicator of abdominal obesity and these studies showed a significant decrease in waist circumference following electroacupuncture treatment. Electroacupuncture treatment used in primary obese women had a clinically significant effect, however, further RCT are needed.

The Impact of Joint Mobilization and Transcutaneous Electrical Nerve Stimulation on Pain in Patients With Lumbar Spinal Stenosis

  • Go, Jun Hyeok;An, Ho Jung
    • 국제물리치료학회지
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    • 제10권1호
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    • pp.1746-1749
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    • 2019
  • Background: Surgery has been known as an inefficient approach to reduce back pain in patients with lumbar spinal stenosis; therefore, non-surgical treatments are necessary. However, there has been little research to analyze the effect of non-surgical treatments on lumbar spinal stenosis pain. Objective: To identify the effectiveness of 2 physiotherapeutic treatment approaches to relieve pain due to lumbar spinal stenosis. Design: Randomized controlled trial Methods: The participants were 36 lumbar spinal stenosis patients who were randomized in the joint mobilization group (JMG) and transcutaneous electrical nerve stimulation group (TENSG). Joint mobilization (JM) was conducted at the posteroanterior joint in the spinous process of the lumbar spine with stenosis. Transcutaneous electrical nerve stimulation (TENS) was applied on the lumbar spine with stenosis at a high frequency and intensity. Results: Visual analog scale (VAS) pain score significantly decreased in both groups, and the VAS value decreased more after JMG than that after TENSG. The pain thresholds of both groups also significantly increased, and that of JMG increased more compared to TENSG. In both the groups, significant improvements in VAS and pain thresholds were found, and JMG showed better results than TENSG. Conclusions: JM and TENS showed significant relief in both pain threshold and painpain, and JM showed more advanced relief compared to TENS.

요통에 대한 매선 임상연구의 중국 현황 분석 - 중국 내(內) 출판 저널을 중심으로 (Research Trends on the Thread Embedding Therapy of Low back pain in Traditional Chinese Medicine - Focusing on published articles in China)

  • 전푸르메;류연;박지은;정소영;한창현
    • 동의생리병리학회지
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    • 제31권1호
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    • pp.25-35
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    • 2017
  • About 60% to 90% of a total population experience low back pain at least once of life, and about 35% to 79% among them experience a recurrent and chronic low back pain. thread-embedding therapy is mainly used to improve appearance or treat obesity in early stage, but recently it is also used to treat musculoskeletal pain. This study aimed to search Chinese study using thread-embedding therapy on low back pain and to analyse their methodology. Three Chinese database(CNKI(www.cnki.net), WANFANG(www.wanfangdata.com), WEIPU(www.cqvip.com)) were searched for clinical study of thread-embedding therapy up to March 2016. The characteristics of included studies and regimen of thread-embedding in those studies were analyzed. The total 21 studies (4 case studies, 16 non-randomized controlled trials, 1 randomized controlled trial) were included. All studies on thread embedding treatment of low back pain reported that its effectiveness was very good. The most frequently used acupoints was Ashi acupoints and acupoints on bladder meridian(BL) or governor vessel(GV). Thread-embedding therapy is considered very useful for low back pain in Traditional Chinese medicine. Further studies are needed to investigate the effect of thread-embedding therapy and to expand its application. This study is limited in that the literature search in the Chinese database were restricted.

The Effects of Sa-am Acupuncture Simpo-jeongkyeok Treatment on the Blood Pressure, Pulse Rate, and Body Temperature

  • Choi, Woo-Jin;Cho, Yoon-Young;Sun, Seung-Ho
    • 대한약침학회지
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    • 제18권2호
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    • pp.33-41
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    • 2015
  • Objectives: The present study evaluated the effects of sa-am acupuncture (SAA) simpo-jeongkyeok (SPJK) treatment on the blood pressure (BP), pulse rate (PR), and body temperature (BT) of patients with hwa byung (HB). Methods: This patient assessor blind, randomized, placebo controlled trial included 50 volunteers, divided randomly into two groups. The treatment group underwent SPJK (PC9, LR1, PC3, KI10) while the control (sham) group received minimal needle insertion at non acupoints. The BP in both arms, PR, and BT at several acupoints were measured before and after treatment at the $1^{st}$, $2^{nd}$, $3^{rd}$, and $4^{th}$ visits and before treatment at the follow-up visit. We analyzed data by using the repeated measured analysis of variance (RM ANOVA), Mann-Whitney U, and wilcoxon signed rank tests; differences at P < 0.05 were considered significant. Results: No significant differences in the systolic blood pressure (SBP), diastolic blood pressure (DBP) and PR between the treatment and control group were observed at each visit. However, the decrease in the SBP for the treatment group before and after each visit was significantly higher than it was in the control group. The SBP in both arms in the treatment group was decreased between visits 1 and 2, 1 and 3, 1 and 4, and 1 and follow-up. The DBP in both arms and in the right arm between visits 1 and 3 in the treatment group showed decreases. A minimal BT increase for treatment at CV06 and CV12 and a minimal BT decrease for treatment at CV17 and (Ex) Yintang were found. Patients in the treatment group who visited more frequently experienced a greater decrease in the PR, but that effect was not maintained. Conclusion: The results suggest that SAA SPJK treatment has instant positive effects on the BP, PR, and BT in patients with HB, but the effects on the BP and PR are not maintained.

The effects of a maternal nursing competency reinforcement program on nursing students' problem-solving ability, emotional intelligence, self-directed learning ability, and maternal nursing performance in Korea: a randomized controlled trial

  • Kim, Sun-Hee;Lee, Bo Gyeong
    • 여성건강간호학회지
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    • 제27권3호
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    • pp.230-242
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    • 2021
  • Purpose: The purpose of this study was to develop a maternal nursing competency reinforcement program for nursing students and assess the program's effectiveness in Korea. Methods: The maternal nursing competency reinforcement program was developed following the ADDIE model. This study employed an explanatory sequential mixed methods design that applied a non-blinded, randomized controlled trial with nursing students (28 experimental, 33 control) followed by open-ended interviews with a subset (n=7). Data were analyzed by both qualitative and quantitative analysis methods. Results: Repeated measures analysis of variance showed that significant differences according to group and time in maternal nursing performance; assessment of and intervention in postpartum uterine involution and vaginal discharge (F=24.04, p<.001), assessment of and intervention in amniotic membrane rupture (F=36.39, p<.001), assessment of and intervention in delivery process through vaginal examination (F=32.42, p<.001), and nursing care of patients undergoing induced labor (F=48.03, p<.001). Group and time improvements were also noted for problem-solving ability (F=9.73, p<.001) and emotional intelligence (F=4.32, p=.016). There were significant differences between groups in self-directed learning ability (F=13.09, p=.001), but not over time. The three main categories derived from content analysis include "learning with a colleague by simulation promotes self-reflection and learning," "improvement in maternal nursing knowledge and performance by learning various countermeasures," and "learning of emotionally supportive care, but being insufficient." Conclusion: The maternal nursing competency reinforcement program can be effectively utilized to improve maternal nursing performance, problem-solving ability, and emotional intelligence for nursing students.

Changes in body weight, blood pressure and selected metabolic biomarkers with an energy-restricted diet including twice daily sweet snacks and once daily sugar-free beverage

  • Nickols-Richardson, Sharon M.;Piehowski, Kathryn E.;Metzgar, Catherine J.;Miller, Debra L.;Preston, Amy G.
    • Nutrition Research and Practice
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    • 제8권6호
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    • pp.695-704
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    • 2014
  • BACKGROUND/OBJECTIVES: The type of sweet snack incorporated into an energy-restricted diet (ERD) may produce differential effects on metabolic improvements associated with body weight (BW) loss. This study compared effects of incorporating either twice daily energy-controlled dark chocolate snacks plus once daily sugar-free cocoa beverage (DC) to non-chocolate snacks plus sugar-free non-cocoa beverage (NC) into an ERD on BW loss and metabolic outcomes. MATERIALS/METHODS: In an 18-week randomized comparative trial, 60 overweight/obese premenopausal women were assigned to DC (n = 30) or NC group (n = 30). Dietary intake was measured at baseline and week 18, and BW, anthropometrics, blood pressure (BP) and serum glucose, insulin and lipid concentrations were measured at baseline, and weeks 6, 12 and 18. Data were analyzed using repeated measures ANOVA. RESULTS: Using intention-to-treat analysis, women in DC and NC groups reduced energy intake (both P < 0.001) and lost $4.4{\pm}0.6kg$ and $5.0{\pm}0.9kg$ (both P < 0.001), respectively. Both groups lowered systolic and diastolic BP [DC = 2.7 (P < 0.05), 2.7 (P < 0.01); NC = 3.4 (P < 0.01), 4.2 (P < 0.01) mmHg, respectively]. Glucose and insulin concentrations decreased by 0.72 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01) in DC group and by 0.83 mmol/L (P < 0.001) and 13.20 pmol/L (P < 0.01), respectively, in NC group. Total cholesterol increased in NC group (P < 0.05), with no significant lipid changes in DC group. There were no significant differences in biomarker outcomes between groups. CONCLUSIONS: Overweight/obese premenopausal women following an 18-week ERD that included either DC or NC sweet snack and sugar-free beverage lost equivalent amounts of BW and improved BP measurements and glucose and insulin concentrations.

전문가 설문조사에 기반한 재난 경험자에 대한 침치료 임상연구 프로토콜 개발 (Clinical Trial Protocol Development of Acupuncture for Disaster Survivors: Results from an Expert Survey)

  • 곽희용;권찬영;임정태;김상호
    • 동의신경정신과학회지
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    • 제35권1호
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    • pp.15-26
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    • 2024
  • Objectives: The objective of this study is to develop a specialized clinical research protocol for acupuncture treatment specifically designed for disaster survivors based on insights from an expert survey. Methods: An expert panel comprising specialists in neuropsychiatry, acupuncture, and clinical research methodology was assembled. Initial data to inform the clinical research protocol design was collected utilizing open-ended responses, multiple-choice questions, and a 5-point Likert scale to gauge agreement levels. Next, this data was disseminated to a panel of experts. A cohesive clinical research protocol was then formulated during a core panel meeting by integrating insights from a panel of 10 experts. Results: The protocol developed herein entails a non-randomized controlled study involving participants aged 19~64 years old who have been identified as high-risk or cautious according to the National Trauma Center screening test. The study design includes the establishment of an active control group, which allows for the assessment of an additional effect through comparison with conventional therapy. The selected acupuncture approach involves a combination of manual acupuncture and ear acupuncture. For clinical outcome assessment, the Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 was proposed to gauge trauma symptoms. Representative scales for various domains such as depression, anxiety, anger, insomnia, pain, and quality of life were also provided for reference. Conclusions: The developed protocol is anticipated to streamline the swift design and initiation of clinical trials during disaster scenarios. It is also designed to be scalable, thereby enabling its application in both non-randomized control group studies and single-group before-and-after comparisons.

초음파 결합형 압통계를 활용한 압통시 소화불량 환자와 건강인의 복강내 조직 변화 비교: 비무작위 대조군 예비 임상시험 (Investigation of changes in abdominal cavity between dyspepsia patients and healthy participants when pressure pain occurs using an algometer combined with an ultrasound device: a non-randomized, controlled, pilot trial)

  • 임진웅;정태성;정호석;강선이;최창민;김동웅
    • 대한예방한의학회지
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    • 제27권1호
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    • pp.43-52
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    • 2023
  • Objectives : The aim of this study was to evaluate the differences in the abdominal cavity between functional dyspepsia patients and healthy people using an algometer combined with an ultrasound device. Methods : A non-randomized, controlled, pilot trial was conducted. Thirty patients in the experimental group and fifteen participants in the control group were recruited. We collected demographical data, and measured abdominal circumference, height of the body cavity, subcutaneous fat thickness, visual analogue scale of dyspepsia symptoms in the experimental group, depth of algometer and pressure of algometer when pressure pain occurred, and the whole ultrasonic image from the beginning of pressurization to the time when pressure pain occurred. The measurements were carried out twice with the duration of 1 week. Generalized linear regression was conducted to adjust baseline characteristics. Results : A total of 45 participants (30 in experimental group, 15 in control group) were recruited and finished the trial. Females were recruited more in the experimental group than in the control group and it was statistically significant. The difference in thickness of abdominal cavity between a second before the pressure pain and at the time when pressure pain occurred was statistically significant on 1st visit, and other measurements were not statistically significant. From the results of the regression analysis, the difference between two groups was statistically significant in the differences in the thickness of stomach and up to abdominal aorta on 1st visit, and the thickness of stomach on 2nd visit, and other measurements were not statistically different. Conclusions : According to the results, there were not statistically significant differences in abdominal examination when pressure pain occurred between dyspepsia patients and healthy people. Further studies are warranted to assess the abdominal examination using devices including algometer and ultrasound devices, regarding the results of the present study.

노년 여성의 신맥.조해 저주파 자극이 뇌파에 미치는 영향 (EEG Changes due to Low-Frequency Electrical Stimulation to the BL62 and KI6 of Elderly Women)

  • 이상훈;최광호;조성진;최선미;홍권의;류연희
    • Korean Journal of Acupuncture
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    • 제30권2호
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    • pp.135-142
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    • 2013
  • 목적 : 본 연구는 노년층의 여성에게 신맥(BL62), 조해(KI6)혈에 대한 저주파자극이 뇌파에 어떠한 영향을 미치는지 알아보고 뇌 기능을 개선하는데 비화학적이고 비침습적인 자극 방법의 후보로써 가능성을 탐구해보고자 실시된 탐색적 연구이다. 방법 : 31명의 건강한 여성 피험자(평균연령, 54.5세)를 대상으로 이중맹검 무작위배정 임상연구가 12세션동안 실시되었다. 시험군에서는 감지할 수 없는 최대의 저주파자극이 실시되었으며(평균전류량, $0.04{\mu}A$), 대조군에서는 거짓자극이 실시되었다. 결과분석을 위해 12세션을 전후로 배경뇌파가 측정되었다. 결과 : 12세션의 자극이 실시된 후 대조군에 비해 실험군의 알파파 상대값은 11채널에서 유의한 증가를 보였으며(p<0.05), 감마파의 상대값은 7채널에서, 세타파의 상대값은 10채널에서 유의한 감소를 보였다. 결론 : 발목관절에 있는 신맥(BL62), 조해(KI6)혈에 대한 저주파 자극은 노년의 여성의 뇌에 베타, 세타, 감마파의 감소를 일으키는 반면 알파파를 선택적으로 증가시켜 뇌를 안정시키는 효과가 있는 것으로 보인다. 이러한 결과는 저주파자극이 향후 스트레스와 관련된 인지 문제를 치료하는 비침습적이고 비화학적인 도구로써의 가능성을 제공할 수 있을 것으로 보이며, 그 기전에 대한 추가적 연구가 필요할 것으로 보인다.