• Title/Summary/Keyword: Quality of clinical trial

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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.

The Effect of Intervention on Improving Cognitive Function of Patients with Dementia in Korea : A Systematic Review of Randomized Controlled Trials (국내 치매환자의 인지기능 향상을 위한 중재의 효과: 무작위 대조군 실험연구의 체계적 문헌고찰)

  • Jung, Jae-Hun
    • Journal of Industrial Convergence
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    • v.19 no.5
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    • pp.91-102
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    • 2021
  • The purpose of this study was to systematically review about randomized controlled trials the characteristics and effect of cognitive function intervention for patient with dementia. We searched studies published from January 2010 to June 2021 in 5 databases. A total 1,104 studies were found and included 27 studies in final analysis. Methodological quality was assessment with the Cochrane's RoB(risk of bias) tool. Mini-Mental State Examination(MMSE) was the most used as the assessment tool for identifying the cognitive function. Cognitive function intervention were exercise, art, cognitive stimulation, reminiscence, music, multimodal cognitive rehabilitation, virtual reality, horticultural, computerized cognitive training, intentional snoezelen, beauty, cooking, korean traditional familiarity program. Most of the intervention except exercise 2, virtual reality 1, beauty 1 were effective in improving cognitive function. This study provided a clinical evidence for planning and implementing intervention for cognitive function intervention. In the future, various intervention studies suitable for the characteristics of dementia should be conducted by improving the quality of research methods.

Study on Nutrition Intakes of Long-Lived Men and Women Living in Seven Regions in Jellanam-do: Comparisons between Spring and Fall (전라남도 7개 지역에 거주하는 남녀 장수인의 봄과 가을 영양섭취 실태 비교 연구)

  • Chun, Soon-Sil;Jung, Su-Young;Bing, Dong-Joo;Yoon, Eunju
    • Journal of the East Asian Society of Dietary Life
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    • v.24 no.6
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    • pp.723-738
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    • 2014
  • This study examined nutrient intake of long-lived men and women living in Jeollanam-do (Gangjin, Goksung, Gurye, Damyang, Boseong, Suncheon, Jangheung) which is known as representative Korean longevity area. Using the 24 hr recall method, dietary nutrient intake data were collected from 134 subjects (67 for 80~89 years old, 67 for more than 90 years old) in spring and fall 2012. Nutrient for each subject were calculated using CAN-pro. Subjects' daily mean intake levels of macronutrients, vitamins and minerals were higher in fall than in spring. Compared to KDRIs, subjects less than recommend (RNI/AI). East consumed nutrients compared to KDRIs were folate, potassium, calcium, vitamin $B_1$, vitamin $B_2$ and vitamin E. Subjects 232.8~363.1% of recommended intake level for natrium. The nutrient adequacy ratio (NAR) was 0.87 for subjects in their 80s and 0.79 for than 90 years old. The average NAR of all subjects was 0.83. The index of nutritional quality (INQ) exceeded 1 for most nutrients except for Ca (0.87), K (0.77), vitamin $B_1$ (0.84), vitamin $B_2$ (0.70) and folate (0.68). The average INQ was 1.31. This study concluded that even though long-lived men and women living in Jeollanam-do consumed less than RNIs, nutrition consumption quality was relatively fine based on NAR and INQ results.

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.

Recent Studies of Breast Cancer in Traditional Chinese Medicine Journals (중의학 논문에 나타난 유방암의 연구 동향에 대한 고찰 - 중의학 논문을 중심으로 -)

  • Jerng, Ui-Min;Jeong, Jong-Soo;Park, Jae-Woo;Jung, Hyun-Sik;Yoon, Seong-Woo
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.1
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    • pp.263-278
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    • 2009
  • Purpose: The purpose of this study is to research trends in the study of breast cancer in Traditional Chinese Medicine (TCM) and to establish the further direction for its study. Methods: We reviewed TCM papers published in the last 29 years (1979-2008). Results: 1. We researched 49 papers and the patterns of study were as follows: in vitro studies were 27 papers (55.1%), in vivo studies were 9 papers (18.4%) and clinical studies were 19 papers (38.8%). 2. In vitro studies on breast cancer research in TCM were focused on cytotoxicity (17 papers) and apoptosis (8 papers). Most of in vivo studies (6 papers) were done for the purpose of inducing growth suppression of tumor cell after administration of the test drug. Each drug acted on this effect through various types of mechanism. 3. Unlike in vitro and in vivo studies, clinical studies on growth suppression of tumor cell were rare (4 papers). Most of the studies were focused on reduction of side effect of chemotherapy or synergistic effect with chemotherapy (7 papers), immune regulation (7 papers), and improvement of quality of life (6 papers). 4. Among the treatment method we reviewed, 'Runing Ⅱ(Ⅱ號方)' was the only medication that further studied as clinical trial after experimental study. 5. Since almost all studies have defects like poorly designed model or insufficient data description, it was difficult to make any definite conclusion about these studies. Conclusion: More subsequent clinical studies based on experimental study will be needed afterwards. Strict and high-level study design with detailed description will be needed in further study.

Comparison of X-ray Image Quality Between Multi-Function Device(MFD) and Weight Bearing Platforms(WBPs) (다기능 보조기구와 체중부하검사 보조기구의 X선 화질 비교)

  • Gil, Jong-Won;Lee, Kwang-Sung
    • Journal of the Korean Society of Radiology
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    • v.13 no.4
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    • pp.605-611
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    • 2019
  • The purpose of this study is to manufacture a multi-function device (MFD) which can be applied to various types of weight-bearing view of the lower leg, and to compare the results with the images from the existing weight-bearing platforms (WBPs), thereby suggesting a clinical utilization. The MFD was manufactured, by considering the minimum adjustable heights of the platform for weight-bearing foot/ankle, platform for hindfoot alignment view, and X-ray tube of the X-ray device. A foot/ankle phantom was used to take the images of weight-bearing lateral foot in MFD and WBPs to compare the resolutions of the X-ray images using a quick modulation transfer function (MTF) program. Between both the images taken from the MFD and WBPs, there was no statistically significant difference found in the mean cycles per pixel (C/P) and the lines per image height (LPH) of the 50%-Contrast Spatial Frequency (MTF50), and 10-90% of Maximum Energy Rise Distance (10-90%), where p>0.05. The MFD is suggested for its clinical trial as a useful positioning device that can secure the patient's safety and manifoldly perform various inspections. Also, the recommendation of the positioning device as a policy can activate dedicated manufacturers, while also improving the quality of medical services.

Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.

Safety and Efficacy of the Mandibular Advancement Device 'Bioguard' for the Treatment of Obstructive Sleep Apnea : A Prospective, Multi-Center, Single Group, and Non-Inferiority Trial (폐쇄성 수면무호흡증의 치료에 사용되는 하악전방이동장치-'바이오가드'의 안전성과 유효성 검증을 위한 전향적, 다기관, 단일군 및 비열등성 연구)

  • Kim, Hyoung Wook;Hwang, Chungpoong;Eun, Hun Jeong
    • Sleep Medicine and Psychophysiology
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    • v.23 no.2
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    • pp.84-92
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    • 2016
  • Objectives: The purpose of this study was to estimate the safety and efficacy of a mandibular advancement device (MAD), 'Bioguard,' for the treatment of obstructive sleep apnea (OSA). Methods: In this 5-week prospective, multi-center, single group, and non-inferiority trial, patients who chose 'Bioguard' as their treatment option were evaluated using both questionnaires (Pittsburgh Sleep Quality Index (PSQI), Epworth sleepiness scale (ESS)) and polysomonography (PSG) (apnea hypopnea index (AHI), oxygen saturation). All patient data, including clinical records, PSG studies (both pre- and post-treatment), and adverse events (AEs), were reviewed and analyzed. Results: Results were obtained for 59 of 62 patients (95.16%). No significant difference in success rate was found between the MAD treatment and surgical treatment (95% CI). AHI, PSQI, ESS and oxygen saturation demonstrated significant improvement (p < 0.001) after MAD treatment, and 39 of 62 patients (62.9%) reported 85 AEs. 79 of the 85 AEs (91.8%) were mild cases, and there were no severe AEs related to the MAD treatment. Conclusion: The MAD 'Bioguard' should be considered as an alternative treatment option for OSA patients.

Comparative evaluation of the effectiveness of two innovative methods in the management of anxiety in a dental office: a randomized controlled trial

  • Panchal, Jay;Panda, Anup;Trivedi, Krishna;Chari, Deepika;Shah, Rushita;Parmar, Binny
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.4
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    • pp.295-304
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    • 2022
  • Background: The first dental experience is vital in molding a child's attitude towards dentistry and dental outcomes. The cooperation of a child during dental treatment is essential to render successful and high-quality treatment. Dental anxiety is common in children undergoing dental treatment. The success of pediatric dental treatments and patient comfort depends on controlling the levels of patient anxiety in clinical settings. This study aimed to compare the effectiveness of the recorded maternal voice and virtual cognitive tool (Roogies application) in the management of pediatric dental patients. Methods: The study was carried out with children aged of 4-7 years [n = 80, (40 male and 40 female)], without any past dental history, and were randomly allocated into two groups. After informed consent was obtained, the entire procedure was explained to the parents. Anxiety was assessed pre-, during, and post-treatment by measuring pulse rate, and recording Venham Picture Test (VPT) scores. Group A [n = 40; 20 boys and 20 girls)] was provided with a headphone that played a recorded maternal voice. Group B [n = 40; 20 boys and 20 girls)] was administered the virtual cognitive tool. After conditioning the children, oral prophylaxis was performed for both groups. A comparative evaluation was conducted for each treatment session. Results: The intra-group comparison of VPT scores and heart rate for patients assigned to the recorded maternal voice showed a statistically significant difference in dental anxiety (P-value ≤0.001). Conclusion: This study demonstrated that a reduction in dental anxiety with the help of recorded maternal voice forms an important component of non-pharmacological behavior management. Alternatively, the use of a virtual cognitive tool as an anxiety-reducing technique can also be advocated.

Ginseng for Reducing the Blood Pressure in Patients with Hypertension: A Systematic Review and Meta-Analysis

  • Hur, Myung-Haeng;Lee, Myeong-Soo;Yang, Hye-Jeong;Kim, Chan;Bae, Ik-Lyul;Ernst, Edzard
    • Journal of Ginseng Research
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    • v.34 no.4
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    • pp.342-347
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    • 2010
  • Ginseng is one of the most-widely used herbal remedies. This systematic review evaluates the current evidence for its use in the reducing blood pressure (BP) in patients with hypertension. Systematic searches of 12 electronic databases were conducted without language restrictions. All randomized clinical trials (RCTs) of ginseng as a treatment for hypertension were candidates for inclusion. Methodological quality was assessed using the Cochrane risk of bias. Five RCTs met the inclusion criteria. The risk of bias was low in most of the trials. Four of the included RCTs compared the effectiveness of ginseng to placebo. The meta-analysis of these data failed to show a statistically significant acute effect on systolic BP (SBP) or diastolic BP (DBP). However, subgroup analyses showed beneficial effects of Korean red ginseng (KRG) on both SBP (n=54, mean difference [MD], -6.52; 95% confidence interval [CI], -9.99 to -3.04; p=0.0002) and DBP (n=54, MD, -5.21; 95% CI, -7.90 to -2.51; p=0.0001). Two RCTs tested the long-term effects of ginseng for BP for 24hours. One of these trials failed to show any benefits of KRG compared to no treatment, and the other failed to show superior effects of North American ginseng compared to placebo. Adverse events with ginseng were none in one trial or not assessed. Collectively, these RCTs provide limited evidence for the acute effectiveness of KRG in the treatment of high BP. The total number of RCTs included in the analysis and the total sample size were insufficient to draw definitive conclusions. More rigorous studies are warranted.