• Title/Summary/Keyword: randomized clinical controlled trial

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EFFECTS OF ANTHOCYANOSIDE OLIGOMER ON MESOPIC CONTRAST SENSITIVITY IN MILD TO MODERATE MYOPIA

  • Seong Gong Je
    • Proceedings of the Korean Society of Food Science and Nutrition Conference
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    • 2001.12a
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    • pp.52-60
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    • 2001
  • Purpose: We performed a randomized, double-blind, placebo-controlled trial in mild to moderate myopia patients to evaluate the benefit of taking a nutrient supplement containing anthocyanoside oligomers for improving nocturnal visiual function and/or clinical symptoms. Methods: The subjects included have refractive error between -lD(Diopters) $\~$-8D in both eyes, symptoms of decreased night vision and asthenopia based on the scoring result of a pre-structured questionnaire, and abnormal results of mesopic contrast sensitivity(MCS) screening test showing abnormal curve of contrast sensitivity in the middle and high frequency level, between 6.0 and 30.0 CPD(Cycles per degree) at mesopic condition(-2$\~$0 log cd/$m^2$). Total 60 people who qualified the criteria above were enrolled and the subjects were instructed to take the investigational product (anthocyanoside or placebo) twice daily for a 4 week period. The enrolled subjects were investigated for nocturnal vision performance by MCS and clinical symptoms at their first visit and re-evaluated at post-intervention (4 weeks later). MCS was measured and improvement of contrast threshold level according to each CPD was calculated by subtracting initial values from final values. Age, refractive error, and MCS were compared between the placebo and anthocyanoside. Results: After 4 weeks of drug administration 22 of the anthocyanoside group showed symptom improvement compared to 1 of the placebo group (p=0.000). Contrast sensitivity levels according to each CPD before and after drug treatment showed significant improvement in the anthocyanoside group but not in the placebo group. Mean MCS change of anthocyanoside group is 2.41$\pm$1.91 which showed significant improvement compared to -0.40$\pm$2.47 of the placebo group(p=0.000). MCS changes of anthocyanoside group showed significant improvement compared to placebo group in all levels of CPD(p<0.05). During our investigation none of the subjects complained of specific side effects related to anthocyanoside use. Conclusion: Our results show that under careful selection of people with significant symptoms and definite MCS abnormalities, anthocyanoside oligomers may improve the subjective symptoms and objective MCS results.

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Pain and quality of life related to suture removal after 3 or 7 days at the extraction sites of impacted lower third molars

  • Rodanant, Pirasut;Wattanajitseree, Kannika;Shrestha, Binit;Wongsirichat, Natthamet
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.16 no.2
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    • pp.131-136
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    • 2016
  • Background: This study aimed to evaluate the patient's pain and quality of life after suture removal at either 3 or 7 days following the bilateral surgical extraction of impacted lower third molars. Methods: This study was a prospective, randomized controlled clinical trial carried out in 30 patients, who acted as their own control. Each patient required the bilaterally impacted mandibular third molars to be extracted. The impacted teeth were removed and the wound margins were approximated and sutured with black braided silk. The suture material was removed on day 3 on one side and on day 7 on the other. Each participant was asked to complete a questionnaire after the removal of the suture material on each designated day. Results: Regarding overall clinical symptoms, the mean VAS scores of male and female participants on day 3 were not significantly different from those on day 7. A significant difference was found in female participants, in that overall daily activity was better on day 7. There were significant differences in the ability to smile and laugh in both sexes and the ability to chew in the male participants was better on day 7. Conclusions: There were no significant differences in the patient's pain and quality of life between suture removal on day 3 or on day 7 following surgery to remove impacted lower third molars.

Interventions Using Technologies for Older Adults in Long-term Care Facilities: A Systematic Review (장기요양시설 거주 노인 대상 테크놀로지 활용 중재에 관한 체계적 문헌고찰)

  • Kim, Da Eun;Kim, Hyang;Hyun, Junghee;Lee, Hyojin;Sung, Hyehyun;Bae, Soyoung;Tak, Sunghee H;Park, Yeon-Hwan;Yoon, Ju Young
    • Research in Community and Public Health Nursing
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    • v.29 no.2
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    • pp.170-183
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    • 2018
  • Purpose: Although innovative interventions using technologies have been introduced in long-term care settings, available evidence is still anecdotal. The purpose of this study is to investigate and synthesize the outcomes of interventions using technologies delivered to nursing home residents. Methods: Published clinical trials were identified through PubMed, CINHAL, Cochrane and PsycINFO databases and manually hand-searching. Eligible studies were articles published between 1997-2016 in English or Korean with a randomized controlled trial or quasi-experimental design in which interventions using technologies were delivered to nursing home residents. Results: A total of 20 studies were selected for this review. Types of interventions using technologies were classified into the electronic documentation technology (n=1), the clinical decision support system (n=1), the safety technology (n=1), the health and wellness technology (n=10), and the social connectedness technology (n=7). Overall resident outcomes indicated that interventions using technologies improved behavioral symptoms and psycho-social outcomes, but mixed results were shown in the aspects of physical function, cognitive function, social relationship and quality of service. Conclusion: This review demonstrates that incorporating technologies into nursing home care have positive effects on residents' psycho-social outcomes and behavioral symptoms. To disseminate the effectiveness of interventions using technologies, further research is needed to determine what mechanisms underlying such relationships exist.

Investigation of Clinical Research of Acupuncture Treatment on Hyperemesis Gravidarum in Medline (Medline 검색을 통한 임신오저에 대한 국외 침치료의 연구 동향 분석)

  • Kim, Eun-Gyung;Hwang, Deok-Sang;Lee, Jin-Moo;Lee, Chang-Hoon;Jang, Jun-Bok;Lee, Kyung-Sub
    • The Journal of Korean Obstetrics and Gynecology
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    • v.25 no.4
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    • pp.66-80
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    • 2012
  • Purpose: The purpose of this study is to examine acupuncture treatment suggested on the papers of hyperemesis gravidarum(HG) in medicine journals and to establish the future direction. Methods: The papers which were associated with acupuncture and HG published between 2000 and 2012 in Medline were searched. Results: 14 studies met the condition. They were 13 randomized controlled trial (RCT)s and 1 clinical study. 13 studies revealed that acupuncture has efficacies in HG. 1 study was shown to have no statistically significant efficacy. 2 studies revealed that acupuncture was safe treatment, and 1 study revealed that acupuncture was reliable treatment. Conclusions: From the paper research, acupuncture treatment seems to be effective on HG. However, due to the lack sufficient research of HG, it would be necessary to fulfill further study about the period of acupuncture treatment on HG and the selection of acupoint through well-designed study and establish standard of evidence of them.

A Literature Review on the Recent Tendency of the Treatment about Atypical Hyperplasia of Breast on the Chinese Herbal Medicine (비정형유방증식에 대한 최근 중의 약물치료 동향에 대한 문헌연구)

  • Kim, Jun-Hee;Lee, In-Seon
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.36-58
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    • 2020
  • Objectives: We conducted a literature study on the treatment trends in China to find out the possibility of Oriental medicine treatment of atypical hyperplasia of breast (AHB). Methods: RCTs (randomized controlled trial) on AHB were collected from CNKI (China National Knowledge Infrastructure). The search words were "乳腺增生", "乳腺囊性增生", "乳癖", "中医", "中药" and "中西医结合". The search period was limited from July 2006 to May 2017. Finally, we selected 107 RCTs which were clinical studies to find out the effectiveness of Chinese herbal medicine in comparison with Western medicine. After reviewing, we investigated Chinese herbal medication guide, Chinese treatment method and prescriptions. And the correlation between the treatments and the medicinal herbs was investigated to be useful in the clinical practice. Results: 1. The administration of herbal medicine was 58.9 percent in 63 cases, followed by menstrual cycles, and 41.1 percent in 44 cases, regardless of menstrual cycles. 2. In the basic frequency analysis between the treatment and the medicinal herb, the frequency of dissipate binds (散結) was the highest. Next, there was a high frequency of therapies such as activating blood-activating (活血), relieve pain (止痛), soothe the liver (疏肝), regulate qi (理氣), resolve phlegm (化痰), soften hardness (軟堅), resolve depression (解鬱), move qi (行氣) of frequency was high. In herbal medicine, bupleuri radix (柴胡), cyperi rhizoma (香附子), angelicae gigantis radix (當歸), fritillaria thunbergii bulb (貝母), paeoniae radix alba (白芍藥), prunellae spica (夏枯草), corydalis rhizoma (玄胡索) showed high frequency. 3. We finded out the correlation between the frequent treatment methods and the medicinal herbs using Text Mining. Conclusions: These findings are thought to help implement Korean traditional medicine treatments for AHB.

Effect of SLCO1B1 T521C on Statin-induced Myotoxicity: A Systematic Review and Meta-analysis (SLCO1B1 T521C가 스타틴에 의한 근육독성 발생에 미치는 영향: 체계적 문헌고찰 및 메타분석)

  • Lee, Young Sook;Chun, Pusoon
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.4
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    • pp.320-332
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    • 2018
  • Background: This study was performed to clarify the effect of SLCO1B1 T521C on statin-induced myotoxicity. Methods: The PubMed, Embase, Ovid, and Cochrane Library databases were searched for all published studies between database inception and April 2018. Using Review Manager 5, the pooled odds ratio (OR) and corresponding 95% confidence interval (CI) were determined to assess the effect of SLCO1B1 T521C on statin-induced myotoxicity by using different genetic models. Results: Eleven observational studies and one randomized controlled trial were included in the meta-analysis. The pooled analysis showed that the incidence of statin-induced myotoxicity was significantly associated with the SLCO1B1 521C variant allele. Among patients using statins, the incidence of myotoxicity was higher in those carrying the 521TC or 521CC variant than in those carrying the 521TT variant in the dominant model (TC + CC vs TT, OR: 1.57; 95% CI: 1.20, 2.05; p = 0.001). The 521TC genotype was associated with a higher risk of myotoxicity than the 521TT genotype (OR: 1.42; 95% CI: 1.09, 1.86; p = 0.009). Furthermore, the incidence of myotoxicity was higher in 521CC carriers than in 521TC carriers (OR: 1.40; 95% CI: 1.06, 1.83; p = 0.02) and noticeably higher in 521CC carriers than in 521TT carriers (OR: 2.26; 95% CI: 1.23, 4.17; p = 0.009). Conclusion: The identification of individuals with the SLCO1B1 521C variant allele prior to the initiation of statin therapy might be useful to predict the risk of toxicity development, determine the individual dose, and prevent myotoxicity.

A Review on Clinical Research Trends in the Treatment of Acupuncture on Schizophrenia in Traditional Chinese Medicine (조현병의 침 치료에 대한 중의학 임상연구 동향)

  • Hong, Min-Ho;Song, Sue-Jin;Kim, Ju-Young;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.29 no.4
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    • pp.281-290
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    • 2018
  • Objectives: The objective of this study was to review the research trends in the treatment of acupuncture on schizophrenia in traditional Chinese medicine. Methods: Articles in the China National Knowledge Infrastructure (CNKI) from September 2008 to August 2018 were reviewed. The selected articles were evaluated by the Jadad Scale. Results: 11 articles were selected from a total of 33 articles. 1 study was single group before-and-after study while the other 10 studies were randomized controlled trial studies. Chinese Classification of Mental Disorders-3 was most frequently used as a diagnostic criterion. Brief Psychiatric Rating Scale was most commonly used as an outcome measurement. From Jadad Quality Assessment Scale of the 11 articles, the quality of the studies generally was low. Conclusions: BaekHoi (GV20) and YinDang (EX-HN3) are most commonly used in acupuncture treatment. According to this study, acupuncture treatment in addition to western medication on schizophrenia is more effective as compared to the controls. In future, this study could be primary data for development of more clinical research on the treatment of schizophrenia in Korean medicine.

Immuno-enhancement effects of Korean Red Ginseng in healthy adults: a randomized, double-blind, placebo-controlled trial

  • Hyun, Sun Hee;Ahn, Ha-Young;Kim, Hyeong-Jun;Kim, Sung Won;So, Seung-Ho;In, Gyo;Park, Chae-Kyu;Han, Chang-Kyun
    • Journal of Ginseng Research
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    • v.45 no.1
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    • pp.191-198
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    • 2021
  • Background: Most clinical studies of immune responses activated by Korean Red Ginseng (KRG) have been conducted exclusively in patients. However, there is still a lack of clinical research on immune-boosting benefits of KRG for healthy persons. This study aims to confirm how KRG boosts the immune system of healthy subjects. Methods: A total of 100 healthy adult subjects were randomly divided into two groups that took either a 2 g KRG tablet or a placebo per day for 8 weeks. The primary efficacy evaluation variables included changes in T cells, B cells, and white blood cells (WBCs) before and after eight weeks of KRG ingestion. Cytokines (TNF-α, INF-γ, IL-2 and IL-4), WBC differential count, and incidence of colds were measured in the secondary efficacy evaluation variables. Safety evaluation variables were used to identify changes in laboratory test results that incorporated adverse reactions, vital signs, hematological tests, blood chemistry tests, and urinalysis. Results: Compared to the placebo group, the KRG intake group showed a significant increase in the number of T cells (CD3) and its subtypes (CD4 and CD8), B cells, and the WBC count before and after eight weeks of the intake. There were no clinically significant adverse reactions or other notable results in the safety evaluation factors observed. Conclusion: This study has proven through its eight-week intake test and subsequent analysis that KRG boosts the immune system through an increase in T cells, B cells, and WBCs, and that it is safe according to the study's safety evaluation.

Sinus floor elevation and simultaneous implant placement in fresh extraction sockets: a systematic review of clinical data

  • Ekhlasmandkermani, Mehdi;Amid, Reza;Kadkhodazadeh, Mahdi;Hajizadeh, Farhad;Abed, Pooria Fallah;Kheiri, Lida;Kheiri, Aida
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.47 no.6
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    • pp.411-426
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    • 2021
  • Combining different procedures to reduce the number of surgical sessions and patient discomfort in implant placement and sinus floor elevation has been recommended, and evidence supports good outcomes. The aim of this study was to review the results of clinical studies on sinus floor elevation through extraction sockets and simultaneous immediate posterior implant placement. An electronic search was carried out in PubMed, Scopus, and Web of Science to find English articles published in or before August 2020. A manual search was also performed. Titles, abstracts, and the full-text of the retrieved articles were studied. Thirteen studies met our eligibility criteria: 6 retrospective case series, 3 case reports, 2 prospective cohort case-series, 1 prospective case series, and 1 randomized controlled trial. Overall, 306 implants were placed; 2 studies reported implant survival rates of 91.7% and 98.57%. The others either did not report the survival rate or reported 100% survival. Sinus floor elevation through a fresh extraction socket and simultaneous immediate implant placement appears to be a predictable modality with a high success rate. However, proper case selection and the expertise of the clinician play fundamental roles in the success of such complex procedures.

A Study on Thermal Effect and Medication Compliance of Red Ginseng Extract (홍삼의 온열 효과와 복약 순응도에 관한 연구)

  • Choi, Min-Sun;Jeong, Jae-Cheol;Park, Jang-Kyung;Ahn, Hong-Yeop;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.22 no.3
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    • pp.223-235
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    • 2009
  • Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.