• 제목/요약/키워드: Randomized controlled study

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경증의 간 기능 이상 소견을 보이는 건강한 성인에 대한 인삼종자오일의 유효성 및 안전성 연구 : 무작위배정, 이중눈가림, 위약대조 연구 (Study of Efficacy and Safety of Ginseng Seed Oil in Heathy Subjects Who Have Mild Liver Dysfunction : A Randomized, Double Blinded, Placebo-Controlled Study)

  • 김영지;권정연;고호연;이동녕;고성권;공경환
    • 대한한의학회지
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    • 제39권2호
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    • pp.36-55
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    • 2018
  • Objectives: The purpose of this study was to investigate the effectiveness and safety of ginseng seed oil in healthy subjects who have mild liver dysfunction. Methods: A randomized, double blinded, placebo-controlled trial was conducted. A total of 167 subjects visited Semyung University Hospital from July 1st, 2016 to June 10th 2017. Except for the 103 excluded subjects, 64 subjects were randomized into one of the two groups: an treatment group(n=33) and control group(n=31). Subjects were randomly given either ginseng oil seed capsules or indistinguishable placebo capsules(2 capsules per dose, twice per day). Laboratory tests(aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transpeptidase, triglyceride, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol) were performed to evaluate the effectiveness after 6, 12 weeks of treatment. Vital sign, laboratory test were performed to assess safety at every visit. Results: There were no significant differences in efficacy between treatment group and control group. There were some adverse events with no significant difference in symptoms and frequency between treatment group and control group. Conclusions: Although the efficacy of ginseng seed oil was not proved, ginseng seed oil did not worsen liver function and proved its safety. More study of ginseng seed oil and clinical trials are necessary to increase the usefulness of above-ground parts of ginseng.

소아 안면 열상 봉합을 위한 케타민 진정시 국소 마취가 필요한가: 전향적 무작위대조, 이중맹검 연구 (Is Local Anesthesia Necessary in Ketamine Sedation for Pediatric Facial Laceration Repair?: A Double-Blind, Randomized, Controlled Study)

  • 고민정;최재형;조영순;이정원;임훈;문형준
    • Journal of Trauma and Injury
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    • 제27권4호
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    • pp.178-185
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    • 2014
  • Purpose: The aim of this study was to assess the clinical efficacy of combined treatment with local anesthesia and ketamine procedural sedation for pediatric facial laceration repair in the Emergency Department (ED). Methods: Patients aged 1 to 5 years receiving ketamine for facial laceration repair were prospectively enrolled in a double-blind, randomized, and controlled study at an ED. All patients were to receive intravenous ketamine (2 mg/kg). The local anesthesia group (LA group) received a local anesthetic along with ketamine, whereas the no local anesthesia group (NLA group) received only ketamine. The total time of sedation, the patients' movements and groans, adverse events, and the satisfaction ratings of physicians, nurses, and parents were recorded. Results: A total of 186 patients were randomized (NLA group: 90, LA group: 96). The total time of sedation (30.5 minutes for the NLA group, 32.6 minutes for the LA group; p=0.660), patients' groans (26 (28.9%) versus 23 (24.0%); 0.446) and movements (27 (30%) versus 35 (36.5%); p=0.350) was not affected by the addition of local anesthesia. Other adverse events were similar between the two groups. Also, the satisfaction ratings of physicians (median 4 for the NLA group versus 4 for the LA group (p=0.796)), nurses (2 versus 2.5 (p=0.400)), and parents (4 versus 4 (p=0.199)) were equivalent between the two groups. Conclusion: In this study, we found that local anesthesia was not required along with ketamine sedation for pediatric facial laceration repair.

웃음치료가 위장암 생존자의 우울, 불안, 피로, 수면의 질에 미치는 영향 (Effects of a Laughter Therapy on Depression, Anxiety, Fatigue and Quality of Sleep in Gastrointestinal Cancer Patients Post-Treatment: a Randomized Controlled Trial)

  • 박세연;이임선;정현훈;최스미
    • Journal of Korean Biological Nursing Science
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    • 제21권3호
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    • pp.188-198
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    • 2019
  • Purpose: The purpose of this study was to examine the effect of laughter therapy on depression, anxiety, fatigue, and quality of sleep in gastrointestinal cancer survivors. Methods: This study was a randomized controlled trial. We compared the effect of laughter therapy with usual care only in post chemotherapy gastrointestinal patients. Outcomes included changes in depression and anxiety (according to the Hospital Anxiety and Depression Scale), fatigue (according to the Fatigue Severity Scale), and quality of sleep (according to the Verran & Synder-Halpern Sleep Scale). Data was collected July 2015 through January 2016. Seventy nine participants who agreed to participate in this study were randomized to either the experimental group (n= 40) or the control group (n= 39). Therapy included eight sessions (60 minutes each, once weekly). Data were analyzed using the Windows SPSS 22.0 program. Results: Laughter therapy was effective in reducing fatigue (p= .019) and increasing satisfaction of sleep (p= .030). There were no differences between the groups after therapy for depression (p= .129) and anxiety (p= .200). Conclusion: Results of this study indicate that laughter therapy may be an effective nursing intervention for improving the health status of gastrointestinal cancer survivors after chemotherapy.

치과용 국소마취 주사시 압력조절형 주사장치 사용의 효과에 대한 연구 (Study on Effect of Pressure-Controlled Injection System in Dental Local Anesthesia)

  • 윤필영;김영균
    • 대한치과마취과학회지
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    • 제6권2호
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    • pp.98-102
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    • 2006
  • The purpose of this study was to evaluate the difference on pain intensity and discomfort between pressure-controlled injection system and conventional syringe injection technique from the patients undergoing oral and maxillofacial surgery. In a prospective, randomized, case-controlled study, 60 patients were divided into two groups (n=30 in each). In experimental group, pressure-controlled injection system was applied. In control group, conventional syringe injection system was applied. Pain rating score (PRS) and visual analogue scale (VAS) were assessed. The average of VAS in experimental group ($16.67{\pm}15.07$) was smaller than that of control group ($25.63{\pm}22.21$), though there were no significant differences (P=0.072). In PRS, fifteen patients (50.0%) of experimental group answered that they experienced mild pain. However sixteen patients (53.3%) of control group answered that they experienced intermediate pain. From the results, pressure-controlled injection system may be an effective method to reduce pain during the dental local anesthetic procedure.

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Acupuncture in Patients with a Vertebral Compression Fracture: A Protocol for a Randomized, Controlled, Pilot Clinical Trial

  • Lee, Hyun-Jong;Seo, Jung-Chul;Park, Sung-Hoon;Kwak, Min-Ah;Shin, Im Hee;Min, Bo-Mi;Cho, Min-Su;Roh, Woon-Seok;Jung, Jin-Yong
    • 대한약침학회지
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    • 제18권1호
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    • pp.79-85
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    • 2015
  • Objectives: A vertebral compression fracture (VCF) is characterized by back pain and fracture of a vertebral body on spinal radiography. VCFs of the thoraco lumbar spine are common in the elderly. In general, appropriate analgesics should be prescribed to reduce pain and, thus, promote early mobilization. The ideal treatment approach for VCFs has not been determined. In Korea, acupuncture and herbal medication have been used to treat VCFs for many years. There is empirical evidence that acupuncture might benefit patients with a VCF. However, no randomized, controlled, clinical trials evaluating the efficacy and the safety of acupuncture for treating a VCF have been published. Therefore, we designed a randomized, controlled, pilot, clinical trial to obtain information for the design of a further full scale trial. Methods: A five week protocol for a randomized, controlled, pilot, clinical trial is presented. Fourteen patients will be recruited and randomly allocated to two groups: a control group receiving interlaminar epidural steroid injections once a week for three weeks, and an experimental group receiving interlaminar epidural steroid injections plus acupuncture treatment (three acupuncture sessions per week for three weeks, nine sessions in total). The primary outcomes will be the pain intensity (visual analogue scale and PainVision$^{TM}$ system). The secondary outcome measurements will be the answers on the short form McGill pain questionnaire and the oswestry disability index. Assessments will be made at baseline and at one, three, and five weeks. The last assessment (week five) will take place two weeks after treatment cessation. This study will provide both an indication of feasibility and a clinical foundation for a future large scale trial. The outcomes will provide additional resources for incorporating acupuncture into existing treatments, such as nonsteroidal anti-inflammatory medications, narcotics and vertebral augmentation. This article describes the protocol.

중환자의 경관영양 공급 지표로서 위 잔여량의 임상적 효용성: 체계적 문헌고찰 (Clinical Usefulness of Gastric Residual Volume as An Indicator to Provide Approximately Enteral Nutrition for Patients in Intensive Care Units: A Systematic Literature Review)

  • 김현정;장선주
    • Journal of Korean Biological Nursing Science
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    • 제16권4호
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    • pp.267-275
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    • 2014
  • Purpose: The practice of enteral nutrition with gastric residual volumes (GRVs) as a clinical indicator is poorly standardized in intensive care units. This study aims to summarize the results from studies that evaluated the clinical outcomes related to the GRVs. Methods: This systematic review study analyzed 11 studies consisting of four randomized controlled trials, one non-randomized controlled trial, and six observational studies. Results: No consistent relationship between GRV thresholds and clinical outcomes was observed. Higher GRVs were not consistently correlated with clinical outcomes such as higher gastrointestinal complications, aspiration pneumonia, or mortality. Higher GRVs significantly generate complications more often. Findings show that a single GRV more than 200 mL or two consecutive GRVs more than 150 mL should raise concern about negative consequences. Conclusion: Critical care nurses need to monitor GRVs closely during their practice of enteral nutrition. For critically ill patients receiving enteral nutrition, a GRV threshold of 200 ml would be a desirable limit to provide safe and adequate nutrition with a conservative approach.

PubMed로 검색한 과민성장증후군의 침치료에 관한 문헌 고찰 (A PubMed Literature Study of Korean Medicine Treatment (Acupuncture) in Irritable Bowel Syndrome)

  • 장석주;김장현;민상연
    • 대한한방소아과학회지
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    • 제32권3호
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    • pp.119-130
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    • 2018
  • Objectives The purpose of this study is to review the effectiveness of acupuncture treatment in irritable bowel syndrome (IBS). Methods We reviewed 8 randomized controlled trials (RCT) of acupuncture treatment in IBS which were published from 2008 to 2018 in PubMed. The acupoints, methods of assessment, treatment, results and adverse events were analyzed. Results There were 8 RCT of acupuncture treatment in IBS. The most commonly used acupoints were 天樞 (ST25), and 上巨虛 (ST37). Frequently used assessments in IBS were Bristol scale, visual analogue scale, IBS-symptom severity score, quality of life, and symptom scale. 3 out of 8 studies, the acupuncture treatment group showed significant effectiveness than that of the control group. Conclusions All of the studies have not shown that the acupuncture treatment was effective in relieving IBS symptoms. More clinical studies are needed to prove the effectiveness of the acupuncture treatment in IBS.

중풍 후 강직의 침구치료에 대한 계통적 연구 (A Systematic Review of Clinical Trials on Acupuncture on the Post-stroke Muscle Spasticity)

  • 서병관;백용현;박동석
    • Journal of Acupuncture Research
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    • 제27권6호
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    • pp.1-10
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    • 2010
  • Objectives : The aim of this systematic review was to assess the efficacy of acupuncture and its relevant modality on post-stroke muscle spasticity Methods : We included 7 randomized controlled trials(RCTs) and 1 crossover study on acupuncture on the post-stroke muscle spasticity. Articles searches were performed in various databases in October 2009. Eight studies from 38 articles met the inclusion criteria and were used to assess the quality of clinical trials by means of Jadad scale, STRICTA, CONSORT statement and cochrane-handbook for systematic reviews of interventions. Results : Electrical stimulation such as electroacupuncture and TENS on acupoints was used in five studies. Repeatition of electroacupuncture showed significant decrease of the post-stroke muscle spasticity and persistence of the effect. Only three studies were assessed high quality as the methodological assessment tool(Jadad scale) and none of the studies matched STRICTA recommendations. Conclusions : This systematic review shows that there is beneficial effects of electroacupuncture on the post-stroke muscle spasticity. Further study of large population with high methodological quality will be needed.

한약을 이용한 한국에서의 무작위 임상시험 개괄적 검토 (Randomized Clinical Controlled Trials of a Herb Remedies in Korea - Systematic Review)

  • 오래영;설인찬;손창규
    • 대한한의학회지
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    • 제31권4호
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    • pp.1-8
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    • 2010
  • Objective: The study aimed to review all randomized controlled clinical trials (RCTs) performed in Korea with herbal medicine, to produce further useful information for herbal-drug development. Methods: All papers reporting RCT with herbal drugs were collected via public database of Korea Science and Technology Integration Services, and various Oriental medicine journals. Then, the clinical question, herbal medicine, result, RCT design, and its conductor were analyzed. Results: A total of 20 RCTs were finally selected, and most of them were performed after 2003. The main subjects of RCT were related to heart and blood circulation, dermatitis, respiration disorder, Sasang constitution, or psychiatric disorders. Eight RCTs were done with a single herb while 12 RCTs were with multiple herbal formulae. In particular, three RCTs for atopic dermatitis with three formulae showed positive results. The quality of RCT was considered as better than average. Conclusions: This study revealed the current status of RCT using herbal drugs. This result would provide helpful information for research and drug development using traditional herbal medicine.

Effect of onion peel extract supplementation on the lipid profile and antioxidative status of healthy young women: a randomized, placebo-controlled, double-blind, crossover trial

  • Kim, Jungmi;Cha, Yong-Jun;Lee, Kyung-Hea;Park, Eunju
    • Nutrition Research and Practice
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    • 제7권5호
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    • pp.373-379
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    • 2013
  • The consumption of fruits and vegetables that have high polyphenol content has been previously associated with a reduced risk for cardiovascular disease. We investigated the effects of onion peel extract on plasma total antioxidant capacity, lipid peroxidation, and leukocyte DNA damage. This study was a randomized, double-blind, placebo-controlled, crossover trial. Healthy female subjects received either onion peel extract or placebo (dextrin) for two weeks, underwent a 1-week washout period, and then received the other treatment for an additional two weeks. After two weeks of onion peel extract supplementation, the total cholesterol level, low-density lipoprotein cholesterol level, and atherogenic index significantly decreased (P < 0.05). No changes were observed in activities of erythrocyte antioxidant enzymes or levels of lipid peroxidation markers following onion peel extract supplementation. Additionally, no significant difference was found in plasma antioxidant vitamin (retinol, tocopherols, carotenoids, and coenzyme Q10) levels or ex vivo $H_2O_2$-provoked oxidative DNA damage after onion peel extract supplementation. The present interventional study provides evidence of the health benefits of onion peel extract and demonstrates its effects in modulating lipid profiles in healthy young Korean women.