• 제목/요약/키워드: Double Blinded

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Efficacy of Roflumilast in Bronchiectasis Patients with Frequent Exacerbations: A Double-Blinded, Randomized, Placebo-Controlled Pilot Clinical Trial

  • Juthong, Siwasak;Panyarath, Pattaraporn
    • Tuberculosis and Respiratory Diseases
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    • 제85권1호
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    • pp.67-73
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    • 2022
  • Background: Bronchiectasis patients with neutrophilic airway inflammation develop symptoms of chronic cough, sputum production, and recurrent exacerbations. Roflumilast has anti-inflammatory actions via decreased neutrophilic airway inflammation. The effectiveness of roflumilast to reduce bronchiectasis exacerbation has never been evaluated. Methods: We conducted a double-blinded, randomized, placebo-controlled trial. Our primary objective was to assess the effect of roflumilast compared with that of a placebo in reducing exacerbation rates in bronchiectasis patients. The secondary objectives were the changes in forced expiratory volume in 1 second (FEV1) and St. George's Respiratory Questionnaire (SGRQ). Bronchiectasis patients older than 18 years who had had two exacerbations during the previous 12 months were randomly assigned to receive either 500 ㎍ of either roflumilast or a placebo once daily for 6 months in a 1:1 ratio. Results: Forty bronchiectasis patients who had experienced exacerbations were screened. Thirty patients completed the study after 6 months of treatment: roflumilast group (n=15) and placebo group (n=15). The rates of exacerbations were 0.57 and 0.59 per patient in the roflumilast and placebo groups, respectively. Prebronchodilator FEV1 increased by 0.07 L from baseline in the roflumilast group and decreased by 0.015 L in the placebo group, but the difference was not significant. No significant differences were observed in the change of SGRQ scores between the roflumilast and placebo groups. Roflumilast had significant side effects, including loss of appetite and headache. Conclusion: Roflumilast did not significantly affect the rate of exacerbations or quality of life. However, FEV1 tended to improve more in the roflumilast group than in the placebo group.

Assessment of Double-blindness at the Conclusion of the $\beta-Blocker$ Heart Attack Trial

  • Byington Robert P.;Curb J. David;Mattson Margaret E.
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 1994년도 교수 연수회(역학)
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    • pp.293-296
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    • 1994
  • At the conclusion of a double-blinded, randomized clinical trial of propranolol hydrochloride, but before un blinding, the patients and clinic personnel were asked to guess the treatment group assignment of each patient. While 79.9% of the patients receiving propranolol correctly Identified their treatment group assignment, 57.2% of the patients receiving placebo incorrectly guessed that they were aiso in the propranolol group. No specific mechanism was identified to explain why more patients receiving propranolol were better able to guess' their group assignment. Clinic physicians correctly identified the group assignment of 69.9% of the patients receiving propranolol and 68.8% of the patients receiving placebo. Clinic coordinators correctly identified the group assignment of 67.1% of the patients receiving propranolol and 70.6% of the patients receiving placebo. For clinic personnel, heart rate level and heart rate change seem to be the mechanisms employed to Identify their patients' treatment assignment.

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The immediate effects of 830-nm low-level laser therapy on the myofascial trigger point of the upper trapezius muscle in visual display terminal workers: A randomized, double-blind, clinical trial

  • Lee, Jung-Hoon;Lee, Sun-Min
    • International Journal of Contents
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    • 제7권2호
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    • pp.59-63
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    • 2011
  • The aim of our study was to evaluate the immediate effects of an 830-nm Aluminium gallium arsenide (GaAlAs) laser, by examining the changes, in pressure-pain threshold (PPT) and tenderness at 3 kg of the myofascial trigger point (MTrP) of the upper trapezius muscle in visual display terminal (VDT) workers in comparison with placebo treatment. Thirty VDT workers (13 males, 17 females) with complaints of upper trapezius muscle were recruited. All participants were given either active GaAlAs laser (830 nm wavelength, 450 mW, 9 J at point) or placebo GaAlAs laser, according to the double-blinded and placebo-controlled trial. Both active and placebo low-level laser therapy (LLLT) treatments showed no significant effect on PPT and tenderness at 3 kg. These results suggest that a higher dosage may be necessary to produce immediate effects when applying LLLT to the MTrP of relatively large muscles such as the upper trapezius muscle.

경막외 Naloxone 투여가 경막외 Sufentanil에 의한 가려움증에 미치는 영향 (Effects of Epidural Naloxone on Pruritus Induced by Epidural Sufentanil)

  • 임의성;김기준;윤주선;남순호;공명훈
    • The Korean Journal of Pain
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    • 제20권2호
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    • pp.123-129
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    • 2007
  • Background: Postoperative pruritus following the administration of epidural narcotics is a very common and undesirable side effect. Therefore, we evaluated the use of a combination of naloxone and sufentanil via patient controlled epidural analgesia to determine if the incidence of pruritus was decreased when compared to the use of sufentanil alone. Methods: Patients scheduled for subtotal gastrectomy under general anesthesia were enrolled in a prospective, double-blinded and randomized trial. All patients received a $20{\mu}g$ epidural bolus of sufentanil in 5 ml of 0.2% ropivacaine. Following administration of the epidural, patients in the sufentanyl group (S) received a continuous epidural comprised of sufentanil ($0.75{\mu}g/ml$) in 0.2% ropivacaine, whereas patients in the naloxone group (N) received an epidural infusion comprised of naloxone ($4{\mu}g/ml$) and sufentanil ($0.75{\mu}g/ml$) in 0.2% ropivacaine. The infusion rate, demand dose and lockout interval were 5 ml/hr, 0.5 ml and 15 minutes respectively. Next, the occurrence of postoperative analgesia and side effects were evaluated by blinded observers. Results: The incidence of pruritus (47.4% versus 20.0%, P = 0.013) and nausea (42 .1 % versus 20.0%, P = 0.043) were lower in group N than in group S. In addition, there were no significant differences observed in the visual analogue scale, the incidence of vomiting or the incidence of sedation. Furthermore, epidural infusion of naloxone at $0.25-0.4{\mu}g/kg/hr$ did not affect the requirement for postoperative sufentanil. Conclusions: Epidural naloxone reduces epidural sufentanil induced pruritus and nausea without reversing its analgesic effects.

제 2 상, 이중맹검, 무작위배정, 다기관 공동임상시험의 결과 : 당뇨병성 족부궤양에 대한 표피 성장인자(Epidermal Growth Factor, EGF)의 치료 효과를 평가 (A Phase II, double-blinded, randomized, multicenter clinical trial for evaluation of efficacy and safety of rhEGF in patients with diabetic foot ulcer)

  • 최지현;정귀옥;손호영;김영설;이홍규;이기업;이현철;이병두;박병주
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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    • pp.305-307
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    • 2001
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삼음교(SP6)지압이 산부의 분만통증, 분만소요시간에 미치는 효과 (Effects of San-Yin-Jiao(SP6) Acupressure on Labor Pain, Delivery Time in Women during Labor)

  • 이미경
    • 대한간호학회지
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    • 제33권6호
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    • pp.753-761
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    • 2003
  • Purpose: The study was done to examine the effects of San- Yin-Jiao(SP6) acupressure treatment on subjective labor pain, length of delivery time in women during labor. Method: The study design was a randomized controlled clinical trial study using a double-blinded method. Data were collected using a structured questionnaire, a subjective labor pain scale and measurement of delivery time. The experimental group(n=29) was received SP6 acupressure and control group(n=29), SP6 touch for the duration of each uterine contraction, during 30 minutes after 3cm dilatation of cervical os. Result: The subjective labor pain scores was significantly different between the two groups(p=0.042). The total length of delivery time in the group which had the SP6 acupressure was shorter than SP6 touch group (p=0.036). Conclusion: These findings showed that SP6 acupressure was effective related to labor pain, length of time for delivery. SP6 acupressure during labor could be applied as an effective nursing treatment.

지각과 상엽 혼합추출물이 지질 개선에 미치는 영향 (The Improvement of Mixed Extracts of Fructus Aurantii and Mulberry Leaves on Lipid Metabolism)

  • 박성우;신용철;고성규
    • 대한예방한의학회지
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    • 제12권1호
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    • pp.135-147
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    • 2008
  • Background : Diabetes is a chronic disease characterized by deficiency of insulin. It has been reported that Fructus aurantii and mulberry leaves have the effect of anti-diabetes. Methods : To investigate the improvement of mixed extracts of Fructus aurantii and mulberry leaves on lipid metabolism, we performed double-blinded, randomized and placebo-controlled multi-center clinical trial. Results : Mixed extracts of Fructus aurantii and mulberry leaves significantly reduced total cholesterol. Conclusion : These results suggest that mixed extracts of Fructus aurantii and mulberry leaves improve lipid metabolism.

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Comparative Evaluation between 1.5T vs 3.0T MRI in Brain Metastasis According to its Size

  • 정우석;정태섭;허진;이재훈
    • 대한자기공명의과학회:학술대회논문집
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    • 대한자기공명의과학회 2003년도 제8차 학술대회 초록집
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    • pp.22-22
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    • 2003
  • The purpose of this study was to compare the detection rate of brain metastasis according to size of nodule between 1.5T and 3.0T MRI 대상 및 방법: We reviewed 44 patients with primary tumors and clinical symptoms suggesting brain metastasis. After administration of double dose gadolinium-DTPA, MR imaging was performed with 3D SPGR sequence by 3.0T MRI and then with T1 SE sequence by 1.5T MRI. Consequently, comparison was done in 1.5T T1 SE sequence and 3.0T 3D SPGR sequence. With use of the signal intensity (SI) measurements in the metastatic nodules and adjacent tissue, metastatic nodule-to-adjacent tissue SI ratio were calculated. In each patient, the number of metastatic lesions detected in 1.5T and 3.0T, and their size were assessed qualitatively by three blinded readers.

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

  • 임현주;김석환;이상룡;강위창;정인철
    • 동의신경정신과학회지
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    • 제20권3호
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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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오수유와 마황이 저열량식이요법을 병행한 비만여성환자의 체구성성분 및 휴식대사량에 미치는 영향 (The Effects of Evodia Rutaecarpa and Ephedra Sinica on the Resting Metabolic Rate and Body Composition of Obese Women on a Low-Calorie Diet: A Double-blinded Randomized Controlled Clinical Trial)

  • 박정미;김호준;김진아;김수진;고병표
    • 대한한의학회지
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    • 제26권3호
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    • pp.249-262
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    • 2005
  • Backgrounds : As obesity prevails as an epidemic. diet programs including low-calorie diets are developed continuously. It is generally believed that a low-calorie diet is commonly followed by resting metabolic rate decrease and ultimate weight regain. Ephedra and Evodia are known to have sympathomimetic and anti-obesity effect. Objectives : This study was a prospective, double-blinded, randomized md placebo-controlled clinical trial to evaluate the effects of Ephedra sinica and Evodia rutaecarpa on resting metabolic rate (RMR), weight, body composition, and short-term safety in obese women on low-calorie diet. Methods : 125 otherwise healthy obese women (body mass Index ${\geq}\;25kg/m^2$) were recruited and randomly assigned to three groups: Ephedra group (n=41), Evodia group (n =45), and placebo group (n=39). Subjects were administered Ephedra extract in capsules (pseudo-ephedrine 31.52mg) or Evodia extract in capsules (evodiamine 6.75mg, rutaecarpine 0.66mg) or placebo capsules as well as participating in a low-calorie diet for 8 weeks, Resting metabolic rate and body composition were measured at baseline,4 and 8 weeks. Basic serum exams were performed to evaluate the short-term safety of the herbs and changes of lipid variables. Results : All three groups showed significant BMI decreases probably due to low-calorie diet. Among them, the Ephedra group manifested most prominent BMI-reducing effect and towered total cholesterol and triglycerides significantly. The RMR was not changed during the 8-week diet in all groups. No significant difference among the groups was found in RMR, either. Stbject with higher RMR than the mean at the baseline showed a tendency to keep their RMR more stable during the diet program. Conclusions : Ephedra with a low-calorie diet was effective in reducing BMI. RMR change was not compensated by herbal medicines. RMR change seemed to be affected rather by constitution and body composition than medicine. Ephedra and Evodia were proven to be safe for sort-term use in herbal form. Especially, Ephedra was effective in lowering total cholesterol and triglycerides during the 8 weeks.

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