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

검색결과 177건 처리시간 0.031초

침 임상시험 논문에 적용한 Sham Acupuncture에 대한 고찰 (The Study of the Sham Acupuncture for Acupuncture Clinical Trials)

  • 정찬영;장민기;조재용;김은정;박인식;김갑성
    • Journal of Acupuncture Research
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    • 제25권6호
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    • pp.77-93
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    • 2008
  • Objectives : Though there were many clinical studies of acupuncture effects they didn't have appropriate control group or use another therapy for control group. So, we didn't say it was true acupuncture effect, though subjects in clinical study improved. Recently several sham needles for control group were developed and validated. This study aimed at summarizing the validation studies of these needles and evaluating the control group of the acupuncture clinical study. Methods : Computerized literature searches were performed using 'acupuncture' and 'placebo or sham' with a limitation of the results to RCTs in Pubmed, Sciencedirect, NDSL, KISS, RISS. Data were extracted regarding study design, sample size, acupuncture point, stimulation form, credibility testing. And We have examined 106 acupuncture clinical studies published by Pubmed from January 1, 2005 to April 30, 2008. Data were extracted author's country, subject of study, type of study groups, type of control groups, type of blinding, difference between the results in the control groups. Results : Streitberger's placebo needle, Fink's sham needle, Park sham needle, Kim sham needle were developed. They were validated at domestic and abroad. But the results were deviation depending on the each of the researcher. They has shown that sample, acupuncture points, experiences or knowledge of acupuncture dependent on the results. Recent three years, acupuncture clinical trial had different results. Significant differences between Study group and control group emerged from using other therapy or non-treatment for control group. Many study has no significant differences using sham acupuncture for control groups. Conclusions : Acupuncture clinical studies need to meet several requirements. First of all, they require the basics of randomized controlled clinical studies such as blinding and the accurate implementation and description of randomization. And also need to research the unique circumstances of these studies such as the development of sham acupuncture and blinding method which differs from other clinical trials.

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스트레스 정도에 따라 침 치료가 뇌파(EEG)에 미치는 영향: 무작위배정 플라시보 대조군 교차연구 (Different Responses to Acupuncture in Electroencephalogram according to Stress Level: A Randomized, Placebo-Controlled, Cross-Over Trial)

  • 김송이;김상우;박히준
    • Korean Journal of Acupuncture
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    • 제31권3호
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    • pp.136-145
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    • 2014
  • 목적 : 본 무작위배정 플라시보 대조군 교차연구는 신문혈의 침 치료가 뇌 활성도와 자율신경계에 어떠한 영향을 미치는지 뇌파(EEG)와 심박변이도(HRV)를 통해 알아보고자 한 연구이다. 방법 : 18명의 건강인 피험자가 참여하여 1-3일의 간격을 두고 무작위배정 순서에 따라 신문혈에 진짜침과 가짜침으로 시술받았고, 치료 전, 후에 각각 뇌파와 심박변이도를 측정하였다. 피험자의 스트레스 정도에 따른 반응의 차이를 살펴보기 위하여 스트레스설문지를 이용하여 서브그룹분석을 시행하였다. 결과 : 그 결과, 침 치시술은 뇌파 중 ${\alpha}$밴드 값의 증가를 나타냈으며, 진짜침 그룹의 경우 심박변이도의 결과값 중 HF와 RMS-SD의 증가가 대조군에 비해 유의하게 높았다. 스트레스 정도에 따른 서브그룹 분석에서는 진짜침 그룹 중 스트레스 정도가 높은 피험자는 ${\alpha}$밴드 값이 증가한 반면, 스트레스 정도가 낮은 피험자는 감소하거나 증가의 폭이 낮은 것을 알 수 있었으며, 거짓침 그룹에서는 비교적 적은 변화를 나타내었다. 결론 : 본 연구 결과를 통해 침이 뇌 활성도 및 자율신경계에 영향을 미치며, 이는 부교감신경계통과 관련이 있음을 알 수 있었다. 또한 이러한 결과는 환자의 스트레스 정도에 따라 다른 반응을 나타냄을 보여주었다.

Randomized controlled trial to compare oral analgesic requirements and patient satisfaction in using oral non-steroidal anti-inflammatory drugs versus benzydamine hydrochloride oral rinses after mandibular third molar extraction: a pilot study

  • Goswami, Devalina;Jain, Gaurav;Mohod, Mangesh;Baidya, Dalim Kumar;Bhutia, Ongkila;Roychoudhury, Ajoy
    • Journal of Dental Anesthesia and Pain Medicine
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    • 제18권1호
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    • pp.19-25
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    • 2018
  • Background: Third molar extraction is associated with considerable pain and discomfort, which is mostly managed with oral analgesic medication. We assessed the analgesic effect of benzydamine hydrochloride, a topical analgesic oral rinse, for controlling postoperative pain following third molar extraction. Methods: A randomized controlled trial was conducted in 40 patients divided into two groups, for extraction of fully erupted third molar. Groups A received benzydamine hydrochloride mouthwash and group B received normal saline gargle with oral ibuprofen and paracetamol. Oral ibuprofen and paracetamol was the rescue analgesic drug in group A. Patients were evaluated on the $3^{rd}$ and $7^{th}$ post-operative days (POD) for pain using the visual analogue score (VAS), trismus, total number of analgesics consumed, and satisfaction level of patients. Results: The VAS in groups A and B on POD3 and POD7 was $4.55{\pm}2.54$ and $3.95{\pm}1.8$, and $1.2{\pm}1.64$ and $0.95{\pm}1.14$, respectively and was statistically insignificant. The number of analgesics consumed in groups A and B on POD3 ($5.25{\pm}2.22$ and $6.05{\pm}2.43$) was not statistically different from that consumed on POD7 ($9.15{\pm}5.93$ and $10.65{\pm}6.46$). The p values for trismus on POD3 and POD7 were 0.609 and 0.490, respectively and those for patient satisfaction level on POD3 and POD7 were 0.283 and 0.217, respectively. Conclusions: Benzydamine hydrochloride oral rinses do not significantly reduce intake of oral analgesics and are inadequate for pain relief following mandibular third molar extraction.

국내 중년기 비만 여성의 생리적 지표에 대한 복부비만관리프로그램의 효과: 메타분석 (Effects of an Abdominal Obesity Management Program on Physiological Bio-markers of Middle-aged Women in Korea: A Meta-analysis)

  • 김경진;홍해숙;박완주;고상진;나연경
    • Journal of Obesity & Metabolic Syndrome
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    • 제25권3호
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    • pp.138-148
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    • 2016
  • 배경: 한국의 중년여성의 복부비만 유병률은 급속하게 증가하고 있으나 복부비만 관리프로그램의 종류와 그 효과가 다양하고 효과적인 중재 방법을 선택하는 데 어려움이 있다. 따라서 본 연구의 목적은 한국의 중년 비만여성을 대상으로 실시한 복부비만관리 프로그램의 효과를 체계적이고 종합적으로 규명하여 학문적 기초자료를 제시하는데 있다. 방법: 학술지 392편, 학위논문 380편으로 총 772편의 논문 중 중복된 자료를 제외한 647편에서 조사연구이거나 나이에 적합하지 않거나 대조군이 선정되지 않는 등, 선정기준에 부합하지 않는 604편을 제외하여 총 43편의 복부비만관리 프로그램 논문을 분석대상으로 선정하여 주요 비만지표의 효과크기를 분석하고, 각 효과크기의 이질성에 대한 설명을 위해 메타 ANOVA와 메타회귀분석을 활용하여 조절효과분석을 실시하였다. 또한 출간오류분석을 통해 연구 결과의 타당성을 확인하였다. 결과: 본 연구의 결과는 다음과 같다. 비만 중년여성을 대상으로 실시한 복부비만관리 프로그램의 표준화된 평균 효과크기는 0.22로 작은 효과크기를 나타냈고, 염증성 지표와 지방분포율은 각각 0.36으로 중간 정도의 효과크기를 나타냈으며, 대사성 지표는 0.21, 신체계측 지표는 0.18로 작은 효과크기를 보였다. 이질성은 중간 정도의 이질성($I^2=44.5%$, Q = 844.57, P<0.001)을 보였고, Randomized Controlled Trial (RCT) 여부나 출판여부에 따라 효과크기에 차이가 없었다. 결론: 본 연구 결과에 근거하여 최근 대두되고 있는 비만 여성에 대한 건강 증진 및 복부비만 개선에 대한 중재효과를 계량적으로 분석한 점에서 복부비만프로그램 중재의 효과파악을 위한 근거 자료로 활용될 수 있을 것이다.

Low-Tube-Voltage CT Urography Using Low-Concentration-Iodine Contrast Media and Iterative Reconstruction: A Multi-Institutional Randomized Controlled Trial for Comparison with Conventional CT Urography

  • Kim, Sang Youn;Cho, Jeong Yeon;Lee, Joongyub;Hwang, Sung Il;Moon, Min Hoan;Lee, Eun Ju;Hong, Seong Sook;Kim, Chan Kyo;Kim, Kyeong Ah;Park, Sung Bin;Sung, Deuk Jae;Kim, Yongsoo;Kim, You Me;Jung, Sung Il;Rha, Sung Eun;Kim, Dong Won;Lee, Hyun;Shim, Youngsup;Hwang, Inpyeong;Woo, Sungmin;Choi, Hyuck Jae
    • Korean Journal of Radiology
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    • 제19권6호
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    • pp.1119-1129
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    • 2018
  • Objective: To compare the image quality of low-tube-voltage and low-iodine-concentration-contrast-medium (LVLC) computed tomography urography (CTU) with iterative reconstruction (IR) with that of conventional CTU. Materials and Methods: This prospective, multi-institutional, randomized controlled trial was performed at 16 hospitals using CT scanners from various vendors. Patients were randomly assigned to the following groups: 1) the LVLC-CTU (80 kVp and 240 mgI/mL) with IR group and 2) the conventional CTU (120 kVp and 350 mgI/mL) with filtered-back projection group. The overall diagnostic acceptability, sharpness, and noise were assessed. Additionally, the mean attenuation, signal-to-noise ratio (SNR), contrast-to-noise ratio (CNR), and figure of merit (FOM) in the urinary tract were evaluated. Results: The study included 299 patients (LVLC-CTU group: 150 patients; conventional CTU group: 149 patients). The LVLC-CTU group had a significantly lower effective radiation dose ($5.73{\pm}4.04$ vs. $8.43{\pm}4.38mSv$) compared to the conventional CTU group. LVLC-CTU showed at least standard diagnostic acceptability (score ${\geq}3$), but it was non-inferior when compared to conventional CTU. The mean attenuation value, mean SNR, CNR, and FOM in all pre-defined segments of the urinary tract were significantly higher in the LVLC-CTU group than in the conventional CTU group. Conclusion: The diagnostic acceptability and quantitative image quality of LVLC-CTU with IR are not inferior to those of conventional CTU. Additionally, LVLC-CTU with IR is beneficial because both radiation exposure and total iodine load are reduced.

복강경 자궁근종절제술을 받은 여성에서 정맥 내 아스코르브산 투여가 피로에 미치는 영향: 무작위 배정 양측맹검 위약대조 임상시험 (Effect of intravenous ascorbic acid administration on fatigue after laparoscopic myomectomy: A randomized, double-blind, placebo-controlled trial)

  • 황우연;김기동
    • 한국산학기술학회논문지
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    • 제22권2호
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    • pp.434-439
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    • 2021
  • 본 논문은 복강경 자궁근종절제술을 받은 여성에서 정맥 내 아스코르브산 주입이 피로에 미치는 영향 알아보고자 하였다. 우리는 무작위 배정 양측맹검 위약대조 임상시험의 2차 평가변수의 결과를 분석하였다. 복강경 자궁근종절제술을 받은 환자 50명은 수술 중 아스코르브산 (2g)이나 위약을 수술 중 투여받았다. 환자 비율은 임의로 1:1 비로 하였다. 수술 후 2일차에는 간이 피로 평가지 (Brief Fatigue Inventory-Korean version, BFI-K)을 사용하여 피로수준을 평가하였다. 대상자가 동의를 철회하거나 수술을 취소한 경우 또는 평가변수가 측정되지 않은 5명은 제외되어 총 45명(시험군 23명, 대조군 22명)을 대상으로 분석하였다. 분석에 포함된 대상자의 임상적 특성은 실험군과 대조군간의 차이가 없었으며, 전체 피로도 점수도 실험군 (4.56 ± 2.63). 대조군 (5.21 ± 2.02 P = 0.351)으로 두 군간에 차이를 보이지 않았다. 그러나 대조군의 피로도 점수는 대부분의 영역에서 대조군의 피로도 점수보다 낮은 경향을 보였다. 결론적으로 복강경 자궁근종절제술을 시행받은 여성에서 정맥 내 아스코르브산 주입은 피로도를 크게 줄이지 못했으며, 추가적인 연구가 필요하다.

요부신전강화 운동프로그램이 단순추간판탈출증 수술환자의 요부근육 및 통증 그리고 사회복귀에 미치는 영향 (The effects of lumbar extensors strengthening program on low back muscle power and mass, pain, return to work of patients who took laser operation for herniated lumbar disc)

  • 황성수;김명준
    • 대한정형도수물리치료학회지
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    • 제10권2호
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    • pp.45-56
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    • 2004
  • OBJECTIVE: The objective of this study was to know the effects of the postoperative lumbar extensor strengthening exercise program on back muscles strength and volume, pain, and the time of return to work. METHODS: A prospective controlled trial of lumbar extensor exercise program in patients who underwent microdiscectomy or percutaneous endoscopic discectomy for prolapsed lumbar intervertebral disc. Seventy-five patients were randomized into exercise group (20 male, 15 female) and non-exercise group (18 male, 22 female). Six weeks after surgery, patients in exercise group undertook a 12-week lumbar extension exercise (MedX) program. Assessment of spinal function was performed in all patients on postoperative 6 weeks, 18 weeks. The assessment included measures of lumbar extensor power, muscle mass of erector spinalis. All patients completed the visual analog scale (VAS) for evaluation of pain, and return to work. RESULTS: In muscle power, there were statistically significant improvements between pre and post test on muscle power in exercise group. But there were not statistically significant difference on muscle power in non-exercise group. In muscle mass, there were statistically significant difference between pre and post test on muscle mass in exercise group. But there were not statistically significant difference on muscle mass in non-exercise group. In the pain, there were statistically significant decrease between pre and post test on both group. But there were not statistically significant difference on fatty tissue and obesity in non-exercise group. The percentages of return to work in postoperative 4 months were significantly greater in the exercise group than in the non -exercise group. CONCLUSIONS: Postoperative lumbar extensor strengthening exercise program appears to be more beneficial to the patients who underwent operation for prolapsed lumbar intervertbral disc.

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실금간호 프로토콜 수용개작 및 효과 검증 (Adaptation and Evaluation of the Incontinence Care Protocol)

  • 박경희;최희정
    • 대한간호학회지
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    • 제45권3호
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    • pp.357-366
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    • 2015
  • Purpose: This study was done to develop an evidence-based incontinence care protocol through an adaptation process and to evaluate the effects of the protocol. Methods: The protocol was developed according to the guideline of adaptation. A non-randomized controlled trial was used for testing the effects of the new Incontinence Care Protocol. A total of 120 patients having bowel incontinence with Bristol stool type 5, 6, and 7 and admitted to intensive care units were recruited to this study. The newly developed incontinence care protocol was used with patients in the experimental group and conventional skin care was given to patients in the control group. Outcome variables were incontinence-associated dermatitis (IAD) severity, pressure ulcer occurrence and severity. Results: The experimental group had significantly less severe IAD (t=6.69, p <.001), lower occurrence of pressure ulcers (${\chi}^2=7.35$, p =.007), and less severity of pressure ulcers (Mann-Whitney=86.00, p =.009) than the control group. Conclusion: Use of this incontinence care protocol has the effects of preventing pressure ulcers and inhibiting worsening of IAD and pressure ulcers. Therefore, this incontinence care protocol is expected to contribute to managing IAD and pressure ulcers.

외상후 스트레스장애에 대한 하타 스타일 요가 치료의 해외 임상연구 동향 (A Review on Clinical Research Trends in the Treatment of Hatha-Style Yoga for Post Traumatic Stress Disorder)

  • 홍희연;홍민호;구병수;김근우
    • 동의신경정신과학회지
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    • 제31권1호
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    • pp.13-23
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    • 2020
  • Objectives: The purpose of this study was to review the research trends in the treatment of hatha-style yoga on Post Traumatic Stress Disorder (PTSD). Methods: We searched articles in Pubmed and the China National Knowledge Infrastructure (CNKI) January 2010-December 2019, for studies to treat PTSD using hatha-style yoga. Selected studies were evaluated by the CLEAR-NPT (A Checklist to Evaluate a Report of a Non-pharmacological Trial). Results: Seven randomized controlled clinical trials were selected. PSS-I (PTSD Symptom Scale-Interview) was the most frequently used as diagnostic criteria. The PCL (PTSD Checklist) was also the most commonly used outcome measurement. Of the seven articles, most studies reported that hatha-style yoga was effective to reduce symptoms of PTSD. Conclusions: Hatha-style yoga practice intervention can be used to relieve symptoms of PTSD. More studies should be conducted to make hatha-style yoga as protocol (complementary therapy) for PTSD patients.

소아 천식 치료의 국외 보완대체의학 임상 연구 동향 (The Trends in Foreign Clinical Trials for Pediatric Asthma in Complementary and Alternative Medicine)

  • 방미란;김장현;민상연
    • 대한한방소아과학회지
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    • 제29권3호
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    • pp.1-11
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    • 2015
  • Objectives : The purpose of this study is to analyze the trends in foreign clinical trials for pediatric asthma in complementary and alternative medicine (CAM). Methods : We reviewed 31 randomized controlled trials (RCT) for pediatric asthma treatment in CAM published from 2005 to 2015 in PubMed and analyzed their treatments, compounds of herbal medicines, acupoints, methods of assessment, and treatment results. Results : The treatments used in the studies were herbal medicines, acupuncture, acupoint application, breathing training, supplement, normocaloric diet, yoga, massage therapy, and art therapy. The frequently used herbs were Asari Herba Cum Radix (細辛). Ephedrae Herba (麻黃), Astragali Radix. The most common acupoints were Feishu (肺兪, BL13). The methods of assessment in pediatric asthma were symptom scale, questionnaire of Quality of Life, lung function test, laboratory studies, and medication usage. In 28 out of 31 studies, treatment group gets better than non-treated group. Conclusions : This study shows that CAM is effective in treating pediatric asthma. More clinical studies using objective outcome measures are needed to prove its efficacy clearly.