• 제목/요약/키워드: Randomized Clinical Trials

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EBM 구축을 위한 쌍화탕의 실험 연구 문헌 분석 (Analysis of Studies on Ssanghwa-tang for Establishment of Evidence Based Medicine)

  • 이준경;이남헌;하혜경;이호영;서창섭;정다영;이진아;신현규
    • 한국한의학연구원논문집
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    • 제14권3호
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    • pp.41-47
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    • 2008
  • Objective : The purpose of this report was to provide the information about activity and safety of Ssanghwa-tang by analyzing domestic papers and theses about Ssanghwa-tang. Methods : Domestic papers and theses related to Ssanghwa-tang were reviewed and analyzed. These papers were then classified by year, experimental method, and activity subject. Results : The following result s were obtained in this study. 1. The study of Ssanghwa-tang started from 1981 and continued steadily 1990s and it was decreased 2000s. 2. The paper of Ssanghwatang was entire domestic paper, 20 volumes. 3. In classified by experimental method and animal of Ssanghwa-tang paper, more than a half study used rat in vivo experiment. Furthermore clinical experiments were performed about anti-fatigue effect of Ssanghwa-tang and Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. 4. Decursin, glycyrrhizin, paeoniflorin were determined in Ssanghwa-tang by using HPLC analysis. 5. As these studies were classified by subject, papers related to anti-fatigue effect were most abundant by 7 papers. Besides there were several papers related to liver funtion, anti-inflammatory, alleviation, smooth muscle relaxation effect and so on. 6. According to experimental data, it is supported that Ssanghwa-tang was safety herbal medicine and it has a several activity about anti-fatigue, anti-inflammatory, alleviation, smooth muscle relaxation. Conclusion : Many study of basic science experiments and clinical experiments were performed and reported on Ssanghwa-tang in domestic journal. Ssanghwa-tang is being used in various ways associating with anti-fatigue, anti-inflammatory, alleviation and smooth muscle relaxation. furthermore Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. However, studies on randomized controlled trials of Ssanghwatang need to be completed at the clinical level.

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수술후 급성 동통에 대한 Tramadol/Acetaminophen과 Codeine/Acetaminophen/Ibuprofen의 효과 발현시점과 진통효과의 비교 (COMPARISON OF TRAMADOL/ACETAMINOPHEN AND CODEINE/ACETAMINOPHEN/IBUPROFEN IN ONSET OF ANALGESIA AND ANALGESIC EFFICACY FOR POSTOPERATIVE ACUTE PAIN)

  • 정영수;김동기;김문기;김형준;차인호;한무영;이의웅
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • 제30권2호
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    • pp.143-149
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    • 2004
  • Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

본태성 진전에 대한 중의학 연구동향 (A Review on Treatment of Essential Tremor in Traditional Chinese Medicine)

  • 신아리;배영롱;임재유;이승환;김상호;임정화
    • 동의신경정신과학회지
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    • 제28권2호
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    • pp.95-107
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    • 2017
  • Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

Efficacy of glycine powder air-polishing in supportive periodontal therapy: a systematic review and meta-analysis

  • Zhu, Mengyuan;Zhao, Meilin;Hu, Bo;Wang, Yunji;Li, Yao;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • 제51권3호
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    • pp.147-162
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    • 2021
  • Purpose: This systematic review and meta-analysis was conducted to assess the effects of glycine powder air-polishing (GPAP) in patients during supportive periodontal therapy (SPT) compared to hand instrumentation and ultrasonic scaling. Methods: The authors searched for randomized clinical trials in 8 electronic databases for relevant studies through November 15, 2019. The eligibility criteria were as follows: population, patients with chronic periodontitis undergoing SPT; intervention and comparison, patients treated by GPAP with a standard/nozzle type jet or mechanical instrumentation; and outcomes, bleeding on probing (BOP), patient discomfort/pain (assessed by a visual analogue scale [VAS]), probing depth (PD), gingival recession (Rec), plaque index (PI), clinical attachment level (CAL), gingival epithelium score, and subgingival bacteria count. After extracting the data and assessing the risk of bias, the authors performed the meta-analysis. Results: In total, 17 studies were included in this study. The difference of means for BOP in patients who received GPAP was lower (difference of means: -8.02%; 95% confidence interval [CI], -12.10% to -3.95%; P<0.00001; I2=10%) than that in patients treated with hand instrumentation. The results of patient discomfort/pain measured by a VAS (difference of means: -1.48, 95% CI, -1.90 to -1.06; P<0.001; I2=83%) indicated that treatment with GPAP might be less painful than ultrasonic scaling. The results of PD, Rec, PI, and CAL showed that GPAP had no advantage over hand instrumentation or ultrasonic scaling. Conclusions: The findings of this study suggest that GPAP may alleviate gingival inflammation more effectively and be less painful than traditional methods, which makes it a promising alternative for dental clinical use. With regards to PD, Rec, PI, and CAL, there was insufficient evidence to support a difference among GPAP, hand instrumentation, and ultrasonic scaling. Higher-quality studies are still needed to assess the effects of GPAP.

뇌졸중 후 경련성 편마비의 침치료에 대한 최신 임상 연구 동향 - CAJ 검색을 중심으로 (Review of Clinical Research about Acupuncture for Spastic Hmiplegia after Stroke - Research on China Academic Journal)

  • 조명재;김다혜;김선우;박철우;김영광;장혜연;김민욱
    • 동의생리병리학회지
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    • 제35권1호
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    • pp.28-35
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    • 2021
  • To analyze the clinical efficacy of acupuncture for spastic hemiplegia after stroke, this study was accomplished by considering Randomized Controlled Trials. We searched for papers that performed acupuncture for spastic hemiplegia after stroke in the China Academic Journal of the China National Knowledge Infrastructure, from January 1, 2017 to June 30, 2020. In total, 23 reports were included in this review. There are 18 studies conducted with more than 50 subjects and less than 100 subjects. The largest number of treatment was 20 times. 28days(4weeks) was the largest number of treatment period, which accounted 10 studies. The most frequently used evaluation index was The Fugl-Meyer Assessment(FMA) and Clinical Efficacy, each used 21 times and 17 times. The most frequently used acupuncture point was LI3, which was used 13 times. The retention time was 30 minutes and 11 studies were conducted. Western medicine treatment was the most common control group in 15 studies. Most of studies showed result of the intervention group was statistically significant, compared with the control group. These results suggest that acupuncture for spastic hemiplegia after stroke was effective and it was statistically more significant than the control group. However, it is difficult to confirm a conclusion, because the quality of most of studies was low.

두개천골요법의 국내외 임상 연구 동향: 스코핑 리뷰 (Trends in Domestic and International Clinical Research of Craniosacral Therapy: Scoping Review)

  • 곽민제;한윤희;금지혜;박신혁;우현준;하원배;이정한
    • 한방재활의학과학회지
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    • 제32권3호
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    • pp.13-27
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    • 2022
  • Objectives This study investigated the trends in domestic and international clinical research in craniosacral therapy, classified as a type of Chuna manual therapy, and suggested further directions in Korean medicine. Methods This scoping review was performed using the Arksey and O'Malley methodological framework and preferred reporting items as per the preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews checklist. Eight electronic databases (PubMed, EMBASE, Cochrane Library, Koreanstudies Information Service System [KISS], KMBASE, Oriental Medicine Advanced Searching Integrated System [OASIS], Research Information Sharing Service [RISS], ScienceON) were searched to identify articles with the search terms "craniosacral therapy" and "cranial osteopathy" until December 2021. Results Forty-five studies were eligible as per our inclusion criteria. Most research studies (n=44) were conducted in the field of medicine and pharmacy, especially in rehabilitation medicine (n=16). As a result of the study design, randomized controlled trials (n=20) were the most common, and chronic pain (n=9) was the most frequently targeted disease, followed by headache (n=7). Thirty-two studies suggested interventions and 20 studies used Upledger's 10-step protocol. The average duration of craniosacral therapy was 41 min per session, administered 1.4 times per week. Outcome measurements were analyzed and categorized with the examination procedure for the patient. Conclusions This is the first scoping review of craniosacral therapy in Korea, and we believe that our findings could support its utility as Chuna. In the future, more studies should be conducted to establish the evidence of clinical efficacy of craniosacral therapy and develop standard techniques in Korean medicine.

Full-Endoscopic versus Minimally Invasive Lumbar Interbody Fusion for Lumbar Degenerative Diseases : A Systematic Review and Meta-Analysis

  • Son, Seong;Yoo, Byung Rhae;Lee, Sang Gu;Kim, Woo Kyung;Jung, Jong Myung
    • Journal of Korean Neurosurgical Society
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    • 제65권4호
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    • pp.539-548
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    • 2022
  • Objective : Although full-endoscopic lumbar interbody fusion (Endo-LIF) has been tried as the latest alternative technique to minimally invasive transforaminal lumbar interobody fusion (MIS-TLIF) since mid-2010, the evidence is still lacking. We compared the clinical outcome and safety of Endo-LIF to MIS-TLIF for lumbar degenerative disease. Methods : We systematically searched electronic databases, including PubMed, EMBASE, and Cochrane Library to find literature comparing Endo-LIF to MIS-TLIF. The results retrieved were last updated on December 11, 2020. The perioperative outcome included the operation time, blood loss, complication, and hospital stay. The clinical outcomes included Visual analog scale (VAS) of low back pain and leg pain and Oswestry disability index (ODI), and the radiological outcome included pseudoarthosis rate with 12-month minimum follow-up. Results : Four retrospective observational studies and one prospective observational study comprising 423 patients (183 Endo-LIF and 241 MIS-TLIF) were included, and the pooled data analysis revealed low heterogeneity between studies in our review. Baseline characteristics including age and sex were not different between the two groups. Operation time was significantly longer in Endo-LIF (mean difference [MD], 23.220 minutes; 95% confidence interval [CI], 10.669-35.771; p=0.001). However, Endo-LIF resulted in less perioperative blood loss (MD, -144.710 mL; 95% CI, 247.941-41.478; p=0.023). Although VAS back pain at final (MD, -0.120; p=0.586), leg pain within 2 weeks (MD, 0.005; p=0.293), VAS leg pain at final (MD, 0.099; p=0.099), ODI at final (MD, 0.141; p=0.093) were not different, VAS back pain within 2 weeks was more favorable in the Endo-LIF (MD, -1.538; 95% CI, -2.044 to -1.032; p<0.001). On the other hand, no statistically significant group difference in complication rate (relative risk [RR], 0.709; p=0.774), hospital stay (MD, -2.399; p=0.151), and pseudoarthrosis rate (RR, 1.284; p=0.736) were found. Conclusion : Relative to MIS-TLIF, immediate outcomes were favorable in Endo-LIF in terms of blood loss and immediate VAS back pain, although complication rate, mid-term clinical outcomes, and fusion rate were not different. However, the challenges for Endo-LIF include longer operation time which means a difficult learning curve and limited surgical indication which means patient selection bias. Larger-scale, well-designed study with long-term follow-up and randomized controlled trials are needed to confirm and update the results of this systematic review.

소아 식욕부진에 대한 이공산(異功散) 치료의 효과 : 체계적 문헌고찰 및 메타분석 (Effects of Yigong-san for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis)

  • 이보람;하다정;허태영;박상은;이선행;장규태
    • 대한한방내과학회지
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    • 제43권4호
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    • pp.542-558
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    • 2022
  • Objectives: The purpose of this study was to assess the effect of Yigong-san on anorexia in children by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Eleven electronic databases were searched on May 30, 2022 to collect relevant studies. All studies published up to the search date were considered. RCTs reporting the effect of Yigong-san on the treatment of anorexia in children were included. The primary outcome was an improvement in clinical anorexia symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data were presented as the mean difference and risk ratio with their 95% confidence intervals. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Results: A total of nine studies were included in this systematic review. The treatment group (Yigong-san only or Yigong-san plus conventional treatment) showed a statistically significant effect compared to the control group (conventional treatment only) in total effective rate (Yigong-san only: RR 1.26, 95% CI 1.17, 1.36, I2=0%; Yigong-san plus conventional treatment: RR 1.32, 95% CI 1.18, 1.47, I2=0%), clinical symptoms, some of the anthropometric outcomes, and biological markers related to appetite and growth in children with anorexia. No serious adverse events related to Yigong-san were reported. Conclusions: Yigong-san showed statistically significant effects as a treatment for anorexia in children. However, the number of studies included in the meta-analysis was insufficient, and the herbs contained in the Yigong-san used in the included studies were not standardized. Future research should focus on the implementation of methodologically robust clinical research.

캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석 (Effects for kangaroo care: systematic review & meta analysis)

  • 임정희;김가은;신영희
    • 한국산학기술학회논문지
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    • 제17권3호
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    • pp.599-610
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    • 2016
  • 본 연구는 미숙아와 어머니를 대상으로 캥거루 케어 효과를 비교하기 위해 수행된 체계적 문헌고찰 및 메타분석 연구이다. 2015년 2월까지 출간된 무작위 임상실험연구를 검토하였으며, 국내문헌은 연구설계수준에 따른 제한 없이 비무작위 임상실험연구를 포함하였다. 문헌은 Ovid-Medline, CINAHL, PubMed와 국내 DB인 KoreaMed, 국립중앙도서관, 국회도서관, 국가과학기술전자도서관, KISS, RISS, 한국의학논문을 통해 ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((캥거루 OR 캉가루 OR 캉가루식) AND (케어 OR 간호 OR 관리 OR 돌보기 OR 피부접촉)) 등을 주요어로 조합하여 검색하였으며, 선택배제과정을 거쳐 최종 25편(n=3051)의 문헌이 분석에 포함되었다. 문헌에 대한 질평가는 SIGN에서 제시한 평가도구를 사용하였으며, 질평가 결과는 16편에서 ++, 9편에서 +로 평가되어 전반적으로 비뚤림 위험은 없는 것으로 판단하였다. 미숙아를 대상으로 한 캥거루 케어의 효과에 대한 메타분석 결과, 미숙아 사망률, 중증 감염/패혈증 발생률, 저체온 발생률, 병원입원기간, 모유수유율, 수면상태, 어머니의 불안, 어머니 역할수행 자신감, 어머니 역할수행 만족도에서 통계적으로 유의한 효과가 있었으며, 고체온 발생률, 미숙아의 성장발달(신장, 체중), 모아애착, 우울, 스트레스는 유의미한 차이가 없었다. 국내에서 캥거루 케어에 대한 무작위 임상실험연구 수가 적어 효과크기에 대한 확증적 결과를 얻는 데에는 다소 제한이 있었으므로 향후 이와 관련된 무작위 임상실험연구의 효과검증에 대한 노력이 지속적으로 이루어져야 할 것으로 사료된다.

반복 경두개자기자극술의 우울증 치료효과 및 최신동향에 대한 고찰 (Clinical Efficacy of Repetitive Transcranial Magnetic Stimulation for Treatment of Depression and Latest Trends in TMS Techniques)

  • 김신태;김혜원;김세주;강지인
    • 생물정신의학
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    • 제24권3호
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    • pp.95-109
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    • 2017
  • 본 종설에서는 우울증에서의 rTMS 임상연구를 임상특성과 TMS 적용방법을 고려하여 체계적으로 고찰하였으며 새로운 TMS 치료기법에 대해 살펴보았다. rTMS는 항우울제에 반응이 적은 단극성 우울증 환자의 치료에 병용 혹은 단독요법으로 사용될 수 있는 안전하고 비침습적인 뇌조절술이다. rTMS는 고빈도 좌측 DLPFC, 저빈도 우측 DLPFC, 그리고 양측성 DLPFC 적용방법이 비슷한 수준으로 허위자극에 비해 유의하게 항우울효과를 가지고 있다. 그러나 치료저항성 단극성 우울증에 대한 항우울효과 크기는 작았다. 또한 정신병적 증상이 동반된 우울증의 치료와 양극성 장애의 우울삽화에 대해서는 치료효과가 불분명하다. 기존 rTMS의 항우울효과 크기는 작은 정도로 그 효과를 증진시키기 위해 고용량의 자극, 보다 깊이 자극할 수 있는 코일을 이용한 rTMS 치료, 표적영역에 보다 정확하게 코일을 위치시키는 신경항법 등을 이용한 TMS 적용 등의 새로운 시도들이 진행되고 있다. 또한 세타돌발자극과 자기경련치료와 같은 새로운 치료기법을 이용한 시도가 우울증 치료의 새로운 장을 열고 있다. 비록 현재까지 rTMS의 항우울효과가 만족할 만한 수준은 아니지만 임상양상을 세분화한 치료적용과 개선된 치료기법의 적용 등을 통해 더 많은 후속 연구가 이루어질 필요가 있다. 또한 여러 형태의 TMS 기법에 대해 잘 설계된 허위자극에 대한 통제연구뿐만 아니라 서로의 비교연구를 통해 우울증 치료에서의 근거수준을 높일 수 있을 것으로 기대한다.