• 제목/요약/키워드: Quality of clinical trial

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갱년기 증상에 대한 한약 사용 - 국내 한의 임상연구 분석 (Usage of Korean Herbal Medicine for Climacteric Symptoms - Analysis of Korean Clinical Studies)

  • 배민정;하재운;윤영주
    • 대한예방한의학회지
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    • 제27권2호
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    • pp.85-107
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    • 2023
  • Objective : To investigate the usage of Korean herbal medicine (KHM) for climacteric symptoms, this study reviewed clinical studies conducted in Korea. Method : Literature search was performed on three Korean database; OASIS, RISS and NDSL. Studies published before July 2023 were categorized and analyzed according to the study type and herbal prescriptions. Results : Fifty-eight studies including 7 controlled trial, 27 case series and 24 single case reports were included in our review and the total number of case patients was 420. 52 prescriptions based on syndrome identifications and 11 prescriptions of Sasang constitutions were used and the most frequently used prescriptions were Soyosan(逍遙散) and Guibitang(歸脾湯). Thirty-two prescriptions were also mentioned in previous delphi research or clinical practice guideline, and the rest were not. Thirty-five studies used acupuncture combined with KHM and 10 studies used pharmacopuncture and 5 studies used herbal hipbath. Conclusion : To increase the therapeutic effect of KHM and establish KHM as an alternative to hormone treatment, various prescriptions should be used according to syndrome identifications in the clinical field. High-quality RCTs on frequently used prescriptions and the development of various type of KHM are also necessary.

뇌졸중 후 우울증의 진단과 치료 (Diagnosis and Treatment of Poststroke Depression)

  • 김재민;신희영
    • 생물정신의학
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    • 제12권2호
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    • pp.89-97
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    • 2005
  • Depression is a frequently developed psychiatric symptom after stroke. Poststroke depression(PSD) causes not only psychological distress related to depression but also other disturbances in many areas such as cognitive function, activities of daily living and quality of life. Therefore, a comprehensive understanding of accurate detection and appropriate treatment of depression is mandatory in patients with stroke. This review focused on the current knowledge of PSD.

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해외논문고찰을 통한 천식 및 기침${\cdot}$가래 치료제의 유효성 평가지표 개발연구 (Research on Outcome Indicators in Clinical Trials of Asthma, Cough, and Sputum by Reviewing Papers Searched from PubMed)

  • 오미현;이지형;장보형;정승기;선승호;고호연;전찬용;박종형;고성규
    • 대한한방내과학회지
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    • 제28권3호
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    • pp.519-530
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    • 2007
  • Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

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고창 복분자의 기능성원료 표준화를 위한 지표성분으로서 Ellagic Acid의 분석법 개발 (Method Development of Ellagic Acid as Marker Compound for Standardization of Gochang Bokbunja (Rubus coreanus Miquel) as Functional Ingredient)

  • 김윤정;한송희;전지영;황민호;임용진;채수완;김민걸
    • 한국식품영양과학회지
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    • 제41권11호
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    • pp.1554-1558
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    • 2012
  • 고창 복분자의 개별인정형 건강기능식품 기능성 원료로 개발하기 위하여 지표성분 표준화를 위한 ellagic acid의 분석법 설정과 분석법에 대한 밸리데이션을 실시하였다. 1% formic acid가 첨가된 water와 acetonitrile을 이동상으로 하고 Symmetry$^{(R)}$ (C18, $4.6{\times}250mm$, $5.0{\mu}m$) 칼럼을 사용하여 기울기용리(gradient elution) 방법으로 분석하였다. 본 연구에서는 분석법을 확립하고 분석법에 대하여 특이성, 직선성, 정확성과 정밀성 그리고 회수율에 대하여 확인하였다. Ellagic acid의 검량선은 $R^2=0.9996$으로 좋은 선형성을 보였으며 LLOQ와 LOD는 각각 $1{\mu}g/mL$$0.3{\mu}g/mL$였다. 일내와 일간 분석에서 상대표준편차(RSD)는 각각 2.28%와 2.84%미만으로 나왔다. 회수율 측정결과에서는 89.17~97.92%로 나왔고, RSD는 0.05~0.14%였다. 그러므로 HPLC를 이용한 ellagic acid의 분석법이 고창 복분자 추출물의 기능성원료 표준화를 위한 지표성분 분석을 위한 적합한 시험법임이 검증되었다. 본 시험법에 따라 분석한 고창 미숙과 복분자 추출물 내의 ellagic acid의 함량은 세 lot를 3번씩 분석하였을 때 약 $1.92{\mu}g/mg$(0.192%)이 나왔으며 RSD값은 2.36% 이하였다. 따라서 본 연구를 통하여 확립된 ellagic acid의 분석법이 고창 복분자의 개별인정형 건강기능식품 기능성 원료 개발을 위한 기초자료로 활용될 것으로 본다.

봉독을 이용한 무작위배정 임상연구의 국내 현황 (The Review on the Randomized Controlled Clinical Trials of Bee Venom in the Journal of Korean Medicine)

  • 이용석;이영준;한창현
    • 한방재활의학과학회지
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    • 제23권3호
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    • pp.87-106
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    • 2013
  • Objectives We will provide basic information on bee venom clinical tests and aid the practical use of bee venom in such tests, through examination of RCT research related to bee venom that was reported domestically. Methods We collected 365 articles on Bee venom study result from the OASIS system using the Keyword 'bee venom, apitoxin, apitherapy, bee sting'. The initially selected theses were primarily screened for clinical research. Out of these, case studies and non randomized controlled trial (non-RCT) were ruled out. As a result, 39 studies of randomized controlled trial (RCT) research were chosen as the subjects of study. Results RCT research related to bee venom was first presented in 2003, and 39 studies have been published until 2012. 18 studies were tests to confirm the effectiveness of bee venom, 7 studies were comparisons between SBV and BV, and 13 studies were comparisons with other types of treatment. Research conducted through appropriate randomization methods were 20 studies, and inappropriate randomization methods were used in 19 studies. In therms of Jadad score, 12 studies received 4~5 points, 15 studies received 1-3 points, and 12 studies received zero point. Conclusions In order to assure good quality RCT research, appropriate guidelines should be provided, and proper evaluation standards should be established. In-depth study is needed concerning the difference of responses to treatment according to the types of treatment received. A standardization of treatment should be reached as a result.

암성통증에 대한 침치료의 고찰 (An overview of acupuncture for cancer related pain)

  • 김준래;유화승;이남헌;윤담희;조정효;이연월;손창규;조종관
    • 혜화의학회지
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    • 제15권1호
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    • pp.41-45
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    • 2006
  • Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.

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Therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain: cost utility analysis based on a randomized controlled trial

  • Manchikanti, Laxmaiah;Pampati, Vidyasagar;Kaye, Alan D.;Hirsch, Joshua A.
    • The Korean Journal of Pain
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    • 제31권1호
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    • pp.27-38
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    • 2018
  • Background: Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods: Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results: Patients in this trial on average received $5.6{\pm}2.6$ procedures over a period of 2 years, with average relief over a period of 2 years of $82.8{\pm}29.6$ weeks with $19{\pm}18.77$ weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions: The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

침구 임상시험에서의 중도탈락 관련요인 (Factors Related to Dropout in Clinical Trials of Acupuncture and Moxibustion)

  • 김애란;이무식;홍지영
    • 대한한의학회지
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    • 제32권4호
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    • pp.128-138
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    • 2011
  • Objective: This study aimed at providing preliminary data useful in reducing participant dropout and improving the quality of clinical trials, by analyzing the factors related to dropout. Methods: The data came from 15 acupuncture and/or moxibustion clinical trials (n=638; August 2005 to December 2009). Logistic regression analysis was used to reveal factors influencing participant dropout. Results: Gender, age, treatment method (intervention), treatment frequency, availability of follow-up, and presence of compensation treatment for the control group were factors influencing participant dropout. Conclusion: Subsequent studies of large-scale acupuncture and moxibustion clinical trials should address dropout factors that consider the character of each clinical trial, or general characters like participants' gender, age, occupation, and diverse diseases.

Efficacy of Commiphora myrrha and Honey in Primary Dysmenorrhea: A Randomized Controlled Study

  • Aneesa K, Haleema;Roqaiya, Mariyam;Quadri, Mohd Aqil
    • 셀메드
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    • 제11권4호
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    • pp.19.1-19.8
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    • 2021
  • Background: Dysmenorrhea is the most common menstrual complaint in young women with a prevalence as high as 90% and is responsible for substantial repeated short-term absenteeism from school and work in young women. The objective of this study was to compare the efficacy of Commiphora myrrha and honey with mefenamic acid in primary dysmenorrhea. Materials and Methods: This prospective standard controlled trial was conducted at Luqman Unani Medical College Hospital and Research Center Vijayapura, India where 40 diagnosed patients of primary dysmenorrhea were randomly assigned to receive test drug (powdered Commiphora myrrha gum resin10g with 30g honey in two divided doses) or active control drug (mefenamic acid 250mg TID) for first 3days of menstruationfor two consecutive cycles. The primary outcome measure was reduction in severity of pain assessed by numerical pain rating scale (NPRS), and secondary outcome measures were improvement in quality of life (QOL) assessed by SF-36 and reduction in perceived stress score (PSS). Results: During first cycle treatment no significant difference was found in NPRS score (p=0.085) between the groups however significant difference in NPRS score (p<0.001) was seen during 2nd treatment cycle. Significant reduction (p=0.022) in the perceived stress score was noted and overall quality of life was markedly improved after treatment in both the groups. Conclusion: These data suggest that Commiphora myrrha gum resin with honey is an effective herb in reducing symptoms of primary dysmenorrhea. These results need to be confirmed by a properly designed trial with a larger sample size. Trial registration: Clinical Trial Registry India CTRI/2017/09/009596.

방풍통성산 및 대시호탕의 항비만효과 분석: 단일기관 무작위배정 이중맹검 임상시험 프로토콜 (The Anti-obesity Effects of Bangpungtongseong-san and Daesiho-tang: A Study Protocol of Randomized, Double-blinded Clinical Trial)

  • 오지홍;심혜윤;차지윤;김호석;김민지;안은경;이명종;이준환;김호준
    • 한방비만학회지
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    • 제20권2호
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    • pp.138-148
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    • 2020
  • Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.