• 제목/요약/키워드: RCT(Randomized Controlled Trial)

검색결과 140건 처리시간 0.032초

갱년기 안면홍조에 대한 침 임상시험 방법론 연구 (A Study on the Methodology of Acupuncture Clinical Trial on the Postmenopausal and Perimenopausal Hot Flashes)

  • 노진주;김동일
    • 대한한방부인과학회지
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    • 제21권4호
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    • pp.193-206
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    • 2008
  • Purpose: In spite of many arguments on the result of WHI (Women's Health Initiative) study, no one can deny the necessity for researches on the alternative treatment to HRT (hormone replacement therapy). In this study, the author wanted to investigate the method of precedent acupuncture RCTs (randomized controlled trials) to make out the appropriate acupuncture study design on postmenopausal and perimenopausal hot flashes in Korea. Methods: Precedent studies were investigated using Pubmed search and key-words "acupuncture and hot flash", "acupuncture and menopause", "acupuncture and vasomotor", limited to RCT, from 2000 to 2008 April. Results: As a result. 10 studies were searched. In the hereafter studies, multi-center clinical trials which consist of population group of postmenopausal and perimenopausal women that would be pre-stratified and more than 50 patients per treatment arm seem adequate. Sham control study can make out the proper consequence because many people are get used to acupuncture in Korea. Flexible choice of acupoints addressed an individual's symptoms using standardized algorithm is recommended. Treatment consist of 4 weeks' observation, 11 acupuncture sessions during 7 weeks, follow-up of 3 months or more after treatment and hot flash score as a primary outcome measure seem appropriate. After all, higher level of description according to global standard must be obtained in the study report and publishing. Conclusion: The researchers should develope the methodology of acupuncture clinical trial on the postmenopausal and perimenopausal hot flashes.

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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.

여성의 주요우울증에 대한 노에스액(육울탕)의 안전성, 유효성 평가 : 무작위배정, 양측눈가림, 위약대조, 평행설계 임상시험 프로토콜 (A Research to Evaluate the Safety and Efficacy of Yukwool-tang (Liuyu-tang) for Major Depression in Women: A Study Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial)

  • 서영경;이은희;김환;이지윤;박채린;최선영;장은수;권오진;김형준;정인철
    • 동의신경정신과학회지
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    • 제29권1호
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    • pp.35-46
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    • 2018
  • Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

원발성 월경곤란증의 뜸 치료에 대한 체계적 문헌고찰 및 메타분석 (The Effectiveness of Moxibustion Treatment for Primary Dysmenorrhea: A Systematic Review and Meta-Analysis)

  • 이혜인;백선은;이호정;박경선;이진무;유정은
    • 대한한방부인과학회지
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    • 제30권2호
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    • pp.107-119
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    • 2017
  • Objectives: The purpose of this study is to investigate the effectiveness of moxibustion for primary dysmenorrhea (PD). Methods: We searched 10 electronic databases (CNKI, WANFANG, VIP, AMED, CiNii, Embase, PubMed, Cochrane, OASIS, Korea Traditional Knowledge Portal) to identify eligible studies published before November 2016. We included randomized controlled clinical trials (RCTs) using moxibustion for primary dysmenorrhea. The methodological quality of each RCT was assessed by the Cochrane risk of bias tool. Results: Ten RCT studies were eligible in our review. The overall risk of bias was evaluated as unclear. The meta-analysis of 4 trials indicated that favorable results for the use of moxibustion. Conclusions: This systematic review and meta-analysis of clinical trials suggests that moxibustion can achieve good efficacy for PD patients. However, because of studies included analysis was biased due to unclear risk of bias and unreliable study design, future high-quality RCT studies are needed to determine the association moxibustion with PD.

다운증후군 (Down's syndrome)의 한의학적(韓醫學的) 치료(治療)에 관한 고찰(考察) - 중의학(中醫學) 저널을 중심(中心)으로 - (The Literature Study on Treatment of Down's Syndrome - Within Chinese Medical Journal -)

  • 정준석;김기봉
    • 대한한방소아과학회지
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    • 제26권4호
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    • pp.61-70
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    • 2012
  • Objectives: Literature Study of clinical cases with Traditional Chinese Medicine (TCM) as reference for Korean medicine based treatment of juvenile patients with Down's syndrome. Methods: 4 TCM journals with the highest impact factors were searched and selected among the journals listed in www.cnki.net. The search keywords were "蒙古症", "唐氏症(産生唐氏症)", "唐氏症候群", "先天愚型", "伸舌樣痴呆", "21三体綜合徵", "三染色体症", "Down's syndrome", and "Mongolism". Accordingly, searched papers were analyzed. Results: Total 6 studies were selected: RCT(5), case report(1). Among the RCT related studies, 2 studies tested the effect of Electroacupuncture (電鍼), 1 study tested the effect of Electroacupuncture and Pharmacopuncture (藥鍼) treatment together, and 2 studies tested the effect of Electroacupuncture and Herbal Medicines (藥物) co-treatment. In all the studies, the study groups showed significantly improved intelligence quotient (IQ) in comparison with the control groups. The case report showed improvement of cognitive ability and other clinical parameters as a result of Acupuncture (鍼) and Herbal Medicines co-treatment in juvenile patients with Down's syndrome. Conclusions: Clinical studies testing the effect of TCM for the treatment of Down's syndrome have been conducted in small scales, and all the studies showed a certain level of brain function improvement of the patients in the study groups. These results implicate that the methods in Korean medicine can be highly potential treatment options for the treatment of Down's syndrome. Conduction of accurate and well-controlled studies in large scale would be required to prove the effect of Korean medicine for the treatment of patients with Down's syndrome.

비만 여성에서 한방 비만 변증에 따른 홍삼의 비만 개선 효과 : 무작위 배정, 이중 맹검, 위약 대조 임상시험 (Efficacy of Red Ginseng by Oriental Medical Obesity Syndrome Differentiation on Obese women : Randomized, Double-blind, Placebo-controlled Trial)

  • 권동현;이명종;임지연;;이수진;김호준
    • 한방비만학회지
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    • 제11권1호
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    • pp.1-14
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    • 2011
  • Objectives This trial was conducted to evaluate the efficacy of Red Ginseng by oriental medical obesity syndrome differentiation on obese women as compared to placebo. Methods 50 obese women were recruited and randomized to receive Korean Red Ginseng(n=24) or placebo(n=26) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure, pulse rate, resting metabolic rate, Korean version of obesity-related quality of life(KOQOL) scale and oriental medical obesity syndrome differentiation questionnaire were measured at baseline and 8 weeks. Adeverse events and safety outcomes variables were also checked during trials. Results and Conclusion There was significant efficacy of Red Ginseng on obese women in body weight, body fat mass, waist-hip ratio, food intake, KOQOL as compared with baseline. But there was no efficacy as compared with placebo group except KOQOL. There was no difference of efficacy compared with the oriental medical obesity syndrome differentiation.

다계통 위축증의 치료에 대한 임상연구 동향 - CNKI검색을 중심으로 (A Review of Clinical Studies for Treatment of Multiple System Atrophy Using the CNKI Database)

  • 김민지;원서영;김해융;유주영;정은선;유호룡;설인찬;김윤식
    • 대한한방내과학회지
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    • 제41권4호
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    • pp.612-623
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    • 2020
  • Objectives: The aim of this research was to investigate and review the trends in recent clinical studies of multiple system atrophy (MSA) in China. Methods: We searched for clinical studies discussing Oriental medicine-based treatments for MSA in the China National Knowledge Infrastructure (CNKI) database. The search focused on the authors; publication year; type of study; method and duration of treatment; evaluation criteria; and results of the selected articles. Results: Among the articles retrieved from the database, eight case series, two randomized controlled trials (RCTs), and one non-randomized controlled trial (nRCT) were analyzed. Eight articles used acupuncture; ten used herbal medicine. The most frequently used acupoints were GV20, GV24, GB20, PC6, Hyeopcheok Acupoint, CV4, EX-HN3, and GV17. Jihwangeumja was the most commonly used herbal prescription. All 13 studies confirmed the efficacy of Oriental medicine treatments. Conclusions: More varied and scientifically designed clinical studies are required to develop treatments for MSA. The results of this study may provide guidance for further studies of MSA.

견관절 통증에 대한 팔단금 운동의 효과: 체계적 문헌 고찰 (Baduanjin Exercise for Shoulder Pain: A Systematic Review)

  • 김현태;이상현;박선영;허인;황만석;신병철;황의형
    • 척추신경추나의학회지
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    • 제15권1호
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    • pp.89-100
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    • 2020
  • Objectives : This study aimed to verify the clinical effectiveness of Baduanjin for shoulder pain. Methods : We searched 10 electronic databases (PubMed, EMBASE, Cochrane Library, CAJ, KISS, KISTI, KMBASE, RISS, NDSL, and OASIS) up to May 2020. We included randomized controlled trials (RCTs) using Baduanjin for shoulder pain. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : As a result of the search, a total of 6 RCTs were eligible for analysis. Of these 6 studies, one applied Baduanjin alone and 5 cases used Baduanjin in combination with other treatments, such as acupuncture or electroacupuncture. Except for 2 studies, descriptive analysis was performed without meta-analysis due to the high level of heterogeneity between studies. A high risk of bias was observed in all studies. Conclusions : When considering the results of the included papers, there was limited information derived on the therapeutic effect of using Baduanjin as a single intervention, but the results showed significant effectiveness when Baduanjin was combined with other oriental interventions, such as acupuncture and electroacupuncture, in the clinical field. Although all RCTs included in the analysis were biased to CAJ and the number was limited, this study was conducted in accordance with the methodological process of systematic literature reviews and revealed the clinical effects of Baduanjin on shoulder pain.

경도인지장애의 침 치료에 대한 무작위배정 대조 임상시험(RCT) 연구 논문에 대한 질 평가 : STRICTA와 CONSORT 지침을 바탕으로 (Quality Assessment of Studies on Randomized Controlled Trials (RCTs) of Acupuncture Treatment for Mild Cognitive Impairment: Based on the STRICTA and CONSORT Guidelines)

  • 신여옥;허우영;이인
    • 대한한방내과학회지
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    • 제40권6호
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    • pp.1101-1111
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    • 2019
  • Objective: The purpose of this study was to investigate quality of reporting acupuncture intervention for mild cognitive impairment (MCI) based on the STRICTA and CONSORT guidelines Methods: We searched for randomized controlled trial studies of acupuncture treatment for MCI in the MEDLINE (PubMed) database. Once the online search was completed, studies were selected manually by the inclusion criteria, and the selected studies were evaluated by STRICTA and CONSORT guidelines. Results: Five studies were included. The most frequently selected points for acupuncture treatment of MCI were on the head, such as GV20, EX-HN1, GV24, and GB20. By STRICTA guidelines, all items from STRICTA were reported except three items on the checklist. By CONSORT guidelines, apart from six items which were not available, quality assessment was performed with 31 items. Eighteen items were reported by 80% of the studies. Four items were reported by 40% of the studies and another four items were reported by 20% of the studies. One item was not reported in all studies. Conclusion: Most items were reported by STRICTA guidelines, whereas many items were insufficiently reported based on CONSORT guidelines. This needs to be considered in future RCTs of acupuncture treatment for MCI.

Meta-analysis for Efficacy and Safety of Propofol during Dental Sedation

  • Choi, Seong-Seok;Seo, Kwang-Suk;Kim, Hyun-Jeong
    • 대한치과마취과학회지
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    • 제12권2호
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    • pp.75-91
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    • 2012
  • Background: Dental sedation reduces fear and phobia during dental treatment and helps patients get quality treatment by inducing adequate consciousness control. Propofol has recently grabbed the spotlight, but no meta-analysis for efficacy and safety of propofol in dentistry has yet been performed. Thus, the purpose of this study was to perform meta-analysis to verify the efficacy and safety of propofol for use in dental sedation. Methods: Articles published between 1980 and 2010 were searched in the web sites, journals and medical database including The Cochrane Library, MEDLINE and EMBASE. And a total of 22 studies were selected among the randomized controlled trials (RCTs) that compared the use of propofol with other sedatives (control group). The data was collected from these studies and meta-analysis for efficacy and safety was performed using Comprehensive Meta-Analysis 5.0 (CMA 5.0). Results: The patient recovered significantly faster and discharged significantly earlier in the propofol group (SMD = -1.442, P < 0.001). The satisfaction of patient and that of operator was higher in the propofol group (P < 0.05). The incidence of arrhythmia and apnea/ hypoventilation was significantly lower in the propofol group (OR = 0.071, P < 0.05), and there was no significant difference in the other side effects. On the level of sedation, although the sedation score was significantly lower in the propofol group (SMD = -0.430, P < 0.05). Conclusions: The present analysis showed that the use of propofol resulted in high satisfaction levels on the part of the patients and operators, a shorter recovery time, and faster hospital discharge. The incidence of complications, however, was lower in the propofol groups or not much different between the propofol and control groups. Thus, the adequate use of propofol in dentistry is believed to be helpful for the effective and safe sedation of the patients.