• 제목/요약/키워드: Randomized Clinical Trial

검색결과 887건 처리시간 0.024초

귀비탕과 그 변방의 만성피로증후군 증상완화에 대한 효용성: 체계적인 문헌고찰 (Is Gwibitang and its modification beneficial for alleviating symptoms in chronic fatigue syndrome: A systematic review and meta-analysis)

  • 남동현
    • 대한한의학방제학회지
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    • 제28권2호
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    • pp.199-209
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    • 2020
  • Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I2=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial

  • Sotoodehnia, Mehran;Farmahini-Farahani, Mozhgan;Safaie, Arash;Rasooli, Fatemeh;Baratloo, Alireza
    • The Korean Journal of Pain
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    • 제32권2호
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    • pp.97-104
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    • 2019
  • Background: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). Methods: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. Results: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was $34.2{\pm}9.9$ and $37.9{\pm}10.6\;years$ in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. Conclusions: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

직장 탈출증에 대한 보중익기탕과 수술 치료 병용요법의 임상 연구 고찰 - 무작위 대조군 연구를 중심으로 (A Review of Clinical Studies about Bojungikgi-tang Combined with Surgical Therapy on Rectal Prolapse - Focusing on Randomized Controlled Trial)

  • 공경환;김도현
    • 동의생리병리학회지
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    • 제38권2호
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    • pp.59-65
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    • 2024
  • Rectal prolapse is a condition where the rectal wall protrudes outside the anus. While it is a rare condition, it can cause discomfort for patients due to the protrusion of the rectal structure, discharge of mucus and blood, fecal incontinence, constipation, and other inconveniences. In this review, we analyzed a randomized controlled trial (RCT) study that used the herbal medicine Bojungikgi-tang(Buzhongyiqi-tang) as a complementary therapy to improve the weaknesses and side effects of the standard treatment, surgical therapy, for rectal prolapse. The analysis included 12 RCT studies, and in all studies, the prescription involved the use of Astragali Radix at the highest dosage. Among the 11 studies that evaluated efficacy, 7 studies showed a significant effect compared to the control group. In all 3 studies that evaluating recurrence rates and all 5 studies investigating complications after surgery, the experimental group showed significant effects. Based on these findings, this study could be considered as a foundational evidence for the application of bojungikgi-tang(Buzhongyiqi-tang) in clinical practice in Korean medicine for patients with rectal prolapse. It could also serve as foundational data for future research.

임신오조(姙娠惡阻) 관련 무작위대조군연구(RCT)에 관한 고찰 - 경혈을 이용한 치료를 중심으로 - (Review on RCT Research Papers Related Nausea and Vomiting in Pregnancy - Focusing on Acupoint Treatment -)

  • 장석우;안인숙;최민선;김동일
    • 대한한방부인과학회지
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    • 제26권2호
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    • pp.138-150
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    • 2013
  • Objectives: To observe randomized controlled trials(RCTs) related to investigating the effects of acupoint treatments on nausea and vomiting in pregnancy to establish the basis of korean medical treatments, and suggest the problems of future clinical research. Methods: After searching for national and international papers published after 2000 and restricting the parameters to 'clinical trial', 'controlled clinical trial', 'randomized controlled trial', then comparing the subjects, methods, research tools, and results to understand the effects and re-comparing the conflicting results to assume the cause. Results: Of the 9 research papers that applied acupressure, four of them used control and experimental groups, and three(75%) research papers indicated significant reduction in vomiting and nausea, and of the seven research papers that utilized the experimental and placebo groups, five(71.4%) reported significant reducing effects. Of the four research papers the used acupuncture treatments, four research papers using control and placebo groups, two showed improvements in symptoms but did not have significant results compared to sham acupuncture groups, and two showed significant reduction of symptoms compared to the control groups. The one research paper that used electrical stimulation showed significant results in the reduction of vomiting and nausea compared to the control group. Conclusions: Acupressure and electrical stimulation showed efficacy reducing the symptoms. Acupuncture treatments did not indicate efficacy some experiments. Therefore it is thought that future acupuncture treatments should use methods that resemble actual clinical medicine to establish efficacy to produce significant results.

양측 눈가림, 무작위배정, 다기관공동 제 3 상 임상시험 결과 : 퇴행성 관절염에 대한 조인스(SKI 306X)정과 Diclofenac과의 비열등성 임상시험 (A randomized, double-dummy, multicenter non-inferiority clinical trials to evaluate the efficacy and the safety of Joins(SKI 306X) compared to diclofenac in patients with osteoarthritis of the knee)

  • 정귀옥;정영복;성상철;안진환;노권재;김정만;박병주
    • 대한예방의학회:학술대회논문집
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    • 대한예방의학회 2001년도 제53차 추계 학술대회 연제집
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    • pp.302-304
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    • 2001
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산림 치유 관련 논문에 관한 체계적 고찰 (Systemic Review on Forest Healing Journals)

  • 선승호;이선구
    • 동의생리병리학회지
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    • 제24권4호
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    • pp.566-570
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    • 2010
  • This review was conducted to investigate clinical trial trend, clinical effect, and study methods of forest healing. Literature search was performed using the search engines of eight electronic databases from inception to march 2010 without language limitation. The search terms were "forest healing", "forest experience", "forest therapy", "forest treatment", "clinical trial", and "clinical study". Inclusion criteria were randomized controlled trials (RCTs) among all kinds of study searched about forest healing. Selection literature and data extraction was performed by authors(SH Sun and SG Lee) independently. Total three studies were selected finally. The methodological quality in all study was low because of poor reporting. Study indications were metal health, depression, self-esteem, and stress. The scale of studies was very small, which was the level of pilot study. There were no description for obtaining informed consent and being reviewed by Institutional Review Board (IRB), and could be any problems for statistical method in any studies. It is difficult to accept the fact that each studies had the significant effect for study indications in the results of studies. It is concluded that the evidence that health healing have a significant effect is insufficient. Further systematic and methodological study and well-designed clinical trial will be needed.

뜸 임상시험 가이드라인 개발 연구 (Development of the General Guideline for Clinical Trial of Moxibustion)

  • 김혜수;김소연;유정은;이은정;김영일;정인철
    • 동의생리병리학회지
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    • 제31권4호
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    • pp.233-237
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    • 2017
  • In this study, we report on the procedure of developing a guideline for clinical research protocol using moxibustion. Systematic review of the literature about moxibustion was conducted as a preliminary study to make basic content. Review and consulting by experts from each field was conducted to improve the quality. And we made checklist by arranging keypoint of this guideline. This guideline, Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE), aims to be a guide for future researchers in planning clinical study using moxibustion as an intervention. MOXRATE also reports on an ethical issues.

간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer])

  • 한가진;김동훈;박은주;성신;김성수;임정태
    • 대한한방내과학회지
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    • 제40권1호
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

치매 치료 한약(처방 및 한약재) 연구 논문 동향 분석 (Analysis of papers on Oriental herbal medicines(prescriptions and herbs) for dementia)

  • 구진숙;서부일;박지하;노성수
    • 대한본초학회지
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    • 제25권3호
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    • pp.131-137
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    • 2010
  • Objectives:In this study, we surveyed papers about Oriental herbal medicines(prescriptions and herbs) for dementia. Method:We collected 64 research papers on Oriental herbal medicines(prescriptions and herbs) for dementia in the internet site OASIS using the keyword dementia. Then we analysed them according to year, research method, etc. Result & Conclusion:The absolute majority of research papers on Oriental herbal medicines(prescriptions and herbs) for dementia was experimental papers. And there were not enough clinical papers. In the future, we have to perform more studies such as RCT(Randomized Controlled Trial) and research papers on combined medication of the oriental and the western medicines for dementia.

Overview of RCT for Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis

  • Son, Chang-Gue
    • 대한한의학회지
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    • 제32권3호
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    • pp.44-49
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    • 2011
  • Objective: This study aimed to get information on the current status of therapies to date for non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH). Methods: All randomized clinical controlled trial (RCT)-derived papers for NAFLD or NASH were reviewed via PubMed Database. Results: 39 RCTs met the review criteria, of which 15 and 24 papers were for NAFLD and NASH, respectively. 83% of the papers were released since 2006, and 30 studies were conducted for western medicines, antioxidants and lifestyle intervention whereas nine trials were done using herbal medicine or acupuncture which showed positive outcome. Conclusions: NAFLD and NASH are new epidemic disorders which can be a target of traditional Oriental medicine. This study will be helpful for the Oriental medicine-based strategies or therapeutic development for them.