• Title/Summary/Keyword: Controlled trial

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만성피로증후군의 증상관리를 위한 추나요법의 유용성: 체계적인 문헌고찰과 메타분석 (Benefit of chuna for managing symptoms in chronic fatigue syndrome patients: A systematic review and meta-analysis)

  • 송정윤;김준열;남동현
    • 대한한의학회지
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    • 제41권3호
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    • pp.205-220
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    • 2020
  • Objectives: The aim of this review is to assess the clinical benefit of chuna for managing symptoms in chronic fatigue syndrome (CFS) Methods: We searched eligible studies from the following 11 databases with no language restriction: Pubmed, CENTRAL, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS and Koreamed. We selected randomized controlled trial (RCT), quasi-randomized controlled trial (Quasi-RCT) and controlled clinical trial (CCT) in which patients with chronic fatigue syndrome were treated with chuna. The results of the included studies were synthesized through meta-analysis, and their risk of bias were also assessed. Results: We searched 914 potentially relevant studies, and only 20 studies were selected for this systematic review. Meta-analysis showed that chuna was more effective in improving general symptoms (n=291, RR 0.19 [95% CI 0.11 to 0.32], Z=6.08, p<0.00001, I2=0%), fatigue (n=487, SMD -0.95 [95% CI -1.19 to -0.71], Z=7.76, p<0.00001, I2=37%) and sleep disorder (n=139, SMD -0.58 [95% CI -0.92 to -0.24], Z=3.36, p=0.0008, I2=0%) compared to health supplements or usual care. When chuna was used as an added intervention, it was more effective in improving general symptoms(n=729, RR 0.25 [95% CI 0.15 to 0.42], Z=5.19, p<0.00001, I2=0%) and fatigue severity alone(n=217, SMD -1.21 [95% CI -1.53 to -0.89], Z=7.45, p<0.00001, I2=15%) compared to control. Conclusion: We found that chuna was beneficial for improving severity of general symptoms and fatigue at post treatment in CFS patients.

기능성 소화불량에 대한 육군자탕 엑스과립의 사상체질별 치료효과: 위약 대조, 이중 맹검, 무작위 시험 (Effects of a Herbal Medicine, Yukgunja-Tang Extract Granule, on Functional Dyspepsia Patients by Sasang Constitution: Placebo-Controlled, Double-Blind, Randomized Trial)

  • 전수형;김종원
    • 사상체질의학회지
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    • 제30권2호
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    • pp.42-54
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    • 2018
  • Objectives This study was aimed to compare effects of Yukgunja-tang (YGJT) extract granule on functional dyspepsia (FD) by sasang constitution. Methods A placebo-controlled, double-blind, randomized, two-center trial was performed. We obtained 3D face images of FD patients participating in this study using face-only scanner and classified them into two types as narrow face and wide face by 3D facial shape diagnosis system (3-FSDS). 96 subjects (48 subjects per type) were enrolled and were randomly allocated into treatment or control groups in a 2:1 ratio. YGJT extract granule or placebo were administered to each group during the 8 week treatment period. One of sasang constitutional specialist diagnosed their constitutions by referring to questionnaires and 3D face images. The primary outcome was total dyspepsia symptom scale (TDS scale), the secondary outcomes were single dyspepsia symptom scale (SDS scale), visual analog scale (VAS) and so on. This trial was registered with clinical research information service identifier: KCT0001920, 15 May, 2016. Results In the Taeeumin treatment group, the TDS scale was significantly decreased after 8 weeks compared to the control group (t=2.331, p=0.025) and the SDS scale also significantly decreased. (t=2.042, p=0.048). The specific effects of the YGJT extract granule without the placebo effect on the Taeeumin with functional dyspepsia were 30.61% in TDS scale and 28.33% in SDS scale. Conclusions The effects of Yukgunja-tang extract granule on functional dyspepsia was different according to Sasang constitution. So the constitution should be considered in randomized controlled trials using herbal extract granules.

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.

A Randomized Controlled Trial to Verify Effects of Kuesu Point on Low Back Pain and Accompanied Sciatica

  • Lee, Jeong-Won;Kim, Dong-Il
    • 대한한의학회지
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    • 제28권4호
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    • pp.86-94
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    • 2007
  • Objective : Kuesu point is a newly discovered point, it is located in 3-cun from the centre of sacrum laterally, paralleled to the 4th foramen on the sacrum. This controlled trial was to evaluate the superior effect of Kuesu point on back pain which radiated to lower extremities. Methods : Randomized Controlled Trial (RCT) and Single Blind in patient was designed. Patients (n=31) were randomized to two groups, Kuesu-point acupuncture group (Group A, n=16) and non Kuesu point acupuncture group (Group B, n=15). Group A was acupunctured on B25 (大腸兪), B26 (關元兪) and B60 (崑崙) with Kuesu point. Group B was acupunctured on the same points without Kuesu point. The clinical subjects were female patients. Beside acupuncture, the other therapies were excluded. Clinical period was three weeks total. Each group was treated 4-5 times per week for 3 weeks. The outcome measurements were The Estimation Index of Backache (quality of life), Pain Rating Scale (pain intensity) and other physical examinations (ROM, SLR, etc.). Results : 31 patients (Group A: n=16, Group B: n=15) were Randomized, 6 of them dropped out. Eventually 25 patients (Group A: n=15, Group B: n=10) were included in the analysis. Group A acupunctured on Kuesu point scored more significant Estimation Index of Backache and lower PRS (Pain Rating Scale) than Group B acupunctured without Kuesu point (p=0.003/2). It turned out that the group acupunctured on Kuesu point show meaningful high improvement index. And other examination's results showed that the treatment effects of Group A are twice as better as Group B. Conclusion : These results suggest that Kuesu point acupuncture was more effective on lower back pain and improved the life quality of patients, being compared with non Kuesu point acupuncture.

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마황복용이 성인여성의 상태-특성 불안에 미치는 영향: 무작위배정 이중맹검 임상연구 (Effects of Ephedra on the State-Trait Anxiety in Female Adults: A Double-Blind Randomized Controlled Study)

  • 양창섭;형례창;정현숙;김락형;곽민정;서의석;장인수
    • 대한한방내과학회지
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    • 제28권2호
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    • pp.346-353
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    • 2007
  • Background : Over a thousand years of clinical preparation of Ephedrain traditional Korean medicine has confirmed effectiveness and security. Recently. Ephedra-containing herbal preparations to treat obesity are common. The aim of this study is to identify effects of Ephedra on psychological anxiety. Objectives : To determine effects of Ephedraon psychoactivity and autonomic nervous system. Methods : The study design was a double-blind randomized controlled trial. The subjects of this study were healthy adults. They were allocated to either the Ephedragroup (N =66) or the placebo group (N =32), Ephedra(8 g) or a placebo in similar opaque capsules was given twice a day for 2 weeks. Anxiety score was estimated with State-Trait Anxiety Inventory before first and after last medication. 36 of the Ephedragroup and 24 of the placebo group finished the trial and were analyzed. Paired samples T-test and independent samples T-test were applied to statistical analysis. Results : The following result was obtained: After taking Ephedra. state anxiety increased significantly. In the placebo group. both state and trait anxiety increased although significance was not reached. Conclusions : It is concluded that the intake of Ephedraplays a significant role in the increase of anxiety in healthy adults. It is suggested that anxiety level change should be considered when using Ephedra in clinics.

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원발성 월경곤란증에 대한 침구치료 관련 무작위배정 임상시험의 체계적 고찰: 한국 문헌을 중심으로 (Acupuncture and Moxibustion for Primary Dysmenorrhea in Korean Literatures: A Systematic Review of Randomized Controlled Trials)

  • 김정완;박봉기;전종익;임윤경
    • Journal of Acupuncture Research
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    • 제32권2호
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    • pp.123-130
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    • 2015
  • Objectives : Primary dysmenorrhea is one of the most common female gynecological diseases. Acupuncture and moxibustion therapy have been used to treat dysmenorrhea in Korea. The aim of this review was to examine the effectiveness of acupuncture and moxibustion therapy for primary dysmenorrhea as described in studies in Korea. Methods : A total of 8 databases were searched, with the search concluding February 15, 2015. These were the Oriental Medicine Advanced Searching Integrated System, DBpia, Korean Studies Information Service System, National Digital Science Library, Korean Traditional Knowledge Portal, Research Information Sharing Service, and Pubmed. Randomized controlled Trails(RCTs) comparing acupuncture or moxibustion therapy with non acupoints stimulation or medication were selected. Data abstraction and assessment of methodology was conducted by authors and disagreements were resolved by discussion. Results : 7 trials were included in this review, with a total of 308 participants. 4 trials reported on acupuncture, 1 trial reported on acupress by magnet, 1 trial reported on pharmacopuncture, and the other trial reported on moxibustion. Quality of methodology was low. 2 trials showed that experimental therapy was effective for pain relief compared to the controlled group. However, 5 trials did not show a significant difference in pain relief. Conclusions : Acupuncture and moxibustion therapy may reduce period pain, however, it is needed for well designed RCTs in Korea.

Localized probiotic-guided pocket recolonization in the treatment of chronic periodontitis: a randomized controlled clinical trial

  • Kumar, Vikram;Singhal, Rameshwari;Rastogi, Pavitra;Lal, Nand;Pandey, Shivani;Mahdi, Abbas Ali
    • Journal of Periodontal and Implant Science
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    • 제51권3호
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    • pp.199-212
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    • 2021
  • Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.

자살시도자에 대한 무작위대조군연구의 등록 현황 분석: WHO-ICTRP를 중심으로 (Analysis of Registration Information of Randomized Controlled Clinical Trials on Suicide Attempters Based on WHO-ICTRP)

  • 박민령;이지원;황인준;권찬영
    • 동의신경정신과학회지
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    • 제34권3호
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    • pp.213-234
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    • 2023
  • Objectives: To investigate current status of randomized controlled clinical trial (RCT) registration for suicide attempters. Methods: The World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) was used to search for data using 'suicide' as a search term. All registration information of RCTs registered up to April 2023 were collected. Results: Among a total of 68 RCTs registered, the United States ranked the highest in terms of quantity in this field (n=30, 46.15%), whereas Asia had only six (8.82%). A total of 62 (91.18%) RCTs involved individual interventions, while nine (13.24%) RCTs involved group interventions. Among individual interventions, 11 (16.18%) and 54 (79.41%) RCTs were on pharmacotherapy and psychotherapy, respectively. Within psychotherapy, there were a total of 17 (25%) studies utilizing digital media, with cognitive behavioral therapy (CBT) via phone being the most common approach. Among non-digital media-based studies, CBT was used the most frequently (n=11, 16.18%), followed by attempted suicide short intervention program (n=6, 8.82%). There were no studies using interventions from East Asian traditional medicine, including Korean medicine (KM). The most frequently used main outcome was the Beck scale for suicidal ideation. Conclusions: Studies on suicide attempts in Asia, especially in South Korea, are very scarce. Despite vigorous psychotherapeutic research in this field, KM psychotherapy has not been used. Thus, KM clinical trial for suicide attempters might be planned in the future based on our findings.

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.

폐암으로 폐 절제술을 시행한 환자에게 적용한 운동 효과: 체계적 문헌고찰과 메타분석 (Exercise Effect Applied to Patients Who Underwent Lung Resection with Lung Cancer: Systematic Review and Meta-Analysis)

  • 박영주;배필원
    • 한국콘텐츠학회논문지
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    • 제18권6호
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    • pp.652-666
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    • 2018
  • 본 연구는 폐암으로 폐절제술을 시행 받은 환자에게 적용한 운동 중재를 파악하고 그 효과의 차이를 규명하기 위하여 체계적 문헌고찰 및 메타분석을 실시하였다. 국내외 전자데이터베이스를 통해 1990년부터 2016년까지 총 1,322개의 논문이 검색되었으며, 문헌 선별 과정을 통해 최종 13개의 문헌을 선정하였다. 최종적으로 925명을 대상자가 포함된 8개의 대조군이 있는 무작위 대조군(randomized controlled trial; RCT)논문와 5개의 대조군이 있는 비무작위 대조군(non-randomized controlled trial; NRCT)논문을 확인하였다. 결과변수에 대한 중재의 효과크기를 메타분석한 결과, 중재군의 건강관련 삶의 질 EORTC QOL-C13/30 (the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire) (MD-0.50 95 % CI -0.83-0.18)과 중재군의 건강관련 삶의 질 SF-36 PCS (the Medical Outcomes 36-Item Short Form Health Survey PCS) (MD 0.75, 95 % CI 0.41-1.10)에서 대조군보다 통계적으로 유의하게 높게 나타났다. 따라서 본 연구의 결과는 운동 중재가 폐암으로 폐 절제술을 시행 받은 환자의 건강관련 삶의 질을 잠재적으로 향상시킬 수 있음을 시사한다.