• Title/Summary/Keyword: non-randomized controlled trial

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A Systematic Review of Clinical Studies for Herbal Medicine of Dementia - based on Korean Literature - (치매의 한약물 치료에 대한 체계적 임상논문 고찰 - 국내문헌을 중심으로 -)

  • Kwon, Yong-Ju;Cho, Hye-Young;Whang, Wei-Wan;Cho, Seung-Run
    • Journal of Oriental Neuropsychiatry
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    • v.21 no.4
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    • pp.151-161
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    • 2010
  • Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

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

  • Lee, Yong-Seok;Lee, Young-Joon;Han, Chang-Hyun
    • Journal of Korean Medicine Rehabilitation
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    • v.23 no.3
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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 Systematic Review from the Journals of the Korean Oriental Medical Society. (대한한의학회지 및 대한한의학회 산하 정회원 학회의 학술진흥재단 등재지에 대한 천식 임상연구의 체계적 고찰)

  • Choi, Jun-Yong;Bang, Ji-Hyung;Shen, Feng-Yan;Jung, Hee-Jae;Jung, Sung-Ki
    • The Journal of Korean Medicine
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    • v.31 no.1
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    • pp.14-22
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    • 2010
  • Objectives: This study aimed to evaluate any clinical research regarding asthma published by the Korean Oriental Medical Society and its sub-societies for future rigorous clinical research. Methods: Every article relevant to asthma was initially obtained from journals in the Korean Oriental Medical Society and its sub-societies by electronic search at journal web sites or manual search. Journals were limited to those registered by the Korea Research Foundation. From initial findings, two independent reviewers selected clinical articles and these articles were further analyzed separately into predefined criteria according to prospective and retrospective studies. For prospective studies, quality assessment was also conducted. Results: From 99 articles initially obtained, 19 were finally analyzed. 14 were prospective whereas 5 were retrospective. Among the prospective articles, there were no randomized controlled trials and the non-randomized studies had no control groups, with several problems of quality regarding pre-calculated study size and unbiased assessment. None of the retrospective studies described asthma diagnosis objectively and outcome measures were either non-relevant to asthma or non-validated. Conclusions: Well-designed randomized controlled studies for asthma are needed and more rigorous non-randomized controlled studies should be conducted.

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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    • v.31 no.1
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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.

Review of Intention-to-Treat Analysis in Randomized Controlled Trials (무작위 대조군 실험 연구에서 치료의향분석 (Intention-to-treat analysis)에 대한 고찰)

  • Kim, Junghun Aj
    • Therapeutic Science for Rehabilitation
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    • v.9 no.2
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    • pp.27-38
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    • 2020
  • Introduction : This review aims to introduce an intention-to-treat analysis(ITT) method and demonstrate the importance of rigorous utilization of this method to researchers in Korea. Discussion : ITT analysis includes all data as results in randomized control trials (RCT). Thereby the result of RCT is high validated to adapt in the real-world so that the result should be expected at clinical practice. Therefore, many RCT quality assessment tools include the question of the utilization of ITT analysis in individual trials. However, many researchers omit to report ITT, not utilize ITT or use ITT incorrectly. Conclusion : Through this review, more Korean researchers may understand and utilize ITT which is expected to enhance the quality of RCT papers.

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

  • Park, Young-Joo;Bae, Phil-Won
    • The Journal of the Korea Contents Association
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    • v.18 no.6
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    • pp.652-666
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    • 2018
  • The purpose of this study was to investigate systematic review and meta-analysisto identify exercise intervention effect applied to patients who underwent lung resection with lung cancer. A total of 1,322 publications were searched from 1990 to 2016 through domestic and foreign electronic databases, and the final 13 publications were selected through literature selection process. Finally, eight RCT (randomized controlled trial) and five NRCT (non-randomized controlled trial) were identified, including 925 participants. The results of the meta-analysis of the effect sizes of the intervention on the outcome variables showed that the health-related quality of life 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) and SF-36 PCS (the Medical Outcomes 36-Item Short Form Health Survey PCS) (MD 0.75, 95 % CI 0.41-1.10) in the intervention group were significantly higher than the control group. The results of this study suggest that exercise interventions can potentially improve the quality of life of patients who underwent lung resection with lung cancer.

Review of Randomized Controlled Trials on Korean Traditional Medicine Treatment for Postpartum Pain (산후신통의 한방 치료에 대한 무작위대조군연구에 관한 고찰)

  • Noh, Eun-Ji;Choi, Su-Ji;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.2
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    • pp.90-111
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    • 2020
  • Objectives: The purpose of this study was to analyze randomized controlled trials (RCTs) related to the effect and safety of Korean Traditional Medicine treatment for postpartum pain, and to suggest desirable future clinical research trend. Methods: Randomized controlled trials (RCTs) on postpartum pain were searched using domestic and foreign search engines to investigate the effect and safety of Korean Traditional Medicine on postpartum pain, and 12 studies were selected as a result. Results: There were 4 studies using Acupoint Therapy, 3 studies using Herbal Medicine, 3 studies using Using Acupoint Therapy and Herbal Medicine together, and 2 studies using Manipulative Therapy for postpartum pain. As control interventions, non-treatment, other Korean Traditional Medicine treatment, or Western medicine were used. All the studies reported a significant effect in experimental group compared to the control group, with no or minor side effects. Conclusions: Korean Traditional Medicine treatment showed effectiveness and safety for postpartum pain. In the future, it is necessary to eliminate the ambiguity of recruiting subjects and to study the most effective application method of Korean Traditional Medicine treatment for postpartum pain.

Efficacy of non-surgical treatment accompanied by professional toothbrushing in the treatment of chronic periodontitis in patients with type 2 diabetes mellitus: a randomized controlled clinical trial

  • Lee, Jae Young;Choi, Yoon Young;Choi, Youngnim;Jin, Bo Hyoung
    • Journal of Periodontal and Implant Science
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    • v.50 no.2
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    • pp.83-96
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    • 2020
  • Purpose: The present study aimed to evaluate the clinical benefit of additional toothbrushing accompanying non-surgical periodontal treatment on oral and general health in patients with type 2 diabetes mellitus (T2DM). Methods: We conducted a doubled-blind randomized controlled trial in 60 T2DM patients between June 2013 and June 2014. The patients were randomly assigned to the scaling and root planing (SRP) group; the scaling and root planing with additional toothbrushing (SRPAT) group, in which additional toothbrushing was performed by toothpick methods; or the control group. Microbiological and oral examinations were performed for up to 12 weeks following treatment. Non-surgical treatment was conducted in the experimental groups. The SRP group received scaling and root planing and the SRPAT group received additional toothbrushing with the Watanabe method once a week from the first visit through the fifth visit. The primary outcomes were changes in haemoglobin A1c (or glycated haemoglobin; HbA1c) levels, serum endotoxin levels, and interleukin-1 beta levels. Periodontal health status was measured by periodontal pocket depth, the calculus index, and bleeding on probing (BOP). Results: Both the SRP and SRPAT groups showed improvements in periodontal health and HbA1c, but the SRPAT group showed significantly less BOP than the SRP group. Furthermore, only the SRPAT group showed a statistically significant decrease in serum endotoxin levels. Conclusions: Non-surgical periodontal treatment was effective in improving HbA1c and serum endotoxin levels in T2DM patients. Furthermore, non-surgical treatment with additional tooth brushing had a more favourable effect on gingival bleeding management. Trial RegistrationClinical Research Information Service Identifier: KCT000416.

What Should Thoracic Surgeons Consider during Surgery for Ground-Glass Nodules?: Lymph Node Dissection

  • Kim, Hong Kwan
    • Journal of Chest Surgery
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    • v.54 no.5
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    • pp.342-347
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    • 2021
  • Thoracic surgeons need to be aware of several important points regarding intraoperative lymph node dissection during surgery for non-small cell lung cancer with ground-glass opacities. The first point relates to the need for lymph node dissection during sublobar resection. Since even patients undergoing sublobar resection may benefit from lymph node dissection, it should be selectively performed according to adequate indications, which require further study. Second, there seems to be no difference in postoperative morbidity between systematic sampling and systematic dissection, but the survival benefit from systematic dissection remains unclear. The results of randomized controlled trials on this topic are conflicting, and their evidence is jeopardized by a high risk of bias in terms of the study design. Therefore, further randomized controlled trials with a sound design should investigate this issue. Third, more favorable survival outcomes tend to be positively associated with the number of examined lymph nodes. Minimum requirements for the number of examined lymph nodes in non-small cell lung cancer should be defined in the future. Finally, lobe-specific lymph node dissection does not have a negative prognostic impact. It should not be routinely performed, but it can be recommended in selected patients with smaller, less invasive tumors. Results from an ongoing randomized controlled trial on this topic should be awaited.

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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    • v.51 no.3
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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.