• Title/Summary/Keyword: randomized clinical trial

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Recent Clinical Research on Effect of Acupuncture for Strabismus (사시의 침치료에 대한 최근 임상 연구 동향)

  • Lee, Ji Na;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.30 no.2
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    • pp.23-30
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    • 2016
  • Objectives The purpose of this study is to investigate recent clinical studies on effect of acupuncture for strabismus in Korea and other countries. We have analyzed 10 years (from 2006 to 2015) of case studies and randomized controlled trials (RCT) on effect of acupuncture for strabismus. Methods The search database includes Oasis, KTKP (Korean Traditional Knowledge Portal), Medline, Embase, and Cochrane library. To narrow the search, the following key search terms were used: 'strabismus, acupuncture'. The search was limited to the publication date from 2006 to 2015. 7 case studies and 5 control studies were selected for analysis. Results and Conclusions 1. The acupuncture treatment is effective for paralytic strabismus 2. The studies used BL1, GB1, ST2, TE23, GB15, EX-HN5, ST1, and LI4 acupoints and also an electroacupuncture treatment, which is 15 minutes of extraocular muscle stimulation, was used. 3. Degree of strasbismus was tested by Ocular motor range test, Corneal light reflex test, Ocular abducent scale test (Scott and Kraft, Diploptic range test).

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.

Korean Medicine for Thoracolumbar Compression Fracture in Korean Literature : a Systematic Review (흉요추 압박 골절의 한의학적 치료에 대한 국내 임상 근거 : 체계적 문헌 고찰)

  • Bae, Ji Min;Kim, Dae Hun;Kim, Jae Kyu;Lee, Byung Ryul;Yang, Gi Young;Kim, Kun Hyung
    • Journal of Acupuncture Research
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    • v.32 no.4
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    • pp.147-156
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    • 2015
  • Objectives : This study aims to evaluate the effectiveness and safety of Korean medicine for a thoracolumbar compression fracture. Methods : We searched six Korean databases (DBPIA, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, National Digital Science Library, Research Information Sharing Service, KoreaMed) (up to June 2015) and the Journal of Korean Acupuncture and Moxibustion Society. Unpublished studies were also searched. Clinical research, other than case reports involving less than 10 patients, were eligible. The effectiveness and safety of Korean Medicine was analyzed. The 'Risk of Bias' was assessed using the 'Risk of Bias' assessment tool for non-randomized studies as well as the Cochrane Collaboration's 'Risk of Bias' tool. Results : We found 12 before-after studies (374 patients). There was no randomized trial. All studies combined at least three different types of Korean medicine treatments. The period of treatment varied between less a week and 154 days. All the included studies reported improvements in pain, functional disability related to lower back pain, global assessment, and benefits in the compression ratio of a fractured vertebrae and skin temperature measured by digital infrared thermal imaging in comparison with the baseline. However, all studies had a high risk of bias and three studies reported mild adverse events. Conclusions : There is no randomized trial for the role of Korean medicine for patients with a thoracolumbar compression fracture. The effectiveness and safety of Korean medicine for this population remains unclear. Findings in this review are seriously biased due to observational design and a high risk of bias included in the studies. Future high-quality randomized trials are warranted.

Applying Clinical Judgment Rubric for Evaluation of Simulation Practice for Nursing Students : A Non-Randomized Controlled Trial

  • Kim, Hyun-Ju
    • International Journal of Contents
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    • v.14 no.2
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    • pp.35-40
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    • 2018
  • The purpose of this study is to investigate the effects of debriefing using Lasater's Clinical Judgment Rubric to study nursing students' academic self-efficacy, clinical performance, and clinical judgment. The experiment group was subjected to debriefing by applying the Clinical Judgment Rubric, while general debriefing was applied to the control group. The results of the study are as follows: Clinical judgment scores were improved after debriefing for both groups, significantly higher for students in the experimental group compared to the control group. However, there was no significant difference between the two groups in academic self-efficacy or clinical performance. In conclusion, the debriefing based on the Clinical Judgment Rubric used in this study proved to be effective in improving the clinical judgment of nursing students.

The quality of Reports on Randomized Controlled Trials abstracts from Korean Science Citation Index journal and NEJM; Evaluation and Comparison of adherence to the CONSORT Statement (CONSORT statement를 기반으로 한 국내 Science Citation Index 저널과 NEJM의 Randomized Controlled Trial의 abstracts 질적 비교 평가 연구)

  • Kyung, Eun-Jung;Kim, Hyo-Seon;Kim, Eun-Young
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.2
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    • pp.131-136
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    • 2012
  • Objective: This study evaluated and compared the adherence to the CONSORT for quality of reports on the randomized controlled trials (RCT) abstracts by four major Korean Science Citation Index (SCI) journals and The New England Journal of Medicine (NEJM). Methods: A descriptive analysis of published RCT abstracts in Korean SCI journals and NEJM from 2007/01 to 2011/06 was conducted by two reviewers, independently extracting data from a PubMed search. A modification of CONSORT for abstract was used including 16 checklist items. Reporting of checklist items for individual group was conducted to compare adherence patterns between two groups. Results: We identified the potential 57 RCT abstracts from Korean SCI and 50 from NEJM meeting our inclusion criteria; among them, three abstracts from Korean SCI and one from NEJM were excluded. Among total 16 checklist items based on CONSORT statement, Korean SCI journals and NEJM were statistically equivalent in 4 items; Korean journals were better in three items and NEJM were in nine. The methodological quality domains were inadequately reported in both journals: allocation concealment about 1.9% and 4.0%, and blinding 44.4% and 40.8%. In general, The CONSORT adherence of NEJM was better than that of Korean SCI in the method and result domain (p < 0.0001). Conclusions: The quality of NEJM reporting of RCT abstracts was better than that of Korean SCI, in general. This study on adherence of RCT reports from Korean SCI journals and NEJM abstracts to the CONSORT statement reveals that there is a need for improvement, especially Korean SCI. Further investigation on the quality of RCT reports and ways to improve reporting quality is required.

Randomized clinical trial on the efficacy of Escherichia coli-derived rhBMP-2 with ${\beta}$-TCP/HA in extraction socket

  • Huh, Jung-Bo;Lee, Hyo-Jung;Jang, Ji-Woong;Kim, Myung-Jin;Yun, Pil-Young;Kim, Su-Hong;Choi, Kyung-Hee;Kim, Young-Kyun;Cho, Kyoo-Sung;Shin, Sang-Wan
    • The Journal of Advanced Prosthodontics
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    • v.3 no.3
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    • pp.161-165
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    • 2011
  • PURPOSE. This randomized clinical trial was conducted to assess the safety and effectiveness of the ErhBMP-2 in alveolar bone regeneration as well as preservation of the ${\beta}$-TCP bone graft material that contains ErhBMP-2. MATERIALS AND METHODS. This study involved 72 patients at the 3 study centers. The patients, who were divided into 2 groups: the experiment group who had ErhBMP-2 coated TCP/HA and the control group who had TCP/HA graft material alone transplanted immediately after tooth extraction. CT was taken before and 3 months after the transplantation and healing status was compared between the two groups. The efficacy endpoints that were used to measure the degree of bone induction included alveolar bone height and 3 measurements of bone width. The paired t test was used to determine the significance of the changes (P<.05). RESULTS. Changes in alveolar bone height were $-1.087{\pm}1.413$ mm in the control group and $-.059{\pm}0.960$ mm in the experimental group (P<.01). At 25% extraction socket length [ESL], the changes were $0.006{\pm}1.149$ mm in the control group and $1.279{\pm}1.387$ mm in the experimental group. At 50% ESL, the changes were $0.542{\pm}1.157$ mm and $1.239{\pm}1.249$ mm, respectively (P<.01 for 25% ESL, and P<.05 for 50% ESL). During the experiment, no adverse reactions to the graft material were observed. CONCLUSION. ErhBMP-2 coated ${\beta}$-TCP/HA were found to be more effective in preserving alveolar bone than conventional ${\beta}$-TCP/HA alloplastic bone graft materials.

Evaluation of the clinical and radiographic effectiveness of treating peri-implant bone defects with a new biphasic calcium phosphate bone graft: a prospective, multicenter randomized controlled trial

  • Jae-Hong Lee;Hyun-wook An;Jae-Seung Im;Woo-Joo Kim;Dong-Won Lee ;Jeong-Ho Yun
    • Journal of Periodontal and Implant Science
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    • v.53 no.4
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    • pp.306-317
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    • 2023
  • Purpose: Biphasic calcium phosphate (BCP), a widely used biomaterial for bone regeneration, contains synthetic hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), the ratio of which can be adjusted to modulate the rate of degradation. The aim of this study was to evaluate the clinical and radiographic benefits of reconstructing peri-implant bone defects with a newly developed BCP consisting of 60% β-TCP and 40% HA compared to demineralized bovine bone mineral (DBBM). Methods: This prospective, multicenter, parallel, single-blind randomized controlled trial was conducted at the periodontology departments of 3 different dental hospitals. Changes in clinical (defect width and height) and radiographic (augmented horizontal bone thickness) parameters were measured between implant surgery with guided bone regeneration (GBR) and re-entry surgery. Postoperative discomfort (severity and duration of pain and swelling) and early soft-tissue wound healing (dehiscence and inflammation) were also assessed. Data were compared between the BCP (test) and DBBM (control) groups using the independent t-test and the χ2 test. Results: Of the 53 cases included, 27 were in the test group and 26 were in the control group. After a healing period of 18 weeks, the full and mean resolution of buccal dehiscence defects were 59.3% (n=16) and 71.3% in the test group and 42.3% (n=11) and 57.9% in the control group, respectively. There were no significant differences between the groups in terms of the change in mean horizontal bone augmentation (test group: -0.50±0.66 mm vs. control groups: -0.66±0.83 mm, P=0.133), postoperative discomfort, or early wound healing. No adverse or fatal complications occurred in either group. Conclusions: The GBR procedure with the newly developed BCP showed favorable clinical, radiographic, postoperative discomfort-related, and early wound healing outcomes for peri-implant dehiscence defects that were similar to those for DBBM.

The Review of Clinical Studies Published in The Journal of Korean Medical Ophthalmology & Otolaryngology & Dermatology (한방안이비인후피부과학회지에 게재된 임상실험연구에 대한 고찰)

  • Kim, Chul-Yun;Seo, Hyung-Sik;Kim, Nam-Kwen;Lee, Dong-Jin;Kwon, Kang
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.27 no.4
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    • pp.1-15
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    • 2014
  • Objective : This study was carried out to analyze the quality and quantity of Clinical Trials that have been published in the journal of korean medical ophthalmology, otolaryngology, dermatology(JKOOD). Methods : We analyzed 25 clinical trials that published in JKOOD from 1988 to 2014. We excluded case reports, protocol and retrospective studies and classified searched papers into three categories; Randomized Clinical Trials(RCT), Non Randomized Clinical Trials(NRCT), Before After Study(BAS) by using study Design Algorithm for Medical literature of Intervention(DMAI). All articles were analyzed according to diagnosis, statistics program and intervention period. The bias of RCTs were evaluated by Cochrane Risk of Bias(RoB). Result : 1. The number of searched journals is 25 papers; 13 RCT, 2 NRCT, 10 BAS 2. Distribution of clinical trial; 'Atopic dermatitis' ranked the highest(44%) in disease, 'External application' raked the highest(71%) in treatment method. 3. 'allocation sequence' and 'prevention of allocated intervent to patients and therapists' are graded 'Low' but 'incomplete outcome date' and 'selective outcome' are graded 'Uncertain'. Conclusions : It is necessary to study more RCT. It will be helpful to study systematic reviews and meta analysis in JKOOD.

Mandibular arch orthodontic treatment stability using passive self-ligating and conventional systems in adults: A randomized controlled trial

  • Rahman, Norma Ab;Wey, Mang Chek;Othman, Siti Adibah
    • The korean journal of orthodontics
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    • v.47 no.1
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    • pp.11-20
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    • 2017
  • Objective: This randomized controlled trial aimed to compare the stability of mandibular arch orthodontic treatment outcomes between passive self-ligating and conventional systems during 6 months of retention. Methods: Forty-seven orthodontic patients with mild to moderate crowding malocclusions not requiring extraction were recruited based on inclusion criteria. Patients (mean age $21.58{\pm}2.94years$) were randomized into two groups to receive either passive self-ligating ($Damon^{(R)}$ 3MX, n = 23) or conventional system (Gemini MBT, n = 24) orthodontic treatment. Direct measurements of the final sample comprising 20 study models per group were performed using a digital caliper at the debonding stage, and 1 month, 3 months, and 6 months after debonding. Paired t-test, independent t-test, and non-parametric test were used for statistical analysis. Results: A significant increase (p < 0.01) in incisor irregularity was observed in both self-ligating and conventional system groups. A significant reduction (p < 0.01) in second interpremolar width was observed in both groups. Mandibular arch length decreased significantly (p = 0.001) in the conventional system group but not in the self-ligating system group. A similar pattern of stability was observed for intercanine width, first interpremolar width, intermolar width, and arch depth throughout the 6-month retention period after debonding. Comparison of incisor irregularity and arch dimension changes between self-ligating system and conventional system groups during the 6 months were non-significant. Conclusions: The stability of treatment outcomes for mild to moderate crowding malocclusions was similar between the self-ligating system and conventional system during the first 6 months of retention.

External apical root resorption 6 months after initiation of orthodontic treatment: A randomized clinical trial comparing fixed appliances and orthodontic aligners

  • Toyokawa-Sperandio, Katia Cristina;Conti, Ana Claudia de Castro Ferreira;Fernandes, Thais Maria Freire;de Almeida-Pedrin, Renata Rodrigues;de Almeida, Marcio Rodrigues;Oltramari, Paula Vanessa Pedron
    • The korean journal of orthodontics
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    • v.51 no.5
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    • pp.329-336
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    • 2021
  • Objective: To compare the magnitude of external apical root resorption (EARR) 6 months after starting orthodontic treatment using orthodontic aligners (OAs) and fixed appliances (FAs). Methods: This parallel randomized clinical trial included 40 patients randomized into two groups: OA group (n = 20, 160 incisors) and FA group (n = 20, 160 incisors). For evaluation of the tooth length, periapical radiographs and standardized linear measurements of the maxillary and mandibular incisors were acquired before (T0) and 6 months after treatment initiation (T1). EARR was calculated through the difference in length between the two time points (T1-T0). Statistical comparisons were performed by means of using t-tests, chi-squared test and covariance analysis (a = 5%). Results: Rounding of the root apex was observed in both groups; the resorption involved 2.88% of the root length, so 97.12% of the tooth length remained intact. Intragroup comparisons between the two time points revealed a significant difference, with (T1-T0) ranging from -0.52 to -0.88 mm in the FA group and from -0.52 to -0.85 mm in the OA group. In the intergroup comparisons, only tooth #21 presented a statistically significant difference (OA: -0.52 ± 0.57 mm, FA: -0.86 ± 0.60 mm); however, the overall differences between groups were not clinically relevant, ranging from 0.03 to 0.35 mm. Conclusions: OA and FA treatment resulted in a similar degree of EARR in the maxillary and mandibular incisors at 6 months after treatment initiation. However, the amount of resorption was small and does not impair tooth longevity.