• Clinical and Experimental Pediatrics
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• v.55 no.11
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• pp.403-407
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• 2012

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

• Journal of Korean Medicine Rehabilitation
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• v.27 no.3
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• pp.95-105
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• 2017

Objectives To evaluate the evidence supporting the effectiveness of Soyeom pharmacopuncture therapy for Pain. Methods We conducted search across 6 electronic databases (Pubmed, CAJ, Oasis, RISS, DBPIA and KoreanTK) and 2 journals to find clinical trials that used Soyeom pharmacopuncture therapy as treatment for pain. The methodological quality of Randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias (RoB) tool, while NRCTs (Non-Randomized controlled clinical trials) were assessed using the Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Among 75 articles that were searched, 5 RCTs and 2 NRCTs were finally selected. Among 7 selected studies, all studies showed that Soyeom pharmacopuncture therapy has significant effect on Pain. Conclusions Our systematic review found encouraging but limited evidence of Soyeom pharmacopuncture therapy for Pain. We recommend clinical trials which compare the effectiveness of Soyeom pharmacopuncture therapy with other pharmacopuncture therapies to clarify the effectiveness of Soyeom pharmacopuncture therapy from other pharmacopuncture therapies.

• The Journal of Internal Korean Medicine
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• v.43 no.3
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• pp.423-435
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• 2022

Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO₂max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

• Journal of Dental Anesthesia and Pain Medicine
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• v.21 no.4
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• pp.269-282
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• 2021

This review aimed to assess and compare the outcomes of the anesthetic efficacy of inferior alveolar nerve block (IANB) and Gow-Gates mandibular nerve block (GGMNB) in patients with symptomatic irreversible pulpitis. A descriptive systematic review of quantitative research was conducted wherein the "Preferred Reporting Items for Systematic Reviews (PRISMA)" was adopted, and the Problem/Patient/Population, Intervention/Indicator, Comparison, Outcome (PICO) criteria were used to structure the research question. A literature search was performed using PubMed/Medline, Cochrane Library, Google Scholar, and Ovid. Selection criteria were applied for populations over nine years of age, of either sex, with irreversible pulpitis, and articles published in English regarding conventional IANB or IANB and Gow-Gates techniques between 2009 and 2019. Prospective randomized clinical trials or randomized controlled trials were included in the review, in which anesthetic efficacy or success was measured. After screening, four articles were included. Three studies were randomized clinical trials, and two were randomized controlled trials. The validity and reliability of the individual studies were examined. There was evidence of the higher efficacy of the GGMNB technique than that of the IANB technique. However, both techniques can be mastered through training.

• The Journal of Korean Obstetrics and Gynecology
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• v.32 no.4
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• pp.87-101
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• 2019

Objectives: The purpose of this study is to investigate the effect of herbal medicine during the Western medicine therapy in adenomyosis. Methods: The author searched 5 electronic databases and search keywords were 'Adenomyosis' and 'Herbal Medicine'. We included randomized controlled clinical trials (RCTs) using herbal medicine therapy combined Western medicine for adenomyosis patients. Results: The author selected 12 studies. The systematic review of the 12 trials indicated that herbal medicine therapy integrated Western medicine therapy was more effective than Western medicine therapy alone. Conclusions: The herbal medicine therapy combined Western medicine for adenomyosis patients seems to improve pain relief and improvement of illness from this research. However, this result should be taken cautiously by unclear risk of bias. More clinical research will be needed to standardize the results of this study through herbal medicine.

• The Journal of Pediatrics of Korean Medicine
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• v.36 no.3
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• pp.75-86
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• 2022

Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.1
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• pp.13-29
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• 2023

Objectives To evaluate the evidence supporting the effectiveness of acupuncture for facet joint syndrome. Methods We conducted search across 9 electronic databases (PubMed, EMBASE, Cochrane CENTRAL (CENTRAL), KoreaMed, Kmbase, Koreanstudies Information Service System (KISS), ScienceOn, China National Knowledge Infrastructure (CNKI), and Wanfang) to find clinical trials that used acupuncture as treatment for facet joint syndrome. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (nRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Nine RCTs and one nRCT met our inclusion criteria. Fire needle was more effective than medial branch block in terms of visual analogue scale (VAS) after 1 month (p=0.02). Also, Fire needle was more effective than Ibuprofen in terms of VAS and oswestry disability index (ODI) (p<0.05). However, in the rest of the study results, the intervention group did not show a statistically significant difference than the control group. Conclusions Although our review found encouraging but limited evidence of acupuncture for facet joint syndrome, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

• The Journal of Korean Medicine
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• v.30 no.5
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• pp.115-126
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• 2009

Objective: By assessing the quality of methodology and synthesis of results of RCTs (Randomized Controlled Clinical Trials) with herbal acupuncture (pharmacopuncture), we hope to help with administrating herbal acupuncture therapy in clinic and conducting RCT with herbal acupuncture. Methods: Reports of RCT conducted in Korea published in medical journals until February 2009 were collected. We surveyed elementary information of RCTs, evaluated randomization, double-blinding, allocation concealment and put together the results of RCTs by seven clinical topics. Results: 38 RCTs with herbal acupuncture were selected, then adequate methods for randomization and allocation concealment were found in 39% and 5% of studies. Complete double-blinding and a clear accounting of all participants were conducted in 42% and 50% of reports. The synthesis of RCTs revealed that herbal acupuncture was useful and effective on degenerative gonarthritis, omarthralgia on cerebrovascular accident, acute ankle sprain, back sprain, neck sprain, headache, rheumatoid arthritis and tennis elbow, generally. Conclusions: Although further improvement in quality of methodology of RCTs with herbal acupuncture is required, clinical usefulness of herbal acupuncture was shown especially on disorders of musculoskeletal system via RCTs.

• 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.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.2
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• pp.947-950
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• 2013

Background: We performed this meta-analysis to assess the effectiveness and safety of axillary dissection in old women. Methods: The Cochrane Library, PubMed, EMBASE and Chinese Biomedical Literature Database were searched and all randomized controlled trials of axillary dissection in old women (at least 60 years old) were considered. Meta-analyses were completed using RevMan5.1. Results: Three eligible randomized controlled trials (RCTs) including 5,337 patients were considered. There was weak evidence in favour of axillary dissection (AD) in old women. The meta-analysis showed that the overall survival (OS) after 1, 3, 5 and 7 years and the disease free survival (DFS) after 1, 3 and 5 year were not statistically significantly different between AD and no AD groups. However, there was a difference in the 7 year DFS. Conclusions: Axillary dissection did not provide survival benefit to the old women with breast cancer analysed. Therefore, axillary dissection is not well-indicated in old women with breast cancer.