• Asian Pacific Journal of Cancer Prevention
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• 제17권7호
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• pp.3185-3190
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• 2016

Background: This study was designed to compare radioguided versus routine wire localization of nonpalpable non-malignant breast lesions in terms of efficacy for complete excision, ease of use, time saving, and cosmetic outcome. Materials and Methods: Patients with non-palpable breast masses and non-malignant core biopsy results who were candidates for complete surgical lumpectomy were enrolled and randomly assigned to radioguided or wire localization groups. Radiologic, surgical, and pathologic data were collected and analyzed to determine the difficulty and duration of each procedure, ease of use, accuracy, and cosmetic outcomes. Results: This prospective randomized study included 60 patients, randomly divided into wire guided localization (WGL) or radioguided occult lesion localization (ROLL) groups. The mean duration of localization under ultrasound guidance was shorter in the ROLL group (14.4 min) than in the WGL group (16.5 min) (p<0.001). The ROLL method was significantly easier for radiologists (p=0.0001). The mean duration of the surgical procedure was 22.6 min (${\pm}10.3min$) for ROLL and 23.6 min (${\pm}9.6min$) for WGL (p=0.6), a non-significant difference. Radiography of the surgical specimens showed 100% lesion excision with clear margins, as proved by pathologic examination, with both techniques. The surgical specimens were slightly heavier in the ROLL group, but the difference was not significant (p=0.06). Conclusions: The ROLL technique provides effective, fast, and simple localization and excision of non-palpable non-malignant breast lesions.

• Journal of Acupuncture Research
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• 제32권4호
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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 Unpublished studies were also searched.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.

• 대한한의학회지
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• 제33권1호
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• pp.12-23
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• 2012

Objectives: This study evaluated clinical trials of acupuncture treatment for hypertension and to assess their methodology and results. Methods: Eight Korean databases and four international databases were searched for clinical trials of acupuncture treatment for hypertension up to June 2011. Study quality was assessed using the risk of bias (ROB) tool. Results: Twenty-four trials of acupuncture for hypertension were included. There were 14 randomized and 1 non-randomized controlled trials and 9 before-after studies. The most frequently used acupuncture points were zsnli (ST36), qch (LI11), fngch (GB20), snynjio (SP06), snjin (LI03) and hgu (LI04). In more than half of the studies, needle retention time was 20~30 minutes. Compared to baseline, change of blood pressure after treatment was significant in all studies. However, the results of effect on blood pressure between acupuncture and control were not consistent. Conclusions: There is insufficient evidence to suggest that acupuncture is an effective treatment for hypertension. Further well-designed clinical trials will be required to evaluate the effects and safety of acupuncture treatment for hypertension.

• Communications for Statistical Applications and Methods
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• 제24권6호
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• pp.561-581
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• 2017

Bayesian statistics can play a key role in the design and analysis of clinical trials and this has been demonstrated for medical device trials. By 1995 Bayesian statistics had been well developed and the revolution in computing powers and Markov chain Monte Carlo development made calculation of posterior distributions within computational reach. The Food and Drug Administration (FDA) initiative of Bayesian statistics in medical device clinical trials, which began almost 20 years ago, is reviewed in detail along with some of the key decisions that were made along the way. Both Bayesian hierarchical modeling using data from previous studies and Bayesian adaptive designs, usually with a non-informative prior, are discussed. The leveraging of prior study data has been accomplished through Bayesian hierarchical modeling. An enormous advantage of Bayesian adaptive designs is achieved when it is accompanied by modeling of the primary endpoint to produce the predictive posterior distribution. Simulations are crucial to providing the operating characteristics of the Bayesian design, especially for a complex adaptive design. The 2010 FDA Bayesian guidance for medical device trials addressed both approaches as well as exchangeability, Type I error, and sample size. Treatment response adaptive randomization using the famous extracorporeal membrane oxygenation example is discussed. An interesting real example of a Bayesian analysis using a failed trial with an interesting subgroup as prior information is presented. The implications of the likelihood principle are considered. A recent exciting area using Bayesian hierarchical modeling has been the pediatric extrapolation using adult data in clinical trials. Historical control information from previous trials is an underused area that lends itself easily to Bayesian methods. The future including recent trends, decision theoretic trials, Bayesian benefit-risk, virtual patients, and the appalling lack of penetration of Bayesian clinical trials in the medical literature are discussed.

• Journal of Acupuncture Research
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• 제29권3호
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• pp.19-28
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• 2012

Objectives : The aim of this study is to evaluate present clinical evidence of oriental medical treatment for cancer in Korea. Method : A search was performed in the Korean Studies Information, Korea Institute of Science and Technology Information, KoreaMed, Oriental Medicine Advanced Searching Integrated System, National Assembly Library, RISS4u, DBPIA, and Oasis using the keyword 'cancer', 'leukemia', 'malignant tumor', 'lymphoma', 'multiple myeloma', 'melanoma'. The search period spanned between Jan 1, 1980~June 30, 2011 and the results were analyzed and evaluated according to the publication date, journal, method of treatment, type of study, and the primary outcome. Randomized clinical trials (RCTs) and Non randomized clinical trial(NRCT) were reviewed separately. Result : The results yielded 133 trials during the period of Jan 1, 1980~June 30, 2011. Most of the trials were concerned with lung cancer and 94 of the trials were simple case studies or case series studies. 61 trials used herbal Formula/herbal medicine as the primary method of treatment. A total of 4 RCTs existed compared to only one NRCT. Conclusion : The use of oriental medicine for the treatment of cancer is gaining popularity in the field of medical scientific research. However most of the studies that have been published up to date are mostly case studies or case series studies, and RCT/NRCT are rare. In order to provide appropriate evidence regarding the effectiveness of oriental medicine in the treatment of cancer, more rigorous and well-designed studies are warranted.

• 한방재활의학과학회지
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• 제29권2호
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• pp.171-188
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• 2019

Objectives The purpose of this thesis is to compare and analyze outcomes of case studies and controlled studies about Hwangryunhaedok-tang (HHT) pharmacopuncture in clinical studies. Based on these studies reporting clinical effects by using HHT pharmacopuncture, we object to deduct the comparative review in applying clinical disorders limitedly. And conclusionally, by using this comparative review, we aim to make the fine evidence in treating clinical specific diseases. Methods We searched 106 studies about HHT pharmacopuncture from 6 Korean web databases by using in Korean word 'Hwangryunhaedok-tang pharmacopuncture'. This search had been progressed throughout 1 month (January, 2019). There was 106 thesis and we excluded studies that are not related to HHT pharmacopuncture, experimental research, not the case report or randomized controlled trials, non-randomized controlled trials, not using HHT pharmacopuncture, not using only one pharmacopuncture, and not using HHT pharmacopuncture for major treating method. As a result, 39 thesis are selected as a population. Results We analyzed 34 case reports and 5 controlled studies. As the final outcome, HHT pharmacopuncture was used in musculoskeletal diseases, dermatopathy, and 32 specific diseases. Conclusions After analyzing 39 studies, effective symptom changes clinically and statistically by using HHT pharmacopuncture herbal acupuncture were identified. However, these thesis designs were reported deficiently in many parts such as not excluding other confounding variables. After modifying defects of thesis design and conduct study, it can play a role as the evidence using HHT pharmacopuncture more precisely.

• 대한한방내과학회지
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• 제42권6호
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• pp.1184-1198
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• 2021

Objectives: The aim of this study was to investigate the latest clinical studies on Korean medicine treatment of post-concussion syndrome (PCS) in the Chinese National Knowledge Infrastructure Database (CNKI). Methods: We searched the last 10 years of clinical studies discussing Oriental medicine-based treatments for PCS in the CNKI database. The search focused on the authors, publication year, type of study, purpose of the study, method and duration of treatment, evaluation criteria, and results of each article. Results: Of the 22 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 19 were randomized controlled trials (RCTs). Treatments included oral herbal medicine in 16 studies, oriental medicine through external use in 2 studies, acupuncture in 3 studies, and traditional Chinese medicine injection in 2 studies. The most frequently used herb was Cnidii Rhizoma (川芎). All 22 studies confirmed the efficacy of Oriental medicine treatments. Conclusion: More varied and scientifically designed clinical studies are required to develop treatments for PCS. The results of this study could be used as basic data for further PCS studies.

• The Journal of Advanced Prosthodontics
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• 제16권1호
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• pp.57-65
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• 2024

PURPOSE. The aim of this stuldy was to compare the clinical marginal fit of CAD-CAM inlays obtained from intraoral digital impression or addition silicone impression techniques. MATERIALS AND METHODS. The study included 31 inlays for prosthodontics purposes of 31 patients: 15 based on intraoral digital impressions (DI group); and 16 based on a conventional impression technique (CI group). Inlays included occlusal and a non-occlusal surface. Inlays were milled in ceramic. The inlay-teeth interface was replicated by placing each inlay in its corresponding uncemented clinical preparation and taking interface impressions with silicone material from occlusal and free surfaces. Interface analysis was made using white light confocal microscopy (WLCM) (scanning area: 694 × 510 ㎛²) from the impression samples. The gap size and the inlay overextension were measured from the microscopy topographies. For analytical purposes (i.e., 95-%-confidence intervals calculations and P-value calculations), the procedure REGRESS in SUDAAN was used to account for clustering (i.e., multiple measurements). For p-value calculation, the log transformation of the dependent variables was used to normalize the distributions. RESULTS. Marginal fit values for occlusal and free surfaces were affected by the type of impression. There were no differences between surfaces (occlusal vs. free). Gap obtained for DI group was 164 ± 84 ㎛ and that for CI group was 209 ± 104 ㎛, and there were statistical differences between them (p = .041). Mean overextension values were 60 ± 59 ㎛ for DI group and 67 ± 73 ㎛ for CI group, and there were no differences between then (p = .553). CONCLUSION. Digital impression achieved inlays with higher clinical marginal fit and performed better than the conventional silicone materials.

• Journal of Acupuncture Research
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• 제24권1호
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• pp.209-216
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• 2007

Objectives : To review and summarize the existing evidence on acupuncture treatment for cancer and cancer related symptoms. Methods: Literature searches were made through domestic and international databases. Data were extracted according to pre-defined criteria. The methodological quality was assessed using the Modified Jadad scale. Results: Seven studies were included. Two of the studies were high in methodological quality. One study concerning acupuncture treatment for cancerous dyspnea reported insignificant differences between the treatment group and placebo group. The other study concerning auricular acupuncture for cancer related pain showed significant pain relief compared with the control group. All the other studies were non-blinded or uncontrolled trials. Conclusion : The hypothesis that acupuncture may be effective for the treatment of cancer is not supported by the data in recent clinical trials. More accurately designed randomized control trials (RCT) are needed.

• Journal of Chest Surgery
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• 제28권1호
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• pp.90-95
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• 1995

Effective relief of dysphagia in unresectable esophageal cancer patients not only prolong survival but also is prerequisite for other treatment modalities.We tried surgical resection in 4 patients who had unresectable esophageal cancer,managed initially with esophageal prosthesis then followed by chemotherapy with good response. Curative resection was possible in 2 patients and palliative resection in one and exploration only in one case.Curatively resected patients are alive without recurrence for 57 months,8 months,each.Other non-curatively resected patients died after 10 months,7 months. Above results suggest that initial esophageal prosthesis to relieve dysphagia followed by chemotherapy in unresectable esophageal cancer may provide another chances for curative resection that promise better survival and need more clinical experience and trial.