Jun, Ji Hee;Choi, Tae-Young;Lee, Myeong Soo;Song, Eunhye;Ang, Lin;Park, Sunju
Journal of Society of Preventive Korean Medicine
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v.24
no.1
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pp.1-14
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2020
Objectives : The purpose of this systematic review was to investigate the efficacy and safety of Sanjoin-tang (Suanzaoren decoction, SZRD) for insomnia in menopausal syndromes. Method : We searched the following databases: PubMed, Cochrane Library, EMBASE, China National Knowledge Infrastructure (CNKI), Chinese Science and Technique Journals Database (VIP), Wanfang, Research Information Service System (RISS), OASIS, Korean studies Information Service System (KISS), and National Digital Science Library (NDSL) databases. Randomized controlled trials (RCTs) or quasi-RCTs that used SZRD for women in menopause were included. The methodological quality of each RCT was assessed using the risk of bias tool. Results : In total, nine RCTs were finally included. The included RCTs had a high risk of bias across their domains. Three RCTs examined the effects of SZRD compared with western medicine (WM) in insomnia. Three RCTs showed favorable effects of SZRD with insomnia. Infrastructure also showed that SZRD resulted in better clinical WM (RR 1.19, 95% CI 1.07 to 1.32, P=0.001, I2=0%). Four RCTs showed favorable effects of Modified SZRD with insomnia. Infrastructure also showed that Modified SZRD resulted in better clinical WM (RR 1.13, 95% CI 1.04 to 1.23, P=0.004, I2=0%). Among the 4 RCTs, three RCTs showed an equivalent effect on the total Pittsburh Sleep Quality Index (PSQI). The meta-analysis also showed that Modified SZRD had a superior effect on the total of PSQI (total of PSQI : MD -2.55, 95% CI -3.72 to -1.37, P<0.0001, I2=85%). Only 2 trials reported adverse events and none reported severe adverse events. Conclusion : SZRD appears to be safe, but there is insufficient evidence to make a definitive conclusion because only a few studies reported adverse events. Due to the poor methodological quality of the included studies and the small number of trials included, the evidence cannot be reproduced and assessed. Well-designed RCTs with a larger sample size are needed in the future.
Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.
Artificial intelligence (AI) will likely affect various fields of medicine. This article aims to explain the fundamental principles of clinical validation, device approval, and insurance coverage decisions of AI algorithms for medical diagnosis and prediction. Discrimination accuracy of AI algorithms is often evaluated with the Dice similarity coefficient, sensitivity, specificity, and traditional or free-response receiver operating characteristic curves. Calibration accuracy should also be assessed, especially for algorithms that provide probabilities to users. As current AI algorithms have limited generalizability to real-world practice, clinical validation of AI should put it to proper external testing and assisting roles. External testing could adopt diagnostic case-control or diagnostic cohort designs. A diagnostic case-control study evaluates the technical validity/accuracy of AI while the latter tests the clinical validity/accuracy of AI in samples representing target patients in real-world clinical scenarios. Ultimate clinical validation of AI requires evaluations of its impact on patient outcomes, referred to as clinical utility, and for which randomized clinical trials are ideal. Device approval of AI is typically granted with proof of technical validity/accuracy and thus does not intend to directly indicate if AI is beneficial for patient care or if it improves patient outcomes. Neither can it categorically address the issue of limited generalizability of AI. After achieving device approval, it is up to medical professionals to determine if the approved AI algorithms are beneficial for real-world patient care. Insurance coverage decisions generally require a demonstration of clinical utility that the use of AI has improved patient outcomes.
PURPOSE. Zirconia has been used in clinical dentistry for approximately a decade, and there have been several reports regarding the clinical performance and survival rates of zirconia-based restorations. The aim of this article was to review the literatures published from 2000 to 2010 regarding the clinical performance and the causes of failure of zirconia fixed partial dentures (FPDs). MATERIALS AND METHODS. An electronic search of English peer-reviewed dental literatures was performed through PubMed to obtain all the clinical studies focused on the performance of the zirconia FPDs. The electronic search was supplemented by manual searching through the references of the selected articles for possible inclusion of some articles. Randomized controlled clinical trials, longitudinal prospective and retrospective cohort studies were the focuses of this review. Articles that did not focus on the restoration of teeth using zirconia-based restorations were excluded from this review. RESULTS. There have been three studies for the study of zirconia single crowns. The clinical outcome was satisfactory (acceptable) according to the CDA evaluation. There have been 14 studies for the study of zirconia FPDs. The survival rates of zirconia anterior and posterior FPDs ranged between 73.9% - 100% after 2 - 5 years. The causes of failure were veneer fracture, ceramic core fracture, abutment tooth fracture, secondary caries, and restoration dislodgment. CONCLUSION. The overall performance of zirconia FPDs was satisfactory according to either USPHS criteria or CDA evaluations. Fracture resistance of core and veneering ceramics, bonding between core and veneering materials, and marginal discrepancy of zirconia-based restorations were discussed as the causes of failure. Because of its repeated occurrence in many studies, future researches are essentially required to clarify this problem and to reduce the fracture incident.
Herbal medicines have an accurate effect on atopic dermatitis, and at the same time, they hardly have adverse reactions. However, herbal medicines are difficult to be quantitatively analyzed due to low-quality preparation and types. In addition, herbal medicines have raised many problems as they have not been standardized and their active components have not been analyzed. Patients with atopic dermatitis began to recognize the effectivity and safety of herbal medicines. Accordingly, standardization, biological analyses, animal experiments and clinical trials should be generally performed in order that herbal medicines may be recognized all over the world. A standard, which is to objectively judge the curative effect of atopic dermatitis, should be established as soon as possible. Case studies and RCTs (Randomized Controlled Trials) should be actively performed on the basis of rigid clinical trial design to the end that the curative effect of herbal medicines is recognized all the world over.
Background: The multitude of the therapeutic usefulness of intra-articular injection of hyaluronate on oateoarthritis of the knee is still in question. The objective of this systemic review was to elucidate both the therapeutic efficacy and the safety of intra-articular administration of hyaluronic acid for degenerative osteoarthritis of the knee joints. Methods: I searched MEDLINE and Korea Medical Database (KMbase) from January 1990 to April 2007 using a combination search terms for knee osteoarthritis and hyaluronic acid and a filter for randomized controlled trials. I extracted data on pain at rest, and during or just after movement, on joint function, and on adverse events. Results: Ten trials that reported usable quantitative information on any of the predefined end points were identified and included in the systemic review. Intra-articular injection of hyaluronic acid can decrease symptoms of osteoarthritis of the knee. The study revealed significant improvements in pain and functional outcomes with few adverse effects. However, there was significant between-study heterogeneity in the estimates of the efficacy of hyaluronic acid. Sub-group analysis showed that lower methodological quality such as a single-blind or single-center design resulted in higher estimates hyaluronic acid efficacy, and that patients older than sixty years of age and those with the most advanced radiographic stage of osteoarthritis were less likely to benefit from intra-articular injection of hyaluronic acid. Conclusion: According to the currently available evidence, intra-articular hyaluronic acid has been proven clinically effective for the patients bearing the knee osteoarthritis with NSAID-induced GI troubles or inapplicable to any surgery, and may be associated with lower risk of adverse events.
Seo, Ha-Ra;Li, Yu-Chen;Lee, Jae-Eun;Kim, Myoung-Kyu
Journal of Korean Medicine Rehabilitation
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v.27
no.3
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pp.81-93
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2017
Objectives The purpose of this study is to evaluate the effectiveness of Chuna therapy for primary dysmenorrhea. Methods Researchers searched on 7 electronic databases (Pubmed, National Digital Science Library, China National Knowledge Infrastructure, Wangfang med online, Korean Studies Information Service System, Research Information Sharing Service and Oriental medicine Advanced Searching Integrated System). The search included Korean, English, Chinese reports and there was no limit on the search period. All of randomized controlled clinical trials (RCTs) that used Chuna manual therapy for primary dysmenorrhea were selected. Results 27 RCTs met required condition. Meta-analysis showed positive results for Chuna manual therapy for primary dysmenorrhea in terms of therapeutic effects and reduction of symptom scores compared to west medicine, herbal medicine, acupucture and other treatments. Conclusions Above results showed that performing chuna is effective in treating dysmenorrhea. However, in some studies, there was no statistic significance between the experimental group and the control group. Also, according to Cochrane Risk of Bias (RoB) evaluation method, quality of the studies were not high enough. Since most of the materials were in Chinese, more high-quality clinical trials about Chuna therapy for primary dysmenorrhea are needed in Korea.
Kim, Hyo-seop;Bae, Jin-soo;Lee, Seung-Hwan;Lim, Jung-Hwa;Seong, Woo-Yong
Journal of Oriental Neuropsychiatry
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v.28
no.3
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pp.217-230
/
2017
Objectives: This study was conducted to review studies on somatization disorder in traditional Chinese medicine. Methods: We reviewed studies in the China National Knowledge Infrastructure (CNKI) to 2017. Keywords were 軀體化障碍, Somatization disorder, somatic symptom disorder. We included Randomized Controlled Trial (RCT), and excluded non-Randomized Controlled Trial (nRCT), non-related somatization disorder or traditional Chinese medicine, non-clinical trials, dissertations for degrees. Jadad scale and Cochrane Library's Risk of Bias (RoB) were used for assessment of the quality of studies. Results: Twelve studies were selected. The Chinese Classification of Mental Disorders-3 (CCMD-3) was most frequently used as diagnostic criteria for somatization disorder. As for outcome measurement, Hamilton Rating Scale for Depression (HAMD) was used most commonly. Meta-analysis of 10 studies revealed effective rate of Chinese Herbal Medicine groups (CHM) was significantly higher than Western Medicine groups (WM) (RR: 1.14, 95% CI: 1.02 to 1.27, p=0.02, $I^2=40%$). There was no significant difference in effective rate of CHM+WM and WM (RR: 1.12, 95% CI: 0.84 to 1.49, p=0.46, $I^2=83%$). And also, effective rate of Acupuncture group (Acu) revealed no significant difference compared to that of WM (RR: 1.17, 95% CI: 0.95 to 1.44, p=0.13, $I^2=84%$). For HAMD, there was significant difference in CHM vs, WM group and Acu vs. WM group. Quality of selected 12 RCTs was low. Conclusions: Therapies practiced in traditional Chinese medicine may be effective options for somatization disorder. treatment. For further clinical studies in Korean medicine, this study could be groundwork for development of diagnosis and treatment on somatization disorder.
Schnutenhaus, Sigmar;Doering, Isabel;Dreyhaupt, Jens;Rudolph, Heike;Luthardt, Ralph G.
Journal of Periodontal and Implant Science
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v.48
no.4
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pp.236-250
/
2018
Purpose: Resorption of the alveolar bone is an unavoidable consequence of tooth extraction when appropriate alveolar ridge preservation (ARP) measures are not taken. The objective of this trial was to test the hypothesis that dimensional changes in the alveolar bone after tooth extraction would be reduced by inserting an equine collagen membrane and a collagen cone to fill and seal the alveolus (as ARP), in comparison to extraction with untreated alveoli. Methods: In this randomized clinical trial, 31 patients were directly treated with the collagen material after extraction of a tooth from the maxilla (the ARP group). Twenty-nine patients served as the control group. After extraction, no further treatment (i.e., no socket preservation measures) was performed in the control group. Changes in the alveolar process immediately after extraction and after an 8 (${\pm}1$)-week healing period were evaluated 3-dimensionally. Blinded analyses were performed after superimposing the data from the digitalized impressions and surfaces generated by cone-beam computed tomography. Results: Both the ARP and control groups showed a reduction of bone in the alveolar area after tooth extraction. However, significantly less bone resorption was detected in the clinically relevant buccal region in the ARP group. The median bone reduction was 1.18 mm in the ARP group and 5.06 mm in the control group (P=0.03). Conclusions: The proposed hypothesis that inserting a combination material comprising a collagen cone and membrane would lead to a difference in alveolar bone preservation can be accepted for the clinically relevant buccal distance. In this area, implantation of the collagen material led to significantly less alveolar bone resorption. German Clinical Trials Register at www.drks.de, DRKS00004769.
Objective: A meta-analysis was performed to determine effect of ginseng on blood pressure. Methods: The databases of PubMed, Embase, Cochrane Library, RISS, DBpia, KISS, and Koreamed were searched for all published studies from inception to January 2016. The following terms were used: "ginseng", "hypertension", and "blood pressure". Using the Review Manager 5, mean differences (MDs) were pooled to measure the effect of ginseng on blood pressure compared to that of placebo. Results: Eleven randomized controlled trials were included. In this meta-analysis, ginseng treatment significantly lowered systolic blood pressure (SBP) in a dose-independent way (MD: -1.99, p = 0.04). In subgroup analysis, 8-12 week consumption of ginseng achieved significantly greater reduction in SBP (MD: -3.14, p = 0.03), while single administration of ginseng failed to show BP-lowering effect. When ingested over 8-12 weeks, ginseng significantly lowered diastolic blood pressure (DBP) (MD: -1.96, p = 0.03). No significant association was found between ginseng dose and the magnitude of BP-lowering effect. However, a significant positive relationship was observed between baseline SBP level and the magnitude of SBP reduction (r = 0.848, p = 0.033). Such a relationship was not seen in DBP. Conclusion: Consumption of ginseng for 8-12 weeks achieved significant reductions in SBP and DBP in a dose-independent way. There was a significant positive relationship between baseline SBP level and the magnitude of SBP reduction.
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