• Title/Summary/Keyword: Randomized Clinical Trials

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Is dentin biomodification with collagen cross-linking agents effective for improving dentin adhesion? A systematic review and meta-analysis

  • Julianne Coelho Silva;Edson Luiz Cetira Filho;Paulo Goberlanio de Barros Silva;Fabio Wildson Gurgel Costa;Vicente de Paulo Aragao Saboia
    • Restorative Dentistry and Endodontics
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    • v.47 no.2
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    • pp.23.1-23.18
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    • 2022
  • Objectives: The aim of this investigation was to evaluate the effectiveness of collagen cross-linking agents (CCLAs) used in combination with the adhesive technique in restorative procedures. Materials and Methods: In this systematic review, the authors followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist. An electronic search was performed using PubMed, Scopus, Web of Science, Cochrane Library, LILACS, and DOSS, up to October 2020. The gray literature was also researched. Only randomized clinical trials were selected. Results: The selection process yielded 3 studies from the 838 retrieved. The addition of CCLAs in the retention of restorations increased the number of events. The postoperative sensitivity scores and marginal adaptation scores showed no significant difference between the CCLA and control groups, and the marginal pigmentation scores showed a significant increase in the CCLA group. There were no caries events in any group throughout the evaluation period. Conclusions: This systematic review showed that there is no clinical efficacy to justify the use of CCLAs in the protocols performed.

Chinese Patients with Gastric Cancer Need Targeted Adjuvant Chemotherapy Schemes

  • Shi, Wen-Tao;Wei, Lei;Xiang, Jin;Su, Ke;Ding, Qiong;Tang, Meng-Jie;Li, Ji-Qiang;Guo, Yi;Wang, Pu;Zhang, Jing-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.10
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    • pp.5263-5272
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    • 2012
  • Background: Gastric cancer (GC) is one of the most common cancers in China. Adjuvant chemotherapy (AC) is a routine auxiliary treatment for GC recommended by the guidelines issued in 2011 by the Ministry of Health of the People's Republic of China, but the relevant credible consequences in China have been insufficient because of China's late start and ethical concerns. Methods: A series of databases, including Cochrane Library, MEDLINE, EMBASE, the Chinese database of the National Knowledge Infrastructure and the VIP database, were searched by 2 reviewers independently for studies investigating AC for GC through March 2012. The retrieved literature was screened according to the eligibility criteria. Results: A total of 35 randomized control trials (RCTs) were subjected to the final analysis, including 4,043 patients in treatment group and 3,884 in the control group, as well as 4 clinical-control trials (CCTs), which accessed the final analysis with 238 and 252 patients, respectively. AC reduced the risk of death as a protective treatment with statistical significance (HR=0.91, 95%CI: [0.85, 0.97], P=0.002), and it seemed more effective for Asian than non-Asian patients. The effects of AC were not influenced by the starting time (P>0.05). D2 lymphadenectomy-based chemotherapy was effective (HR=0.89, 95%CI: [0.80, 0.99], P=0.04). Oral S-1 40 mg/m2 after D2 lymphadenectomy might be a better choice for Asians with advanced GC and might result in a greater reduction of adverse events than in non-Asian patients. GRADE quality assessment determined that the strength of the evidence from foreign studies from Europe, the United States and Asian countries other than China was high, while it was moderate for Chinese studies. Conclusion: AC was effective or even curative in Chinese patients in general, although it is still necessary to optimize a targeted AC scheme for Chinese patients with GC.

Research on Immune Enhancing Effect and Safety of Wasong (Orostachys japonicus) Extract: Study Protocol for a Single Center, Randomized, Double-blind, Placebo-controlled, Clinical Trial (와송 추출물의 면역기능 개선 효과 및 안전성 연구: 단일기관, 무작위배정, 이중눈가림, 위약대조 비교, 임상연구 프로토콜)

  • Choi, Jin Yong;Choi, Jun Yong;Lim, Hyun Woo;Kim, Jeong;Kim, So Yeon;Han, Chang Woo
    • Herbal Formula Science
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    • v.25 no.2
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    • pp.135-143
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    • 2017
  • Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

Effects of applying nerve blocks to prevent postherpetic neuralgia in patients with acute herpes zoster: a systematic review and meta-analysis

  • Kim, Hyun Jung;Ahn, Hyeong Sik;Lee, Jae Young;Choi, Seong Soo;Cheong, Yu Seon;Kwon, Koo;Yoon, Syn Hae;Leem, Jeong Gill
    • The Korean Journal of Pain
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    • v.30 no.1
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    • pp.3-17
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    • 2017
  • Background: Postherpetic neuralgia (PHN) is a common and painful complication of acute herpes zoster. In some cases, it is refractory to medical treatment. Preventing its occurrence is an important issue. We hypothesized that applying nerve blocks during the acute phase of herpes zoster could reduce PHN incidence by attenuating central sensitization and minimizing nerve damage and the anti-inflammatory effects of local anesthetics and steroids. Methods: This systematic review and meta-analysis evaluates the efficacy of using nerve blocks to prevent PHN. We searched the MEDLINE, EMBASE, Cochrane Library, ClinicalTrials.gov and KoreaMed databases without language restrictions on April, 30 2014. We included all randomized controlled trials performed within 3 weeks after the onset of herpes zoster in order to compare nerve blocks vs active placebo and standard therapy. Results: Nine trials were included in this systematic review and meta-analysis. Nerve blocks reduced the duration of herpes zoster-related pain and PHN incidence of at 3, 6, and 12 months after final intervention. Stellate ganglion block and single epidural injection did not achieve positive outcomes, but administering paravertebral blockage and continuous/repeated epidural blocks reduced PHN incidence at 3 months. None of the included trials reported clinically meaningful serious adverse events. Conclusions: Applying nerve blocks during the acute phase of the herpes zoster shortens the duration of zoster-related pain, and somatic blocks (including paravertebral and repeated/continuous epidural blocks) are recommended to prevent PHN. In future studies, consensus-based PHN definitions, clinical cutoff points that define successful treatment outcomes and standardized outcome-assessment tools will be needed.

Significant Efficacy of Additional Concurrent Chemotherapy with Radiotherapy for Postoperative Cervical Cancer with Risk Factors: a Systematic Review and Meta-analysis

  • Qin, Ai-Qiu;Liang, Zhong-Guo;Ye, Jia-Xiang;Li, Jing;Wang, Jian-Li;Chen, Chang-Xian;Song, Hong-Lin
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.8
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    • pp.3945-3951
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    • 2016
  • Background: Whether concurrent chemotherapy treatment is superior to radiotherapy alone as an adjuvant regimen for postoperative cervical carcinoma with risk factors remains controversial. Materials and Methods: A literature search strategy examined Pubmed, Embase, the Cochrane Library, the China National Knowledge Internet Web, the Chinese Biomedical Database and the Wanfang Database. Article reference lists and scientific meeting abstracts were also screened. Controlled trials comparing concurrent chemoradiotherapy versus radiotherapy alone in postoperative cervical cancer were included. The methodological quality of non-randomized controlled trials was evaluated using the Newcastle-Ottawa Scale. Randomized controlled studies were evaluated with the Cochrane handbook. A meta-analysis was performed with RevMan 5.3. Results: A total of 1,073 patients from 11 clinical trials were analysed, with 582 patients in the concurrent chemoradiotherapy group and 491 patients in the radiotherapy group. Hazard ratios (HR) of 0.47 (95% CI 0.31-0.72) and 0.50 (95% CI 0.35-0.72) were observed for overall survival and progression-free survival, indicating a benefit from the additional use of concurrent chemotherapy. Subgroup analyses demonstrated that cervical cancer with high risk factors significantly benefitted from concurrent chemotherapy when examining overall survival (HR 0.44, 95% CI 0.28-0.67) and progression-free survival (HR 0.48, 95% CI 0.33-0.70), but patients with intermediate risk factors showed no benefit from concurrent chemotherapy in overall survival (HR 1.72, 95% CI 0.28-10.41) and progression-free survival (HR 1.09, 95% CI 0.19-6.14). No significant differences were observed for grade 3-4 anaemia (risk ratio (RR) 3.87, 95% CI 0.69-21.84), grade 3-4 thrombocytopenia (RR 3.04, 95% CI 0.88-10.58), grade 3-4 vomiting or nausea (RR 1.71, 95% CI 0.27-10.96), or grade 3-4 diarrhoea (RR 1.40, 95% CI 0.69-2.83). Significant differences were observed for grade 3-4 neutropenia in favour of the radiotherapy group (RR 7.23, 95% CI 3.94-13.26). Conclusions: In conclusion, concurrent chemoradiotherapy improves survival in postoperative cervical cancer with high risk factors but not in those with intermediate risk factors.

Review of Studies on Taeumin Yeoldahanso-tang since 2000 (열다한소탕(熱多寒少湯) 관련 기존 연구 분석)

  • Oh, Hye-Won;Shin, Seung-Won;Jang, Hyeung-Jin;Ahn, Kwang-Seok;Lee, Seok-Geun;Lee, Eui-Ju;Koh, Byung-Hee;Lee, Jun-Hee
    • Journal of Sasang Constitutional Medicine
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    • v.26 no.1
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    • pp.98-109
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    • 2014
  • Objectives This paper was aimed to review experimantal and clinical articles on Yeoldahanso-tang(YDHS), figuring out the recent tendency and suggesting the future prospects of YDHS-related studies. Methods The articles published in Korean or English since 2000 were searched, screened, and classified into experimental or clinical studies. And we structured designs, methods and results of the included studies into each table for the experimental studies or the clinical studies. Especially tools to diagnose constitutions and patterns identified in clinical researches were also summarized in the tables. Results 28 articles are finally included. 14 experimental studies are mostly in vitro designs to show efficacy of YDHS. There are only 2 studies for the safety. Among 14 clinical studies, 12 case studies target disorders of central nervous system, viral infection, skin ulcer and so on. 2 studies are before and after studies on cerebral infarction and effects on liver function. Conclusions Based on the efficacy of YDHS on central nervous system, it acquires higher level of evidence such as randomized controlled trials in the future. In addition other diseases such as skin ulcer and so on, it needs to be done more specific experimental or clinical studies so that we can get statistically significant results.

Research on Korean Pharmacopuncture in South Korea since 2007

  • Lim, ChungSan;Park, SangKyun;Sun, SeungHo;Lee, KwangHo
    • Journal of Pharmacopuncture
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    • v.17 no.4
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    • pp.15-21
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    • 2014
  • Objectives: The purpose of this study was to investigate the current trends in research on pharmacopuncture in Korea since 2007. Methods: A literature review was performed by using the search engines 'Science and Technology Society Village', 'Korean Studies Information Service System', 'National Discovery for Science Leaders', and 'Oriental Medicine Advanced Searching Integrated System' in Korea from January 2007 to December 2013. Searched key words were 'pharmacopuncture', 'herbal acupuncture', 'aqua-acupuncture', and 'bee venom'. Finally, we selected 457 papers, including Korean experimental studies and clinical studies. Selected papers were classified according to year of publication, type of pharmacopuncture, disease & topic, research type and the publishing journal. Results: One hundred fifty pharmacopunctures were studied in 457 papers. Single compound pharmacopuncture was the most studied pharmacopuncture in experimental studies while animal-based pharmacopuncture was the most studied pharmacopuncture in clinical studies. Bee venom placed first among the various pharmacopunctures, followed by placenta, sweet bee venom, mountain-ginseng, and anti-inflammatory pharmacopunctures. Experimental research on pharmacopuncture has fallen since 2007 when 55 papers were published. However, clinical research has been increasing steadily. In clinical studies, case reports were numerous than randomized clinical trials (RCTs). Musculoskeletal diseases were the most frequently-treated diseases in studies on pharmacopuncture; among the musculoskeletal diseases, rheumatoid arthritis was the most frequently-treated disease in experimental studies and low back pain was the most frequently-treated condition in clinical studies. Since 2007, 45 different journals have published studies on pharmacopuncture, with the Journal of the Korean Acupuncture and Moxibustion Medicine Society having the largest number of papers on pharmacopuncture and the Journal of Pharmacopuncture the second largest number. Conclusion: The trends in research on pharmacopuncture published in studies from 2007 to 2013 were similar to those in studies published before 2006. Many studies on pharmacopuncture focused on bee venom and musculoskeletal diseases. Additional studies on diverse types of and indications for pharmacopuncture are needed.

The Literary Trends of Herbal Prescription Ukgan-san and its Application in Modern Traditional Korean Medicine (동의보감에 수록되지 않았던 억간산의 문헌상 흐름과 현대 한의학에서의 응용 현황)

  • Cho, Ki-Ho;Kim, Tae-Hun;Jin, Chul;Lee, Ji-Eun;Kwon, Seungwon
    • The Journal of Korean Medicine
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    • v.39 no.3
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    • pp.17-27
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    • 2018
  • Objectives: Ukgan-san does not appear in Traditional Korean Medicine classics. However, it has been used in research and clinical applications in Korea. In this paper, we are aiming to examine the records concerned with Ukgan-san to the present, and announce the present usage state in Korea. Methods: We searched and summarized the contents of previous medical books about Ukgan-san. In order to investigate the current status of utilization of Ukgan-san in Korea, a bibliographic database of Korea, a database of clinical researches, and a database of pharmaceuticals of the Korea Food and Drug Administration were searched. Results: As a result of searching Ukgan-san related documents, Ukgan-san has been developed in China (Ming dynasty). However, its clinical application has been expanded by modern Japanese kampo medicine doctors. In Korea, cases of Parkinson's disease, other movement disorders, and psychiatric disorders have been reported, and randomized controlled trials had been done and planned. In addition, some extracts which are consisted of Ukgan-san are also available. Conclusions: In Korea, Ukgan-san has been influenced by Japan and has been used for clinical and research purposes. The utilization rate in Korea is still small, but the utilization rate will increase according to the results of clinical studies.

Clinical Research Trends in Respiratory Diseases Related to Particulate Matter (미세먼지 관련 호흡기질환 임상연구 동향)

  • Lyu, Yee Ran;Kim, JinHoo;Yang, Won-kyung;Kim, Seung-hyeong;Park, Yang-Chun
    • The Journal of Internal Korean Medicine
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    • v.40 no.3
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    • pp.443-457
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    • 2019
  • Objectives: This study aimed to review the clinical research trends in respiratory diseases related to particulate matter (PM) to help design clinical studies on herbal medicine that protects against PM. Methods: We searched three international databases (Pubmed, EMBASE, and CENTRAL) to investigate clinical studies on respiratory diseases related to PM and to analyze their study design, respiratory-related disease, inclusion/exclusion criteria, study period, outcome measure, study results, measurement method of PM and range of PM. Results: A total of 18 studies were finally selected, including 13 observational studies and 5 randomized controlled trials. The selected studies showed an increasing trend from 1985 to 2018 and were conducted mostly in North America, followed by Europe and Asia. Subject disease and age were decided in variety by each study objective, although asthma accounted for the majority. For the outcome assessment, pulmonary function test was mostly used for lung function. Quality of life questionnaires and biomarkers in blood and sputum were also used. Conclusion: A well-designed clinical study on herbal medicine that protects against PM is needed, and this study is expected to be used as base data.

Review of Domestic Clinical Research about Dysmenorrhea: A Systematic Review of Clinical Studies in Korean Medical Journals (월경통의 한의학적 치료에 대한 국내 임상 연구 경향 : 체계적 문헌 고찰)

  • Koh, Ji-yoon;Gwon, Gi-hyeon;Shin, Hyeon-su;Lee, Ju-hyeon;Jo, Seung-wan
    • The Journal of Internal Korean Medicine
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    • v.40 no.4
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    • pp.612-628
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    • 2019
  • Objective: The aim of this review was to investigate clinical studies on Korean medical treatments for dysmenorrhea. Method: Using the keywords "dysmenorrhea," "Korean medical treatment," "acupuncture," and "herbal medicine," searches were conducted using domestic databases, including the National Discovery for Science Leaders (NDSL), the Research Information Sharing Service(RISS), and the Oriental Medicine Advanced Searching Integrated System (OASIS). The keywords were combined in various ways, instead of being searched individually. Papers that did not cover clinical studies or were not matched with the subject, absent of the abstract and text, were excluded. Results: Using the above searching method, 20 studies were found. Of these, 15 were in the form of case reports and five were in the form of randomized controlled trials. Acupuncture, herb medicine, pharmacopuncture, moxibustion, and cupping were used as treatments for dysmenorrhea. All of these studies reported that the Korean medical treatment was effective. Conclusion: According to the results, Korean medical treatments can provide an effective treatment for dysmenorrhea. However, more clinical studies on dysmenorrhea should be conducted for further clinical applications.