• 제목/요약/키워드: Randomized Clinical Trials

검색결과 940건 처리시간 0.026초

Searching for Novel Candidate Small Molecules for Ameliorating Idiopathic Pulmonary Fibrosis: a Narrative Review

  • Kyung-il Kim;Rajib Hossain;Xin Li;Hyun Jae Lee;Choong Jae Lee
    • Biomolecules & Therapeutics
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    • 제31권5호
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    • pp.484-495
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    • 2023
  • Idiopathic pulmonary fibrosis (IPF) can be defined as a progressive chronic pulmonary disease showing scarring in the lung parenchyma, thereby resulting in increase in mortality and decrease in the quality of life. The pathophysiologic mechanism of fibrosis in IPF is still unclear. Repetitive microinjuries to alveolar epithelium with genetical predisposition and an abnormal restorative reaction accompanied by excessive deposition of collagens are involved in the pathogenesis. Although the two FDA-approved drugs, pirfenidone and nintedanib, are under use for retarding the decline in lung function of patients suffered from IPF, they are not able to improve the survival rate or quality of life. Therefore, a novel therapeutic agent acting on the major steps of the pathogenesis of disease and/or, at least, managing the clinical symptoms of IPF should be developed for the effective regulation of this incurable disease. In the present review, we tried to find a potential of managing the clinical symptoms of IPF by natural products derived from medicinal plants used for controlling the pulmonary inflammatory diseases in traditional Asian medicine. A multitude of natural products have been reported to exert an antifibrotic effect in vitro and in vivo through acting on the epithelial-mesenchymal transition pathway, transforming growth factor (TGF)- β-induced intracellular signaling, and the deposition of extracellular matrix. However, clinical antifibrotic efficacy of these natural products on IPF have not been elucidated yet. Thus, those effects should be proven by further examinations including the randomized clinical trials, in order to develop the ideal and optimal candidate for the therapeutics of IPF.

The socket shield technique and its complications, implant survival rate, and clinical outcomes: a systematic review

  • Stefano Oliva;Mario Capogreco;Giovanna Murmura;Ettore Lupi;Di Carlo Mariachiara;Maurizio D'Amario
    • Journal of Periodontal and Implant Science
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    • 제53권2호
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    • pp.99-109
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    • 2023
  • Purpose: The aim of this systematic review was to evaluate the effectiveness of the socket shield technique (SST), an innovative surgical method introduced in 2010, for reducing buccal bone plate resorption. Methods: The review was conducted following the PRISMA guidelines. Clinical studies conducted in humans and investigating the SST were searched on PubMed (MEDLINE), Embase, Web of Knowledge, and Google Scholar in November and December 2021. The implant survival rate, percentage of complications, and clinical parameters (marginal bone loss [MBL], pink esthetic score [PES], and buccal bone plate resorption [BBPR]) were analyzed using the collected data. Results: The initial search resulted in 132 articles. After article screening, the full texts of 19 studies were read and 17 articles were finally included in the review. In total, 656 implants were installed with the SST. Nine of the 656 implants experienced failure, resulting in an implant survival rate of 98.6%. The percentage of complications was about 3.81%. The analysis of clinical parameters (MBL, PES, and BBPR), showed favorable results for the SST. The mean MBL in implants placed with the SST was 0.39±0.28 mm versus 1.00±0.55 mm in those placed without the SST. PES had a better outcome in the SST group, with an average of 12.08±1.18 versus 10.77±0.74. BBPR had more favorable results in implants placed with the SST (0.32±0.10 mm) than in implants placed with the standard technique (1.05±0.18 mm). Conclusions: The SST could be considered beneficial for preserving the buccal bone plate. However, since only 7 of the included studies were long-term randomized controlled trials comparing the SST with the standard implant placement technique, the conclusions drawn from this systematic review should be interpreted with caution.

범불안장애의 한약 치료에 관한 체계적 문헌고찰 및 메타분석: 최근 5년 임상연구를 중심으로 (Systematic Review and Meta-Analysis on Herbal Medicine for Generalized Anxiety Disorder: Focusing on Clinical Studies over the Past 5 Years)

  • 김민재;박현섭;권찬영
    • 동의신경정신과학회지
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    • 제34권4호
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    • pp.403-420
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    • 2023
  • Objectives: This study investigated the effectiveness of herbal medicine for generalized anxiety disorder (GAD) based on recent clinical studies. Methods: Studies were searched through four databases. Clinical research studies on herbal medicine treatment for GAD patients were included. The studies were analyzed according to study design, diagnostic criteria, population, and intervention. A risk of bias assessment was performed to assess the quality of the included randomized controlled trials (RCT). If the intervention applied to the treatment and control groups was the same and two or more studies were reporting the same items as outcome indicators, a meta-analysis was performed. Results: A total of 19 studies, including 12 RCTs were selected. The most common pattern identification was 'Phlegm fire disturbing upward' (痰熱上擾), and the most used herb for therapeutic purposes was 'Rhizome of Poria cocos' (茯苓). Meta-analysis results of three studies showed that there were no significant differences in effectiveness between the herbal medicine intervention and the Western medicine intervention. Meta-analysis results of five studies showed that the Hamilton Anxiety Rating Scale was significantly reduced in the case of herbal medicine intervention compared to Western medicine intervention. Conclusions: The results of our study demonstrated that herbal medicine treatment for GAD is effective in alleviating anxiety symptoms and chief symptoms of GAD. However, this study has several limitations; there was a lack of placebo-controlled RCT and an absence of objective diagnostic criteria in case reports. Therefore, further well-designed clinical studies, conducted based on the results of this study, are recommended.

괄사요법의 국내외 최신 임상 연구 동향: 주제범위 문헌고찰 (Recent Domestic and International Clinical Research Trends in Gua Sha Therapy: A Scoping Review)

  • 정승원;최승관;조정호;한윤희;우현준;전병현;하원배;이정한
    • 한방재활의학과학회지
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    • 제34권1호
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    • pp.23-38
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    • 2024
  • Objectives This study examined recent domestic and international clinical research trends in Gua sha therapy to suggest future direction for research. Methods We used six domestic and international databases (Research Information Sharing Service, Korean studies Information Service System, Oriental Medicine Advanced Searching Integrated System, PubMed, Embase, Cochrane Library) to select clinical studies with an original text in English or Korean published after 2018. Results Finally, 55 studies were selected. Randomized controlled trials accounted for the largest amount with 42 studies. Instrument assisted soft tissue mobilization was the most frequent term referring to Gua sha. Muscle shortening, limited range of motion, and plantar fasciitis were the most common symptoms, with six cases each. Additionally, there were two studies targeting symptoms other than the musculoskeletal system. Conclusions Additional research is needed on the effects of Gua sha therapy on the back of the lower extremities and hip joints, and research is needed on the possibility of their clinical use for diseases or symptoms other than those of the musculoskeletal system. And standards for the terminology of Gua sha and the types and methods of applied interventions are needed.

특발성 혈소판 감소성 자반증의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로 (A Review of Clinical Studies for Chinese Medicine Treatment of Idiopathic Thrombocytopenic Purpura Using the CNKI Database)

  • 배지은;박재원;임준규;박미소;홍정수;김동진
    • 대한한방내과학회지
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    • 제43권6호
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    • pp.1045-1062
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    • 2022
  • Objectives: The aim of this study was to analyze the latest clinical studies on Korean medicine treatment of idiopathic thrombocytopenic purpura (ITP) in the Chinese National Knowledge Infrastructure (CNKI) database. Methods: We searched the last 6 years of clinical studies discussing Oriental medicine-based treatments for ITP in the CNKI database. A meta-analysis of 13 RCTs was performed by synthesizing the outcomes, including the measured platelet count and total effective rate. The quality of the studies was assessed using Cochrane's risk of bias (RoB) tool. RevMan 5.4.1 software was used for data analysis. Results: Of the 15 selected studies, 1 was a non-randomized controlled trial (nRCT), 2 were case series, and 12 were randomized controlled trials (RCTs). Treatments in all studies included oral herbal medicine. The most frequently used herbal decoction was the Liangxue Jiedu prescription (凉血解毒方), and the most commonly used herb was Agrimonia pilosa (仙鶴草), Astragali Radix (黃芪), Fossilia Glycyrrhizae Radix et Rhizoma (甘草), and Rehmannia glutinosa Liboschitz ex Steudel (地黃). The meta-analysis showed significantly better improvement in platelet counts and total effective rate for ITP in the treatment group than in the control group. Conclusion: Treatment with herbal medicine was effective in treating ITP. However, the significance of this conclusion is somewhat limited due to the low quality of the available studies. Multifaceted and scientifically designed clinical studies are required to develop treatments for ITP based on Korean medicine. The results of this study could be used as basic data for further ITP studies.

경항통에 침치료를 시행한 무작위대조군연구(RCT)들에 대한 계통적 연구 (A Systematic Review of Randomized Controlled Trials on Acupuncture Treatment for Neck Pain)

  • 김현욱;김성수;강정아;남동우;김은정;홍권의;김성철;이재동;김갑성;이건목
    • Journal of Acupuncture Research
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    • 제26권2호
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    • pp.103-123
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    • 2009
  • Objectives : The aim of this study is to review RCTs of acupuncture treatment for neck pain and to establish standards of acupuncture treatment for neck pain. Methods : We searched articles in Pubmed using ICD 10. Study quality was assessed using the FEAS and Jadad score. Results and Conclusions : Three review studies and nineteen clinical trials were searched and reviewed. Among the nineteen clinical trials reviewed, positive outcome was reported in thirteen studies. Most frequently used meridians were GB, BL, SI, GV and LI, The most frequently used acupuncture points were $GB_{20}$, $GB_{21}$, $LI_4$, $BL_{10}$, $GV_{14}$ and $SI_3$. More than two needles were inserted in the studies and needle retention time was more than 10 minutes. The most frequently used needle length was 40mm, and diameter was 0.25mm and 0.30mm. The mean number of treatment sessions were more than 10 times. Frequency of treatment was more than once a week, And treatment duration was more! than 5 weeks. The total FEAS scores ranged from 3 to 15.5, and the mean value was 9.39. Jadad score ranged from 2 to 5, and the mean value was 3.42. The number of studies scoring over three points on the Jadad scale was sixteen.

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Effectiveness and Safety of Pemetrexed Versus Docetaxel as a Treatment for Advanced Non-small Cell Lung Cancer: a Systematic Review and Meta-analysis

  • Di, Bao-Shan;Wei, Kong-Ping;Tian, Jin-Hui;Xiao, Xiao-Juan;Li, Yan;Zhang, Xu-Hui;Yu, Qin;Yang, Ke-Hu;Ge, Long;Huang, Wen-Hui;Zhang, Fang-Wa
    • Asian Pacific Journal of Cancer Prevention
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    • 제15권8호
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    • pp.3419-3424
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    • 2014
  • Background: Our aim was to conduct a meta-analysis to compare the efficacy and safety of pemetrexed and docetaxel for non-small cell lung cancer (NSCLC). Materials and Methods: We systematically searched the Cochrane Library, PubMed, Embase, China Biology Medicine Database for randomized controlled trials (RCTs) comparing the efficacy and toxicities of pemetrexed versus docetaxel as a treatment for advanced NSCLC. We limited the languages to English and Chinese. Two reviewers independently screened articles to identify eligible trials according to the inclusion and exclusion criteria and assessed the methodological quality of included trials, and then extracted data. The meta-analysis was performed using STATA12.0. Results: Six RCTs involving 1,414 patients were identified. We found that there was no statistically significant differences in overall response rate, survival time, progression-free survival, disease control rate, and 1-2yr survival rate (p>0.050) but it is worthy of mention that patients in the pemetrexed arms had significantly higher 3-yr survival rate (P=0.002). With regard to the grade 3 or 4 hematological toxicity, compared with docetaxel, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, and leukocyts toxicity (p<0.001). There was no significant difference in anemia between the two arms (p=0.08). In addition, pemetrexed led to higher rate of grade 3-4 thrombocytopenia toxicity (p=0.03). As for the non-hematological toxicities, compared with docetaxel, pemetrexed group had lower rate of grade 3-4 diarrhea and alopecia. Conclusions: Pemetrexed was almost as effective as docetaxel in patients with advanced NSCLC. At the same time, pemetrexed might increase the 3-yr survival rate. As for safety, pemetrexed led to lower rate of grade 3-4 febrile neutropenia, neutropenia, leukocytes, diarrhea and alopecia toxicity. However, it was associated with a higher rate of grade 3-4 thrombocytopenia.

천식 아동 및 청소년에서 원격모니터링 중재의 효과: 체계적 문헌고찰 및 메타분석 (Effectiveness of Telemonitoring Intervention in Children and Adolescents with Asthma: A Systematic Review and Meta-Analysis)

  • 정유진;김지민;박동아
    • 대한간호학회지
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    • 제48권4호
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    • pp.389-406
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    • 2018
  • Purpose: This review aimed to evaluate the effectiveness of telemonitoring (TM) in the management of children and adolescents with asthma. Methods: We searched Ovid-MEDLINE, Ovid-EMBASE, CENTRAL (Cochrane Central Register of Controlled Trials), CINAHL (Cumulative Index to Nursing and Allied Health Literature), and 5 domestic databases to identify randomized controlled trials (RCTs) published through December 2017. Two reviewers independently selected relevant studies, assessed methodological quality and extracted data. We performed a meta-analysis of TM versus usual care and summarized the intervention characteristics of included studies. Results: Of the 3,095 articles identified, 8 RCTs (9 articles) were included in this review. The type of TM intervention of included studies was varying across studies (transmitted data, transmission frequency, data review, etc.). The pooled asthma control score was not significantly different between TM and usual care (standardized mean difference 0.04, 95% confidence interval (CI) -0.20~0.28). Another pooled analysis demonstrated no statistically significant difference in asthma exacerbation between TM and usual care (odds ratio 0.95, 95% CI 0.43~2.09). Overall, the pooled results from these studies revealed that TM did not lead to clinically significant improvements in health outcomes, but some studies in our analysis suggested that TM increased patient medication adherence and intervention adherence. Conclusion: The current evidence base does not demonstrate any differences between TM intervention and usual care, but TM intervention might be considered a promising strategy for the delivery of self-management support for children and adolescents with asthma. Further well-designed studies are needed to assess the effects on clinical outcomes.

진행성 대장직장암 환자군에 있어서 5-FU 혹은 capecitabine의 최적 시간 치료법에 대한 체계적 고찰 : 메타분석 (5-FU or capecitabine based chronomodulated chemotherapy for advanced colorectal cancer: mata-analysis and systematic review)

  • 이지영;오혜경;류한성;윤성우
    • 대한암한의학회지
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    • 제20권1호
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    • pp.31-44
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    • 2015
  • Background : The purpose of this study is to investigate the efficacy and safety of the circadian delivery schedule of fluorouracil or capecitabine based chemotherapy for advanced colorectal cancer. Patients and methods : A meta-analysis was performed using individual data from eight international randomized clinical trials, especially phase II or III trials, comparing 5-fluorouracil, or capeticabine in chronomodulated or conventional schedule. The data from 8 studies was composed of 692 patients receiving chronomodulated chemotheray and 684 patients receiving conventional chemotherapy. The main end point was response rate. Results : Response rate was insignificantly different from each group (RR 1.14, 95%CI 0.74-1.74, p=0.55). Overall survival and progresseion-free survival were not significant either. Chemotherapy induced anemia, diarrhea, and nausea/vomiting were worse in the chronotherapy group, with statistic significance respectively. On the other hand, chemotherapy induced thrombocytopenia, stomatitis, peripheral neuropathy, and dermatotoxicity were better but they were not statistically significant results. Conclusions : Patients lived longer but not significantly on chronomodulated chemotherapy rather than on conventional chemotherapy. Patients on chronomodulated chemotherapy experienced adverse events more. The chronomodulated chemotherapy schedule needs adjustment of its delivery schedule and further research is required.

산부를 위한 마사지 중재 효과에 대한 메타분석 (Meta Analysis of the Effects of Massage Intervention for the Laboring Women)

  • 여정희;최환석
    • 대한예방한의학회지
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    • 제13권3호
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    • pp.87-99
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    • 2009
  • Objectives : The study was to examine the empirical evidence concerning the effects of massage intervention for the laboring women and to investigate the effect sizes related to the characteristics of intervention. Methods : Meta analysis was performed. A total of 11 trials related to massage intervention between 2000 and 2007 were reviewed. Results : Massage intervention showed a beneficial effect on length of labor(1st stage : U=46.75, p=0.00, 2nd stage : U=6.13, p=0.01), perception of childbirth experience(U=12.57, p=0.00), intensity of uterine contraction at the active(U=6.34, p=0.01) and the transition phases(U=24.83, p=0.00), and interval of uterine contraction at the active phase(U=4.83, p=0.03). Massage decreased systolic(U=10.81, p=0.00) and diastolic blood pressure at the transition phase(U=10.60, p=0.00). However, massage had no effect on subjective and objective labor pain and anxiety. No differences were found in effectiveness of massage according to characteristics of intervention(massage material, massager, and massage site) except for anxiety(QB=4.82, p=0.03) and diastolic blood pressure at the active phase by massage site(QB=4.52, p=0.03). Conclusions :We found that massage intervention for the laboring women had an empirical evidence on improving perception of childbirth experience and shortening length of labor. These results should be interpreted with caution due to the lack of studies. More full-scale randomized clinical trials with reliable designs are recommended to further warrant the effectiveness of massage.

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