• Title/Summary/Keyword: Randomized Clinical Trials

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Clinical Benefits of Self-monitoring of Blood Glucose in Non-insulin Treated Patients with Type 2 Diabetes : A systematic Review and Meta-analysis (제 2형 당뇨 환자에서 자가혈당측정의 임상적 유용성 : 체계적문헌고찰 및 메타분석)

  • Choi, Yoon-Young;Sohn, Hyun-Soon;Shin, Hyun-Taek
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.3
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    • pp.183-192
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    • 2010
  • While Self-monitoring of blood glucose (SMBG) has been recommended in some diabetes mellitus (DM) patients population according to the 2010 American Diabetes Association (ADA), 2007 Korean Diabetes Association (KDA), 2005 International Diabetes Federation guideline, it is excluded from a routine insurance coverage for outpatients in Korea. The objective of this study is to meta-analyze the impact of SMBG on HbA1c in non insulin-treated diabetes mellitus (NIT) DM patients. Published clinical literatures were identified through electronic database searches from inception and until May 2010. Studies were selected if they met the following inclusion criteria: 1) randomized controlled trials (RCTs), 2) comparing SMBG with non-SMBG in NIT type 2 diabetes, 3) measuring HbA1c as an outcome. Literature qualities were assessed by the Scottish Intercollegiate Guidelines Network Checklist. The mean difference of HbA1c between the 2 groups was pooled from non-heterogeneous 6 RCTs by meta-analysis using Review Manger (RevMan) Version 5.0 program. Pooled results demonstrated that SMBG is associated with a statistically significant improvement in glycemic control (mean HbA1c difference -0.23, 95%CI -0.32, -0.13). Sensitivity analysis showed that glycemic controls were significantly improved in patients with shorter study duration, more frequent self-monitoring, higher baseline HbA1c value, and without prior SMBG experiences. Conclusively SMBG is effective in improving glycemic control in NIT DM patients, but additional evidences from further researches in Korean patients and cost-effectiveness analysis would be necessary to make a suggestion for coverage expansion.

Standardizing the evaluation criteria on treatment outcomes of mandibular implant overdentures: a systematic review

  • Kim, Ha-Young;Shin, Sang-Wan;Lee, Jeong-Yol
    • The Journal of Advanced Prosthodontics
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    • v.6 no.5
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    • pp.325-332
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    • 2014
  • PURPOSE. The aim of this review was to analyze the evaluation criteria on mandibular implant overdentures through a systematic review and suggest standardized evaluation criteria. MATERIALS AND METHODS. A systematic literature search was conducted by PubMed search strategy and hand-searching of relevant journals from included studies considering inclusion and exclusion criteria. Randomized clinical trials (RCT) and clinical trial studies comparing attachment systems on mandibular implant overdentures until December, 2011 were selected. Twenty nine studies were finally selected and the data about evaluation methods were collected. RESULTS. Evaluation criteria could be classified into 4 groups (implant survival, peri-implant tissue evaluation, prosthetic evaluation, and patient satisfaction). Among 29 studies, 21 studies presented implant survival rate, while any studies reporting implant failure did not present cumulative implant survival rate. Seventeen studies evaluating peri-implant tissue status presented following items as evaluation criteria; marginal bone level (14), plaque Index (13), probing depth (8), bleeding index (8), attachment gingiva level (8), gingival index (6), amount of keratinized gingiva (1). Eighteen studies evaluating prosthetic maintenance and complication also presented following items as evaluation criteria; loose matrix (17), female detachment (15), denture fracture (15), denture relining (14), abutment fracture (14), abutment screw loosening (11), and occlusal adjustment (9). Atypical questionnaire (9), Visual analog scales (VAS) (4), and Oral Health Impact Profile (OHIP) (1) were used as the format of criteria to evaluate patients satisfaction in 14 studies. CONCLUSION. For evaluation of implant overdenture, it is necessary to include cumulative survival rate for implant evaluation. It is suggested that peri-implant tissue evaluation criteria include marginal bone level, plaque index, bleeding index, probing depth, and attached gingiva level. It is also suggested that prosthetic evaluation criteria include loose matrix, female detachment, denture fracture, denture relining, abutment fracture, abutment screw loosening, and occlusal adjustment. Finally standardized criteria like OHIP-EDENT or VAS are required for patient satisfaction.

Stem Cells in Plastic Surgery: A Review of Current Clinical and Translational Applications

  • Salibian, Ara A.;Widgerow, Alan D.;Abrouk, Michael;Evans, Gregory R.D.
    • Archives of Plastic Surgery
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    • v.40 no.6
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    • pp.666-675
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    • 2013
  • Background Stem cells are a unique cell population characterized by self-renewal and cellular differentiation capabilities. These characteristics, among other traits, make them an attractive option for regenerative treatments of tissues defects and for aesthetic procedures in plastic surgery. As research regarding the isolation, culture and behavior of stem cells has progressed, stem cells, particularly adult stem cells, have shown promising results in both translational and clinical applications. Methods The purpose of this review is to evaluate the applications of stem cells in the plastic surgery literature, with particular focus on the advances and limitations of current stem cell therapies. Different key areas amenable to stem cell therapy are addressed in the literature review; these include regeneration of soft tissue, bone, cartilage, and peripheral nerves, as well as wound healing and skin aging. Results The reviewed studies demonstrate promising results, with favorable outcomes and minimal complications in the cited cases. In particular, adipose tissue derived stem cell (ADSC) transplants appear to provide effective treatment options for bony and soft tissue defects, and non-healing wounds. ADSCs have also been shown to be useful in aesthetic surgery. Conclusions Further studies involving both the basic and clinical science aspects of stem cell therapies are warranted. In particular, the mechanism of action of stem cells, their interactions with the surrounding microenvironment and their long-term fate require further elucidation. Larger randomized trials are also necessary to demonstrate the continued safety of transplanted stem cells as well as the efficacy of cellular therapies in comparison to the current standards of care.

Clinical results of conservative management in patients with full-thickness rotator cuff tear: a meta-analysis

  • Karasuyama, Masaki;Gotoh, Masafumi;Tahara, Keiji;Kawakami, Junichi;Madokoro, Kazuya;Nagamatsu, Takashi;Imai, Takaki;Harada, Nobuya;Kudo, Yu;Shiba, Naoto
    • Clinics in Shoulder and Elbow
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    • v.23 no.2
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    • pp.86-93
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    • 2020
  • Background: Several systematic reviews have reported on the conservative treatment of full-thickness rotator cuff tears; however, clinical results of this treatment still remain determined. Methods: PubMed, Cochrane Library, PEDro, and CINAHL databases were systematically searched for randomized clinical trials and observational studies. Two independent researchers reviewed a total of 2,981 articles, 28 of which met the criteria for inclusion in the study. Clinical outcome measures included Constant score, visual analog scale score for pain, range of motion, and short-form 36 questionnaires. The meta-analysis used a linear mixed model weighted with the variance of the estimate. Results: The meta-analysis showed a significant improvement after surgery. Pain score is 26.2 mm (1 month) to 26.4 mm (3 months), and 24.8 mm (12 months) (P<0.05); active abduction: 153.2° (2 months), 159.0° (6 months), 168.1° (12 months) (P<0.05); Constant score: 67.8 points (2 months) to 77.2 points (12 months) (P<0.05); short-form 36 questionnaires "vitality" section: 57.0 points (6 months) to 70.0 points (12 months) (P<0.05). Conclusions: Our data confirmed the effectiveness of conservative treatment in patients with full-thickness rotator cuff tears 12 months post-intervention. The results suggest that conservative treatment for patients with full-thickness rotator cuff tears should be the first line of treatment before considering surgery.

Analysis of Clinical Researches on Traditional Medicine Treatment for Behcet's Disease in Korea, China, and Japan (한중일의 베체트병에 대한 한의약 임상연구 분석)

  • Yong, Seokil;Gu, Hyungyung;Kim, Daehun;Sohn, Kyungwoo;Yun, Youngju
    • Journal of Society of Preventive Korean Medicine
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    • v.18 no.1
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    • pp.67-82
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    • 2014
  • Objective : To find a treatment strategy, this study aimed to review and compare the clinical studies of Korea, China, and Japan on traditional medicine treatment for Behcet's disease. Method : Literature searches were performed on six databases in each country and English databases, such as OASIS, KoreanTK, CNKI, J-STAGE, PubMed, and Cochrane CENTRAL. In addition, using the limited keywords, the area was restricted to traditional medicine treatment, but the period was not limited. Studies were categorized according to the study design and we analyzed the difference of treatment among three countries. Results : One hundred and forty-one clinical studies met our inclusion criteria: 11 studies in Korea, 15 in Japan, 115 in China. Randomized controlled trials (RCT) have increased in China, however, no RCT was reported in Korea and Japan. The method of treatment was mainly traditional herbal medicine in all the three countries, but there were significant differences in the field of syndrome identification and prescription among countries. The studies in China made use of most various treatment modalities and reported the highest effectiveness. Conclusion : Traditional medicine treatment showed a considerable effect for improving various symptoms of Behcet's disease. However, more research for answering the safety and well-designed studies considering characteristics of Behcet's disease should be performed to evaluate the effectiveness of traditional medicine treatment objectively in the future.

Montelukast Reduces Serum Levels of Eosinophil-Derived Neurotoxin in Preschool Asthma

  • Kim, Chang-Keun;Callaway, Zak;Park, Jin-Sung;Nishimori, Hisashi;Ogino, Tikatoshi;Nagao, Mizuho;Fujisawa, Takao
    • Allergy, Asthma & Immunology Research
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    • v.10 no.6
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    • pp.686-697
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    • 2018
  • Purpose: Several markers for eosinophilic inflammation have been proposed to predict response to asthma treatment. However, definitive criteria for treatment decisions have not yet been established. We investigate a potentially useful relatively non-invasive biomarker, eosinophil-derived neurotoxin (EDN), to predict favorable responses to budesonide or montelukast, common treatment for children with asthma. Methods: Young children (1 to 6 years old) were enrolled in this randomized, parallel, 2-group, open-label trial. Criteria for eligibility included: 1) being symptomatic during the run-in period; and 2) having a serum EDN (sEDN) level ${\geq}53ng/mL$, with positive specific immunoglobulin E to house dust mite. Eligible patients were randomly placed into 2 groups: the BIS group received budesonide inhalation suspension (BIS) 0.5 mg once daily; the MONT group received montelukast 4 mg once daily. Ineligible patients were invited to receive montelukast 4 mg once daily (OBS group). Treatment period was 12 weeks. Results: Asthma control days increased significantly in the BIS and MONT groups (P < 0.000) over the 12-week study period. There was no significant change in sEDN in the BIS group but there was a significant decrease in the MONT group (P < 0.000). Patients in the OBS group with high EDN levels (> 53 ng/mL) showed a significant decrease due to MONT treatment (P = 0.023). Rescue medication usage significantly decreased in the BIS and MONT groups (P < 0.000). Conclusions: EDN is a useful relatively non-invasive biomarker for predicting responses to montelukast and budesonide treatment of preschool children with beta2-agonist responsive recurrent wheeze and multiple-trigger wheeze (Trial registry at UMIN Clinical Trials Registry, UMIN000008335).

Review of Clinical Study over the Last 10 Years on Korean Medicine Treatment for Cancer: Focusing on Korean Database (한방 암 치료에 대한 최근 10년간 임상연구 고찰: 국내 데이터베이스를 중심으로)

  • Choi, Ji-Won;Nam, Yeon-Kyeong;Lee, Jung-Han;Woo, Hyeon-Jun
    • Journal of Korean Medicine Rehabilitation
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    • v.31 no.4
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    • pp.75-86
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    • 2021
  • Objectives This study aimed to analyze the research trends in clinical studies on the traditional Korean medicine used for cancer treatment between 2011 and 2020. Methods We searched 7 Korean web databases (Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS], Koreanstudies Information Service System [KISS], Korean Medical database [KMBASE], DBpia, Korea Institute of Science and Technology Information [KISTI], and KoreaMed) and classified collected papers dated between 2011 and 2020 by the year of publication, publication journal, study design, type of cancer affecting the patients, interventions used, evaluation system used, and combination with conventional medicine. Results A total of 167 papers were collected. More than 10 papers were published annually. The papers were mainly published in the Journal of Korean Traditional Oncology (28.7%). The predominant type of the study was case study (67.7%). The main type of cancer was breast cancer, affecting 262 patients. Most of the studies reported using multiple traditional Korean medicine treatments (55.1%). Eighty-nine studies reported using clinical laboratory tests for evaluation. Most of the patients took conventional medicine simultaneously (608 patients). Conclusions Research related to Korean medicine for cancer patients is at a rudimentary level. Therefore, for further clarity, high evidence-based researches, including randomized controlled trials and cohort studies, should be conducted.

The Efficacy of Early Start Denver Model Intervention in Young Children with Autism Spectrum Disorder Within Japan: A Preliminary Study

  • Tateno, Yukie;Kumagai, Kahoru;Monden, Ryunosuke;Nanba, Kotaro;Yano, Ayumi;Shiraishi, Eri;Teo, Alan R.;Tateno, Masaru
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.32 no.1
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    • pp.35-40
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    • 2021
  • Objectives: Among the many intervention programs for children with autism spectrum disorder (ASD), the Early Start Denver Model (ESDM) is one of the few approaches that has succeeded in demonstrating clinical efficacy in randomized control trials. Here, we investigate the clinical efficacy of ESDM intervention in young children with ASD in a community setting within Japan. Methods: All subjects were children with ASD who received ESDM intervention during the study period. Each ESDM session lasted 75 min and occurred once per week for at least 12 weeks. The outcome measures consisted of the Kyoto Scale of Psychological Development (K-test), Aberrant Behavior Checklist-Japanese version (ABC-J), and the Clinical Global Impression-Severity scale (CGI-S). Results: Twenty-seven subjects (29.4±6.4 months old) received ESDM intervention that lasted for 8.0±2.6 months on average. The score on Language and Social developmental quotient on the K-test increased significantly after the intervention. The total scores on the ABC-J and CGI-S significantly decreased after completion of the ESDM intervention. Conclusion: Our results suggest that ESDM intervention could reduce the severity of distinct clinical features of ASD, such as impairments in social interaction and communication assessed by the K-test, and maladaptive behavior rated by the ABC-J and CGI-S. We believe that the ESDM adapted to each institution might become one of the standard options for children with ASD in Japan.

A Review of Recent Clinical Studies of Transcutaneous Electrical Nerve Stimulation (TENS) on Xerostomia - PubMed and Domestic Studies (구강건조증에 대한 경피적전기신경자극(Transcutaneous electrical nerve stimulation)의 최근 임상연구 동향 고찰 - Pubmed와 국내 논문을 중심으로)

  • Lee, Eunkyung;Jun, Hyejin;Kim, Minjeong;Park, Jae-Woo;Ko, Seok-Jae
    • The Journal of Internal Korean Medicine
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    • v.43 no.3
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    • pp.375-386
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    • 2022
  • Objectives: The purpose of this study was to summarize current clinical study trends and results regarding transcutaneous electrical nerve stimulation (TENS) treatment for xerostomia. Methods: Studies published from 2017 to 2022 were searched on domestic databases and PubMed. The included studies were analyzed according to the year, language, study design, diagnosis xerostomia method, and TENS treatment method. Results: Nine studies were included. There were three randomized controlled trials (RCTs), three case series, one case report, one case-control study, and one cross-sectional study. Conventional TENS was used in seven studies, and acupuncture-like TENS (ALTENS) was used in one study. The most common TENS attachment site was externally on the skin overlying the parotid gland region, and the setting of TENS was 50 Hz-250 μs the most. In all nine studies, TENS was effective for xerostomia as assessed by salivary flow rate or quality of life questionnaire. Additionally, no persistent adverse events were reported after TENS treatment. Conclusions: TENS treatment for xerostomia can be considered effective and safe, so it can be used in clinical practice.

A Review of Clinical Studies for Chinese Medicine Treatment of Idiopathic Edema Using the CNKI Database (특발성 부종의 중의치료에 대한 임상연구 동향 - CNKI검색을 중심으로)

  • Park, Mi-so;Kim, Soo-duk;Kong, Geon-sik;Choi, Yo-sup;Bae, Ji-eun;Baek, Hye-kyung;Kim, Young-jun;Shin, Dong-guk
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.596-605
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    • 2022
  • Objectives: This study investigated the latest clinical studies on Korean medicine treatment of idiopathic edema in the Chinese National Knowledge Infrastructure Database (CNKI). Methods: We searched the last 9 years of clinical studies discussing Oriental medicine-based treatments for idiopathic edema in the CNKI database. The search focused on the authors, publication year, type of study, purposes of study, method and duration of treatment, evaluation criteria, and results of the selected articles. Results: The search identified 7 randomized controlled trials (RCTs) and 9 others. All studies used oral herbal medicine for treatment. The most commonly used herbs were Poria Sclerotium (茯苓), Atractylodis Rhizoma Alba (白朮), and Alismatis Rhizoma (澤瀉), which are the constituent herbs of Oryeong-san (五苓散). All 16 studies confirmed the efficacy of Oriental medicine treatments. Conclusion: More varied and scientifically designed clinical studies are required to develop treatments for idiopathic edema. The results of this study could be used as basic data for further studies on idiopathic edema.