• Title/Summary/Keyword: randomized clinical

Search Result 2,003, Processing Time 0.03 seconds

Clinical Effectiveness of Traditional Herbal Medicine in the Treatment of Central Post-Stroke Pain and Thalamic Syndrome: a Systemic Review and Meta-analysis of Randomized Clinical Trials Based on Traditional Chinese Medicine Journals (뇌졸중 후 중추성 통증 및 시상증후군에 대한 한약치료의 효과 : 체계적 고찰 및 메타분석 - 중의학 저널을 중심으로)

  • Jung, Yu-jin;Kang, Eun-jin;Hong, Sang-hoon
    • The Journal of Internal Korean Medicine
    • /
    • v.40 no.3
    • /
    • pp.295-311
    • /
    • 2019
  • Objectives: This research aimed to investigate Chinese clinical studies on the treatment of central post-stroke pain (CPSP) and thalamic syndrome after stroke with traditional herbal medicine (THM). Methods: Randomized controlled trials verifying the effects of herbal medicine on treating CPSP and thalamic syndrome after stroke were included in the study. Electrical and hand search were conducted in the China National Knowledge Infrastructure (CNKI), National Discovery for Science Leaders (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (Oasis) for CPSP and thalamic syndrome after stroke. A literature search was performed in the Chinese and Korean databases for papers published from January 1, 2010 to October 1, 2018. The selected literature was assessed by Cochrane's risk of bias. Results: Twelve reports on randomized controlled trials met the inclusion criteria from the 227 identified reports. Effective rate, comparison of visual analogy scale, present pain intensity, pain grading index, recurrence rate, follow-up, and a 36-item short form survey instrument were used to evaluate the treatments. The effective rate of the treatment group was significantly higher than that of the control group in all papers. Side effects occurred less frequently in the treatment group than in the western medicine control group. Conclusions: The treatment of CPSP and thalamic syndrome after stroke with THM was shown to be highly effective. Additional well-designed clinical trials are needed. This study can be used as a basis for further research on the treatment of CPSP and thalamic syndrome after stroke.

Pharmacological Treatment of Major Depressive Episodes with Mixed Features: A Systematic Review

  • Shim, In Hee;Bahk, Won-Myong;Woo, Young Sup;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
    • /
    • v.16 no.4
    • /
    • pp.376-382
    • /
    • 2018
  • We reviewed clinical studies investigating the pharmacological treatment of major depressive episodes (MDEs) with mixed features diagnosed according to the dimensional criteria (more than two or three [hypo]manic symptoms+principle depressive symptoms). We systematically reviewed published randomized controlled trials on the pharmacological treatment of MDEs with mixed features associated with mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD). We searched the PubMed, Cochrane Library, and ClinicalTrials.gov databases through December 2017 with the following key word combinations linked with the word OR: (a) mixed or mixed state, mixed features, DMX, mixed depression; (b) depressive, major depressive, MDE, MDD, bipolar, bipolar depression; and (c) antidepressant, antipsychotic, mood stabilizer, anticonvulsant, treatment, medication, algorithm, guideline, pharmacological. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We found few randomized trials on pharmacological treatments for MDEs with mixed features. Of the 36 articles assessed for eligibility, 11 investigated MDEs with mixed features in mood disorders: six assessed the efficacy of antipsychotic drugs (lurasidone and ziprasidone) in the acute phase of MDD with mixed features, although four of these were post hoc analyses based on large randomized controlled trials. Four studies compared antipsychotic drugs (olanzapine, lurasidone, and ziprasidone) with placebo, and one study assessed the efficacy of combination therapy (olanzapine+fluoxetine) in the acute phase of BD with mixed features. Pharmacological treatments for MDEs with mixed features have focused on antipsychotics, although evidence of their efficacy is lacking. Additional well-designed clinical trials are needed.

Hyaluronic acid reduces inflammation and crevicular fluid IL-1β concentrations in peri-implantitis: a randomized controlled clinical trial

  • Sanchez-Fernandez, Elena;Magan-Fernandez, Antonio;O'Valle, Francisco;Bravo, Manuel;Mesa, Francisco
    • Journal of Periodontal and Implant Science
    • /
    • v.51 no.1
    • /
    • pp.63-74
    • /
    • 2021
  • Purpose: This study investigated the effects of hyaluronic acid (HA) on peri-implant clinical variables and crevicular concentrations of the proinflammatory biomarkers interleukin (IL)-1β and tumor necrosis factor (TNF)-α in patients with peri-implantitis. Methods: A randomized controlled trial was conducted in peri-implantitis patients. Patients were randomized to receive a 0.8% HA gel (test group), an excipient-based gel (control group 1), or no gel (control group 2). Clinical periodontal variables and marginal bone loss after 0, 45, and 90 days of treatment were assessed. IL-1β and TNF-α levels in crevicular fluid were measured by enzyme-linked immunosorbent assays at baseline and after 45 days of treatment. Clustering analysis was performed, considering the possibility of multiple implants in a single patient. Results: Sixty-one patients with 100 dental implants were assigned to the test group, control group 1, or control group 2. Probing pocket depth (PPD) was significantly lower in the test group than in both control groups at 45 days (control 1: 95% CI, -1.66, -0.40 mm; control 2: 95% CI, -1.07, -0.01 mm) and 90 days (control 1: 95% CI, -1.72, -0.54 mm; control 2: 95% CI, -1.13, -0.15 mm). There was a trend towards less bleeding on probing in the test group than in control group 2 at 90 days (P=0.07). Implants with a PPD ≥5 mm showed higher levels of IL-1β in the control group 2 at 45 days than in the test group (P=0.04). Conclusions: This study demonstrates for the first time that the topical application of a HA gel in the peri-implant pocket and around implants with peri-implantitis may reduce inflammation and crevicular fluid IL-1β levels.

Clinical Effect of Gyeongok-go: A Systematic Review of Randomized Controlled Trials (경옥고의 임상 효능 : 체계적 고찰)

  • Kang, Heekyung;Han, Changwoo
    • The Journal of Internal Korean Medicine
    • /
    • v.43 no.3
    • /
    • pp.423-435
    • /
    • 2022
  • Purpose: The purpose of this study was to confirm the clinical efficacy of Gyeongok-go. Methods: Public/Publisher MEDLINE (PubMed), Cochrane Central Register of Controlled Trials (CENTRAL), Excerpta Medica dataBASE (EMBASE), Research Information Sharing Service (RISS), ScienceON, Korean Traditional Knowledge Portal (KTKP), and China National Knowledge Infrastructure (CNKI) were searched for randomized controlled clinical trials administering Gyeongok-go as an intervention, published from inception to December 31, 2021. The risk-of-bias of the included trials was assessed with the Cochrane risk-of-bias tool for randomized trials version 2. From the experimental and control groups of the selected trials, the mean value (or rate) of each outcome was extracted and statistically compared. Results: Statistically significant mean differences were in VO2max (MD 6.82), post-exercise heart rate (MD -8.76 at 5 min, -11.58 at 30 min, -14.6 at 60 min), senescence scale (MD -6.52), Th1 cells and Th2 cells in pulmonary tuberculosis (MD 2.79 and -1.64), yin-deficient and qi-deficient score (MD -9.64 and -9.76), and phlegm-dampness score (MD 5.56). Overall risk-of-bias was 20% low risk, 80% some concerns, and 0% high risk. There were no reports of adverse events. Conclusions: Gyeongok-go is likely to have the effect of improving cardiorespiratory endurance, increasing fatigue recovery ability, reducing senescence, and enhancing immune function in tuberculosis patients. Also, it is more suitable for those who are yin-deficient or qi-deficient, and those with phlegm-dampness probably need caution.

A Preliminary Study Protocol to Evaluate Patient Outcomes, Feasibility, Preliminary Effectiveness, Safety and Economic Evaluation of Korean Medicine Treatment for Periodontal Disease (치주질환에 대한 한의치료의 환자성과, 연구 가능성, 예비 효과, 안전성 및 경제성 평가를 위한 예비 연구 프로토콜)

  • Jiyun Lee;Kyungsun Han
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
    • /
    • v.37 no.2
    • /
    • pp.14-26
    • /
    • 2024
  • Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

Necessity of pharyngeal anesthesia during transoral gastrointestinal endoscopy: a randomized clinical trial

  • Tomoyuki Hayashi;Yoshiro Asahina;Yasuhito Takeda;Masaki Miyazawa;Hajime Takatori;Hidenori Kido;Jun Seishima;Noriho Iida;Kazuya Kitamura;Takeshi Terashima;Sakae Miyagi;Tadashi Toyama;Eishiro Mizukoshi;Taro Yamashita
    • Clinical Endoscopy
    • /
    • v.56 no.5
    • /
    • pp.594-603
    • /
    • 2023
  • Background/Aims: The necessity for pharyngeal anesthesia during upper gastrointestinal endoscopy is controversial. This study aimed to compare the observation ability with and without pharyngeal anesthesia under midazolam sedation. Methods: This prospective, single-blinded, randomized study included 500 patients who underwent transoral upper gastrointestinal endoscopy under intravenous midazolam sedation. Patients were randomly allocated to pharyngeal anesthesia: PA+ or PA- groups (250 patients/group). The endoscopists obtained 10 images of the oropharynx and hypopharynx. The primary outcome was the non-inferiority of the PA- group in terms of the pharyngeal observation success rate. Results: The pharyngeal observation success rates in the pharyngeal anesthesia with and without (PA+ and PA-) groups were 84.0% and 72.0%, respectively. The PA- group was inferior (p=0.707, non-inferiority) to the PA+ group in terms of observable parts (8.33 vs. 8.86, p=0.006), time (67.2 vs. 58.2 seconds, p=0.001), and pain (1.21±2.37 vs. 0.68±1.78, p=0.004, 0-10 point visual analog scale). Suitable quality images of the posterior wall of the oropharynx, vocal fold, and pyriform sinus were inferior in the PA- group. Subgroup analysis showed a higher sedation level (Ramsay score ≥5) with almost no differences in the pharyngeal observation success rate between the groups. Conclusions: Non-pharyngeal anesthesia showed no non-inferiority in pharyngeal observation ability. Pharyngeal anesthesia may improve pharyngeal observation ability in the hypopharynx and reduce pain. However, deeper anesthesia may reduce this difference.

Effects of Tai Chi on Fall Risk Factors: A Meta-Analysis (낙상 위험요인에 대한 타이치 운동 효과의 메타분석)

  • Park, Moonkyoung;Song, Rhayun
    • Journal of Korean Academy of Nursing
    • /
    • v.43 no.3
    • /
    • pp.341-351
    • /
    • 2013
  • Purpose: This study was done to analyze the effects of Tai Chi on fall-related risk factors through meta-analysis of randomized clinical trials published in English and Korean between 2000 and 2010. Methods: Using health related database and hand search of references and Google, 28 randomized studies were collected from doctoral dissertation and published peer reviewed articles. The Comprehensive Meta-analysis version 2.0 was used for the analysis. Results: The effect sizes for Tai Chi for 3 months were significant with ES=0.54 for static balance, ES=0.24 for dynamic balance, ES=0.69 for balance measured by scale, and ES=0.40 for flexibility, ES=0.48 for muscle strength, ES=0.71 for ADL, and ES=0.37 for fear of falling. Also, the effect sizes of Tai Chi for 6 months were significant for most fall-related variables. The 6 month data for flexibility was not analyzed since only one study was published. Conclusion: The analysis of studies of randomized clinical trials indicate that Tai Chi is effective in improving balance, flexibility, muscle strength, activities of daily living, and fear of falling when applied for 3 or 6 months. The findings provide the objective evidence to apply Tai Chi as a fall preventive intervention.

A Review of Recent Clinical Studies of Herbal Medicine Treatment for Children's Stomatitis : Focusing on Randomized Controlled Trials in Traditional Chinese Medicine (소아 구내염의 한약치료에 대한 임상연구 동향: 중의학 무작위대조군 임상시험을 중심으로)

  • Heo, Yu Jin;Lee, Shin Hee;Cho, Yun Soo
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.35 no.4
    • /
    • pp.125-140
    • /
    • 2021
  • Objectives This study aims to find out the recent trend of the herbal medicine treatment in children's stomatitis in China, and propose better methods to treat children's stomatitis in Korea. Methods The randomized controlled trials (RCT) relevant to 'Herbal medicine treatment on children's stomatitis' were searched using China Academic Journal (CAJ). The search method we used included search formula, (SU = '口內炎' + '口腔炎' + 'stomatitis') and (SU = '儿童' + '小儿' + 'children' + 'child') from 2000 to September 2021. Results A total of 9 RCTs were selected and analyzed. All reports showed that oral administration of herbal medicine were effective and improved clinical symptoms. The most-used herbal medicine category was Heat-clearing medicine (淸熱藥). Conclusions The literatures from China have shown that herbal medicine improves children's stomatitis. These outcomes may be helpful for the treatment of children's stomatitis in Korea. However, further studies are needed to develop treatment guidelines for children's stomatitis.

A Review of Clinical Researches for Acupuncture Treatment on Tourette Syndrome (투렛장애 (Tourette syndrome)의 침 치료에 대한 중의학 임상 연구 고찰)

  • Kim, Boram;Choi, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.36 no.2
    • /
    • pp.13-25
    • /
    • 2022
  • Objective This study aimed to analyze randomized controlled trials of the effect of acupuncture on Tourette syndrome and to evaluate the efficacy of the treatment. Methods Based on the China National Knowledge Infrastructure (CNKI) and Pubmed search with the key search terms of 'Tourette syndrome, acupuncture', dated from 2000 to 2021, ten randomized controlled trials were identified and analyzed for this study. Results 1. The most commonly used acupoints were Taechung (LR3), Sinmun (HT7), Hapgok (LI4), Pungji (GB20) and Backhoe (GV20). 2. The most commonly used meridians were Bladder Meridian, Stomach Meridian and Gallbladder Meridian. 3. Acupuncture treatment was found to be significantly more or equally effective than western medicine such as haloperidol and tiapride. Conclusions Based on the results of the randomized controlled trials analyzed in this study, acupuncture was found to be effective in the treatment of Tourette syndrome. However, more clinical studies are needed to prove the effectiveness of acupuncture in Tourette syndrome.

A Review of Clinical Studies for Tuina Treatment on Attention Deficit Hyperactivity Disorder (ADHD) - Focused on Chinese Randomized Controlled Trials - (소아 주의력결핍 과잉행동장애 (ADHD)의 추나요법 효과에 대한 임상연구 고찰 - 중의학 무작위 대조군 임상연구를 중심으로 -)

  • Lee, Min Yeong;Ryu, Eui Seong;Choi, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
    • /
    • v.36 no.3
    • /
    • pp.63-74
    • /
    • 2022
  • Objective This study aimed to analyze the efficacy and safety of Tuina therapy for attention-deficit hyperactivity disorder (ADHD) through a randomized controlled clinical study in China. Methods We used the China National Knowledge Infrastructure (CNKI) as a resource and conducted a search using key words: 'ADHD', '推拿'. Six randomized control studies were identified and analyzed in this study. Results 1. The Tuina treatment group showed significant changes compared to the control group. 2. The most commonly used meridians were Spleen meridian (脾經穴), Liver meridian (肝經穴), Errenshangma (二人上馬穴), Xiaotianxin (小天心), Qinghetianshu (清河天水), Kidney meridian (腎經穴). Conclusions The results of this study showed that Tuina therapy is effective for ADHD patients with ADHD. It can be used for future research on Tuina therapy for ADHD.