• Title/Summary/Keyword: randomized clinical

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Rview of Recent Clinical Research for Herbal Medicine Treatment on Vitiligo in Children - Focused on Chinese Randomized Controlled Trials - (소아 백반증의 한약 치료에 대한 최신 임상 연구 동향 - 중국 무작위 대조군 연구를 중심으로 -)

  • Jang, Jin Woo;Choi, Il Shin;Park, Beom Chan;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.141-155
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    • 2021
  • Objective The purpose of this study is to gather information from clinical studies conducted in China and analyze the effects of herbal medicine treatment for childhood vitiligo. Methods The randomized controlled trials (RCTs) with herbal medicine treatment for childhood vitiligo from the Chinese Academic Journal (CAJ) from China National Knowledge Infrastructure (CNKI) were searched. Then, each study was analyzed by demographics, disease durations, interventions, treatment periods, outcomes, adverse events, and compositions of the herbal medicine used. Result A total of 6 RCTs were included. All the trials except for one used a combination of Chinese herbal medicine with Western medicine as their treatment groups. The total efficacy rate was used to measure the effectiveness, and the treatment groups reported a significantly higher total efficacy rate compared to the control groups in all studies. In one study, a control group treated with compound glycyrrhizin capsule and topical compound kaliziran tincture combination treatment was compared with a treatment group which used the same treatment that the control group received in addition to oral herbal medicine. This study also showed higher total effectiveness in the treatment group than the control group. Conclusions In pediatric vitiligo, a combination of herbal medicine treatment rather than Western medical treatment alone can improve symptoms. In addition, it was suggested that the therapeutic effect can be enhanced when oral herbal medicine is used in combination with other herbal medicine treatments.

External apical root resorption 6 months after initiation of orthodontic treatment: A randomized clinical trial comparing fixed appliances and orthodontic aligners

  • Toyokawa-Sperandio, Katia Cristina;Conti, Ana Claudia de Castro Ferreira;Fernandes, Thais Maria Freire;de Almeida-Pedrin, Renata Rodrigues;de Almeida, Marcio Rodrigues;Oltramari, Paula Vanessa Pedron
    • The korean journal of orthodontics
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    • v.51 no.5
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    • pp.329-336
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    • 2021
  • Objective: To compare the magnitude of external apical root resorption (EARR) 6 months after starting orthodontic treatment using orthodontic aligners (OAs) and fixed appliances (FAs). Methods: This parallel randomized clinical trial included 40 patients randomized into two groups: OA group (n = 20, 160 incisors) and FA group (n = 20, 160 incisors). For evaluation of the tooth length, periapical radiographs and standardized linear measurements of the maxillary and mandibular incisors were acquired before (T0) and 6 months after treatment initiation (T1). EARR was calculated through the difference in length between the two time points (T1-T0). Statistical comparisons were performed by means of using t-tests, chi-squared test and covariance analysis (a = 5%). Results: Rounding of the root apex was observed in both groups; the resorption involved 2.88% of the root length, so 97.12% of the tooth length remained intact. Intragroup comparisons between the two time points revealed a significant difference, with (T1-T0) ranging from -0.52 to -0.88 mm in the FA group and from -0.52 to -0.85 mm in the OA group. In the intergroup comparisons, only tooth #21 presented a statistically significant difference (OA: -0.52 ± 0.57 mm, FA: -0.86 ± 0.60 mm); however, the overall differences between groups were not clinically relevant, ranging from 0.03 to 0.35 mm. Conclusions: OA and FA treatment resulted in a similar degree of EARR in the maxillary and mandibular incisors at 6 months after treatment initiation. However, the amount of resorption was small and does not impair tooth longevity.

Low-dose intravenous ketamine versus intravenous ketorolac in pain control in patients with acute renal colic in an emergency setting: a double-blind randomized clinical trial

  • Sotoodehnia, Mehran;Farmahini-Farahani, Mozhgan;Safaie, Arash;Rasooli, Fatemeh;Baratloo, Alireza
    • The Korean Journal of Pain
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    • v.32 no.2
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    • pp.97-104
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    • 2019
  • Background: This study was conducted to compare the effectiveness of low-dose ketamine versus ketorolac in pain control in patients with acute renal colic presenting to the emergency department (ED). Methods: This is a double-blind randomized clinical trial. The initial pain severity was assessed using the numerical rating scale (NRS). Then, ketamine or ketorolac was administered intravenously at a dose of 0.6 mg/kg and 30 mg respectively. The pain severity and adverse drug reactions were recorded 5, 15, 30, 60, and 120 min thereafter. Results: The data of 62 subjects in the ketamine group and 64 patients in the ketorolac group were analyzed. The mean age of the patients was $34.2{\pm}9.9$ and $37.9{\pm}10.6\;years$ in the ketamine and ketorolac group, respectively. There was no significant difference in the mean NRS scores at each time point, except for the 5 min, between the two groups. Despite a marked decrease in pain severity in the ketamine group from drug administration at the 5 min, a slight increase in pain was observed from the 5 min to the 15 min. The rate of adverse drug reactions, including dizziness (P = 0.001), agitation (P = 0.002), increased systolic blood pressure (> 140 mmHg), and diastolic blood pressure (> 90 mmHg) was higher in the ketamine group. Conclusions: Low dose ketamine is as effective as ketorolac in pain management in patients with renal colic presenting to the ED. However, it is associated with a higher rate of adverse drug reactions.

A Systematic Review and Meta-Analysis of Fire Needling Treatment for Knee Osteoarthritis: Focused on Comparative Studies with Manual Acupuncture Treatment during Recent Five Years (퇴행성 슬관절염의 화침 치료에 대한 체계적 문헌 고찰 및 메타분석: 최근 5년간의 호침 치료 비교 연구를 중심으로)

  • Ko, Hong-Je;Yoo, Jae-Hee;Shin, Jeong-Cheol
    • Korean Journal of Acupuncture
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    • v.36 no.2
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    • pp.104-114
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    • 2019
  • Objectives : The purpose of this study is to review the effectiveness of fire needling treatment for knee osteoarthritis in comparison with manual acupuncture treatment. Methods : Through four foreign online databases (PubMed, Cochrane library, EMBASE, and CNKI) and five domestic online databases (NDSL, RISS, KISS, OASIS, and KTKP), we searched for clinical studies that performed fire needling treatment for knee osteoarthritis until May 10, 2019. Only randomized controlled trials were selected and we assessed the risk of bias according to the Cochrane RoB criteria. This review examined the selected studies into first author, publication year, sample size, outcome measurements, results, acupoints, treatment time & period and so on. Results : A total of 7 RCTs were selected in this review and all were conducted in China. Treatment period of more than 4 weeks and treatment visits of 10 to 20 times were the most common. EX-LE4 and ST35 (=EX-LE5) acupoints were most frequently selected in treatment. Among the evaluation indexes, a total efficacy rate was used the most. Most of fire needling groups showed more significant results compared with the manual acupuncture groups statistically. Conclusions : All studies showed that fire needling treatments for knee osteoarthritis were more effective than manual acupuncture treatments statistically. Therefore, the results of this study could be utilized as a preliminary data for another clinical research on fire needling treatment for knee osteoarthritis. However, further well-designed randomized controlled trials will be needed to develop sufficient evidence about the effectiveness and safety of fire needling treatment for knee osteoarthritis in the future.

Recent Trends in Clinical Research of Herbal Medicine for Tic Disorder in Children - Focused on Chinese Randomized Controlled Trials - (소아 틱장애의 한약치료에 대한 최신 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Kim, Jae Hyun;Park, Yong Seok;Jeong, Yoon Kyoung;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.1
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    • pp.38-56
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    • 2022
  • Objectives The purpose of this study was to analyze the trend of recent randomized controlled trials (RCTs) that used herbal medicine for the treatment of tic disorders in China and to evaluate the efficacy and safety of the treatment. Methods RCTs published from January 2017 to December 2021 were searched for using the China National Knowledge Infrastructure (CNKI). These were then analyzed using herbal medicine treatment methods and their results. Results A total of 35 randomized controlled trials were selected and analyzed. In most studies, evaluation indicators such as the Yale tic symptom scale and total effective rate were significantly improved in the herbal medicine treatment group compared to the control group. The most commonly used herb for tic disorder was Uncaria Rhynchophylla (釣鉤藤), followed by Glycyrrhizae Radix (甘草), Gastrodiae Rhizoma (天麻), Paeoniae Radix Alba (白芍藥), Batryticatus (白殭蠶), Poria (茯笭), and Bupleuri Radix (柴胡). In all studies that reported adverse events, herbal medicine was identified as a relatively safe treatment with fewer adverse reactions or no significant difference compared with the control group. Conclusions Based on the results of RCTs, herbal medicine has been shown to be safe and effective for the treatment of intellectual disability. However, additional well-designed large-scale clinical trials are needed to confirm these findings.

Chuna Manual Therapy for Postpartum Low Back Pain: Systematic Review (출산 후 요통에 대한 추나요법의 효과: 체계적 문헌고찰)

  • Cho, Ju-chan;Park, In-hwa;Hwang, Man-Suk;Heo, In
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.16 no.2
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    • pp.1-8
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    • 2021
  • Objectives This study aimed to evaluate the effect of chuna manual therapy (CMT) for postpartum low back pain using a systematic review. Methods We performed a literature search using 12 electronic databases up to the end of September 2021. We included randomized controlled trials (RCTs) that evaluated the effect of CMT in the treatment of postpartum low back pain. The risk of bias was evaluated using the Cochrane risk-of-bias tool. Results Four randomized controlled trials were reported statistically significant effect in pain VAS, ODI and JOA of chuna manual therapy compared with moxibution, electro acupuncture, hyperthermia or usual care. As a result of assessing the risk of bias tool, most of the contents of the evaluation items were not identified, so it was evaluated as an uncertain risk. Conclusions CMT may be effective in treating postpartum low back pain. However, evidence was limited due to the small sample size, lack of well-designed RCTs and regional bias. Further well-designed studies are required to obtain stronger evidence.

Comparison of Two pMDIs in Adult Asthmatics: A Randomized Double-Blind Double-Dummy Clinical Trial

  • Nam, Tae-Hyun;Kang, Sung-Yoon;Lee, Sang Min;Kim, Tae-Bum;Lee, Sang Pyo
    • Tuberculosis and Respiratory Diseases
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    • v.85 no.1
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    • pp.25-36
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    • 2022
  • Background: Only a few studies directly compared the therapeutic efficacy and safety of two pressurized metered-dose inhalers (pMDIs) in asthma. We analyzed the asthma treatment outcomes, safety, and patient preferences using formoterol/beclomethasone (FORM/BDP), a pMDI with extra-fine particles, compared with formoterol/budesonide (FORM/BUD), another pMDI with non-extra-fine particles. Methods: In this randomized, double-blind, double-dummy parallel group study, 40 adult asthmatics were randomized to FORM/BDP group (n=18; active FORM/BDP and placebo FORM/BUD) or FORM/BUD group (n=22; active FORM/BUD and placebo FORM/BDP). During the two visits (baseline and end of 8-week treatment), subjects were asked to answer questionnaires including asthma control test (ACT), asthma control questionnaires (ACQ), and Quality of Life Questionnaire for Adult Korean Asthmatics (QLQAKA). Lung function, compliance with inhaler, and inhaler-handling skills were also assessed. Results: Ten subjects in the FORM/BDP group and 14 in the FORM/BUD group completed follow-up visits. ACT, ACQ, QLQAKA (a primary outcome), and adverse events did not differ between two groups. We found that the increase in forced expiratory volume in 1 second/forced vital capacity and forced expiratory flow at 25% to 75% of the pulmonary volume in the FORM/BDP group was higher than in the FORM/BUD group. Regarding preference, subjects responded that the flume velocity of FORM/BDP was higher, but more adequate than that of FORM/BUD. They also answered that FORM/BDP reached the trachea and bronchus and irritated them significantly more than FORM/BUD. Conclusion: The use of pMDI with extra-fine particles may relieve small airway obstruction more than the one with non-extra-fine particles despite no significant differences in overall treatment outcomes. Some asthmatics have a misconception about the adequacy of high flume velocity of pMDIs.

The Impact of Fractional Flow Reserve on Clinical Outcomes after Coronary Artery Bypass Grafting: A Meta-analysis

  • Yoonjin, Kang;Heeju, Hong;Suk Ho, Sohn;Myoung-jin, Jang;Ho Young, Hwang
    • Journal of Chest Surgery
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    • v.55 no.6
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    • pp.442-451
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    • 2022
  • Background: This meta-analysis was conducted to evaluate the effect of fractional flow reserve (FFR) on clinical outcomes after coronary artery bypass grafting (CABG). Methods: Five online databases were searched for studies that (1) enrolled patients who underwent isolated CABG or CABG with aortic valve replacement and (2) demonstrated the effect of an FFR-guided strategy on major adverse cardiac events (MACE) after surgery based on a randomized controlled trial or adjusted analysis. MACE included cardiac death, acute myocardial infarction (MI), and repeated revascularization. The primary outcomes were all MACE outcomes and a composite of all-cause death and MI, and the secondary outcomes were the individual MACE outcomes. Publication bias was assessed using a funnel plot and the Egger test. Results: Six articles (3 randomized and 3 non-randomized studies: n=1,027) were selected. MACE data were extracted from 4 studies. The pooled analyses showed that the risk of MACE was not significantly different between patients who underwent FFR-guided CABG and those who underwent angiography-guided CABG (hazard ratio [HR], 0.80; 95% CI, 0.57-1.12). However, the risk of the composite of death or MI was significantly lower in patients undergoing FFR-guided CABG (HR, 0.62; 95% CI, 0.41-0.94). The individual MACE outcomes were not significantly different between FFR-guided and angiography-guided CABG. Conclusion: FFR-guided CABG might be beneficial in terms of the composite outcome of death or MI compared with angiography-guided CABG although data are limited.

A Literature Review of Randomized Controlled Trials on Tobacco Cessation Using Auricular Acupuncture and Auricular Acupressure

  • Min-Gi, Jo;Jun-Yeong, Jang;Min-Jung, Ko;Sang-Yeup, Chae;Seungeun, Lee;Dongmin, Lee;Won Suk, Sung;Jung-Hyun, Kim;Bonhyuk, Goo;Yeon-Cheol, Park;Yong-Hyeon, Baek;Sang-Soo, Nam;Byung-Kwan, Seo
    • Journal of Acupuncture Research
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    • v.39 no.4
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    • pp.258-266
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    • 2022
  • This study aimed to analyze auricular acupressure and auricular acupuncture used in smoking cessation research by analyzing published randomized controlled trials. Eight databases (PubMed, Cochrane, EMBASE, CNKI, CiNII, KMbase, KISS, OASIS) were searched until December 2021, and 21 out of 1,919 studies met inclusion criteria. Data on the treatment site, time, frequency, period, and outcomes were analyzed. Lung (MA-IC1) and Ear Shenmen (MA-TF1) were the most used acupoints. The number of treatments varied between a minimum of 2 to a maximum of 24, and treatment duration varied between a minimum of 2 weeks to a maximum of 8 weeks. Cigarette consumption and smoking cessation rate were the most studied outcome, followed by multiple other psychological indications.

Effect and stability of miniscrew-assisted rapid palatal expansion: A systematic review and meta-analysis

  • Huang, Xinyi;Han, Yu;Yang, Shuangyan
    • The korean journal of orthodontics
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    • v.52 no.5
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    • pp.334-344
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    • 2022
  • Objective: This study aimed to systematically analyze the effect and stability of miniscrew-assisted rapid palatal expansion (MARPE) to provide a reference for the clinical treatment of patients with maxillary transverse deficiency (MTD). Methods: We searched PubMed, Science Direct, Web of Science, Embase, Cochrane Library, CNKI, and Wanfang Database for relevant studies published before February 18, 2021 and selected them according to the eligibility criteria. The Cochrane Handbook for Systematic Reviews (version 5.1.0) criteria were used for the quality assessment of randomized controlled trials, while the scoring protocol of the methodological index for non-randomized studies was used for non-randomized controlled trials. Statistical analysis was performed using the RevMan5.3 software. Results: All the included studies showed a relatively high success rate of expansion. The changes in both the intermolar and alveolar widths after MARPE were statistically significant. MARPE exhibited greater skeletal expansion effects than did conventional RPE. The midpalatal suture was opened in parallel after MARPE. A small amount of relapse was observed 1 year after expansion. MARPE caused tooth inclination and a decrease in alveolar height, but it was less significant than in conventional RPE. Conclusions: MARPE may be an effective treatment modality for patients with MTD. It causes great transverse skeletal expansion in late adolescence. In comparison to conventional RPE, MARPE has lower detrimental periodontal effects and has certain clinical advantages.