• Title/Summary/Keyword: randomized controlled trials (RCTs)

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Effects of Cardiovascular Training on Interleukin-6 in Stroke Patients: a Systematic Review and Meta-analysis of Randomized Controlled Trials

  • Jeong Keun Song;Ju Hui Moon
    • Physical Therapy Rehabilitation Science
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    • v.12 no.2
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    • pp.115-122
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    • 2023
  • Objective: A previous study reported that cardiovascular training (CT) decreased interleukin-6 (IL-6), a pro-inflammatory cytokine with bidirectional effects. However, because of conflicting results of increasing and decreasing IL-6 levels in stroke patients, it is essential to clarify the effects of CT on IL-6 levels in this population. Therefore, this review aimed to investigate the effects of CT on IL-6 levels in stroke patients through a meta-analysis of randomized controlled trials (RCTs), synthesizing and analyzing the effects qualitatively and quantitatively. Design: A systematic review and meta-analysis of randomized controlled trials. Methods: In this review, conducted in April 2023, electronic databases (Web of Science, CINAHL, Embase, MEDLINE, Google Scholar) were searched to ascertain the effects of CT on IL-6 levels in stroke patients. For qualitative evaluation, ReVMan, provided by the Cochrane Group, was used, and for quantitative evaluation, a random-effects model and SMD (Standardized Mean Difference) were used. Results: Three RCTs measured IL-6 in 117 patients with stroke. The experimental group to which CT was applied showed no significant change compared to the control group.The result of analysis using the random effect model is SMD=-0.23; 95% confidence interval, -0.66 to 0.20. Conclusions: CT does not affect IL-6 levels in stroke patients. These results suggest that CT can be applied regardless of its positive or negative effect on IL-6 levels in stroke patients.

Acupuncture Treatment for Restless Legs Syndrome: A Review of Randomized Controlled Trials

  • Go Eun Chae;Hyun Woo Kim;Hye Jeong Jo;Ahra Koh;Young Jin Lee;Ji Eun Choi;Woo Young Kim
    • Journal of Acupuncture Research
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    • v.40 no.4
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    • pp.308-318
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    • 2023
  • To determine the effectiveness of acupuncture in treating restless legs syndrome (RLS), we conducted a literature review of randomized controlled trials (RCTs) that utilized acupuncture as an intervention for patients diagnosed with RLS. Relevant clinical studies (n = 158) from seven databases (the Cochrane Library, PubMed, Embase, CNKI, KISS, RISS, and OASIS) were included based on the inclusion and exclusion criteria and analyzed. Moreover, 6 RCTs were selected for review. In all six studies, it was indicated people who underwent acupuncture treatment showed significant improvements in their overall health. An increase in the treatment efficacy rate, sleep quality, and quality of life indicators after the acupuncture treatment was confirmed. The severity of pain as assessed using the visual analog scale (VAS) scores and International RLS Study Group Rating Scale (IRLSRS) scores and the severity of RLS symptoms were significantly reduced. Any significant side effects were not reported. Acupuncture is suggested as an effective and safe treatment method for RLS. However, further large-scale RCT studies are needed to confirm our findings.

Emotional Freedom Techniques (EFT) for Students' Mental Health: A Systematic Review (학생들의 정신건강을 위한 감정자유기법(EFT): 체계적 문헌고찰)

  • Lee, Seung Hwan;Jeong, Bo Eun;Chae, Han;Lim, Jung Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.3
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    • pp.165-182
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    • 2017
  • Objectives: The purpose of this systematic review was to understand clinical usefulness of Emotional Freedom Techniques (EFT) on students' mental health. Methods: Ten databases were included to extract clinical studies on effects of EFT intervention with students. Characteristics of selected studies were described, and biases were assessed with Risk of Bias (RoB) or Risk of Bias Assessment for Non-Randomized Studies (RoBANS). Results: A total of 14 clinical trials were extracted for analysis. There were 8 randomized-controlled trials (RCTs), 2 non-randomized-controlled trials (nRCTs), and 4 before-after studies. EFT have significant clinical usefulness in public speaking anxiety, test anxiety, stress, depression, learning related emotions, adolescent anxiety, and eating issues. The risk of selection bias in most studies was high or uncertain. Conclusions: EFT is an effective clinical technique for managing students' mental health issues. However, the included studies have been conducted with relatively poor quality and small sample size. Clinical trials with high quality study design and well-designed EFT education programs are needed to generalize clinical usefulness.

Review of Recent Clinical Research for Oral Herbal Medicine Treatment on Primary Hyperhidrosis in Children - Focused on Chinese Randomized Controlled Trials - (소아 일차성 다한증의 경구 한약치료에 대한 중의학 임상연구 동향 - 중국 무작위 대조군 임상연구를 중심으로 -)

  • Choil, Il Shin;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.75-86
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    • 2022
  • Objectives The purpose of the study is to review the trend of clinical trials conducted in China with oral herbal medicine treatment on childhood primary hyperhidrosis. Methods We searched the randomized controlled trials (RCTs) with oral herbal medicine treatment on childhood primary hyperhidrosis from the China National Knowledge Infrastructure (CNKI). The demographic data, duration of illness, intervention, treatment period, outcome and composition of herbal medicine were analyzed for this study. Results A total of five RCTs were selected and analyzed. The effectiveness of the oral administration of herbal medicines on childhood primary hyperhidrosis was found to be significant. In one study, there was no statistical difference between the treatment group and the control group when curative effect was evaluated two weeks after the intervention; however, the treatment group showed a statistically higher curative effect than the control group at one and two months after intervention, and also one month after the intervention was terminated. Conclusions Oral herbal medicine has been shown to be an effective treatment for childhood primary hyperhidrosis, and it takes at least one month for the administered oral herbal medicines to take effect. However, further well-designed large-scale randomized controlled trials are needed to confirm the efficacy and safety of oral herbal medicines in childhood primary hyperhidrosis.

Paradigm Shift in Intra-Arterial Mechanical Thrombectomy for Acute Ischemic Stroke : A Review of Randomized Controlled Trials after 2015

  • Sheen, Jae Jon;Kim, Young Woo
    • Journal of Korean Neurosurgical Society
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    • v.63 no.4
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    • pp.427-432
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    • 2020
  • Three randomized control trials (RCTs), published in 2013, investigated efficacy of mechanical thrombectomy in large vessel occlusions and did not show better results compared to intravenous (IV) recombinant tissue-type plasminogen activator (tPA) alone. However, most clinicians treating stroke consider mechanical thrombectomy as the standard treatment rather than using IV tPA alone. This paradigm shift was based on five RCTs investigating efficacy of mechanical thrombectomy in acute ischemic stroke conducted from 2010 to 2015. They demonstrated that mechanical thrombectomy was effective and safe in acute ischemic stroke with anterior circulation occlusion when performed within 6 hours of stroke onset. There are four reasons underlying the different results observed between the trials conducted in 2013 and 2015. First, the three RCTs of 2013 used low-efficiency thrombectomy devices. Second, the three RCTs used insufficient image selection criteria. Third, following the initial presentation at the hospital, reperfusion treatment required a long time. Fourth, the three RCTs showed a low rate of successful recanalization. Time is the most important factor in the treatment of acute ischemic stroke. However, current trends utilize advanced imaging techniques, such as diffusion-weighted imaging and multi-channel computer tomographic perfusion, to facilitate the detection of core infarction, penumbra, and collateral flows. These efforts demonstrate that patient selection may overcome the barriers of time in specific cases.

A Systematic review for the development of cosmetic clinical trial protocol (화장품 임상시험 프로토콜 개발을 위한 체계적 문헌 고찰)

  • Jo, Ga-Won;Hwang, Chung-Yeon;Hong, Seok-Hoon;Kim, Nam-Kwen
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.26 no.1
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    • pp.104-117
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    • 2013
  • Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

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.

Neoadjuvant Chemotherapy for Resectable Esophageal Carcinoma: A Meta-analysis of Randomized Clinical Trials

  • Xu, Xiao-Hua;Peng, Xue-Hong;Yu, Ping;Xu, Xiao-Yuan;Cai, Er-Hui;Guo, Pi;Li, Ke
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.1
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    • pp.103-110
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    • 2012
  • Neoadjuvant chemotherapy for resectable esophageal carcinoma has been a focus of study, but no agreement has been reached on clinical randomized controlled trials and relevant systematic evaluation. The purpose of this study was to perform a meta-analysis on published randomized controlled trials (RCTs) that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Medline and manual searches was conducted in PubMed, ASCO (American Society of Clinical Oncology) meeting summary, Embase, the Cochrane Library (up to October 2010), Chinese Biomedical Literature Database, China National Knowledge Infrastructure, VIP Database, Wanfang Database. The selection contents were to identify all published and unpublished RCTs that compared neoadjuvant chemotherapy and surgery with surgery alone for resectable esophageal carcinoma. Sixteen RCTs which included 2,594 patients were selected. The risk ratio (RR) (95% confidence interval [CI]; P value), expressed as neoadjuvant chemotherapy and surgery versus surgery alone (treatment versus control), was 1.02 (0.95, 1.10; P=0.54) for 1-year survival, 1.29 (1.13, 1.47; P=0.0001) for 3-year survival, 1.31 (1.13, 1.51; P=0.0003) for 5-year survival, 1.00 (0.95, 1.04; P= 0.85) for rate of resection and 0.89 (0.64, 1.23; P=0.48) for operative mortality. The results showed that neoadjuvant chemotherapy for resectable esophageal carcinoma can raise the overall survival rate of patients with esophageal carcinoma, but it does not affect treatment-related mortality.

Review and Analysis of Sham Acupuncture in Acupuncture Clinical Trials (침 임상연구에 사용된 거짓침의 분석)

  • Jang, Jin-Young;Kim, So-Jung;Kim, Nam-Sik;Nam, Sang-Soo;Kim, Yong-Suk
    • Journal of Acupuncture Research
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    • v.28 no.5
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    • pp.29-38
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    • 2011
  • Objectives : Recent well-designed randomized controlled trials(RCTs) and their meta-analysis have been published on the efficacy of acupuncture in different condition. In most of them, real acupuncture is compared with sham acupuncture including invasive and non-invasive sham methods. But it is not clear how active sham methods are. These results tend to lead the conclusion that acupuncture has no more effective than sham acupuncture. In order to investigate that sham acupuncture is appropriate as a control, we reviewed several acupuncture trials using different sham acupuncture as a control. Methods : We searched Cochrane researches of acupuncture, reviewed and analyzed 25 RCTs in 42 Cochrane reviews. And especially we compared the effect of acupuncture according to the type of sham acupuncture. Results : Invasive sham acupunctures are used in 12 RCTs and non-invasive types are used in the rest. The majority of studies(19 RCTs) fail to show effects beyond a sham acupuncture. Streitberger's sham needle is a validated sham acupuncture of non-invasive type that was used in 8 trials and also no significant group differences are shown except one trial. Conclusions : Acupuncture is a complex intervention. Clinical trials of acupuncture need to be reexamined and redesigned to remove several bias. Especially, sham acupuncture as a control might be investigated for physiological effects as well as validation test including patient-blinding and de qi sensation. Other research need to be investigated and developed for acupuncture trials.

The Effect of Aerobic Exercise on Brain-Derived Neurotrophic Factor (BDNF) in Individuals with Mild Cognitive Impairment: a Systematic Review and Meta-Analysis of a Randomized Controlled Trials

  • Kim, Hyun-Joong;Lee, DongJin;Lee, YeonSeop
    • Physical Therapy Rehabilitation Science
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    • v.11 no.3
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    • pp.304-310
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    • 2022
  • Objective: Mild cognitive impairment (MCI) is a condition in which cognitive and executive functions are reduced, and older adults with MCI are ten times more likely to develop dementia than healthy older adults. Expression of brain-derived neurotrophic factor (BDNF) through aerobic exercise is associated with increased cognitive and executive functions. in this review, randomized controlled trials (RCTs) on the effects of aerobic exercise on BDNF in individuals with mild cognitive impairment are summarized and qualitatively and quantitatively analyzed to suggest the necessity of aerobic exercise. Design: a systematic review and meta-analysis. Methods: RCTs were searched for changes in BDNF through aerobic exercise using four international databases. Quality assessment and quantitative analysis were performed using RevMan 5.4. Quantitative analysis was quantified with a standardized mean difference (SMD) and presented as a random effect model. Results: Three RCTs evaluated BDNF in 123 patients with MCI. There was a significant improvement in the experimental group that performed aerobic exercise compared to the control group. The results analyzed using the random effects model were SMD = 0.48. Conclusions: In this review, we reported the effects and mechanisms of aerobic exercise in individuals with MCI. As a result of synthesizing RCTs that performed aerobic exercise, a significant increase in BDNF was confirmed.