Randomized Controlled Trials
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2021 ◽  
Vol 22 (1) ◽  
Raffaele Ornello ◽  
Valeria Caponnetto ◽  
Susanna Ratti ◽  
Giulia D’Aurizio ◽  
Chiara Rosignoli ◽  

Abstract Background Transcranial direct current stimulation (tDCS) could counteract the pathophysiological triggers of migraine attacks by modulating cortical excitability. Several pilot randomized controlled trials (RCTs) assessed the efficacy of tDCS for migraine prevention. We reviewed and summarized the state of the art of tDCS protocols for migraine prevention, discussing study results according to the stimulations parameters and patients’ populations. Main body We combined the keywords ‘migraine’, ‘headache’, ‘transcranial direct current stimulation’, and ‘tDCS’ and searched Pubmed, Scopus, and Web of Science, from the beginning of indexing to June 22, 2021. We only included RCTs comparing the efficacy of active tDCS with sham tDCS to decrease migraine frequency, intensity, and/or acute drug utilization. The risk of bias of each RCT was assessed by using the RoB-2 tool (Cochrane Collaboration). Thirteen RCTs (from 2011 to 2021) were included in the review. The included patients ranged from 13 to 135. RCTs included patients with any migraine (n=3), chronic migraine (n=6), episodic migraine (n=3) or menstrual migraine (n=1). Six RCTs used cathodal and five anodal tDCS, while two RCTs compared the efficacy of both cathodal and anodal tDCS with that of sham. In most of the cathodal stimulation trials, the target areas were the occipital regions, with reference on central or supraorbital areas. In anodal RCTs, the anode was usually placed above the motor cortical areas and the cathode on supraorbital areas. All RCTs adopted repeated sessions (from 5 to 28) at variable intervals, while the follow-up length spanned from 1 day up to 12 months. Efficacy results were variable but overall positive. According to the RoB-2 tool, only four of the 13 RCTs had a low risk of bias, while the others presented some concerns. Conclusions Both anodal and cathodal tDCS are promising for migraine prevention. However, there is a need for larger and rigorous RCTs and standardized procedures. Additionally, the potential benefits and targeted neurostimulation protocols should be assessed for specific subgroups of patients.

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Gao-Feng Liu ◽  
Zhen Gao ◽  
Zheng-Nan Liu ◽  
Min Yang ◽  
Sheng Zhang ◽  

Background. Temporomandibular joint disorders (TMDs) are a common and prevalent disease with main symptoms of pain, joint sounds, and mandibular movement disorders, which seriously affects the mental health and quality of life of the sufferers. In recent years, there have been an increasing number of studies utilizing warm needle acupuncture (WNA) for the treatment of TMD, and the quality of the studies has gradually improved. However, evidence from evidence-based medicine is lacking. This study aims to use a systematic review and meta-analysis method to understand the efficacy of WNA for the treatment of TMD. Methods and Analysis. We searched randomized controlled trials (RCTs) of WNA for the treatment of TMD from 9 electronic databases, including 5 English databases (PubMed, EMBASE, Cochrane Library, Web of Science, and MEDLINE) and 4 Chinese databases (Chinese National Knowledge Infrastructure (CNKI), Chinese VIP Information, Wanfang Database, and Chinese Biomedical Literature Database (CBM)) from their inception to May 2021. The included RCTs compared WNA with acupuncture, electroacupuncture, pharmacological therapy, or other therapies. And outcome indicators such as total effective rate and cure rate were assessed. All analyses were conducted using RevMan software V5.3 and Stata16. Measurement count data used the relative risk (RR) as the efficacy statistic, and each effect size was given its point estimate value and 95% confidence interval (CI). Results. The meta-analysis included 10 studies with a total of 670 patients, which included 340 patients in the experimental group and 330 patients in the control group. The data in this review showed that WNA is superior to treatments such as acupuncture alone, acupuncture therapy combined with TDP, drug therapy, and ultrasonic therapy in terms of effective rate (RR = 1.20; 95% CI, 1.06 to 1.35; and P = 0.003) and cure rate (RR = 1.82; 95% CI, 1.46 to 2.28; and P < 0.00001) for the treatment of TMD. Conclusions. This systematic review and meta-analysis provides new evidence for the effectiveness of WNA for the treatment of TMD. However, the above conclusions need to be further verified by multicenter prospective studies of larger samples and higher-quality RCTs. Protocol registration number: INPLASY202160030.

2021 ◽  
Vol 11 (1) ◽  
Joris Pensier ◽  
Audrey De Jong ◽  
Gerald Chanques ◽  
Emmanuel Futier ◽  
Elie Azoulay ◽  

Abstract Background Critical care randomized controlled trials (RCTs) are often published in high-impact journals, whether general journals [the New England Journal of Medicine (NEJM), The Lancet, the Journal of the American Medical Association (JAMA)] or critical care journals [Intensive Care Medicine (ICM), the American Journal of Respiratory and Critical Care Medicine (AJRCCM), Critical Care Medicine (CCM)]. As rejection occurs in up to 97% of cases, it might be appropriate to assess pre-submission probability of being published. The objective of this study was to develop and internally validate a simplified score predicting whether an ongoing trial stands a chance of being published in high-impact general journals. Methods A cohort of critical care RCTs published between 1999 and 2018 in the three highest impact medical journals (NEJM, The Lancet, JAMA) or the three highest impact critical care journals (ICM, AJRCCM, CCM) was split into two samples (derivation cohort, validation cohort) to develop and internally validate the simplified score. Primary outcome was journal of publication assessed as high-impact general journal (NEJM, The Lancet, JAMA) or critical care journal (ICM, AJRCCM, CCM). Results A total of 968 critical care RCTs were included in the predictive cohort and split into a derivation cohort (n = 510) and a validation cohort (n = 458). In the derivation cohort, the sample size (P value < 0.001), the number of centers involved (P value = 0.01), mortality as primary outcome (P value = 0.002) or a composite item including mortality as primary outcome (P value = 0.004), and topic [ventilation (P value < 0.001) or miscellaneous (P value < 0.001)] were independent factors predictive of publication in high-impact general journals, compared to high-impact critical care journals. The SCOTI score (Sample size, Centers, Outcome, Topic, and International score) was developed with an area under the ROC curve of 0.84 (95% Confidence Interval, 0.80–0.88) in validation by split sample. Conclusions The SCOTI score, developed and validated by split sample, accurately predicts the chances of a critical care RCT being published in high-impact general journals, compared to high-impact critical care journals.

Sun Yong Lee ◽  
Isabel E. Allen ◽  
Celso Diaz ◽  
Xiaofan Guo ◽  
Cara Pellegrini ◽  

Abstract Background Rotating and laser sheaths are both routinely used in transvenous lead extraction (TLE) which can lead to catastrophic complications including death. The efficacy and risk of each approach are uncertain. To perform a meta-analysis to compare success and mortality rates associated with rotating and laser sheaths. Methods We searched electronic academic databases for case series of consecutive patients and randomized controlled trials published 1998–2017 describing the use of rotating and laser sheaths for TLE. Among 48 studies identified, rotating sheaths included 1,094 patients with 1,955 leads in 14 studies, and laser sheaths included 7,775 patients with 12,339 leads in 34 studies. Patients receiving rotating sheaths were older (63 versus 60 years old) and were more often male (74% versus 72%); CRT-P/Ds were more commonly extracted using rotating sheaths (12% versus 7%), whereas ICDs were less common (37% versus 42%), p > 0.05 for all. Infection as an indication for lead extraction was higher in the rotating sheath group (59.8% versus 52.9%, p = 0.002). The mean time from initial lead implantation was 7.2 years for rotating sheaths and 6.3 years for laser sheaths (p > 0.05). Results Success rates for complete removal of transvenous leads were 95.1% in rotating sheaths and 93.4% in laser sheaths (p < 0.05). There was one death among 1,094 patients (0.09%) in rotating sheaths and 66 deaths among 7,775 patients (0.85%) in laser sheaths, translating to a 9.3-fold higher risk of death with laser sheaths (95% CI 1.3 to 66.9, p = 0.01). Conclusions Laser sheaths were associated with lower complete lead removal rate and a 9.3-fold higher risk of death.

2021 ◽  
Vol 11 (1) ◽  
Chun-Hung Chang ◽  
Chieh-Yu Liu ◽  
Shaw-Ji Chen ◽  
Hsin-Chi Tsai

AbstractMultiple N-methyl-d-aspartate (NMDA) receptor enhancing agents have had promising effects on cognition among patients with dementia. However, the results remain inconsistent. This exploratory meta-analysis investigated the effectiveness of NMDA receptor enhancing agents for cognitive function. PubMed, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews were searched for randomized controlled trials (RCTs). Controlled trials assessing add-on NMDA receptor enhancing agent treatment in patients with dementia and using cognition rating scales were eligible and pooled using a random-effect model for comparisons. The standardized mean difference (SMD) was calculated in each study from the effect size; positive values indicated that NMDA receptor enhancing agent treatment improved cognitive function. Funnel plots and the I2 statistic were evaluated for statistical heterogeneity. Moderators were evaluated using meta-regression. We identified 14 RCTs with 2224 participants meeting the inclusion criteria. Add-on NMDA receptor enhancing agents had small positive significant effects on overall cognitive function among patients with dementia (SMD = 0.1002, 95% CI 0.0105–0.1900, P = 0.02860). Subgroup meta-analysis showed patients with Alzheimer’s Disease and trials using the Alzheimer Disease Assessment Scale-cognitive subscale as the primary outcome had small positive significant effects (SMD = 0.1042, 95% CI 0.0076–0.2007, P = 0.03451; SMD = 0.1267, 95% CI 0.0145–0.2388, P = 0.2686). This exploratory meta-analysis showed a very small, positive, and significant effect on overall cognition function in patients with dementia. Studies with larger samples are needed to evaluate different cognitive domains and phases of dementia.

2021 ◽  
pp. 026921552110576
Renny Wulan Apriliyasari ◽  
Pham Van Truong ◽  
Pei-Shan Tsai

Objective To evaluate the effectiveness of proprioceptive training on balance performance, trunk control, and gait speed in people with stroke. Methods We searched PubMed, Science Direct, Cochrane, Embase, and Medline for randomized controlled trials that evaluated the effects of proprioceptive training for patients with stroke from the date of each database's inception to July 26, 2021. Two reviewers independently screened the titles and abstracts of potentially eligible articles that were identified on the basis of the search criteria. Methodological quality was determined using version 2 of the Cochrane risk of bias tool for randomized trials. Data were analyzed using Comprehensive Meta-Analysis software. The treatment effect was estimated by calculating Hedges’ g and 95% confidence intervals (CIs) using a random-effects model. Statistical heterogeneity was assessed according to the I2 value. The primary outcome was balance performance and secondary outcomes were trunk control, gait speed, and basic functional mobility. Results In total, 17 trials involving 447 people with stroke were included. Proprioceptive training had a significant effect on balance performance (Hedges’ g = 0.69, 95% CI = 0.36–1.01), gait speed (Hedges’ g = 0.57, 95% CI = 0.19–0.94), trunk control (Hedges’ g = 0.75, 95% CI = 0.33–1.17), and basic functional mobility (Hedges’ g = 0.63, 95% CI = 0.31–0.94) among people with stroke. Conclusion Proprioceptive training may be effective in improving balance performance, gait speed, trunk control, and basic functional mobility among people with stroke.

2021 ◽  
Vol 38 (4) ◽  
pp. 284-292
Hyo Jung Choi ◽  
Hye Kyung Back ◽  
Young-Jun Kim ◽  
Da Yoon Oh ◽  
Cheol Woo Park ◽  

The purpose of this study was to review randomized controlled trials (RCTs) of pes anserinus tendinitis or bursitis (PATB) syndrome in the China National Knowledge Infrastructure database to investigate the efficacy of traditional Chinese medicine treatment for PATB syndrome. There were 20 RCTs published from 2001 to 2021 which were selected for analysis by publication year, number of samples, evaluation criteria, treatment duration, and treatment method. Out of the 142 retrieved RCTs, 20 were relevant to this review, and had performed Chinese medicine treatments including acupuncture (the most common treatment typically using acupoints SP10, ST35, SP9, and LR8), manipulation (typically using acupoints ST35, SP10, and SP9), and external application therapy (typically herbal medicine) in the treatment of PATB syndrome. Chinese medicine treatments were used widely in the treatment of PATB syndrome. We hope in the future, this review may initiate the development of treatments for PATB syndrome using Korean medicine.

2021 ◽  
Vol 38 (4) ◽  
pp. 265-275
Jung Hyeon Park ◽  
Gyu Hui Kim ◽  
Tae Kyung Kim ◽  
Eun Ju Lee ◽  
Hyun Min Yoon ◽  

This review investigated the effectiveness and safety of acupotomy treatment for scoliosis. There were 7 online databases used in the search from inception to March 17, 2021, for randomized controlled trials of the use of acupotomy in patients with scoliosis. The Cochrane risk-of-bias tool was used to assess the methodological quality of the studies included (n = 12). A quantitative synthesis of the randomized controlled trials was performed using RevMan Version 5.3. The effect sizes of studies were presented as mean differences for continuous outcomes and risk ratios for dichotomous outcomes, with a 95% confidence interval. As part of combined therapy, acupotomy was reported to significantly improve Cobb’s angle compared with other treatments. Likewise, the Visual Analog Scale score, the Oswestry Disability Index score, and pulmonary function were also reported to be improved following acupotomy combination therapy. Although 5 studies mentioned the criteria for reporting adverse events, only 1 study reported adverse events. In conclusion, acupotomy may be an effective treatment for scoliosis. However, the small number, and heterogeneity of the included studies, as well as the poor methodological quality, indicate that higher-quality studies should be conducted to verify the effectiveness and safety of acupotomy treatment for scoliosis.

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