Number Of Randomized Controlled Trials Research Articles

Efficacy of piracetam in children with breath-holding spells: a systematic review and meta-analysis.

A number of randomized-controlled trials (RCTs) have been conducted comparing the efficacy of piracetam with placebo and other medications in children with breath-holding spells (BHS). However, no systematic review has yet collated all this evidence. All RCTs comparing the efficacy and/or safety of piracetam with placebo or other medications in children with BHS were included. The pooled estimates were compared for the number of participants with a favorable response, the change in monthly frequency of BHS, compliance, and adverse effects in both groups. The ROB 2.0 tool was used to assess the risk of bias, and the GRADE system was used to determine the certainty of the collated evidence. We included 5 RCTs (437 participants) in the review. Piracetam group had significantly more participants with favorable responses at 1, 2 and 3months after randomization, as compared to placebo group (RR: 6.5 (95% CI-1.8-23.2), I2 = 75%, p = 0.004, RR: 4.7 (95% CI-3.3-6.7), I2 = 49%, p < 0.0001, RR: 5.4 (95% CI-3.4-8.5), I2 = 0%, p < 0.0001 respectively). Number of participants with complete response or total cessation of attacks was more in thepiracetam group compared to placebo (RR: 5.7 (95% CI-1.4-23.2), I2 = 88%, p = 0.01). Change in theaverage number of BHS was significantly more in thepiracetam group, as compared to theplacebo group (mean difference-4.9 (95% CI-0.7-9.0), I2 = 99%, p = 0.02). Number of participants with treatment-emergent adverse effects were comparable in both piracetam and placebo groups (RR: 1.9 (95% CI-0.5-7.6), I2 = 0%, p = 0.33). Conclusion: Oral piracetam is efficacious and safe in children with BHS, and its efficacy may further increase by co-administration of oral docosahexaenoic acid. What is known? • Breath-holding spells (BHS) are a common pediatric condition, affecting 0.1% to 4.6% of otherwise healthy children. • Several studies have investigated the efficacy of piracetam in reducing the frequency and severity of BHS, with mixed results. What is new? • Oral piracetam is efficacious and safe in children with BHS. • Its efficacy is further increased by co-administration of oral docosahexaenoic acid.

An evaluation study on the randomized controlled trial of preoperative skin preparation for emergency percutaneous coronary intervention based on GRADE system

Objective To systematically evaluate and analyze the evidence level of randomized controlled trials (RCT) of preoperative skin preparation for emergency percutaneous coronary intervention (PCI) , and to understand the current research status and evidence level of preoperative skin preparation randomized controlled trials for emergency PCI, and provide reference for skin preparation for emergency PCI. Methods PubMed, EMbase, The Cochrane Library, CINAHL, JBI, CBM, CNKI, Wanfang DATA were searched by computer from inception to March, 2018 for emergency PCI preoperative skin preparation randomized controlled trials. Two evidence panel members searched and selected articles independently and the quality was assessed in accordance with Cochrane Manual. The articles were analyzed with Review Manager 5.3, and the evidence quality was assessed with GRADE profiler 3.6.1 software. Results A total of 5 RCTs were included, of which the number of RCTs with grade A quality was 1 and the number of RCTs with grade B was 4. The results of the Meta analysis showed that there was no significant difference in the incidence of skin infections at the postoperative puncture site by conventional methods for routine removal of surgical wild hair and no removal of hair prior to emergency PCI (P<0.05) . In addition, regular removal of hair before surgery may result in prolonged preoperative preparation and may cause psychological discomfort to the patient. After the GRADE system rating, the quality of the evidence body was of a lower level. Conclusions It is more beneficial to shorten the treatment time without routine removal of all the hair at the puncture site and the surrounding patients. The evidence included is not yet certain whether the incomplete removal of hair can reduce the infection rate. In the future, more large-scale, multi-center, high-quality research should be carried out to provide more credible evidence for this study. Key words: Preoperative care; Emergency percutaneous coronary intervention; Skin preparation; GRADE system; Evidence evaluation

Long-term effect of second-generation drug-eluting stents for coronary artery disease, everolimus-eluting versus zotarolimus-eluting stents: a meta-analysis.

Compared with the zotarolimus-eluting stent (ZES), the everolimus-eluting stent (EES) has reduced the risk of stent restenosis and thrombosis as found in a number of randomized-controlled trials (RCTs). However, the benefits have been variable. We evaluate the long-term effect of EES and ZES on the risk of stent thrombosis and target lesion revascularization in patients receiving PCI. We identified RCTs by a systematic search of MEDLINE, EMBASE, and Cochrane Database. Five RCTs (9853 patients) were included. Overall, EES significantly reduced the risk of target lesion revascularization [odds ratio (OR), 0.77; 95% confidence interval (CI), 0.62-0.95; P=0.01] compared with ZES therapy. However, there was no difference in the risk of target vessel revascularization (OR, 0.93; 95% CI, 0.78-1.10; P=0.38) and definite/probable stent thrombosis (OR, 0.83; 95% CI, 0.56-1.25; P=0.37) between the two groups. Furthermore, the risk of mortality (OR, 1.04; 95% CI, 0.84-1.27; P=0.73), myocardial infarction (OR, 0.95; 95% CI, 0.74-1.23; P=0.70), and major adverse cardiac event (OR, 0.96; 95% CI, 0.84-1.10; P=0.53) was similar between the two groups. The new-generation Resolute-ZES and EES have a similar long-term safety and efficacy profile.

Pre-operative chemotherapy for non-small cell lung carcinoma.

The roll by the cytotoxic chemotherapy and its efficacy in the treatment of non-small cell carcinoma (NSCLC) was not clearly identified until the 1980s when studies showed that cisplatin was beneficial in the treatment of NSCLC. The first randomized controlled trial (RCT) to evaluate the efficacy of post-operative (adjuvant) chemotherapy using the cisplatin regimen for resectable NSCLC was reported in 1988. Since then, an increasing number of RCTs have been carried out to evaluate post-operative chemotherapy. Pre-operative (neo-adjuvant) chemotherapy is a relatively new treatment strategy, as its name indicates. Compared with post-operative chemotherapy, fewer RCTs have been carried out to evaluate pre-operative chemotherapy. Given the inconsistency of the results from the RCTs, at least 12 meta-analyses have been published. Most of these meta-analyses reported overall survival (OS) benefit with hazard ratios (HRs) in the range of 0.81 to 0.89 in favor of pre-operative chemotherapy. An individual patient data meta-analysis by Burdett in 2014 indicates that the option of pre-operative chemotherapy + surgery is associated with better OS (HR 0.87, 95% CI, 0.78-0.96, P=0.007) and recurrence-free survival (RFS) (HR 0.85, 95% CI, 0.76-0.94, P=0.002) survival for operable NSCLC when compared with treatment with surgery alone. Although the current consensus recommends the use of post-operative chemotherapy, pre-operative chemotherapy has equivalent efficacy. Both strategies should be regarded as the first choice treatment options. Despite Burdett's comment, indication of pre-operative chemotherapy for stage IA disease should be judged carefully.

Health-related quality of life assessment in EORTC cancer clinical trials.

6090 Background: Over the last three decades health-related quality of life (HRQOL) has become an important part of the randomised controlled trials (RCTs) conducted by the European Organisation for Research and Treatment of Cancer (EORTC). This review aims to undertake a descriptive database evaluation of all the HRQOL studies conducted in EORTC since 1980. Methods: The EORTC protocol database (n=785) was reviewed, restricting the search to between 1980 and 2011 (n=735). We investigated the number of HRQOL studies conducted in EORTC trials, the RCTs’ status and the use of HRQOL tools since 1980. Results: 157 protocols with HRQOL assessment were identified involving 70,903 patients. 73 studies ended as defined in the protocol; 27 studies closed early due to poor accrual; 17 are at the final analysis of the primary end point stage; 14 studies are still open to recruitment; 11 are closed to patient entry; and 15 new RCTs are pending activation with HRQOL. The majority of phase III (n=135) and phase II/III (n=9) RCTs have HRQOL as secondary endpoint. EORTC also conducted a number of large scale field studies (n=11), where HRQOL was the primary endpoint. During the early period of 1980 to 1989 HRQOL was assessed in 12 EORTC RCTs by using a small number of HRQOL items, but from 1990 to 2000, HRQOL was assessed in 97 RCTs using more comprehensive HRQOL tools. Between 2001 and 2011 the number of RCTs with HRQOL was 48. The EORTC clinical groups with the most RCTs containing HRQOL were Radiation Oncology (n=22), Genito-Urinary (n=20), Gynaecological (n=16), Breast Cancer (n=16), Lung (n=13), Gastrointestinal, (n=13) and Brain (n=10). The EORTC HRQOL tools were used in 90% of the trials, with other validated tools being used when required. Conclusions: Our review of EORTC RCTs has shown how patient perspective has been constantly considered of major importance in oncology during the last three decades. The inclusion of patient perspective in drug development shows that a more comprehensive HRQOL assessment has taken place over time as better instruments have become available. As the positive value of patient perspective grows to clinicians, regulatory bodies and industry, we expect that EORTC will continue its support by including HRQOL endpoints where appropriate.

Medical therapeutics for pulmonary arterial hypertension: from basic science and clinical trial design to evidence-based medicine

Pulmonary arterial hypertension is a severe disease with poor prognosis, caused by obliteration of the pulmonary vasculature as a result of pulmonary-vascular remodeling, active vasoconstriction and in situ thrombosis. Left untreated, pulmonary arterial hypertension results in right-ventricular failure and death. There has been dramatic progress in the treatment of pulmonary arterial hypertension during recent years. A remarkable number of randomized-controlled trials with agents known to target specific abnormalities present in pulmonary arterial hypertension have been completed. Most commonly, therapeutic efficacy was judged by the ability of the drug under study to improve exercise capacity and to decrease the rate of severe complications. Completed clinical trials have mainly evaluated patients with relatively advanced disease. Despite these advances, responses to therapy in pulmonary arterial hypertension are not uniformly favorable and frequently incomplete. In addition, the methods of delivery and the adverse effect profile of the currently available pulmonary arterial hypertension-specific drugs create further management difficulties. Based on newly identified pathobiologic abnormalities in the pulmonary vasculature, future studies are likely to focus on the discovery of new therapeutic targets. Clinical trial design will continue to evolve in an attempt to enable inclusion of patients with less advanced disease and evaluation of treatment combinations or comparisons of the currently approved drugs.