scholarly journals Comment on: Gao B, Lu Q, Wan R, Wang Z, Yang Y, Chen Z, Wang Z. “Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials”. Naunyn Schmiedebergs Arch Pharmacol. 2021 Apr;394(4):819–828. Epublished November 2020

2021 ◽  
Author(s):  
Steve Barash ◽  
Verena Ramirez Campos ◽  
Xiaoping Ning ◽  
Maurice T. Driessen ◽  
Lynda J. Krasenbaum ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Episodic Migraine ◽  
Pooled Analysis ◽  
Systemic Review ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Study Results ◽  
Significant Difference ◽  
Dosing Regimens

AbstractRecently, Gao et al. published an article titled “Monthly versus quarterly fremanezumab for the prevention of migraine: a systemic review and meta-analysis from randomized controlled trials” which concluded that monthly administration of fremanezumab led to significant reduction in monthly migraine days (MMD) when compared to quarterly fremanezumab. We have noted a critical flaw in Gao et al. meta-analysis wherein the authors have mistakenly utilized standard error values in place of standard deviation values in performing their pooled analyses. This error directly impacts the study results and conclusions. In this brief communication, we present revised analysis using correct methods. Using the correct SD values, our pooled analysis showed no significant difference in mean change from baseline in MMD between the two fremanezumab dosing regimens (P = 0.17). Furthermore, in the corrected subgroup analyses by type of migraine, there were no significant differences in mean change from baseline in MMD between monthly fremanezumab and quarterly fremanezumab (chronic migraine, P = 0.50; episodic migraine, P = 0.69). Overall, results from our corrected meta-analyses show that there is no significant difference in migraine prevention efficacy between monthly and quarterly fremanezumab dosing.

scholarly journals Efficiency and Safety of Chinese Herbal Medicine in the Treatment of Prediabetes: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-16
Author(s):  
Yanan Song ◽  
Haiyan Wang ◽  
Lingling Qin ◽  
Mei Li ◽  
Saiyue Gao ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Randomized Controlled Trials ◽  
Chinese Herbal Medicine ◽  
Meta Analysis ◽  
Outcome Data ◽  
Systemic Review ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Chinese Herbal ◽  
Significant Difference

Objective. The aim of this study was to review existing evidence on the efficiency and safety of Chinese herbal medicine for the treatment of prediabetes. Methods. Randomized controlled trials (RCTs) of Chinese herbal medicine (CHM) to treat prediabetes were searched in the following databases from their inception date onwards until 2 May 2020: MEDLINE, Cochrane, EMBASE, Web of Science, EBSCO, CINAHL, CNKI, VIP database, CBM, and Wanfang database. Quality assessment of included trials was accessed according to the guidance in Cochrane. Researchers independently assessed the validity of included trials and extracted outcome data for synthesis. RevMan 5.3 was used for the meta-analysis. Results. Twenty-two RCTs including 3923 participants were included in the study. Our findings upon the 22 RCTs showed CHM is effective in the treatment of prediabetes, which can statistically reduce the incidence of diabetes (RR = 0.48; 95% CI = (0.41, 0.57); P < 0.001 ), increase the incidence of normalization of prediabetes (RR = 1.76; 95% CI = (1.57, 1.96); P < 0.001 ), and lower FPG (MD = −0.38; 95% CI = (−0.60, −0.16); P < 0.001 ), 2hPG (MD = −1.13; 95% CI = (−1.60, −0.67); P < 0.001 ), TG (MD = −0.23; 95% CI = (−0.33, −0.13); P < 0.001 ), TC (MD = −0.34; 95% CI = (−0.52, −0.16); P < 0.001 ), and BMI (MD = −0.48; 95% CI = (−0.78, −0.18); P < 0.001 ) after treatment, and there was no difference of HbA1c ( P > 0.05 ). Conclusion. CHM is effective for the treatment of prediabetes. CHM can statistically reduce the incidence of diabetes, increase the incidence of normalization of prediabetes, and lower the FPG, 2hPG, TG, TC, and BMI levels, but with no significant difference in HbA1c. In addition, CHM was relatively safe in clinical practice. More high-quality RCTs should be conducted to strengthen the finding.

Cartilage Restoration of the Knee

2015 ◽  
Vol 44 (7) ◽  
pp. 1888-1895 ◽  
Author(s):  
Raman Mundi ◽  
Asheesh Bedi ◽  
Linda Chow ◽  
Sarah Crouch ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Randomized Trials ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Cartilage Defects ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Standardized Mean Difference

Background: Focal cartilage defects of the knee are a substantial cause of pain and disability in active patients. There has been an emergence of randomized controlled trials evaluating surgical techniques to manage such injuries, including marrow stimulation (MS), autologous chondrocyte implantation (ACI), and osteochondral autograft transfer (OAT). Purpose: A meta-analysis was conducted to determine if any single technique provides superior clinical results at intermediate follow-up. Study Design: Systematic review and meta-analysis of randomized controlled trials. Methods: The MEDLINE, EMBASE, and Cochrane Library databases were systematically searched and supplemented with manual searches of PubMed and reference lists. Eligible studies consisted exclusively of randomized controlled trials comparing MS, ACI, or OAT techniques in patients with focal cartilage defects of the knee. The primary outcome of interest was function (Lysholm score, International Knee Documentation Committee score, Knee Osteoarthritis Outcome Score) and pain at 24 months postoperatively. A meta-analysis using standardized mean differences was performed to provide a pooled estimate of effect comparing treatments. Results: A total of 12 eligible randomized trials with a cumulative sample size of 765 patients (62% males) and a mean (±SD) lesion size of 3.9 ± 1.3 cm2 were included in this review. There were 5 trials comparing ACI with MS, 3 comparing ACI with OAT, and 3 evaluating different generations of ACI. In a pooled analysis comparing ACI with MS, there was no difference in outcomes at 24-month follow-up for function (standardized mean difference, 0.47 [95% CI, –0.19 to 1.13]; P = .16) or pain (standardized mean difference, –0.13 [95% CI, –0.39 to 0.13]; P = .33). The comparisons of ACI to OAT or between different generations of ACI were not amenable to pooled analysis. Overall, 5 of the 6 trials concluded that there was no significant difference in functional outcomes between ACI and OAT or between generations of ACI. Conclusion: There is no significant difference between MS, ACI, and OAT in improving function and pain at intermediate-term follow-up. Further randomized trials with long-term outcomes are warranted.

Abstract 046: PCSK9 Inhibitors in Familial Hypercholesterolemia: a Meta-analysis of 9 Randomized Controlled Trials

2017 ◽  
Vol 10 (suppl_3) ◽  
Author(s):  
Avinainder Singh ◽  
Simon C Gaviria ◽  
Lourdes Chada ◽  
Omar Abu Qamar ◽  
Omar Soliman ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Familial Hypercholesterolemia ◽  
Meta Analysis ◽  
Pooled Analysis ◽  
Mean Difference ◽  
Controlled Trials ◽  
Significant Heterogeneity ◽  
Pcsk9 Inhibitors ◽  
Randomized Controlled ◽  
Significant Difference

Background: The prevalence of Familial Hypercholesterolemia (FH) is estimated to be 1 in 250 US adults. The advent of PCSK9 inhibitors has led a to a paradigm shift in the management of these patients. The purpose of this study was to analyze the efficacy of PCSK9 inhibitors in patients with heterozygous or homozygous FH. Methods: Pubmed, EMBASE and clinicaltrials.gov were searched for randomized controlled trials of PCSK9 inhibitors. Trials that exclusively recruited FH patients or those that reported data separately for FH patients were included. The primary outcome of this analysis was mean difference in LDL-C in patients treated with a PCSK9 inhibitor compared with placebo. Secondary endpoints were change in other lipids and incidence of adverse events. A random effects model was used to analyze the pooled estimates. Results: A pooled analysis of 9 trials with a total of 1361 patients was performed. Overall the mean difference in LDL-C reduction with PCSK9 inhibition was -48.6% (95% CI: -51.3 to -45.9; p<0.001), as compared with placebo. There was no significant difference in LDL-C reduction between trials using alirocumab vs. those using evolocumab. There was significant heterogeneity among the included trials I 2 =75.9%. The risk of bias in all included studies was low. Conclusions: Among patients with FH, PCSK9 inhibitors were highly effective and reduced LDL-C levels by nearly 50% compared with placebo. No differences in magnitude of reduction were observed between alirocumab and evolocumab.

scholarly journals The Antihypertensive Effects and Safety of LCZ696 in Patients with Hypertension: A Systemic Review and Meta-Analysis of Randomized Controlled Trials

2021 ◽  
Vol 10 (13) ◽  
pp. 2824
Author(s):  
Su-Kiat Chua ◽  
Wei-Ting Lai ◽  
Lung-Ching Chen ◽  
Huei-Fong Hung
Keyword(s):  
Blood Pressure ◽  
Systolic Blood Pressure ◽  
Randomized Controlled Trials ◽  
Diastolic Blood Pressure ◽  
Publication Bias ◽  
Meta Analysis ◽  
Systemic Review ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
The Mean

Background: The management of hypertension remains suboptimal throughout the world. Methods: We performed a random-effects model meta-analysis of randomized controlled trials to determine the effectiveness and safety of sacubitril/valsartan (LCZ696) for the treatment of high arterial pressure. Relevant published articles from PubMed, Cochrane base, and Medline were examined, and the last search date was December 2020. Only published randomized controlled trials and double-blind studies were selected for further analysis. The mean reductions in systolic blood pressure (msSBP) and diastolic blood pressure (msDBP) in the sitting position, as well as the mean reductions in ambulatory systolic blood pressure (maSBP) and ambulatory diastolic blood pressure (maDBP), were assumed as efficacy endpoints. Adverse events (AEs) were considered as safety outcomes. Results: Ten studies with a total of 5931patients were included for analysis. Compared with placebo, LCZ696 had a significant reduction in msSBP (weight mean difference (WMD) = −6.52 mmHg, 95% confidence interval (CI): −8.57 to −4.47; p < 0.001), msDBP (WMD = −3.32 mmHg, 95% CI: −4.57 to −2.07; p < 0.001), maSBP (WMD = −7.08 mmHg, 95% CI: −10.48 to −3.68; p < 0.001), maDBP (WMD = −3.28 mmHg, 95% CI: −4.55 to −2.02, p < 0.001). In subgroup analysis, only 200 mg and 400 mg LCZ696 showed a significant BP reduction. There was no difference in the AE rate between the LCZ696 and placebo groups (WMD = 1.02, 95% CI: 0.83 to 1.27, p = 0.54). Egger’s test revealed a potential publication bias for msSBP (p = 0.025), but no publication bias for other outcomes. Conclusion: LCZ696 may reduce blood pressure more efficaciously than traditional therapy in hypertensive patients without increasing adverse effects.

Early Versus Routine Stoma Closure in Patients With Colorectal Resection: A Meta-Analysis of 7 Randomized Controlled Trials

2020 ◽  
Vol 27 (3) ◽  
pp. 291-298
Author(s):  
Yinyin Guo ◽  
Yanxin Luo ◽  
Hui Zhao ◽  
Liangliang Bai ◽  
Juan Li ◽  
...  
Keyword(s):  
Colorectal Surgery ◽  
Randomized Controlled Trials ◽  
Bowel Obstruction ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Wound Complications ◽  
Controlled Trials ◽  
Stoma Closure ◽  
Randomized Controlled ◽  
Significant Difference

Background. A substantial proportion of patients undergoing colorectal surgery receive a temporary stoma, and the timing for stoma closure remains unclear. The aim of this study was to evaluate the safety and feasibility of early stoma closure (ESC) compared with routine stoma closure (RSC) after colorectal surgery. Methods. We comprehensively searched PubMed, Embase, and the Cochrane Library for randomized controlled trials that compared ESC and RSC after colorectal surgery. Results. A total of 7 randomized controlled trials with 814 enrolled patients were identified for this meta-analysis. There were no significant differences between the ESC and RSC groups regarding the complications of stoma closure (26.8% and 16.6%, respectively; odds ratio [OR]: 1.30; 95% confidence interval [CI]: 0.89-1.90; P = .17). A subgroup analysis was conducted by Clavien-Dindo grade of complication, and no significant difference was observed in any subgroup ( P > .05). However, the ESC group had a significantly higher risk of wound complications than the RSC group (17.6% and 7.8%, respectively; OR: 2.61; 95% CI: 1.43-4.76; P = .002), and the RSC group had more cases of small bowel obstruction than the ESC group (3.1% and 8.4%, respectively; OR: 0.37; 95% CI: 0.15-0.87; P = .02). Conclusions. ESC is a safe and effective therapeutic approach in patients who have undergone colorectal surgery; it is associated with a reduced risk of bowel obstruction but a higher risk of wound complications.

scholarly journals The Effect of Virtual Reality on Preoperative Anxiety: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 9 (10) ◽  
pp. 3151
Author(s):  
Chang-Hoon Koo ◽  
Jin-Woo Park ◽  
Jung-Hee Ryu ◽  
Sung-Hee Han
Keyword(s):  
Virtual Reality ◽  
Randomized Controlled Trials ◽  
Pediatric Patients ◽  
Meta Analysis ◽  
Random Effect Model ◽  
Preoperative Anxiety ◽  
Control Group ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Significant Difference

Virtual reality (VR), a technology that provides a stimulated sensory experience, has recently been implemented in various fields of medicine. Several studies have investigated the efficacy of VR on preoperative anxiety. The purpose of this meta-analysis was to validate whether VR could relieve preoperative anxiety in patients undergoing surgery. Electronic databases were searched to identify all randomized controlled trials (RCTs) investigating the effect of VR on preoperative anxiety. The primary outcome was defined as the preoperative anxiety scores. We estimated the effect size using the standard mean difference (SMD) with a 95% confidence interval (CI) using a random effect model. Ultimately, 10 RCTs, with a total of 813 patients, were included in the final analysis. Preoperative anxiety was significantly lower in the VR group than in the control group (SMD −0.64, 95% CI −1.08 to −0.20, p = 0.004). In a subgroup analysis, the preoperative anxiety scores were lower in the VR group than in the control group in pediatric patients (SMD −0.71, 95% CI −1.14 to −0.27, p = 0.002), whereas a significant difference was not observed between the two groups in adult patients (p = 0.226). The results of this meta-analysis indicated that VR could decrease preoperative anxiety, especially in pediatric patients.

scholarly journals Intravenous Colistin Monotherapy versus Combination Therapy against Carbapenem-Resistant Gram-Negative Bacteria Infections: Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 7 (8) ◽  
pp. 208 ◽  
Author(s):  
I-Ling Cheng ◽  
Yu-Hung Chen ◽  
Chih-Cheng Lai ◽  
Hung-Jen Tang
Keyword(s):  
Combination Therapy ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Gram Negative Bacteria ◽  
Gram Negative ◽  
Randomized Controlled ◽  
Carbapenem Resistant ◽  
Significant Difference ◽  
All Cause Mortality

This meta-analysis aims to compare intravenous colistin monotherapy and colistin-based combination therapy against carbapenem-resistant gram-negative bacteria (GNB) infections. PubMed, Embase, and Cochrane databases were searched up to July 2018. Only randomized controlled trials (RCTs) evaluating colistin alone and colistin-based combination therapy in the treatment of carbapenem-resistant GNB infections were included. The primary outcome was all-cause mortality. Five RCTs including 791 patients were included. Overall, colistin monotherapy was associated with a risk ratio (RR) of 1.03 (95% confidence interval (CI), 0.89–1.20, I2 = 0%) for all-cause mortality compared with colistin-based combination therapy. The non-significant difference was also detected in infection-related mortality (RR, 1.23, 95% CI, 0.91–1.67, I2 = 0%) and microbiologic response (RR, 0.86, 95% CI, 0.72–1.04, I2 = 62%). In addition, no significant difference was observed in the subgroup analysis—high or low dose, with or without a loading dose, carbapenem-resistant Acinetobacter baumannii infections, and in combination with rifampicin. Finally, colistin monotherapy was not associated with lower nephrotoxicity than colistin combination therapy (RR, 0.98; 95% CI, 0.84–1.21, I2 = 0%). Based on the analysis of the five RCTs, no differences were found between colistin monotherapy and colistin-based combination therapy against carbapenem-resistant GNB infections, especially for A. baumannii infections.

Protective Effects of Vitamin E on Chemotherapy-Induced Peripheral Neuropathy: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Author(s):  
Huikai Miao ◽  
Rongzhen Li ◽  
Dongni Chen ◽  
Jia Hu ◽  
Youfang Chen ◽  
...  
Keyword(s):  
Vitamin E ◽  
Peripheral Neuropathy ◽  
Randomized Controlled Trials ◽  
Lower Incidence ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Modest Improvement ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Vitamin E Supplementation

Abstract Background Chemotherapy often causes chemotherapy-induced peripheral neuropathy (CIPN), but effective prevention measures are still lacking. Whether vitamin E can prevent peripheral neurotoxicity caused by chemotherapy is inconclusive. Therefore, we collected related randomized controlled trials (RCTs) and conducted a meta-analysis to examine whether vitamin E could prevent CIPN. Methods We searched PubMed, EMBASE and the Cochrane databases in November 2019 for eligible trials. Two reviewers conducted the analysis independently when studies were homogeneous enough. Results Eight RCTs, involving 555 patients, were identified. Upon pooling these RCTs, patients who received vitamin E supplementation of 600 mg/day had a significantly lower incidence of peripheral neuropathy (RR 0.31; 95% CI 0.14 to 0.65; P = 0.002) induced by chemotherapy compared with the placebo group. Vitamin E played a key role in decreasing the incidence of peripheral neuropathy in the cisplatin chemotherapy group (RR 0.28; 95% CI 0.14 to 0.54; P = 0.0001). With regard to improvements in sural amplitude, vitamin E supplementation significantly decreased patients’ sural amplitude after three rounds of chemotherapy (RR -2.66; 95% CI -5.09 to -0.24; P =0.03) in contrast with that of placebo supplementation, while no significant difference was observed when patients were treated with vitamin E after six rounds of chemotherapy. In addition, the vitamin E group had better improvement in the neurotoxicity score (RR -2.65; 95% CI -4.01to -1.29; P = 0.0001) and a lower incidence of reflexes and distal paraesthesias (RR 0.50; 95% CI 0.29 to 0.87; P = 0.01) compared to the control group. Conclusion Available data included in this meta-analysis showed that vitamin E supplementation can confer modest improvement in the prevention of CIPN. However, large-scale, well-designed RCTs are needed to confirm the exact role of vitamin E supplementation in the prevention of CIPN.

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