scholarly journals The Use of Oseltamivir as Adjunctive Therapy for the Treatment of Hand-Food-and-Mouth Disease: A Meta-Analysis of Randomized Clinical Trials

2021 ◽  
Vol 12 ◽  
Author(s):  
Yijing Zhao ◽  
Yangyang Sun ◽  
Raphael N. Alolga ◽  
Gaoxiang Ma ◽  
Fan Wang
Keyword(s):  
Clinical Trials ◽  
Adjunctive Therapy ◽  
Adverse Reactions ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Final Analysis ◽  
Mouth Disease ◽  
Increased Risk ◽  
Fever Clearance Time ◽  
Significant Difference

Background: Hand-foot-and-mouth disease (HFMD) is a common childhood illness caused by enteroviruses. Oseltamivir (OS), a neuraminidase inhibitor, has been frequently used as an adjunctive therapy for the treatment of HFMD. Solid evidence, however, is lacking regarding the efficacy of such adjunctive therapy. This work is to conduct a meta-analysis of randomized clinical trials (RCTs) to assess the efficacy of oseltamivir for HFMD in children.Methods: Eligible studies from inception to October 10, 2020 were identified by searching six databases (PubMed, Embase, CENTRAL, CNKI, Wanfang, and VIP database). Quality of evidence was assessed using the Cochrane Collaboration tool.Results: Of a total of 91 entries, 11 RCTs involving 977 HFMD children were included in the final analysis. The results showed that the therapy combined with oseltamivir was more effective, with higher effective rate (RR, 0.84; 95% CI, 0.80 to 0.87; p < 0.01), shorter fever clearance time (days) (SMD, −0.74; 95% CI, −1.12 to −0.35; p < 0.01), shorter rash regression time (days) (MD, −0.89; 95% CI, −1.05 to −0.72; p < 0.01) and shorter clinical cure time (SMD, −1.08; 95% CI, −1.55 to −0.61; p < 0.01). No significant difference was observed in the risk of adverse reactions between the groups with and without oseltamivir.Conclusion: The use of oseltamivir as adjunctive therapy shows effectiveness and no increased risk of adverse reactions for the treatment of HFMD in children.

scholarly journals Suicidality: Once Again, Don’t Blame the Drug Class

2021 ◽  
pp. 153575972110531
Author(s):  
Faught Edward
Keyword(s):  
Clinical Trials ◽  
Suicidal Ideation ◽  
Risk Ratio ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Adjunctive Treatment ◽  
Current Evidence ◽  
Phase 2 ◽  
Increased Risk

Importance Mostantiseizure medications (ASMs) carry a US Food and Drug Administration–mandated class label warning of increased suicidality risk, based on a meta-analysis comparing suicidality between individuals treated with medications vs placebo in randomized clinical trials done before 2008. ASMs approved since then carry this warning although they were not similarly studied. Objective To review all placebo-controlled phase 2 and 3 studies of 10 ASMs approved since 2008 to evaluate the risk of suicidality of these drugs compared with placebo. Data Sources Primary publications and secondary safety analyses in PubMed of all phase 2 and 3 randomized placebo-controlled epilepsy trials of ASMs approved since 2008, using keywords epilepsy, antiepileptic drugs, seizures, suicidality, suicidal ideation, and the names of individual drugs. Study Selection All phase 2 and 3 randomized clinical trials of adjunctive treatment of drug-resistant epilepsy and their secondary safety analyses. Data Extraction and Synthesis Articles were reviewed for frequency of suicidality (ideation, attempts, and completed suicides). Mode of suicidality ascertainment included treatment-emergent adverse event reports, Standardized Medical Dictionary for Regulatory Activities queries for events in prespecified categories including suicidal ideation and behavior, prospective collection of suicidality data as a prespecified safety outcome using the Columbia-Suicide Severity Rating Scale, and retrospective evaluation by blinded review using the Columbia-Classification Algorithm of Suicide Assessment. A meta-analysis compared risk for drugs vs placebo of each outcome for all drugs overall and by individual drugs and trials. Main Outcomes and Measures Suicidality (total and by ideation), attempts, and completed suicides. Results Excluding studies that did not evaluate suicidality (everolimus and fenfluramine) or did not evaluate it prospectively (lacosamide, ezogabine, and clobazam), 5 drugs were analyzed: eslicarbazepine, perampanel, brivaracetam, cannabidiol, and cenobamate. Suicidality was evaluated in 17 randomized clinical trials of these drugs, involving 5996 patients, of whom 4000 patients were treated with ASMs and 1996 with placebo. There was no evidence of increased risk of suicidal ideation (drugs vs placebo overall risk ratio, .75; 95% CI, .35–1.60) or attempt (risk ratio, .75; 95% CI, .30–1.87) overall or for any individual drug. Suicidal ideation occurred in 12 of 4000 patients treated with ASMs (.30%) vs 7 of 1996 patients treated with placebo (.35%) ( P  =  .74). Three patients treated with ASMs and no patients treated with placebo attempted suicide ( P  =  .22). There were no completed suicides. Conclusions and Relevance There is no current evidence that the 5 ASMs evaluated in this study increase suicidality in epilepsy and merit a suicidality class warning

Different Doses of Erenumab for Preventive Treatment of Episodic Migraine: A Systematic Review and Network Meta-Analysis

2020 ◽  
Author(s):  
Yanbo Yang ◽  
Mingjia Chen ◽  
Zilan Wang ◽  
Yue Sun ◽  
Fan Jiang ◽  
...  
Keyword(s):  
Randomized Clinical Trials ◽  
Response Rate ◽  
Meta Analysis ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Cochrane Library ◽  
Migraine Treatment ◽  
Increased Risk ◽  
Significant Difference ◽  
Safety Outcomes

Abstract Background Erenumab is a novel monoclonal calcitonin gene–related peptide receptor antibody that is used for the preventive treatment of migraine.Objectives To evaluate overall safety and efficacy and dose-response relationship of erenumab in patients with episodic migraine and patients with prior migraine treatment failures.Methods We searched randomized clinical trials on PUBMED, EMBASE database, and Cochrane Library database. A pair-wise meta-analysis and Bayesian network analysis were performed.Results For efficacy outcomes, the network meta-analysis suggests that compared with erenumab 70 mg, participants received erenumab 140 mg reported significantly decreased MSMD and increased 50% response rate, and erenumab was most likely to be ranked first for MMD, MSMD and 50% response rate. For safety outcomes, the network meta-analysis has found no significant difference between the 70 mg group and the 140 mg group measured by AE and SAE. For patients with ≥2 treatment failures, 140mg erenumab group, patients with ≥2 treatment failures reported significantly reduced MMD and MSMD, increased 50%, and 75% response rate, compared with placebo. For safety outcomes, no significant difference was found between 140 mg erenumab group and the placebo group.Conclusion Erenumab was effective in patients with episodic migraine. 140 mg erenumab was associated with better efficacy outcomes without increased risk for developing adverse events compared with 70 mg erenumab, and 140 mg erenumab was effective in patients with prior migraine treatment failures.Registration number: CRD42020198985

scholarly journals Comparison of Poly (ADP-ribose) Polymerase Inhibitors (PARPis) as Maintenance Therapy for Platinum-Sensitive Ovarian Cancer: Systematic Review and Network Meta-Analysis

Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3026
Author(s):  
Amos Stemmer ◽  
Inbal Shafran ◽  
Salomon M. Stemmer ◽  
Daliah Tsoref
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Progression Free Survival ◽  
Wild Type ◽  
Brca Mutations ◽  
Increased Risk ◽  
Significant Difference ◽  
Indirect Comparisons

Background: Three PARPis (olaparib, niraparib and rucaparib) are currently FDA-approved as maintenance therapy in newly diagnosed and recurrent ovarian cancer. However, thus far, no trial has compared the three approved PARPis in the overall population, in patients with BRCA mutations, or in those with wild-type BRCA. Methods: A frequentist network meta-analysis was used for indirect comparisons between the different PARPis with respect to progression free survival (PFS), overall survival (OS), and adverse events. Results: Overall, six randomized clinical trials involving 2,770 patients, were included in the analysis. Results from the indirect comparisons revealed no statistically significant differences between the three PARPis with respect to PFS or OS in the entire population and in patients with mutated and wild-type BRCA, separately. Niraparib showed a statistically significant increased risk for grade 3 and 4 thrombocytopenia (risk-difference [RD] from placebo: 0.3; 95% confidence interval [CI], 0.27‒0.34) and any grade neutropenia (RD from placebo: 0.22; 95% CI, 0.18‒0.25) as compared with the other PARPis. Conclusion: No statistically significant difference was found between the three PARPis with respect to PFS or OS (overall and in subpopulations by BRCA status). There is, however, a statistical difference in toxicity as niraparib is associated with a greater risk for thrombocytopenia and neutropenia.

scholarly journals Effect of Omega-3 Polyunsaturated Fatty Acids Treatment on Lipid Pattern of HIV Patients: A Meta-Analysis of Randomized Clinical Trials

Marine Drugs ◽  
2020 ◽  
Vol 18 (6) ◽  
pp. 292 ◽  
Author(s):  
Federica Fogacci ◽  
Enrico Strocchi ◽  
Maddalena Veronesi ◽  
Claudio Borghi ◽  
Arrigo F. G. Cicero
Keyword(s):  
Fatty Acids ◽  
Clinical Trials ◽  
Polyunsaturated Fatty Acids ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Plasma Lipid ◽  
Density Lipoprotein ◽  
Lipoprotein Cholesterol ◽  
Omega 3 ◽  
Increased Risk

Even though omega-3 polyunsaturated fatty acids (PUFAs) seem to be effective in the treatment of human immunodeficiency virus (HIV)-associated dyslipidemia, their impact is still debated. For this reason, our aim was to perform a meta-analysis of the clinical evidence available to date. A systematic literature search was conducted in order to identify published clinical trials assessing the effect of PUFAs treatment on serum lipoproteins, and its safety profile. The effect sizes for lipid changes were expressed as mean difference (MD) and 95% confidence interval (CI). For safety analysis, odd ratios and the 95% CI were calculated with the Mantel–Haenszel method. Data were pooled from nine clinical studies comprising overall 578 HIV-affected subjects. Meta-analysis of the data suggested that omega-3 PUFAs significantly reduced triglycerides (TG) (MD = −1.04, 95% CI: −1.5, −0.58 mmol/L, p < 0.001), while increasing high-density lipoprotein cholesterol (MD = 0.36, 95% CI: 0.12, 0.61 mmol/L, p = 0.004), without affecting serum levels of total cholesterol, very-low- and low-density lipoprotein cholesterol, and apolipoprotein B and A1. Change in TG was significantly associated with eicosapentaenoic acid administered via daily dose. PUFA treatment did not lead to an increased risk of adverse events. In conclusion, PUFAs are safe and exert a significant plasma lipid improving effect in HIV-positive patients.

Partial breast irradiation or whole breast radiotherapy for early breast cancer: A meta-analysis of randomized controlled trials

2009 ◽  
Vol 27 (18_suppl) ◽  
pp. CRA532-CRA532 ◽  
Author(s):  
A. Valachis ◽  
D. Mauri ◽  
N. P. Polyzos ◽  
D. Mavroudis ◽  
V. Georgoulias ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Radiation Therapy ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Partial Breast Irradiation ◽  
Breast Irradiation ◽  
Breast Radiotherapy ◽  
Increased Risk ◽  
Whole Breast Radiotherapy ◽  
Significant Difference

CRA532 Background: The purpose of the study was to compare treatment outcomes in patients with breast cancer treated with partial breast irradiation and of those treated with whole breast radiation therapy. Methods: We conducted a systematic review and meta-analysis of published. Randomized clinical trials comparing partial breast irradiation versus whole breast radiation therapy. Primary outcome was overall survival and secondary outcomes were locoregional, distant and supraclavicular recurrences. Results: A search of the literature identified 3 trials with pooled total of 1,140 patients. We found no statistically significant difference between partial and whole breast radiation arms associated with death (OR 0.912, 95% CI 0.674–1.234, p = 0.550), distant metastasis (OR 0.740, 95% CI, 0.506–1.082, p = 0.120), or supraclavicular recurrences (pooled OR 1.415, 95% CI 0.278–7.202, p = 0.560). However, partial breast irradiation was statistically significantly associated with an increased risk of both local (pooled OR 2.150, 95% CI, 1.396–3.312; p = 0.001) and regional disease recurrences (pooled OR 3.430, 95% CI, 2.058–5.715; p < 0.0001) compared with whole breast radiation. Conclusions: Partial breast irradiation does not jeopardize survival and may be used as an alternative to whole breast radiation. Nevertheless, the issue of locoregional recurrence needs to be further addressed. No significant financial relationships to disclose.

scholarly journals Carbon dioxide versus air insufflation enteroscopy: a systematic review and meta-analysis based on randomized controlled trials

2018 ◽  
Vol 06 (06) ◽  
pp. E637-E645 ◽  
Author(s):  
Julio Aquino ◽  
Wanderley Bernardo ◽  
Diogo de Moura ◽  
Flávio Morita ◽  
Rodrigo Rocha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Ambient Air ◽  
Quality Analysis ◽  
Cochrane Library ◽  
Eligibility Criteria ◽  
Co2 Insufflation ◽  
Significant Difference

Abstract Objectives To compare the insufflation of CO2 and ambient air in enteroscopy. Search sources The investigators researched the electronic databases MedLine, Cochrane Library, Central, LILACS, BVS, Scopus and Cinahl. The grey search was conducted in the base of theses of the University of São Paulo, books of digestive endoscopy and references of selected articles and in previous systematic revisions. Study eligibility criteria The evaluation of eligibility was performed independently, in a non-blind manner, by two reviewers, firstly by title and abstract, followed by complete text. Disagreements between the reviewers were resolved by consensus. Data collection and analysis method Through the spreadsheet of data extraction, where one author extracted the data and a second author checked the extraction. Disagreements were resolved by debate between the two reviewers. The quality analysis of the studies was performed using the Jadad score. The software RevMan 5 version 5.3 was used for the meta-analysis. Results Four randomized clinical trials were identified, totaling 473 patients submitted to enteroscopy and comparing insufflation of CO2 and ambient air. There was no statistical difference in the intubation depth between the two groups. When CO2 insufflation was reduced, there was a significant difference in pain levels 1 hour after the procedure (95 % IC, –2.49 [–4.72, –0.26], P: 0.03, I2: 20%) and 3 hours after the procedure (95% IC, –3.05 [–5.92, –0.18], P: 0.04, I2: 0 %). There was a usage of lower propofol dosage in the CO2 insufflation group, with significant difference (95 % IC, –67.68 [–115.53, –19.84], P: 0.006, I2: 0 %). There was no significant difference between the groups in relation to the use of pethidine and to the oxygen saturation. Limitations Restricted number of randomized clinical trials and nonuniformity of data were limitations to the analysis of the outcomes. Conclusion The use of CO2 as insufflation gas in enteroscopy reduces the pain levels 1 hour and 3 hours after the procedure, in addition to the reduction of the sedation (propofol) dosage used.

scholarly journals Acupuncture Treatments for Post-stroke Depression: A Systematic Review and Network Meta-analysis

2021 ◽  
Author(s):  
Lam Wai Ching ◽  
Hui Juan Li ◽  
Jianwen Guo ◽  
Liang Yao ◽  
Janita Chau ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Rating Scale ◽  
Meta Analysis ◽  
Cochrane Library ◽  
Depression Symptoms ◽  
Post Stroke ◽  
Significant Difference ◽  
Post Stroke Depression ◽  
The Impact

Abstract Background: Depression is one of the most common complications after stroke, with a prevalence of 30-33%. Patients with post-stroke depression (PSD) usually experience anxiety, hopelessness, and insomnia, which have a negative impact on their daily activities and post-stroke rehabilitation. In this review, we aimed to explore the impact of acupuncture in alleviating symptoms of PSD and to evaluate the difference in effectiveness between acupuncture combined with pharmacotherapies and various non-pharmacotherapies in order to provide guides and advice for clinical personnel. Methods: Six databases (Cochrane Library, PubMed, EMBASE, China National Knowledge Infrastructure, Wanfang Database, Chongqing VIP Database) and two clinical trials registration platforms were searched from inception to May 2021. Randomized clinical trials (RCTs) comparing needle-based acupuncture with pharmacotherapy, and other non-pharmacotherapy or invalid group were included. Two independent reviewers identified eligible studies. Two reviewers independently abstracted and recorded data into a pre-made form. A Bayesian network meta-analysis (NMA) was conducted to assess and compare different techniques using RStudio 3.6.0. The primary outcome was the change in scores of scales measuring depressive symptoms. The secondary outcomes were changes in serotonin levels and in quality of life. Results: Fifty-nine RCTs were included. The results of this NMA showed that compared with western medicine (WM), acupuncture alone or with repetitive transcranial magnetic stimulation (RTMS), Traditional Chinese medicine (TCM) alone or with WM, were superior for alleviating depression symptoms. Compared to Usual Care, acupuncture alone or plus other therapies could significantly decrease scores of the Hamilton Depression Rating scale. However, there was no significant difference found among acupuncture, WM, TCM with AC plus any of other treatment.Conclusions: The results of this study indicate that acupuncture alone or combined with other therapies appear to be effective in improving depression symptoms of stroke survivors. Moreover, in comparison with WM, acupuncture alone or plus RTMS, TCM, TCM with WM, or WM, were more effective in improving depression symptoms. Also, acupuncture with RTMS seems to be the most effective with the highest probability.

Effects of lipid-lowering therapy on major adverse limb events in patients with peripheral arterial disease: A meta-analysis of randomized clinical trials

Vascular ◽  
2021 ◽  
pp. 170853812110439
Author(s):  
Walter Masson ◽  
Martín Lobo ◽  
Leandro Barbagelata ◽  
Graciela Molinero ◽  
Ignacio Bluro
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Meta Analysis ◽  
Arterial Disease ◽  
Lipid Lowering ◽  
Placebo Control ◽  
Lipid Lowering Therapy ◽  
Lowering Therapy ◽  
Increased Risk ◽  
Peripheral Arterial

Objective Patients with peripheral artery disease (PAD) are at increased risk of major adverse limb events (MALE). Furthermore, MALE have several clinical implications and a poor prognosis, so prevention is a fundamental issue. The main objective of the present meta-analysis of randomized clinical trials is to evaluate the effect of different lipid-lowering therapies on MALE incidence in patients with PAD. Methods A meta-analysis of randomized studies that evaluated the use of lipid-lowering therapy in patients with PAD and reported MALE was performed, after searching the PubMed/MEDLINE, Embase, ScieLO, Google Scholar, and Cochrane Controlled Trials databases. A fixed- or random-effects model was used. Results Five randomized clinical trials including 11,603 patients were identified and considered eligible for the analyses (5903 subjects were allocated to receive lipid-lowering therapy, while 5700 subjects were allocated to the respective placebo/control arms). The present meta-analysis revealed that lipid-lowering therapy was associated with a lower incidence of MALE (OR: 0.76, 95% confidence interval: 0.66–0.87; I2: 28%) compared to placebo/control groups. The sensitivity analysis shows that the results are robust. Conclusion This study demonstrated that the use of lipid-lowering therapy compared with the placebo/control arms was associated with a marked reduction in the risk of MALE. Physicians involved in the monitoring and treatment of patients with PAD must work hard to ensure adequate lipid-lowering medication in these patients.

Sign in / Sign up

Export Citation Format

Share Document