scholarly journals Safety of Human Papillomavirus 9-Valent Vaccine: A Meta-Analysis of Randomized Trials

2017 ◽  
Vol 2017 ◽  
pp. 1-6 ◽  
Author(s):  
Ana Paula Ferreira Costa ◽  
Ricardo Ney Oliveira Cobucci ◽  
Janine Medeiros da Silva ◽  
Paulo Henrique da Costa Lima ◽  
Paulo César Giraldo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Human Papillomavirus ◽  
Adverse Effects ◽  
Randomized Trials ◽  
Web Of Science ◽  
Meta Analysis ◽  
Developed Countries ◽  
Electronic Data ◽  
Tetravalent Vaccine ◽  
Significant Difference

Vaccination against human papillomavirus (HPV) has been progressively implemented in most developed countries for approximately 10 years. In order to increase the protection of the vaccines, a 9-valent vaccine (HPV9) was developed, which provides protection against nine types of the virus. Studies evaluating its safety are rare. Thus, we performed a meta-analysis of three clinical trials assessing adverse effects on women randomly vaccinated with HPV9 or tetravalent vaccine (HPV4), with the objective of analyzing whether the HPV9 is as safe as HPV4. An electronic data search was performed through the PubMed, Embase, Scopus, Web of Science, and SciELO databases. The studies selected 27,465 women who received one of the two vaccines. Pain (OR 1.72; 95% CI 1.62–1.82) and erythema (OR 1.29; 95% CI 1.21–1.36) occurred significantly more in the HPV9 group. However, there was no significant difference between the groups for the following adverse effects: headache (OR 1.07; 95% CI 0.99–1.15), dizziness (OR 1.09; 95% CI 0.93–1.27), and fatigue (OR 1.09; 95% CI 0.91–1.30), and the occurrence of serious events related to vaccination was similarly rare among those vaccinated. Therefore, our findings demonstrate that HPV9 in female patients is as safe as the tetravalent vaccine.

scholarly journals Cardiovascular Toxicities Secondary to Biotherapy and Molecular Targeted Therapies in Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials

Cancers ◽  
2021 ◽  
Vol 13 (9) ◽  
pp. 2159
Author(s):  
Charalampos Aktypis ◽  
Maria-Eleni Spei ◽  
Maria Yavropoulou ◽  
Göran Wallin ◽  
Anna Koumarianou ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Targeted Therapies ◽  
Safety Profile ◽  
Meta Analysis ◽  
Mtor Inhibitors ◽  
Risk Of Bias ◽  
Neuroendocrine Neoplasms ◽  
Controlled Trials

A broad spectrum of novel targeted therapies with prime antitumor activity and/or ample control of hormonal symptoms together with an overall acceptable safety profile have emerged for patients with metastatic neuroendocrine neoplasms (NENs). In this systematic review and quantitative meta-analysis, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and clinicaltrials.gov databases were searched to assess and compare the safety profile of NEN treatments with special focus on the cardiovascular adverse effects of biotherapy and molecular targeted therapies (MTTs). Quality/risk of bias were assessed using GRADE criteria. Placebo-controlled randomized clinical trials (RCTs) in patients with metastatic NENs, including medullary thyroid cancer (MTC) were included. A total of 3695 articles and 122 clinical trials registered in clinicaltrials.gov were screened. We included sixteen relevant RCTs comprising 3408 unique patients assigned to different treatments compared with placebo. All the included studies had a low risk of bias. We identified four drug therapies for NENs with eligible placebo-controlled RCTs: somatostatin analogs (SSAs), tryptophan hydroxylase (TPH) inhibitors, mTOR inhibitors and tyrosine kinase inhibitors (TKI). Grade 3 and 4 adverse effects (AE) were more often encountered in patients treated with mTOR inhibitors and TKI (odds ratio [OR]: 2.42, 95% CI: 1.87–3.12 and OR: 3.41, 95% CI: 1.46–7.96, respectively) as compared to SSAs (OR:0.77, 95% CI: 0.47–1.27) and TPH inhibitors (OR:0.77, 95% CI: 0.35–1.69). MTOR inhibitors had the highest risk for serious cardiac AE (OR:3.28, 95% CI: 1.66–6.48) followed by TKIs (OR:1.51, 95% CI: 0.59–3.83). Serious vascular AE were more often encountered in NEN patients treated with mTOR inhibitors (OR: 1.72, 95% CI: 0.64–4.64) and TKIs (OR:1.64, 95% CI: 0.35–7.78). Finally, patients on TKIs were at higher risk for new-onset or exacerbation of pre-existing hypertension (OR:3.31, 95% CI: 1.87–5.86). In conclusion, SSAs and TPH inhibitors appear to be safer as compared to mTOR inhibitors and TKIs with regards to their overall toxicity profile, and cardiovascular toxicities in particular. Special consideration should be given to a patient-tailored approach with anticipated toxicities of targeted NEN treatments together with assessment of cardiovascular comorbidities, assisting clinicians in treatment selection and early recognition/management of cardiovascular toxicities. This approach could improve patient compliance and preserve cardiovascular health and overall quality of life.

The global prevalence of familial multiple sclerosis: an updated systematic review and meta-analysis

2021 ◽  
Author(s):  
Naeim Ehtesham ◽  
Maryam Zare Rafie ◽  
Meysam Mosallaei
Keyword(s):  
Multiple Sclerosis ◽  
Web Of Science ◽  
Meta Analysis ◽  
Disease Onset ◽  
Inclusion Criteria ◽  
Multifactorial Diseases ◽  
Pooled Prevalence ◽  
Significant Difference ◽  
Meta Regression ◽  
Genetic And Environmental Factors

Abstract Background: Considering that familial multiple sclerosis (FMS) can reveal the extent to which genetic and environmental factors each involve in the etiopathogenesis of the disease, we performed an updated meta-analysis of the worldwide prevalence of FMS by addition of recent publications. Methods: A search in PubMed, Scopus, the ISI Web of Science, and Google Scholar up to 20 December 2020 was done. The inclusion criteria were based on the CoCoPop approach (condition, context, and population). The qualified studies entered the process of the meta-analysis by using comprehensive meta-analysis ver. 2 software.Results: The pooled prevalence of MS in relatives of 16179 FMS cases was estimated to be 11.8% (95% CI: 10.7-13) based on a random-effects model. The pooled mean age of disease onset in adult probands was calculated to be 28.7 years (95% CI: 27.2± 30.2). In 13 studies that reported the data of FMS in pediatrics (n=6636) and adults (n=877), the FMS prevalence was 10.8% (95% CI: 8.1-14.2) and 15.5% (95% CI: 13.8-17.4), respectively. Considering the data of 9 studies, the prevalence of FMS in males (n=5243) and females (n=11503) patients was calculated to be 13.7% (95% CI: 10.1-18.2) and 15.4% (95% CI: 10.3-22.4), respectively. The odds ratio of male/female in FMS cases was not statistically significant (OR= 0.9; 95% CI: 0.6-1.2, P=0.55). Subgroup analysis demonstrated a significant difference in the prevalence of FMS between the geographical areas (P= 0.007). The meta-regression model for FMS prevalence was significantly lower in terms of higher latitude (P< 0.001) and increased MS prevalence (P< 0.001). In contrast, meta-regression based on prevalence day was not statistically significant (P=0.29).Conclusions: The prevalence of FMS is more in the pediatric group than that of adults, is distinct between geographical areas, and diminishes with the increment of MS prevalence and latitude. Also, the symptoms initiate relatively at lower ages in FMS cases. By contrast with multifactorial diseases, our analysis unveiled that the prevalence of FMS was not more prevalent in men than women and the risk of MS development in relatives was not more when the affected proband was male.

scholarly journals Opioid Use and the Risk of Respiratory Depression and Death in the Pediatric Population

2013 ◽  
Vol 18 (4) ◽  
pp. 269-276 ◽  
Author(s):  
Marianne R. Whittaker
Keyword(s):  
Clinical Trials ◽  
Adverse Effects ◽  
Respiratory Depression ◽  
Pediatric Patients ◽  
Pediatric Population ◽  
Opioid Use ◽  
Randomized Controlled ◽  
Randomized Controlled Studies ◽  
Increased Risk ◽  
Significant Difference

BACKGROUND Pediatric patients may be at an increased risk of adverse effects from various medications. Recently, there have been a number of serious adverse events, including several pediatric patients experiencing severe respiratory depression and death as a result of the use of codeine for pain control following tonsillectomy and adenoidectomy. OBJECTIVE To assess the safety of opioid agonists in pediatric patients undergoing operative procedures or have experienced trauma and to evaluate the risk of respiratory depression and death among this population. METHODS PubMed and Medline were searched to identify randomized controlled studies from 1994 to 2012 addressing postsurgery/trauma opioid use in pediatric patients. Relative risks and confidence intervals (CIs) were calculated using data available in clinical trials. RESULTS A total of 16 clinical trials were evaluated for this review. Randomized controlled trials included studies comparing opioids versus non-opioids for a variety of painful conditions. The relative risk of respiratory depression associated with opioid use in 1 trial was 1.63 (95% CI: 0.64–6.13). The remaining 15 trials reviewed described no significant difference in respiratory depression or adverse effects associated with treatment. No deaths were attributed to opioid use in any of these studies. CONCLUSION Opioid-associated respiratory depression was very rare and no deaths were reported in the reviewed studies. These findings under the well-defined conditions of controlled studies may not be the best means of determining overall opioid-associated side effects in pediatric patients.

scholarly journals The Use of Green Coffee Extract as a Weight Loss Supplement: A Systematic Review and Meta-Analysis of Randomised Clinical Trials

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
Igho Onakpoya ◽  
Rohini Terry ◽  
Edzard Ernst
Keyword(s):  
Weight Loss ◽  
Clinical Trials ◽  
Methodological Quality ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Significant Heterogeneity ◽  
Green Coffee ◽  
Significant Difference ◽  
Using Data

The purpose of this paper is to assess the efficacy of green coffee extract (GCE) as a weight loss supplement, using data from human clinical trials. Electronic and nonelectronic searches were conducted to identify relevant articles, with no restrictions in time or language. Two independent reviewers extracted the data and assessed the methodological quality of included studies. Five eligible trials were identified, and three of these were included. All studies were associated with a high risk of bias. The meta-analytic result reveals a significant difference in body weight in GCE compared with placebo (mean difference: kg; 95%CI: , ). The magnitude of the effect is moderate, and there is significant heterogeneity amongst the studies. It is concluded that the results from these trials are promising, but the studies are all of poor methodological quality. More rigorous trials are needed to assess the usefulness of GCE as a weight loss tool.

scholarly journals Comparative effectiveness of vitamin D supplementation via buccal spray versus oral supplements on 25(OH)D concentrations: a systematic review

2020 ◽  
Vol 79 (OCE2) ◽  
Author(s):  
Lucy Pritchard ◽  
Mary Hickson ◽  
Stephen Lewis
Keyword(s):  
Systematic Review ◽  
Vitamin D ◽  
Adverse Effects ◽  
Crossover Study ◽  
Comparative Effectiveness ◽  
Meta Analysis ◽  
Systemic Circulation ◽  
Vitamin D Supplementation ◽  
Future Research ◽  
Significant Difference

AbstractVitamin D (vitD) deficiency is the most common nutritional deficiency worldwide. Most patients are treated with oral vitD capsules (either vitD2 or vitD3). A few studies have reported equal efficacy of buccal spray vitD. This is a new formulation that is absorbed via the oral mucosa into the systemic circulation, bypassing the gastrointestinal route. The main objective of this systematic review was to identify RCT evidence for the comparative effectiveness of buccal spray versus oral vitD on serum 25-hydroxyvitaminD [25-OHD] concentrations and any adverse effects of buccal spray vitD. We have published an a priori protocol using Joanna Briggs Institute (JBI) methodology (PROSPERO CRD42018118580). A three-step search strategy to identify RCTs was conducted, which reported serum 25-OHD concentrations from five databases from 2008–2018. Retrieved abstracts were screened; included papers imported into JBI SUMARI and assessed for study quality (GRADE) by two authors. Meta-analysis was planned. Three RCTs met our inclusion criteria. Due to heterogeneity of studies, meta-analysis was not possible. In a RCT crossover study, mean serum 25-OHD concentrations were significantly higher in patients with malabsorption syndrome (n = 20) on 1000IU buccal spray + 117.8%(10.46, 95%CI6.89,14.03ng/ml) vs.1000IU oral vitD3 + 36.02%(3.96, 95%CI2.37, 5.56ng/ml) at 30days (p < 0.0001). Mean serum 25-OHD were also significantly higher in healthy adults (n = 20) on buccal spray + 42.99%(7.995, 95%CI6.86,9.13ng/ml)vs.oral vitD3 + 21.72%(4.06, 95%CI3.41,4.71ng/ml) at 30days (p < 0.0001). In another RCT crossover study, ANCOVA revealed no significant difference in the mean and SD change from baseline total 25-OHD concentrations in adults (n = 22) on 3000IU buccal spray vs. 3000IU oral vitD3 + 44%,26.15 (SD17.85) vs. + 51%,30.38 (SD17.91)nmol/l, respectively;F = 1.044, adjusted r20.493,p = 0.313 at 4 weeks. In a RCT, 800IU buccal spray was equally effective as 750IU oral vitD3 in children with neurodisabilities(n = 24) at 3 months. Both groups had a significant increase in 25-OHD; 11.5 ng/ml(median8–19) to 26.5(13.6–39)ng/ml and 15.5ng/ml(8–20) to 34.5(22–49)ng/ml, respectively (z = 150;p < 0.0001). The overall certainty of evidence was very low to moderate. No adverse effects were reported. The evidence from these studies suggests that 800IU-3000IU doses of buccal spray vitD3 given daily may be an effective alternative as oral vitD3 in obtaining short-term haematological responses in serum 25-OHD concentrations. Buccal spray vitD3 may be a useful alternative for patients with intestinal malabsorption or dysphagia. Future research should compare buccal spray VD3 to intramuscular injections and confirm these findings in well-designed trials.

scholarly journals Opioid-induced constipation in palliative care: state of the art

2020 ◽  
pp. 1116-1124
Author(s):  
Erlania do Carmo Freitas ◽  
Geslaney Reis da Silva ◽  
Rudval Souza da Silva ◽  
Rita Narriman Silva de Oliveira Boery ◽  
Maria Patricia Milagres
Keyword(s):  
Palliative Care ◽  
Clinical Trials ◽  
Adverse Effects ◽  
Exploratory Study ◽  
Adverse Reactions ◽  
State Of The Art ◽  
Meta Analysis ◽  
Life Quality ◽  
Limited Data ◽  
Inclusion Criteria

OBJECTIVE: The study’s purpose has been to address the state of the art in investigations such as clinical trials, systematic reviews with meta-analysis and case studies, which report how to minimize opioid-induced constipation in patients undergoing palliative care. METHODS: This is an exploratory study through an integrative review of four databases addressing published articles from 2013 to 2017. RESULTS: A total of 117 publications were presented, which 17 presented the inclusion criteria. The studies describe the prevalence of constipation rates induced by the use of opioids. CONCLUSION: Although these drugs alleviate pain, the adverse reactions may generate discomfort and loss of the patient’s life quality. There are limited data on the treatment of constipation. It was observed that few authors mentioned diet as a helper on this situation, emphasizing the use of medications. Further studies should be encouraged aiming to find the balance between analgesia and reduction of adverse effects.

scholarly journals Aflatoxin M1 in Milk Worldwide from 1988 to 2020: A Systematic Review and Meta-Analysis

2020 ◽  
Vol 2020 ◽  
pp. 1-14
Author(s):  
Nader Salari ◽  
Mohsen Kazeminia ◽  
Aliakbar Vaisi-Raygani ◽  
Rostam Jalali ◽  
Masoud Mohammadi
Keyword(s):  
Systematic Review ◽  
Sample Size ◽  
Web Of Science ◽  
Animal Feed ◽  
Meta Analysis ◽  
Food Contamination ◽  
Aflatoxin M1 ◽  
Significant Difference ◽  
Animal Milk ◽  
Review Study

Background. Aflatoxins are found in various types of food and animal feed. Food contamination with aflatoxin toxin is of particular importance today. Various studies have reported different prevalence of aflatoxin M1 in animal milk. Therefore, due to the importance of this toxin, its role in health, and lack of general statistics about it worldwide, the present study aimed to determine the prevalence of aflatoxin M1 in milk worldwide with a systematic review and meta-analysis study. Methods. In this review study, national and international databases were extracted from SID, MagIran, IranMedex, IranDoc, Embase, ScienceDirect, Scopus, PubMed, and Web of Science (ISI) between January 1988 and February 2020. A random effects model was used for analysis, and heterogeneity of studies with an I2 index was investigated. Data were analyzed using Comprehensive Meta-Analysis (version 2). Results. The prevalence of aflatoxin M1 in milk worldwide from January 1988 to February 2020 in 122 articles with a sample size of 18921 was 79.1% (95% CI: 75.5–82.3%). Regarding the heterogeneity based on metaregression, there was a significant difference between the effect of the year of study (p≤0.001) and sample size (p≤0.001) with the prevalence of aflatoxin M1 in animal milk. Conclusion. The results of this study show that the prevalence of aflatoxin M1 in milk is high worldwide. Therefore, considering the importance of the milk group and its products, special measures should be taken to protect the ration from aflatoxin molds and milk quality.

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