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Imiquimod for Cervical and Vaginal Intraepithelial Neoplasia: A Systematic Review and Meta-analysis.Obstetrics and Gynecology Aug 2023To evaluate the treatment efficacy and the risk of adverse events of imiquimod for cervical intraepithelial neoplasia (CIN) and vaginal intraepithelial neoplasia (VAIN),... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To evaluate the treatment efficacy and the risk of adverse events of imiquimod for cervical intraepithelial neoplasia (CIN) and vaginal intraepithelial neoplasia (VAIN), compared with placebo or no intervention.
DATA SOURCES
We searched Cochrane, PubMed, ISRCTN registry, ClinicalTrials.gov , and the World Health Organization International Clinical Trials Registry Platform up to November 23, 2022.
METHODS OF STUDY SELECTION
We included randomized controlled trials and prospective nonrandomized studies with control arms that investigated the efficacy of imiquimod for histologically confirmed CIN or VAIN. The primary outcomes were histologic regression of the disease (primary efficacy outcome) and treatment discontinuation due to side effects (primary safety outcome). We estimated pooled odds ratios (ORs) of imiquimod, compared with placebo or no intervention. We also conducted a meta-analysis of the proportions of patients with adverse events in the imiquimod arms.
TABULATION, INTEGRATION, AND RESULTS
Four studies contributed to the pooled OR for the primary efficacy outcome. An additional four studies were available for meta-analyses of proportions in the imiquimod arm. Imiquimod was associated with increased probability of regression (pooled OR 4.05, 95% CI 2.08-7.89). Pooled OR for CIN in the three studies was 4.27 (95% CI 2.11-8.66); results of one study were available for VAIN (OR, 2.67, 95% CI 0.36-19.71). Pooled probability for primary safety outcome in the imiquimod arm was 0.07 (95% CI 0.03-0.14). The pooled probabilities (95% CI) of secondary outcomes were 0.51 (0.20-0.81) for fever, 0.53 (0.31-0.73) for arthralgia or myalgia, 0.31 (0.18-0.47) for abdominal pain, 0.28 (0.09-0.61) for abnormal vaginal discharge or genital bleeding, 0.48 (0.16-0.82) for vulvovaginal pain, and 0.02 (0.01-0.06) for vaginal ulceration.
CONCLUSION
Imiquimod was found to be effective for CIN, whereas data on VAIN were limited. Although local and systemic complications are common, treatment discontinuation is infrequent. Thus, imiquimod is potentially an alternative therapy to surgery for CIN.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO, CRD42022377982.
Topics: Female; Humans; Imiquimod; Antineoplastic Agents; Prospective Studies; Aminoquinolines; Uterine Cervical Dysplasia; Uterine Cervical Neoplasms
PubMed: 37411024
DOI: 10.1097/AOG.0000000000005256 -
Journal of Global Health Jul 2023The coronavirus (COVID-19) pandemic caused enormous adverse socioeconomic impacts worldwide. Evidence suggests that the diagnostic accuracy of clinical features of... (Meta-Analysis)
Meta-Analysis
Diagnostic accuracy of clinical signs and symptoms of COVID-19: A systematic review and meta-analysis to investigate the different estimates in a different stage of the pandemic outbreak.
BACKGROUND
The coronavirus (COVID-19) pandemic caused enormous adverse socioeconomic impacts worldwide. Evidence suggests that the diagnostic accuracy of clinical features of COVID-19 may vary among different populations.
METHODS
We conducted a systematic review and meta-analysis of studies from PubMed, Embase, Cochrane Library, Google Scholar, and the WHO Global Health Library for studies evaluating the accuracy of clinical features to predict and prognosticate COVID-19. We used the National Institutes of Health Quality Assessment Tool to evaluate the risk of bias, and the random-effects approach to obtain pooled prevalence, sensitivity, specificity, and likelihood ratios.
RESULTS
Among the 189 included studies (53 659 patients), fever, cough, diarrhoea, dyspnoea, and fatigue were the most reported predictors. In the later stage of the pandemic, the sensitivity in predicting COVID-19 of fever and cough decreased, while the sensitivity of other symptoms, including sputum production, sore throat, myalgia, fatigue, dyspnoea, headache, and diarrhoea, increased. A combination of fever, cough, fatigue, hypertension, and diabetes mellitus increases the odds of having a COVID-19 diagnosis in patients with a positive test (positive likelihood ratio (PLR) = 3.06)) and decreases the odds in those with a negative test (negative likelihood ratio (NLR) = 0.59)). A combination of fever, cough, sputum production, myalgia, fatigue, and dyspnea had a PLR = 10.44 and an NLR = 0.16 in predicting severe COVID-19. Further updating the umbrella review (1092 studies, including 3 342 969 patients) revealed the different prevalence of symptoms in different stages of the pandemic.
CONCLUSIONS
Understanding the possible different distributions of predictors is essential for screening for potential COVID-19 infection and severe outcomes. Understanding that the prevalence of symptoms may change with time is important to developing a prediction model.
Topics: United States; Humans; COVID-19; SARS-CoV-2; Myalgia; Cough; Pandemics; COVID-19 Testing; Dyspnea; Fatigue
PubMed: 37441773
DOI: 10.7189/jogh.13.06026 -
Zeitschrift Fur Naturforschung. C,... Jan 2023The COVID-19 mainly causes respiratory disorders with high infection and severe morbidity and mortality. Neurologists have concerns about potential neurological side... (Review)
Review
The COVID-19 mainly causes respiratory disorders with high infection and severe morbidity and mortality. Neurologists have concerns about potential neurological side effects, profits, and timing of COVID-19 vaccines. This study aimed to review systematically research for the COVID-19 vaccine and neurological complications. Data was searched in Scopus, ISI web of knowledge, Medline, PubMed, Wiley, Embase, International Clinical Trials Registry Platform and Clinical Trials, Cochrane Library, and Google Scholar. Two reviewer authors individually searched and assessed the titles and abstracts of all articles. The third reviewer resolved disagreement between them. Data were documented regarding study location, study design, type of complications, number of patients, various types of COVID-19 vaccine, and type of neurological complications. Six studies in COVID-19 vaccine and neurological complications include two studies about neurological manifestations after the mRNA vaccines, four records about side effects of vector-based vaccine were included in the study. The main neurological complication associated mRNA vaccines were body aches, paresthesia, and difficulty walking, erythema migrans lesion, fatigue, myalgia, and pain in the left lateral deltoid region. The major neurological complication related to vector-based vaccines were urinary retention difficulty, feeding and ambulating, arm soreness, mild fatigue, chills, left-sided facial droop, headaches, a generalized epileptic seizure, hemianopia, and mild aphasia, acute somnolence and right-hand hemiparesis, acute transverse myelitis, deep vein thrombosis in her left leg, a vigilance disorder and a twitching, a severe immobilizing opsoclonus myoclonus syndrome, and encephalitis. A large spectrum of severe neurological unfavorable has been reported. These complications could occur as a result of molecular stimulation and later neuronal damage. Generally, the advantages of COVID-19 vaccination are dominant on the risks of a neurological complication at both individual and population levels. Future investigations will be required to find any relationship between neurological complications and COVID-19 vaccines principally as new strains of the virus and new vaccines are technologically advanced against them.
Topics: Humans; Female; COVID-19 Vaccines; COVID-19
PubMed: 36087300
DOI: 10.1515/znc-2022-0092 -
Archives of Disease in Childhood Dec 2020To undertake a systematic review of reviews of the prevalence of symptoms and signs of COVID-19 in those aged under 20 years.
OBJECTIVE
To undertake a systematic review of reviews of the prevalence of symptoms and signs of COVID-19 in those aged under 20 years.
DESIGN
Narrative systematic review of reviews. PubMed, medRxiv, Europe PMC and COVID-19 Living Evidence Database were searched on 9 October 2020.
SETTING
All settings, including hospitalised and community settings.
PATIENTS
Children and young people (CYP) under age 20 years with laboratory-proven COVID-19.
STUDY REVIEW, DATA EXTRACTION AND QUALITY
Potentially eligible articles were reviewed on title and abstract by one reviewer. Quality was assessed using the modified AMSTARS criteria and data were extracted from included studies by two reviewers.
MAIN OUTCOME MEASURES
Prevalence of symptoms and signs of COVID-19.
RESULTS
1325 studies were identified and 18 reviews were included. Eight were high quality, 7 medium and 3 low quality. All reviews were dominated by studies of hospitalised children. The proportion of asymptomatic CYP ranged from 14.6% to 42%. Fever and cough were the the most common symptoms; proportions with fever ranged from 46% to 64.2% and with cough from 32% to 55.9%. All other symptoms or signs including rhinorrhoea, sore throat, headache, fatigue/myalgia and gastrointestinal symptoms including diarrhoea and vomiting were infrequent, occurring in less than 10%-20%.
CONCLUSIONS
Fever and cough are the most common symptoms in CYP with COVID-19, with other symptoms infrequent. Further research on symptoms in community samples are needed to inform pragmatic identification and testing programmes for CYP.
PubMed: 33334728
DOI: 10.1136/archdischild-2020-320972 -
Journal of the American Academy of... Apr 2018Systemic corticosteroids are often used to treat atopic dermatitis (AD). However, few studies have assessed the safety and efficacy of systemic corticosteroids in AD. (Review)
Review
BACKGROUND
Systemic corticosteroids are often used to treat atopic dermatitis (AD). However, few studies have assessed the safety and efficacy of systemic corticosteroids in AD.
OBJECTIVE
To systematically review the literature on efficacy and safety of systemic corticosteroid use (oral, intramuscular, and intravenous) in AD.
METHODS
PubMed, Embase, Medline, Scopus, Web of Science, and Cochrane Library were searched. We included systematic reviews, guidelines, and treatment reviews of systemic corticosteroid use among patients of all ages with a diagnosis of AD (52 reviews and 12 studies).
RESULTS
There was general consensus in the literature to limit the use of systemic steroids to short courses as a bridge to steroid-sparing therapies. Systemic side effects include growth suppression in children, osteoporosis, osteonecrosis, adrenal insufficiency, Cushing syndrome, hypertension, glucose intolerance, diabetes, gastritis, gastroesophageal reflux, peptic ulcer disease, weight gain, emotional lability, behavioral changes, opportunistic infections, cataracts, glaucoma, myopathy, myalgia, dysaesthesia, pseudotumor cerebri, hyperlipidemia, malignancy, thrombosis, skin atrophy, sleep disturbance, and rebound flaring.
LIMITATIONS
Baseline clinical severity, corticosteroid delivery and dose, and treatment response were reported incompletely and heterogeneously across studies.
CONCLUSIONS
Evidence is not strong enough to determine optimal delivery or duration of systemic corticosteroids in AD.
Topics: Adrenal Cortex Hormones; Dermatitis, Atopic; Humans; Treatment Outcome
PubMed: 29032119
DOI: 10.1016/j.jaad.2017.09.074 -
Reviews in Medical Virology Jan 2023Several phase-1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti-Zika vaccines. In this systematic review, we systematically... (Review)
Review
Several phase-1 clinical trials have been performed to evaluate the safety and efficacy of candidate anti-Zika vaccines. In this systematic review, we systematically evaluated the safety and immunogenicity of candidate vaccines, which would aid researchers in formulating an effective vaccination strategy for phase-2 trials based on current evidence. A literature search was conducted using the electronic databases MEDLINE through Pubmed, Web of Science, and Cochrane Database for relevant studies on candidate anti-zika vaccines. Studies on animal models were excluded from our study. Healthy individuals who were administered candidate Zika vaccines to evaluate the immune response and adverse events (AEs) compared to placebo were considered. Data were extracted, tabulated, and analysed using Microsoft Excel, while the risk of bias plots were generated using tidyverse and Robvis packages in R-studio. A total of five phase-1 clinical trials were included in our analysis comprising of studies on inactivated, viral vector, and DNA vaccines. Immunogenicity ranged from 10% to 100% after vaccination with the lowest seroconversion rate (10%) and geometric mean titre (GMT) (6.3; 95% confidence interval (CI):3.7-10.8) observed among recipients of single-dose inactivated anti-zika vaccine (ZPIV). For DNA vaccines, the seroconversion rate ranged from 60% to 100% with the highest seroconversion rate (100%) and GMT (2871; 95% CI:705.3-11688) observed among recipients of three shots of high dose GLS-5700 vaccine. For viral vector vaccine (Ad26.ZIKV.001) seroconversion rate (100%) and GMT peaked after two shots with both low and high-dose vaccines. In all those studies AEs were mostly local including injection site pain, erythema, and itching. The most common systemic AEs included fever, myalgia, nausea, and fatigue. In phase-1 clinical trials, all candidate vaccines were found to be highly immunogenic and relatively safe, especially when administered in higher doses and with the help of needle-free devices.
Topics: Animals; Zika Virus; Zika Virus Infection; Vaccines, DNA; Viral Vaccines; Vaccination; Antibodies, Viral
PubMed: 35986594
DOI: 10.1002/rmv.2385 -
Acta Tropica Feb 2017Murine or endemic typhus, a febrile disease caused by Rickettsia typhi, is often misdiagnosed due to its non-specific presentation. We sought to evaluate all available... (Review)
Review
Murine or endemic typhus, a febrile disease caused by Rickettsia typhi, is often misdiagnosed due to its non-specific presentation. We sought to evaluate all available evidence in the literature regarding the clinical and laboratory manifestations, epidemiological characteristics, and outcomes of murine typhus. Pubmed was searched for all articles providing available data. In an effort to incorporate contemporary data, only studies from 1980 were included. Thirty-three case series including 2074 patients were included in final analysis. Available evidence suggests that the classic triad of fever, headache and rash is encountered in only one-third of patients. Other frequent symptoms were chills, malaise, myalgia, and anorexia. A tetrad of reported laboratory abnormalities consisting of elevated liver enzymes, lactate dehydrogenase, erythrocyte sedimentation rate and hypoalbuminemia was detected. Complications were observed in one-fourth of patients, reported mortality was extremely low, but untreated patients had notably longer duration of fever. Among epidemiological characteristics, a seasonal distribution with most cases reported during warmer months, was the most prominent finding. Murine typhus in children exhibits several different characteristics, with abdominal pain, diarrhea, and sore throat reported more commonly, higher frequency of anemia, lower frequency of hypoalbuminemia, hematuria and proteinuria and a much lower rate of complications. This systematic review of published evidence provides a thorough description of the clinical and laboratory features of murine typhus and highlights important differences in children.
Topics: Animals; Child; Exanthema; Fever; Headache; Humans; Treatment Outcome; Typhus, Endemic Flea-Borne
PubMed: 27983969
DOI: 10.1016/j.actatropica.2016.10.018 -
Vaccine Apr 2022Vaccinations are essential for preventing infectious diseases in children with chronic diseases as they have increased risk of infection from frequent use of biologics.... (Meta-Analysis)
Meta-Analysis Review
UNLABELLED
Vaccinations are essential for preventing infectious diseases in children with chronic diseases as they have increased risk of infection from frequent use of biologics. Response to immunizations in this group is not well known.
OBJECTIVE
A systematic review was performed to evaluate three primary outcomes: efficacy; immunogenicity; and safety of vaccines in children with chronic conditions treated with biologics.
METHODS
The protocol for our systematic review and meta-analysis was registered and published with PROSPERO. We searched electronic bibliographic databases for studies published from 2009 to 2019, focusing on vaccinations in children with chronic conditions treated with biologics.
RESULTS
We retrieved 532 records. Thirty-one full-text articles were selected, and 14 were included in the meta-analysis. No significant publication bias was found.
EFFICACY
limited data are available regarding the efficacy of vaccination, as most studies have focused on immunogenicity as surrogate outcome for efficacy. Immunogenicity: patients receiving anti-TNF-alpha therapy had a statistically significant risk of poor seroconversion (p = 0.028) and seroprotection by the serotype B influenza vaccine [inflammatory bowel disease (IBD) p = 0.013; juvenile idiopathic arthritis (JIA) p = 0.004]. We found adequate responses with H1N1 and H3N2 serotypes. Few studies existed for pneumococcal, hepatitis A virus, hepatitis B virus, varicella-zoster virus, Measles Mumps Rubella virus, and multiple vaccine administration.
SAFETY
vaccine administration was not associated with serious side effects, but JIA patients on anti-TNF alpha therapy had a statistically significant risk of presenting with myalgia or arthralgia postinfluenza vaccine (p = 0.014).
CONCLUSIONS
More evidence concerning efficacy, immunogenicity, and safety of vaccinations is needed to guide physicians in the vaccine decision process for this pediatric population.
Topics: Biological Products; Child; Humans; Immunogenicity, Vaccine; Influenza A Virus, H1N1 Subtype; Influenza A Virus, H3N2 Subtype; Measles-Mumps-Rubella Vaccine; Pneumococcal Vaccines; Tumor Necrosis Factor Inhibitors
PubMed: 35370019
DOI: 10.1016/j.vaccine.2022.03.041 -
A systematic review and meta-analysis on the safety of newly adjuvanted vaccines among older adults.Vaccine Jul 2018New adjuvants have been developed to improve the efficacy of vaccines and for dose-sparing capacity and may overcome immuno senescence in the elderly. We reviewed the... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
New adjuvants have been developed to improve the efficacy of vaccines and for dose-sparing capacity and may overcome immuno senescence in the elderly. We reviewed the safety of newly-adjuvanted vaccines in older adults.
METHODS
We searched Medline for clinical trials (CTs) including new adjuvant systems (AS01, AS02, AS03, or MF59), used in older adults, published between 01/1995 and 09/2017. Safety outcomes were: serious adverse events (SAEs); solicited local and general AEs (reactogenicity); unsolicited AEs; and potentially immune-mediated diseases (pIMDs). Standard random effects meta-analyses were conducted by type of safety event and adjuvant type, reporting Relative Risks (RR) with 95% confidence intervals (95% CI).
RESULTS
We identified 1040 publications, from which we selected 7, 7, and 12 CTs on AS01/AS02, AS03 and MF59, respectively. 47,602 study participants received newly-adjuvanted vaccine and 44,521 control vaccine, or placebo. Rates of SAEs (RR = 0.99, 95% CI = 0.96-1.02), deaths (RR = 0.99, 95% CI = 0.92-1.06) and pIMDs (RR = 0.94, 95% CI = 0.79-1.1) were comparable in newly-adjuvanted and control groups. Vaccine-related SAEs occurred in <1% of the subjects in both groups. The reactogenicity of AS01/AS02 and AS03 adjuvanted vaccines was higher compared to control vaccines, whereas MF59-adjuvanted vaccines resulted only in more pain. Grade 3 reactogenicity was reported infrequently, with fatigue (RR = 2.48, 95% CI = 1.69-3.64), headache (RR = 2.94, 95% CI = 1.24-6.95), and myalgia (RR = 2.68, 95% CI = 1.86-3.80) occurring more frequently in newly-adjuvanted groups. Unsolicited AEs occurred slightly more frequently in newly-adjuvanted groups (RR = 1.04, 95% CI = 1.00-1.08).
CONCLUSIONS
Our review suggests that, within the clinical trial setting, the use of new adjuvants in older adults has not led to any safety concerns, with no increase in SAEs or fatalities. Higher rates for solicited AEs were observed, especially for AS01/AS02 and AS03 adjuvanted vaccines, but AEs were mostly mild and transient. Further evidence will need to come from the use of new adjuvants in the real-world setting, where larger numbers can be studied to potentially detect rare reactions.
Topics: Adjuvants, Immunologic; Aged; Aged, 80 and over; Clinical Trials as Topic; Drug-Related Side Effects and Adverse Reactions; Humans; Middle Aged; Vaccines
PubMed: 29885773
DOI: 10.1016/j.vaccine.2018.06.004 -
Therapeutics and Clinical Risk... 2023The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide.... (Review)
Review
The Efficacy of Herbs as Complementary and Alternative Therapy in Recovery and Clinical Outcome Among People with COVID-19: A Systematic Review, Meta-Analysis, and Meta-Regression.
BACKGROUND
The COVID-19 pandemic continues, and this condition has caused many cases in various countries around the world, resulting in more than 6 million deaths worldwide. Herbal medicines can act as immunomodulators, anti-inflammatories, antioxidants, antimicrobials, and others depending on the type and content of the herbs used. Previous studies have shown that several types of herbs, such as , have proven their effectiveness as herbal plants for COVID-19.
METHODS
We conducted a comprehensive literature search through five databases, namely, PubMed, Scopus, Embase, Wiley, and ProQuest to assess the efficacy of phytopharmaceuticals until July 12, 2022. We used the Cochrane RoB 2.0 for the quality assessment of the study.
RESULTS
Phytopharmaceuticals significantly improved patients' recovery rate (OR = 3.54; < 0.00001) and reduced deaths (OR = 0.24; < 0.0001) compared to the control group. Phytopharmaceuticals also performed as a protective factor for COVID-19 clinical symptoms, such as dyspnea (OR = 0.42; < 0.05) and myalgia (OR = 0.31; = 0.02) compared to the control group. However, there is no statistically significant effect on cough (OR = 0.76; = 0.61) and fever (OR = 0.60; < 0.20). The results were not affected by patients' covariates [hypertension, diabetes mellitus, and cardiovascular diseases (meta-regression > 0.05)].
CONCLUSION
Herbal medicine has the potential as an adjuvant therapy in the management of COVID-19.
PubMed: 37484695
DOI: 10.2147/TCRM.S405507