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Journal of Medical Virology Jun 2022We analyzed published studies on the efficacy and safety of the third dose of the COVID-19 vaccine in various general population settings. We conducted systematic...
We analyzed published studies on the efficacy and safety of the third dose of the COVID-19 vaccine in various general population settings. We conducted systematic searches of PubMed and EMBASE for series published in the English language through November 15, 2021, using the search terms "third" or "booster" or "three" and "dose" and "COVID-19" or "SARS-CoV-2." All articles were selected according to the MOOSE guidelines. The seroconversion risk after third doses was descriptively expressed as a pooled rate ratio ([seroconversion rate after the third dose]/[seroconversion rate after the second dose]). The search returned 30 studies that included a total of 2 734 437 vaccinated subjects. In more than 2 700 000 Israeli patients extracted from the general population, the reduction in the risk of infection ranged from 88% to 92%. Conversion rates for IgG anti-spike ranged from 95% to 100%. In cancer or immunocompromised patients, mean IgG seroconversion was 39.4% before and 66.6% after third doses. A third dose seems necessary to protect against all COVID-19 infection, severe disease, and death risk.
Topics: Antibodies, Viral; COVID-19; COVID-19 Vaccines; Humans; Immunoglobulin G; SARS-CoV-2; Seroconversion
PubMed: 35118680
DOI: 10.1002/jmv.27644 -
Infectious Diseases of Poverty Dec 2023Non-National Immunization Program (NIP) vaccines have played an important role in controlling vaccine-preventable diseases (VPDs) in China. However, these vaccines are... (Review)
Review
BACKGROUND
Non-National Immunization Program (NIP) vaccines have played an important role in controlling vaccine-preventable diseases (VPDs) in China. However, these vaccines are paid out of pocket and there is room to increase their coverage. We focused on four selected non-NIP vaccines in this study, namely Haemophilus influenzae type b (Hib) vaccine, human papillomavirus (HPV) vaccine, pneumococcal conjugate vaccine (PCV), and rotavirus vaccine. We aimed to conduct a scoping review of their vaccination rates and the major barriers faced by health systems, providers, and caregivers to increase coverage.
METHODS
We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR). We searched five English databases (PubMed, Web of Science, EMBASE, Scopus, and WHO IRIS) and four Chinese databases using the search strategy developed by the study team. Two independent reviewers screened, selected studies, and examined their quality. We summarized the non-NIP vaccine coverage data by vaccine and applied the 5A framework (Access, Affordability, Acceptance, Awareness, Activation) to chart and analyze barriers to increasing coverage.
RESULTS
A total of 28 articles were included in the analysis (nine pertaining to vaccine coverage, and another 19 reporting challenges of increasing uptake). Among the four selected vaccines, coverage for the Hib vaccine was the highest (54.9-55.9% for 1 dose or more from two meta-analyses) in 2016, while the coverage of the other three vaccines was lower than 30%. Eight of the nine included articles mentioned the regional disparity of coverage, which was lower in under-developing regions. For example, the three-dose Hib vaccination rate in eastern provinces was 38.1%, whereas the rate in central and western provinces was 34.3% and 26.2%, respectively in 2017. Within the 5A framework, acceptance, awareness, and affordability stood out as the most prominent themes. Among the 12 identified sub-themes, high prices, low vaccine awareness, concerns about vaccine safety and efficacy were the most cited barriers to increasing the uptake.
CONCLUSIONS
There is an urgent need to increase coverage of non-NIP vaccines and reduce disparities in access to these vaccines across regions. Concerted efforts from the government, the public, and society are required to tackle the barriers and challenges identified in this study, both on the demand and supply side, to ensure everybody has equal access to life-saving vaccines in China. Particularly, the government should take a prudent approach to gradually incorporate non-NIP vaccines into the NIP step by step, and make a prioritizing strategy based on key factors such as disease burden, financial resources, and market readiness, with special attention to high-risk populations and underdeveloped regions.
Topics: Humans; Vaccines; Vaccination; Immunization Programs; China; Cost of Illness
PubMed: 38062480
DOI: 10.1186/s40249-023-01150-8 -
BioDrugs : Clinical Immunotherapeutics,... Nov 2021Immunogenicity with formation of anti-drug antibodies (ADA) to biologics is an important reason for treatment failure in inflammatory bowel disease (IBD). Our aim was to... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIMS
Immunogenicity with formation of anti-drug antibodies (ADA) to biologics is an important reason for treatment failure in inflammatory bowel disease (IBD). Our aim was to assess the rate of ADA, the effect of combination therapy with immunomodulators on ADA and the influence of ADA on efficacy and safety of biologics for IBD treatment.
METHODS
MEDLINE, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to April 2020 for trials of biologics that assessed immunogenicity. The overall certainty of evidence was evaluated using Grading of Recommendations, Assessment, Development and Evaluations (GRADE). The primary outcome was rate of ADA. Secondary outcomes included efficacy and safety outcomes among patients with detectable versus undetectable ADA. For dichotomous outcomes, pooled risk ratios (RR) and 95% confidence intervals (CI) were calculated.
RESULTS
Data from 68 studies were analyzed and 33 studies (5850 patients) were included in the meta-analysis. Pooled ADA rates for biologic monotherapy were 28.0% for infliximab, 7.5% for adalimumab, 3.8% for golimumab, 10.9% for certolizumab, 6.2% for ustekinumab and 16.0% for natalizumab. Pooled ADA rates were 8.4% for vedolizumab and 5.0% for etrolizumab for combo- and monotherapy combined. In all biologics, ADA rates were underestimated by use of drug-sensitive ADA assays and higher dose and/or frequency. ADA rate was significantly reduced in patients treated with combination therapy for infliximab (RR 0.52; 95% CI 0.44-0.62), adalimumab (RR 0.31; 95% CI 0.14-0.69), golimumab (RR 0.29; 95% CI 0.10-0.83), certolizumab pegol (RR 0.30; 95% CI 0.14-0.67) and natalizumab (RR 0.20; 95% CI 0.11-0. 39). ADA to infliximab were associated with lower clinical response rates (RR 0.75; 95% CI 0.61-0.91) and higher rates of infusion reactions (RR 2.36; 95% CI 1.85-3.01).
CONCLUSIONS
Differences in analytical methods to detect ADA hamper comparison of true ADA rates across biologics in IBD. Use of combination therapy with immunomodulators appeared to reduce ADA positivity for most biologics. For infliximab, ADA were associated with reduced drug efficacy and increased adverse events.
Topics: Adalimumab; Antibody Formation; Biological Factors; Humans; Inflammatory Bowel Diseases; Infliximab
PubMed: 34797516
DOI: 10.1007/s40259-021-00507-5 -
Sexual Medicine Feb 2021Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but... (Review)
Review
INTRODUCTION
Clomipramine is effective in treating premature ejaculation, a common form of male sexual dysfunction that affects individual's mental health and quality of life, but its optimal dosage remains controversial.
AIM
In this systematic review and meta-analysis, we aimed to evaluate the efficacy, safety, and optimal dose of clomipramine for treating premature ejaculation among men.
METHODS
Eligible studies of PubMed, Embase, and Web of Science were identified from the date of inception to June 21, 2020. We conducted the study according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data of the study characteristics, intravaginal latency ejaculatory time (IELT), adverse events, success rate, and satisfaction rate of clomipramine vs placebo were extracted and analyzed. The risk ratio and mean difference were used for quantitatively analyzing binary outcomes and continuous outcomes. The standardized mean difference was applied to the outcome of satisfaction rate. The Mantel-Haenszel method was used for meta-analysis under random-effects model. To assess dose effect of clomipramine, a meta-regression analysis was performed.
MAIN OUTCOME MEASURES
The primary outcomes were the IELT and adverse events, and the secondary outcomes were the success rate and satisfaction rate of clomipramine treatment relative to the placebo.
RESULTS
A total 14 randomized controlled trials with 710 patients were included for quantitative analysis. Clomipramine significantly increased the IELT compared with the placebo (mean difference: 1.47, 95% CI: 0.73-2.21). However, clomipramine was associated with higher risks of overall adverse events and adverse events in the nervous and respiratory systems. Significant dosage effects on the IELT (estimate: 0.0637, 95% CI: 0.0074-0.12) and a slightly increasing slope on adverse events were revealed.
CONCLUSION
Clomipramine increased the IELT and yielded greater satisfaction than the placebo, and the higher dose results in a superior IELT without leading to higher risk of adverse events under a dosage of 50-mg clomipramine. Wu P-C, Hung C-S, Kang Y-N, et al. Tolerability and Optimal Therapeutic Dosage of Clomipramine for Premature Ejaculation: A Systematic Review and Meta-Analysis. Sex Med 2021;9:100283.
PubMed: 33291044
DOI: 10.1016/j.esxm.2020.10.011 -
Digestive Diseases and Sciences Dec 2023The rate of adequate cleansing (ACR) and complete examinations (CR) are key quality indicators in capsule colonoscopy (CC) and pan-intestinal capsule endoscopy (PCE). (Meta-Analysis)
Meta-Analysis
BACKGROUND
The rate of adequate cleansing (ACR) and complete examinations (CR) are key quality indicators in capsule colonoscopy (CC) and pan-intestinal capsule endoscopy (PCE).
AIMS
To evaluate the efficacy of bowel preparation protocols regarding ACR and CR.
METHODS
We conducted a systematic review and meta-analysis, search terms regarding colon capsule preparation, publication date from 2006/01, and date of search 2021/12, in six bibliographic databases. Multiple steps of the cleansing protocol were assessed: diet, adjunctive laxatives, purgative solution, use of prokinetic agents, and "booster". The meta-analytical frequency of ACR and CR was estimated, and subgroup analyses performed. Strategies associated with higher ACR and CR were explored using meta-analytical univariable and multivariable regression models.
RESULTS
Twenty-six observational studies and five RCTs included (n = 4072 patients). The pooled rate of ACR was 72.5% (95% C.I. 67.8-77.5%; I = 92.4%), and the pooled rate of CR was 83.0% (95% C.I. 78.7-87.7%; I = 96.5%). The highest ACR were obtained using a low-fibre diet [78.5% (95% C.I. 72.0-85.6%); I = 57.0%], adjunctive laxatives [74.7% (95% C.I. 69.8-80.1%); I = 85.3%], and split dose < 4L polyethylene glycol (PEG) as purgative [77.5% (95% C.I. 68.4-87.8%); I = 47.3%]. The highest CR were observed using routine prokinetics prior to capsule ingestion [84.4% (95% C.I. 79.9-89.2%); I = 89.8%], and sodium phosphate (NaP) as "booster" [86.2% (95% C.I. 82.3-90.2%); I = 86.8%]. In univariable models, adjunctive laxatives were associated with higher ACR [OR 1.81 (95% C.I. 1.13; 2.90); p = 0.014]. CR was higher with routine prokinetics [OR 1.86 (95% C.I. 1.13; 3.05); p = 0.015] and split-dose PEG purgative [OR 2.03 (95% C.I. 1.01; 4.09), p = 0.048].
CONCLUSIONS
Main quality outcomes (ACR, CR) remain suboptimal for CC and PCE. Despite considerable heterogeneity, our results support low-fibre diet, use of adjunctive sennosides, split dose < 4L PEG, and routine prokinetics, while NaP remains the most consistent option as booster.
Topics: Humans; Cathartics; Laxatives; Capsule Endoscopy; Colonoscopy; Polyethylene Glycols
PubMed: 37833441
DOI: 10.1007/s10620-023-08133-7 -
Scientific Reports Jun 2023To quantify the pooled rate and risk ratio of seroconversion following the uncomplete, complete, or booster dose of COVID-19 vaccines in patients living with HIV.... (Meta-Analysis)
Meta-Analysis
To quantify the pooled rate and risk ratio of seroconversion following the uncomplete, complete, or booster dose of COVID-19 vaccines in patients living with HIV. PubMed, Embase and Cochrane library were searched for eligible studies to perform a systematic review and meta-analysis based on PRIMSA guidelines. The pooled rate and risk ratio of seroconversion were assessed using the Freeman-Tukey double arcsine method and Mantel-Haenszel approach, respectively. Random-effects model was preferentially used as the primary approach to pool results across studies. A total of 50 studies involving 7160 patients living with HIV were analyzed. We demonstrated that only 75.0% (56.4% to 89.9%) patients living with HIV achieved a seroconversion after uncomplete vaccination, which improved to 89.3% (84.2% to 93.5%) after complete vaccination, and 98.4% (94.8% to 100%) after booster vaccination. The seroconversion rates were significantly lower compared to controls at all the stages, while the risk ratios for uncomplete, complete, and booster vaccination were 0.87 (0.77 to 0.99), 0.95 (0.92 to 0.98), and 0.97 (0.94 to 0.99), respectively. We concluded that vaccine doses were associated with consistently improved rates and risk ratios of seroconversion in patients living with HIV, highlighting the significance of booster vaccination for patients living with HIV.
Topics: Humans; COVID-19 Vaccines; COVID-19; Vaccination; Hepatitis B Vaccines; HIV Infections
PubMed: 37336939
DOI: 10.1038/s41598-023-37051-x -
Frontiers in Endocrinology 2023To appraise the current randomized clinical trials (RCTs) for evidence of the association of growth hormone (GH) with improved outcomes in infertile women with... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To appraise the current randomized clinical trials (RCTs) for evidence of the association of growth hormone (GH) with improved outcomes in infertile women with diminished ovarian reserve (DOR) undergoing fertilization (IVF).
METHODS
Relevant RCTs published in Chinese or English were identified through a comprehensive search of nine databases from the period of database inception to April 20, 2023. We included trials investigating adjuvant GH during ovarian stimulation and reported the subsequent outcomes. The group with adjuvant GH treatment and the group without adjuvant GH treatment were set up as the trial and control groups, respectively. The quality of RCTs was measured according to the Cochrane Collaboration Handbook.
RESULTS
Of the 579 studies initially identified, 10 RCTs comprising 852 infertile women with DOR were included. The GH dose of individual trials ranged between 3 and 5 IU/day. Overall, we judged the trials to be at high risk of bias in the blinding domain. Pooled results showed that GH was associated with an increased clinical pregnancy rate (RR = 1.63, 95%CI [1.31, 2.03], < 0.0001) and a greater number of oocytes retrieved (MD = 0.91, 95%CI [0.47, 1.35], < 0.0001). Favorable associations were also observed when ovarian stimulation was combined with GH therapy for improving the optimal embryos rate (RR = 1.84, 95%CI [1.30, 2.59], = 0.0005) and the number of optimal embryos (MD = 0.28, 95%CI [0.08, 0.48], = 0.005) along with reducing the cycle cancellation rate (RR = 0.46, 95%CI [0.24, 0.89], = 0.02). Moreover, GH resulted in an increase in the fertilization rate (RR = 1.33, 95%CI [1.18, 1.50], < 0.00001) and the embryo implantation rate (RR = 1.56, 95%CI [1.21, 2.01], = 0.0006). In addition, there was a significant enhancement in estradiol levels (SMD = 1.18, 95%CI [0.46, 1.91], = 0.001) and endometrial thickness (MD = 0.75, 95%CI [0.41, 1.09], < 0.0001) on the day of hCG. With regard to the total number of days and total dose of gonadotrophins used, GH treatment was correlated with shorter days (MD = -0.26, 95%CI [-0.46, -0.06], = 0.01) and lower dose (MD = -460.97, 95%CI [-617.20, -304.73], < 0.00001) of gonadotrophins applied during ovarian stimulation. Furthermore, GH in conjunction with the GnRH antagonist protocol was more conducive to improving the number of oocytes retrieved when compared with the GnRH agonist protocol ( < 0.0001). Moreover, a notable association was also seen in IVF combined with GH more than or equal to 4.5 IU/day to increase the number of optimal embryos and estradiol levels on the day of hCG ( < 0.05).
CONCLUSION
For infertile women with DOR undergoing IVF, adjuvant treatment with GH during ovarian stimulation protocols showed better clinical outcomes, shorter days and lower dosages of gonadotrophin required. Furthermore, well-designed RCTs are needed to verify our results in the future.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk PROSPERO (CRD42023421739).
Topics: Pregnancy; Female; Humans; Growth Hormone; Gonadotropin-Releasing Hormone; Ovarian Reserve; Gonadotropins; Fertilization in Vitro; Infertility, Female; Human Growth Hormone; Ovarian Diseases; Estradiol
PubMed: 38027219
DOI: 10.3389/fendo.2023.1215755 -
The American Journal of Clinical... Aug 2023Serving whey protein before a meal in order to lower postprandial blood glucose concentrations is known as a premeal. The underlying mechanisms are only partly... (Meta-Analysis)
Meta-Analysis
Whey Protein Premeal Lowers Postprandial Glucose Concentrations in Adults Compared with Water-The Effect of Timing, Dose, and Metabolic Status: a Systematic Review and Meta-analysis.
BACKGROUND
Serving whey protein before a meal in order to lower postprandial blood glucose concentrations is known as a premeal. The underlying mechanisms are only partly understood but may involve stimulation of glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP), and insulin secretion together with a slower gastric emptying rate.
OBJECTIVES
The objective of this systematic review and meta-analysis was to review all randomized clinical trials investigating premeals with whey protein in comparison with a nonactive comparator (control) that evaluated plasma glucose, GLP-1, GIP, insulin, and/or gastric emptying rate. Secondary aims included subgroup analyses on the timing and dose of the premeal together with the metabolic state of the participants [lean, obese, and type 2 diabetes mellitus (T2DM)].
METHODS
We searched EMBASE, CENTRAL, PUBMED, and clinicaltrials.gov and found 16 randomized crossover trials with a total of 244 individuals. The last search was performed on 9 August, 2022.
RESULTS
Whey protein premeals lowered peak glucose concentration by -1.4 mmol/L [-1.9 mmol/L; -0.9 mmol/L], and the area under the curve for glucose was -0.9 standard deviation (SD) [-1.2 SD; -0.6 SD] compared with controls (high certainty). In association with these findings, whey protein premeals elevated GLP-1 (low certainty) and peak insulin (high certainty) concentrations and slowed gastric emptying rate (high certainty) compared with controls. Subgroup analyses showed a more pronounced and prolonged glucose-lowering effect in individuals with T2DM compared with participants without T2DM. The available evidence did not elucidate the role of GIP. The protein dose used varied between 4 and 55 g, and meta-regression analysis showed that the protein dose correlated with the glucose-lowering effects.
CONCLUSIONS
In conclusion, whey protein premeals lower postprandial blood glucose, reduce gastric emptying rate, and increase peak insulin. In addition, whey protein premeals may elevate plasma concentrations of GLP-1. Whey protein premeals may possess clinical potential, but the long-term effects await future clinical trials.
Topics: Humans; Adult; Whey Proteins; Glucagon; Blood Glucose; Diabetes Mellitus, Type 2; Water; Insulin; Glucagon-Like Peptide 1; Gastric Inhibitory Polypeptide; Glucose; Gastric Emptying; Postprandial Period
PubMed: 37536867
DOI: 10.1016/j.ajcnut.2023.05.012 -
Frontiers in Endocrinology 2023Polycystic ovary syndrome (PCOS) is a common endocrinopathy causing infertility in childbearing women. Progestin-primed ovarian stimulation (PPOS) protocol has recently... (Meta-Analysis)
Meta-Analysis
UNLABELLED
Polycystic ovary syndrome (PCOS) is a common endocrinopathy causing infertility in childbearing women. Progestin-primed ovarian stimulation (PPOS) protocol has recently been used for infertile women. However, whether PPOS provides a significant benefit over gonadotropin-releasing hormone (GnRH) analogue protocols in PCOS is still controversial. The objective of this systematic review is to investigate the efficacy of PPOS in patients with PCOS during fertilization (IVF) or intracytoplasmic sperm injection (ICSI). We searched Medline, Embase, Google Scholar, ClinicalTrials, and Cochrane Central Register of Controlled Trials from inception to April 1, 2023. Randomized controlled trials (RCTs) and observational studies comparing the efficacy between PPOS and conventional GnRH analogue protocols in patients with PCOS in English were included. The primary outcomes included live birth rate, the incidence of moderate or severe ovarian hyperstimulation syndrome (OHSS), and the number of metaphase II oocytes. The pooled estimates were calculated using the random-effects models as odds ratios (OR) or mean differences (MD) with 95% confidence intervals (CIs). Three RCTs and six cohort studies involving 2289 patients were included. Results from RCTs suggest that PPOS leads to no significant difference in the risk of OHSS, the number of metaphase II oocytes, or the rate of live birth when compared to GnRH analogue protocols. The pooling estimates of cohort studies showed consistent results. Additionally, in cohort studies, PPOS required a higher dose of Gn and tended to improve the implantation rate, clinical pregnancy rate, and ongoing pregnancy rate. For subgroup analyses, the higher implantation rate, clinical pregnancy rate, and ongoing pregnancy rate were found in PPOS compared to the GnRH agonist short protocol. However, the certainty of the evidence for the outcomes was generally low. Overall, There is currently no evidence to support that PPOS could reduce the risk of OHSS, increase oocyte maturation, or improve pregnancy outcomes in women with PCOS undergoing IVF/ICSI when compared to GnRH analogue protocols. Considering its efficiency and safety, this protocol could be a patient-friendly and viable alternative for PCOS patients, especially when frozen-thawed embryo transfer is planned. Future high-quality randomized trials with children's long-term safety and cost-effective analyses are still required.
SYSTEM REVIEW REGISTRATION
NPLASY (202340059). https://inplasy.com/inplasy-2023-4-0059/.
Topics: Female; Humans; Pregnancy; Fertilization in Vitro; Gonadotropin-Releasing Hormone; Ovarian Hyperstimulation Syndrome; Ovulation Induction; Polycystic Ovary Syndrome; Progestins; Steroids
PubMed: 37795363
DOI: 10.3389/fendo.2023.1224858 -
Heliyon May 2023Low dose naltrexone (LDN) is used off-label by many individuals with fibromyalgia to help manage their pain. There is no current systematic literature review summarising... (Review)
Review
A systematic literature review on the clinical efficacy of low dose naltrexone and its effect on putative pathophysiological mechanisms among patients diagnosed with fibromyalgia.
BACKGROUND
Low dose naltrexone (LDN) is used off-label by many individuals with fibromyalgia to help manage their pain. There is no current systematic literature review summarising the evidence to support this use of LDN. The objectives of this study were to evaluate if patients with fibromyalgia prescribed LDN have reduced pain scores and greater quality of life compared with those allocated to placebo in randomized controlled trials. Secondly to determine if changes in inflammatory markers and brain structure and function are observed among patients with fibromyalgia taking LDN.
METHODS
Systematic literature searches were conducted in MEDLINE Embase Classic + Embase, APA PsychInfo, and The Cochrane Library from inception to May 2022. Reference lists from the selected papers were cross-checked with database search results.
RESULTS
Three studies met our inclusion criteria for the assessment of efficacy, and two studies on potential LDN mechanisms. Results indicated some evidence to suggest LDN reduces pain and increases quality of life. One study reported baseline erythrocyte sedimentation rate (ESR) predicted LDN response (≥30% reduction in fibromyalgia symptoms) and a second study showed plasma concentrations of inflammatory biomarkers were lower after LDN treatment. To our knowledge, there are no brain imaging studies reporting the effect of LDN in patients with fibromyalgia. All studies were based on small sample sizes, were restricted to women and the risk of bias was assessed to be high. There is also some evidence of publication bias.
CONCLUSION
The strength of evidence from randomized controlled trials to support the use of LDN among patients with fibromyalgia is low. Two small studies suggest ESR and cytokines may be involved in the mechanism by which LDN exerts its effects. Two trials (INNOVA and FINAL) are currently in progress, but further work is needed among men and different ethnic groups.
PubMed: 37206027
DOI: 10.1016/j.heliyon.2023.e15638