Does Influenza Vaccination during Pregnancy Have Effects on Non-Influenza Infectious Morbidity? A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
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SUBMITTER: Hansen KP
PROVIDER: S-EPMC8707251 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
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Does Influenza Vaccination during Pregnancy Have Effects on Non-Influenza Infectious Morbidity? A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
Hansen Katrine Pedersbæk KP Benn Christine Stabell CS Aamand Thomas T Buus Martin M da Silva Isaquel I Aaby Peter P Fisker Ane Bærent AB Thysen Sanne Marie SM
Vaccines 20211208 12
The recommendation to provide inactivated influenza vaccine (IIV) to pregnant women is based on observed protection against influenza-related morbidity in mother and infant. Non-live vaccines may have non-specific effects (NSEs), increasing the risk of non-targeted infections in females. We reviewed the evidence from available randomised controlled trials (RCTs) of IIV to pregnant women, to assess whether IIV may have NSEs. Four RCTs, all conducted in low- and middle-income settings, were identi ...[more]
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Project description:BackgroundMaternal influenza immunisation can reduce morbidity and mortality associated with influenza infection in pregnant women and young infants. We aimed to determine the vaccine efficacy of maternal influenza immunisation against maternal and infant PCR-confirmed influenza, duration of protection, and the effect of gestational age at vaccination on vaccine efficacy, birth outcomes, and infant growth up to 6 months of age.MethodsWe did a pooled analysis of three randomised controlled trials done in Nepal (2011-2014), Mali (2011-2014), and South Africa (2011-2013). Pregnant women, gestational age 17-34 weeks in Nepal, 28 weeks or more in Mali, and 20-36 weeks in South Africa, were enrolled. Women were randomly assigned 1:1 to a study group, in which they received trivalent inactivated influenza vaccine (IIV) in all three trials, or a control group, in which they received saline placebo in Nepal and South Africa or quadrivalent meningococcal conjugate vaccine in Mali. Enrolment at all sites was complete by April 24, 2013. Infants and women were assessed for respiratory illness, and samples from those that met the case definition were tested for influenza by PCR testing. Growth measurements, including length and weight, were obtained at birth at all sites, at 24 weeks in South Africa, and at 6 months in Nepal and Mali. The three trials are registered with ClinicalTrials.gov, numbers NCT01430689, NCT01034254, and NCT02465190.Findings10 002 women and 9800 liveborn infants were included. Pooled efficacy of maternal vaccination to prevent infant PCR-confirmed influenza up to 6 months of age was 35% (95% CI 19 to 47). The pooled estimate was 56% (28 to 73) within the first 2 months of life, 39% (11 to 58) between 2 and 4 months, and 19% (-9 to 40) between 4 and 6 months. In women, from enrolment during pregnancy to the end of follow-up at 6 months postpartum, the vaccine was 50% (95% CI 32-63) efficacious against PCR-confirmed influenza. Efficacy was 42% (12 to 61) during pregnancy and 60% (36 to 75) postpartum. In women vaccinated before 29 weeks gestational age, the estimated efficacy was 30% (-2 to 52), and in women vaccinated at or after 29 weeks, efficacy was 71% (50 to 83). Efficacy was similar in infants born to mothers vaccinated before or after 29 weeks gestation (34% [95% CI 12 to 51] vs 35% [11 to 52]). There was no overall association between maternal vaccination and low birthweight, stillbirth, preterm birth, and small for gestational age. At 6 months of age, the intervention and control groups were similar in terms of underweight (weight-for-age), stunted (length-for-age), and wasted (weight-for-length). Median centile change from birth to 6 months of age was similar between the intervention and the control groups for both weight and length.InterpretationThe assessment of efficacy for women vaccinated before 29 weeks gestational age might have been underpowered, because the point estimate suggests that there might be efficacy despite wide CIs. Estimates of efficacy against PCR-confirmed influenza and safety in terms of adverse birth outcomes should be incorporated into any further consideration of maternal influenza immunisation recommendations.FundingBill & Melinda Gates Foundation.
| S-EPMC7284303 | biostudies-literature
Project description:BackgroundIn the Northern Hemisphere, influenza season typically starts in December and lasts through March. Pregnant people are at increased risk for influenza-related morbidity and mortality. Potentially, new viral strains or reduced provider suspicion leading to delayed diagnosis of late-season influenza could result in an increased risk of severe infection.ObjectiveThis study aimed to assess the incidence and morbidity associated with late-season influenza in pregnancy, compared with influenza in other seasons.Study designThis was a retrospective cohort study using the 2007-2018 National Inpatient Sample. Pregnant patients with discharge diagnosis codes consistent with influenza infection were compared on the basis of hospital admission quarter (quarter 1: October to December; quarter 2: January to March; quarter 3: April to June; quarter 4: July to September), with quarter 3 defined as "late-season." The primary outcome was the severe maternal morbidity composite defined by the Centers for Disease Control and Prevention. The secondary outcomes included sepsis, shock, acute renal failure, acute heart failure, temporary tracheostomy, and invasive mechanical ventilation. Associations between outcomes and quarter of infection were adjusted for age, hospitalization type (antepartum, delivery, or postpartum), and comorbid conditions using relative risk regression, weighted to reflect the National Inpatient Sample design.ResultsOf 7355 hospitalizations, corresponding to a weighted national estimate of 36,042, 2266 (30.8%) occurred in quarter 1, 4051 (55.0%) in quarter 2, 633 (8.6%) in quarter 3, and 405 (5.5%) in quarter 4. A nonsignificant trend toward higher rates of severe maternal morbidity was seen in the "late-season" compared with other quarters (13.9% [quarter 3] vs 10.5% [quarter 1] vs 12.1% [quarter 2] vs 13.6% [quarter 4]; P=.07). Moreover, sepsis was more common in patients with late-season influenza (8.0% [quarter 3] vs 4.8% [quarter 1] vs 5.8% [quarter 2] vs 5.9% [quarter 4]; P=.03). In the adjusted analyses, patients with late-season influenza had a 1.34 (95% confidence interval, 1.01-1.78) higher risk of severe maternal morbidity and 1.57 (95% confidence interval, 1.06-2.32) higher risk of sepsis than patients with influenza in quarter 1.ConclusionInfluenza infection between April and June, that is, late-season influenza, is associated with a higher risk of severe maternal morbidity and sepsis in pregnant patients. Obstetrical providers must continue to have awareness and suspicion for influenza infection during these months.
| S-EPMC8899770 | biostudies-literature
Project description:BackgroundThe optimal antiviral drug for treatment of severe influenza remains unclear. To support updated WHO influenza clinical guidelines, this systematic review and network meta-analysis evaluated antivirals for treatment of patients with severe influenza.MethodsWe systematically searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature, Global Health, Epistemonikos, and ClinicalTrials.gov for randomised controlled trials published up to Sept 20, 2023, that enrolled hospitalised patients with suspected or laboratory-confirmed influenza and compared direct-acting influenza antivirals against placebo, standard care, or another antiviral. Pairs of coauthors independently extracted data on study characteristics, patient characteristics, antiviral characteristics, and outcomes, with discrepancies resolved by discussion or by a third coauthor. Key outcomes of interest were time to alleviation of symptoms, duration of hospitalisation, admission to intensive care unit, progression to invasive mechanical ventilation, duration of mechanical ventilation, mortality, hospital discharge destination, emergence of antiviral resistance, adverse events, adverse events related to treatments, and serious adverse events. We conducted frequentist network meta-analyses to summarise the evidence and evaluated the certainty of evidence using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach. This study is registered with PROSPERO, CRD42023456650.FindingsOf 11 878 records identified by our search, eight trials with 1424 participants (mean age 36-60 years for trials that reported mean or median age; 43-78% male patients) were included in this systematic review, of which six were included in the network meta-analysis. The effects of oseltamivir, peramivir, or zanamivir on mortality compared with placebo or standard care without placebo for seasonal and zoonotic influenza were of very low certainty. Compared with placebo or standard care, we found low certainty evidence that duration of hospitalisation for seasonal influenza was reduced with oseltamivir (mean difference -1·63 days, 95% CI -2·81 to -0·45) and peramivir (-1·73 days, -3·33 to -0·13). Compared with standard care, there was little or no difference in time to alleviation of symptoms with oseltamivir (0·34 days, -0·86 to 1·54; low certainty evidence) or peramivir (-0·05 days, -0·69 to 0·59; low certainty evidence). There were no differences in adverse events or serious adverse events with oseltamivir, peramivir, and zanamivir (very low certainty evidence). Uncertainty remains about the effects of antivirals on other outcomes for patients with severe influenza. Due to the small number of eligible trials, we could not test for publication bias.InterpretationIn hospitalised patients with severe influenza, oseltamivir and peramivir might reduce duration of hospitalisation compared with standard care or placebo, although the certainty of evidence is low. The effects of all antivirals on mortality and other important patient outcomes are very uncertain due to scarce data from randomised controlled trials.FundingWorld Health Organization.
| S-EPMC11369965 | biostudies-literature
Project description:AimThe aims of this systematic review and meta-analysis were to assess to what extent probiotics/synbiotics reduce infectious complications after colorectal surgery and whether probiotics or synbiotics should be considered as perioperative measures preventing or reducing infectious complications after CRS and should be included in enhanced recovery programmes (ERP). Secondary aims were to answer practical questions precisely on the best formulation and the type and timing of probiotics or synbiotics in CRS.MethodThis systematic review and quantitative meta-analysis were conducted in accordance with PRISMA 2020 guidelines. Inclusion criteria were randomised trials comparing perioperative probiotics/synbiotics with a placebo or standard care in elective colorectal surgery. Exclusion criteria were non-randomised trials. Overall infectious complications and surgical site infections (SSIs including both deep abdominal infections and wound (skin or under the skin) infections) were the primary outcomes. Secondary outcomes were pulmonary and urinary infections, wound infections, and anastomotic leaks. The databases consulted were Medline, Cochrane Database of Systematic Reviews, Scopus, and Clinical Trials Register. Risk of bias was assessed according to the GRADE approach. The analysis calculated the random effects estimates risk ratio (RR) for each outcome.Results21 trials were included; 15 evaluated probiotics, and 6 evaluated synbiotics. There were significantly fewer infectious complications (risk ratio (RR) 0.59 [0.47-0.75], I2 = 15%) and fewer SSI (RR 0.70 [0.52-0.95], I2 = 0%) in the probiotic or synbiotic group. There were also significantly fewer pulmonary infections (RR 0.35 [0.20-0.63]) and urinary infections RR 0.41 [0.19-0.87]) as opposed to anastomotic leaks (RR 0.83 [0.47-1.48]) and wound infections (RR 0.74 [0.53-1.03]). Sensitivity analyses showed no significant difference between probiotics and synbiotics in reducing postoperative infections (RR 0.55 [0.42-0.73] versus RR 0.69 [0.42-1.13], p = 0.46).ConclusionsBased on the finding of this study, probiotics/synbiotics reduce infectious complications after colorectal surgery. The effect size was more pronounced for pulmonary and urinary infections. From a practical aspect, some of the questions related to formulations and duration of probiotics or synbiotics need to be answered before including them definitively in enhanced recovery after colorectal surgery programmes.
| S-EPMC9332115 | biostudies-literature
Project description:Objective Pregnant and postpartum women are vulnerable to psychological problems with a high estimated prevalence. To date, there is no meta-analysis that specifically assesses the effectiveness of art-based interventions to improve mental health in pregnant and postpartum women. The objective of this meta-analysis was to assess the efficacy of art-based interventions when delivered to pregnant and postpartum women. Methods Systematic literature searches were conducted from the inception to 6 March 2022 in seven English databases, including PubMed, Embase, Cochrane Central Register, CINAHL, ProQuest, Scopus, and Web of Science. Randomised controlled trials (RCTs) reporting art-based interventions targeting the improvement of women’s mental health in pregnancy and postpartum were included. Cochrane risk of bias tool was applied to assess evidence quality. Results Twenty-one randomised controlled trials (RCTs) involving 2,815 participants were eligible for data analysis. A pooled analysis demonstrated that art-based interventions significantly reduced anxiety (SMD = −0.75, 95% CI = −1.10 to −0.40) and depression symptoms (MD = −0.79, 95% CI = −1.30 to −0.28). However, art-based interventions did not alleviate stress symptoms as expected in our findings. Subgroup analysis demonstrated that intervention implementation time, intervention duration and music selected by the participants vs. not could have influence on the efficacy of art-based intervention for anxiety. Conclusion In perinatal mental health, art-based interventions may be effective in alleviating anxiety and depression. In the future, we still need to conduct high-quality RCTs to validate our findings and enrich clinical application of art-based interventions.
| S-EPMC9976780 | biostudies-literature
Project description:ObjectiveTo investigate the effectiveness and safety of surgery compared with non-surgical treatment for sciatica.DesignSystematic review and meta-analysis.Data sourcesMedline, Embase, CINAHL, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, and the World Health Organisation International Clinical Trials Registry Platform from database inception to June 2022.Eligibility criteria for selecting studiesRandomised controlled trials comparing any surgical treatment with non-surgical treatment, epidural steroid injections, or placebo or sham surgery, in people with sciatica of any duration due to lumbar disc herniation (diagnosed by radiological imaging).Data extraction and synthesisTwo independent reviewers extracted data. Leg pain and disability were the primary outcomes. Adverse events, back pain, quality of life, and satisfaction with treatment were the secondary outcomes. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst pain or disability). Data were pooled using a random effects model. Risk of bias was assessed with the Cochrane Collaboration's tool and certainty of evidence with the grading of recommendations assessment, development, and evaluation (GRADE) framework. Follow-up times were into immediate term (≤six weeks), short term (>six weeks and ≤three months), medium term (>three and <12 months), and long term (at 12 months).Results24 trials were included, half of these investigated the effectiveness of discectomy compared with non-surgical treatment or epidural steroid injections (1711 participants). Very low to low certainty evidence showed that discectomy, compared with non-surgical treatment, reduced leg pain: the effect size was moderate at immediate term (mean difference -12.1 (95% confidence interval -23.6 to -0.5)) and short term (-11.7 (-18.6 to -4.7)), and small at medium term (-6.5 (-11.0 to -2.1)). Negligible effects were noted at long term (-2.3 (-4.5 to -0.2)). For disability, small, negligible, or no effects were found. A similar effect on leg pain was found when comparing discectomy with epidural steroid injections. For disability, a moderate effect was found at short term, but no effect was observed at medium and long term. The risk of any adverse events was similar between discectomy and non-surgical treatment (risk ratio 1.34 (95% confidence interval 0.91 to 1.98)).ConclusionVery low to low certainty evidence suggests that discectomy was superior to non-surgical treatment or epidural steroid injections in reducing leg pain and disability in people with sciatica with a surgical indication, but the benefits declined over time. Discectomy might be an option for people with sciatica who feel that the rapid relief offered by discectomy outweighs the risks and costs associated with surgery.Systematic review registrationPROSPERO CRD42021269997.
| S-EPMC10498296 | biostudies-literature
Project description:BackgroundA rigorous systematic review and meta-analysis focused on randomised controlled trials (RCTs) of non-individualised homeopathic treatment has not previously been reported. We tested the null hypothesis that the main outcome of treatment using a non-individualised (standardised) homeopathic medicine is indistinguishable from that of placebo. An additional aim was to quantify any condition-specific effects of non-individualised homeopathic treatment.MethodsLiterature search strategy, data extraction and statistical analysis all followed the methods described in a pre-published protocol. A trial comprised 'reliable evidence' if its risk of bias was low or it was unclear in one specified domain of assessment. 'Effect size' was reported as standardised mean difference (SMD), with arithmetic transformation for dichotomous data carried out as required; a negative SMD indicated an effect favouring homeopathy.ResultsForty-eight different clinical conditions were represented in 75 eligible RCTs. Forty-nine trials were classed as 'high risk of bias' and 23 as 'uncertain risk of bias'; the remaining three, clinically heterogeneous, trials displayed sufficiently low risk of bias to be designated reliable evidence. Fifty-four trials had extractable data: pooled SMD was -0.33 (95% confidence interval (CI) -0.44, -0.21), which was attenuated to -0.16 (95% CI -0.31, -0.02) after adjustment for publication bias. The three trials with reliable evidence yielded a non-significant pooled SMD: -0.18 (95% CI -0.46, 0.09). There was no single clinical condition for which meta-analysis included reliable evidence.ConclusionsThe quality of the body of evidence is low. A meta-analysis of all extractable data leads to rejection of our null hypothesis, but analysis of a small sub-group of reliable evidence does not support that rejection. Reliable evidence is lacking in condition-specific meta-analyses, precluding relevant conclusions. Better designed and more rigorous RCTs are needed in order to develop an evidence base that can decisively provide reliable effect estimates of non-individualised homeopathic treatment.
| S-EPMC5366148 | biostudies-literature
Project description:ObjectiveTo assess the effects of the neuraminidase inhibitors oseltamivir and zanamivir in treatment of children with seasonal influenza and prevention of transmission to children in households.DesignSystematic review and meta-analysis of data from published and unpublished randomised controlled trials.Data sourcesMedline and Embase to June 2009, trial registries, and manufacturers and authors of relevant studies. Review methods Eligible studies were randomised controlled trials of neuraminidase inhibitors in children aged </=12 in the community (that is, not admitted to hospital) with confirmed or clinically suspected influenza. Primary outcome measures were time to resolution of illness and incidence of influenza in children living in households with index cases of influenza.ResultsWe identified four randomised trials of treatment of influenza (two with oseltamivir, two with zanamivir) involving 1766 children (1243 with confirmed influenza, of whom 55-69% had influenza A), and three randomised trials for postexposure prophylaxis (one with oseltamivir, two with zanamivir) involving 863 children; none of these trials tested efficacy with the current pandemic strain. Treatment trials showed reductions in median time to resolution of symptoms or return to normal activities, or both, of 0.5-1.5 days, which were significant in only two trials. A 10 day course of postexposure prophylaxis with zanamivir or oseltamivir resulted in an 8% (95% confidence interval 5% to 12%) decrease in the incidence of symptomatic influenza. Based on only one trial, oseltamivir did not reduce asthma exacerbations or improve peak flow in children with asthma. Treatment was not associated with reduction in overall use of antibiotics (risk difference -0.30, -0.13 to 0.01). Zanamivir was well tolerated, but oseltamivir was associated with an increased risk of vomiting (0.05, 0.02 to 0.09, number needed to harm=20).ConclusionsNeuraminidase inhibitors provide a small benefit by shortening the duration of illness in children with seasonal influenza and reducing household transmission. They have little effect on asthma exacerbations or the use of antibiotics. Their effects on the incidence of serious complications, and on the current A/H1N1 influenza strain remain to be determined.
| S-EPMC2724601 | biostudies-literature
Project description:IntroductionAlthough interest in including non-randomised studies of interventions (NRSIs) in meta-analysis of randomised controlled trials (RCTs) is growing, estimates of effectiveness obtained from NRSIs are vulnerable to greater bias than RCTs. The objectives of this study are to: (1) explore how NRSIs can be integrated into a meta-analysis of RCTs; (2) assess concordance of the evidence from non-randomised and randomised trials and explore factors associated with agreement; and (3) investigate the impact on estimates of pooled bodies of evidence when NRSIs are included.Methods and analysisWe will conduct a systematic survey of 210 systematic reviews that include both RCTs and NRSIs, published from 2017 to 2022. We will randomly select reviews, stratified in a 1:1 ratio by Core vs non-Core clinical journals, as defined by the National Library of Medicine. Teams of paired reviewers will independently determine eligibility and abstract data using standardised, pilot-tested forms. The concordance of the evidence will be assessed by exploring agreement in the relative effect reported by NRSIs and RCT addressing the same clinical question, defined as similarity of the population, intervention/exposure, control and outcomes. We will conduct univariable and multivariable logistic regression analyses to examine the association of prespecified study characteristics with agreement in the estimates between NRSIs and RCTs. We will calculate the ratio of the relative effect estimate from NRSIs over that from RCTs, along with the corresponding 95% CI. We will use a bias-corrected meta-analysis model to investigate the influence on pooled estimates when NRSIs are included in the evidence synthesis.Ethics and disseminationEthics approval is not required. The findings of this study will be disseminated through peer-reviewed publications, conference presentations and condensed summaries for clinicians, health policymakers and guideline developers regarding the design, conduct, analysis, and interpretation of meta-analysis that integrate RCTs and NRSIs.
| S-EPMC10373676 | biostudies-literature
Project description:ObjectiveAcupuncture is emerging as a potential therapy for relieving pain, but the effectiveness of acupuncture for relieving low back and/or pelvic pain (LBPP) during the pregnancy remains controversial. This meta-analysis aims to investigate the effects of acupuncture on pain, functional status and quality of life for women with LBPP pain during the pregnancy.DesignSystematic review and meta-analysis.Data sourcesThe PubMed, EMBASE databases, Web of Science and Cochrane Library were searched for relevant randomised controlled trials (RCTs) from inception to 15 January 2022.Eligibility criteria for selecting studiesRCTs evaluating the effects of acupuncture on LBPP during the pregnancy were included.Data extraction and synthesisThe data extraction and study quality assessment were independently performed by three reviewers. The mean differences (MDs) with 95% CIs for pooled data were calculated. We assessed the confidence in the evidence using the Grading of Recommendations Assessment, Development and Evaluation framework.Main outcomes and measuresThe primary outcomes were pain, functional status and quality of life. The secondary outcomes were overall effects (a questionnaire at a post-treatment visit within a week after the last treatment to determine the number of people who received good or excellent help), analgesic consumption, Apgar scores >7 at 5 min, adverse events, gestational age at birth, induction of labour and mode of birth.ResultsThis meta-analysis included 10 studies, reporting on a total of 1040 women. Overall, acupuncture significantly relieved pain during pregnancy (MD=1.70, 95% CI: (0.95 to 2.45), p<0.00001, I2=90%) and improved functional status (MD=12.44, 95% CI: (3.32 to 21.55), p=0.007, I2=94%) and quality of life (MD=-8.89, 95% CI: (-11.90 to -5.88), p<0.00001, I2 = 57%). There was a significant difference for overall effects (OR=0.13, 95% CI: (0.07 to 0.23), p<0.00001, I2 = 7%). However, there was no significant difference for analgesic consumption during the study period (OR=2.49, 95% CI: (0.08 to 80.25), p=0.61, I2=61%) and Apgar scores of newborns (OR=1.02, 95% CI: (0.37 to 2.83), p=0.97, I2 = 0%). Preterm birth from acupuncture during he study period was reported in two studies. Although preterm contractions were reported in two studies, all infants were in good health at birth. In terms of gestational age at birth, induction of labour and mode of birth, only one study reported the gestational age at birth (mean gestation 40 weeks). Thus, prospective randomised clinical studies or clinical follow-up studies were hence desirable to further evaluate these outcomes.ConclusionsAcupuncture significantly improved pain, functional status and quality of life in women with LBPP during the pregnancy. Additionally, acupuncture had no observable severe adverse influences on the newborns. More large-scale and well-designed RCTs are still needed to further confirm these results.Prospero registration numberCRD42021241771.
| S-EPMC9723856 | biostudies-literature