Meta-Analysis: Does Vitamin D Reduce the Risk of Progression from Prediabetes to Diabetes?
BACKGROUND AND PURPOSE:
Pittas et al. (Annals of Internal Medicine, 2023) evaluated whether administration of vitamin D decreases risk for diabetes among people with prediabetes
METHODS:
Systematic review and individual patient data (IPD) meta-analysis
Study inclusion criteria
RCTs
Studies specifically designed to test the effects of oral vitamin D vs placebo on new-onset diabetes in adults with prediabetes
Study design
Analyses were conducted by intention to treat
Studies testing cholecalciferol and eldecalcitol vs matching placebos were included
Primary outcome
Time to event for new-onset diabetes
Secondary outcomes
Regression to normal glucose regulation
Adverse events
RESULTS:
3 trials | 4190 participants
Risk of bias was low
Vitamin D reduced risk for diabetes in adults with prediabetes
Adjusted hazard ratio (aHR) 0.85 (95% CI, 0.75 to 0.96)
3-year absolute risk reduction: 3.3% (95% CI, 0.6 to 6.0)
The effect of vitamin D did not differ in prespecified subgroups
Among participants assigned to the vitamin D group who maintained a mean serum 25-hydroxyvitamin D level of ≥125 nmol/L (50 ng/mL) during follow-up vs 50 to 74 nmol/L (20 to 29 ng/mL), cholecalciferol reduced the risk for diabetes
HR 0.24 (95% CI, 0.16 to 0.36)
3-year absolute risk reduction: 18.1% (95% CI, 11.7 to 24.6)
Vitamin D increased the likelihood of regression to normal glucose regulation
Rate ratio 1.30 (95% CI, 1.16 to 1.46)
There was no evidence of difference in the rate ratios for adverse events
Kidney stones: rate ratio 1.17 (95% CI, 0.69 to 1.99)
Hypercalcemia: rate ratio 2.34 (95% CI, 0.83 to 6.66)
Hypercalciuria: rate ratio 1.65 (95% CI, 0.83 to 3.28)
Death: rate ratio 0.85 (95% CI, 0.31 to 2.36)
CONCLUSION:
For adults with prediabetes, vitamin D supplements reduce the risk of progression to diabetes
The authors state
This IPD meta-analysis of vitamin D trials, specifically designed and conducted for diabetes prevention, overcame limitations of meta-analyses that used aggregate data from heterogeneous studies and provides evidence supporting the use of vitamin D in people with prediabetes to reduce their risk for progression to type 2 diabetes
ALERT: Get Updates on USPSTF 2022 Pap Smear Changes
The USPSTF will soon release new draft recommendations for cervical cancer screening. The proposed changes will impact our practices and most importantly – our patients. We will only have a brief window of time to comment on the proposed recommendations.
Can Women with Mild Cognitive Impairment Revert Back to Normal Cognition?
BACKGROUND AND PURPOSE:
Reversion to normal cognition (NC) from mild cognitive impairment (MCI) is possible, although most individuals with MCI do progress to dementia
Iraniparast et al. (Neurology, 2022) estimated transition rates from mild cognitive impairment (MCI) to normal cognition (NC) and dementia as well as associated impact of risk factors
METHODS:
Secondary analysis of longitudinal data
Nun Study
Cognitive ability of cohort of religious sisters assessed at baseline and yearly until death or study end (12 annual assessments)
≥75 years
Population
Women from the Nun Study Cohort
Exposures
Age
APOE
e4 allele of the APOE gene increases risk for late-onset Alzheimer disease
Cognitive reserve indicators
Education
Academic performance: High school grades
Written language skills: Idea density | Grammatical complexity
Study design
Modelling was used to estimate transition between cognitive states
Transitions were considered
Reversible between NC and MCI
Nonreversible from dementia and MCI
Primary outcome
Instantaneous transition rates between NC, MCI and dementia
Rate of reversion to NC vs progression to dementia
RESULTS:
619 participants
MCI during study period: 472
MCI patient outcomes during study period
≥1 reverse transition to NC: 30.3%
Never developed dementia: 83.9%
Mean follow-up: 8.6 years
In models that adjusted for age group and APOE
Higher level of education significantly increased the relative rate ratio (RR) of reversion vs. progression
Bachelor’s degree: aRR ratio 2.60 (95% CI, 1.05 to 6.45)
Master’s degree or higher: aRR ratio 2.94 (95% CI, 1.27 to 7.22)
Cognitive reserve indicators were significantly associated with a higher adjusted RRs of reversion vs. progression
Higher vs. lower levels for English grades
RR ratio: 1.83 (95% CI, 1.07 to 3.14)
Idea density
RR ratio: 3.93 (95% CI, 1.30 to 11.92)
Grammatical complexity
RR ratio: 5.78 (95% CI, 1.56 to 21.42)
CONCLUSION:
Many participants with MCI did not progress to dementia, and in ~30% of cases actually experienced reversion to normal cognition
Indicators of cognitive reserve, such as education level and written language skills, were associated with higher rates of reversion vs progression
Limitations of the study include: The Nun Study cohort may not be generalizable | Transitions may reflect cognitive reserve but may also reflect normal variation over time
The authors state
Knowledge of predictors of reversion from MCI to NC is important to inform the design and interpretation of clinical trials, given that a substantial proportion of participants may experience improvement from MCI to NC even without intervention
Evidence of predictors of these reverse transitions may also inform population-level intervention strategies targeting these characteristics to prevent or postpone MCI and dementia
Does Maternal COVID-19 Vaccination Protect Against Infant Hospitalization Due to COVID?
BACKGROUND AND PURPOSE:
Halasa et al. (CDCMMWR, 2022) assessed the effectiveness of maternal completion of a 2-dose mRNA COVID-19 vaccination series during pregnancy against COVID-19 hospitalization in infants
METHODS:
Test-negative, case-control study
Real-world evaluation at 20 US pediatric hospitals during a period of Delta and Omicron variant circulation
Participants
Infants aged <6 months admitted outside of their birth hospitalization to a pediatric hospital during July, 2021 to January, 2022
Case infants had a positive COVID-19 test
Control infants had a negative COVID-19 test
Exposure
Maternal vaccination ≥14 days before delivery
Defined as completion of a 2-dose series of either Pfizer-BioNTech or Moderna mRNA COVID-19 vaccine
Study design
Control-infants were matched to case-infants by site and were hospitalized within 3 to 4 weeks of a case-infant’s admission date
In a secondary analysis, effectiveness of maternal receipt of the second dose of COVID-19 vaccination early in pregnancy (within the first 20 weeks) and late in pregnancy (21 weeks through 14 days before delivery) was assessed
Primary outcome
Vaccine effectiveness (VE) of maternal vaccination against infant COVID-19 hospitalization
RESULTS:
Case infants: 176 | Control infants: 203
Median age 2 months
Had at least one underlying medical condition: 21%
Born premature (<37 weeks): 22%
Effectiveness of maternal vaccination during pregnancy against COVID-19 hospitalization in infants aged <6 months
VE: 61% (95% CI, 31 to 78%)
Effectiveness of a completed 2-dose COVID-19 vaccination series early in pregnancy (first 20 weeks)
VE: 32% (95% CI, –43% to 68%)
Effectiveness of vaccine completion late in pregnancy (21 weeks through 14 days before delivery)
VE: 80% (95% CI, 55 to 91%)
CONCLUSION:
Maternal COVID-19 immunization appears to provide protection to infants through passive transplacental antibody transfer
Maternal vaccination had a VE of 61% for preventing COVID-19 hospitalization in infants
The authors state
Overall, these findings indicate that maternal vaccination during pregnancy might help protect against COVID-19 hospitalization among infants aged <6 months
Does Epidural Use During Vaginal Delivery Reduce the Risk of Severe Maternal Morbidity?
BACKGROUND AND PURPOSE:
Guglielminotti et al. (JAMA Network Open, 2022) assessed the association between the use of labor neuraxial analgesia for vaginal delivery and Severe Maternal Morbidity (SMM)
METHODS:
Population-based cross-sectional study
Data derived from hospital discharge records from New York between January 2010 and December 2017
Population
5 to 49 years
Undergoing first vaginal delivery
Exposures
Neuraxial analgesia: Epidural or combined spinal-epidural
No neuraxial analgesia
Study design
Odds ratios (OR) of SMM associated with neuraxial analgesia were estimated using inverse propensity score–weighting and stratified according to
Race and ethnicity (non-Hispanic White vs racial and ethnic minority women, including non-Hispanic Asian or Pacific Islander, non-Hispanic Black, Hispanic, and other race and ethnicity)
The comorbidity index for obstetric patients (low-risk vs high-risk women)
Primary outcome
Severe maternal morbidity (SMM)
Secondary outcome
Postpartum hemorrhage (PPH)
RESULTS:
575,524 included women
Mean age: 26 (SD, 6) years
Race/ethnicity
Non-Hispanic Asian or Pacific Islander: 8.0%
Non-Hispanic Black: 15.4%
Hispanic: 18.2%
Non-Hispanic White: 44.9%
Other race and ethnicity: 13.0%
Comorbidity index
Low-risk: 69.6%
High-risk: 30.4%
Received neuraxial analgesia: 47.4%
Incidence of SMM and PPH
SMM: 1.3%
Of these, PPH: 35.6%
Incidence of SMM by neuraxial analgesia exposure, before weighting
With neuraxial analgesia: 1.3%
No neuraxial analgesia: 1.4%
There was a decreased risk of SMM associated with neuraxial analgesia
Risk difference for SMM: −0.21% (95% CI, −0.30 to −0.12)
Adjusted OR 0.86 (95% CI, 0.82 to 0.90)
This association was similar between
Non-Hispanic White women and racial and ethnic minority women
Low-risk and high-risk women
More than one-fifth of the observed association of neuraxial analgesia with the risk of SMM was mediated through the decreased risk of PPH
21% (95% CI, 14 to 28%)
CONCLUSION:
Neuraxial analgesia exposure during vaginal delivery is associated with a 14% decreased risk of severe maternal morbidity
This associated risk reduction was similar across race, ethnicity, and comorbidity index
More than 20% of the observed SMM risk reduction was due to a decreased risk of PPH
Limitations of the study include
Oservational design which demonstrates association but not causation | Only intrapartum SMM documented, not the 15% of severe adverse outcomes that occur following discharge
The authors suggest the following reasons why neuraxial analgesia may reduce PPH and SMM
Earlier evaluation and management of early PPH due to enhanced maternal monitoring and early detection of blood loss following delivery
How Effective are IUDs Compared to Tubal Ligation?
BACKGROUND AND PURPOSE:
Schwarz et al. (Journal of General Internal Medicine, 2022) compare the effectiveness and safety of IUDs to laparoscopic tubal ligation for Medicaid clients
METHODS:
Retrospective cohort study
California database
Medicaid claims data
Population
IUD placed or laparoscopic tubal ligation
Procedure performed between 2008 and 2014
Exposures
IUD placement
Tubal ligation
Study design
Study included stakeholder advisory board including patients and clinicians
Linear regression models used to test associations between contraceptive procedure and outcomes
Adjustments for sociodemographic variables and pre-procedure health status
In unadjusted analyses, rates of pregnancy within 1 year were similar among the groups
Levonorgestrel IUD: 2.40%
Copper IUD: 2.99%
Tubal ligation: 2.64%
In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of
Levonorgestrel IUD
Adjusted incident rate ratio (aIRR) 0.72 (95% CI, 0.64 to 0.82)
Copper IUD
aIRR 0.92 (95% CI, 0.82 to 1.05)
Procedural complications such as infection were significantly less common with IUD placement than tubal ligation
IUD placement: 0.35%
Tubal ligation: 2.91%
Claims for pelvic and abdominal pain decreased in frequency over time regardless of contraceptive approach
At 6 to 12 months post-procedure, pelvic pain claims were less common after
Levonorgestrel IUD placement
aIRR 0.69 (95% CI, 0.65 to 0.73)
Copper IUD placement
aIRR 0.70 (95% CI, 0.66 to 0.75)
Results unchanged even after excluding patients at highest risk for post-procedure complications
CONCLUSION:
Among patients with medicaid insurance, placement of a levonorgestrel or copper IUD is at least as effective at preventing pregnancy as tubal ligation 1-year post-procedure
Compared to tubal ligation, pregnancy within 1 year was
Lower than laparoscopic tubal ligation
Similar for copper IUD
Pain and infection were less common in patients who received an IUD vs tubal ligation
The authors state
As desire for reversal of tubal ligation is known to occur, it is important that all patients considering tubal ligation receive thorough counseling regarding the comparative safety and effectiveness of IUC prior to undergoing tubal ligation
Can Vaccination Lead to Improved Long-COVID Symptoms?
BACKGROUND AND PURPOSE:
Risk factors and disease progression of Long-COVID or post-acute sequelae of SARS-CoV-2 infection are not well understood
It isn’t clear whether vaccination can help prevent or improve symptoms of long-COVID
Nehme et al. (Journal of General Internal Medicine, 2022) described the association of vaccination and the evolution of six cardinal symptoms embodying post-acute sequelae of SARS-CoV-2
METHODS:
Survey based study
Participants
Individuals who previously tested positive for SARS-CoV-2 infection (RT-PCR test) at a testing center in Switzerland
Survey was sent between April 23 to July 27, 2021
Exposures
Post-acute sequelae of SARS-CoV-2
Vaccination status
Study design
At the time of the study, the public health recommendations in Switzerland were for previously infected individuals to preferably receive one dose of vaccination only
Primary outcome
Persistence of symptoms
Fatigue | Difficulty concentrating or memory loss | Loss of or change in smell | Loss of or change in taste | Shortness of breath | Headache
RESULTS:
2094 participants
Vaccinated, one dose: 26.6%
Vaccinated, two doses: 20.5%
Symptom status following vaccination
Symptoms disappeared: 30.8%
Symptoms improved: 35.5%
Symptoms remained stable: 28.7%
Symptoms worsened: 3.3%
Vaccination (one or two doses) was associated with a decreased prevalence of the six cardinal post-SARS-CoV-2 symptoms
Adjusted odds ratio (aOR) 0.72 (95% CI, 0.56 to 0.92)
Vaccination with 2 doses was associated with a decreased prevalence of
Dyspnea: aOR 0.34 (95% CI, 0.14 to 0.82)
Change in taste: aOR 0.38 (95% CI, 0.18 to 0.83)
Any one symptom: aOR 0.60 (95% CI, 0.43 to 0.83)
CONCLUSION:
Compared to no vaccination, participants who were vaccinated reported improvement in post-acute SARS-CoV-2 sequelae
The authors state
If confirmed, this would mean that vaccination not only prevents infection but also can potentially improve post-acute sequelae of SARS-CoV-2
RCT Results: Paxlovid and Risk Reduction for Severe Progression of COVID-19
BACKGROUND AND PURPOSE:
Hammond et al. (NEJM, 2022) evaluated the safety and efficacy of nirmatrelvir plus ritonavir (Paxlovid) in nonhospitalized adults with mild-to-moderate COVID-19 at high risk for progression to severe disease
Nirmatrelvir group: 300 mg of nirmatrelvir plus 100 mg of ritonavir (a pharmacokinetic enhancer) every 12 hours for 5 days
Control group: placebo
Study design
Planned interim analysis was conducted on patients treated within 3 days after symptom onset (modified intention-to treat population, comprising 774 of the 1361 patients in the full analysis population)
Primary outcome
COVID-19-related hospitalization or death from any cause through day 28
In the planned interim analysis (774 patients) fewer patients in the treatment group were hospitalized or died by day 28
Incidence of hospitalization or deaths
Nirmatrelvir group: 0.77% (0 deaths)
Control: 7.01% (7 deaths)
Difference of −6.32 percentage points (95% CI, –9.04 to –3.59; P<0.001)
Relative risk (RR) reduction: 89.1%
Efficacy was maintained in the final analysis
Difference between groups: −5.81 percentage points (95% CI, −7.78 to −3.84); P<0.001
RR reduction: 88.9%
All 13 deaths occurred in the control group
When treatment was initiated within 3 days of treatment, viral load was lower in the nirmaltrelvir group at day 5 of treatment
Adjusted mean difference: −0.868 log10 copies per mL
The incidence of adverse events that emerged during the treatment period was similar in the two groups
Any adverse event
Nirmatrelvir: 22.6%
Control: 23.9%
Serious adverse events
Nirmaltrelvir: 1.6%
Control: 6.6%
Adverse events leading to discontinuation of the drugs or placebo
Nirmaltrelvir: 2.1%
Control 4.2%
The following occurred more frequently in the nirmaltrelvir group
Dysgeusia
Nirmaltrelvir: 5.6%
Control: 0.3%
Diarrhea
Nirmaltrelvir: 3.1%
Control: 1.6%
CONCLUSION:
Risk of progression to severe COVID-19 was reduced by ~89% for symptomatic COVID-19 patients who began a 5 day course of nirmatrelvir plus ritonavir
Unlike monoclonal antibodies, this treatment can be taken orally and targets an enzyme necessary for general viral replication, making it less susceptible to different SARS-CoV-2 variants
Meta-Analysis: Which Interventions are Best for Preventing Spontaneous Preterm Birth?
BACKGROUND AND PURPOSE:
Care et al. (BMJ, 2022) performed a network meta-analysis of various treatment options for the prevention of spontaneous preterm birth in at-risk women
METHODS:
Systematic review with Bayesian network meta-analysis
Study inclusion criteria
RCTs
Study participants who are at high risk of spontaneous preterm birth due to history of spontaneous preterm birth or short cervical length
Data included assessment of treatment options
Study design
Treatments: Bed rest | Cervical cerclage (McDonald, Shirodkar, or unspecified type of cerclage) | Cervical pessary | Fish oils or omega fatty acids | Nutritional supplements (zinc) | Progesterone (intramuscular, oral, or vaginal) | Prophylactic antibiotics | Prophylactic tocolytics | Combinations of interventions
Controls: Placebo or no treatment
Relative treatment effects (odds ratios and 95% credible intervals) and certainty of evidence were calculated for outcomes of preterm birth <34 weeks and perinatal death
Primary outcome
Preterm birth <34 weeks
Perinatal death
Other maternal and fetal outcomes
RESULTS:
61 studies | 17,273 pregnant women
Preterm Birth <34 weeks
Compared to placebo or no treatment, vaginal progesterone was associated with fewer women with preterm birth <34 weeks
Odds ratio (OR) 0.50 (95% CrI, 0.34 to 0.70); high certainty of evidence
Effect size of treatment was highest for Shirodkar cerclage, but certainty was low
OR 0.06 (95% CrI, 0.00 to 0.84); low certainty of evidence
The following treatments may also reduce preterm birth <34 weeks
17OHPC (17α-hydroxyprogesterone caproate)
OR 0.68 (95% CrI, 0.43 to 1.02); moderate certainty
Vaginal pessary
OR 0.65 (95% CrI, 0.39 to 1.08); moderate certainty
Fish oil or omega 3
OR 0.30 (95% CrI, 0.06 to 1.23); moderate certainty
Perinatal death
Compared to placebo or no treatment, vaginal progesterone was the only treatment that showed clear evidence of benefit for reducing perinatal death
OR 0.66 (95% CrI, 0.44 to 0.97); moderate certainty
The following treatments might reduce perinatal death rates, but credible intervals could not exclude the possibility of harm
17OHPC
OR 0.78 (95% CrI, 0.50 to 1.21); moderate certainty
McDonald cerclage
OR 0.59 (95% CrI, 0.33 to 1.03); moderate certainty
Unspecified cerclage
OR 0.77 (95% CrI, 0.53 to 1.11); moderate certainty
Only progesterone treatments are associated with reduction the following neonatal outcomes
Neonatal respiratory distress syndrome
Neonatal sepsis
Necrotizing enterocolitis
Admission to neonatal intensive care unit
CONCLUSION:
Vaginal progesterone is the best preventative treatment option for asymptomatic women at risk of preterm birth due to short cervix and history of preterm birth
The authors suggest that future trials use vaginal progesterone as the ‘gold standard’ comparator group when assessing other treatment options
Administering placebo or no treatment will be difficult to offer
The authors state
Vaginal progesterone is currently the best preterm birth prevention treatment for women with a singleton pregnancy who are asymptomatic but at high risk of preterm birth
No other treatment can be regarded as superior, but promising results have been observed for alternative routes of administration (oral, intramuscular), and treatments such as cerclage and pessary
Is there a Causal Link Between Obesity and Female Reproductive Disorders?
BACKGROUND AND PURPOSE:
Observational studies have found an association between obesity and adverse reproductive outcomes
Venkatesh et al. (PloS Medicine, 2022) estimated observational and genetically predicted causal associations between obesity, metabolic hormones, and female reproductive disorders
METHODS:
Mendelian randomization study on prospective cohort data
Data derived from the UK Biobank
Population
Individuals self-identifying as females of white ancestry
Exposures
BMI
Waist-to-hip ratio (WHR): Waist/hip circumference
WHR adjusted for BMI (WHRadjBMI)
Study design
Systematic genetics-based causal investigation
Logistic regression models were used to estimate the associations of BMI, WHR, and WHRadjBMI with prevalence of primary outcomes
Primary outcomes
Endometriosis
Heavy menstrual bleeding (HMB)
Infertility
Self-reported stillbirth
Spontaneous miscarriage or termination
PCOS
Pre-eclampsia
Uterine fibroids (UF)
RESULTS:
BMI, WHR, and WHRadjBMI were all associated with uterine fibroids, PCOS, heavy menstrual bleeding and preeclampsia, both
Observationally: Odds ratios (ORs) 1.02 to 1.87 per 1-SD increase in obesity trait
Genetically: ORs 1.06 to 2.09
Genetically predicted visceral adipose tissue (VAT) mass was associated with
Heavy menstrual bleeding (P=0.0130)
OR per 1-kg increase in predicted VAT mass 1.32 (95% CI, 1.06 to 1.64)
PCOS (P=0.0000324)
OR 1.15 (95% CI, 1.08 to 1.23)
Preeclampsia (P=0.000000665)
OR 3.08 (95% CI, 1.98 to 4.79)
Increased waist circumference posed a higher genetic risk for the development of these disorders and uterine fibroids vs increased hip circumference
Waist circumference: ORs 1.16 to 1.93
Hib circumference: ORs 1.06 to 1.10
Between 20% and 50% of the total genetically predicted association between obesity and preeclampsia was mediated by
Leptin
Fasting insulin
Insulin resistance
Reproductive conditions clustered based on shared genetic components of their etiological relationships with obesity
CONCLUSION:
Indices of obesity were associated with increased risk of female reproductive disorders, particularly uterine fibroids, polycystic ovary syndrome, heavy menstrual bleeding, and preeclampsia
Limitations to this study include the low prevalence of female reproductive conditions among women in the UK Biobank
Endocrine factors, such as leptin and insulin resistance, may be drivers of the underlying causative mechanism that results in adverse reproductive outcomes in women with obesity
The authors state
The strongest association of generalized obesity was found with pre-eclampsia, while more modest associations were observed for nearly all other studied conditions
Ovarian endometrioma (OMA; potentially associated with SUP)
Deep endometriosis (DE; potentially associated with SUP and OMA)
Control: No clinical endometriosis symptoms
Study design
Association between endometriosis and the primary outcome was assessed through univariate and multivariate logistic regression analyses
Adjusted for preterm risk factors
Maternal age | BMI before pregnancy | Country of birth | Parity | Previous cesarean delivery | History of myomectomy and hysteroscopy, and preterm birth
The same analysis was performed according to the 3 endometriosis phenotypes
Primary outcome
Preterm birth between 22w0d and 36w6d
RESULTS:
1351 study participants
Mean (SD) age 32.9 (5.0) years
Endometriosis diagnosis: 470 participants
SUP: 10.2%
OMA: 17.7%
DE: 72.1%
There was no difference in the rate of preterm birth between groups
Endometriosis: 7.2%
Control: 6.0%
P=0.38
After adjustment, endometriosis was still not associated with preterm birth
aOR 1.07 (95% CI, 0.64 to 1.77)
Results were comparable across different disease phenotypes (P=0.84)
SUP: 6.2% preterm birth
OMA: 7.2% preterm birth
DE: 7.4% preterm birth
CONCLUSION:
In this cohort, there was no association between endometriosis and incidence of preterm birth
Endometriosis phenotype did not modify this finding
The authors state
Pregnant women with endometriosis should not be considered to have an exceptionally high risk for preterm birth; thus, monitoring their pregnancy beyond the normal protocols or changing management strategies may not be warranted
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