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BMC Cancer Oct 2023The use of regorafenib in the treatment of hepatocellular carcinoma (HCC) is widespread. Albumin-Bilirubin (ALBI) has been shown to be a potential prognostic marker for... (Meta-Analysis)
Meta-Analysis
Baseline Albumin-Bilirubin grade as a predictor of response and outcome of regorafenib therapy in patients with hepatocellular carcinoma: a systematic review and meta-analysis.
BACKGROUND
The use of regorafenib in the treatment of hepatocellular carcinoma (HCC) is widespread. Albumin-Bilirubin (ALBI) has been shown to be a potential prognostic marker for regorafenib treatment, but its prognostic value remains controversial. Therefore, we conducted a meta-analysis to investigate the value of the baseline ALBI grade in predicting the efficacy and survival outcomes of HCC patients after regorafenib treatment.
METHODS
PubMed, Embase, Cochrane library, Web of Science, CNKI, Wan Fang Data, and Vip Database were searched from January 2010 to October 2022. Studies treating HCC patients with regorafenib and with ALBI as a categorical variable, overall survival (OS) and progression-free survival (PFS) as outcome indicators were included. After applying Newcastle-Ottawa Scale (NOS) to evaluate the quality of the included studies, Review Manager 5.4 was used to statistically analyze. Chi-square Q test and I statistics were used to detect heterogeneity. Funnel plot asymmetry, Egger's and Begg's test were used to evaluate publication bias.
RESULTS
A total of 12 studies, comprising 1,918 patients, were included in the meta-analysis. The included studies were all evaluated as high quality. Compared to the high-grade baseline ALBI group, patients in the low-grade group had a longer survival time after receiving regorafenib and also more suitable for regorafenib treatment [odds ratio (OR) = 6.50, 95% confidence interval (CI): 2.22-18.96, P < 0.01]. The low-grade baseline ALBI group before sorafenib treatment was significantly correlated with better OS [hazard ratio (HR) = 2.36, 95% CI: 1.68-3.31, P < 0.00001] and PFS (HR = 1.56, 95% CI: 1.16-2.08, P = 0.003). Likewise, the low-grade baseline ALBI group before regorafenib was also significantly correlated with better OS (HR = 1.56, 95% CI: 1.15-2.13, P = 0.005) and PFS (HR = 2.06, 95% CI: 1.37-3.11, P = 0.0005). In addition, the ALBI grade was significantly correlated with disease control rate (DCR) (OR = 2.90, 95% CI: 1.45-5.79, P = 0.003), but not the objective response rate (OR = 1.98, 95% CI: 0.71-5.46, P = 0.19).
CONCLUSIONS
The baseline ALBI grade could be a valuable prognostic indicator for predicting response and outcomes in HCC patients treated with regorafenib.
Topics: Humans; Carcinoma, Hepatocellular; Bilirubin; Liver Neoplasms; Serum Albumin; Prognosis; Retrospective Studies
PubMed: 37858207
DOI: 10.1186/s12885-023-11488-9 -
Journal of Integrative Neuroscience Aug 2023Many studies have shown that the levels of homocysteine (Hcy), vitamin B12 (Vit B12), and folate (FA) are abnormal in patients with Parkinson's disease (PD), but the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many studies have shown that the levels of homocysteine (Hcy), vitamin B12 (Vit B12), and folate (FA) are abnormal in patients with Parkinson's disease (PD), but the results have not been consistent. Therefore, we conducted this meta-analysis to summarize the features of Hcy, Vit B12, and FA in PD patients.
METHODS
A systematic literature search was conducted on PubMed, Cochrane Library, Web of Science, and Embase databases.
RESULTS
A total of 71 studies were included. The analysis showed the following. (1) PD patients had significantly increased Hcy level (standardized mean difference [SMD] 0.80, 95% confidence interval [CI] [0.61, 0.99]; < 0.001), and decreased Vit B12 (SMD -0.33, 95% CI [-0.43, -0.22]; <0.001) and FA levels (SMD -0.13, 95% CI [-0.19, -0.06]; < 0.001) compared to healthy controls. (2) Higher Hcy level (SMD 0.48, 95% CI [0.30, 0.67]; < 0.001) was found in Dopaminergic medications treated PD patients than in untreated patients. (3) PD patients with cognitive impairment had higher Hcy level (SMD 0.71, 95% CI [0.50, 0.92]; < 0.001) and lower Vit B12 (SMD -0.22, 95% CI [-0.34, -0.09]; = 0.001) and FA levels (SMD -0.17, 95% CI [-0.29, -0.04]; = 0.009) than those with no cognitive impairment. (4) PD patients with neuropathy had significantly increased Hcy level (SMD 0.87, 95% CI [0.43, 1.31]; < 0.001) and decreased Vit B12 level (SMD -0.40, 95% CI [-0.81, -0.00]; = 0.049) compared to PD patients with no neuropathy.
CONCLUSIONS
In conclusion, PD patients may have higher Hcy levels and lower Vit B12 and FA levels than the healthy population. Thus, Hcy, Vit B12, and FA may play a role in cognitive impairment and neuropathy in PD patients.
Topics: Humans; Vitamin B 12; Parkinson Disease; Cognitive Dysfunction; Folic Acid; Homocysteine
PubMed: 37735121
DOI: 10.31083/j.jin2205115 -
World Journal of Gastroenterology Mar 2024() infects over half the global population, causing gastrointestinal diseases like dyspepsia, gastritis, duodenitis, peptic ulcers, G-MALT lymphoma, and gastric... (Meta-Analysis)
Meta-Analysis
BACKGROUND
() infects over half the global population, causing gastrointestinal diseases like dyspepsia, gastritis, duodenitis, peptic ulcers, G-MALT lymphoma, and gastric adenocarcinoma. Eradicating is crucial for treating and preventing these conditions. While conventional proton pump inhibitor (PPI)-based triple therapy is effective, there's growing interest in longer acid suppression therapies. Potassium competitive acid blocker (P-CAB) triple and dual therapy are new regimens for eradication. Initially used in Asian populations, vonoprazan (VPZ) has been recently Food and Drug Administration-approved for eradication.
AIM
To assess the efficacy of regimens containing P-CABs in eradicating infection.
METHODS
This study, following PRISMA 2020 guidelines, conducted a systematic review and meta-analysis by searching MEDLINE and Scopus libraries for randomized clinical trials (RCTs) or observational studies with the following command: [("" OR "H pylori") AND ("Treatment" OR "Therapy" OR "Eradication") AND ("Vonaprazan" OR "Potassium-Competitive Acid Blocker" OR "P-CAB" OR "PCAB" OR "Revaprazan" OR "Linaprazan" OR "Soraprazan" OR "Tegoprazan")]. Studies comparing the efficacy of P-CABs-based treatment to classical PPIs in eradicating were included. Exclusion criteria included case reports, case series, unpublished trials, or conference abstracts. Data variables encompassed age, diagnosis method, sample sizes, study duration, intervention and control, and eradication method were gathered by two independent reviewers. Meta-analysis was performed in R software, and forest plots were generated.
RESULTS
A total of 256 references were initially retrieved through the search command. Ultimately, fifteen studies (7 RCTs, 7 retrospective observational studies, and 1 comparative unique study) were included, comparing P-CAB triple therapy to PPI triple therapy. The intention-to-treat analysis involved 8049 patients, with 4471 in the P-CAB intervention group and 3578 in the PPI control group across these studies. The analysis revealed a significant difference in eradication between VPZ triple therapy and PPI triple therapy in both RCTs and observational studies [risk ratio (RR) = 1.17, 95% confidence interval (CI): 1.11-1.22, < 0.0001] and (RR = 1.13, 95%CI: 1.09-1.17, < 0.0001], respectively. However, no significant difference was found between tegoprazan (TPZ) triple therapy and PPI triple therapy in both RCTs and observational studies (RR = 1.04, 95%CI: 0.93-1.16, = 0.5) and (RR = 1.03, 95%CI: 0.97-1.10, = 0.3), respectively.
CONCLUSION
VPZ-based triple therapy outperformed conventional PPI-based triple therapy in eradicating , positioning it as a highly effective first-line regimen. Additionally, TPZ-based triple therapy was non-inferior to classical PPI triple therapy.
Topics: Humans; Anti-Bacterial Agents; Clarithromycin; Helicobacter pylori; Proton Pump Inhibitors; Drug Therapy, Combination; Helicobacter Infections; Pyrroles; Amoxicillin; Treatment Outcome; Randomized Controlled Trials as Topic; Observational Studies as Topic; Benzene Derivatives; Imidazoles; Sulfonamides
PubMed: 38577188
DOI: 10.3748/wjg.v30.i9.1213 -
BMC Oral Health Mar 2024Recurrent Aphthous Stomatitis (RAS) known as recurrent aphthous ulcer is a common and painful ulcerations in oral cavity. It has been suggested that hematological... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Recurrent Aphthous Stomatitis (RAS) known as recurrent aphthous ulcer is a common and painful ulcerations in oral cavity. It has been suggested that hematological parameters seems to be considered as an etiologic factor. So, this meta-analysis and systematic review was aimed to examine the relationship between RAS and hematological parameters.
METHODS
Relevant studies were found using online international databases including Scopus, Science direct, Web of science (ISI), PubMed, and Google Scholar search engine between 2000 and October 2023. The quality of all papers was determined by NOS checklist. Heterogeneity between the results of primary studies was evaluated with I-square index and publication bias was performed by Egger's test and funnel plots. Also, sensitivity analysis was done to check the effect of each of the primary studies on the overall estimate. Also, the statistical analyses were done using Stata software Ver. 11.
RESULTS
By combining the results of primary studies, the standardized mean difference (SMD) of vitamin B12, ferritin, folic acid, hemoglobin, iron and zinc indices with a 95% confidence interval (CI) between the case (patients with RAS) and control (Healthy) groups were estimated -0.52(-0.89, -0.14), -0.20(-0.51, 0.11), -0.42(-0.95, 0.11), -0.58(-0.90, -0.27), 0.01(-0.12, 0.15), -0.33(-0.81, 0.14) respectively. The patients with vitamin B12, ferritin, folic acid, and iron deficiencies and reduced hemoglobin (Hb) level reported 2.93(2.28, 3.78), 2.50(1.48, 4.22), 1.51(0.53, 4.29), 1.46(0.70, 3.03), and 2.14(1.38, 3.32), times more susceptible to develop RAS than healthy individuals.
CONCLUSION
The results of the meta-analysis indicated that the SMD of vitamin B12 serum and Hb levels in the case group was 52%. Our result have also showed that the odds ratio of vitamin B12, ferritin deficiencies, and decreased Hb level in case group was 2.93, 2.50, and 2.14 times more than healthy group.
Topics: Humans; Stomatitis, Aphthous; Vitamin B 12 Deficiency; Folic Acid Deficiency; Folic Acid; Vitamin B 12; Hemoglobins; Ferritins
PubMed: 38493289
DOI: 10.1186/s12903-024-04072-5 -
Saudi Journal of Gastroenterology :... 2023Vonoprazan-amoxicillin (VA) dual therapy has recently been proposed to eradicate Helicobacter pylori (H. pylori) with controversial results. We, therefore, conducted a... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vonoprazan-amoxicillin (VA) dual therapy has recently been proposed to eradicate Helicobacter pylori (H. pylori) with controversial results. We, therefore, conducted a meta-analysis to assess the effect of this therapy for H. pylori eradication.
METHODS
We searched PubMed, Embase, Cochrane Library, and Web of Science database from inception until November 2022, collecting randomized controlled trials (RCTs) comparing VA dual therapy with other regimens for H. pylori eradication. Pooled relative risks (RRs) were calculated using random effects model.
RESULTS
Five RCTs were ultimately included. Compared with the vonoprazan-amoxicillin-clarithromycin (VAC) triple therapy, the eradication rate of VA dual therapy was lower in intention-to-treat (ITT) analysis (n = 3 RCTs, RR = 0.94, 95% CI: 0.88-0.99, P = 0.03), but there was no significant difference between them in the per-protocol (PP) analysis (RR = 0.96, 95% CI: 0.91-1.01, P = 0.11). For clarithromycin-resistant H. pylori strains, the eradication rate of VA dual therapy was significantly higher than that of the VAC triple therapy (n = 2 RCTs, RR = 1.20, 95% CI: 1.03-1.39, P = 0.02). Compared with the PPI-based triple therapy (PAC), VA dual therapy had a superior eradication rate (n = 2 RCTs, ITT analysis: RR = 1.13, 95% CI: 1.04-1.23, P = 0.003; PP analysis: pooled RR = 1.14, 95% CI: 1.06-1.22, P = 0.0004). Compared with VAC or PAC triple therapy, VA dual therapy has a similar incidence of total adverse events and compliance.
CONCLUSIONS
VA dual therapy had a similar effect compared to VAC triple therapy and was superior to PAC triple therapy. Future RCTs are needed to ascertain the optimal dosage and duration of vonoprazan and amoxicillin, and the effect of VA dual therapy compared with the mainstream regimens recommended by current guidelines.
Topics: Humans; Amoxicillin; Clarithromycin; Anti-Bacterial Agents; Helicobacter pylori; Helicobacter Infections; Proton Pump Inhibitors; Randomized Controlled Trials as Topic; Drug Therapy, Combination; Treatment Outcome
PubMed: 37602635
DOI: 10.4103/sjg.sjg_153_23 -
International Journal of Nursing Studies May 2024Practices related to umbilical cord clamping at birth should be evidence-based. Deferred cord clamping, compared to immediate cord clamping, shows benefits for preterm... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Practices related to umbilical cord clamping at birth should be evidence-based. Deferred cord clamping, compared to immediate cord clamping, shows benefits for preterm neonates but this may also apply to healthy term neonates. Different blood sampling techniques are used to measure effect of deferred and immediate cord clamping.
OBJECTIVE
To assess the statistical and effect size differences between blood biomarkers from umbilical cord and capillary blood samples of healthy term neonates following either immediate or deferred cord clamping.
DESIGN
Systematic review and meta-analysis.
METHODS
The databases PubMed, Medline, CENTRAL, CINAHL and EMBASE were systematically searched. We included studies with a randomised clinical trial design comparing deferred and immediate cord clamping among healthy term neonates born by a spontaneous vaginal birth, reporting on blood biomarkers. Studies including caesarean births and premature births/neonates were excluded. Study attributes, sampling technique, blood biomarkers, mean differences, and standard deviations were extracted. The standardised mean differences (SMD) and sampling errors were calculated for effect size estimation. Meta-analyses were performed if ≥2 studies reported the same outcome using RevMan 5. Subgroup analyses distinguished effects from umbilical cord and capillary blood samples. Moderator tests and publication bias analyses were performed using JASP.
RESULTS
Fifteen studies were included for analysis. The biomarkers haematocrit, haemoglobin, and bilirubin were reported in ≥2 studies and thus eligible for pooling. No differences were found in haemoglobin (SMD -0.04, 95%CI -0.57 to 0.49) or bilirubin values (SMD 0.13, 95%CI -0.03 to 0.28) between umbilical cord blood samples collected after deferred or immediate cord clamping. Deferred cord clamping led to lower haematocrit values (SMD -0.3, 95%CI -0.53 to -0.07). Higher haematocrit (SMD 0.67, 95%CI 0.37 to 0.97) and haemoglobin values (SMD 0.76, 95%CI 0.56 to 0.97) from capillary blood samples, collected 2 to 72 h postpartum, showed when cord clamping was deferred. No effect was found on bilirubin values (SMD 0.13, 95%CI -0.03 to 0.28) irrespective of the sampling technique.
CONCLUSIONS
Blood collected after deferred umbilical cord clamping showed increased haemoglobin and haematocrit values up to 72 h after birth, opposed to bilirubin values. Clinical evaluation of blood biomarkers from the umbilical cord shows different values compared to capillary blood. Sampling time and technique therefore seem essential in estimating the effects of deferred cord clamping.
TWEETABLE ABSTRACT
This meta-analysis shows that sampling time and technique are essential in estimating the effects of deferred cord clamping on neonatal blood values.
Topics: Humans; Infant, Newborn; Umbilical Cord Clamping; Fetal Blood; Biomarkers; Umbilical Cord; Hemoglobins; Bilirubin; Pregnancy; Female
PubMed: 38417349
DOI: 10.1016/j.ijnurstu.2024.104718 -
Medicine Oct 2023The optimal drug for treatment with polycystic ovary syndrome (PCOS) was in debate. We did this network meta-analysis to assess the efficacy and safety of different... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The optimal drug for treatment with polycystic ovary syndrome (PCOS) was in debate. We did this network meta-analysis to assess the efficacy and safety of different drugs for reducing testosterone levels in women with PCOS.
METHODS
We searched studies from inception until January 10, 2023, through PubMed, Embase, and Cochrane Library database. All studies comparing different drugs for reducing testosterone levels in women with polycystic ovary syndrome were included in this network meta-analysis. Outcomes were total testosterone levels, free testosterone levels, and withdraw due to adverse events. We calculated the surface under the cumulative ranking curve (SUCRA) for each treatment.
RESULTS
Finally, a total of 13 studies were finally included in this network meta-analysis. In head-to-head comparison, atorvastatin (WMD -3.1, 95% CrI: -3.7 to -2.5), metformin (WMD -2.6, 95% CrI: -3.5 to -1.6), metformin + simvastatin (WMD -2.8, 95% CrI: -4.1 to -1.5), simvastatin (WMD -2.7, 95% CrI: -4.2 to -1.3), spironolactone (WMD -3.1, 95% CrI: -4.3 to -1.9), spironolactone + metformin (WMD -3.2, 95% CrI: -4.5 to -2.0) were all more effective than the placebo, and the difference was statistically significant (P < .05). The SUCRA shows that spironolactone + metformin ranked first (SUCRA, 85.0%), Atorvastatin ranked second (SUCRA, 77.7%), Spironolactone ranked third (SUCRA, 77.2%), and metformin + simvastatin ranked the fourth. The SUCRA of different drugs for free testosterone levels shows that atorvastatin ranked first (SUCRA, 75.0%), spironolactone + metformin ranked second (SUCRA, 5.3%), metformin + simvastain ranked third (SUCRA, 62.6%), and spironolactone ranked the fourth (SUCRA, 56.4%). No statistically significant differences were found between the 2 treatment groups for withdrawn due to adverse events (P > .05).
CONCLUSIONS
Considering the network meta-analysis and rankings, atorvastatin was recommended to be the optimal drug for treatment PCOS. However, the optimal dose of atorvastatin was unknown and should be verified by more randomized controlled trials.
Topics: Humans; Female; Spironolactone; Atorvastatin; Network Meta-Analysis; Polycystic Ovary Syndrome; Metformin; Simvastatin; Testosterone
PubMed: 37832133
DOI: 10.1097/MD.0000000000035152 -
Journal of Gastroenterology and... May 2024Up to 40% of gastroesophageal reflux disease (GERD) patients experience inadequate symptom relief with a proton pump inhibitor (PPI), termed PPI-resistant or refractory... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND AIM
Up to 40% of gastroesophageal reflux disease (GERD) patients experience inadequate symptom relief with a proton pump inhibitor (PPI), termed PPI-resistant or refractory GERD. Vonoprazan, a potassium-competitive acid blocker, has better efficacy than PPI in suppressing gastric acid secretion. This meta-analysis summarizes the efficacy and safety of vonoprazan for treating PPI-resistant GERD (both erosive esophagitis [EE] and non-erosive reflux disease [NERD]).
METHODS
Four electronic databases (Medline, Embase, SCOPUS, and CENTRAL) were searched for studies indexed until August 1, 2023. Both observational studies and clinical trials assessing the efficacy and safety of vonoprazan in PPI-resistant GERD were included. Efficacy outcomes included healing and maintenance rates of EE and improvement of the Frequency Scale for Symptoms of GERD (FSSG) scores. Serious adverse events (SAEs) were considered a safety outcome. The modified Newcastle-Ottawa Scale (NOS) was used to assess study quality.
RESULTS
Twelve studies were included in this meta-analysis. Healing rates of PPI-resistant EE with vonoprazan 20 mg were 91.7% (95% CI 86.8-94.8%) and 88.5% (95% CI 69.7-96.2%) at weeks 4 and 8, respectively. For healed PPI-resistant EE, the overall maintenance rates with vonoprazan 10 mg were 82.6% (95% 61.2-95.0%) at week 8, 86.0% (95% CI 72.1-94.7%) at week 24, and 93.8% (95% CI 69.8-99.8%) at week 48. FSSG scores were improved in 74.6% (95% CI 65.8-81.7%) and 51.9% (95% CI 37.8-65.7%) of patients at weeks 4 and 8. Overall, no SAE was reported.
CONCLUSION
Vonoprazan demonstrated high efficacy in the healing and maintenance of PPI-resistant EE and moderate efficacy for the improvement of FSSG score. Vonoprazan was well tolerated in PPI-resistant GERD patients.
Topics: Proton Pump Inhibitors; Humans; Pyrroles; Gastroesophageal Reflux; Sulfonamides; Treatment Outcome; Drug Resistance
PubMed: 38263507
DOI: 10.1111/jgh.16475 -
International Journal of Molecular... May 2024The published data on the vitamin status of patients with phenylketonuria (PKU) is contradictory; therefore, this systematic review and meta-analysis evaluated the... (Meta-Analysis)
Meta-Analysis Review
The published data on the vitamin status of patients with phenylketonuria (PKU) is contradictory; therefore, this systematic review and meta-analysis evaluated the vitamin status of PKU patients. A comprehensive search of multiple databases (PubMed, Web of Sciences, Cochrane, and Scopus) was finished in March 2024. The included studies compared vitamin levels between individuals diagnosed with early-treated PKU and healthy controls while excluding pregnant and lactating women, untreated PKU or hyperphenylalaninemia cases, control groups receiving vitamin supplementation, PKU patients receiving tetrahydrobiopterin or pegvaliase, and conference abstracts. The risk of bias in the included studies was assessed by the Newcastle-Ottawa scale. The effect sizes were expressed as standardised mean differences. The calculation of effect sizes with 95% CI using fixed-effects models and random-effects models was performed. A -value < 0.05 was considered statistically significant. The study protocol was registered in the PROSPERO database (CRD42024519589). Out of the initially identified 11,086 articles, 24 met the criteria. The total number of participants comprised 770 individuals with PKU and 2387 healthy controls. The meta-analyses of cross-sectional and case-control studies were conducted for vitamin B12, D, A, E, B6 and folate levels. PKU patients demonstrated significantly higher folate levels (random-effects model, SMD: 1.378, 95% CI: 0.436, 2.320, = 0.004) and 1,25-dihydroxyvitamin D concentrations (random-effects model, SMD: 2.059, 95% CI: 0.250, 3.868, = 0.026) compared to the controls. There were no significant differences in vitamin A, E, B6, B12 or 25-dihydroxyvitamin D levels. The main limitations of the evidence include a limited number of studies and their heterogeneity and variability in patients' compliance. Our findings suggest that individuals with PKU under nutritional guidance can achieve a vitamin status comparable to that of healthy subjects. Our study provides valuable insights into the nutritional status of PKU patients, but further research is required to confirm these findings and explore additional factors influencing vitamin status in PKU.
Topics: Phenylketonurias; Humans; Vitamins; Vitamin D; Folic Acid; Vitamin B 12; Vitamin A
PubMed: 38791104
DOI: 10.3390/ijms25105065 -
The Cochrane Database of Systematic... Jan 2024Vitamin B deficiency is a major public health problem worldwide, with the highest burden in elderly people, pregnant women, and young children. Due to its role in DNA...
BACKGROUND
Vitamin B deficiency is a major public health problem worldwide, with the highest burden in elderly people, pregnant women, and young children. Due to its role in DNA synthesis and methylation, folate metabolism, and erythropoiesis, vitamin B supplementation during pregnancy may confer longer-term benefits to maternal and child health outcomes.
OBJECTIVES
To evaluate the benefits and harms of oral vitamin B supplementation during pregnancy on maternal and child health outcomes.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the World Health Organization International Clinical Trials Registry Platform (ICTRP) on 2 June 2023, and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs), quasi-RCTs, or cluster-RCTs evaluating the effects of oral vitamin B supplementation compared to placebo or no vitamin B supplementation during pregnancy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Four review authors independently assessed trial eligibility. Two review authors independently extracted data from included studies and conducted checks for accuracy. Three review authors independently assessed the risk of bias of the included studies using the Cochrane RoB 1 tool. We used GRADE to evaluate the certainty of evidence for primary outcomes.
MAIN RESULTS
The review included five trials with 984 pregnant women. All trials were conducted in low- and middle-income countries, including India, Bangladesh, South Africa, and Croatia. At enrolment, 26% to 51% of pregnant women had vitamin B deficiency (less than 150 pmol/L), and the prevalence of anaemia (haemoglobin less than 11.0 g/dL) ranged from 30% to 46%. The dosage of vitamin B supplementation varied from 5 μg/day to 250 μg/day, with administration beginning at 8 to 28 weeks' gestation through to delivery or three months' postpartum, and the duration of supplementation ranged from 8 to 16 weeks to 32 to 38 weeks. Three trials, involving 609 pregnant women, contributed data for meta-analyses of the effects of vitamin B supplementation compared to placebo or no vitamin B supplementation. Maternal anaemia: there may be little to no difference for maternal anaemia by intervention group, but the evidence is very uncertain (70.9% versus 65.0%; risk ratio (RR) 1.08, 95% confidence interval (CI) 0.93 to 1.26; 2 trials, 284 women; very low-certainty evidence). Maternal vitamin B status: vitamin B supplementation during pregnancy may reduce the risk of maternal vitamin B deficiency compared to placebo or no vitamin B supplementation, but the evidence is very uncertain (25.9% versus 67.9%; RR 0.38, 95% CI 0.28 to 0.51; 2 trials, 272 women; very low-certainty evidence). Women who received vitamin B supplements during pregnancy may have higher total vitamin B concentrations compared to placebo or no vitamin B supplementation (mean difference (MD) 60.89 pmol/L, 95% CI 40.86 to 80.92; 3 trials, 412 women). However, there was substantial heterogeneity (I = 85%). Adverse pregnancy outcomes: the evidence is uncertain about the effect on adverse pregnancy outcomes, including preterm birth (RR 0.97, 95% CI 0.55 to 1.74; 2 trials, 340 women; low-certainty evidence), and low birthweight (RR 1.50, 95% CI 0.93 to 2.43; 2 trials, 344 women; low-certainty evidence). Two trials reported data on spontaneous abortion (or miscarriage); however, the trials did not report quantitative data for meta-analysis and there was no clear definition of spontaneous abortion in the study reports. No trials evaluated the effects of vitamin B supplementation during pregnancy on neural tube defects. Infant vitamin B status: children born to women who received vitamin B supplementation had higher total vitamin B concentrations compared to placebo or no vitamin B supplementation (MD 71.89 pmol/L, 95% CI 20.23 to 123.54; 2 trials, 144 children). Child cognitive outcomes: three ancillary analyses of one trial reported child cognitive outcomes; however, data were not reported in a format that could be included in quantitative meta-analyses. In one study, maternal vitamin B supplementation did not improve neurodevelopment status (e.g. cognitive, language (receptive and expressive), motor (fine and gross), social-emotional, or adaptive (conceptual, social, practical) domains) in children compared to placebo (9 months, Bayley Scales of Infant and Toddler Development Third Edition (BSID-III); 1 trial; low-certainty evidence) or neurophysiological outcomes (72 months, event-related potential measures; 1 trial; low-certainty evidence), though children born to women who received vitamin B supplementation had improved expressive language domain compared to placebo (30 months, BSID-III; 1 trial; low-certainty evidence).
AUTHORS' CONCLUSIONS
Oral vitamin B supplementation during pregnancy may reduce the risk of maternal vitamin B deficiency and may improve maternal vitamin B concentrations during pregnancy or postpartum compared to placebo or no vitamin B supplementation, but the evidence is very uncertain. The effects of vitamin B supplementation on other primary outcomes assessed in this review were not reported, or were not reported in a format for inclusion in quantitative analyses. Vitamin B supplementation during pregnancy may improve maternal and infant vitamin B status, but the potential impact on longer-term clinical and functional maternal and child health outcomes has not yet been established.
Topics: Child; Child, Preschool; Female; Humans; Infant; Infant, Newborn; Pregnancy; Abortion, Spontaneous; Anemia; Dietary Supplements; Outcome Assessment, Health Care; Vitamin B 12; Vitamins
PubMed: 38189492
DOI: 10.1002/14651858.CD013823.pub2