Safety and immunogenicity of a new formulation of a pentavalent DTwP-HepB-Hib vaccine in healthy Indian infants-A randomized study.

BACKGROUND: Pentavalent vaccines (DTP-HepB-Hib) have been introduced in many countries in their routine public immunization programmes to protect against diphtheria (D), tetanus (T), pertussis (P), hepatitis B (Hep B) and Hemophilus influenzae type b (Hib) diseases. This study compared the safety and immunogenicity of a new formulation of a whole-cell Bordetella pertussis (wP) based pentavalent vaccine (DTwP-HepB-Hib). The new formulation was developed using well-characterized hepatitis B and pertussis whole cell vaccine components. METHODS: This was a phase III, observer-blind, randomized, non-inferiority, multi-center study conducted in India among 460 infants who were followed up for safety and immunogenicity for 28 days after administration of three doses of either investigational or licensed comparator formulations at 6-8, 10-12 and 14-16 weeks of age. RESULTS: The investigational formulation of DTwP-HepB-Hib vaccine was non-inferior to the licensed formulation in terms of hepatitis B seroprotection rate (% of subjects with HepB antibodies ≥10mIU/mL were 99.1% versus 99.0%, respectively, corresponding to a difference of 0.1% (95% CI, -2.47 to 2.68)) and pertussis immune responses (adjusted geometric mean concentrations of antibodies for anti-PT were 76.7 EU/mL versus 63.3 EU/mL, with a ratio of aGMTs of 1.21 (95% CI, 0.89-1.64), and for anti-FIM were 1079 EU/mL versus 1129 EU/mL, with a ratio of aGMTs of 0.95 (95% CI, 0.73-1.24), respectively). The immune responses to other valences (D, T, and Hib) in the two formulations were also similar. The safety profile of both formulations was found to be similar and were well tolerated. CONCLUSIONS: The investigational DTwP-HepB-Hib vaccine formulation was immunogenic and well-tolerated when administered as three dose primary series in infants. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry India number: CTRI/2018/12/016692.

Effect of thiamine supplementation on glycaemic outcomes in adults with type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) have been shown to have thiamine deficiency. Dietary supplementation is an economic strategy to control blood glucose. Objective: To evaluate effectiveness of thiamine supplementation on glycaemic outcomes in patients with T2DM. METHODS: Eligibility criteria: Studies that assessed effect of thiamine supplementation in adults with T2DM which measured glycaemic outcomes-HbA1c, fasting blood glucose (FBG) and/or postprandial blood glucose (PPG) were included. Information sources: PUBMED, Tripdatabase, the Cochrane Central Register, National Institute of Health Clinical Database and Google Scholar were searched until December 2021 for RCTs. Risk of bias: It was assessed using standardised critical appraisal instruments from the Joanna Briggs Institute for RCTs. Synthesis of results: Where possible, studies were pooled in a meta-analysis. Results were presented in a narrative format if statistical pooling was not possible. RESULTS: Included studies: Six trials involving 364 participants. Synthesis of results: No significant beneficial effects were observed on glycaemic outcomes with 100-900 mg/day of thiamine or benfotiamine for up to 3 months (HbA1c: MD, -0.02%, 95% CI: -0.35 to 0.31; FBG: MD,-0.20 mmol/L; 95% CI: -0.69 to 0.29; PPG: MD, - 0.20 mmol/L, 95% CI: -2.05 to 1.65 (mean difference, MD)). There was a significant increase in high-density lipoprotein (HDL) (MD, 0.10; 95% CI: 0.10 to 0.20) at 3-month follow-up. Benfotiamine reduced triglyceride level (MD, -1.10; 95% CI: -1.90 to -0.30) in 120 mg/day dose as compared with placebo 150 mg/day, however this was not demonstrated in higher doses. DISCUSSION: Limitations of evidence: Inclusion of single-centre trials published only in English, small sample sizes of included studies, lack of trials investigating outcomes for same comparisons and varying follow-up periods. Interpretation: Thiamine supplementation does not affect glycaemic outcomes, however reduces triglycerides while increasing HDL. Multicentre well-designed RCT with higher doses of thiamine and a follow-up period of 1-2 years will provide better evidence. PROSPERO REGISTRATION NUMBER: CRD42020170520.

Effect of tree nuts on glycemic outcomes in adults with type 2 diabetes mellitus: a systematic review.

OBJECTIVE: The objective of this review was to synthesize the best available research evidence regarding the effectiveness of tree nuts on glycemic outcomes in adults with type 2 diabetes mellitus. INTRODUCTION: There has been an increase in the use of complementary therapy, particularly botanical products, for management of type 2 diabetes mellitus. It has been reported that increasing mono- and polyunsaturated fatty acids in diet effectively lowers the risk of development of type 2 diabetes mellitus. Hence, it was hypothesized that consumption of nuts, which are high in polyunsaturated fatty acids and mono-unsaturated fatty acids, may aid in preventing diabetes and reducing levels of blood glucose by reducing glycemic load by displacing dietary carbohydrates present in diet. INCLUSION CRITERIA: This systematic review included randomized controlled trials that compared the consumption of any type and form of tree nut with a placebo or any other intervention in adults with type 2 diabetes mellitus. Trials were included if they measured fasting blood glucose, postprandial blood glucose, and/or glycated hemoglobin. Trials that assessed triglyceride levels and weight postintervention were also considered for inclusion. Trials were restricted to the English language. METHODS: A three step search of PubMed, CINAHL, Embase, Trip database, and Cochrane Central Register of Controlled Trials (CENTRAL) was done in July 2019. To find unpublished studies, ClinicalTrials.gov and Google Scholar were searched. Studies from the search were reviewed against the inclusion criteria by two reviewers. The JBI critical appraisal checklist for randomized controlled trials was used to assess the potential studies for methodological quality. A meta-analysis and subgroup analysis was conducted among trials with the same type of intervention and outcome measures. Results are presented in a narrative format where statistical pooling was not possible. RESULTS: Fifteen trials were included with a total sample size of 667. Consumption of pistachios demonstrated a significant reduction in triglyceride levels (mmol/L) at three month or earlier follow-up (mean difference [MD] -0.28; confidence interval -0.33, -0.23; P <0.00001). The meta-analysis including all tree nuts combined showed reduction in both fasting blood glucose and glycated hemoglobin (MD -0.26 mmol/L and -0.11% respectively) at three month or earlier follow-up. The subgroup analysis demonstrated MD of -0.45, -0.16, and -0.90 mmol/L in fasting blood glucose following ingestion of walnuts, almonds, and hazelnuts, respectively, and -0.17% in glycated hemoglobin following ingestion of walnuts at three month or earlier follow-up. Although not clinically significant, these figures give an indication that further research with larger sample sizes and longer follow-up may show encouraging results. CONCLUSIONS: The authors found that pistachio consumption for three months or less significantly reduced triglyceride levels. Other tree nuts (walnuts, almonds, and hazelnuts) reduced fasting blood glucose and glycated hemoglobin levels by varying degrees. Further robust randomized controlled trials with power calculation-based sample size, comparing same type, dose, and method of nut intervention, will provide more evidence. For now, clinical decisions should be based on standard practice local guidelines. SYSTEMATIC REVIEW REGISTRATION NUMBER: PROSPERO CRD42019133558.

Omega-3 Fatty Acids Supplementation in Children to Prevent Asthma: Is It Worthy?-A Systematic Review and Meta-Analysis.

Asthma is one of the most common respiratory diseases affecting all age groups. The world is now trying to identify some dietary factors which can play a preventive role. We performed this systematic review and meta-analysis of RCTs to assess the effect of intake of polyunsaturated fatty acid (PUFA) in infancy and/or childhood on incidence of asthma or wheezing episodes. We searched MEDLINE, EBSCO, Trip, and Google Scholar up to January 31, 2015. All RCTs where infants or children who were given omega-3 fatty acid supplementation and which reported incidence of asthma and/or wheezing episodes as dichotomous outcomes were included in this review. Random effects model was used for pooling the risk estimates. Total five articles were included. Most of them were from Australia. On meta-analysis, the pooled estimate of odds ratios by random effects model showed no significant change in incidence of asthma after supplementation of omega-3 FA in infancy or childhood (OR 0.974; CI 0.646, 1.469; p = 0.900). We concluded that a multicentric RCT is required to assess the effect of omega-3 FA supplementation exclusively to infants or children to predict the best time of omega-3 FA supplementation to prevent asthmatic or wheezing episodes later in life.

ALA, fatty fish or marine n-3 fatty acids for preventing DM?: a systematic review and meta-analysis.

Diabetes mellitus (T2DM) has become a global problem. Role of n-3 FA in its prevention is still not completely understood. We carried out this systematic review and meta-analysis to assess the relation of dietary intake of fish and n-3PUFA with risk of diabetes. We searched PUBMED, EMBASE and GOOGLE with cross references to identify relevant articles. Since no RCTs were available, we searched for prospective cohort studies. Sixteen studies with 6,79,763 participants which assessed the association of dietary intake of fish and n-3 PUFA (marine or alpha-linolenic acid) with incidence of T2DM in > 18 years population and provided relative risk (RR) or hazard ratio (HR) with the corresponding 95% confidence interval (CI) of T2DM for each category of fish or n-3 PUFA intake were included. Three independent reviewers reviewed all eligible studies and abstracted the relevant information from individual studies. Meta-analysis confirmed the previous finding that marine n-3 FA increased risk of T2DM in Americans but reduced the same in Asians. We observed that two and seven times increased intake of ALA and fatty fish respectively reduced the risk of T2DM significantly and ALA did not increase the risk in Americans. We concluded that ALA may have some role in preventing T2DM, but is not studied widely. Hence, it should be studied in greater details (with higher degrees of intake; more than two times) to aid in developing effective preventive strategies against diabetes.

The association of positive chest radiograph and laboratory parameters with community acquired pneumonia in children.

CONTEXT: This study was designed to compare the sensitivities of different investigations for the diagnosis of Community Acquired Pneumonia (CAP). A prospective study was carried out which compared the sensitivities of the chest radiographs, CRP, TLC, ESR and the blood cultures in sixty-six patients who were diagnosed with WHO defined CAP. METHOD AND MATERIAL: The chest radiographs, serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), total leucocyte count (TLC) and blood cultures were determined in sixty-six patients who were amongst the age group of one month to five years of age, who were diagnosed with WHO defined CAP. STATISTICAL ANALYSIS: It was carried out by calculating the proportion, mean, standard deviation (SD) and the sensitivity of the test/.able RESULTS: The chest radiographs were found to be positive in 93.9% (n=62) patients, CRP was positive in 90.9% (n=60) patients, ESR was positive in 72.7% (n=42) patients, TLC was positive in 48.5% (n=38) patients and the blood cultures were positive in 6.1% (n=4) patients. Hence, the sensitivity of the chest radiograph, CRP, ESR, TLC and the blood culture in the diagnosis of CAP were 93.9%, 90.9%, 72.7%, 48.5% and 6.1%. CONCLUSION: In view of the high sensitivity of CRP, which is almost similar to that of chest X-Ray in detecting CAP, CRP can be used as an alternative test to the chest radiographs at peripheral centres, where X-ray machines are not available.

Safety of inhaled fluticasone propionate therapy for pediatric asthma - a systematic review.

CONTEXT AND AIM: Asthma is a common problem in paediatric population. International treatment guidelines recognize the role of inhaled corticosteroids for asthma in young children. Inhaled fluticasone propionate is reported to have greater systemic effects like other corticosteroids. Limited data is available on safety of this drug when used for longer duration. So, we conducted a systematic review to study the effect of inhaled fluticasone propionate on adrenal suppression, growth and bone mineral density in paediatric patients. DESIGN: A systematic review. METHODS: We searched for Randomized controlled trials in MEDLINE from January 2000 to December 2012. References of included study were hand searched. Information on study design, study population, drugs and dosage used, follow up period, measures used to evaluate safety and outcomes was abstracted independently by three reviewers. DETAILS OF INCLUDED STUDIES: In all included studies, participants were asthmatic children below 18 years and treated with fluticasone propionate. Minimum follow up considered was three months and should have measured HPA suppression or growth velocity or bone mineral density. RESULTS: Total ten studies were included. Studies which had monitored HPA function varied in dosage of drug, mode of administration and duration. Inspite of that it has been observed that serum cortisol level is affected by fluticasone propionate, no significant effect on bone mineral density was reported with fluticasone propionate, but the sample size was inadequate and dietary calcium intake was not recorded. None of the studies reported any significant reduction in growth when inhaled fluticasone propionate was used for the treatment of asthma, but the baseline growth and final adult height attained were not assessed. LIMITATION: This systematic review included only free full text articles published in English. Only randomized controlled trials were included. Cohort studies were not included. CONCLUSION: With available evidences, the safety of inhaled fluticasone propionate cannot be questioned. This systematic review could not derive any significant adverse effect on HPA function, growth and bone mineral density in asthmatic children when used for long duration and followed for up to three months.

Effect of nonsurgical periodontal therapy during gestation period on adverse pregnancy outcome: a systematic review.

OBJECTIVE: To confirm effectiveness of nonsurgical periodontal treatment during pregnancy on pregnancy outcome in terms of preterm birth and low birth weight (LBW). METHOD: We searched for Randomized controlled trials in MEDLINE, CINAHL and EMBASE. from January 2000 to October 2012. References of included studies were hand searched. Studies which measured incidence of either preterm labor (PTL), LBW or both were included. Information on study design, population, risk of bias, periodontal parameters, time and type of periodontal treatment given and pregnancy outcome were abstracted independently by three reviewers. RESULTS: Total thirteen studies were included. Five studies had low risk of bias. Conclusive results could not be obtained for incidence of PTL or LBW because of heterogeneity in results due to various reasons, but all studies which assessed PTL and LBW combined showed significant difference in incidence of same in group which received non surgical periodontal treatment. CONCLUSION: Our study suggests that treatment of periodontitis during gestation improves pregnancy outcome in terms of PTLBW, a fact which may be used for health and economical benefits but better RCTs with adequate sample size are required for conclusive evidence.

Coffee to reduce risk of type 2 diabetes?: a systematic review.

Type 2 DM is associated with high rates of morbidity and premature mortality. Various potential health effects of coffee have been extensively studied, but data on habitual coffee consumption and the risk of type 2 diabetes mellitus have only recently been published. We systematically reviewed cohort studies (identified after searching through MEDLINE) from the period of January 2001 to August 2011 to find out the relation of degree of coffee consumption with development of diabetes mellitus. Information on study design, participant characteristics, measurement of coffee consumption and outcomes, adjustment for potential confounders, and estimates of associations was reviewed independently by 3 reviewers. The review included 13 cohort studies including 12, 47,387 participants and 9473 incident cases of type 2 diabetes. We compared the risk of diabetes amongst people with different degrees of coffee consumption. We concluded that habitual coffee consumption is associated with a lower risk of type 2 diabetes. Participants who drank 4 to 6 cups and more than 6 to 7 cups of coffee per day had a lower risk of type 2 diabetes compared with those who drank less than 2 cups per day. Advantage of filtered coffee over pot boiled, decaffeinated coffee over caffeinated coffee and stronger inverse correlation in < 60 years age group was also noted. However, based on this review, increasing coffee consumption as a public health strategy can't be recommended. More detailed studies of coffee consumption, including appropriate measures of postprandial hyperglycemia and insulin sensitivity, are required.