Blinding in randomized control trials: the enigma unraveled.

The search for new treatments and testing of new ideas begins in the laboratory and then established in clinical research settings. Studies addressing the same therapeutic problem may produce conflicting results hence Randomised Clinical Trial is regarded as the most valid method for assessing the benefits and harms of healthcare interventions. The next challenge face by the medical community is the validity of such trials as theses tend to deviate from the truth because of various biases. For the avoidance of the same it has been suggested that the validity or quality of primary trials should be assessed under blind conditions. Thus blinding, is a crucial method for reducing bias in randomized clinical trials. Blinding can be defined as withholding information about the assigned interventions from people involved in the trial who may potentially be prejudiced by this knowledge. In this article we make an effort to define blinding, explain its chronology, hierarchy and discuss methods of blinding, its assessment, its possibility, un-blinding and finally the latest guidelines

Role of Gut Microbiome and Enteric Bacteria in Gallbladder Cancer

Gallbladder cancer (GBC) is associated with a sinister prognosis, a short survival time, and early metastasis to distant sites. Chronic inflammation of the gallbladder due to gallstone disease and biliary bacteria remain key factors in the pathogenesis of GBC. The association of chronic bacterial infections with the development of GBC has provided a new perspective on the causation of GBC. A strong link between chronic Salmonella infection and enterohepatic strains of Helicobacter species with GBC has been suggested. It is believed that many other enteric bacterial strains, predominantly the Enterobacteriaceae species, are associated with the development of GBC. However, the available literature mainly comprises observational studies and small meta-analyses necessitating the requirement of a higher level of evidence. This chapter discusses the role of the gut microbiome, dysbiosis and its association with carcinogenesis, and the organisms associated with the causation of GBC

Gut Microbiome and Crohn’s Disease: An Enigmatic Crosstalk

Crohn’s disease (CD) is a chronic, recurrent, immune-mediated inflammatory bowel disease that demonstrates a spectrum of intestinal and extra-intestinal manifestations. The pathogenesis of CD is multifactorial and involves a complex interplay between environmental and microbiological factors in a genetically susceptible host. There is robust evidence suggesting the role of gut microbial dysbiosis in the development as well as exacerbation of CD by immune dysregulation and alteration in the immune microbiota crosstalk. Patients with CD show reduced commensal microbial diversity, along with increased numbers of pathogenic Enterobacteriaceae and Proteobacteriaceae. Faecalibacterium prausnitzii, an anti-inflammatory molecule-producing bacteria, is also seen in reduced numbers in patients with CD and is associated with an increased risk of recurrence. There has been a paradigm shift in the management of patients of CD, from controlling symptoms to controlling inflammation and promoting mucosal healing. Current treatment strategies aim to replace, remove, reset, or redesign the gut microbiota for the therapeutic benefits of patients with CD. These include microbial restoration therapies such as dietary modification, the use of pre-, pro-, and postbiotics, and fecal microbiota transfer (FMT). This chapter focuses on the role of gut microbiota in the pathophysiology of CD and the emerging concepts in microbial therapeutics

Prevalence and Health related effects of Internet Addiction on Medical students in a Tertiary care center

Background: Internet usage has increased exponentially in recent years. This growing use of internet has become worrisome as to whether to consider this excessive use as an addiction and if it negatively impacts one’s physical, mental and social health Aim: To investigate the prevalence of internet addiction and its association with health related factors in Medical students. Methods and Materials: A cross-sectional study was conducted with a sample size of 250. The students were asked to self-administer a semi-structured proforma regarding internet usage, Young’s IAT and Duke’s Health Profile. Young’s IAT was used to measure the addition level. Duke’s Health Profile was used to assess the physical, mental and social status. Result: 250 students participated in the study, 62% male and 38% female. 86% were found to be average online user and 1.2% had scores of category of Internet addiction. There was a significantly positive association between monthly expenditure and Young Score Grade. Those falling in category of Internet Addiction had low physical, mental and general health score and high Anxiety and Depression Score. Conclusion: From this study it can be concluded that internet addiction may have negative impact on physical, mental and social well-being of Medical students

Peri-conceptional supplementation of folic acid-knowledge and practices of pregnant women and health providers

Context: Neural tube defects (NTDs) are one of the most common congenital anomalies. NTDs are preventable if folic acid (FA) is supplemented before and during conception. Knowledge and supplementation of FA by pregnant women as well as it's timely provision by health providers is crucial in reducing the burden of NTDs in the community. Aim: To study the knowledge and supplementation of FA by pregnant women and it's prescription/provision by health providers. Settings and Design: A cross-sectional study was conducted in the block Doiwala, District Dehradun, Uttarakhand. Subjects and Methods: A total of 400 pregnant women and 121 government health providers (5 medical officers, 25 auxiliary nurse midwives [ANMs], and 91 accredited social health activists [ASHAs]) were interviewed on predesigned, pretested questionnaire by study/field investigator. Statistical Analysis Used: Proportion of different variables calculated and Chi-square test with Yates correction was applied. Results: Of 400, 73.50% of women had heard of FA. Overall, knowledge scores suggested intermediate to low level of knowledge about FA. Totally 94.25% of women had planned pregnancies; however, only 4.75% of women reported FA supplementation before conception. This indicates that if these women would have been properly counseled and prescribed FA, they might have taken it. About 60% of medical officers, 4% of ANMs, and 3.3% of ASHAs knew FA deficiency as one of the causes of NTD. None of the health providers reported to be prescribing/counseling FA to pregnant women. FA was out of supply on the block at the time of the study. Conclusions: Knowledge and supplementation practices related with FA are poor

Urine Zinc-alpha-2-glycoprotein as a potential biomarker for incipient diabetic nephropathy: A pilot study at a tertiary care hospital

Introduction: Urine albumin-creatinine ratio (UACR) continues to be used as ana indicator for detecting diabetic nephropathy (DN); however, damage starts much before that. Currently, no biomarkers are there to indicate incipient damage. As a result, researchers are looking for new biomarkers that could be used to detect DN threats sooner and perhaps hinder the development of end-stage renal disease. The present study intended to know if urine Zinc-alpha-2-glycoprotein (ZAG) levels correlate with glomerular filtration rate (GFR) in the study participants of type 2 diabetes mellitus (T2DM). Materials and Methods: The study included 68 participants with a known history of T2DM. Serum urea and creatinine levels, fasting plasma glucose, serum cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, total protein, glycated hemoglobin (HbA1c) and urine ZAG were estimated and UACR along with estimated GFR (eGFR) were calculated for all individuals. The characteristics of the study participants in the microalbuminuric and normoalbuminuric groups were compared. Results: The levels of urine ZAG in the microalbuminuric and normoalbuminuric groups were not observed to be substantially different. The relationship between urine ZAG and diabetes mellitus duration was found to be highly significant in normoalbuminuric patients. Urinary ZAG and correlation with categories of HbA1c % (good 9 poor) among normoalbuminuric individuals were not found to be significant. Conclusion: Despite previous research, we were unable to find a positive relationship between urinary ZAG concentrations and eGFR in this study. Prospective studies with greater sample sizes and follow-up are required to fully comprehend the possible use of ZAG as a biomarker in diabetic nephropathy

Assessment of Folic Acid Supplementation in Pregnant Women by Estimation of Serum Levels of Tetrahydrofolic Acid, Dihydrofolate Reductase, and Homocysteine

Background. Status of folic acid use in pregnant women of the hilly regions in North India was little known. This study was carried out to assess the folic acid use and estimate folate metabolites in pregnant women of this region. Materials and Methods. This cross-sectional study is comprised of 76 pregnant women, whose folic acid supplementation was assessed by a questionnaire and serum levels of homocysteine, tetrahydrofolic acid (THFA), and dihydrofolate reductase (DHFR) were estimated using Enzyme Linked Immunoassays. Results. The study data revealed awareness of folic acid use during pregnancy was present in 46.1% and 23.7% were taking folic acid supplements. The study depicted that there was no statistically significant difference between serum levels of THFA and DHFR in pregnant women with and without folic acid supplements (p=0.790). Hyperhomocysteinemia was present in 15.78% of the participants. Conclusion. Less awareness about folic acid supplementation and low use of folic acid by pregnant women were observed in this region. Sufficient dietary ingestion may suffice for the escalated requirements in pregnancy, but since this cannot be ensured, hence folic acid supplementation should be made as an integral part of education and reproductive health programs for its better metabolic use, growth, and development of fetus

Genetic Variations in IL-1β, TNF-α, and TGF-β Associated with the Severity of Chronic Cervical Spondylitis in Patients

Chronic cervical spondylitis (CCS), a degenerative disorder of the spine, is known for causing disability among old and young people. Single-nucleotide polymorphisms (SNPs) in various cytokine genes have demonstrated an impactful association with several inflammatory disorders. In the present study, we have investigated the SNPs and allelic distribution of the three most prevalent cytokines genes, IL-1β (-511C/T), TNF-α (-308G/A), and TGF-β (-509C/T), along with serum levels of these cytokines in 252 subjects. SNPs were analyzed using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP), and digested fragments were separated and visualized using agarose gel electrophoresis and Native Polyacrylamide gel electrophoresis (PAGE). The serum cytokine levels were analyzed with a flow cytometer using a customized multiplex bead-based assay. It was observed that these SNPs did not reflect the susceptibility to CCS but were associated with susceptibility to CCS. We found a significant association between the C/C and G/G genotypes and the C and G alleles of IL-1β and TNF-α, respectively, suggesting a lower risk of CCS. The frequency distribution of risk alleles (-511T) and (-308A) were simultaneously higher in CCS compared to the control, reflecting the susceptibility to CCS. TGF-β showed a significant association with disease susceptibility, along with a significant correlation between age and the chronicity of CCS. The serum cytokine levels were significantly different in CCS and controls