Tulsi Adhikari

Potential of Mw as a prophylactic vaccine against pulmonary tuberculosis

Mycobacterium w (Mw), is a cultivable, non-pathogenic mycobacterium and has been tried extensively as an immunomodulator in leprosy. This has been found to be safe and has shown beneficial immunoprophylactic effect in population based, double blind placebo controlled trials in North India. These effects were also observed in the vaccine trials in South India. Keeping in view these beneficial effects and its earlier reported protective effect against tuberculosis in animals, its protective efficacy was evaluated in a rural population of about 28,948 people belonging to 272 villages in Ghatampur, Kanpur (India). The population was vaccinated with two doses (1st dose of 1x10(9) heat killed organisms followed 6 months later with a 2nd dose of 5x10(8) organisms) of Mw 10-13 years ago originally to investigate its effect against leprosy. The vaccine/placebo was given to healthy contacts of leprosy patients who had no evidence of suffering from tuberculosis. Incidence and prevalence of pulmonary tuberculosis in the present study was assessed in a blind manner by an active field survey and also retrospectively by history of anti tuberculosis treatment received by the patient in the intervening period (since vaccination), which was also corroborated by scrutinizing the medical records. Diagnosis was confirmed by standard clinical and bacteriological criteria. A total of 69 patients were diagnosed to be suffering from pulmonary tuberculosis during the survey which included 17 new sputum smear positive cases and 52 previously partially treated but still active pulmonary tuberculosis cases. The difference in the new sputum positive cases between the vaccinated (5/17) and placebo groups (12/17) was significant at 5% level of significance for 1 tailed test (Z>1.64). As 75% (52/69) of the cases had been diagnosed as suffering from pulmonary tuberculosis but had not taken adequate therapy all the cases diagnosed during the intervening period were recorded and re-analysis done. The differences are more significant at 1% level of significance for 1 tail test (Z>2.59) when all cases were analysed as a group. A small proportion 12.85% (total number=3036) of the contacts in the study population had BCG scars. On analysis of results on protection against tuberculosis in this group, BCG did provide protection against tuberculosis (p<0.01). In the placebo group the prevalence of tuberculosis was 1.11% which reduced to 0.70% for those who received Mw vaccine (p<0.01) which further decreased to 0.53% in those who had BCG scars and received Mw. These results thus provide evidence suggesting protective efficacy of Mw against pulmonary tuberculosis and that Mw merits investigation in future prospective immunoprophylactic trials along with other candidates for protection against pulmonary tuberculosis.

Outcome of adenotonsillectomy for children with sleep apnea

BACKGROUND AND OBJECTIVES The prevalence of obstructive sleep apnea syndrome is about 1%-4.9% in children aged 2-18 years. This is a prospective study carried out to evaluate the role of adenotonsillectomy (AT) in pediatric sleep apnea. METHODS Fifty children aged less than 15 years presenting with the chief complaints of snoring, mouth breathing, recurrent upper respiratory infections, and adenotonsillar hypertrophy were included in the study. Physical examination included body mass index (BMI) z-score, orodental and nasal examination, modified Mallampati scoring; whole-night level I polysomnography was conducted and repeated after three to six months of AT. RESULTS The mean preoperative BMI z-score was -0.76, which improved significantly to -0.15 (p < 0.001) after AT. A negative correlation was seen between respiratory distress index (RDI) and pre surgery BMI z-score. As per pre-operative RDI, OSA was classified mild in 6.7% children (31.1% as per apnea-hypopnea index [AHI]), moderate in 35.6% (31.1% as per AHI), and severe in 57.8% (37.8% as per AHI). The average RDI value reduced significantly from 16.2 ± 10.7 to 6.46 ± 4.8 (p < 0.001) and AHI from 8.5 (SD ± 5.7) to 1.3 (SD ± 1) post-operatively. Only 6.7% children could be cured with surgery, of whom none belonged to moderate or severe category. Multivariate analysis shows that initial severity of disease, modified Mallampati scores III and IV, high-arched palate, and age above eight years were associated with significant residual disease after AT. CONCLUSION AT was associated with a statistically significant change in RDI and AHI. However, complete resolution of OSA could be seen in a small percentage of patients with a mild degree of disease.

Metabolic changes in normal- and underweight children with obstructive sleep-disordered breathing

OBJECTIVE This study evaluates the metabolic profile of normal- and underweight children with sleep-disordered breathing (SDB) due to adenotonsillar hypertrophy. METHODS A total of 39 children aged 3-15 years with SDB and 28 age- and gender-matched controls were included in the study. Body mass index z score, blood pressure, and fasting serum levels of triglycerides (TGs), high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, very-low-density lipoprotein (VLDL), blood glucose, plasma insulin, and homeostatic model assessment (HOMA) were determined in both case patients and controls. RESULTS We observed significantly lower levels of fasting blood glucose (p = 0.015) and higher levels of HDL (p = 0.002), LDL (p = 0.002), and cholesterol (p = 0.001) in case patients than in controls. The mean values of fasting insulin and HOMA were higher in case patients (6.42 ± 6.47 and 1.40 ± 1.48) than in controls (5.31 ± 3.40 and 1.20 ± 0.84) respectively. No direct correlation between indices of severity of SDB and various metabolic and blood pressure parameters was found. When the effect of body weight was studied by subgrouping case patients according to normal weight and underweight, significant increases in the levels of fasting insulin (p = 0.039), HOMA (p = 0.017), and fasting blood glucose (p = 0.021) were observed. Also, a significant correlation was observed between the duration of illness and fasting insulin (p = 0.023), HOMA (p = 0.020), fasting glucose (p = 0.004), and diastolic blood pressure (p = 0.030). CONCLUSION This study shows an independent effect of body weight and duration of illness on various metabolic and blood pressure parameters in normal- and underweight children with SDB.

Obesity may be the common pathway for sleep-disordered breathing in women with polycystic ovary syndrome

OBJECTIVE Polycystic ovary syndrome (PCOS) is one of the most common endocrinological disorders in women of reproductive age, and is characterized by hyperandrogenism. It is associated with long-term metabolic dysfunctions including sleep-disordered breathing (SDB). We hypothesized that the increased prevalence of SDB in PCOS results from raised testosterone levels. METHODS This was a prospective, cross-sectional, case-control study in which 50 case patients with untreated PCOS and 100 control subjects were included. All the case patients and control subjects went through a detailed clinical, biochemical, and hormonal evaluation. Overnight polysomnography was performed in all case patients and the snorers (16 of 100) in the control group. RESULTS SDB was seen in 66% of the case patients and in 4% of control group with (odds ratio [OR] = 46.5, 95% confidence interval [CI] = 14.6-148.4; p <0.001). After adjustment for body mass index (BMI) and waist circumference (WC), the difference was not significant (p = 0.993 and p = 0.931, respectively). The SDB patients with PCOS showed significantly higher respiratory distress index (RDI) values than SDB patients in the control group (22.5 ± 21.5 vs 9.0 ± 5.6, p = 0.01). On the Epworth Sleepiness Scale the PCOS case patients reported feeling more sleepy than did the control subjects (12.5 ± 3.2 vs 9.32 ± 1.7, p <0.001). Free testosterone levels were also significantly higher in the PCOS group than in the control subjects (2.95 ± 3.44 vs 1.5 ± 1.0, p <0.001). There was a significant correlation between free testosterone level and RDI values (r = 0.377; p = 0.007), WC (r = 0.315; p = 0.026), and BMI (r = 0.398; p = 0.004). A significant correlation of WC (r = 0.551; p <0.001) and BMI (r = 0.572; p <0.001) was observed with RDI. CONCLUSION Testosterone-induced obesity is probably the common pathway for the development of SDB in PCOS.

Comparison of haemoglobin estimates using direct & indirect cyanmethaemoglobin methods

Background & objectives: Estimation of haemoglobin is the most widely used method to assess anaemia. Although direct cyanmethaemoglobin method is the recommended method for estimation of haemoglobin, but it may not be feasible under field conditions. Hence, the present study was undertaken to compare indirect cyanmethaemoglobin method against the conventional direct method for haemoglobin estimation. Methods: Haemoglobin levels were estimated for 888 adolescent girls aged 11-18 yr residing in an urban slum in Delhi by both direct and indirect cyanmethaemoglobin methods, and the results were compared. Results: The mean haemoglobin levels for 888 whole blood samples estimated by direct and indirect cyanmethaemoglobin method were 116.1 ± 12.7 and 110.5 ± 12.5 g/l, respectively, with a mean difference of 5.67 g/l (95% confidence interval: 5.45 to 5.90, P<0.001); which is equivalent to 0.567 g%. The prevalence of anaemia was reported as 59.6 and 78.2 per cent by direct and indirect methods, respectively. Sensitivity and specificity of indirect cyanmethaemoglobin method were 99.2 and 56.4 per cent, respectively. Using regression analysis, prediction equation was developed for indirect haemoglobin values. Interpretation & conclusions: The present findings revealed that indirect cyanmethaemoglobin method overestimated the prevalence of anaemia as compared to the direct method. However, if a correction factor is applied, indirect method could be successfully used for estimating true haemoglobin level. More studies should be undertaken to establish agreement and correction factor between direct and indirect cyanmethaemoglobin methods.

Factors associated with utilization of antenatal care services among tribal women: A study of selected States

Background & objectives: Despite various efforts by the Government of India, utilization of antenatal care (ANC) services continues to be low among women from rural areas particularly those belonging to the Scheduled Tribes. The present study was undertaken to examine the factors associated with the utilization of ANC services among women in four States including Rajasthan, Odisha, Chhattisgarh and Madhya Pradesh which constitute a good share of tribal population of the country. Methods: Data from third round of District Level Household and Facility Survey, 2007-08 (DLHS-3) have been used. Bivariate and multivariate analyses (logistic regression model) were used to study the association between the utilization of ANC services and the independent variables at individual, household and village levels along with the motivational factors (motivation by health workers and family members). Results: The utilization of ANC services among Scheduled Tribes women varied from about 4 per cent in Madhya Pradesh and Rajasthan to 10-14 per cent in Chhattisgarh and Odisha. Utilization was highest among those women with level of education 9th class and above (15-28%) and those women who visited health facility for pregnancy confirmation test (9-27%). Across the States, women who visited health facility for pregnancy testing (adjusted odds ratio, AOR = 1.5-2.5; P<0.001) except in Madhya Pradesh; registration of pregnancy (AOR = 2.1-4.5; P<0.01) and sought treatment of pregnancy related problems (AOR = 1.5-1.8; P<0.06) except in Rajasthan, were more likely to avail complete ANC services than their counterparts. Interpretation & conclusions: The utilization of antenatal care among Scheduled Tribe women across four States was very poor. The reasons behind non-utilisation include both socio-economic and health system factors. For improving ANC utilization among tribes, these factors need to be addressed with special emphasis on womans educational attainment of high school and above. In addition, the study highlighted the need to create awareness among both pregnant tribal women as well as her family members on the importance of early ANC care.

Sleep Pattern of Adolescents in a School in Delhi, India: Impact on their Mood and Academic Performance

ObjectivesTo examine the sleep pattern and observe differences in sleep routines, phase preferences, mood, attendance, and academic performance among different adolescent age students. Secondly, to observe the age at which sleep phase transition and changes in sleep requirement become evident.MethodsA cross-sectional study was conducted among 501 students (aged 11–15 y) of a school in Delhi, India. Students were evaluated for their sleep patterns, sleep duration, habits of napping, quality of sleep, sleepiness, depression, phase preferences by self-reported school sleep habits survey questionnaire along with school performance and attendance.ResultsSignificant differences were found in sleep pattern of students aged 11–12 y and 13–15 y. Bedtime shifted to a later time with increasing age but early morning schools kept the wake time same, leading to a decline in total sleep duration of older adolescents. Older adolescents had higher depression but poor attendance and academic performance. Prevalence of sleep deprivation increased with age, from 83.7% to 87.1% in 11–12 y to 90.5% to 92.5% in 13–15 y.ConclusionsThe study clearly identifies 12–13 y as age of transition of sleep pattern among adolescents. Though significant differences were found in the academic performance, mood and attendance among preteens and teens but no direct association was seen between academic performances and sleep pattern. A complex multifactorial association between sleep patterns, attendance, mood and academic performance which may change over days, months, or years should be explored further in a longitudinal follow up study.

Testing of Hypothesis in Equivalence and Non Inferiority Trials-A Concept.

Establishing the appropriate hypothesis is one of the important steps for carrying out the statistical tests/analysis. Its understanding is important for interpreting the results of statistical analysis. The current communication attempts to provide the concept of testing of hypothesis in non inferiority and equivalence trials, where the null hypothesis is just reverse of what is set up for conventional superiority trials. It is similarly looked for rejection for establishing the fact the researcher is intending to prove. It is important to mention that equivalence or non inferiority cannot be proved by accepting the null hypothesis of no difference. Hence, establishing the appropriate statistical hypothesis is extremely important to arrive at meaningful conclusion for the set objectives in research.

Share of tobacco related cancers: gender and time gaps-Indian scenario.

INTRODUCTION Cancer is one of the leading causes of mortality in Indian population with control approach of varied kind which the health system of the country needs to prioritize. The tobacco related cancer which account for major share of all the cancers could be largely controlled through primary prevention a strategy effective in terms of resources hence take priority in terms of cancer control activities. It would be worthwhile to study the cancer of sites and relative magnitude of the cancers which are tobacco related and are amenable for prevention. MATERIALS AND METHODS The age specific cancer incidence rates of cancer as available from the consolidated reports of the National Cancer Registry Program of Indian Council of Medical Research for the years 1990-96 an 2001-04 were utilized for computing proportion of tobacco related cancers which included population based cancer registries at Bangalore, Bhopal, Barshi a rural registry in Maharashtra, Chennai, Delhi and Mumbai. As defined cancer of the sites oral cavity, lip, tongue, oropharynx, hypopharnx, pharynx, oesophagus, larynx, lung, urinary bladder were considered as tobacco related cancers. The statistical evaluation of proportion of tobacco related cancers between two time periods under consideration was carried out by proportion test. RESULTS There was a significant decline of proportion of tobacco related cancers from 1990-96 to 2003 for all the registries except Bhopal where around 50% of the total cancers attributed to tobacco habits for the two time periods under consideration. The Barshi also reported a decline but was not statistically significant. In females the proportion of tobacco related cancers ranged between 17% in Bangalore 10% in Delhi for the two time periods under review. All the registries showed significant decline in proportion of tobacco related cancers for the periods under consideration, except Delhi and Bhopal, while rural registry at Barshi revealed an increase of 3.3 %. The gender difference of the proportion of tobacco related cancers ranges between 19.8% to 34% during the period 1990-96, while it was 18.5% to 35% for the period 2001-03. While examining the difference between gender gap between the two time periods, the results from Mumbai registry revealed significant decline.

The Impact of Sleep-Disordered Breathing on Severity of Pregnancy-Induced Hypertension and Feto-Maternal Outcomes

BackgroundThere is a close association between sleep-disordered breathing (SDB) and preeclampsia. Both conditions have poor pregnancy outcomes.MethodsForty women with new-onset hypertension of pregnancy and 60 age-matched normotensive pregnant women were subjected to polysomnography. The maternal and fetal outcomes of all the subjects were noted.ResultsSDB occurs more frequently (p = 0.018; OR 13.1) and with more severity (p 0.001; OR 1.8) in women with hypertensive disorders of pregnancy even after controlling for pre-pregnancy body mass index (BMI). Furthermore, the BMI significantly correlated with both the Apnea–Hypopnea Index (AHI; r = 0.745; p < 0.001) and the blood pressure (r = 0.617; p < 0.001) highlighting the contribution of obesity in the causation of hypertension and SDB. We also found a significant correlation between AHI and blood pressure even after adjustment for BMI pointing toward an independent role of SDB in the development of hypertension (r = 0.612; p = 0.01). Maternal and fetal complications significantly correlated with different parameters of SDB–AHI, Arousal Index and minimum oxygen saturation, in the cases and with the fetal complications in the controls as well.ConclusionSDB occurs more frequently and with more severity in women with pregnancy-induced hypertension and is associated with more severe preeclampsia and adverse feto-maternal outcomes.