Clinical presentation and mortality risk factors for COVID-19 among diabetic patients in a tertiary care center in South India.

BACKGROUND: Non-communicable diseases (NCD) like hypertension, diabetes, cardiovascular and cerebrovascular diseases are the most common comorbidities among COVID-19 patients. The clinical presentation and mortality pattern of COVID-19 are different for patients with comorbidities and without comorbidities. OBJECTIVE: To determine the clinical presentation of COVID-19 and risk factors for COVID-19 mortality among diabetic patients in a tertiary care hospital in South India. METHODS: A record-based cross-sectional study was conducted by reviewing the case records of COVID-19 patients admitted for treatment from June 2020 to September 2020 in a tertiary care centre in South India. Potential risk factors for COVID-19 mortality were analysed using univariate binomial logistic regression, generalized linear models (GLM) with the Poisson distribution. Survival curves were made using the Kaplan-Meier method. RESULTS: Out of 200 COVID-19 patients with diabetes with a mean (SD) age of 56.1 (11.8) years, 61% were men. The median survival time was slightly lesser in male COVID-19 patients (15 days) as compared to female patients (16 days). The risk of mortality among COVID-19 patients with diabetes is increased for patients who presented with breathlessness (aRR = 4.5 (95% CI: 2.3-8.8)), had positive history of smoking (aRR = 1.9 (95% CI: 1.1-3.8)), who had CKD (aRR = 1.8 (95% CI: 1.1-2.8)) and who had cardiac illness (aRR = 1.6 (95% CI: 0.9-2.7)). CONCLUSION: Diabetes patients with COVID-19 need to be given additional care and monitoring especially if they present with breathlessness, positive history of smoking, cardiac illness and, CKD. Public health campaigns and health education activities to control smoking is needed to reduce the COVID-19 mortality in diabetes patients.

A Systematic Review and Meta-Analysis of Premenstrual Syndrome with Special Emphasis on Herbal Medicine and Nutritional Supplements.

Herbal medicine and nutritional supplements are suggested to treat premenstrual somatic and psycho-behavioural symptoms in clinical guidelines; nonetheless, this is at present based on poor-quality trial evidence. Hence, we aimed to design a systematic review and meta-analysis for their effectiveness in alleviating premenstrual symptoms. The published randomized controlled trials (RCTs) were extracted from Google scholar, PubMed, Scopus and PROSPERO databases. The risk of bias in randomized trials was assessed by Cochrane risk-of-bias tool. The main outcome parameters were analysed separately based on the Premenstrual Symptom Screening Tool and PMTS and DRSP scores. Secondary parameters of somatic, psychological, and behavioural subscale symptoms of PSST were also analysed. Data synthesis was performed assuming a random-effects model, and standardized mean difference (SMDs) was analysed using SPSS version 28.0.0 (IBM, Armonk, NY, USA). A total of 754 articles were screened, and 15 RCTs were included (n = 1211 patients). Primary results for participants randomized to an intervention reported reduced PSST (n = 9), PMTS (n = 2), and DSR (n = 4) scores with (SMD = -1.44; 95% CI: -1.72 to -1.17), (SMD = -1.69; 95% CI: -3.80 to 0.42) and (SMD = 2.86; 95% CI: 1.02 to 4.69) verses comparator with substantial heterogeneity. Physical (SMD = -1.61; 95% CI = -2.56 to -0.66), behavioural (SMD = -0.60; 95% CI = -1.55 to0.35) and mood (SMD = 0.57; 95% CI = -0.96 to 2.11) subscale symptom groupings of PSST displayed similar findings. Fifty-three studies (n = 8) were considered at low risk of bias with high quality. Mild adverse events were reported by four RCTs. Based on the existing evidence, herbal medicine and nutritional supplements may be effective and safe for PMS.

Effect of Indian Music as an Auditory Stimulus on Physiological Measures of Stress, Anxiety, Cardiovascular and Autonomic Responses in Humans-A Randomized Controlled Trial.

Among the different anthropogenic stimuli humans are exposed to, the psychological and cardiovascular effects of auditory stimuli are less understood. This study aims to explore the possible range of change after a single session of auditory stimulation with three different 'Modes' of musical stimuli (MS) on anxiety, biomarkers of stress, and cardiovascular parameters among healthy young individuals. In this randomized control trial, 140 healthy young adults, aged 18−30 years, were randomly assigned to three MS groups (Mode/Raga Miyan ki Todi, Malkauns, and Puriya) and one control group (natural sounds). The outcome measurements of the State-Trait Anxiety Inventory, salivary alpha-amylase (sAA), salivary cortisol (sCort), blood pressure, and heart rate variability (HRV) were collected at three time points: before (M1), during (M2), and after the intervention (M3). State anxiety was reduced significantly with raga Puriya (p = 0.018), followed by raga Malkauns and raga Miyan Ki Todi. All the groups showed a significant reduction in sAA. Raga Miyan ki Todi and Puriya caused an arousal effect (as evidenced by HRV) during the intervention and significant relaxation after the intervention (both p < 0.005). Raga Malkauns and the control group had a sustained rise in parasympathetic activity over 30 min. Future studies should try to use other modes and features to develop a better scientific foundation for the use of Indian music in medicine.

A comparison of nutritional status between children with and without disabilities: A community-based study.

BACKGROUND: Children with disabilities are expected to have poor nutritional status in comparison to children without disabilities. However, limited data on nutritional status of children with and without disabilities in rural settings in India. OBJECTIVE: To assess and compare the nutritional status of children with and without disability. METHODS: A cross-sectional study among children aged 5-15 years was conducted in the rural practise area of a medical college in Karnataka. 290 children (145 with and 145 children without disability) of similar age and sex were studied. Age and sex-specific World Health Organization (WHO) BMI centiles, 24 h dietary calorie and protein intakes were assessed and compared. Median and interquartile ranges were calculated for quantitative variables. Mann-Whitney U test was used to assess the differences in quantitative variables among the two groups. RESULTS: As per WHO BMI centiles, 33.1% with and 37.20% without disabilities were undernourished. The median calorie consumed by children with disabilities was 1169.0 (946.5-1586.0) significantly lower compared to that of children without disability, that is, 1362.0 (1167.0-1641.0). The median protein consumed by children with disabilities was 28.0 (22.5-38.0) significantly lower compared to that of children without disability, that is, 32.0 (28.0-40.0). CONCLUSIONS: Children with disabilities had similar rates of undernutrition as that of their non-disabled peers and their lesser dietary intake in terms of calories and proteins.

Clinical profile and risk factors for mortality among COVID-19 inpatients at a tertiary care centre in Bengaluru, India.

COVID-19 is an emerging viral disease affecting more than 200 countries worldwide and it present with varied clinical profile throughout the world. Without effective drugs to cure COVID-19, early identification and control of risk factors are important measures to combat COVID-19.  This study was conducted to determine the clinical profile and risk factors associated with mortality among COVID-19 patients in a tertiary care hospital in South India. This record-based longitudinal study was conducted by reviewing the case records of COVID-19 patients admitted for treatment from June 2020 to September 2020 in a tertiary care centre in South India. The clinical details, discharge/death details, were collected and entered in MS Excel. Potential risk factors for COVID-19 mortality were analysed using univariate binomial logistic regression, generalized linear models (GLM) with Poisson distribution. Survival curves were made using the Kaplan-Meier method. Log-rank test was used to test the equality of survivor functions between the groups. Out of 854 COVID-19 patients, 56.6% were men and the mean (standard deviation) age was 45.3(17.2) years. The median survival time was significantly lesser in male COVID-19 patients (16 days) as compared to female patients (20 days). Increasing age, male gender, patients presenting with symptoms of fever, cough, breathlessness, smoking, alcohol consumption, comorbidities were significantly associated with mortality among COVID-19 patients. Patients with older age, male gender, breathlessness, fever, cough, smoking and alcohol and comorbidities need careful observation and early intervention.  Public health campaigns aimed at reducing the prevalence of risk factors like diabetes, hypertension, smoking and alcohol use are also needed.

Deprescribing of benzodiazepines and Z-drugs amongst the psychiatric patients of a tertiary care Hospital.

BACKGROUND: In current clinical practice, regardless of the clinical guidelines, BZDs and Z drugs are used beyond the period of indication, resulting in undesirable effects. This study aimed to assess feasibility of deprescribing amongst patients utilizing BZDs and Z drugs inappropriately for longer duration than the prescribed period. The study also analysed the Quality of Sleep (QoS) and Cost Savings incurred amongst deprescribed patients. METHODS: It was a prospective interventional study conducted in IP and OP settings of Psychiatry Department, Bangalore, India. Based on inclusion criteria, 109 patients were recruited for the study for a period of 7 months. Deprescribing was advised to inappropriate BZD and Z-drug users by clinical pharmacist after discussing with the prescribing psychiatrist. The patients were followed-up twice in a month after deprescribing. QoS was assessed by using Pittsburg Sleep Quality Index (PSQI) scale. The total medications cost incurred per patient/month before and after the intervention among both the groups was measured. RESULTS: Post-intervention, 40(30.69%) BZD users were deprescribed i.e, either dose tapered 6(5.5%), completely ceased 27(24.8%) or on si opus sit (SOS) BZDs prescription 7(6.4%). A majority of 44(40.36%) patients continued BZDs according to the algorithm. Clonazepam 35(87.5%) was the most deprescribed BZD. Deprescribing of BZDs showed an association with QoS of patients, p-value (<0.05). A statistically significant cost reduction was observed after deprescribing BZDs, (Z = 5.465, p=<0.001). DISCUSSION: Deprescribing BZDs was associated with decline in its usage; implementing deprescribing practice amongst the inappropriate BZD users is feasible, provides an improved QoS and an economic benefit.

Safety Profile of Levonorgestrel: A Disproportionality Analysis of Food and Drug Administration Adverse Event Reporting System (Faers) Database.

BACKGROUND: Levonorgestrel is most commonly utilized as an emergency oral contraceptive. Little is known and/or studied about the adverse effects of levonorgestrel, therefore, current investigation was aimed to generate signal for unreported adverse drug reactions of levonorgestrel using disproportionality analysis in food and drug administration adverse events reporting system database. METHODS: In FDA Adverse Events Reporting System (FAERS) database, all adverse event reports for levonorgestrel between January 2006 to June 2015 were identified and disproportionality analysis was conducted for selected adverse events of levonorgestrel using Reporting Odds Ratio, Proportional Reporting Ratio and Information Component with 95% confidence interval. RESULTS: A disproportionality analysis was done for 15 adverse events of levonorgestrel; out of these, signal for 10 adverse events was found and among them menstruation delayed was reported maximum (1791), followed by pregnancy after post-coital contraception (942), breast tenderness (901), metrorrhagia (899), dysmenorrhea (822), menorrhagia (541), nipple disorder (141), breast enlargement (77), ectopic pregnancy (61) and premenstrual syndrome (35). Pregnancy after post-coital contraception showed the highest signal having the Information Component value of 129.2, Reporting Odds Ratio value of 6.51 and Proportional Reporting Ratio value of 6.49. CONCLUSION: In this paper, ten novel AEs were identified that were disproportionately reported with the use of LNG by using data mining techniques. Although a causal relationship cannot be established, the number of cases reported suggests that there might be an association. If confirmed by epidemiologic studies, the findings from this study would have potential implications for the use of LNG and patient management in clinical practice.

Adverse Drug Reaction Monitoring in a Tertiary Care Psychiatry Setting: A Comparative Study between Inpatients and Outpatients.

BACKGROUND: Psychotropic medications are the mainstay of treatment in psychiatric disorders and are associated with ADRs which affect the compliance and treatment course. Previous studies have looked at the frequency, profile of ADRs and their management aspects. However, the systematic comparison between IP and OP was lacking even though there is a prescription pattern difference. Hence this study was aimed to compare the proportion, pattern, severity and resolution of ADRs once detected. METHODS: This is a hospital based, prospective follow up study done in the psychiatry ward and outpatient setting for a period of 6 months. A total of 491 patients (200 IP, 291 OP) who received psychotropics were monitored in the study. UKU side effect rating scale was used to detect ADRs, WHO - UMC scale for causality, Modified Hartwig and Siegel Scale to assess severity of ADR and CDSCO suspected ADR form for reporting it. RESULTS: Out of 491 patients who were recruited for the study, 83 patients developed ADRs (34 IP, 49 OP, P = 0.963). The mean number of ADRs per patient was found to be higher in IP (IP-2.17±1.14, OP-1.65±1.12, P-0.01). Severe ADRs were observed to be higher IP (IP-67.64%, OP-38.7%, P-0.014) which was statistically significant. There is no statistically significant difference in distribution of ADRs across all age groups (P-0.475). CONCLUSION: The study results emphasises the need for active pharmacovigilance so that ADRs are detected and managed at the earliest, hence reducing the morbidity and improving compliance. There is also need for systematic long term, multicentric study to further examine and correlatethe observations of our study.

Meteorological parameters and pollutants on asthma exacerbation in Bangalore, India - an ecological retrospective time-series study.

BACKGROUND: Literature has shown a significant association between asthma exacerbations and pollutant levels during that time. There is very limited evidence in India, especially Bangalore, for impacts of meteorological changes and pollution on asthma hospital admissions in adults. The objective was to study the impact of air pollution and meteorological parameters on asthma exacerbation in Bangalore. METHODS: This study quantitatively analyzed the relation between acute exacerbations of asthma and related admissions to the hospital with the air pollution and the meteorological conditions during that time. Data regarding the daily hospital admissions in about 13 tertiary care centers in Bangalore, Karnataka and air pollutant levels and the meteorological conditions prevailing during each day over a year were collected from the Karnataka State pollution control board and meteorology departments, respectively. RESULTS: An average daily asthma admission of 4.84±2.91, with clear seasonal variation and autocorrelations between meteorological parameters and pollutants was observed. Multiple linear regression analysis revealed that average temperature (p=0.005) and nitrogen dioxide (NO2) (p=0.034) were the two factors that were affecting the number of admissions. Quasi-poisson regression analysis using multi-pollutants and meteorological variables showed that particulate matter and NO2 had significant lag effect for up to 5 days (p<0.05) and rainfall for 1 day (p<0.001). CONCLUSIONS: In Bangalore city, levels of NO2 and particulate matter, temperature, rainfall, and season increase asthma exacerbations.

Combination of music with lifestyle modification versus lifestyle modification alone on blood pressure reduction - A randomized controlled trial.

OBJECTIVE: To evaluate the change in blood pressure (BP) after 3 months of music intervention combined with lifestyle modifications, in comparison with conventional lifestyle modifications. METHODS: A Prospective randomized control trial was conducted on hundred prehypertensives or stage I hypertensives who were randomly divided into two groups (n = 50 each). Both the groups were given lifestyle modifications while one had added music intervention (raga bhimpalas) for 3 months. Main outcome measures were 24 h ambulatory BP monitoring, stress levels, and biomarkers of hypertension. RESULTS: Mean (SD) of diastolic BP (DBP) pre and post intervention were overall = 85.1(6.8) and 83(8.7){P = 0.004}, awake = 87.7(7.6) and 85.9(9.2){P = 0.021}. Regression analysis showed association between diastolic BP change and post-intervention stress score in the music intervention group. Significant change in BP was seen among those who were prehypertensives prior to intervention. CONCLUSION: Music decreased DBP and when used as an adjunct benefitted subjects with initial BP in prehypertension range.

Competing Risk Approach (CRA) for Estimation of Disability Adjusted Life Years (DALY's) for Female Breast Cancer in India.

BACKGROUND: Competing Risk Approach (CRA) has been used to compute burden of disease in terms of Disability Adjusted Life Years (DALYs) based on a life table for an initially disease-free cohort over time. OBJECTIVE: To compute Years of Life Lost (YLL) due to premature mortality, Years of life lost due to Disability (YLD), DALYs and loss in expectation of life (LEL) using competing risk approach for female breast cancer patients for the year 2008 in India. MATERIALS AND METHODS: The published data on breast cancer by age & sex, incidence & mortality for the year 2006-2008 relating to six population based cancer registries (PBCR) under Indian Council of Medical Research (ICMR), general mortality rates of 2007 in India, published in national health profile 2010; based on Sample Registration System (SRS) were utilized for computations. Three life tables were constructed by applying attrition of factors: (i) risk of death from all causes ('a'; where a is the general death rate); (ii) risk of incidence and that of death from causes other than breast cancer ('b-a+c'; where 'b' is the incidence of breast cancer and 'c' is the mortality of breast cancer); and (iii) risk of death from all other causes after excluding cancer mortality ('a-c'). Taking the differences in Total Person Years Lived (TPYL), YLD and YLL were derived along with LEL. RESULTS: CRA revealed that the DALYs were 40209 per 100,000 females in the life time of 0-70+ years with a LEL of 0.11 years per person. Percentage of YLL to DALYs was 28.20% in the cohort. CONCLUSION: The method of calculation of DALYs based on the CRA is simple and this will help to identify the burden of diseases using minimal information in terms of YLL, YLD, DALYs and LEL.

Music versus lifestyle on the autonomic nervous system of prehypertensives and hypertensives--a randomized control trial.

OBJECTIVES: Ragas of Indian music are said to be beneficial in normalizing blood pressure (BP). The objective of this study was to evaluate the effect of passive listening to relaxing raga on the autonomic functions of hypertensives and prehypertensives and provide scientific evidence. METHODS: Ethical clearance was obtained from the institutional review board. A prospective, randomized controlled trial was done on hundred prehypertensives/stage I hypertensives, randomly divided into two groups (n=50 in each). Group 1 received music intervention along with lifestyle modifications while Group 2 received only lifestyle modifications (according to Joint national committee VII guidelines). Group 1 listened to raga bhimpalas played on flute for 15min daily for at least 5 days/week for 3 months. The main outcome measures were heart rate variability (HRV) (Power lab 15T, AD Instruments), BP and stress levels (State Trait anxiety inventory score). All HRV variables were log transformed for analysis. Statistical analysis was done using SPSS version 18.0 with P<0.05 being considered statistically significant. RESULTS: Group 1 exhibited significant reduction in stress levels, diastolic BP and systolic BP decreased in Group 2 after intervention. Insignificant rise in parasympathetic parameters of HRV (SDNN, RMSSD, HF ms(2), HF nu) was seen after intervention in both the groups. We found significantly increased parasympathetic and lower sympathetic parameters (LF ms(2), LF nu, LF/HF) in Group 1 and 2 males and females of Group 2. The results suggest that females of Group 1 were least compliant with the given intervention. CONCLUSIONS: Passive listening to Indian music along with conventional lifestyle modifications has a role in normalizing BP through autonomic function modification and thus can be used as a complementary therapy along with other lifestyle modifications.

Effect of Yoga Practice on Levels of Inflammatory Markers After Moderate and Strenuous Exercise.

BACKGROUND AND OBJECTIVES: To evaluate the effect of yoga practice and exercise challenge on Tumour Necrosis Factor alpha (TNF-α), Interleukin-6 (IL-6) levels and lipid profile. MATERIALS AND METHODS: Two hundred and eighteen subjects participated in the study. One hundred and nine volunteers (51 males and 58 females) in the age group of 20 to 60 years, who practiced yoga regularly for over five years for a period of one hour daily, performed a bout of moderate exercise and a bout of strenuous exercise as per Standardized Shuttle Walk test protocol. Anthropometrically matched, age matched and gender matched subjects, who did not practice yoga (non-yoga group) were chosen as controls (non-yoga, n=109). The non-yoga group also performed similar exercises. The blood samples of both the groups were collected before and after the exercises. TNF-α and IL-6 was analysed before and after the exercise by Sandwich ELISA (Enzyme Linked Immunosorbent Assay). RESULTS: Resting plasma TNF-α concentration was significantly higher in non-yoga group when compared to yoga group (p<0.05). There was an increase in TNF-α levels in both the groups in response to strenuous exercise. There was no gender difference in TNF-α and IL-6 levels before and after exercise in yoga and non-yoga groups. CONCLUSION: Regular practice of yoga lowers basal TNF-α and IL-6 levels. It also reduces the extent of increase of TNF-α and IL-6 to a physical challenge of moderate exercise and strenuous exercise. There is no significant gender difference in the TNF-α and IL-6 levels. Regular practice of yoga can protect the individual against inflammatory diseases by favourably altering pro-inflammatory cytokine levels.

BIS Targeted Propofol Sparing Effects of Dexmedetomidine Versus Ketamine in Outpatient ERCP: A Prospective Randomised Controlled Trial.

BACKGROUND: Endoscopic Retrograde Cholangio Pancreatography (ERCP) is routinely performed under propofol sedation. Adjuvant drugs have improved the quality of propofol sedation while minimizing complications. The aim of the study was to compare the propofol consumption, recovery and hemodynamic profiles of dexmedetomidine versus ketamine against a placebo control with BIS targeted in the sedative range for outpatient ERCP procedures. MATERIALS AND METHODS: The study comprised of 72 patients undergoing ERCP, who were randomly allocated into one of the 3 groups: Group Dexmedetomidine (n =24) receiving a bolus and infusion of dexmedetomidine (1µg/kg and 0.5µg/kg/hr); Group Ketamine (n = 24) receiving a bolus and infusion of ketamine (0.25mg/kg and 5µg/kg/min) and Group Control (n =24) receiving saline placebo as a bolus and infusion with variable propofol boluses administered in all groups targeting BiSpectral Index between 60-70. RESULTS: The total propofol consumption was significantly lower in both Dexmedetomidine (162.5 ± 71.7 mg ) and Ketamine groups (158.3 ± 66.89 mg) when compared with Control group (255.83 ± 114.12 mg)(p=0.001) .Time taken (minutes) to achieve Modified Aldrette Score (MAS) >9 and Observer Assessment of Alertness and Sedation (OAAS) score >4 was significantly prolonged in Dexmedetomidine group (MAS 16.6 ± 3.18 and OAAS 16.67 ± 2.82) compared to Ketamine (MAS 10 ± 4.17 and OAAS 8.75 ± 3.68) and Control (MAS 7.5 ± 3.29 and OAAS 6.88 ± 2.47) (p<0.001). Hemodynamic profiles were comparable although patients in dexmedetomidine had a statistically significant lower heart rate (p<0.001) although without clinical significance. CONCLUSION: Low dose ketamine with background propofol boluses resulted in lesser propofol consumption, with earlier recovery and favourable hemodynamics when compared with Dexmedetomidine and control group in outpatient ERCP.