Effect of L-Carnosine in children with autism spectrum disorders: a systematic review and meta-analysis of randomised controlled trials.

Autism spectrum disorders (ASD) are an emerging health problem worldwide. So far, no definite cure for ASD exists. L-Carnosine is an amino acid containing ß-alanine and L-histidine which has been proposed to have neuroprotective, antioxidant and anti-convulsive properties that may benefit affected children with this disorder. This review aimed to assess the effect of L-Carnosine in the management of ASD in children. We systematically reviewed randomised controlled trials (RCTs) which documented the effect of L-Carnosine in children with ASD. A literature search was performed in PubMed, Cochrane Library, Google Scholar, ClinicalTrials.gov, Clinical Trial Registry-India databases from inception to December 20, 2020. Articles were selected based on pre-set inclusion/exclusion criteria. The primary outcomes were changes in social, communication and behavioural responses and the secondary outcomes were improvement in sleep disorders, gastrointestinal problems, oxidative stress markers and adverse effects. Jadad scale was used to assess the quality of RCTs and modified Cochrane risk of bias tool was used to check the risk of bias of the included studies. The meta-analysis was reported based on the fixed-effects model. Four double-blinded, placebo-controlled, RCTs and one open label trial with a total of 215 participants were selected for the review. All the trials were methodological of high quality according to the Jadad scale. The modified Cochrane risk of bias tool showed a low to high risk of bias. Results from the meta-analysis of three studies showed no significant difference between L-Carnosine and placebo groups in the Gilliam autism rating scale (GARS) (MD = - 2.57; 95% CI - 10.30, 5.16, p = 0.52) and in its socialisation (MD = - 1.51; 95% CI - 6.16, 3.14, p = 0.53), behaviour (MD = - 0.48; 95% CI - 4.82, 3.87, p = 0.83) and communication (MD = - 3.94; 95% CI - 10.00, 2.11, p = 0.20) subscales as well as the childhood autism rating scale (CARS) (MD = - 0.88; 95% CI - 6.96, 5.20; p = 0.78). Current data do not support the use of L-Carnosine in the management of children with ASD due to a low number of studies and sample size available. Further studies are warranted to know the effect of L-Carnosine for ASD management.

Effect of sertraline in patients with newly diagnosed depression and type 2 diabetes mellitus or hypertension: An observational study from south India.

BACKGROUND AND AIMS: Patients with either type II diabetes mellitus (T2DM) or hypertension (HTN) are more prone to develop depression when compared with the general population. Along with comorbid of either T2DM or HTN, treatment of depression may become an even bigger challenge. The present study aimed to observe the effect of sertraline in newly diagnosed depression patients with T2DM or HTN. METHODS: A prospective, observational study was conducted in the T2DM or HTN patients who were newly diagnosed as depression patients. Parameters such as, glycated hemoglobin (HbA1c), systolic blood pressure (SBP), diastolic blood pressure (DBP) and Hamilton Depression Rating Scale (HAM-D) score for depression were measured before and after initiating sertraline therapy (50 mg, twice daily). Paired t-test was used to find out the statistical significance. RESULT: Of the 546 enrolled patients, 291 patients were in T2DM and 255 patients with HTN. No statistically significant difference (p > 0.05) was observed between baseline and 12th week of comparison with respect to HbA1c, SBP and DBP values. While at the end of treatment, the number of patients suffered from depression in severe state were improved to moderate to a mild state of depression. Statistically significant difference (p < 0.001) was observed in both T2DM and HTN groups when comparing the total score of HAM-D before and after sertraline treatment. CONCLUSION: Sertraline is effective in the management of newly diagnosed depression among T2DM or HTN patients. However, the results should be confirmed by a double blinded placebo studies.

Prevalence of metabolic syndrome in patients with chronic obstructive pulmonary disease: An observational study in South Indians.

BACKGROUND AND AIMS: Metabolic syndrome (MetS) has a significant association with airflow obstruction and physical inactivity, which are the relevant extra-pulmonary markers of chronic obstructive respiratory disease (COPD). This study aimed to estimate the prevalence of MetS and its correlation with comorbidities and health related quality of life (HRQoL) in South Indian patients with COPD. METHODS: A cross-sectional study was conducted among the 76 COPD patients. Pulmonary function test (PFT) and parameters for MetS such as waist circumference, blood pressure, fasting blood glucose, triglycerides (TGs) and high density lipoprotein cholesterol (HDL-C) levels of COPD patients were measured. HRQoL was calculated using Saint George Respiratory Questionnaire (SGRQ). RESULTS: 54% of COPD patients were presented with MetS especially in stage II and III. TGs and HDL-C were significantly associated with the severity of COPD (p < 0.05), while waist circumference, TGs and HDL-C were significantly (p < 0.05) correlated with PFT. Symptom, activity, impact and total scores of SGRQ was increased statistically (p < 0.05) in COPD patients with MetS than without MetS. CONCLUSION: According to our findings, screening the grade II and III COPD patients for the presence of MetS is a reasonable option. The results of this study should be confirmed with a larger sample of population.

Surveillance of adverse drug reactions and drug-drug interactions with pediatric oncology patients in a south Indian tertiary care hospital.

OBJECTIVE: The present study was conducted to evaluate the pattern of occurrence of adverse drug reactions and drug-drug interaction in a pediatric oncology unit of a tertiary care hospital. METHODS: A prospective, observational study was conducted in the Department of Pediatric Oncology, Sri Ramachandra Medical College and Hospital, India. Patients were monitored actively for the occurrences of any adverse drug reaction during the study period. Patient's demographic details, clinical, and treatment data were collected for drug-drug interaction analysis. The detected adverse drug reaction was assessed for causality, severity, and preventability. Drug-drug interaction identified was rated based on their level of urgency and the nature of actions necessary to respond to an interaction. RESULTS: Of 176 patients, 118 were detected for the occurrence of various adverse drug reaction. The majority of the cases were suffering with acute lymphocytic leukemia (67.9%). Vincristine was noted for a maximum number of adverse drug reaction in cytotoxic drugs. Rash is the most frequently occurred reaction. Assessment of causality showed that the majority of cases are "probable" (60.16%). In evaluating the severity of adverse drug reactions, 57.6% reactions were moderately severe and 74.5% of the reactions were preventable. Upon assessing the drug-drug interaction, 38.13% of the prescription needs to be monitored and 10 drug-drug interactions were under the risk category of "X." The majority of the adverse drug reaction was moderately severe in nature and those were preventable. CONCLUSION: Since pediatrics are vulnerable population, they must have a thorough surveillance system for adverse drug reaction and drug-drug interaction; thereby, a positive impact on the medication-use system and improved patient care can be achieved.

Effect of rifampin with bio-enhancer in the treatment of newly diagnosed sputum positive pulmonary tuberculosis patients: A double-center study.

OBJECTIVE: To compare a fixed-dose combination (FDC) of Rifampicin 450 mg, Isoniazid 300 mg, Pyrazinamide 1500 mg and Ethambutol 800 mg (usual care group) and regimen of Rifampicin 200 mg, Isoniazid 300 mg and piperine 10 mg along with Pyrazinamide 1500 mg and Ethambutol 800 mg (intervention care group). METHODS: A randomized, prospective, parallel group study was conducted on newly diagnosed tuberculosis patients. The drugs were given during intensive and continuous phase of treatment to newly diagnosed sputum positive pulmonary tuberculosis. All the patients were subjected to sputum examination, biochemical investigations followed by adverse drug event (ADE) monitoring. RESULTS: A total of 63 patients completed the study. No significant difference was observed in baseline characteristics of patients between the study groups. At the end of the continuous phase, both the groups showed zero bacteria detection. However, in the intervention group, the rate of sputum conversion was much faster than the usual care group. The rate of increase in SGOT and SGPT was much higher in the usual care group (p < 0.0001) than the interventional group (p < 0.05). Urea and creatinine has also increased from pre-treatment to end visit. The number of patients reported ADEs was less in the intervention care group (22.22%) when compared to the usual care group (36.84%). CONCLUSION: Rifampicin 200 mg with piperine 10 mg FDC is compatible with the usual CAT-1 regimen.

Prediction of cardiovascular risk in cancer patients of South India using WHO/ISH risk prediction charts and Framingham score - A prospective study.

Objective Despite the fact that cancer and heart diseases are interconnected, there is lack of information about the prevalence of cardiovascular risk in cancer patients in the South Indian population. With this background, the present study sought to predict the cardiovascular disease in cancer patients. Methods A prospective, cross-sectional study was conducted in the Department of Medical Oncology, Sri Ramachandra University and Hospital, India. Patients' demographic details, medical information, height, weight, body mass index, blood pressure, total cholesterol and HDL-cholesterol were measured. Two risk prediction tools, namely World Health Organization/International Society of hypertension (WHO/ISH) risk prediction charts and Framingham score were used to assess the prevalence of cardiovascular risk over 10 years. Results A total of 70 patients were included for the study. Breast and stomach cancer were found to be most among the study patients. Cardiovascular disease was assessed using WHO/ISH and Framingham risk assessment tool. With respect to WHO/ISH risk, there is a significant difference in gender, type of cancer, smoking status and age between the risk groups. Males have a high risk compared to females, and smokers have a high risk compared to non-smokers. With respect to Framingham score, there is a significant difference in gender, smoking status and systolic blood pressure between the risk groups. Males have a high risk compared to females, and smokers have a high risk compared to non-smokers. A moderate degree of agreement exists between the two risk prediction tools. Conclusion The findings of the study revealed that there is a low risk of cardiovascular disease in cancer patients.

Periostin - A Novel Systemic Biomarker for Eosinophilic Airway Inflammation: A Case Control Study.

INTRODUCTION: Chronic airway inflammation and remodelling are fundamental features of asthma. The molecular phenotypes in asthma are Th2 high and Th2 low. Serum periostin is a biomarker which aid in understanding Th2 high eosinophilic asthma. AIM: The present study aimed to identify whether or not serum periostin is a systemic biomarker for eosinophilic airway inflammation in asthmatics. MATERIALS AND METHODS: The study was designed as a prospective, case control study. Patients who presented with consistent symptoms of asthma and confirmed by spirometry with reversibility were the cases. The controls were healthy subjects who had no history of lung disease with normal lung function. The sputum and blood samples were collected from both the groups. Sputum eosinophils, Absolute Eosinophil Counts (AEC) and serum periostin levels were compared between the groups. RESULTS: The study comprised of 101 participants in which 30 were controls and 71 were cases. In the study group, mean post FEV1 was 64.45. There was a positive correlation of sputum eosinophils with severity of obstruction. The ROC curve analysis showed the cut-off value of 24.556 for serum periostin with the p-value of <0.001. As the severity of obstruction increased, the serum periostin levels were also found to be increased. Serum periostin had a sensitivity and specificity of 97.18% and 86.67% with a diagnostic accuracy of 94.06%. CONCLUSION: Serum periostin appears to be a more sensitive tool for detection of airflow limitation in asthmatic patients with a Th2 high eosinophilic phenotype when compared to AEC and sputum eosinophils.

Effect of vitamin D3 on mild to moderate persistent asthmatic patients: A randomized controlled pilot study.

BACKGROUND: Asthma is a common chronic inflammatory disease of the bronchial airways. Well defined treatment options for asthma are very few. The role of vitamin D3 on asthma is still baffling. AIM: We have examined the effect of vitamin D3 supplementation in mild to moderate persistent asthma patients. MATERIALS AND METHODS: We conducted an open labeled, randomized comparative trial in 48 asthma patients. The study duration was about 90 days. The study had a run-in-period of 2 weeks. At the end of run-in-period, patients were divided into two groups: Usual care group (n = 31) patients received budesonide and formoterol and intervention care group (n = 32) patients received vitamin D3 supplementation along with their regular medicine. RESULTS: The primary outcome of the study was to measure the improvement in forced expiratory volume in 1 second (FEV1). Patients in both groups had a significant improvement in FEV1 at the end of the study. The mean difference in percentage predicted FEV1 in usual care and intervention care group was 4.95 and 7.07 respectively. CONCLUSION: The study concluded that adjunctive therapy of vitamin D3 is effective in asthma patients. The present study will be an evidence based report; however, future studies are warranted in longer duration of time to substantiate the present findings.