Correction: Optically controlled hybrid metamaterial of plasmonic spiky gold inbuilt graphene sheets for bimodal imaging guided multimodal therapy.

Correction for 'Optically controlled hybrid metamaterial of plasmonic spiky gold inbuilt graphene sheets for bimodal imaging guided multimodal therapy' by Ramapurath S. Jayasree et al., Biomater. Sci., 2020, 8, 3381-3391, https://doi.org/10.1039/D0BM00312C.

Supernumerary derivative 22 chromosome resulting from novel constitutional non-Robertsonian translocation: t(20;22)-Case Report.

BACKGROUND: Maternal non-Robertsonian translocation-t(20;22)(q13;q11.2) between chromosomes 20 and 22resulting in an additional complex small supernumerary marker chromosome as derivative (22)inherited to the proband is not been reported yet. CASE PRESENTATION: A 4 years old boy with a history of developmental delay, low set ears, and facial dysmorphism was presented to the genetic clinic. Periauricular pit, downward slanting eyes, medially flared eyebrows, downturned mouth corners, and micrognathia were observed. He had congenital heart defect with atrial septal defect (ASD), ventricular septal defect (VSD), and central nervous system (CNS) anomalies with the gross cranium. Karyotype analysis, Fluorescent in-situ hybridization analysis (FISH), and Chromosomal microarray analysis (CMA) were used to determine the chromosomal origin and segmental composition of the derivative 22 chromosome. Karyotype and FISH analyses were performed to confirm the presence of a supernumerary chromosome, and Microarray analysis was performed to rule out copy number variations in the proband's 22q11.2q12 band point. The probands' karyotype revealed the inherited der(22)t(20;22)(q13;q11.2)dmat. Parental karyotype confirmed the mother as the carrier, with balanced non-Robertsonian translocation-46,XX,t(20;22)(q13;q11.2). CONCLUSION: The mother had a non-Robertsonian translocation t(20;22)(q13;q11.2) between chromosomes 20 and 22, which resulted in Emanuel syndrome in the proband. The most plausible explanation is 3:1 meiotic malsegregation, which results in the child inheriting derivative chromosome. The parental karyotype study aided in identifying the carrier of the supernumerary der(22), allowing future pregnancies with abnormal offspring to be avoided.

Difficult airways: a 3D printing study with virtual fibreoptic endoscopy.

Head and neck cancer patients present unique airway challenges, and oropharyngeal, laryngeal, and hypopharyngeal tumours considerably distort and narrow the anatomy of the airway. We describe the use of 3D augmented reality software combined with 3D printed models to assess the anatomy of difficult airways and to assist in the formulation of the most optimal airway management strategy in such patients. The reported patients had computed tomograms (CT) of the neck prior to their anaesthetic and surgical management. DICOM files of the respective scans were imported to 3D rendering software (OsiriX, Pixmeo). We constructed volume rendered models for initial assessment of the airway then generated serial surface rendered models to create a virtual endoscopic path of the airway to simulate the fibreoptic approach. To further facilitate the study of difficult airways we have subsequently printed 3D models of those that were most difficult using rapid prototyping. Head and neck tumours significantly distort the airway. Thorough study of the relevant anatomy prior to airway management for operating reasons enhances communication between the surgeon and anaesthetist, and aids selection of the most appropriate intubation approach. In conclusion, this paper highlights a useful and novel pre-assessment strategy that allows a virtual, visual, 3-dimensional assessment of the airway anatomy combined with 3D modelling and 3D printing. This enables the airway specialist, anaesthetist, and head and neck surgeon to anticipate any critical steps and adjust the plan accordingly.

Eflapegrastim, a Long-Acting Granulocyte-Colony Stimulating Factor for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial.

BACKGROUND: Eflapegrastim, a novel, long-acting recombinant human granulocyte-colony stimulating factor (rhG-CSF), consists of a rhG-CSF analog conjugated to a human IgG4 Fc fragment via a short polyethylene glycol linker. Preclinical and phase I and II pharmacodynamic and pharmacokinetic data showed increased potency for neutrophil counts for eflapegrastim versus pegfilgrastim. This open-label phase III trial compared the efficacy and safety of eflapegrastim with pegfilgrastim for reducing the risk of chemotherapy-induced neutropenia. MATERIALS AND METHODS: Patients with early-stage breast cancer were randomized 1:1 to fixed-dose eflapegrastim 13.2 mg (3.6 mg G-CSF) or standard pegfilgrastim (6 mg G-CSF) following standard docetaxel plus cyclophosphamide chemotherapy for 4 cycles. The primary objective was to demonstrate the noninferiority of eflapegrastim compared with pegfilgrastim in mean duration of severe neutropenia (DSN; grade 4) in cycle 1. RESULTS: Eligible patients were randomized 1:1 to study arms (eflapegrastim, n = 196; pegfilgrastim, n = 210). The incidence of cycle 1 severe neutropenia was 16% (n = 31) for eflapegrastim versus 24% (n = 51) for pegfilgrastim, reducing the relative risk by 35% (p = .034). The difference in mean cycle 1 DSN (-0.148 day) met the primary endpoint of noninferiority (p < .0001) and also showed statistical superiority for eflapegrastim (p = .013). Noninferiority was maintained for the duration of treatment (all cycles, p < .0001), and secondary efficacy endpoints and safety results were also comparable for study arms. CONCLUSION: These results demonstrate noninferiority and comparable safety for eflapegrastim at a lower G-CSF dose versus pegfilgrastim. The potential for increased potency of eflapegrastim to deliver improved clinical benefit warrants further clinical study in patients at higher risk for CIN. IMPLICATIONS FOR PRACTICE: Chemotherapy-induced neutropenia (CIN) remains a significant clinical dilemma for oncology patients who are striving to complete their prescribed chemotherapy regimen. In a randomized, phase III trial comparing eflapegrastim to pegfilgrastim in the prevention of CIN, the efficacy of eflapegrastim was noninferior to pegfilgrastim and had comparable safety. Nevertheless, the risk of CIN remains a great concern for patients undergoing chemotherapy, as the condition frequently results in chemotherapy delays, dose reductions, and treatment discontinuations.

Optically controlled hybrid metamaterial of plasmonic spiky gold inbuilt graphene sheets for bimodal imaging guided multimodal therapy.

The development of multifunctional molecular diagnostic platforms for the concordant visualization and treatment of diseases with high sensitivity and resolution has recently become a crucial strategy in cancer management. Thus, engineering functional metamaterials with high therapeutic and imaging capabilities to elucidate diseases from their morphological behaviors to physiological mechanisms is an unmet need in the current scenario. Here, we report the design of a unique hybrid plasmonic nanoarchitecture for targeted multiple phototherapies of breast cancer by simultaneous real-time monitoring through fluorescence and surface-enhanced Raman scattering (SERS) techniques. The nanoframework consisted of plasmonic gold-graphene hybrids tethered with folic acid-ligated chitosan-modified photosensitizer (PpIX) to afford target-specific localized photothermal and photodynamic therapy. The hybrid vehicle also served as an excellent nanocarrier for the efficient loading and stimuli-responsive release of the chemotherapeutic drug doxorubicin (DOX) to enhance the therapeutic efficacy, thereby forming a trimodal nanomedicine against cancer. The cytotoxic effects induced by the cumulative action of the triplet therapeutic tools were visualized through both fluorescence and SERS imaging channels. Moreover, it also generated synchronized therapeutic effects resulting in the effective regression of tumor volume without propagating any toxic effects to other organs of the animals. Taken together, by virtue of strong light-matter interactions, the nanoprobe showed enhanced photoadsorption, which facilitated amplified light-reactive therapeutic and imaging efficacies along with targeted and enhanced chemotherapy, both in vitro and in vivo, which may offer promising outcomes in clinical research.

Sexual Dysfunction in Patients with Antidepressant-treated Anxiety or Depressive Disorders: a Pragmatic Multivariable Longitudinal Study.

OBJECTIVE: To investigate early evolution, tolerability, and predictors of antidepressant-emergent sexual dysfunction in patients with anxiety or depressive disorder. METHODS: Patients with anxiety or depressive disorders who were prescribed antidepressant monotherapy (mirtazapine, sertraline, desvenlafaxine, escitalopram, or fluoxetine) at the discretion of the treating clinician were recruited from July 2012 to June 2014 from a hospital outpatient service. All were free of psychotropic medication for least 1 month. Sexual function was assessed at baseline, week 2, and week 6 using the Psychotropic-Related Sexual Dysfunction Questionnaire (PRSexDQ). A PRSexDQ score of ≥2 was considered to indicate sexual dysfunction. Sexual function was dichotomised to 'favourable' or 'impaired'. RESULTS: Of 230 patients recruited, 209 were assessed at baseline of whom 184 were assessed at week 2; of these, 154 were also assessed at week 6. At baseline, 138 (66%) of the 209 patients were diagnosed with depressive disorder and 71 (34%) with anxiety disorder; 29% of patients had sexual dysfunction (in any domain of PRSexDQ). By week 6, the percentage had increased to 41%, although the change in the mean PRSexDQ score was only marginal (from 1.04 at baseline to 1.55 at week 6). With regard to individual questionnaire items, by week 6, sexual desire improved, but erectile and ejaculatory function in men and orgasmic function in women worsened. Fluoxetine and sertraline were associated with impaired sexual function, whereas mirtazapine was associated with favourable sexual function. In a logistic regression analysis, at week 2, mirtazapine and desvenlafaxine were predictors of favourable sexual outcome, whereas fluoxetine and higher baseline PRSexDQ score were predictors of impaired sexual outcome. At week 6, mirtazapine remained a predictor of favourable sexual outcome, whereas fluoxetine, higher 2-week PRSexDQ score, and adequate dose were predictors of impaired sexual outcome. CONCLUSIONS: In patients with anxiety or depressive disorder, the risk of antidepressant-emergent sexual dysfunction at 6 weeks is low when drug doses are initially low with gradual up-titration. Baseline sexual dysfunction was independently associated with impaired sexual outcome. Men may be more likely than women to experience impaired sexual outcome. In patients with baseline sexual dysfunction, prescription of mirtazapine might be preferable to fluoxetine.

Data-Driven Discovery of Extravasation Pathway in Circulating Tumor Cells.

Circulating tumor cells (CTCs) play a crucial role in cancer dissemination and provide a promising source of blood-based markers. Understanding the spectrum of transcriptional profiles of CTCs and their corresponding regulatory mechanisms will allow for a more robust analysis of CTC phenotypes. The current challenge in CTC research is the acquisition of useful clinical information from the multitude of high-throughput studies. To gain a deeper understanding of CTC heterogeneity and identify genes, pathways and processes that are consistently affected across tumors, we mined the literature for gene expression profiles in CTCs. Through in silico analysis and the integration of CTC-specific genes, we found highly significant biological mechanisms and regulatory processes acting in CTCs across various cancers, with a particular enrichment of the leukocyte extravasation pathway. This pathway appears to play a pivotal role in the migration of CTCs to distant metastatic sites. We find that CTCs from multiple cancers express both epithelial and mesenchymal markers in varying amounts, which is suggestive of dynamic and hybrid states along the epithelial-mesenchymal transition (EMT) spectrum. Targeting the specific molecular nodes to monitor disease and therapeutic control of CTCs in real time will likely improve the clinical management of cancer progression and metastases.

A guide to new anticoagulant medications for ENT surgeons.

OBJECTIVES: This study aimed to ascertain otolaryngologists' current knowledge of new (e.g. apixaban, rivaroxaban) and old (e.g. warfarin) anticoagulant medications, and to provide an educational overview of new anticoagulants for use by surgeons. METHODS: A questionnaire survey was distributed across the Wessex region, UK, to ascertain the levels of knowledge of and confidence in managing patients taking various anticoagulants. In total, 50 questionnaires were completed (41 by trainees and 9 by consultants). A literature review of new anticoagulant medications was then conducted. RESULTS: In general, there was poor clinical and pharmacokinetic knowledge of newly licensed anticoagulant medications. Respondents were more confident in the use of older vs newer forms of anticoagulants. This was true across all grades of doctors, but particularly at the senior level. All respondents stated that they would like to see an educational resource on anticoagulants. CONCLUSION: Knowledge of newly licensed anticoagulation medications is poor. This study has produced an educational resource for the management of anticoagulant agents. A thorough knowledge of these drugs is essential for the acute management of bleeding patients and in peri-operative surgical planning.

A study of the socio-demographic profile and treatment outcome of paediatric tuberculosis patients in Bangalore Mahanagar Palike area.

BACKGROUND: Tuberculosis (TB) continues to be one of the most devastating and widespread infections in the world. Of the nine million annual tuberculosis cases, about one million (11%) occur in children (under 15 years of age). Childhood tuberculosis is a neglected aspect of the tuberculosis epidemic. OBJECTIVES: To know the socio-demographic profile, type of tuberculosis and treatment outcome in paediatric tuberculosis patients METHODOLOGY: The study was conducted in nine Tuberculosis units of Bangalore city from January 2009 to December 2009. Five Tuberculosis units from the nine tuberculosis units were selected by simple random sampling, paediatric patients diagnosed as having TB and registered under RNTCP were included in the study till the sample size of 209 was reached. Data regarding socio-demographic profile and type of TB was collected and the patients were followed up to assess treatment outcome. RESULTS: Most of the patients coming to the RNTCP centres belong to the under-privileged group. Most of the patients were in the age group of 1 to < 6 years, (37.7 %), male to female ratio was observed to be 0.6:1. Majority of the patients lived in nuclear families (73.2%), belonged to low socio-economic status (95.5%) and dwelled in overcrowded houses (89.5%). 23% reported history of contact with tuberculosis patients. More than half of the patients (57.4%) were undernurished. In the study, 56.5% had pulmonary TB and 43.5 % had extra-pulmonary TB. 94.7% of the patients completed treatment. CONCLUSION: Paediatric tuberculosis still continues to be a major problem in one-five years of age who are undernourished and belonging to low socio-economic status.

Microbial inactivation and shelf life comparison of 'cold' hurdle processing with pulsed electric fields and microfiltration, and conventional thermal pasteurisation in skim milk.

Thermal pasteurisation (TP) is the established food technology for commercial processing of milk. However, degradation of valuable nutrients in milk and its sensory characteristics occurs during TP due to substantial heat exposure. Pulsed electric fields (PEF) and microfiltration (MF) both represent emerging food processing technologies allowing gentle milk preservation at lower temperatures and shorter treatment times for similar, or better, microbial inactivation and shelf stability when applied in a hurdle approach compared to TP. Incubated raw milk was used as an inoculum for the enrichment of skim milk with native microorganisms before PEF, MF, and TP processing. Inoculated milk was PEF-processed at electric field strengths between 16 and 42 kV/cm for treatment times from 612 to 2105 µs; accounting for energy densities between 407 and 815 kJ/L, while MF was applied with a transmembrane flux of 660 L/h m². Milk was TP-treated at 75°C for 24 s. Comparing PEF, MF, and TP for the reduction of the native microbial load in milk led to a 4.6 log10 CFU/mL reduction in count for TP, which was similar to 3.7 log10 CFU/mL obtained by MF (P≥0.05), and more effective than the 2.5 log10 CFU/mL inactivation achieved by PEF inactivation (at 815 kJ/L (P<0.05)). Combined processing with MF followed by PEF (MF/PEF) produced a 4.1 (at 407 and 632 kJ/L), 4.4 (at 668 kJ/L) and 4.8 (at 815 kJ/L) log10 CFU/mL reduction in count of the milk microorganisms, which was comparable to that of TP (P≥0.05). Reversed processing (PEF/MF) achieved comparable reductions of 4.9, 5.3 and 5.7 log10 CFU/mL (at 407, 632 and 668 kJ/L, respectively (P≥0.05)) and a higher inactivation of 7.1 log10 (at 815 kJ/mL (P<0.05)) in milk than for TP. Microbial shelf life of PEF/MF-treated (815 kJ/L) and TP-treated milk stored at 4°C was analysed over 35 days for total aerobic; enterobacteria; yeasts and moulds; lactobacilli; psychrotroph; thermoduric psychrotroph, mesophilic, and thermophilic; and staphylococci counts. For both PEF/MF and TP-treated milk an overall shelf stability of 7 days was observed based on total aerobic counts (P≥0.05). Milk hurdle processing with PEF/MF at its most effective treatment parameters produced greater microbial inactivation and overall similar shelf stability at lower processing temperatures compared to TP. With higher field strength, shorter treatment time, larger energy density, and rising temperature the efficacy of PEF/MF increased contrary to MF/PEF. Thus, PEF/MF represents a potential alternative for 'cold' pasteurisation of milk with improved quality.

A locus for juvenile myoclonic epilepsy maps to 2q33-q36.

We performed a whole genome linkage analysis in a three-generation south Indian family with multiple members affected with juvenile myoclonic epilepsy (JME). The maximum two-point LOD score obtained was 3.32 at recombination fraction (theta) = 0 for D2S2248. The highest multipoint score of 3.59 was observed for the genomic interval between D2S2322 and D2S2228 at the chromosomal region 2q33-q36. Proximal and distal boundaries of the critical genetic interval were defined by D2S116 and D2S2390, respectively. A 24-Mb haplotype was found to co-segregate with JME in the family. While any potentially causative variant in the functional candidate genes, SLC4A3, SLC23A3, SLC11A1 and KCNE4, was not detected, we propose to examine brain-expressed NRP2, MAP2, PAX3, GPR1, TNS1 and DNPEP, and other such positional candidate genes to identify the disease-causing gene for the disorder.

A prospective, parallel group, open-labeled, comparative, multi-centric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetes.

OBJECTIVE: The present study was a prospective, parallel group, open-labeled, comparative, multicentric, active controlled study to evaluate the safety, tolerability and benefits of fixed dose combination of acarbose and metformin versus metformin alone in type 2 diabetic patients. METHODS: A total of 229 patients with type 2 diabetes were enrolled at 5 medical centers across India. They received either acarbose (50 mg) + metformin (500 mg) bid/tid (n=115) or metformin monotherapy (500 mg) bid/ tid (n=114) for 12 weeks. Primary objective was to evaluate safety and tolerability based on the adverse events reported. Secondary objective was efficacy assessment based on changes in fasting, post prandial blood glucose and HbA1c values. RESULTS: In the acarbose + metformin group 10 patients reported 14 adverse events while in metformin group 9 patients reported 10 adverse events. No patient reported any serious adverse event or was withdraw from study because of adverse events. In the acarbose plus metformin group fasting blood glucose (FBG) decreased from a baseline of 158.85 +/- 18.14 mg/dl to 113.55 +/- 19.38 mg/dl (p < 0.0001) (decrease of 45.30 +/- 15.30 mg/dl) at 12 weeks, while in the metformin group fasting blood glucose decreased from a baseline of 158.31 +/- 26.53 mg/dl to 130.55 +/- 28.31 mg/dl (p < 0.0001) (decrease of 27.76 +/- 22.91 mg/dl) at 12 weeks. In the acarbose plus metformin group postprandial blood glucose (PPBG) decreased from a baseline of 264.65 +/- 34.03 mg/dl to 173.22 +/- 31.40 mg/dl (p < 0.0001) (decrease of 91.43 +/- 28.65 mg/dl) at 12 weeks, while in the metformin group PPBG decreased from a baseline of 253.56 +/- 36.28 mg/dl to 205.36 +/- 39.49 mg/dl (p < 0.0001) (decrease of 48.20 +/- 32.72 mg/dl) at 12 weeks. In the acarbose plus metformin group glycosylated haemoglobin (HbA1c) decreased from a baseline of 9.47 +/- 0.69% to 7.71 +/- 0.85% (p < 0.0001) (% decrease of 1.76 +/- 1.11) at 12 weeks, while in the metformin group HbAlc decreased from a baseline of 9.32 +/- 0.65% to 8.26 +/- 0.68% (p < 0.0001) (% decrease of 1.06 +/- 0.66) at 12 weeks. The combination of acarbose and metformin was found to be significantly superior in lowering the FBC (p < 0.0001), PPBG (p < 0.0001) and HbA1c (p < 0.0001) at 12 weeks as compared to metformin monotherapy. CONCLUSIONS: Fixed dose combination of acarbose and metformin was well tolerated and it was superior to metformin monotherapy in controlling FBG, PPBG and HbA(1C) levels in Type 2 Diabetes Mellitus patients.

Determinants of Pre-eclampsia: A Case-control Study in a District Hospital in South India.

OBJECTIVE: The objective was to study the determinants of pre-eclampsia among pregnant women admitted for delivery in a district hospital. MATERIALS AND METHODS: A case-control study was conducted at District Lady Goschen Hospital, Dakshina Kannada district, Karnataka, South India. The group of pregnant women with pre-eclampsia comprised those with hypertension after the 20th week of gestation with associated proteinuria, and controls were pregnant women not diagnosed with pre-eclampsia. A total of 100 cases and 100 controls were selected for the year 2006. Study variables included mother's age, parity, body mass index, history of chronic hypertension, history of diabetes, history of renal disease, family history of hypertension, and history of pre-eclampsia in earlier pregnancy. STATISTICAL ANALYSIS: Chi-square test, and crude and adjusted odds ratio with 95% confidence intervals were used for statistical analysis. RESULTS: Significant risk factors identified in univariate analysis included prepregnancy body mass index (BMI > 25) (OR = 11.27), history of chronic hypertension (OR = 8.65), history of diabetes (OR = 11.0), history of renal disease (OR = 7.98), family history of hypertension (OR = 5.4), history of pre-eclampsia in earlier pregnancy (OR = 9.63), and multiple pregnancy (OR = 4.85). Multiple logistic regression analysis revealed that the prepregnancy BMI of >25 (OR = 7.56), history of chronic hypertension (OR = 6.69), history of diabetes (OR = 8.66), history of renal disease (OR = 5.6), family history of hypertension (OR = 5.48), and multiple pregnancy (OR = 5.73) are the significant risk factors of pre-eclampsia. CONCLUSION: Pregnant women at risk of pre-eclampsia should be identified and high-quality antenatal care should be given in order to minimize the complications of pre-eclampsia both for the mother and the fetus.

Determinants of low birth weight: a case control study in a district hospital in Karnataka.

A Case-control study was conducted in District Lady Goschen hospital, Dakshina Kannada district, Southern Karnataka. Subjects were mothers who underwent normal delivery and their neonates. A total of 150 cases and 300 controls were selected. Significant risk factors identified in univariate analysis included pre pregnancy maternal weight (<45 kgs)(OR=6.77), anaemia in pregnancy (Hb<11 gm%) (OR=3.11), age less than 20 years (OR=2.96) and maternal height (<145 cms) (OR=2.79). Multiple logistic regression analysis revealed that pre pregnancy maternal weight (<45 kgs)(OR=7.02), anemia in pregnancy (OR=4.37) and maternal age less than 20 years (OR=3.96) were the significant risk factors of low birth weight of term babies. The strategy needs to focus attention on nutrition education to facilitate better weight gain during adolescent period. Discouraging teenage pregnancy is also essential in order to reduce the burden of LBW babies.

Perception, Practices Towards Research and Predictors of Research Career Among UG Medical Students from Coastal South India: A Cross-Sectional Study.

BACKGROUND: The number of physician scientists worldwide is decreasing. A review of literature suggests paucity of information examining perceptions and practices towards research among medical undergraduate students in India. Hence, this study was undertaken. OBJECTIVES: To understand (a) the awareness, skills, perceptions and practices among undergraduate (UG) medical students towards research, (b) the factors responsible for willingness to take up research as a career among the undergraduates. MATERIAL AND METHODS: This is a questionnaire-based qualitative study. This study was conducted in Kasturba Medical College, Mangalore. A pre-tested questionnaire examining their awareness, perceptions and practices towards research in medical field was used. Consent was obtained from the Dean of the College and student participation was voluntary. ANALYSIS: The information was analyzed using SPSS version 11. Univariate and Multivariate analyses were done to know the willingness to consider research as a career. RESULTS: A total of 471 students responded giving a response rate of 55.41%. Nearly 70% were aware about research though their level of awareness varied. Various skills of conducting research were known to 47% of the students. Most (76%) were part of a research team mainly as a part of the medical curriculum, a few (8.3%) were confident of research as a career option. The multivariate reveals that those with good skill and students who involved in research in addition to curriculum were more likely to take up research as career option/would continue to do research in future. CONCLUSIONS: Good training and student support programs exclusively for research would motivate students to opt for research careers.

Randomised study to compare the efficacy and safety of isapgol plus atorvastatin versus atorvastatin alone in subjects with hypercholesterolaemia.

Soluble fibre has been shown to augment the cholesterol-lowering effects of low-fat diets in individuals with mild to moderate hypercholesterolaemia. Combination therapy with a statin poses advantages in certain settings and may allow use of lower doses of multiple drugs rather than maximum doses of a single drug. The primary objective of the study was to compare the efficacy of combination of isapgol and atorvastatin versus atorvastatin alone, in the same dose, in reduction of low-density lipoprotein cholesterol (LDL-C), total-cholesterol levels in hypercholesterolaemic patients after 12 weeks of therapy. In a 12-week study, 100 subjects from both sexes and of > 20 years having hyperlipidaemia, with LDL-C level > 130 mg/dl and total cholesterol > 220 mg/dl were included, and were randomised to receive either a combination of isapgol powder (Naturolax) 5.6 g twice daily and atorvastatin 10 mg once daily or atorvastatin 10 mg once daily alone orally. Serum levels of total cholesterol, LDL-C, high-density lipoprotein cholesterol (HDL-C), and triglyceride were assessed at 8 and 12 weeks. Ninety-seven patients completed the study. At the end of the 8th week, both the groups had a significant reduction in mean LDL-C (20.5% in isapgol + atorvastatin group and 16.0% among atorvastatin alone group) as compared to baseline. But between the groups, however, the difference was not significant. At the end of the 12th week fall in LDL-C at 31.4% for isapgol + atorvastatin was significantly greater than 22.8% among the atorvastatin group (p < 0.05). Serum total cholesterol, HDL-C and triglyceride were significantly lowered within the groups at 8th and 12th weeks but between groups, the difference was not significant. Comparison of adverse events profile in both the groups shows that more number of patients from atorvastatin alone group (n = 14, 28%) had adverse reactions than the number of patients from the combination group (n = 4, 8%; p < 005).

Evaluation of the efficacy, safety and tolerability of miglitol in adult Indian patients with uncomplicated type 2 diabetes mellitus.

Postprandial hyperglycaemia and spikes have deleterious effects on Insulin secretion and sensitivity. The present study was undertaken to evaluate the efficacy, safety and tolerability of miglitol 50 mg three times daily for 12 weeks in 129 patients with type 2 diabetes mellitus, inadequately managed with diet and exercise therapy alone for 3 months after obtaining their written informed consent. The primary efficacy variables were per cent change from baseline at week 12 in fasting and postprandial plasma glucose concentrations and glycosylated haemoglobin (HbA(1C)) levels. After treatment at the end of 12 weeks mean reduction in fasting plasma glucose levels was 35.7% and 44.33% in postprandial plasma glucose levels while the mean HbA(1C) was significantly reduced by 0.88% (p<0.05). Total cholesterol, HDL, LDL and TC/HDL ratio did not showed any significant change but a non-significant reduction in triglyceride levels was observed in some patients. The mean body mass index was reduced non-significantly by 8% from baseline values. A total 19.5% patients treated with miglitol reported adverse events like flatulence, abdominal pain, nausea/vomiting, diarrhoea and dyspepsia. Only one patient reported hypoglycaemia. The results of the present study indicate that miglitol reduces fasting and postprandial plasma glucose levels, Improving glycaemic control, which is reflected in a reduced HbA(1C) level in patients with type 2 diabetes mellitus. It could be a useful first-line therapy in patients with type 2 diabetes mellitus inadequately controlled by diet alone and as adjuvant therapy in patients who are inadequately controlled with diet and sulfonylureas.

Cerebellar ataxia due to isolated vitamin E deficiency.

Ataxia is a common and important neurological finding in medical practice. Severe deficiency of Vitamin E can profoundly affect the central nervous system and can cause ataxia and peripheral neuropathy resembling Friedreich's ataxia. Vitamin E deficiency can occur with abetalipoproteinemia, cholestatic liver disease or fat malabsorption. Ataxia with isolated Vit E deficiency (AVED) is an Autosomal Recessive genetic disorder with a mutation in the alpha tocopherol transfer protein gene (TTPA). This condition responds to high dose of Vit E and is one of the important causes of treatable ataxia. We report a young patient with Ataxia with isolated Vit E deficiency (AVED) who responded partially to replacement of Vitamin E.