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Objective@#This study tried to observe additional benefit of agomelatine (AGO) treatment for major depressive disorder (MDD) in routine practice. @*Methods@#Retrospective chart review (n = 63) was conducted for additional benefit of combination with or switching to AGO in MDD patients without full remission. The primary endpoint was the mean change of Clinical Global Impression-Clinical Benefit (CGI-CB) total scores from baseline to the endpoint. Additional secondary endpoints were also collected. @*Results@#The changes of CGI-CB (Z = −3.073, p = 0.002) and Montgomery-Åsberg Depression Rating Scale (Z = −3.483, p ＜ 0.001) total scores were significantly decreased from baseline to the endpoint, respectively. At the endpoint, the remission rate was 22.6% (n = 18) and 28.6% of patient had improvement in CGI-CB total scores at the endpoint.No significant adverse events were observed. @*Conclusion@#This study has shown additional benefit of AGO treatment as combination or switching agent for MDD patients without full remission in routine practice. However, adequately-powered and well-controlled studies are necessary for generalization of the present findings.
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Objective@#Anxious depression is associated with greater chronicity, higher severity of symptoms, more severe functional impairment, and poor response to drug treatment. However, evidence for first-choice antidepressants in patients with anxious depression is limited. This study aimed to compare the efficacy and safety of escitalopram, desvenlafaxine, and vortioxetine in the acute treatment of anxious depression. @*Methods@#Patients (n = 124) with major depressive disorder and high levels of anxiety were randomly assigned to an escitalopram treatment group (n = 42), desvenlafaxine treatment group (n = 40), or vortioxetine treatment group (n = 42) in a 6-week randomized rater-blinded head-to-head comparative trial. Changes in overall depressive and anxiety symptoms were assessed using the 17-item Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Rating Scale (HAMA), respectively. @*Results@#Patients demonstrated similar baseline-to-endpoint improvement in scores and similar response and remission rates for HAMD and HAMA. Analysis of the individual HAMD items revealed that desvenlafaxine significantly reduced anxiety somatic scores (p= 0.013) and hypochondriasis scores (p = 0.014) compared to escitalopram. With respect to the individual HAMA items, desvenlafaxine treatment showed significantly lower scores for respiratory symptoms (p = 0.013) than escitalopram treatment and cardiovascular symptoms (p = 0.005) than vortioxetine treatment. The treatments were well tolerated, with no significant differences. @*Conclusion@#Our results indicated no significant differences in the efficacy and tolerability of escitalopram, desvenlafaxine, and vortioxetine in this subtype of patients with anxious depression during the acute phase of treatment.
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Snake bite is a major health hazard, moreover in tropical countries where the density of snakes, frequent human contact, lack of diagnostic and treatment facilities further add-on to the high morbidity and mortality. No organ escapes the effect of envenomation from Heart to liver and kidney, CNS to local bite site. While the effect of snake venom on kidney has been documented, the literature available on the pathological effects of envenomation in human liver is lacking. We present a case of an elderly male with renal and hepatic manifestations of envenomation.
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Objective@#This study aimed to compare the efficacy and safety of escitalopram, vortioxetine, and desvenlafaxine for acute treatment of major depressive disorder (MDD) with cognitive complaint (CC). @*Methods@#A total of 129 patients with MDD who also complained of CC were randomized evenly to either escitalopram, vortioxetine, or desvenlafaxine group and underwent a multi-center, six-week, rater-blinded, and head-to-head comparative trial. Differences in depressive symptoms following treatment were measured using the Hamilton Depression Rating Scale (HAMD) and the Montgomery-Åsberg Depression Rating Scale (MADRS). Subjective cognitive function and the presence of adverse events were assessed. @*Results@#The three antidepressant treatment groups did not show significant differences in the improvement of depressive symptoms as measured by HAMD and MADRS. Desvenlafaxine treatment was associated with a superior treatment response rate in depressive symptoms compared to vortioxetine or escitalopram treatment. However, no significant differences were found in the remission rate of depressive symptoms. The three antidepressant treatment groups did not show significant differences in the improvement of CC. Adverse profiles of each treatment group were tolerable, with no significant differences. @*Conclusion@#In acute antidepressant treatment for MDD with CC, escitalopram, vortioxetine, and desvenlafaxine presented similar efficacy in relief of depressive symptoms; however, desvenlafaxine was associated with a superior treatment. Further studies are needed to confirm these results by investigating the therapeutic efficacy and safety profile of long-term antidepressant treatment of MDD with CC (Clinical Trial Registry, http://cris.nih.go.kr/cris/en/: KCT0002173).
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Introduction: Varicose veins of the lower extremities are one of the most common peripheral vascular diseases. A variety of treatments methods have emerged as an alternative to traditional surgery but are limited by their need for equipment and expertise which increases the cost of treatment making it unviable especially in rural India. Thus traditional surgery still forms the mainstay of treatment. Aims: To evaluate and compare the outcomes in patients undergoing Trendelenberg’s procedure with stripping and without stripping of varicose veins. Materials and methods: The study comprised of 50 patients who were admitted with varicose veins. They were allocated into two groups of 25 each where they either underwent Trendelenberg’s procedure with stripping or without stripping of varicose veins. The patients were followed up for six months to assess the efficacy of the procedure as per the parameters of the study. Results were analyzed using SPSS software. Percentages and proportions were used for qualitative data; mean and standard deviation were used for quantitative data. Chisquare test and student t test were applied where appropriate. Results: In the group undergoing stripping, 28% (7 of 25) patients developed hematoma, post operative pain scores on day 0,3,7 and 10 were 3.8±0.9, 2.6±0.7, 1.1±0.6 and 0.2±0.4 respectively. Mean post operative ambulation was achieved on 3.88 days and recurrence at 6 months was seen in 12% (3 of 25) patients. In the group undergoing ligation alone, 4% (1 of 25) patients developed hematoma, post operative pain scores on day 0,3,7 and 10 were 3.0±0.8, 1.6±0.8, 0.8±0.5 and 0.1±0.3 respectively. Mean post op ambulation was achieved on 2.16 days and recurrence at 6 months was seen in 20% (5 of 25) patients. Conclusions: With lesser rates of hematoma formation, better post operative pain scores and quicker ambulation in patients undergong ligation of veins alone, we conclude that Trendelenberg’s procedure without stripping is a better procedure than Trendelenberg’s procedure with stripping of veins in the treatment of varicose veins.
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Objective@#In a number of controlled clinical trials and naturalistic studies, aripiprazole once monthly (AOM) has been found to be effective and safe as acute and maintenance treatment options for schizophrenia. However, such clinical data have been presented in selected patient population (i.e., antipsychotic monotherapy, etc.), in particular, clinical information on switching to AOM from antipsychotic polypharmacy and/or other long acting injectable antipsychotics (LAIs) has been scarce till today. @*Methods@#The study period was from the first switching day to AOM up to 12 months in patients with antipsychotic polypharmacy (APpoly)/LAIs (baseline, month 3, month 6, and month 12). Available demographics and clinical information were retrieved from electronic medical records (EMRs). Available scores of Global Assessment of Functioning (GAF), Clinical Global Impression-Clinical Benefit (CGI-CB), CGI-severity, Visual Analog Scale on Satisfaction-Patient/Health Professional (VAS-P/HP), and the Positive and Negative Syndrome Scale-Insigh (PANSS-I) scores were also taken from EMR. Proportional change of functional impairment before and after AOM was also captured. @*Results@#Data of 18 patients were available. Most commonly used combined APs before AOM were aripiprazole, blonanserin, quetiapine, and risperidone. At least 2 APs (n = 2.4) were combined before AOM. Scores of GAF (10.7% increase), CGI-CB (46.2% decrease), VAS-P (47.8% increase), VAS-HP (40.8% increase), and PANSS-I (27.9% increase) (all p = 0.001) were significantly improved from baseline to month 12, respectively. Approximately 59% of patients improved individual functioning with different level (i.e., employment, back to school, etc.) after AOM treatment at month 12. @*Conclusion@#The present study have clearly shown the clinical benefit and utility of switching to AOM for treatment of patients with APpoly/LAIs in routine practice. Subsequent, adequately-powered, well-controlled clinical trials may be necessary to confirm our findings in near future.
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Antipsychotic monotherapy (APM) is considered best-acceptable treatment option regardless of antipsychotic class and formulation types for treating schizophrenia. However, antipsychotic polypharmacy (APP) has been also widely utilized in routine clinical practice. Despite APP has some clinical benefits it has also numerous pitfalls in relation with increased total number and doses of APs leading to adverse events as well as decrease of treatment adherence and persistence resulting in poor clinical outcomes. Recent introduction of long-acting injectable antipsychotics (LAIs) to the market has offered a chance for better medication adherence/persistence and also provided a simplification of treatment regime leading to more stabilized treatment for schizophrenia patients. When we cannot stay away from APP in the treatment of schizophrenia, clinicians need to find more proper APP regimens and thereby utilization of APP in efficient way should be a practical strategy to benefit schizophrenia patient in a real world treatment setting. With this regard, LAIs can be one of available APP regimen for treatment of schizophrenia in routine practice since their clinical utility and pharmacokinetic stability over oral APs have been well-elaborated today. However, when we have to commence LAIs as a part of APP with oral APs or other LAIs, every effort should be made before doing so whether or not validated and available treatment options or other clinical factors were not done or evaluated yet. Any treatment guidelines do not support APP regardless of the formulation of APP regimen or address two or more LAIs for treatment of schizophrenia till today.
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Objective@#In a number of controlled clinical trials and naturalistic studies, aripiprazole once monthly (AOM) has been found to be effective and safe as acute and maintenance treatment options for schizophrenia. However, such clinical data have been presented in selected patient population (i.e., antipsychotic monotherapy, etc.), in particular, clinical information on switching to AOM from antipsychotic polypharmacy and/or other long acting injectable antipsychotics (LAIs) has been scarce till today. @*Methods@#The study period was from the first switching day to AOM up to 12 months in patients with antipsychotic polypharmacy (APpoly)/LAIs (baseline, month 3, month 6, and month 12). Available demographics and clinical information were retrieved from electronic medical records (EMRs). Available scores of Global Assessment of Functioning (GAF), Clinical Global Impression-Clinical Benefit (CGI-CB), CGI-severity, Visual Analog Scale on Satisfaction-Patient/Health Professional (VAS-P/HP), and the Positive and Negative Syndrome Scale-Insigh (PANSS-I) scores were also taken from EMR. Proportional change of functional impairment before and after AOM was also captured. @*Results@#Data of 18 patients were available. Most commonly used combined APs before AOM were aripiprazole, blonanserin, quetiapine, and risperidone. At least 2 APs (n = 2.4) were combined before AOM. Scores of GAF (10.7% increase), CGI-CB (46.2% decrease), VAS-P (47.8% increase), VAS-HP (40.8% increase), and PANSS-I (27.9% increase) (all p = 0.001) were significantly improved from baseline to month 12, respectively. Approximately 59% of patients improved individual functioning with different level (i.e., employment, back to school, etc.) after AOM treatment at month 12. @*Conclusion@#The present study have clearly shown the clinical benefit and utility of switching to AOM for treatment of patients with APpoly/LAIs in routine practice. Subsequent, adequately-powered, well-controlled clinical trials may be necessary to confirm our findings in near future.
ABSTRACT
Antipsychotic monotherapy (APM) is considered best-acceptable treatment option regardless of antipsychotic class and formulation types for treating schizophrenia. However, antipsychotic polypharmacy (APP) has been also widely utilized in routine clinical practice. Despite APP has some clinical benefits it has also numerous pitfalls in relation with increased total number and doses of APs leading to adverse events as well as decrease of treatment adherence and persistence resulting in poor clinical outcomes. Recent introduction of long-acting injectable antipsychotics (LAIs) to the market has offered a chance for better medication adherence/persistence and also provided a simplification of treatment regime leading to more stabilized treatment for schizophrenia patients. When we cannot stay away from APP in the treatment of schizophrenia, clinicians need to find more proper APP regimens and thereby utilization of APP in efficient way should be a practical strategy to benefit schizophrenia patient in a real world treatment setting. With this regard, LAIs can be one of available APP regimen for treatment of schizophrenia in routine practice since their clinical utility and pharmacokinetic stability over oral APs have been well-elaborated today. However, when we have to commence LAIs as a part of APP with oral APs or other LAIs, every effort should be made before doing so whether or not validated and available treatment options or other clinical factors were not done or evaluated yet. Any treatment guidelines do not support APP regardless of the formulation of APP regimen or address two or more LAIs for treatment of schizophrenia till today.
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The mainstay of schizophrenia treatment is pharmacological therapy using various antipsychotics including first- and second-generation antipsychotics which have different pharmacokinetic and pharmacodynamic property leading to differential presentation of adverse events (AEs) and treatment effects such as negative symptoms, cognitive symptoms and cormorbid symptoms. Major treatment guidelines suggest the use of antipsychotic monotherapy (APM) as a gold standard in the treatment of schizophrenia. However, the effects of APM is inadequate and less potent to achieve symptom remission as well as functional recovery in real practice which has been consistently reported in numerous controlled clinical trials, large practical trials, independent small studies and systematic reviews till today. Therefore antipsychotic polypharmacy (APP) regardless of the class of antipsychotics has been also commonly utilized for many reasons in real world practice. However, APP has also crucial pitfalls including increase of total psychotics including antipsychotics, high-doses of antipsychotics used, poor compliance, drug-drug interaction and risks for developing AEs, all of which are paradoxically related to poor clinical outcomes, whereas APP has also substantial advantages in reduction of re-hospitalization, severe psychopathology and targeted control of concurrent symptoms. Given currently limited therapeutic options, it is also important to properly utilize APP in order to maximize its clinical utility and minimize its risk for better treatment outcomes for patients with schizophrenia, based on risk/benefit with full understanding of pharmacological and clinical issues on APP. The present paper intends to address intriguing and important issues in the use of APP in real world practice.
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Background: Intravenous iron is associated with oxidative stress, and very few studies have assessed change in oxidative stress markers post infusion. Objectives: The study aimed to measure the change in levels of hemoglobin (Hb), serum ferritin, and select oxidative stress markers (malondialdehyde [MDA], superoxide dismutase [SOD], and ferric reducing ability of plasma [FRAP]) 4 weeks following the administration of intravenous iron sucrose (IVIS) among moderately anemic pregnant women who were attending a secondary-level health-care facility, Haryana, North India. Methods: An observational study was conducted (May 2016 to Jan 2018) among pregnant women receiving intravenous iron sucrose i.e., IVIS (300 mg per dose) diluted in 300 mL of normal saline over 20� min and were followed up for a period of 4 weeks after the last dose of IVIS (end line). The study outcomes were measured in the levels of Hb, serum ferritin, MDA, SOD, and FRAP from the baseline to the end line. Results: The mean (95% confidence interval) change in the Hb and serum ferritin level 4 weeks after the last dose of IVIS was an increase of 2.5 (2.1�0) g/dL (P < 0.001) and 63.0 (44.7�.3) ng/mL (P < 0.001), respectively. There were no significant changes (baseline to end line) in mean (standard deviation [SD]) MDA level and mean (SD) FRAP level. The mean (SD) SOD level declined significantly (2.2 [0.4] U/mL to 1.6 [0.5] U/mL [P < 0.001]). No life-threatening adverse events were encountered during the study. Conclusion: IVIS was well tolerated and effective in treating moderate anemia in pregnancy. Body iron store was replenished following IVIS administration. There was no increase in oxidative stress following IVIS therapy.
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Background: Incidence of thyroid nodules varies according to the methods of diagnosis, 4-7% by palpation and 17-67% by high resolution ultrasound. The gold standard of diagnosis for thyroid nodules is fine needle aspiration (FNA); however, fine needle aspiration cytology (FNAC) alone is insufficient to detect cancer because of inadequate cytology (5-15%) and in cases of follicular neoplasm (15-25%) where only surgery is diagnostically conclusive. Therefore, other factors in addition to FNA should be considered to predict malignancy. This study was done to evaluate the association between elevated pre-operative thyroglobulin levels and histopathologically proven thyroid carcinoma.Methods: This retrospective study was conducted in Bowring and Lady Curzon Hospital, from December 2017 to November 2018. All patients above 18 years, undergoing total thyroidectomy, with normal antithyroglobulin levels and with indeterminate thyroid nodules or disease on FNAC were included. Patients proven to have malignancy by FNAC, who underwent hemithyroidectomy and patients with thyroglossal cyst or ectopic thyroid swellings were excluded.Results: A total of 50 patients were included. The Fischer’s exact test shows significant value of 0.037 and also the two-tailed test showed a p value <0.05, hence it is significant to conclude that the mean value of thyroglobulin levels among histopathologically proven malignant thyroid cancers is significantly higher compared to the benign thyroid disease.Conclusions: In addition to thyroid-stimulating hormone, thyroid nodules with elevated thyroglobulin levels were independently associated with the presence of thyroid cancer; therefore, the evaluation of pre-operative thyroglobulin level in patients with indeterminate FNAC might give additional information to predict malignancy.
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Objective@#Genetic variations in the gene encoding zinc finger protein 804A gene (ZNF804A) have been associated with major depression and bipolar disorder. In this work we focused on the potential influence of ZNF804A variations on the risk of developing specific sub-phenotypes as well as the individual response to available treatments. @*Methods@#We used two samples of different ethnic origin: a Korean sample, composed by 242 patients diagnosed with major depression and 132 patients diagnosed with bipolar disorder and 326 healthy controls; an Italian sample composed 151 major depression subjects, 189 bipolar disorder subjects and 38 outpatients diagnosed for a primary anxiety disorder. @*Results@#Our analyses reported an association of rs1344706 with psychotic phenotype in the cross-diagnostic pooled sample (geno p = 4.15 × 10−4, allelic p = 1.06 × 10−4). In the cross-diagnosis Italian sample but not in the Korean one, rs7597593 was involved with depressive symptoms improvement after treatment (geno p = 0.025, allelic p = 0.007). @*Conclusion@#The present study evidenced the role of ZNF804A alterations in symptoms improvement after treatment. Both manic and depressive symptoms seem to be modulated by ZNF804A, though the latter was observed in the bipolar pooled sample only. The role of this factor is likely related to synaptic development and maintenance; however, further analyses will be needed to better understand the molecular mechanics involved with ZNF804A.
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Objective@#This study was done for collection of real world data of Aripiprazole Once Monthly (AOM) in patients with schizophrenia. @*Methods@#The observation was up to 12 months from the first use of AOM in patients with antipsychotic polypharmacy (APpoly)/other long acting injectable antipsychotics (LAIs) for treatment of schizophrenia in daily practice. Demographics and available clinical information such as The Positive and Negative Syndrome Scale (PANSS) and Clinical Global Impression-severity (CGI-S) scores were retrieved from the electronic medical record (EMR). Adverse events were also noted as described in EMR. @*Results@#Eighteen patients were found to be switched from APpoly/LAIs. Mean numbers of previous APs treatment failure and immediate prior APs were 2.2 and 2.4, respectively; most commonly used APs before AOM were aripiprazole, blonanserin, quetiapine, and risperidone. Mean number of combined APs before AOM significantly decreased from 2.4 use to 0.7 at month 12 (p ＜ 0.0001). The PANSS total (71.7 to 62.1, p = 0.000) and CGI-S (3.4 to 3.1, p = 0.008) scores were also significantly decreased from baseline (first use of AOM) to month 12, respectively. Other various psychotropics including anxiolytics were also significantly and substantially decreased at some point from baseline throughout the observation period as well. Mild hand tremor and akathisia were developed in 3 patients. @*Conclusion@#The present observation study clearly confirmed the use of AOM should be also effective and tolerable treatment option for patients with APpoly/LAIs in the real world practice. Subsequent, adequately-powered, and well-controlled clinical trials are warranted in near future.
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Isolated medial rectus palsy in an otherwise healthy individual is a very rare entity. However, this may point towards underlying systemic pathology. This is a case report of an otherwise healthy young adult male who presented with sudden onset non-progressive blurring of vision in right eye. A series of investigations were performed and the patient was diagnosed to have a rheumatological disorder. Isolated muscle palsies in young patient may be masking a systemic disorder and needs to be evaluated thoroughly.
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Pulmonary nocardiosis is an uncommon bacterial infection that may lead to severe disease in immunocompromised patients. The disease is rare in immunocompetent patients. Reported cases are few, and the literature is limited because disease recognition is difficult. We present a case report of two patients of pulmonary nocardiosis, who had different clinicoradiological presentations and also responded differently to treatment. Given the rising incidence of cancer, organ transplantation, and use of parenteral steroids, Nocardia is likely to attain a higher place among the causes of pulmonary infections.
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Background: Neonatal seizures may arise as a result of diverse etiologies and can have varied presentations. Biochemical abnormalities are commonly observed in neonates which can be either primary or secondary. Early recognition and treatment of biochemical disturbances is essential for optimal management and satisfactory long-term outcome.Methods: A total of 100 neonates presenting with seizures admitted to NICU of JJM Medical College, Davanagere, from November 2015 to April 2017 were enrolled in the study. Detailed antenatal, natal, postnatal history along with detailed examination was done along with baseline characteristics of convulsing were recorded at admission along with relevant biochemical investigations before instituting any specific treatment.Results: In the present study, out of 100 neonates studied, 64 were full term of which 49(76.5%) were AGA and 15(23.5%) were SGA, whereas 36 cases were preterm. Most neonatal seizures occurred in first 3 days of life, i.e. 59% of which majority occurred on first day of life (34%). Birth asphyxia and septicemia are common cause of neonatal seizures in present study (38 cases each), followed by pure metabolic disturbances 19%. In pure metabolic seizures, hypoglycemia (47.8%) is most common more in preterm babies (55%) followed by hypocalcemia.Conclusions: Biochemical abnormalities are common in neonatal seizures and often go unrecognized and may significantly contribute to seizure activity. Hence, a biochemical work up is necessary for all cases of neonatal seizures.
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OBJECTIVE: The present study aimed to observe potential benefit of aripiprazole augmentation in the treatment of major depressive disorder with mixed specifier (MDDM) in naturalistic treatment setting. METHODS: Data were collected from MDDM patients using a retrospective chart review for 8 weeks (week –8 and week 0) in routine practice. All patients were on current antidepressants upon starting of aripiprazole. Patients were treated without restriction of doses of aripiprazole. The primary endpoint was the mean change of Montgomery–Åsberg Depression Rating Scale (MADRS) total scores along with various secondary endpoint measures. RESULTS: In total 38 patients were analyzed. The changes of MADRS, Clinical Global Impression (CGI)-severity, Young Mania Rating Scale, Sheehan Disability Scale, and CGI-clinical benefit total scores from baseline to the endpoint were −7.1, −0.8, −4.9, −4.1, and −3.6, respectively (all p < 0.0001). At the endpoint, the responder and remitter rates by MADRS score criteria were approximately 32% and 21%, respectively. CONCLUSION: The present findings have clearly shown the effectiveness and tolerability of aripiprazole augmentation for MDDM patients in routine practice. The present study warrants subsequent, adequately-powered, well-controlled studies for generalizability near future.
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Humans , Antidepressive Agents , Aripiprazole , Bipolar Disorder , Depression , Depressive Disorder , Depressive Disorder, Major , Retrospective StudiesABSTRACT
OBJECTIVE: Genetics factors are likely to play a role in the risk, clinical presentation and treatment outcome in major depressive disorder (MDD). In this study, we investigated the role of three candidate genes for MDD; calcium voltage-gated channel subunit alpha1 C (CACNA1C), cholinergic receptor nicotinic alpha 7 subunit (CHRNA7), and mitogen-activated protein kinase 1 (MAPK1). METHODS: Two-hundred forty-two MDD patients and 326 healthy controls of Korean ancestry served as samples for the analyses. Thirty-nine single nucleotide polymorphisms (SNPs) within CACNA1C, CHRNA7, and MAPK1 genes were genotyped and subsequently tested for association with MDD (primary analysis) and other clinical features (symptoms’ severity, age of onset, history of suicide attempt, treatment outcome) (secondary analyses). Single SNPs, haplotypes and epistatic analyses were performed. RESULTS: Single SNPs were not associated with disease risk and clinical features. However, a combination of alleles (haplotype) within MAPK1 was found associated with MDD-status. Secondary analyses detected a possible involvement of CACNA1C haplotype in resistance to antidepressant treatment. CONCLUSION: These data suggest a role for MAPK1 and CACNA1C in MDD risk and treatment resistance, respectively. However, since many limitations characterize the analysis, the results must be considered with great caution and verified.