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D K Kochar - One of the best experts on this subject based on the ideXlab platform.
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management of diabetic neuropathy by Sodium Valproate and glyceryl trinitrate spray a prospective double blind randomized placebo controlled study
Diabetes Research and Clinical Practice, 2009Co-Authors: Rajesh Agrawal, Jitender Goswami, Shreyans Jain, D K KocharAbstract:Objectives Combination of drugs with different mechanisms of action helps in achieving synergistic analgesic effect in neuropathic pain. Keeping this point in view, the effect and safety aspects of Sodium Valproate and GTN were assessed alone as well as in combination in this study. Design Prospective double-blind randomized placebo-controlled study. Material and method Eighty-seven type 2 diabetics with painful neuropathy were enrolled. Four were excluded: three with HbA1c > 11 while one withdrew consent. The remaining 83 were given either Sodium Valproate and GTN spray (group A) or placebo drug and GTN spray (group B) or Sodium Valproate and placebo spray (group C) or placebo drug and placebo spray (group D). Quantitative assessment of pain was done by McGill pain questionnaire, visual analogue score (VAS) and present pain intensity (PPI) at the beginning of the study and after 3 months along with motor and sensory nerve conduction velocities measurements. Results All the three treatment groups experienced significant improvement in pain score in their drug phase of trial (p < 0.001/ < 0.05) along with some of the electrophysiological parameters. The assessment of the magnitude of therapeutic effect of Sodium Valproate, GTN and their combination gave numbers needed to treat (NNT) of 7, 5 and 4, respectively. Conclusion Sodium Valproate and GTN are well tolerated and provide significant improvement in pain scores as well as in electrophysiological parameters.
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management of diabetic neuropathy by Sodium Valproate and glyceryl trinitrate spray a prospective double blind randomized placebo controlled study
Diabetes Research and Clinical Practice, 2009Co-Authors: R P Agrawal, Shreyans Jain, Jitender Goswami, D K KocharAbstract:Abstract Objectives Combination of drugs with different mechanisms of action helps in achieving synergistic analgesic effect in neuropathic pain. Keeping this point in view, the effect and safety aspects of Sodium Valproate and GTN were assessed alone as well as in combination in this study. Design Prospective double-blind randomized placebo-controlled study. Material and method Eighty-seven type 2 diabetics with painful neuropathy were enrolled. Four were excluded: three with HbA1c > 11 while one withdrew consent. The remaining 83 were given either Sodium Valproate and GTN spray (group A) or placebo drug and GTN spray (group B) or Sodium Valproate and placebo spray (group C) or placebo drug and placebo spray (group D). Quantitative assessment of pain was done by McGill pain questionnaire, visual analogue score (VAS) and present pain intensity (PPI) at the beginning of the study and after 3 months along with motor and sensory nerve conduction velocities measurements. Results All the three treatment groups experienced significant improvement in pain score in their drug phase of trial (p Conclusion Sodium Valproate and GTN are well tolerated and provide significant improvement in pain scores as well as in electrophysiological parameters.
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Sodium Valproate for painful diabetic neuropathy a randomized double blind placebo controlled study
QJM: An International Journal of Medicine, 2004Co-Authors: D K Kochar, R P Agrawal, N Rawat, Arvind Vyas, R Beniwal, Sanjay K Kochar, P GargAbstract:Background: Various drugs are effective in the management of painful diabetic neuropathy, but none is completely satisfactory. We previously found Sodium Valproate to be effective and safe in a short-term study. Aim: To test the effectiveness and safety of Sodium Valproate in the management of painful diabetic neuropathy over 3 months. Design: Randomized double-blind placebo-controlled study. Methods: Consecutive attending patients with type 2 diabetes mellitus with painful neuropathy were asked to participate in the trial: 48 agreed. Five were excluded: three with HbA1c > 11, one with too low a pain level and one who withdrew consent. The remaining 43 were given either drug (group A) or placebo (group B). Each patient was assessed clinically. Quantitative assessment of pain was done by McGill Pain Questionnaire, Visual Analogue Score and Present Pain Intensity, at the beginning of the study, after 1 month and after 3 months. Motor and sensory nerve conduction velocities were measured initially and after 3 months. Liver function tests and other adverse drug-related effects were assessed periodically. Results: Of the 43 patients, four dropped out: one in group A and three in group B. There was significant improvement in pain score in group A, compared to group B, at 3 months ( p < 0.001). Changes in electrophysiological data were not significant. The drug was well-tolerated by all patients, except one, who had raised serum AST and ALT levels after 1 month of treatment, and whose treatment was discontinued. Discussion: Sodium Valproate is well-tolerated, and provides significant subjective improvement in painful diabetic neuropathy.
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Sodium Valproate in the management of painful neuropathy in type 2 diabetes a randomized placebo controlled study
Journal of The Peripheral Nervous System, 2003Co-Authors: D K Kochar, N Jain, R P Agarwal, T Srivastava, P Agarwal, Sunil GuptaAbstract:OBJECTIVE: To study the effectiveness and safety aspects of Sodium Valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. MATERIAL AND METHODS: A randomized double-blind placebo controlled trial of Sodium Valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. RESULTS: Significant improvement was noticed in the pain score of patients receiving Sodium Valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. CONCLUSION: Sodium Valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.
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Sodium Valproate in the management of painful neuropathy in type 2 diabetes a randomized placebo controlled study
Acta Neurologica Scandinavica, 2002Co-Authors: D K Kochar, N Jain, R P Agarwal, T Srivastava, P Agarwal, Sunil GuptaAbstract:Kochar DK, Jain N, Agrawal RP, Srivastava T, Agarwal P, Gupta S. Sodium Valproate in the management of painful neuropathy in type 2 diabetes – a randomized placebo controlled study. Acta Neurol Scand 2002: 106: 248–252. © Blackwell Munksgaard 2002. Objective– To study the effectiveness and safety aspects of Sodium Valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. Material and methods– A randomized double-blind placebo controlled trial of Sodium Valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. Results– Significant improvement was noticed in the pain score of patients receiving Sodium Valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. Conclusion– Sodium Valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.
Sunil Gupta - One of the best experts on this subject based on the ideXlab platform.
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Sodium Valproate in the management of painful neuropathy in type 2 diabetes a randomized placebo controlled study
Journal of The Peripheral Nervous System, 2003Co-Authors: D K Kochar, N Jain, R P Agarwal, T Srivastava, P Agarwal, Sunil GuptaAbstract:OBJECTIVE: To study the effectiveness and safety aspects of Sodium Valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. MATERIAL AND METHODS: A randomized double-blind placebo controlled trial of Sodium Valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. RESULTS: Significant improvement was noticed in the pain score of patients receiving Sodium Valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. CONCLUSION: Sodium Valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.
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Sodium Valproate in the management of painful neuropathy in type 2 diabetes a randomized placebo controlled study
Acta Neurologica Scandinavica, 2002Co-Authors: D K Kochar, N Jain, R P Agarwal, T Srivastava, P Agarwal, Sunil GuptaAbstract:Kochar DK, Jain N, Agrawal RP, Srivastava T, Agarwal P, Gupta S. Sodium Valproate in the management of painful neuropathy in type 2 diabetes – a randomized placebo controlled study. Acta Neurol Scand 2002: 106: 248–252. © Blackwell Munksgaard 2002. Objective– To study the effectiveness and safety aspects of Sodium Valproate in the management of painful neuropathy in patients of type 2 diabetes mellitus. Material and methods– A randomized double-blind placebo controlled trial of Sodium Valproate was done in type 2 diabetic patients to assess its efficacy and safety in the management of painful neuropathy. We screened 60 patients but eight patients could not complete the study; hence, the present study was done on 52 patients. Each patient was assessed by clinical examination, pain score by short form of the McGill pain questionnaire (SF-MPQ) and electrophysiological examination, which included motor and sensory nerve conduction velocity, amplitude and H-reflex initially and at the end of 1 month of treatment. Results– Significant improvement was noticed in the pain score of patients receiving Sodium Valproate in comparison to patients receiving placebo at the end of 1 month (P < 0.05). The changes in electrophysiological data were not significant. The drug was well tolerated by all patients except one who developed a raised aspartate transaminase (AST)/alanine transaminase (ALT) level after 15 days of treatment. Conclusion– Sodium Valproate is a well-tolerated drug and provides significant subjective improvement in painful diabetic neuropathy. These data provide a basis for future trials of longer duration in a larger group of patients.
Jayantee Kalita - One of the best experts on this subject based on the ideXlab platform.
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comparison of lacosamide versus Sodium Valproate in status epilepticus a pilot study
Epilepsy & Behavior, 2017Co-Authors: Usha K Misra, Deepanshu Dubey, Jayantee KalitaAbstract:Abstract Purpose The purpose of this study was to compare the efficacy and safety of lacosamide (LCM) and Sodium Valproate (SVA) in lorazepam (LOR)-resistant SE. Methods Patients with LOR-resistant SE were randomized to intravenous LCM 400mg at the rate of 60 mg/kg/min or SVA 30 mg/kg at the rate of 100 mg/min. The SE severity score (STESS), duration of SE and its etiology, and MRI findings were noted. Primary outcome was seizure cessation for 1 h, and secondary outcomes were 24 h seizure remission, in-hospital death, and severe adverse events (SAE). Results Sixty-six patients were included, and their median age was 40 (range 18–90) years. Thirty-three patients each received LCM and SVA. Their demographic, clinical, STESS, etiology, and MRI findings were not significantly different. One-hour seizure remission was not significantly different between LCM and SVA groups (66.7% vs 69.7%; P = 0.79). Twenty-four-hour seizure freedom was insignificantly higher in SVA (20, 66.6%) compared with LCM group (15, 45.5%). Death (10 vs 12) and composite side effects (4 vs 6) were also not significantly different in LCM and SVA groups. LCM was associated with hypotension and bradycardia (1 patient), and SVA with liver dysfunction (6). Conclusion In patients with LOR-resistant SE, both LCM and SVA have comparable efficacy and safety.
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Sodium Valproate vs phenytoin in status epilepticus a pilot study
Neurology, 2006Co-Authors: Usha K Misra, Jayantee Kalita, Rajesh PatelAbstract:Sixty-eight patients with convulsive status epilepticus (SE) were randomly assigned to two groups to study the efficacy of Sodium Valproate (VPA) and phenytoin (PHT). Seizures were aborted in 66% in the VPA group and 42% in the PHT group. As a second choice in refractory patients, VPA was effective in 79% and PHT was effective in 25%. The side effects in the two groups did not differ. Sodium Valproate may be preferred in convulsive SE because of its higher efficacy.
Anthony G Marson - One of the best experts on this subject based on the ideXlab platform.
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ethosuximide Sodium Valproate or lamotrigine for absence seizures in children and adolescents
Cochrane Database of Systematic Reviews, 2005Co-Authors: Ewa B Posner, Khalid K Mohamed, Anthony G MarsonAbstract:Background This is an updated version of the original Cochrane review published in Issue 3, 2003. Absence seizures are brief epileptic seizures which present in childhood and adolescence. They are characterised by sudden loss of awareness and an electroencephalogram (EEG) typically shows generalised spike wave discharges at three cycles per second. Ethosuximide, Valproate and lamotrigine are currently used to treat absence seizures. This review aims to determine the best choice of anticonvulsant for a child with typical absence seizures. Objectives To review the evidence for the effects of ethosuximide, Valproate and lamotrigine as treatments for children and adolescents with absence seizures, when compared with placebo or each other. Search methods We searched the Cochrane Epilepsy Group's Specialised Register (November 2009), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2009), MEDLINE (1950 to November week 3, 2009) and EMBASE (1988 to March 2005). No language restrictions were imposed. In addition, we contacted Sanofi Winthrop, Glaxo Wellcome (now GlaxoSmithKline) and Parke Davis (now Pfizer), manufacturers of Sodium Valproate, lamotrigine and ethosuximide respectively. Selection criteria Randomised parallel group monotherapy or add-on trials which include a comparison of any of the following in children or adolescents with absence seizures: ethosuximide; Sodium Valproate; lamotrigine or placebo. Data collection and analysis Outcome measures were: (1) proportion of individuals seizure free at 1, 3, 6, 12 and 18 months post randomisation; (2) people with a 50% or greater reduction in seizure frequency; (3) normalisation of EEG and/or negative hyperventilation test and (4) adverse effects. Data were independently extracted by two review authors. Results are presented as relative risks (RR) with 95% confidence intervals (95% CI). Main results Five small trials were found, four of them were of poor methodological quality. One trial (29 participants) compared lamotrigine with placebo using a response conditional design. Individuals taking lamotrigine were significantly more likely to be seizure free than participants taking placebo during this short trial. Another trial compared lamotrigine with Sodium Valproate, the study lacked power to detect the difference in efficacy. Three studies compared ethosuximide, but because of diverse study designs and populations studied, we decided not to pool results in a meta-analysis. None of these studies found a difference between Valproate and ethosuximide with respect to seizure control, but confidence intervals were wide and the existence of important differences could not be excluded. Authors' conclusions Although ethosuximide, lamotrigine and Valproate are commonly used to treat people with absence seizures we have insufficient evidence to inform clinical practice, and the few trials included in this review were of poor methodological quality and did not have sufficient number of participants. More trials of better quality are needed.
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a systematic review of treatment of typical absence seizures in children and adolescents with ethosuximide Sodium Valproate or lamotrigine
Seizure-european Journal of Epilepsy, 2005Co-Authors: Ewa B Posner, Khalid Mohamed, Anthony G MarsonAbstract:Summary Purpose: To evaluate the role of ethosuximide, Sodium Valproate and lamotrigine in children and adolescents with typical absence seizures (AS). Methods: A systematic review of randomized controlled trials that included children or adolescents with typical absence seizures who received treatment with ethosuximide, Sodium Valproate or lamotrigine. Results: Four RCTs fulfilled the inclusion criteria. Due to the heterogeneity of the studies the results could not be pooled in a meta-analysis. Conclusions: We found no reliable evidence to inform clinical practice. The design of further trials should be pragmatic and compare one drug with another.
Usha K Misra - One of the best experts on this subject based on the ideXlab platform.
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comparison of lacosamide versus Sodium Valproate in status epilepticus a pilot study
Epilepsy & Behavior, 2017Co-Authors: Usha K Misra, Deepanshu Dubey, Jayantee KalitaAbstract:Abstract Purpose The purpose of this study was to compare the efficacy and safety of lacosamide (LCM) and Sodium Valproate (SVA) in lorazepam (LOR)-resistant SE. Methods Patients with LOR-resistant SE were randomized to intravenous LCM 400mg at the rate of 60 mg/kg/min or SVA 30 mg/kg at the rate of 100 mg/min. The SE severity score (STESS), duration of SE and its etiology, and MRI findings were noted. Primary outcome was seizure cessation for 1 h, and secondary outcomes were 24 h seizure remission, in-hospital death, and severe adverse events (SAE). Results Sixty-six patients were included, and their median age was 40 (range 18–90) years. Thirty-three patients each received LCM and SVA. Their demographic, clinical, STESS, etiology, and MRI findings were not significantly different. One-hour seizure remission was not significantly different between LCM and SVA groups (66.7% vs 69.7%; P = 0.79). Twenty-four-hour seizure freedom was insignificantly higher in SVA (20, 66.6%) compared with LCM group (15, 45.5%). Death (10 vs 12) and composite side effects (4 vs 6) were also not significantly different in LCM and SVA groups. LCM was associated with hypotension and bradycardia (1 patient), and SVA with liver dysfunction (6). Conclusion In patients with LOR-resistant SE, both LCM and SVA have comparable efficacy and safety.
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Sodium Valproate vs phenytoin in status epilepticus a pilot study
Neurology, 2006Co-Authors: Usha K Misra, Jayantee Kalita, Rajesh PatelAbstract:Sixty-eight patients with convulsive status epilepticus (SE) were randomly assigned to two groups to study the efficacy of Sodium Valproate (VPA) and phenytoin (PHT). Seizures were aborted in 66% in the VPA group and 42% in the PHT group. As a second choice in refractory patients, VPA was effective in 79% and PHT was effective in 25%. The side effects in the two groups did not differ. Sodium Valproate may be preferred in convulsive SE because of its higher efficacy.