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• W3131429023 abstract "INTRODUCTION:Migraine is a common disabling neurological disorder that affects men and women equally. Population based studies suggests that about 10-12% of the general population suffer from migraine. It often remains as a challenging disorder in terms of its management. Frequently recurring, severe, disabling and long-lasting migraine attacks requires long term prophylaxis. The two most common alternatives that is used in the prophylactic therapy is Amitriptyline and Sodium valproate. Both drugs have class 1 recommendation for migraine prophylaxis. Hence it is thought worthwhile to study the efficacy and tolerability of sodium valproate vs Amitriptyline in migraine prophylaxis and find out the best treatment option between the two.AIMS & OBJECTIVES:1. To compare the efficacy of Sodium valproate and Amitriptyline in the prophylaxis of migraine.2. To compare the safety profile of the two drugs used for migraine prophylaxis and assess causality of ADR using WHO Causality assessment scale.MATERIAL & METHODS:This Prospective observational study commenced only after getting approval Institutional research committee (IRC) & Institutional ethics committee (IEC). The study was conducted in the Department of Neurology, Sree Mookambika Institute of Medical Sciences, Kulasekharam. Written informed consent (Annexure -II) was obtained from every participant before enrolling them into the study. Patients were enrolled on the basis of inclusion and exclusion criteria. Data were collected from 120 OPD prescription sheets of migraine patients taking amitriptyline or sodium valproate prophylactic therapy in the department of neurology. The baseline characteristics of the patients was recorded in case record form (Annexure-III). Other data recorded were symptom duration, headache frequency, neurological examination and also migraine pain severity and functional disability before and after treatment were recorded using VAS score (Annexure-IV)) and MIDAS score (Annexure-V) respectively. Efficacy was assessed by noting the reduction in number of migraine attacks per month, severity of pain and functional disability corresponding to the baseline at the end of 3 months and 6 months of treatment .The adverse drug reactions were recorded in ADR form (Annexure-VI) and causality was assessed using WHO Causality assessment scale (Annexure-VII). The data collected were entered into MS Excel 2016 spreadsheet and subsequently analyzed. Demographic details of amitriptyline and sodium valproate group were expressed in percentage and frequency. The severity of pain, frequency of headache and functional disability at baseline ,3 months and 6 months following treatment within the group were comparedusing analysis of variance (ANOVA). The number of patients with the primary and secondary end points at 3 and 6 months was compared by chi-square test. The variables were considered significant if the two-tailed P-value was less than 0.05. The statistical analysis was performed using SPSS for Windows, version 20. RESULTS:◈ Mean age group of study population using Amitriptyline and sodium valproate as prophylactic drugs is 21-40 years. (Amitriptyline group n=49 (88%), Sodium valproate group n=48 (87.5%).◈ Female preponderance was higher in both the groups. (Amitriptyline n=35 (61%), Sodium valproate n=34 (61.5%).◈ The study encounters had migraine symptoms for a period of 1-6 years and headache frequency per month was 4-12 attacks per month on average.◈ Before the treatment with the two alternatives severity of migraine pain and disability associated with migraine were assessed using VAS score and MIDAS score respectively.i. Severity of pain:- In amitriptyline group 98% of migraine encounters had VAS score ranging from 6 to 9 and in sodium valproate group, 95% of patients suffered from severe migraine with VAS score ranging from 7-9.ii. Disability of migraine:In amitriptyline group, 70% (n=40) patients had migraine attack with mild disability, 28% (n=16) with moderate disability and only one had severe disability. Whereas in sodium valproate group, 19.6% (n=10) had migraine with mild disability, 57.4% (n=32) with moderate disability, 23% (n=13) with severe disability and was graded as I, II and III respectively using MIDAS score.◈ At the end of 3 and 6 months of treatment , patients in both the groups showed significant improvement in migraine symptoms.1. Overall improvement (>50% improvement) in migraine headache frequency:- At the end of 3 months 59.6% (n=34) in Amitriptyline group and 91.1% (n=51) in sodium valproate group had > 50% improvement in overall headache frequency (p value 0.067). At the end of 6 months 64.2% (n=34) and 87% (n=47) patients showed >50% improvement in headache frequency in amitriptyline and sodium valproate group respectively. (p value < 0.001).2. Improvement in VAS score: At the end of 3 months ,50% (n=29) and 70% (n=39) patients showed > 50% improvement in VAS score in Amitriptyline and sodium valproate group respectively. (p value < 0.001). At the end of 6 months, 63% (n=36) and 82% (n=46) in Amitriptyline and Sodium valproate group showed greater than 50% improvement in VAS score respectively. (p value < 0.001).3. Improvement in severity of headache:At the end of 3 months 85% (n=48) and 91.1% (n=50) in amitriptyline and sodium valproate group had greater than or equal to one grade improvement in migraine disability. (p value < 0.001). At the end of 6 months, 91.6% (n=52) and 93% (n=52) patients in amitriptyline and sodium valproate group respectively, showed significant improvement in disability. (p value < 0.001).◈ Only 23% in Amitriptyline group had developed ADR, whereas in sodium valproate group 37 patients developed ADR during the study period.◈ Most common side effect in Amitriptyline group was sedation (64%) followed by menstrual irregularities(22%) and weight gain(10%). In Sodium valproate group majority of patients developed significant weight gain (64.5%), Menstrual irregularities (25%), followed by sedation and hair fall. In sodium valproate group 3 patients were withdrawn from the study due to intolerable side effect like photosensitivity reaction and fixed drug eruption.◈ Maximum number of ADR associated with Amitriptyline and sodium valproate usage had probable causal association as per WHO causality assessment scale.CONCLUSION:Sodium valproate had better efficacy at the end of 3 months and 6 months of prophylactic therapy. In terms of tolerability profile, amitriptyline was superior in comparison with sodium valproate, during the study period." @default.
• W3131429023 created "2021-03-01" @default.
• W3131429023 creator A5028552339 @default.
• W3131429023 date "2020-05-01" @default.
• W3131429023 modified "2023-09-27" @default.
• W3131429023 title "Comparison of Efficacy and Tolerability of Sodium Valproate and Amitriptyline in the Prophylaxis of Migraine: An Observational Study in the Neurology OPD of a Tertiary Care Hospital" @default.
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