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Scholars Journal of Applied Medical Sciences | Volume-7 | Issue 11
Comparative study of safety of Propranolol Versus Amitriptyline for prophylaxis of Migraine
Dhananjay Kumar Pandey, Kavita Dhar, P.S. Singh, I. P. Jain4, Amrita
Published: Nov. 24, 2019 | 57 69
DOI: 10.36347/sjams.2019.v07i11.035
Pages: 3662-3667
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Abstract
Migraine headache is a common, disabling condition. When migraine episodes are frequent, treatment can be challenging. Prophylactic therapy for migraine remains one of the more difficult aspects. Although, all of the medications used in treatment have incomplete efficacy, and most produce adverse effects. Material and methods: The study was conducted in Patients with symptoms of Migraine attending Department of Medicine, Santosh Medical College & Hospital, after the approval of the Institutional Ethics Committee. This was a prospective, comparative, parallel, open-label, randomized clinical trial. As per the ICHD III beta diagnostic criteria for migraine. The ADRs related to Propranolol and Amitriptyline were monitored and documented in suitably designed ADR documentation form after initial notification of the suspected ADR by physicians. Severity and causality of the ADRs were assessed by using Modified Hartwig and Siegel scale and Naranjo’s Algorithm, respectively. Result: Mean age in group 1 patients were 27.21±7.71 years and in Group 2 patients were 28.01±7.65. There was no statistically significant difference in mean between both groups. As per the modified Hartwig and Siegel’s scale maximum number of ADRs was mild category and lowest in sever type of reaction was observed in this study. No ADRs were found in lethal type of reaction. Most common adverse drug reaction reported in two groups were includes. In the Group 1: In period 1 maximum ADR was Dizziness and least one constipation whereas in during period 2 highest incidence of ADR was Somnolence and least was Dizziness and constipation. On the other hand, in group 2 during period 1 maximum ADR was Xerostomia and least constipation. Moreover, in during period 2 more ADR were dizziness and followed by weight gain and xerostomia, somnolence and constipation. Conclusion: This trial shows that propranolol is well tolerated as compared with amitriptyline in migraine prophylaxis.................