A comparative study of propranolol versus amitriptyline at a low dose for prophylaxis of episodic migraine at a tertiary care centre

Background: The aim of this study was to assess efficacy and tolerability of propranolol compared to amitriptyline at a low dose in a sample of Indian Population for prophylaxis of episodic migraine. Methods: Episodic migraine patients aged 18 to 55 years, not on any preventive treatment were randomly allocated to receive propranolol (80 mg/day) or amitriptyline (10 mg/day). The primary efficacy outcome was the mean change in migraine attack frequency per month after 3 months of treatment. Multiple secondary efficacy outcomes and adverse events were also assessed. Results: Both study groups showed a reduction of migraine frequency, severity of headache and disability due to migraine at 3 months. Propranolol significantly reduced the frequency of headache (51.6% vs 43.6%, p=0.03) and the number of rescue medications (53.1% vs 43.3%, p=0.01) compared with amitriptyline at 3 months. The responders with ≥50% improvement was significantly more in propranolol group compared to amitriptyline (60% vs 43.3%, p=0.02). There was no significant difference in the incidence of adverse events between the two groups. Conclusions: Propranolol (80 mg/day) was more efficacious than amitriptyline (10 mg/day) in terms of significantly reducing the frequency of headache and the number of rescue medicine at 3 months. Both drugs were comparable in safety profile.