Abstract

A COMPARATIVE PROSPECTIVE STUDY OF THE EFFECTIVENESS OF SUMATRIPTAN/ NAPROXEN COMBINATION AND NAPROXEN MONOTHERAPY FOR SYMPTOMATIC RELIEF IN MIGRAINE PATIENTS

Anitta Mathew*, Anju Thomas, Soumya Mariyam Philip, Anjana M.N., Sheetal S. and Santhosh M. Mathews

ABSTRACT

The primary objective of this study was to compare the effectiveness of Sumatriptan/Naproxen combination (SNC) and Naproxen monotherapy in reducing the headache duration, headache severity and the headache associated symptoms of migraine using patient data collection proforma, headache characteristics questionnaire, Headache Impact Test – 6 (HIT – 6), Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). Patients with migraine (n = 74) and at least 6 months history of migraine and having 2 - 6 migraine attacks per month were chosen for the study. For all endpoints, differences between treatments were compared with z tests. Average duration of headache score of the patients on SNC were decreased from 9.13 to 0.36 and patients on Naproxen monotherapy decreased from 9.82 to 0.94, the average severity score of the patient with SNC was decreased from 10.272 to 6.93 and that of Naproxen monotherapy from 9.717 to 8.158, resolution of clinical symptoms associated with headache, was seen in more patients on SNC therapy, than in patients on Naproxen monotherapy, the recurrence time of most patients on Naproxen monotherapy was within 2 – 12 hours, whereas for patients on SNC therapy it was >24 hours. The mean difference value of the HIT-6 scores of patients on SNC therapy was 17.8, whereas that of Naproxen monotherapy was 12.503 and the mean difference of the Q-LES-Q-SF scores of the patients on SNC therapy 20.42, for patients on Naproxen monotherapy, was 12.18. The overall results of the study suggest that the effectiveness of Naproxen for all the end points, except effect on duration of migraine, is lesser compared to that of Sumatriptan/Naproxen combination. Naproxen was as well tolerated, if not better than, the combination drug.

Keywords: headache; migraine; Naproxen; Sumatriptan; symptoms; duration; severity; recurrence; score.