Original Research Article
Year: 2018 | Month: March | Volume: 8 | Issue: 3 | Pages: 78-89
Evaluation of Efficacy and Safety of Pregabalin as an Add on Therapy to Carbamazepine in Patients of Trigeminal Neuralgia
Arvind Narwat1, Vivek Sharma2, Kiran Bala3
Department of Pharmacology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
3Senior Professor & Head, Department of Neurology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak, Haryana
Corresponding Author: Arvind Narwat
Introduction: Pain and fear of pain continue to be the commonest and strongest motivation for the people to seek facial pain treatment. Pain is a personal experience of the sufferer that cannot be shared and wholly belongs to the sufferer. Trigeminal neuralgia (TN) is a notable facial pain disorder resulting in periodic severe pain that produces one of the most severe kinds of pain known to mankind. Treatment of this debilitating condition may be varied, ranging from medical to surgical interventions. However antiepileptic drugs are commonly used for its treatment. This study was done with an aim to evaluate the efficacy and safety of pregabalin as an add on therapy to carbamazepine in patients of trigeminal neuralgia.
Materials and Methods: This was a prospective, open label, randomized, comparative clinical study conducted on 50 patients. The patients were randomly divided in two groups of 25 patients to receive following two treatments. Group I (n=25) received tablet carbamazepine as a monotherapy initially 200 mg daily per orally in divided doses and gradually built up as per clinical response with maximum titrated dose upto 1000mg/day. Group II (n=25) received capsule pregabalin 75 mg OD and tablet carbamazepine 200 mg daily per orally in divided doses and dose gradually built up as per clinical response with maximum titrated dose upto 300mg/day for pregabalin for a period of 12 weeks. Efficacy assessment was done by Visual analogue scale (VAS), Verbal rating scale (VRS) and safety was assessed by monitoring of adverse drug reactions. The patients were assessed at the end of 4th, 8th and 12th weeks.
Results: There was statistically significant reduction in mean pain score at 4th, 8th and 12 week, in both the groups when compared to the baseline i.e both carbamazepine and pregabalin as an add on therapy to carbamazepine were effective in reducing the pain. However on intergroup comparison, pregabalin as an add on drug to carbamazepine(Group II) produced better response with earlier onset of pain relief with statistically significant reduction in mean pain score at 8th and 12th weeks when compared to carbamazepine alone (Group I). There were no serious adverse effects in either of treatment group. Common adverse effects in group I were drowsiness, nausea and vomiting while in group II, drowsiness and dry mouth were commonly noticed
Conclusion: The present study suggested that pregabalin as an add on therapy to carbamazepine was found to cause significant reduction in pain scoring at 8th & 12 weeks and could be a promising drug in patients of trigeminal neuralgia when therapeutic options are limited.
Key words: carbamazepine, pregabalin, trigeminal neuralgia, visual analogue scale, verbal rating scale