Dr. Andrew Blumenfeld, MD International Headache Congress (IHC) Abstract 2009

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Objectives: To demonstrate that the combination of medical and dental prophylactic treatments for primary headache disorders will produce a greater benefit than either treatment alone.

Background: Preventive treatments for migraine and tension type headache are often limited by patient compliance and poor tolerability, as escalating adverse side effects are anticipted as dosages of preventive medications increase. Primary headache disorders have multiple mechanisms that lead to ongoing headaches and it is likely that more than one treatment might be needed in an individual patient to control the disorder. To date, there are few studies that assess combination treatments in primary headache disorders. In this pilot study we describe a comparative study of the efficacy of nociceptive trigeminal inhibition (NTI) and Valproic acid (VA) in the treatment of migraine and tension-type headaches. 

Methods: Sixty patients, 18 years of age and older, non-pregnant, who met International Headache Society criteria for migraine and tension-type headaches were randomly assigned to three treatment groups. 20 patients per treatment arm as follows: Valproic acid alone, NTI splint alone, and combination of NTI and Valproic Acid. Valproic Acid dose in the treatment arms was 200 mg bid. Clinical follow-up was performed for 8 weeks at weekly intervals. The patients reported headache on a visual analog scale before treatment and also after every week in their treatment period. Side effects were reported. Data were collected and compared between the groups using the Mann-Whitney and Wilcoxon test.

Results: VAS score changes were as follows: Valproic acid users showed a 61% reduction in headache. NTI users showed a 62% reduction in headache. NTI and Valproic acid users showed a 76% reduction in headache. The P-value is <0.0001 for the combination treatment compared with either treatment alone. No side effects reported with the NTI splint. Side effects reported for Valproic Acid included: gastro-intestinal upset, alopecia and depression. No patients discontinued the study due to adverse events. Conclusions: No statistical difference in treatment efficacy was noted between the Valproic acid and NTI treatment arms. However, there was a statically significantly superior improvement for the combination of Valproic Acid and NTI compared to either of the two individual treatments. There were no adverse side-effects with the NTI, while side effects were present for patients treated with Valproic Acid. Greater therapeutic gain, without an escalation of side effects, results from the combination of the two treatments.

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