Amitriptyline and intraoral devices for migraine prevention: a randomized comparative trial.

OBJECTIVES: Nonpharmacological treatments, such as the Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), are approved for migraine prophylaxis. We aimed at evaluating the effectiveness of the NTI-tss and to compare its efficacy with amitriptyline and with a sham intraoral device in the preventive treatment of migraine. METHODS: Consecutive patients with migraine were randomized to receive 25 mg of amitriptyline/day (n = 34), NTI-tss (n = 33) and a non-occlusal splint (n = 30). The headache frequency was evaluated at six and 12 weeks. RESULTS: The amitriptyline group showed, respectively, 60% and 64% reduction in attack frequency at six and 12 weeks (P = 0.000). In the NTI-tss and non-occlusal splint groups, reduction was 39% and 30%, respectively, at six weeks and 48% for both groups at 12 weeks. CONCLUSIONS: Amitriptyline proved superior to the NTI-tss and the non-occlusal splint. Despite its approval by the United States Food and Drug Administration, the NTI-tss was not superior to a sham device.

Amitriptyline and intraoral devices for migraine prevention: a randomized comparative trial / Amitriptilina e dispositivos intraorais para a prevenção da migrânea: estudo randomizado e comparativo

ABSTRACT Objectives: Nonpharmacological treatments, such as the Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), are approved for migraine prophylaxis. We aimed at evaluating the effectiveness of the NTI-tss and to compare its efficacy with amitriptyline and with a sham intraoral device in the preventive treatment of migraine. Methods: Consecutive patients with migraine were randomized to receive 25 mg of amitriptyline/day (n = 34), NTI-tss (n = 33) and a non-occlusal splint (n = 30). The headache frequency was evaluated at six and 12 weeks. Results: The amitriptyline group showed, respectively, 60% and 64% reduction in attack frequency at six and 12 weeks (P = 0.000). In the NTI-tss and non-occlusal splint groups, reduction was 39% and 30%, respectively, at six weeks and 48% for both groups at 12 weeks. Conclusions: Amitriptyline proved superior to the NTI-tss and the non-occlusal splint. Despite its approval by the United States Food and Drug Administration, the NTI-tss was not superior to a sham device.

RESUMO Objetivo: Tratamentos não farmacológicos como o Nociceptive Trigeminal Inhibition Tension Suppression System (NTI-tss), são aprovados para a prevenção da migrânea. Avaliamos a eficácia do NTI-tss no tratamento preventivo da migrânea e comparamos sua eficácia com a de um medicamento tradicional (amitriptilina) e com um dispositivo intraoral que não interfere com a oclusão (placa palatina). Métodos: Pacientes consecutivos com migrânea foram randomizados e receberam 25mg de amitriptilina/dia (n = 34), NTI-tss (n = 33) ou placa palatina não oclusal (n = 30). A frequência da cefaleia foi comparada após seis e 12 semanas. Resultados: No grupo da amitriptilina houve redução de 60% em seis semanas e de 64% em 12 semanas (P = 0.000). Nos grupos do NTI-tss e da placa não oclusal a redução foi respectivamente de 39% e 30% após seis semanas, e de 48% para ambos em 12 semanas. Conclusões: Amitriptilina foi superior ao NTI-tss e à placa palatina no tratamento da migrânea sem aura. O NTI-tss obteve resultados similares aos da placa não oclusal.

A double-blind, randomized clinical trial assessing the effects of a single dose of preemptive anti-inflammatory treatment in orthodontic pain.

OBJECTIVE: Strategies about how to mitigate or prevent the appearance of pain associated with orthodontic treatment are poorly defined. Herein we conduct a prospective, double-blind, randomized controlled clinical trial assessing the effects of a single dose of anti-inflammatory medication to preemptively treat pain following the placement of orthodontic separating elastics. MATERIALS AND METHODS: Fifty one participants were randomly selected and divided into three groups: (a) 17 patients took placebo one hour prior to the elastic separator placement; (b) 17 patients took 400 mg lumiracoxib one hour prior to the elastic separator placement; and (c) 17 patients didn't take anything prior to the procedure. Discomfort and pain intensity levels were measured by an analog 10-points visual scale at 2 hours, 6 hours, 24 hours, 2 days and 4 days after the procedure. RESULTS: When comparing the three groups (no treatment, placebo and active) no significant differences were found. Nonetheless, pain severity was always lower in individuals receiving the drug. Similar pattern was seen for the other time points. CONCLUSIONS: Our study does not support the use of a single dose of medication with anti-inflammatory properties in the preemptive treatment of pain following an orthodontic procedure. Further investigation is required in order to ascertain whether recurrent doses (vs a single dose) can impact outcomes.