We were unable to demonstrate any significant benefit from amitriptyline plus fluoxetine over amitriptyline alone in the treatment of chronic daily headache/transformed migraine. Because of the small number of subjects involved and the short duration of our study, a type II error cannot be excluded.

-Background and objectives: Triptans are effective drugs for the acute treatment of migraine. However, 30-40% of the patients commonly present recurrence before 24 hours therefore requiring another dose. Nonsteroidal anti-inflammatory drugs (NSAID) such as tolfenamic acid and naproxen sodium combined with sumatriptan have demonstrated efficacy in reducing recurrence observed with the single use of this drug. Steroids also have been suggested to treat refractory migraine and status migranosus. The aim of this study was to evaluate whether patients presenting frequent recurrence with the combination triptan plus NSAID, would decrease it with the association of dexamethasone. Method: Twenty three patients, 17 women and 6 men with migraine according to IHS criteria were prospectively studied. All patients presented frequent recurrence (≥ 60%, mean recurrence rate 74,8%) with the single use of sumatritpan 100mg or zolmitriptan 2,5mg or rizatriptan 10mg in at least 5 consecutive attacks, and didn t present a reduction of the recurrence rate superior than 20% with the combination of tolfenamic acid 200mg or rofecoxib 25mg in at least 5 other consecutive attacks (mean recurrence rate 60%). The patients had to treat 6 consecutive moderate or severe migraine attacks with their usual combination plus 4mg of dexamathasone with a maximum of twice a week, and fill out a diary reporting headache parameters. Results: Twenty patients, 16 women and 4 men completed the study. Of those who completed the study, 11 took rizatriptan plus rofecoxib, 4 rizatriptan plus tolfenamic acid, 3 zolmitriptan plus rofecoxib, 1 zolmitriptan plus tolfenamic acid and 1 patient took sumatriptan plus tolfenamic acid, having the 20 patients taken as a third medication, a single tablet of 4mg of dexamethasone. All patients took oral formulations and none presented vomiting after that. Among all 20 patients, one female and one male patient presented recurrence in 3 out of the 6 attacks (50%) while the remaining 18 patients revealed recurrence in 1 or 2 treated attacks (mean 23,4%) (p<0,001). Conclusion: We concluded that the judicious use of oral dexamethasone might be useful for a limited population of migraine patients still presenting recurrence with the combination of a triptan and a NSAID. Case-control studies and studies with a randomized double-blind design are necessary to confirm these observations. KEY WORDS: migraine recurrence, dexamethasone, triptans, nonsteroidal anti-inflammatory drugs.Dexametasona diminui a recorrência de migrânea observada após tratamento com um triptano e um antinflamatório não esteroide RESUMO Tema e objetivos: Triptanos são drogas eficientes para o tratamento agudo da migrânea. Entretanto, cerca de 30 a 40% dos pacientes tratados, comumente apresentam recorrência antes de 24 horas e consequentemente necessitam de uma nova dose. A associação de antinflamatórios não esteroides (AINE) como o ácido tolfenâmico e o naproxeno sódico demonstraram eficácia na redução da recorrência observada com o uso isolado do sum...

Several oral nonsteroidal anti-inflammatory drugs (NSAIDs) are effective to treat migraine attacks. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has proven to be effective in various pain syndromes such as renal colic and muscular pain. The aim of this double-blind, placebo-controlled study was to evaluate the efficacy of oral LC compared to placebo in the acute treatment of migraine. Sixty four patients with the diagnosis of migraine, according to the IHS criteria, were studied prospectively. Patients received LC or placebo once the headache reached moderate or severe intensity for 6 consecutive attacks. With regard to the moderate attacks, LC was superior than placebo after 1, 2 and 4 hours. The consumption of other rescue medications after 4 hours was significantly higher in the placebo group. With regard to the severe attacks, there was no difference between the active drug group and the placebo group concerning headache intensity and consumption of other rescue medications. We conclude that the NSAID lysine clonixinate is effective in treating moderately severe migraine attacks. It is not superior than placebo in treating severe migraine attacks.

-Background and Objective: Nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Lysine clonixinate (LC) and dipyrone (metamizol) have been proven effective to treat acute migraine. The aim of this study was to evaluate the efficacy and tolerability of the intravenous formulations of LC and dipyrone in the treatment of severe migraine attacks. Method: Thirty patients (28 women, 2 men), aged 18 to 48 years with migraine according the International Headache Society (IHS) (2004) were studied. The patients were randomized into 2 groups when presenting to an emergency department with a severe migraine attack. The study was single-blind. Headache intensity, nausea, photophobia and side effects were evaluated at 0, 30, 60 and 90 minutes after the drug administration. Rectal indomethacin as rescue medication (RM) was available after 2 hours and its use compared between groups. Results: All patients completed the study. At 30 minutes, 0% of the dipyrone group 13% of the LC group were pain free (p=0.46). At 60 and 90 minutes, 2 (13%) and 5 (33%) patients from the dipyrone group and 11 (73%) and 13 (86.7%) patients from the LC group were pain free (p<0.001). At 60 minutes, significantly more patients from the LC group were nausea-free (p<0.001). Regarding photophobia, there were no differences between groups at 60 minutes (p=0.11). The use of RM at 2 hours did not differ among groups (p=0.50). Pain in the site of the injection was reported by more patients of the LC group compared to the dipyrone group (p<0.0001). Conclusion: LC is significantly superior to dipyrone in treating severe migraine attacks. LC promotes significantly more burning at the site of the injection.Key woRDS: lysine clonixinate, dipyrone (metamizole), migraine, severe attacks, acute treatment. Clonixinato de lisina versus dipirona (metamizol) para o tratamento agudo de uma crise intensa de enxaqueca: estudo monocego e randomizadoResumo -Contexto e Objetivo: Antiinflamatórios não esteroidais (AINe) são eficazes no tratamento de crises de enxaqueca. o objetivo deste estudo foi comparar a eficácia e a tolerabilidade das apresentações injetáveis do clonixinato de lisina (CL) e da dipirona no tratamento de crises intensas de enxaqueca. Método: Trinta pacientes (28 mulheres, 2 homens), com idades entre 18 e 48 anos e enxaqueca de acordo com a Classificação Internacional de Cefaléias (2004) foram estudados. os pacientes foram randomizados em 2 grupos ao se apresentarem em uma unidade de emergência, com uma crise intensa de enxaqueca. o desenho do estudo foi monocego. A intensidade da cefaléia, a presença de náusea e fotofobia e os efeitos colaterais foram avaliados e comparados na administração das drogas e após 30, 60 e 90 minutos. Indometacina retal foi disponibilizada como droga de resgate (DR) e seu uso comparado entre os grupos. Resultados: Todos os pacientes completaram o estudo. Após 30 minutos, 0% do grupo da dipirona e 13% do CL encontravam-se sem cefaléia (p=0,46). Após 60 e 90 minutos, 2 (13%) e 5 (33%) do g...

RESUMO -Alguns antinflamatórios não esteroidais (AINE) orais são eficientes para o tratamento dos ataques de migrânea ou enxaqueca. A despeito de sua eficiência para o tratamento destas cefaléias e de outras dores, existem comercialmente poucos antinflamatórios não esteroidais disponíveis para administração parenteral. O clonixinato de lisina (CL) é um AINE derivado do ácido nicotínico que foi comprovadamente eficiente em vários tipos de síndromes álgicas como cólica renal, dor de compressão nervosa, dores musculares e odontalgias. O objetivo deste estudo foi avaliar a eficácia do CL intravenoso (IV) no tratamento de um episódio severo de migrânea. Estudamos prospectivamente 19 pacientes, 17 mulheres e 2 homens, com idades de 18 a 57 anos e diagnóstico de migrânea de acordo com os critérios da Sociedade Internacional de Cefaléias (SIC). Os pacientes foram orientados a dirigirem-se à clínica no momento que a dor se iniciasse e, uma vez atingida a intensidade severa, foi iniciada a infusão venosa de CL e salina, em uma veia superficial do antebraço. Avaliadas após 30, 60 e 90 minutos a intensidade da dor e a presença de efeitos colaterais, observamos que todos os 19 pacientes encontravam-se sem dor após 90 minutos. Alguns pacientes apresentaram efeitos adversos leves e não houve alterações significativas nos sinais vitais. Concluímos que o AINE clonixinato de lisina (2-(3-cloro-otoluidino)piridino-3-carboxilato de lisina) IV, derivado do ácido nicotínico, com estrutura química semelhante à do ácido flufenâmico, foi eficiente em abolir um ataque de intensidade severa de migrânea em 90 minutos em 19 pacientes. Estudos controlados com metodologia duplo-cega e randomizada, assim como maior número de pacientes e ataques tratados, são necessários para confirmar estas observações iniciais. PALAVRAS-CHAVE: clonixinato de lisina, tratamento agudo, migrâneas, enxaquecas. Intravenous lysine clonixinate for the acute treatment of migraine: an open pilot studyABSTRACT: Several oral nonsteroidal anti-inflammatory drugs (NSAID) are effective to treat migraine attacks. Despite its efficacy to treat migraine and other pain, there are a few commercial NSAIDs available for intravenous (IV) administration. Lysine clonixinate (LC) is a NSAID derived from nicotinic acid that has been proven effective in various algic syndromes such as renal colic, nerve compression, muscular pain and odontalgias. The aim of this study was to evaluate the efficacy of the IV LC in the treatment of severe attacks of migraine. We studied prospectively 19 patients, 17 women and 2 men , ages from 18 to 57 years, with the diagnosis of migraine according to the International Headache Society criteria. The patients were oriented to proceed to the clinic once the headache has started, and were placed under an IV infusion of LC and saline in a superficial vein of the forearm, once the intensity reached severe. Evaluating the headache intensity after 30, 60 and 90 minutes, as well as the presence of side effects, we observed that all of the 19 patients were headac...