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OBJECTIVES: To systematically evaluate the efficacy and superiority of Flunarizine Hydrochloride when combined with Traditional Chinese Medicine (TCM) Decoctions in treating migraine headaches. METHOD: The authors conducted a comprehensive search for clinical Randomized Controlled Trials (RCTs) investigating the combination of Flunarizine Hydrochloride with Chinese herbal decoctions in treating migraines. The databases searched included CNKI, VIP, Wanfang, PubMed, WOI, Cochrane Library, and Embase, covering the period from January 1, 2019, to November 10, 2023. Two independent researchers meticulously screened, extracted, and assessed the relevant data, employing the Revman 5.3 software for meta-analysis. RESULTS: The meta-analysis revealed that, in comparison to Flunarizine Hydrochloride used in isolation, the combination with Chinese herbal decoctions markedly enhanced the effective rate (RR = 1.26, 95 % CI [1.18, 1.34], p < 0.0001). Moreover, significant improvements were observed in the TCM symptom score (MD = 4.97, 95 % CI [-6.74, -3.19], p < 0.00001). The observation group demonstrated a statistically significant improvement in endothelin levels compared to the control group (I2 = 85 %, MD = -13.66, 95 % CI [-17.87, -9.45], p = 0.0001). The observation group showed a significant reduction in NRS scores compared to the control group, indicating better outcomes (I2 = 95 %, MD = -2.11, 95 % CI [-3.09, -1.12], p < 0.0001). The observation group was superior to the control group in terms of the reduction in the number of episodes (I2 = 63 %, MD = -1.16, 95 % CI [-1.45, -0.87], p = 0.007). CONCLUSIONS: The confluence of Flunarizine Hydrochloride with traditional Chinese medicine decoctions in treating migraine patients demonstrated substantial clinical efficacy and improvement in TCM symptom score over the use of Flunarizine Hydrochloride alone.

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BACKGROUND AND OBJECTIVE: Migraine is a neurological disorder characterized by episodes of moderate-to-severe headache. The emergence of drugs derived from monoclonal antibodies specific for the calcitonin gene has brought forth a therapeutic option for patients in whom the traditional treatments have failed. This study aimed to evaluate the clinical effectiveness of calcitonin gene-related peptide antibodies in the prevention of migraine through a systematic review and meta-analysis of observational cohort studies. METHODS: A literature search for evidence was performed in electronic databases for observational studies that evaluated adult patients with migraine receiving calcitonin gene-related peptide receptor antagonists (e.g. erenumab, fremanezumab, galcanezumab and eptinezumab) and reported effectiveness outcomes (mean reduction in monthly migraine/headache days, and proportion of patients with 50% or greater reduction in migraine/headache days). RESULTS: During the screening process, 47 records were included for data extraction and qualitative and quantitative analyses. The overall rate of patients with a reduction of at least 50% of mean monthly migraine days was 54% (95% CI 49-59%), and overall mean monthly migraine reduction was about 7.7 days (95% CI 8.4-7.0 days). Regarding the outcome ≥ 50% reduction in mean monthly headache reduction, the overall rate of patients with a reduction of at least 50% was 57% (95% CI 48-64%), and the overall mean monthly headache reduction was approximately 8.8 days (95% CI 10.1-7.5 days). Subgroup analyses considering the drug treatment used and type of migraine were consistent with previous results. CONCLUSIONS: The use of calcitonin gene-related peptide antibodies in real-world studies to prevent migraine demonstrates promising effectiveness outcomes, in agreement with those reported in previously published randomized clinical trial reports.

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OBJECTIVE: Medication overuse headache (MOH) in chronic migraineurs may be a cause or consequence of the overuse of symptomatic medications for headache attacks. It is highly prevalent in tertiary centers. We compared the efficacy of 3 anti-CGRP monoclonal antibodies with traditional pharmacological agents in patients with chronic migraine (CM) and MOH. METHODS: A randomized, cross-sectional, prospective, and open trial with real-world comparison groups was carried out. The sample consisted of 100 consecutive patients having CM and MOH. RESULTS: Eighty-eight patients (65 women and 23 men) were included in the study and divided into 4 groups: those having used erenumab (19.3%), galcanezumab (29.6%), fremanezumab (25%) and conventional medications, and the control group (26.1%). Ages ranged from 18 to 78 years (mean, 44.1 ± 13.6 years). In the 6 months of follow-up, there was a significant reduction in the number of headache days in the 3 groups when compared with the control ( P < 0.0001). CONCLUSIONS: The small number of patients included in each group and the open design do not allow definitive conclusions, but the use of anti-CGRP monoclonal antibodies in patients with CM and MOH may result in lessening the number of headache days when compared with conventional treatment with drugs.

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BACKGROUND: Peripheral nerve block (PNB) is usually performed in patients with migraine who are resistant to treatment with medications. OBJECTIVE: To compare the efficacy of PNB alone and PNB combined with prophylactic medications in migraine patients. METHOD: The data on migraine patients who underwent PNB in our clinic between November 2019 and January 2022 were retrospectively reviewed. Blocks of the greater occipital nerve (GON), lesser occipital nerve (LON) and supraorbital nerve (SON) were performed upon admission and in the second week. RESULTS: The study included 116 patients. While 21 out of 39 episodic migraine (EM) patients continued to use prophylactic medications, 18 were followed up with PNB alone. While 49 out of 77 chronic migraine (CM) patients continued to use prophylactic medications, 28 were followed up with PNB alone. Comparison of the admission and second-month data of the patients who only underwent PNB and those who continued the drug treatment together with PNB in both the EM and the CM group showed that the number of days with pain, number of analgesics taken and scores on the Visual Analog Scale (VAS) and the Migraine Disability Assessment (MIDAS) were significantly reduced in both groups (p < 0.01). Comparison of the second-month data of the patients followed up with PNB alone and those followed up with PNB together with prophylactic medications showed that there was no significant difference between the EM and CM patients (p > 0.05). CONCLUSION: Bilateral GON, LON and SON block with lidocaine injection seems to be an effective treatment on its own, without the need for prophylactic medications, in both EM and CM patients during a two-month follow-up.

ANTECEDENTES: O bloqueio de nervos periféricos (BNP) geralmente é realizado em pacientes com migrânea resistentes ao tratamento medicamentoso. OBJETIVO: Comparar a eficácia do BNP isolado e do BNP combinado com medicamentos profiláticos em pacientes com enxaqueca. MéTODO: Os dados de pacientes com enxaqueca submetidos a BNP em nossa clínica entre novembro de 2019 e janeiro de 2022 foram revisados retrospectivamente. Bloqueios do nervo occipital maior (NOM), nervo occipital menor (NOM) e nervo supraorbital (NSO) foram realizados na admissão e na segunda semana. RESULTADOS: O estudo incluiu 116 pacientes. Enquanto 21 dos 39 pacientes com enxaqueca episódica (EE) continuaram a usar medicamentos profiláticos, 18 foram acompanhados apenas com BNP. Enquanto 49 dos 77 pacientes com enxaqueca crônica (EC) continuaram a usar medicamentos profiláticos, 28 foram acompanhados apenas com BNP. A comparação dos dados de admissão e do segundo mês dos pacientes que fizeram apenas BNP e daqueles que continuaram o tratamento medicamentoso junto com BNP, tanto no grupo EE quanto no grupo EC, mostrou que o número de dias com dor, o número de analgésicos tomados e os escores da Escala Visual Analógica (EVA) e da Avaliação da Incapacidade da Enxaqueca (AIE) foram significativamente reduzidos em ambos os grupos (p < 0,01). A comparação dos dados do segundo mês dos pacientes acompanhados apenas com BNP e aqueles acompanhados com BNP juntamente com medicações profiláticas mostrou que não houve diferença significativa entre os pacientes EE e EC (p > 0,05). CONCLUSãO: O bloqueio bilateral de NOM, NOM e NSO com injeção de lidocaína parece ser um tratamento eficaz por si só, sem a necessidade de medicamentos profiláticos, tanto em pacientes EE quanto com EC durante um seguimento de dois meses.

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BACKGROUND: Due to coronavirus disease 2019 (COVID-19) pandemic response measures, the administration of botulinum toxin (BTX) was delayed for many patients during the first lockdown period in Portugal. OBJECTIVES: To review the impact of postponing BTX treatment on migraine control. METHODS: This was a retrospective, single-center study. Patients with chronic migraine who had done at least three previous BTX cycles and were considered responders were included. The patients were divided into two groups, one that has had their treatment delayed (group P), and one that has not (controls). The Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) protocol was used. Migraine-related data were obtained at baseline and at three subsequent visits. RESULTS: The present study included two groups, group P (n = 30; 47.0 ± 14.5 years; 27 females, interval baseline -1st visit: 5.5 [4.1-5.8] months) and the control group (n = 6; 57.7 ± 13.2 years; 6 females; interval baseline-1st visit 3.0 [3.0-3.2] months). No difference between the groups was present at baseline. When compared to baseline, the number of days/month with migraine (5 [3-6.2] vs. 8 [6-15] p < 0.001), days using triptans/month (2.5 [0-6] vs. 3 [0-8], p = 0.027) and intensity of pain (7 [5.8-10] vs. 9 [7-10], p = 0.012) were greater in the first visit for group P, while controls did not present a significant variation. The worsening of migraine-related indicators decreased in the following visits; however, even in the third visit, it had not returned to baseline. Correlations were significant between the delayed time to treatment and the increase in days/month with migraines at the first visit after lockdown (r = 0.507; p = 0.004). CONCLUSIONS: There was a deterioration of migraine control after postponed treatments, with a direct correlation between the worsening of symptoms and the number of months that the treatment was delayed.

ANTECEDENTES: Devido às medidas de resposta à pandemia de coronavirus disease 2019 (covid-19), a administração de toxina botulínica (TXB) foi adiada para muitos pacientes durante o primeiro confinamento em Portugal. OBJETIVOS: Avaliar o impacto do adiamento do tratamento com TXB no controle da enxaqueca. MéTODOS: Estudo retrospectivo unicêntrico. Foram incluídos pacientes com enxaqueca crônica com pelo menos três ciclos prévios de TXB e que tenham sido considerados respondedores. Os pacientes foram divididos em dois grupos, sendo um com atraso do tratamento (grupo P) e outro sem atraso (controles). O protocolo Phase III Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) foi utilizado. Dados clínicos relacionados com a enxaqueca foram obtidos na consulta inicial (T0) e nas três consultas subsequentes (T1­3). RESULTADOS: O presente estudo incluiu dois grupos, o grupo P (n = 30; 47,0 ± 14,5 anos; 27 mulheres, intervalo T0-1ª visita: 5,5 [4,1­5,8] meses) e o grupo controle (n = 6; 57,7 ± 13,2 anos; 6 mulheres; intervalo T0­1ª visita 3,0 [3,0­3,2] meses). Os grupos não apresentavam nenhuma diferença no início do estudo. Quando comparado à T0, o número de dias/mês com enxaqueca (5 [3­6,2] vs. 8 [6­15], p < 0,001), dias usando triptanos/mês (2,5 [0­6] vs. 3 [0­8], p = 0,027) e intensidade da dor (7 [5,8­10] vs. 9 [7­10], p = 0,012) foram maiores na primeira visita no grupo P, não apresentando os controles variação significativa. A piora dos indicadores relacionados com a enxaqueca diminuiu nas visitas seguintes; porém, mesmo na terceira visita, ainda não haviam retornado ao basal. As correlações foram significativas entre o atraso do tratamento e o aumento de dias/mês com enxaqueca na primeira consulta após o confinamento (r = 0,507; p = 0,004). CONCLUSãO: Houve piora clínica da enxaqueca após o adiamento do tratamento em correlação direta com a duração do atraso.

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The coronavirus (COVID-19) pandemic, confinement, fear, lifestyle changes, and worldwide health care impacted almost all diseases. Reports from countries outside Latin America revealed differences in migraine patients. In this study, we describe and compare the immediate changes in migraine symptoms associated with COVID-19 quarantine in patients from Argentina, Mexico, and Peru. An online survey was conducted from May to July 2020. The survey was answered by 243 migraine patients, with questions related to sociodemographic data, quarantine conditions, changes in working conditions, physical activity, coffee intake, healthcare access, acute migraine medication use, symptoms of anxiety, depression, and fear of COVID-19. The results show that 48.6% of migraine patients experienced worsened symptoms, 15.6% improved, and 35.8% remained unchanged. Worsening migraine symptoms were associated with staying at home during the lockdown. Intake of analgesics was associated with an increase in migraine symptoms of 18 times relative to those who did not increase their intake. Migraine symptoms improved when the number of sleep hours was increased, and we observed an improvement when patients decreased analgesic intake. The uncertainty about the end of the pandemic, the news, and social media are three items that contributed to the worsening of migraine symptoms in patients in the three investigated countries. Confinement during the first pandemic wave in Latin America harmed migraine patients who stayed home during the lockdown.

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BACKGROUND AND OBJECTIVE: Several studies on use of erenumab for migraine treatment have been published over recent years. However, its long-term safety and effectiveness have not been consistently established in the literature yet. We aimed to perform a qualitative and quantitative analysis of the long-term safety and effectiveness of erenumab for the treatment of migraine headaches. METHODS: Long-term follow-up was defined as ≥ 1 year. PubMed, Embase and Cochrane Library were systematically searched from inception to 14 June 2022 for studies meeting the inclusion criteria. Risk of bias was assessed using the Newcastle-Ottawa Scale. RESULTS: Fourteen studies, comprising 3574 patients, were included. The total follow-up period ranged from 48 to 268 weeks (i.e., 1 year to 5.6 years). Pooled estimate rates for all adverse events (AEs) were 63% (95% CI 46-78); for serious AEs, 3% (95% CI 1-7); and for AEs leading to discontinuation of erenumab, 3% (95% CI 2-5). Reduction in monthly migraine days (MMDs) was -6.98 (95% CI -8.90 to -5.05) and in migraine-specific medication days (MSMDs) was - 6.09 (95% CI - 9.43 to - 2.75). More than half (57%; 95% CI 51-63) and around one-third (35%; 95% CI 28-42) of patients presented with reductions of ≥ 50% and ≥ 75% in MMDs, respectively. Headache Impact Test-6 (HIT-6) score was decreased by -9.68 points (95% CI - 12.03 to - 7.34). Nine studies were considered of poor methodological quality and five of fair quality. CONCLUSIONS: Erenumab has a favorable safety profile, with a low incidence of serious AEs, and sustained efficacy over ≥1 year of follow-up in the treatment of migraine.

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BACKGROUND: Migraine affects 1 billion people worldwide and > 30 million Brazilians; besides, it is an underdiagnosed and undertreated disorder. OBJECTIVE: The need to disseminate knowledge about the prophylactic treatment of migraine is known, so the Brazilian Headache Society (SBCe, in the Portuguese acronym) appointed a committee of authors with the objective of establishing a consensus with recommendations on the prophylactic treatment of episodic migraine based on articles from the world literature as well as from personal experience. METHODS: Meetings were held entirely online, with the participation of 12 groups that reviewed and wrote about the pharmacological categories of drugs and, at the end, met to read and finish the document. The drug classes studied in part II of this Consensus were: antihypertensives, selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, calcium channel blockers, other drugs, and rational polytherapy. RESULTS: From this list of drugs, only candesartan has been established as effective in controlling episodic migraine. Flunarizine, venlafaxine, duloxetine, and pizotifen were defined as likely to be effective, while lisinopril, enalapril, escitalopram, fluvoxamine, quetiapine, atorvastatin, simvastatin, cyproheptadine, and melatonin were possibly effective in prophylaxis of the disease. CONCLUSIONS: Despite an effort by the scientific community to find really effective drugs in the treatment of migraine, given the large number of drugs tested for this purpose, we still have few therapeutic options.

ANTECEDENTES: Migrânea afeta um bilhão de pessoas em todo o mundo e mais de 30 milhões de brasileiros; além disso, é um distúrbio subdiagnosticado e subtratado. OBJETIVO: Sabe-se sobre a necessidade de difundir o conhecimento sobre o tratamento profilático da migrânea; por isso, a Sociedade Brasileira de Cefaleias (SBCe) nomeou um comitê de autores com o objetivo de estabelecer um consenso com recomendações sobre o tratamento profilático da migrânea episódica com base em artigos da literatura mundial, assim como da experiência pessoal. MéTODOS: As reuniões foram realizadas inteiramente online, com a participação de 12 grupos que revisaram e escreveram sobre as categorias farmacológicas dos medicamentos e, ao final, reuniram-se para a leitura e conclusão do documento. As classes de medicamentos estudadas na parte II deste Consenso foram: anti-hipertensivos, inibidores seletivos de recaptação de serotonina, inibidores de recaptação de serotonina e noradrenalina, bloqueadores dos canais de cálcio, outros medicamentos e politerapia racional. RESULTADOS: Desta lista de medicamentos, apenas o candesartan foi estabelecido como eficaz no controle da migrânea episódica. Flunarizina, venlafaxina, duloxetina e pizotifeno foram definidos como provavelmente eficazes, enquanto lisinopril, enalapril, escitalopram, fluvoxamina, quetiapina, atorvastatina, sinvastatina, ciproheptadina e melatonina foram possivelmente eficazes na profilaxia da doença. CONCLUSõES: Apesar do esforço da comunidade científica em encontrar medicamentos realmente eficazes no tratamento da migrânea, dado o grande número de medicamentos testados para este fim, ainda dispomos de poucas opções terapêuticas.

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The Brazilian Headache Society (Sociedade Brasileira de Cefaleia, SBCe, in Portuguese) nominated a Committee of Authors with the aim of establishing a consensus with recommendations regarding prophylactic treatment for episodic migraine based on articles published in the worldwide literature, as well as personal experience. Migraine affects 1 billion people around the world and more than 30 million Brazilians. In addition, it is an underdiagnosed and undertreated disorder. It is well known within the medical community of neurologists, and especially among headache specialists, that there is a need to disseminate knowledge about prophylactic treatment for migraine. For this purpose, together with the need for drug updates and to expand knowledge of the disease itself (frequency, intensity, duration, impact and perhaps the progression of migraine), this Consensus was developed, following a full online methodology, by 12 groups who reviewed and wrote about the pharmacological categories of the drugs used and, at the end of the process, met to read and establish conclusions for this document. The drug classes studied were: anticonvulsants, tricyclic antidepressants, monoclonal anti-calcitonin gene-related peptide (anti-CGRP) antibodies, beta-blockers, antihypertensives, calcium channel inhibitors, other antidepressants (selective serotonin reuptake inhibitors, SSRIs, and dual-action antidepressants), other drugs, and polytherapy. Hormonal treatment and anti-inflammatories and triptans in minimum prophylaxis schemes (miniprophylaxis) will be covered in a specific chapter. The drug classes studied for part I of the Consensus were: anticonvulsants, tricyclic antidepressants, monoclonal anti-CGRP antibodies, and beta-blockers.

A Sociedade Brasileira de Cefaleia (SBCe) nomeou um Comitê de Autores com o objetivo de estabelecer um consenso com recomendações sobre o tratamento profilático da enxaqueca episódica com base em artigos da literatura mundial e da experiência pessoal. A enxaqueca é um distúrbio subdiagnosticado e subtratado que acomete um bilhão de pessoas no mundo e mais de 30 milhões de brasileiros. É conhecido na comunidade médica de neurologistas e, sobretudo, dos especialistas em cefaleia, a necessidade de se divulgar o conhecimento sobre o tratamento profilático da enxaqueca. Com esta finalidade, aliada às necessidades de atualizações de drogas e de se aumentar o conhecimento sobre a doença em si (frequência, intensidade, duração, impacto e talvez a progressão da enxaqueca), foi elaborado este Consenso, com metodologia totalmente on-line, por 12 grupos que revisaram e escreveram sobre as categorias farmacológicas das drogas e, ao final, reuniram-se para a leitura e conclusão do documento. As classes de drogas estudadas para este Consenso foram: anticonvulsivantes, antidepressivos tricíclicos, anticorpos monoclonais do antipeptídeo relacionado ao gene da calcitonina (peptídeo relacionado ao gene da calcitonina ­ anti-CGRP), betabloqueadores, anti-hipertensivos, inibidores dos canais de cálcio, outros antidepressivos (inibidores seletivos de recaptação de serotonina, ISRSs, e antidepressivos de ação dual), outras drogas, e politerapia. O tratamento hormonal, bem como anti-inflamatórios e triptanas em esquema de profilaxia mínima (miniprofilaxia), será abordado em um capítulo próprio. As classes de drogas estudadas na parte I do Consenso foram: anticonvulsivantes, antidepressivos tricíclicos, anticorpos monoclonais anti-CGRP, e betabloqueadores.

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The result of more than thirty years of research, anti-CGRP monoclonal antibodies are currently the state of the art for migraine preventive therapy. Their efficacy and safety, supported by an already large and growing body of evidence, are added by many other advantages: an early onset of action, favorable posology, negligible pharmacological interaction, and a broad-reaching efficacy in many challenging clinical contexts. When compared to standard prophylactics, these novel medications seem at least as efficacious, clearly more tolerable and, consequently, with a superior adherence profile. Furthermore, recently published analyses indicate that they are cost-effective, especially among those with chronic migraine. Yet, current guidelines endorse their use only after multiple other preventives have failed or have been deemed not tolerable. Although this recommendation may have been sensible at first, the now available data strongly point that time has come for anti-CGRP monoclonal antibodies to be acknowledged as first-line treatments for migraine patients with severe disability. For these individuals, delaying treatment until several other alternatives have failed incurs in significant losses, both economically and to many relevant aspects of their lives.

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