Systematic review and Meta-analysis of efficacy and safety of Toutongning Capsules in treatment of tension-type headache / 中国中药杂志

This study aims to systematically evaluate the clinical efficacy and safety of Toutongning Capsules in the treatment of tension-type headache(TTH), so as to provide a corresponding basis for clinical treatment. Eight commonly used medical research databases and two clinical trial registration systems were retrieved with the time interval from the establishment of the database or system to November 2020. The randomized controlled trials of Toutongning Capsules in the treatment of TTH were screened out according to the pre-set criteria. The quality of the included papers was evaluated by the bias risk assessment tool in Cochrane Reviewers Handbook 6.1 and the data were statistically analyzed by RevMan v5.4 provided by Cochrane collaboration. A total of 13 studies were included and the quality of methodology was generally low. Meta-analysis showed that Toutongning Capsules assisted with western medicine therapy can effectively reduce the pain intensity(MD_(VAS)=-1.94,95%CI[-2.50,-1.38],P<0.000 01;MD_(NRS)=-0.83,95%CI[-0.86,-0.80],P<0.000 01), headache duration(SMD=-0.98,95%CI[-1.17,-0.79],P<0.000 01), headache frequency(MD=-1.01,95%CI[-1.16,-0.85],P<0.000 01), headache index(MD=-11.13,95%CI[-12.10,-10.16],P<0.000 01), anxiety and depression scale score(MD_(HAMA)=-4.02,95%CI[-6.58,-1.46],P=0.002;MD_(HAMD)=-2.67,95%CI[-4.04,-1.29],P=0.000 1), while Toutongning Capsules as monotherapy only reduced the headache score(MD=-2.24,95%CI[-2.97,-1.51],P<0.000 01). The available clinical studies demonstrate that Toutongning Capsules combined with western medicine in the treatment of TTH can improve the related outcome indicators, but the clinical safety and efficacy of Toutongning Capsules alone remain unclear. Due to the small number and low quality of the included studies, large-sample, multi-center, high-quality and strictly designed randomized controlled trials are still needed to verify the clinical efficacy in the future.

Outcome indicators in randomized controlled trials on traditional Chinese medicine intervention for tension-type headache in recent five years / 中国中药杂志

To evaluate the application of outcome indicators in randomized controlled trials(RCTs) concerning the treatment of tension-type headache(TTH) with traditional Chinese medicine(TCM) in recent five years, so as to provide a basis for the study of core outcome set(COS) for TCM intervention in TTH. The RCTs on TCM treatment of TTH in recent five years were systematically retrieved from CNKI, Wanfang, VIP, CBM, EMbase, PubMed, Cochrane Library, Web of Science, ClinicalTrials.gov and China Clinical Trial Registry. After literature screening, data extraction and evaluation of the risk of bias, the outcome indicators in the included RCTs were subjected to qualitative analysis. The preliminary search yielded 19 042 articles, and 10 983 were left after the elimination of duplication. Finally, 52 RCTs(48 in Chinese and 4 in English) were included for qualitative analysis. The outcome indicators of RCTs included in this study were classified into seven domains: TCM syndrome, symptom and sign, physical and chemical detection, quality of life, long-term prognosis, economic evaluation, and safety event. The findings demonstrated that headache characteristic index in the symptom and sign domain was the index with the highest reporting frequency and reporting rate. Seventeen RCTs used TCM syndrome score as the outcome indicator. Further analysis revealed that there existed such problems in research design as non-distinction between primary and secondary outcome indicators, great difference in the adopted measurement tools for outcome indicators, and the neglect of measurement time of outcome indicators. Moreover, the syndrome indicators reflecting TCM advantages, objective evaluation indicators, safety and health-economic indicators were lacking. These limitations have affected the quality and reliability of RCTs on TTH treatment with TCM. It is suggested that the efficacy and characteristics of TCM should be combined into current clinical research, and the COS in RCTs regarding TCM treatment of TTH should be established according to internationally recognized standard procedures.

Devising and validating a headache diary in a series of patients with chronic daily headache from Colombia / Diseño y validación de un diario de cefalea en pacientes con cefalea crónica diaria en Colombia

OBJECTIVE: To devise and test the reliability and validity of a brief headache diary in a series of Colombian patients with chronic daily headache. METHODS: The study was designed in five stages: selection of domains (group of patients and experts); initial devising of the items (writing group); identification of non-understandable items (n=20); assessment of internal consistency (n=100); assessment of validity and assessment of sensitivity to change during seven consecutive days (n=25, 175 observations). RESULTS: Five domains were selected: headache presence, severity and length of pain, analgesics intake, and missing workdays. The headache diary is internally consistent (≈75 percent of rotated variance), correlates with the medical interview (Spearman's rho and Kendall's tau over 0.8 for each domain) and it has an adequate and stable sensitivity and specificity (82 to 96 percent). CONCLUSIONS: This headache diary is a reliable and valid instrument and represents the most important features affecting Colombian patients with chronic daily headache.

OBJETIVO: Diseñar y testar la validez y reproducibilidad de un diario de cefalea en una serie de pacientes Colombianos con cefalea crónica diaria. MÉTODOS: El estudio fue diseñado en cinco fases: selección de los dominios (grupo de pacientes y expertos); diseño inicial de los ítems (grupo redactor); identificación de ítems no comprensibles (n=20); determinación de la consistencia interna (n=100); determinación de la validez y la sensibilidad al cambio durante siete días consecutivos (n=25, 175 observaciones). RESULTADOS: Fueron seleccionados cinco dominios: presencia, severidad y duración del dolor, ingesta de analgésicos y días laborales perdidos. El diario tiene una adecuada consistencia interna (≈75 por ciento de la varianza), se correlaciona con la entrevista médica (rho de Spearman y tau de Kendall >0.8 para cada dominio) y tiene sensibilidad y especificidad estables y satisfactorias (82 a 96 por ciento). CONCLUSIONES: Este diario de cefalea es un instrumento confiable y registra las principales características de las cefaleas en pacientes con cefalea crónica diaria.

Short-term outcomes of tension type and migraine headache in children.

OBJECTIVE: To study the short-term outcome and the factors associated with the outcome in childhood tension type and migraine headache patients. MATERIAL AND METHOD: Children aged 16 years or less with first diagnosed of either migraine or tension-type headache were reassured the cause of headache and treated by avoiding triggering factors, taking intermittent analgesics or a daily preventive medication such as propanolol 10 mg two times a day or amitriptyline 10 mg at night for patients who were suffered from the frequent headache attacks whether had to stop activity or go to sleep. They were followed up at 2 weeks and 2 months to confirm the diagnosis and the response to the treatment. The short-term outcomes and the possible factors associated with the outcomes were analysed. RESULTS: Pre-treatment 81% of migraine patients and 43.5% of tension-type patients were significant frequently suffered from headache attacks. Post-treatment revealed that it reduced to 4% in migraine patients and 16% tension-type patients. Gender; age at onset, severity before treatment, precipitating factors; hot weather sleep deprivation, learning stress, familial stress, night awakening, familial history of headache were not statistically significant in short-term outcomes. CONCLUSION: Treatment childhood tension-type and migraine headache by reassurance, avoid the probably precipitating factors, intermittent analgesics and usage of amitriptyline or propanolol had good efficacy in reducing the severity of attack. The authors cannot identify the associated factor with the outcome of treatment.

Chronic daily headache: medications overuse and psychiatric morbidity

The objectives of the study were: [i] To assess the frequency of different chronic daily headaches in patients using ICHD-2 criteria [ii] To find out the frequency and type of medication overuse and psychiatric morbidity in chronic daily headache subjects. Cross sectional observational study. The study was conducted in the psychiatry outpatient department of a teaching medical institution during January to September 2005. Subjects suffering from chronic daily headache were recruited from a specialized headache clinic in a tertiary care hospital's Psychiatry department. The diagnoses were made according to ICHD-2. Medication overuse was defined according to ICHD-2 criteria and psychiatric illness was diagnosed following ICD-10 criteria in CDH patients. In subjects fulfilling the criteria for 'medication overuse', the culprit drug was stopped immediately and prophylactic therapy was started. Frequency of chronic daily headache was 37% in this sample. Females outnumbered males [1:1.52] and formed higher number of migraine cases [p=0.02]. Tension Type Headache [TTH] was most frequent headache [48.5%]. According to ICHD-2 criteria, probable medication overuse headache could be diagnosed in all patients, which precluded the diagnosis of chronic migraine and chronic TTH. Psychiatric morbidity was seen in 70.3% subjects and mild to moderate depression was the most common illness [53%]. TTH subjects showed predisposition for anxiety disorders [OR= 6.41; p= 0.004]. TTH is the most common subtype of CDH when ICHD-2 is followed. Medication overuse is common in this group of patients and these probably should be discontinued according to substance dependence de-addiction model for better compliance, and even more slowly in subjects with chronic migraine headache. Psychiatric morbidity is prevalent in CDH patients and requires special attention

Cefalea recurrente en la consulta de neurología del Hospital Nacional de Niños: 2001-2002: [revisión] / Recurrent headache in the neurology department of Hospital Nacional de Niños: 2001-2002: [review]

Se estudiaron retrospectivamente, 78 pacientes con cefalea recurrente referidos al servicio de Neurología del HNN durante los años 2001 y 2002. 51 por ciento de los pacientes venían referidos por un pediatra, con un tiempo de espera para ser atendidos en el HNN, menor de dos meses (80 por ciento). El grupo representó el 16,5 por ciento de la consulta de pacientes nuevos. 43 varones (55.1 por ciento) y 35 mujeres (44.9 por ciento), de 2 a 13 años de edad (promedio 8), tenían menos de 1 año de evolución de cefalea (50 por ciento), de intensidad moderada (70 por ciento), pulsátil (70 por ciento) y asociada a náuses, vómitos, defectos visuales y fotofobia en 36, 30, 27 y 13 pacientes respectivamente. En 36 niños no se reportó ningún factor desencadenante pero el estrés precipitaba los síntomas en 35 casos. El 72 por ciento tenían el antecedente familiar de migraña. A 61 pacientes se les realizó una tomografía axial computarizada (TAC), que fue normal en 59, uno tenía atrofia cortical y subcortical y otro hallazgos sugestivos de neurocisticercosis. Los diagnósticos principales fueron migraña (95 por ciento) y cefalea tensional (3 por ciento), con respuesta satisfactoria (85 por ciento de los casos) a las recomendaciones, analgésicos o al tratamiento preventivo, permitiendo remitirles (75 por ciento) a sus consultas de origen. Niños con cefalea recurrente y examen neurológico normal deben recibir recomendaciones, información y seguimiento, no siendo generalmente necesario referir a Neurología, hacer exámenes paraclínicos ni hospitalizar.

Cefaléia do tipo tensional crônica: tratamento alternativo com neuroestimulação elétrica transcutâncea / Alternative treatment with the transcutaneous electrical nerve stimulation (TENS)

Resumo: A neuroestimulação elétrica transcutânea foi avaliada no tratamento da cefaléia do tipo tensional crônica para o que foram selecionados 32 pacientes do ambulatório de Cefaléia do HC-UFPE que preenchiam os critérios diagnósticos emitidos pela SIC e que não estavam em uso de medicação profilática. Na consulta inicial lhe era entregue um diário no qual deviam registrar, por 30 dias consecutivos, os dias com dor e a intensidade de suas algias. Retornavam ao fim de 30 dias quando eram computados o número de dias com dor e estabelecido o escore da dor este representado pôr um número obtido da soma das parcelas: (Nº de dias com dor muito forte x 4) + (Nº de dias com dor forte x 3) (+ Nº de dias com dor fraca x 1 ). Iniciavam o tratamento submetendo-se a três sessões de 30 minutos cada e eram revistos após seis (15 dias) e 12 (30 dias) sessões, os dados assinalados no diário eram então computados e cortejados com os registros na fase pré tratamento. Dezoito dos pacientes, por razões várias, foram afastados do estudo. Dos 14 que completaram apenas três obtiveram resultados: satisfatório em dois (melhora de 83,64por cento no nº de dias com dor e em igual percentual no escora da dor); redução de 70por cento no nº de dias com dor e de 77,56por cento no escore da dor) e pouco significativo (redução de 41,18por cento no nº de dias com dor e de 43,34por cento no escore da dor). Em conclusão a neuroestimulação elétrica transcutânea se mostrou ineficaz no tratamento da cefaléia do tipo tensional crônica

Sertraline in chronic tension-type headache.

OBJECTIVES: To study the effect of Sertraline, a selective serotonin reuptake inhibitor in chronic tension type headache (CTTH) in a double blind placebo controlled randomized trial. MATERIAL AND METHODS: The study design was a double blind placebo controlled randomized study of 50 patients, over a period of 10 weeks including run-in period of two weeks, treatment period four weeks, and follow-up four weeks. The diagnosis of CTTH was based on criteria given by International Headache Society (IHS). The overall response was graded in terms of headache index, analgesic intake per week and percentage reduction in headache frequency using chi-square and 't' test. Anxiety and depression was assessed using Hamilton Rating Scale. RESULTS: The mean analgesic intake per week declined from 4.34 +/- 0.736 tab/week to 1.07 +/- 0.592 tab/week in sertraline group (p < 0.01) while reduction in placebo group was not significant (3.98 +/- 0.729 tab/week to 2.94 +/- 0.665 tab/week) (p > 0.05). The reduction in headache index and percentage reduction in frequency of headache was not significant in drug treatment group. Side effects were seen in 24.4% of patients nausea, nervousness and dizziness being the commonest. CONCLUSION: The drug treatment group showed a significant decline in analgesic intake per week. The study result shows that sertraline can be a useful alternative to amitryptiline in those patients who fail to respond or cannot tolerate it.

Avaliaçäo da utilizaçäo do placebo nas crises agudas de migrânea sem aura, migrânea com aura e cefaléia do tipo tensional episódica / Evaluation of placebo use in migraine without aura, migraine with aura and episodic tension-type headache acute attacks

O presente estudo apresenta a avaliação do efeito placebo no tratamento agudo da migrânea sem aura, migrânea com aura e cefaléia do tipo tensional episódica. Foram estudados pacientes que deram entrada entre 1 de março de 1997 a 31 de novembro de 1999 em dois pronto-socorros. Definiram-se três grupos, cada um com 30 pacientes: 1 - migrânea sem aura (MSA); 2 ó migrânea com aura (MCO); 3 ó cefaléia do tipo tensional episódica (CTTE). Os pacientes participavam de estudo randomizado para avaliar a eficácia de 4 drogas; aqueles randomizados para o placebo foram incluídos também. Os parâmetros avaliados foram: 1 ó dor; 2 - sintomas associados. Avaliados uma hora após a administração do placebo, 50 por cento dos pacientes do grupo MSA, 23,3 por cento dos pacientes do grupo MCA e 26,7 por cento dos pacientes do grupo CTTE apresentavam melhora da dor. A melhora, avaliada pela escala numérica da dor foi, em média, de 41,6 por cento, 23,1 por cento e 36 por cento, respectivamente. Houve também redução significativa de todos os sintomas associados. A utilização do placebo é, portanto, essencial na avaliação de drogas utilizadas no tratamento de cefaléias agudas.

Avaliação clínica da eficácia da combinação paracetamol e cafeína no tratamento da cefaléia tipo tensão / Clinical evaluation of the efficacy of the paracetamol and caffeine combination in the treatment of tension headache

A cefaléia tipo tensão em suas duas modalidades, episódica e crônica, é a forma mais comum de dor de cabeça na população. O tratamento é feito com medidas não farmacológicas e farmacológicas, tanto para o ataque como profilaxia das crises. Este estudo foi realizado com 5490 pacientes, que procuraram ambulatórios e consultórios médicos em várias regiões do Brasil. Cerca de 95 por cento apresentavam cefaléia tipo tensão episódica e 5 por cento cefaléia tipo tensão crônica. A maioria dos pacientes apresentou crises de intensidade moderada (62,19 por cento). Em 5419 pacientes uma crise de cefaléia tipo tensão foi tratada com 1000 mg de paracetamol e 130 mg de cafeína. Em 93,98 por cento início de melhora foi observado em até 2 horas após a ingestão da medicação. Em 77,61 por cento houve reversão completa da crise em até 2 horas. Avaliação da eficácia boa/excelente foi observada em 51,93 por cento/37,80 por cento dos casos quando feita pelos médicos e em 48,51 por cento/40,29 quando pelos pacientes. Efeitos adversos, em geral manifestações gastrointestinais, foram observados em 5,57 por cento. Este estudo representa uma experiência brasileira no tratamento de ataque da cefaléia tipo tensão, demonstrando eficácia e segurança no uso da combinação paracetamol-cafeína.

Tratamento da cefaléia em uma unidade de emergência da cidade de Ribeiräo Preto / Headache treatment in an emergency room of the city of Ribeiräo Preto, Brazil

Cefaléia é dos sintomas mais comuns na prática clínica. Acarreta considerável impacto econômico e sobrecarrega as unidades de emergência. A maioria destas, em nosso país, não dispõe de triptans. O presente estudo analisa o tratamento instituído na Unidade de Emergência do Hospital das Clínicas de Ribeirão Preto. Em 1996, 1254 pacientes foram atendidos com esta queixa e 64 necessitaram de internação. Dos pacientes não internados (NI), 77 por cento apresentavam cefaléias primárias, contra 29,7 por cento dos pacientes internados (I). A percentagem de melhora nos pacientes com migrânea com a dipirona endovenosa foi 83,8 por cento, com o diclofenaco intramuscular 66,7 por cento e com a clorpromazina (endovenosa) 81,8 por cento. As percentagens de pacientes com cefaléia do tipo tensinoal que melhoraram, frente às mesmas drogas foram, respectivamente 77,8 por cento, 80 por cento e 100 por cento. Dos NI 16,3 por cento tiveram melhora sem qualquer tratamento medicamentoso. Concluímos que as drogas utilizadas apresentam perfis semelhantes de eficácia e custo, podendo ser utilizadas em unidades básicas de saúde. O maior inconveniente é a administração parenteral.

Alprazolam in chronic tension type headache.

Alprazolam was evaluated in the treatment of 62 patients of chronic tension type headache using a double blind cross over design with random allocation to drug or placebo. The duration of the trial was 4 months with a 2 week run in period and 2 week washout period separating two treatment periods of 4 weeks each. The patients were followed up for 4 weeks at the completion of the trial. 48 patients completed the trial. There was no significant difference in the overall response rate based in terms of percentage reduction in headache frequency per week, however a significant decrease in headache index was observed during treatment with alprazolam as compared to placebo (P < 0.05). The mean analgesic intake per week was also significantly lower during treatment with alprazolam as compared to the run in period. Side effects were seen in 16.67% patients. In none of the patients was it significant enough to require withdrawal from the study.

Possíveis etapas na patogênese da cefaléia tensional e indicaçöes de tratamento / Possible stages in the pathogenesis of tension headache and indications of treatment

Análise de resultados obtidos no estudo de uma série de 100 pacientes com diagnóstico de cefaléia tensional permitem sugerir 5 etapas de um procesos fisiopatogênico implicado. Com base nesta sugestäo, a indicaçäo para o tratamento e respectiva eficácia, dependeräo da etapa patogênica sobre a qual se pretenda fazer incidir a açäo terapêutica