High resting energy expenditure in women with episodic migraine: exploring the use of predictive formulas.

Introduction: Migraine is a common and disabling primary headache, and its pathophysiology is not fully understood. Previous studies have suggested that pain can increase humans' Resting Energy Expenditure (REE). However, no previous study has investigated whether the REE of individuals with migraine differs from the general population. Therefore, this study aims to assess whether the REE of women with migraine differs from that of women without headaches. We also tested the accuracy of REE predictive formulas in the migraine patients. Methods: This cross-sectional study involves 131 adult women aged between 18 and 65 years, 83 with migraine and 48 without (controls). We collected clinical, demographic, and anthropometric data. Migraine severity was measured using the Migraine Disability Test and Headache Impact Test, version 6. The REE was measured by indirect calorimetry, and it was compared with the predicted REE calculated by formulas. Results: Patients with migraine had higher REE when compared to controls (p < 0.01). There was a positive correlation between REE and the patient-reported number of migraine attacks per month (Rho = 0.226; p = 0.044). Mifflin-St Jeor and Henry and Rees were the predictive formulas that have more accuracy in predicting REE in women with migraine. Discussion: Considering the benefits of nutritional interventions on treating migraines, accurately measuring REE can positively impact migraine patient care. This study enhances our understanding of the relationship between pain and energy expenditure. Our results also provide valuable insights for healthcare professionals in selecting the most effective predictive formula to calculate energy expenditure in patients with migraine.

Home-based tDCS for apathy in Alzheimer's disease: a protocol for a randomized double-blinded controlled pilot study.

BACKGROUND: Apathy is among the most common behavioral symptoms in dementia and is consistently associated with negative outcomes in Alzheimer's disease (AD). Despite its prevalence and clinical relevance, available pharmacological and non-pharmacological strategies to treat apathy in AD have been marked, respectively, by potentially severe side effects and/or limited efficacy. Transcranial direct current stimulation (tDCS) is a relatively novel non-pharmacological method of neuromodulation with promising results. Compared to previous tDCS formats, recent technological advances have increased the portability of tDCS, which creates the potential for caregiver-administered, home use. Our study aims to evaluate the feasibility, safety, and efficacy of home-based tDCS for the treatment of apathy in AD. METHODS/DESIGN: This is an experimenter- and participant-blinded, randomized, sham-controlled, parallel-group (1:1 for two groups) pilot clinical trial, involving 40 subjects with AD. After a brief training, caregivers will administer tDCS for participants at home under remote televideo supervision by research staff to ensure the use of proper technique. Participants will be assessed at baseline, during treatment (week 2, week 4, and week 6), and 6 weeks post-treatment. Dependent measures will cover cognitive performance, apathy, and other behavioral symptoms. Data about side effects and acceptability will also be collected. DISCUSSION: Our study will address apathy, an overlooked clinical problem in AD. Our findings will advance the field of non-pharmacological strategies for neuropsychiatric symptoms, presenting a great potential for clinical translation. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04855643.

Non-Invasive Neuromodulation Methods to Alleviate Symptoms of Huntington's Disease: A Systematic Review of the Literature.

Huntington's disease (HD) is a progressive and debilitating neurodegenerative disease. There is growing evidence for non-invasive neuromodulation tools as therapeutic strategies in neurodegenerative diseases. This systematic review aims to investigate the effectiveness of noninvasive neuromodulation in HD-associated motor, cognitive, and behavioral symptoms. A comprehensive literature search was conducted in Ovid MEDLINE, Cochrane Central Register of Clinical Trials, Embase, and PsycINFO from inception to 13 July 2021. Case reports, case series, and clinical trials were included while screening/diagnostic tests involving non-invasive neuromodulation, review papers, experimental studies on animal models, other systematic reviews, and meta-analyses were excluded. We have identified 19 studies in the literature investigating the use of ECT, TMS, and tDCS in the treatment of HD. Quality assessments were performed using Joanna Briggs Institute's (JBI's) critical appraisal tools. Eighteen studies showed improvement of HD symptoms, but the results were very heterogeneous considering different intervention techniques and protocols, and domains of symptoms. The most noticeable improvement involved depression and psychosis after ECT protocols. The impact on cognitive and motor symptoms is more controversial. Further investigations are required to determine the therapeutic role of distinct neuromodulation techniques for HD-related symptoms.

Decreased plasma levels and dietary intake of minerals in women with migraine.

It has been suggested that an imbalance in mineral levels is involved in the pathophysiology of migraine. However, only a few studies have investigated the circulating levels of mineral in patients with migraine during the pain-free period (i.e. interictal). This study aimed to investigate whether the interictal plasma levels of minerals of women with migraine differ from those of women without migraine (controls). This is a cross-sectional study involving 67 women, of which 38 were diagnosed with migraine and 29 were controls. The groups were similar in age and body mass index. Plasma levels of magnesium (Mg), copper (Cu), calcium (Ca), zinc (Zn), iron (Fe), and selenium (Se) were measured. Dietary intake was assessed using a 24-hour food recall, and migraine impact was evaluated using the Headache Impact Test, version 6 (HIT-6). The association between migraine disability, and plasma levels and dietary intake of minerals was assessed through correlation and logistic regression analyses. Women with migraine had significantly lower plasma levels of Mg, Ca, Cu, and Zn than controls. In parallel, dietary intake of Mg, Cu, and Fe was significantly lower in patients with migraine. Migraine impact was not associated with plasma levels or dietary intake of minerals. The results suggest that patients with migraine have lower plasma levels of minerals, and dietary intervention to ensure adequate mineral intake should be considered as a therapeutic strategy for migraine.

Ginger supplementation does not increase energy expenditure in female adults.

Food components with thermogenic properties are promising antiobesity agents. Ginger (Zingiber officinale Rosc.) bioactive compounds have a capsaicin-like vanillyl portion, which has been attributed to thermogenic effect in previous experimental studies. However, studies conducted in humans have evaluated only the acute thermogenic effect of ginger, and demonstrated contradictory results. We evaluated the effect of long-term consumption of dry ginger extract on the resting energy expenditure (REE) of female adults with high body adiposity. METHODS: This is a secondary analysis of a randomized, double-blind, placebo-controlled clinical trial (NCT02570633). Participants age 18 to 60 y were randomly assigned into two groups: Intervention (600 mg of ginger extract daily) and placebo (cellulose). The intervention lasted 3 mo. Anthropometric measurements, blood pressure, and REE were assessed at each visit. RESULTS: A total of 66 female participants with high body adiposity were included in the analysis (mean age: 29 y [range, 20-55 y]; body mass index: 23.3 ± 2.7), with 30 participants in the ginger group and 36 in the placebo group. There were no significant differences in baseline characteristics between the groups. No differences were observed for group × time interaction on REE. Body composition and blood pressure followed the same pattern (all P > 0.05). CONCLUSIONS: Ginger extract consumption for 3 mo did not change the REE, anthropometric, and clinical data of female adults with excess adiposity.

The quality and inflammatory index of the diet of patients with migraine.

BACKGROUND: The association between diet and migraine has been reported in the literature, but only a few studies have evaluated whether the diet consumed by patients with migraine differs from individuals without migraine. OBJECTIVE: Herein, we aimed to investigate whether the quality and the Dietary Inflammatory Index (DII) of diet consumed by migraine patients differ from that consumed by healthy controls. We also evaluated whether the severity of migraine and headache frequency were associated with these parameters. METHODS: Patients of both sexes, aged between 18 and 65, with episodic migraine and healthy controls were enrolled in this cross-sectional study. Disability and impact caused by migraine and depressive symptoms were evaluated. Dietary intake was assessed using a 24-hour dietary recall and a three-day non-consecutive food record. The quality of the diet was calculated using the Healthy Eating Index (HEI)-2015 adapted to the Brazilian population, and DII was calculated based on the method developed by Shivappa et al. (2014). RESULTS: Ninety patients with migraine and 62 individuals without migraine were included in this study. The groups did not differ regarding age, sex, marital status, years of schooling, anthropometric characteristics, and depressive symptoms. Patients with migraine had lower HEI total score than controls, indicating that these patients have a lower quality of the diet. Patients with migraine also had higher DII than controls. Nevertheless, HEI and DII scores did not correlate with migraine frequency and severity. CONCLUSION: This study corroborates the view that the characteristics of the diet might be involved in migraine pathophysiology.

Diabetes and mood disorders: shared mechanisms and therapeutic opportunities.

OBJECTIVE: The objective of this manuscript is to provide a comprehensive and critical overview of the current evidence on the association between Diabetes mellitus (DM) and mood disorders [i.e., Major depressive disorder (MDD) and bipolar disorder (BD)], and therapeutic opportunities. METHODS: We searched in MEDLINE (via Ovid) for placebo-controlled clinical trials published in the last 20 years that assessed drug repurposing approaches for the treatment of DM or mood disorders. RESULTS: We found seven studies that aimed to verify the effects of antidepressants in patients diagnosed with DM, and eight studies that tested the effect of antidiabetic drugs in patients diagnosed with MDD or BD. Most studies published in the last two decades did not report a positive effect of antidepressants on glycemic control in patients with DM. On the other hand, antidiabetic drugs seem to have a positive effect on the treatment of MDD and BD. CONCLUSIONS: While effect of antidepressants on glycemic control in patients with DM is still controversial, the use of antidiabetic drugs may be a promising strategy for patients with MDD or BD. Prospective studies are still needed.Key pointsMood disorders in patients with DM affect glycemic control, potentially increasing mortality risk.The effect of antidepressants on glycemic control in patients with DM is still controversial. The coexistence of complicated DM and a mood disorders would require a careful, individualised, and comprehensive evaluation.Insulin resistance may increase the risk of depressive symptoms and is associated with worse outcomes in BD.The use antidiabetic drugs may be a promising strategy for patients with MDD or BD. However, prospective trials are needed to prove a potential antidepressant activity of antidiabetic drugs.

Inflammatory Markers Profile in Older Adolescents During Treatment with Selective Serotonin Reuptake Inhibitors.

Objective: This study aimed to investigate the serum levels of inflammatory markers in adolescents with major depressive disorder (MDD) using selective serotonin reuptake inhibitors. Methods: This was an 8-month observational study, involving 30 adolescents with and 38 without (control) MDD diagnosis. Demographic (age and gender) and anthropometric data (weight, height, and calculated body mass index [BMI] z score) were collected. Body composition was assessed with whole-body DXA scan. Depressive and anxiety symptoms were assessed using the Beck Depression and Anxiety Inventories (BDI-II and BAI), respectively. Serum levels of interleukin (IL)-6, IL-8, IL-1ß, tumor necrosis factor, monocyte chemoattractant protein-1 (MCP-1), leptin, resistin, and adiponectin were measured using Bio-Plex Multiplex Immunoassays at baseline and after 8 months. Results: At baseline, patients with MDD and controls did not differ in age, gender, BMI z score, and fat mass index (FMI) z score. At follow-up, 58.3% (21/36) of patients with MDD were in full remission. Patients with MDD had higher levels of resistin at baseline (26274.16 pg/mL [16162.68-54252.72]) than controls (21678.53 pg/mL [11221.17-37343.27]; p < 0.01). This difference remained statistically significant after adjustment for sex, age, and FMI z score. No differences in other inflammatory markers were observed between the groups. By follow up, depressive and anxiety symptom severity had decreased significantly in patients with MDD in parallel with a decrease in the serum levels of TNF (p = 0.02), IL-8 (p < 0.01) and MCP-1 (p = 0.04). Among these markers, BDI-II score was positively correlated with serum levels of MCP-1. Conclusion: These results corroborate the view of involvement of peripheral inflammatory mechanisms in the pathophysiology of MDD in adolescents. This trial is registered at ClinicalTrials.gov: NCT02147184.

The link between nutrition and Alzheimer's disease: from prevention to treatment.

Alzheimer's disease (AD) is the most common cause of dementia. To date, there is no effective pharmacological strategy to slow or stop disease progression. In this context, multiple alternative therapeutic strategies have been investigated for AD. This review addresses the potential role of nutrition interventions in AD prevention and treatment. Nutritional strategies for AD have been based on four pillars: maintaining a healthy weight (i.e., prevention and/or treatment of obesity, especially in midlife and prevention of weight loss in the later stages of AD); correction of nutritional deficiencies; adequate consumption of micronutrients (vitamins and minerals), especially those implicated in the pathways of AD pathophysiology; and microbiota modulation.

Acute effects of dry extract of ginger on energy expenditure in eutrophic women: A randomized clinical trial.

BACKGROUND & AIMS: The thermic effect of food (TEF) is one of the components of total energy expenditure (TEE). Some bioactive compounds present in food could be useful to increase TEE. In this context, ginger has been extensively used as a thermogenic food despite no clear effect has been demonstrated yet. Herein, we evaluated the acute thermogenic effect of gingerol, a bioactive compound present in ginger, in healthy women. METHODS: We carried out a randomized double-masked, cross-over and placebo-controlled clinical trial with 20 healthy eutrophic women. Anthropometric, body composition, indirect calorimetry and clinical variables were collected at baseline and throughout the intervention phase. A standardized breakfast was offered together with two dry extract of ginger capsules (5% gingerol) or a placebo (cellulose). Indirect calorimetry, blood pressure, heart rate, axillary temperature and blood collection were assessed at baseline and thereafter, at 30, 60, 120, 180 and 240 min postprandial. The analyses were repeated with a minimum of seven days' washout period. RESULTS: Ginger intake did not increase the TEF of a standardized breakfast compared to the placebo. Oxygen consumption, respiratory quotient, blood pressure, heart rate, axillary temperature and metabolic profile were not different as well. CONCLUSIONS: Our data show that gingerol did not modify the acute TEF in healthy women. More studies in human subjects, using different concentrations of gingerol, administration methods and intervention type (chronic effect) are necessary to clarify the putative thermogenic effect of ginger. Registered at ClinicalTrials.gov (Thermogenic Effect of Ginger - NCT03089593).

Renin-Angiotensin-Aldosterone System and Migraine: A Systematic Review of Human Studies.

Migraine is a common neurologic condition marked by recurrent episodes of headache. Its pathophysiology is highly complex involving neuronal, inflammatory and vascular mechanisms. The Renin-Angiotensin System (RAS) can modulate all these mechanism, being a potential pharmacological target for migraine treatment. We carried out a systematic review of the studies evaluating the involvement of RAS in patients with migraine. There is evidence from genetic studies exploring the relation between migraine and RAS-related genes and from clinical trials evaluating the efficacy of Angiotensin II Type 1 (AT1) receptor antagonists and angiotensin converting enzyme inhibitors in migraine prophylaxis. RAS seems to play a role in the pathophysiology of migraine, but more direct evidence is still missing.

Double-blind placebo-controlled randomized clinical trial of ginger (Zingiber officinale Rosc.) in the prophylactic treatment of migraine.

BACKGROUND: Previous studies have shown an analgesic effect of ginger in the acute treatment of migraine, and there is anecdotal evidence of its efficacy in migraine prophylaxis. OBJECTIVE: This study aimed to evaluate the potential of ginger to prevent migraine attacks. METHODS: This double-blind, placebo-controlled randomized clinical trial took place at the Headache Clinic, Universidade Federal de Minas Gerais (Belo Horizonte, Minas Gerais, Brazil), involving 107 patients. Only subjects diagnosed with episodic migraine, aged between 18 and 60 years old, and who were not taking any prophylactic medication, were enrolled in the study. After one month of observation, subjects selected for the study were randomized 1:1 into placebo and treatment groups. Patients received capsules three times per day of 200 mg of dry extract of ginger (5% active ingredient) or placebo (cellulose) for three months. Visits were performed monthly and the patients were asked to fill in a migraine diary. The adherence to treatment was evaluated by counting capsules. RESULTS: The percentage of patients who responded to treatment (i.e. a reduction of 50% in the number of migraine attacks at the end of treatment) did not differ between the groups. There was a decrease in the number of days with severe pain, analgesic use for acute migraine and duration of migraine attacks in both groups, without significant difference between ginger and placebo groups. CONCLUSIONS: Ginger provides no greater benefit in the prophylactic treatment of migraine when compared to placebo. This trial is registered at ClinicalTrials.gov (NCT02570633).

Nutritional intervention may improve migraine severity: a pilot study.

OBJECTIVE: Although some studies have investigated the role of nutritional intervention on migraine, they had focused on triggers or on weight change and, to the best of our knowledge, none studied diet quality. OBJECTIVE: To investigate whether nutritional intervention focused on improving diet quality and healthy weight can promote improvement in clinical parameters of women with migraine. METHODS: Non-controlled and non-randomized intervention study conducted for 90 days. Women received an individualized diet meal plan and nutritional orientation according to their nutritional diagnosis. Anthropometric, clinical and nutritional data were measured once a month. Diet energy content and macronutrients were evaluated using 24-hour dietary recall. Diet quality was assessed through the Brazilian Healthy Eating Index-Revised (BHEI-R). The Migraine Disability Assessment and Headache Impact Test version 6 were used to assess the severity of migraine, and the Beck Depression Inventory evaluated depressive symptoms. RESULTS: Fifty-two women aged 44.0 ± 13.0 years were enrolled. Anthropometric characteristics, energy, macronutrients and fiber intake did not change after intervention. However, the BHEI-R scores improved after 60 and 90 days of intervention. Concurrent to this, the Beck Depression Inventory scores and Headache Impact Test scores decreased after 60 and 90 days, respectively. The change in the BHEI-R score was negatively correlated with the migraine severity as assessed by the Headache Impact Test at the end of the intervention. CONCLUSIONS: We concluded that the management of diet quality may be a good strategy for improving migraine severity, regardless of the nutritional status and weight change.

Nutritional intervention may improve migraine severity: a pilot study / Intervenção nutricional melhora a gravidade da migrânea: estudo piloto

ABSTRACT Although some studies have investigated the role of nutritional intervention on migraine, they had focused on triggers or on weight change and, to the best of our knowledge, none studied diet quality. Objective To investigate whether nutritional intervention focused on improving diet quality and healthy weight can promote improvement in clinical parameters of women with migraine. Methods Non-controlled and non-randomized intervention study conducted for 90 days. Women received an individualized diet meal plan and nutritional orientation according to their nutritional diagnosis. Anthropometric, clinical and nutritional data were measured once a month. Diet energy content and macronutrients were evaluated using 24-hour dietary recall. Diet quality was assessed through the Brazilian Healthy Eating Index-Revised (BHEI-R). The Migraine Disability Assessment and Headache Impact Test version 6 were used to assess the severity of migraine, and the Beck Depression Inventory evaluated depressive symptoms. Results Fifty-two women aged 44.0 ± 13.0 years were enrolled. Anthropometric characteristics, energy, macronutrients and fiber intake did not change after intervention. However, the BHEI-R scores improved after 60 and 90 days of intervention. Concurrent to this, the Beck Depression Inventory scores and Headache Impact Test scores decreased after 60 and 90 days, respectively. The change in the BHEI-R score was negatively correlated with the migraine severity as assessed by the Headache Impact Test at the end of the intervention. Conclusions We concluded that the management of diet quality may be a good strategy for improving migraine severity, regardless of the nutritional status and weight change.

RESUMO Estudos investigaram o papel da intervenção nutricional, focada no consumo de alimentos "gatilhos" ou na alteração de peso, na melhora da migrânea. Porém, mudanças na qualidade da dieta ainda não foram abordadas. Objetivo Investigar se intervenção nutricional focada na qualidade da dieta e peso saudável pode melhorar parâmetros clínicos em mulheres com migrânea. Métodos Estudo de intervenção, não controlado e não randomizado. As mulheres receberam plano alimentar individualizado e orientações nutricionais, conforme o diagnóstico nutricional. Dados antropométricos, clínicos e alimentares foram medidos uma vez por mês durante três meses. Recordatório alimentar de 24 horas forneceu informações sobre o consumo alimentar. Qualidade da dieta foi avaliada pelo Índice Brasileiro de Alimentação Saudável (IQD-R). Os questionários Migraine Disability Test (MIDAS) e Headache Impact Test, versão 6 (HIT-6) avaliaram a incapacidade gerada pela enxaqueca e o Inventário de Depressão de Beck (BDI) investigou sintomas depressivos. Resultados Cinquenta e duas mulheres com 44,0 ± 13,0 anos participaram da amostra. Características antropométricas e consumo de energia, macronutrientes e fibras não se alteraram depois da intervenção. No entanto, os escores do IQD-R melhoraram após 60 e 90 dias de intervenção. Os escores do BDI e do HIT-6 diminuíram após 60 e 90 dias, respectivamente. A mudança no escore do IQD-R correlacionou de maneira negativa com a gravidade da enxaqueca avaliada pelo HIT-6 ao final da intervenção. Conclusões O manejo da qualidade da dieta pode ser estratégia para melhorar a gravidade da migrânea, independente do estado nutricional e da mudança de peso dos pacientes.

Deciphering the cellular interplays underlying obesity-induced adipose tissue fibrosis.

Obesity originates from an imbalance between caloric intake and energy expenditure that promotes adipose tissue expansion, which is necessary to buffer nutrient excess. Patients with higher visceral fat mass are at a higher risk of developing severe complications such as type 2 diabetes and cardiovascular and liver diseases. However, increased fat mass does not fully explain obesity's propensity to promote metabolic diseases. With chronic obesity, adipose tissue undergoes major remodeling, which can ultimately result in unresolved chronic inflammation leading to fibrosis accumulation. These features drive local tissue damage and initiate and/or maintain multiorgan dysfunction. Here, we review the current understanding of adipose tissue remodeling with a focus on obesity-induced adipose tissue fibrosis and its relevance to clinical manifestations.

Pathways linking obesity to neuropsychiatric disorders.

Obesity has been associated with cognitive and behavioral syndromes. Individuals who are obese have higher risk for developing neuropsychiatric disorders such as depression and dementia than non-obese. Conversely, patients with neuropsychiatric conditions may exhibit some features that contribute to obesity development such as unhealthy behaviors and treatment with drugs that increase appetite. This review addresses the multiple pathways implicated in the relationship between obesity and neuropsychiatric disorders, mainly mood disorders, schizophrenia, and major neurocognitive disorder or dementia. Both obesity and neuropsychiatric disorders are characterized by a low-grade systemic inflammation and neuroinflammation. Obesity is frequently accompanied by neuroendocrine changes, particularly involving the hypothalamic-pituitary-adrenal (HPA) axis. Indeed, activation of the stress system is commonly seen as a trigger for mood episodes, psychosis exacerbation, and cognitive decline. Growing evidence suggests the role of gut microbiota in obesity and brain functioning through the modulation of the inflammatory response and HPA axis. Owing to the intricate relationship between obesity and neuropsychiatric disorders, tackling one of them may affect the other. Therefore, a better understanding of the pathways underlying the link between obesity and neuropsychiatric disorders can contribute to the development of therapeutic strategies for these conditions.

Ginger (Zingiber officinale Rosc.) Ameliorated Metabolic and Inflammatory Dysfunction Induced by High-Refined Carbohydrate-Containing Diet in Mice.

This study aimed to evaluate the effects and the mechanisms of ginger extract intake in the adiposity gain, metabolic and inflammatory disturbances induced by a high-refined carbohydrate (HC) diet in mice. Ginger extract at doses of 200, 600, and 1800 mg/kg was supplemented in the daily food of obese Balb/c mice during an 8-week experiment. Our findings indicate that consumption of high doses of ginger extracts prevents the increase of adiposity induced by HC diet, improves lipid profile, and promotes decrease of inflammatory markers in mice. We showed that ginger addition to HC diet leads to decrease in the recruitment of cells visualized in vivo in the microvasculature of adipose tissue, decrease of inflammatory cytokines, and increase of adiponectin serum levels. These results indicate that the consumption of ginger decreases the negative metabolic consequences induced by HC diet.

Double-blind placebo-controlled randomized clinical trial of ginger ( Zingiber officinale Rosc.) addition in migraine acute treatment.

BACKGROUND: Previous studies have demonstrated the analgesic effects of ginger in different conditions, but evidence about its efficacy in migraine treatment is scarce. OBJECTIVE: This study aimed to evaluate the potential of ginger to improve acute migraine as an add-on strategy to standard treatment. METHODS: A double-blind placebo-controlled randomized clinical trial in the emergency room of a general hospital was conducted. Patients who sought medical care at the time of migraine attack were enrolled in this study. Only adults with episodic migraine (one to six migraine attacks per month) with or without aura were included. Sixty participants were randomized into two groups in which they received 400 mg of ginger extract (5% active ingredient) or placebo (cellulose), in addition to an intravenous drug (100 mg of ketoprofen) to treat the migraine attack. Patients filled a headache diary before, 0.5 h, 1 h, 1.5 h and 2 h after the medication. Pain severity, functional status, migraine symptoms and treatment satisfaction were also recorded. RESULTS: Patients treated with ginger showed significantly better clinical response after 1 h ( p = 0.04), 1.5 h ( p = 0.01) and 2 h ( p = 0.04). Furthermore, ginger treatment promoted reduction in pain and improvement on functional status at all times assessed. CONCLUSIONS: The addition of ginger to non-steroidal anti-inflammatory drugs may contribute to the treatment of migraine attack. This trial is registered at ClinicalTrials.gov (NCT02568644).