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Dietary ω-3 intake for the treatment of morning headache: A randomized controlled trial.

ABSTRACT: Morning headache (MH) is a frequent condition with a not fully explained pathogenesis. During the past years, several studies have been performed to identify a better diet therapy to reduce the frequency and intensity of headaches. Our study aims to determine if an adequate omega-3 (ω-3) intake in a Modified Mediterranean Diet (MMD) can improve the frequency and intensity of MH and, subsequently, the quality of life. Of the 150 enrolled subjects, 95 met the inclusion criteria (63.3%). Patients were included in the study and randomized into two groups: group A following MMD A and group B following MMD B. The MMD A group was designed to arise at least a 1.5:1 ω-6/ω-3 ratio; the MMD B group was designed to derive at least a 4:1 ω-6/ω-3 ratio. Eighty-four subjects completed the 6 weeks intervention (56%). After 6 weeks (t1), group A showed a significant reduction in both Headache Impact Test-6 and Visual Analog Scale scores (p < 0.001, p < 0.001, respectively). During dietary treatment, group A progressively dismissed ketoprofen-based pharmacological treatment (p = 0.002) from baseline to t1. Furthermore, a decrease in the platelet-to-lymphocyte ratio and neutrophil-to-lymphocyte ratio at t1 in group A (p = 0.02) was observed compared to group B. Concluding, this study provides evidence of a positive impact of ω-3-enriched MMD regimen on the inflammatory status and MH. Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT01890070, identifier: NCT01890070.

SUBMITTER: Marchetti M

PROVIDER: S-EPMC9530603 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Dietary ω-3 intake for the treatment of morning headache: A randomized controlled trial.

Marchetti Marco M Gualtieri Paola P De Lorenzo Antonino A Trombetta Domenico D Smeriglio Antonella A Ingegneri Mariarosaria M Cianci Rossella R Frank Giulia G Schifano Giulia G Bigioni Giulia G Di Renzo Laura L

Frontiers in neurology 20220920

Morning headache (MH) is a frequent condition with a not fully explained pathogenesis. During the past years, several studies have been performed to identify a better diet therapy to reduce the frequency and intensity of headaches. Our study aims to determine if an adequate omega-3 (ω-3) intake in a Modified Mediterranean Diet (MMD) can improve the frequency and intensity of MH and, subsequently, the quality of life. Of the 150 enrolled subjects, 95 met the inclusion criteria (63.3%). Patients w ...[more]

PMID: 36203988

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Project description:BackgroundProponents of consumer genetic tests claim that the information can positively impact health behaviors and aid in chronic disease prevention. However, the effects of disclosing genetic information on dietary intake behavior are not clear.MethodsA double-blinded, parallel group, 2:1 online randomized controlled trial was conducted to determine the short- and long-term effects of disclosing nutrition-related genetic information for personalized nutrition on dietary intakes of caffeine, vitamin C, added sugars, and sodium. Participants were healthy men and women aged 20-35 years (n = 138). The intervention group (n = 92) received personalized DNA-based dietary advice for 12-months and the control group (n = 46) received general dietary recommendations with no genetic information for 12-months. Food frequency questionnaires were collected at baseline and 3- and 12-months after the intervention to assess dietary intakes. General linear models were used to compare changes in intakes between those receiving general dietary advice and those receiving DNA-based dietary advice.ResultsCompared to the control group, no significant changes to dietary intakes of the nutrients were observed at 3-months. At 12-months, participants in the intervention group who possessed a risk version of the ACE gene, and were advised to limit their sodium intake, significantly reduced their sodium intake (mg/day) compared to the control group (-287.3 ± 114.1 vs. 129.8 ± 118.2, p = 0.008). Those who had the non-risk version of ACE did not significantly change their sodium intake compared to the control group (12-months: -244.2 ± 150.2, p = 0.11). Among those with the risk version of the ACE gene, the proportion who met the targeted recommendation of 1500 mg/day increased from 19% at baseline to 34% after 12 months (p = 0.06).ConclusionsThese findings demonstrate that disclosing genetic information for personalized nutrition results in greater changes in intake for some dietary components compared to general population-based dietary advice.Trial registrationClinicalTrials.gov NCT01353014.

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Project description:Background: Patients undergoing pelvic radiotherapy are often advised to omit fiber-rich foods from their diet to reduce the adverse effects of treatment. Scientific evidence supporting this recommendation is lacking, and recent studies on animals and humans have suggested that there is a beneficial effect of dietary fiber for the alleviation of symptoms. Randomized controlled studies on dietary fiber intake during pelvic radiotherapy of sufficient size and duration are needed. As preparation for such a large-scale study, we evaluated the feasibility, compliance, participation rate, and logistics and report our findings here in this preparatory study. Methods: In this preparatory study of a fiber intervention trial, Swedish gynecological cancer patients scheduled for radiotherapy were recruited between January 2019 and August 2020. During the intervention, the participants filled out questionnaires and used an application. They also consumed a fiber supplement at first in powder form, later in capsules. Blood- and fecal samples were collected. The study is registered in clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04534075?cond=fidura&draw=2&rank=1). Results: Among 136 approached patients, 57 started the study and the participation rate for primary outcomes was 63% (third blood sample) and 65% (third questionnaire). Barely half of the participants provided fecal samples. Providing concise and relevant information to the patients at the right time was crucial in getting them to participate and stay in the study. The most common reasons for declining participation or dropping out were the expected burden of radiotherapy or acute side effects. Tailoring the ambition level to each patient concerning the collection of data beyond the primary endpoints was an important strategy to keep the dropout rate at an acceptable level. Using capsules rather than psyllium in powder form made it much easier to document intake and to create a control group. During the course of the preparatory study, we improved the logistics and for the last 12 participants included, the participation rate was 100% for the earliest primary outcome. Conclusion: A variety of adjustments in this preparatory study resulted in an improved participation rate, which allowed us to set a final protocol and proceed with the main study.

Project description:ObjectiveTo evaluate the efficacy of occipital nerve block compared with standard care , defined as acetaminophen with caffeine, for treatment of acute headache in pregnancy.MethodsWe conducted a single-center, unblinded, parallel, randomized controlled trial of pregnant patients with headache and pain score higher than 3 on the visual rating scale. Patients with secondary headache, preeclampsia, or allergy or contraindication to study medications were excluded. Participants were randomized to occipital nerve block or standard care (oral 650 mg acetaminophen and 200 mg caffeine). Crossover treatment was given at 2 hours and second-line treatment at 4 hours to those with worsening visual rating scale score or visual rating scale score higher than 3. The primary outcome was headache improvement to a visual rating scale score of 3 or lower within 2 hours of initial therapy. Secondary outcomes included serial visual rating scale scores, receipt of crossover or second-line therapy, patient satisfaction, and perinatal outcomes. Outcomes were assessed in an intention-to-treat analysis. We estimated that a sample of 62 would provide 80% power to detect a difference from 85% to 50% between groups.ResultsFrom February 2020 to May 2022, 62 participants were randomized to occipital nerve block (n=31) or standard care (n=31). Groups were similar except payer status. The primary outcome, headache improvement to visual rating scale score of 3 or lower, was not significantly different between groups (64.5% vs 51.6%, P =.30). The occipital nerve block group experienced lower median [interquartile range] visual rating scale scores at 1 hour (2 [0-5] vs 6 [2-7], P =.014), and more patients in the occipital nerve block group had visual rating scale scores of 3 or lower at 1 hour. Among patients receiving crossover treatment at 2 hours, the standard care group had a significantly lower visual rating scale score 1 hour after crossover to occipital nerve block than the occipital nerve block group receiving crossover to standard care ( P =.028). There were no significant differences in second-line treatment, refractory headache, satisfaction, or complications. Patients receiving occipital nerve block delivered earlier (36.6 weeks vs 37.8 weeks), but preterm birth did not differ between groups.ConclusionOccipital nerve block is an effective and quick-acting treatment option for acute headache in pregnancy.Clinical trial registrationClinicalTrials.gov , NCT03951649.

Dataset Information

Dietary ω-3 intake for the treatment of morning headache: A randomized controlled trial.

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Dietary ω-3 intake for the treatment of morning headache: A randomized controlled trial.

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