Dataset Information

Auriculotherapy in prevention of migraine attacks: an open randomized trial.

ABSTRACT: Use of auriculotherapy to prevent episodic migraine pain has seldom been reported. The aim of this open study was to show that three sessions of auriculotherapy, 1 month apart, using semi-permanent needles decrease frequency and intensity of an attack in patients presenting episodic migraine. A total of 90 patients were randomized to the treatment group (AUR group, n = 58) or the control group (C group, n = 32). Four patients dropped out during the study (three in the AUR group and one in the C group). The number of days with migraine and non-migraine headache was similar when the analysis focused on the 3 months of the study or on the difference in each group of this number between the 3 months preceding the inclusion and the 3 months of the study (p = 0.123). AUR group patients had fewer days with non-migraine headache (p = 0.011) and took less Triptans (p = 0.045) than group C. Number of days with migraine, sum of the pain intensities of all migraines and non-migraine headaches, and total number of analgesics taken, other than triptan, were similar between groups. MIDAS score decreased with time in the AUR group while it increased in the C group whether in absolute values (p = 0.035) or as categories (p = 0.037). These contrasted results should lead to further study of the effectiveness of auriculotherapy for the prevention of migraine. Clinical trail registration: Protocol registered on the Clinicaltrials.gov, website (January 30, 2017, NCT03036761).

SUBMITTER: Michel-Cherqui M

PROVIDER: S-EPMC10241207 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Auriculotherapy in prevention of migraine attacks: an open randomized trial.

Michel-Cherqui Mireille M Ma Sabrina S d'Ussel Marguerite M Ebbo David D Spassova Antoinette A Chaix-Couturier Carine C Szekely Barbara B Fischler Marc M Lemaire Nicolas N Le Guen Morgan M

Frontiers in neurology 20230522

Use of auriculotherapy to prevent episodic migraine pain has seldom been reported. The aim of this open study was to show that three sessions of auriculotherapy, 1 month apart, using semi-permanent needles decrease frequency and intensity of an attack in patients presenting episodic migraine. A total of 90 patients were randomized to the treatment group (AUR group, <i>n</i> = 58) or the control group (C group, <i>n</i> = 32). Four patients dropped out during the study (three in the AUR group and ...[more]

PMID: 37284181

Similar Datasets

Project description:BackgroundMigraine is a prevalent and debilitating neurological disorder that significantly affects quality of life. While pharmacological treatments exist, they can have limitations such as side effects, contraindications, and incomplete relief, prompting interest in non-pharmacological approaches for better symptom management.ObjectiveThis study aimed to assess the effectiveness of alternate nostril breathing (ANB) as a non-pharmacological intervention to reduce the frequency and severity of migraine attacks and associated disability in adult patients.MethodsA single-center, open-label, two-arm, parallel-group randomized controlled trial was conducted at six Family Health Centers (FHCs) of Dokuz Eylul University, Izmir, Turkey. A total of 86 migraine patients aged 18-50 years, diagnosed with migraine based on ICD-10 criteria, were randomized into control (n = 43) and intervention (n = 43) groups. The intervention group practiced ANB three times daily for three months, while the control group continued their usual care. The primary outcomes were changes in migraine frequency and severity. Secondary outcomes included changes in migraine-related disability, both outcomes measured using the Migraine Disability Assessment Scale (MIDAS).ResultsThe intervention group showed a significant reduction in migraine attack frequency (P = 0.002) and MIDAS scores (P = 0.003) compared to the control group. Both groups experienced a reduction in attack severity (P = 0.001), though no significant difference was observed between the groups (P = 0.074). Within-group comparisons showed significant improvements in attack frequency, severity, and MIDAS scores in the intervention group (P = 0.001 for all).ConclusionANB significantly reduced migraine frequency and disability, making it a promising non-invasive and accessible treatment option for migraine management. Further research with longer follow-up periods is needed to explore its long-term effects and broader applicability.

Project description:ObjectiveTo compare the rate and extent of absorption of zavegepant 10 mg (therapeutic dose) or 20 mg (supratherapeutic dose) nasal spray during a migraine attack versus non-migraine period, assess safety, and explore efficacy and the relationship between zavegepant concentration and therapeutic response.BackgroundPhysiologic changes occurring during a migraine attack could affect the pharmacokinetics of treatments for migraine.MethodsThis was a Phase 1, multicenter, open-label, randomized, single-dose, two-period, fixed-sequence, comparative bioavailability study. Participants with a history of 2-8 migraine attacks per month of moderate or severe pain intensity were randomized to a single dose of zavegepant 10 or 20 mg, administered intranasally during a migraine attack (Period 1) and in a non-migraine period (Period 2). Blood samples were collected pre-dose and at pre-specified intervals up to 24 h post-dose for plasma zavegepant concentration measurement. Safety was monitored throughout, and efficacy (migraine pain intensity score, nausea, photophobia, phonophobia, aura, and functional disability) assessed during Period 1. Plasma zavegepant pharmacokinetic parameters were calculated by standard noncompartmental methods, including maximum plasma concentration (Cmax), area under plasma concentration-time curve from time zero to infinity (AUC0-inf), and time of Cmax (Tmax).ResultsA total of 37 participants were evaluable for pharmacokinetics. Following administration of zavegepant 10 mg, geometric mean ratios for Period 1/Period 2 were 82.8% (90% confidence interval [CI] 60.5-113.2) for Cmax and 90.1% (90% CI 70.2-115.5) for AUC0-inf. Following administration of zavegepant 20 mg, geometric mean ratios for Period 1/Period 2 were 72.5% (90% CI 57.9-90.8) for Cmax and 73.4% (90% CI 58.8-91.7) for AUC0-inf. Averaging over the study period, geometric mean ratios for zavegepant 20 mg/10 mg were 142.5% (90% CI 118.6-171.4) for Cmax and 157.0% (90% CI 133.6-184.5) for AUC0-inf. Median Tmax was 0.5 h for both doses regardless of Period. Zavegepant was well tolerated in both study periods and effective during Period 1 at both dose levels. There was no apparent correlation between concentration at 0.5 h or 2 h post-dose and efficacy outcomes.ConclusionZavegepant exposure was comparable during a migraine attack and a non-migraine period, particularly at the therapeutic dose of 10 mg. When averaging over migraine and non-migraine periods, there was a less-than-dose proportional increase in zavegepant exposure when the dose was doubled from 10 to 20 mg. The median Tmax was 0.5 h regardless of migraine attack or dose. Zavegepant 10 and 20 mg exhibited favorable safety profiles during migraine attacks and non-migraine periods, and were effective to relieve pain, associated symptoms, and functional disability during migraine attacks, with no apparent correlation between zavegepant concentration and efficacy outcomes.

Project description:ImportanceCurrent treatments for long-term prophylaxis in hereditary angioedema have limitations.ObjectiveTo assess the efficacy of lanadelumab, a fully human monoclonal antibody that selectively inhibits active plasma kallikrein, in preventing hereditary angioedema attacks.Design, setting, and participantsPhase 3, randomized, double-blind, parallel-group, placebo-controlled trial conducted at 41 sites in Canada, Europe, Jordan, and the United States. Patients were randomized between March 3, 2016, and September 9, 2016; last day of follow-up was April 13, 2017. Randomization was 2:1 lanadelumab to placebo; patients assigned to lanadelumab were further randomized 1:1:1 to 1 of the 3 dose regimens. Patients 12 years or older with hereditary angioedema type I or II underwent a 4-week run-in period and those with 1 or more hereditary angioedema attacks during run-in were randomized.InterventionsTwenty-six-week treatment with subcutaneous lanadelumab 150 mg every 4 weeks (n = 28), 300 mg every 4 weeks (n = 29), 300 mg every 2 weeks (n = 27), or placebo (n = 41). All patients received injections every 2 weeks, with those in the every-4-week group receiving placebo in between active treatments.Main outcome and measuresPrimary efficacy end point was the number of investigator-confirmed attacks of hereditary angioedema over the treatment period.ResultsAmong 125 patients randomized (mean age, 40.7 years [SD, 14.7 years]; 88 females [70.4%]; 113 white [90.4%]), 113 (90.4%) completed the study. During the run-in period, the mean number of hereditary angioedema attacks per month in the placebo group was 4.0; for the lanadelumab groups, 3.2 for the every-4-week 150-mg group; 3.7 for the every-4-week 300-mg group; and 3.5 for the every-2-week 300-mg group. During the treatment period, the mean number of attacks per month for the placebo group was 1.97; for the lanadelumab groups, 0.48 for the every-4-week 150-mg group; 0.53 for the every-4-week 300-mg group; and 0.26 for the every-2-week 300-mg group. Compared with placebo, the mean differences in the attack rate per month were -1.49 (95% CI, -1.90 to -1.08; P < .001); -1.44 (95% CI, -1.84 to -1.04; P < .001); and -1.71 (95% CI, -2.09 to -1.33; P < .001). The most commonly occurring adverse events with greater frequency in the lanadelumab treatment groups were injection site reactions (34.1% placebo, 52.4% lanadelumab) and dizziness (0% placebo, 6.0% lanadelumab).Conclusions and relevanceAmong patients with hereditary angioedema type I or II, treatment with subcutaneous lanadelumab for 26 weeks significantly reduced the attack rate compared with placebo. These findings support the use of lanadelumab as a prophylactic therapy for hereditary angioedema. Further research is needed to determine long-term safety and efficacy.Trial registrationEudraCT Identifier: 2015-003943-20; ClinicalTrials.gov Identifier: NCT02586805.

Dataset Information

Auriculotherapy in prevention of migraine attacks: an open randomized trial.

Publications

Auriculotherapy in prevention of migraine attacks: an open randomized trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets