Migraine-Specific Quality Of Life Questionnaire Research Articles

Validity and reliability of the Greek Migraine-Specific Quality of Life Questionnaire (MSQ Version 2.1-GR)

BackgroundTo assess the validity and reliability of the Migraine-Specific Quality of Life Questionnaire 2.1 (MSQv.2.1) in a group of Greek migraineurs.Design—sample—methodsThe Greek version of MSQv.2.1 (MSQv.2.1-GR), a self-report measure with 14 items in 3 domains (Role Restrictive (RR), Role Preventive (RP) and Emotional Function (EF)), was administered during a cross-sectional study to 141 Greek adult migraineurs and 135 controls without migraine or any other primary headache disorder, along with Migraine Disability Assessment Scale (MIDAS) and Short Form Health Survey (SF-12) to assess validity. MSQv.2.1-GR was re-administered in a group of participants with migraine two weeks afterwards to assess reliability. Content and construct validity was assessed using Intraclass Correlation Coefficient (ICC), Spearman rho, McDonald’s omega, Cronbach’s alpha. Confirmatory factor analysis (CFA) was used to test the latent structure of the MSQv.2.1-GR in migraineurs.ResultsA total of 276 adults participated in the study. Internal consistency of the three MSQv.2.1-GR scales RR, RP and EF yielded a range of McDonald’s omega from 0.832 to 0.923 (Cronbach’s alpha from 0.814 to 0.923). CFA confirmed the proposed three-factor MSQv.2.1-GR latent structure with acceptable goodness of fit indices and factor loadings. Correlations were established between MSQv2.1-GR component and MIDAS scores, showing moderate and statistically significant relationships (from − 0.519 to −0.562, all p < 0.001) for RR, RP and EF. Correlations between MSQv2.1-GR and SF-12 component scores were identified, with values from 0.1 to 0.4, indicating low to moderate associations. ICC was calculated at 0.997, indicating a high level of reliability between the measures. Notably, all MSQv2.1-GR scores (RR, RP, EF) were significantly higher in the controls compared to migraineurs (p < 0.001 for all scales). These findings suggest that MSQv2.1-GR is internally consistent, shows significant correlations with relevant measures, and is effective in discriminating controls from migraineurs.ConclusionMSQv2.1-GR is a valid and reliable tool to determine the effect migraine has on the quality of life of Greek-speaking migraineurs.

Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab

BackgroundAs new migraine therapies emerge, it is crucial for measures to capture the complexities of health-related quality of life (HRQoL) improvement beyond improvements in monthly migraine day (MMD) reduction. Investigations into the correlations between MMD reduction, symptom management, and HRQoL are lacking, particularly those that focus on improvements in canonical symptoms and improvement in patient-identified most-bothersome symptoms (PI-MBS), in patients treated with eptinezumab. This exploratory analysis identified efficacy measures mediating the effect of eptinezumab on HRQoL improvements in patients with migraine.MethodsData from the DELIVER study of patients with 2–4 prior preventive migraine treatment failures (NCT04418765) were inputted to two structural equation models describing sources of HRQoL improvement via Migraine-Specific Quality-of-Life Questionnaire (MSQ) scores. A single latent variable was defined to represent HRQoL and describe the sources of HRQoL in DELIVER. One model included all migraine symptoms while the second model included the PI-MBS as the only migraine symptom. Mediating variables capturing different aspects of efficacy included MMDs, other canonical symptoms, and PI-MBS.ResultsIn the first model, reductions in MMDs and other canonical symptoms accounted for 35% (standardized effect size [SES] − 0.11) and 25% (SES − 0.08) of HRQoL improvement, respectively, with 41% (SES − 0.13) of improvement comprising “direct treatment effect,” i.e., unexplained by mediators. In the second model, substantial HRQoL improvement with eptinezumab (86%; SES − 0.26) is due to MMD reduction (17%; SES − 0.05) and change in PI-MBS (69%; SES − 0.21).ConclusionsImprovements in HRQoL experienced by patients treated with eptinezumab can be substantially explained by its effect on migraine frequency and PI-MBS. Therefore, in addition to MMD reduction, healthcare providers should discuss PI-MBS improvements, since this may impact HRQoL. Health technology policymakers should consider implications of these findings in economic evaluation, as they point to alternative measurement of quality-adjusted life years to capture fully treatment benefits in cost-utility analyses.Trial registration ClinicalTrials.gov (Identifier: NCT04418765; EudraCT (Identifier: 2019–004497-25; URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004497-25).Graphical

A 12-week randomized double-blind clinical trial of eicosapentaenoic acid intervention in episodic migraine

Omega-3 polyunsaturated fatty acids (PUFAs) may benefit migraine improvement, though prior studies are inconclusive. This study evaluated the effect of eicosapentaenoic acid (EPA) on episodic migraine (EM) prevention. Seventy individuals with EM participated in a 12-week randomized, double-blind, placebo-controlled trial from March 2020 and May 2022. They were randomly assigned to either the EPA (N = 35, 2 g fish oil with 1.8 g of EPA as a stand-alone treatment daily), or the placebo group (N = 35, 2 g soybean oil daily). Migraine frequency and headache severity were assessed using the monthly migraine days, visual analog scale (VAS), Migraine Disability Assessment (MIDAS), Hospital Anxiety and Depression Scale (HADS), Migraine-Specific Quality-of-Life Questionnaire (MSQ), and Pittsburgh Sleep Quality Index (PSQI) in comparison to baseline measurements. The EPA group significantly outperformed the placebo in reducing monthly migraine days (−4.4 ± 5.1 days vs. − 0.6 ± 3.5 days, p = 0.001), days using acute headache medication (−1.3 ± 3.0 days vs. 0.1 ± 2.3 days, p = 0.035), improving scores for headache severity (ΔVAS score: −1.3 ± 2.4 vs. 0.0 ± 2.2, p = 0.030), disability (ΔMIDAS score: −13.1 ± 16.2 vs. 2.6 ± 20.2, p = 0.001), anxiety and depression (ΔHADS score: −3.9 ± 9.4 vs. 1.1 ± 9.1, p = 0.025), and quality of life (ΔMSQ score: −11.4 ± 19.0 vs. 3.1 ± 24.6, p = 0.007). Notably, female particularly benefited from EPA, underscoring its potential in migraine management. In conclusion, high-dose EPA has significantly reduced migraine frequency and severity, improved psychological symptoms and quality of life in EM patients, and shown no major adverse events, suggesting its potential as a prophylactic for EM.

Effectiveness of integrated education and relaxation program on migraine-related disability: a randomized controlled trial

BackgroundMigraine is one of the most disabling disorders worldwide. Globally, in 2019, headache disorders were the cause of 46.6 million years of disability, with migraine accounting for 88.2% of these. The value of integrative strategies in migraine management has been raised due to the recurrent and provoked nature of migraine. So, the current study aimed to evaluate the effectiveness of implementing a therapeutic patient education and relaxation training program versus usual pharmacological treatment alone on the frequency, severity, and duration of migraine attacks as the primary outcome and migraine-related disability and quality of life as the secondary outcome. A randomized controlled trial was conducted at the specialized headache clinic of a tertiary referral center. Sixty patients were randomly assigned to intervention or control groups. Participants in the intervention arm received the education and relaxation training program and were instructed to perform daily relaxation exercises in addition to their routine pharmacological treatment, whereas the control group only received their routine treatments. Follow-up was done after 1 and 3 months using a headache diary and a migraine-specific quality of life questionnaire (MSQ).ResultAfter implementation of the program, there was a significant reduction in migraine attack severity in the intervention group compared to the control group, and they also had significantly fewer migraine headache days/month and duration of migraine attacks compared to patients in the control group. Statistically significant improvement in the role-function restrictive, role-function preventive, and emotional function domains of MSQ.ConclusionAn integrated migraine management program has a significant effect on reducing the burden of migraine attacks and improving the daily activities of migraine sufferers.

Evaluation of the effect of erenumab on migraine-specific questionnaire in patients with chronic and episodic migraine.

Erenumab is a fully human anti-canonical calcitonin gene-related peptide receptor monoclonal antibody approved for migraine prevention. The Migraine-Specific Quality-of-Life Questionnaire (MSQ) is a 14-item patient-reported outcome instrument that measures the impact of migraine on health-related quality of life. Erenumab data from four phase II/III clinical trials were used to develop an item response theory (IRT) model within a nonlinear mixed effects framework, (i) evaluate the MSQ item information with respect to patient disability, (ii) characterize the longitudinal progression of the MSQ, and (iii) quantify the effect of erenumab on the MSQ in patients with migraine. The majority (80%) of information was found to be contained in 9 out of 14 items, extending the current knowledge on the reliability of the MSQ as a psychometric tool. Simulations across three MSQ domains show significant improvement from baseline, exceeding minimally important differences. Overall, the IRT model platform developed herein allows for systematic quantification of the effect of erenumab on the MSQ in patients with migraine.

Functional outcomes between headache surgery and targeted botox injections: A prospective multicenter pilot study

IntroductionChronic migraine headaches (MH) are a principal cause of disability worldwide. This study evaluated and compared functional outcomes after peripheral trigger point deactivation surgery or botulinum neurotoxin A (BTA) treatment in patients with MH. MethodsA long-term, multicenter, and prospective study was performed. Patients with chronic migraine were recruited at the Ohio State University and Massachusetts General Hospital and included in each treatment group according to their preference (BTA or surgery). Assessment tools including the Migraine Headache Index (MHI), Migraine Disability Assessment Questionnaire (MIDAS) total, MIDAS A, MIDAS B, Migraine Work and Productivity Loss Questionnaire-question 7 (MWPLQ7), and Migraine-Specific Quality of Life Questionnaire (MSQ) version 2.1 were used to evaluate functional outcomes. Patients were evaluated prior to treatment and at 1, 2, and 2.5 years after treatment. ResultsA total of 44 patients were included in the study (surgery=33, BTA=11). Patients treated surgically showed statistically significant improvement in headache intensity as measured on MIDAS B (p = 0.0464) and reduced disability as measured on MWPLQ7 (p = 0.0120) compared to those treated with BTA injection. No statistical difference between groups was found for the remaining functional outcomes. Mean scores significantly improved over time independently of treatment for MHI, MIDAS total, MIDAS A, MIDAS B, and MWPLQ 7 (p<0.05). However, no difference in mean scores over time was observed for MSQ. ConclusionsHeadache surgery and targeted BTA injections are both effective means of addressing peripheral trigger sites causing headache pain. However, lower pain intensity and work-related disabilities were found in the surgical group.

Outcomes and Factors Associated with Insufficient Effectiveness of Acute Treatments of Migraine in Japan: Results of the ObserVational survey of the Epidemiology, tReatment, and Care Of MigrainE (OVERCOME [Japan]) Study.

Knowledge of patient outcomes and treatment effectiveness associated with acute migraine treatments in Japan is lacking. To describe patient-reported outcomes (PROs) and treatment effectiveness in three acute treatment groups from OVERCOME (Japan): over-the-counter (OTC) only, prescription nonsteroidal anti-inflammatory drugs/acetaminophen (Rx-NSAIDs/ACE) only, and triptans. OVERCOME (Japan) was an observational, cross-sectional, population-based web survey of people with migraine (July-September 2020). PROs, including the Migraine-Specific Quality of Life Questionnaire (MSQ), Migraine Interictal Burden Scale (MIBS-4), Migraine Disability Assessment (MIDAS), and Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI-M), were compared pairwise between treatment groups. Logistic regression was used to examine treatment effectiveness. The analysis included 9075 survey respondents (OTC only: n=5791; Rx-NSAIDs/ACE only: n=751; triptans: n=2533). Triptan users reported the lowest MSQ scores, most severe disability (MIDAS: 20.7% versus 6.3% and 11.6%) and severe interictal burden (MIBS-4: 50.1% versus 21.2% and 19.8%), and greatest work impairment (WPAI-M: 50.4% versus 32.2% and 30.8%) compared with the OTC and Rx-NSAIDs/ACE groups, respectively. Treatment effectiveness was very poor-to-poor for 60.9%, 43.1%, and 47.6% of the triptan, OTC, and Rx-NSAIDs/ACE groups, respectively. Severe interictal burden was significantly associated with insufficient treatment effectiveness (odds ratios, severe versus no burden: 0.47 [95% confidence interval: 0.40-0.54], 0.56 [0.35-0.89], and 0.41 [0.32-0.52], for the OTC, Rx-NSAIDs/ACE, and triptan groups, respectively). People with high migraine burden used triptans for acute treatment, but many reported poor treatment effectiveness. Education may be required to promote better treatments, including earlier introduction of migraine-specific acute and preventive medications.

P.016 Impact of eptinezumab on patient-reported outcomes in patients with prior preventive treatment failures

Background: In DELIVER, eptinezumab reduced migraine frequency and was well tolerated in patients with migraine and prior preventive treatment failures. This analysis evaluated changes in patient-reported outcomes (PROs). Methods: DELIVER (NCT04418765; phase 3b double-blind study) randomized adults with migraine and 2-4 prior preventive treatment failures to eptinezumab or placebo every 12 weeks. The assessed PROs included EuroQol 5-Dimensions 5-Levels visual analogue scale (EQ-5D-5L VAS); 6-item Headache Impact Test (HIT-6), Patient Global Impression of Change (PGIC), most bothersome symptom (MBS), and Migraine-Specific Quality of Life Questionnaire (MSQ, v2.1). Results: Patients received eptinezumab 100mg (n=299), 300mg (n=294), or placebo (n=298). Mean changes from baseline to Wk12 in EQ-5D-5L VAS scores were 2.0 (100mg, P=0.0007) and 4.4 (300mg, P&lt;0.0001) versus -3.1 (placebo), and were maintained or further improved to Wk24 (2.0, 5.2, -2.8, respectively). Mean baseline HIT-6 total scores were ~66.4, with mean changes of -6.9 (100mg, P&lt;0.0001) and -8.5 (300mg, P&lt;0.0001) versus -3.1 (placebo) at Wk12 that were further improved through Wk24 (-8.9 and -9.9 vs -3.9). PGIC, MBS, and MSQ domain scores showed greater improvement for eptinezumab than placebo. Conclusions: In adults with migraine and prior preventive treatment failures, eptinezumab robustly improved health-related quality of life and migraine-related burden over 24 weeks versus placebo.

Study of electroacupuncture with different frequencies for the treatment of headache and anxiety-depression symptoms in patients with migraine: A randomized clinical trial: 不同频率电针改善偏头痛患者头痛及焦虑抑郁症状的差异性研究-随机临床试验

: To observe the effects of electroacupuncture (EA) with varied frequencies on headache and anxiety-depression symptoms in patients with migraine and to screen optimal frequency of EA for patients with such conditions. : Single-center, randomized, controlled clinical trial was designed, and the outcome assessors and statisticians were blinded. The patients with migraine were randomized into 2 Hz EA group, 100 Hz EA group and sham-stimulation group. In each group, the changes in migraine attacks, days with headache, the scores of visual analogy scale (VAS), self-rating anxiety scale (SAS), self-rating depression scale (SDS) and migraine-specific quality-of-life questionnaire (MSQ), as well as the dosage of analgesics were observed at the baseline, during treatment, in 1, 2 and 3 months of follow-up separately. : Patients were enrolled in the Third Affiliated Hospital of Zhejiang Chinese Medical University, between 1st August 2018 and 31st July 2021. : Sixty-five migraine patients with or without aura. : In the EA groups, the acupoints were bilateral Fengchi (GB20), Gongxue (Extra), Sizhukong (TE23), Taiyang (EX-HN5), Shuaigu (GB8), Waiguan (TE5) and Yanglingquan (GB34). Electric stimulation was exerted at GB20 and Gongxue (Extra), with 2 Hz and 100 Hz separately. In the sham-stimulation group, the shallow acupuncture was operated at the sites 1 cm lateral to GB20 and Gongxue (Extra), and on the radial side of TE5 and GB34. The output wires were cut off after attached to the acupoints. The patients in each group received the treatment 3 times weekly, once every two days, for consecutive 4 weeks. The complete intervention was composed of 12 treatments. : Changes in numbers of migraine attacks at treatment phase (week 1 to week 4) from the baseline(week -4 to week 0) in patients of each group : (1) Changes in migraine attacks and days with headache: In the 2 Hz EA and 100 Hz EA groups, the changes for migraine attacks and days of headache were higher significantly when compared with that in the sham-stimulation group at the same time stage (P < 0.05). There was no statistical difference between two EA groups. (2) Changes of VAS score: In the 2 Hz EA and 100 Hz EA groups, the changes of VAS score were significantly higher when compared with that in the sham-stimulation group at the same time stage (P < 0.05). There was no statistical difference between two EA groups. (3) Assessment of anxiety and depression: The differences in the changes of SAS and SDS scores had no statistical significance in patients of each group at each assessment stage (P > 0.05). (4) Assessment on the quality of life: Compared with the sham-stimulation group at the same time stage, the improvement in MSQ score was increased significantly during treatment in patients of the 2 Hz EA group (P < 0.05). There was no statistical difference between two EA groups. (5) Assessment on safety and compliance: The patients of each group had sound compliance. There was no adverse events during trial, suggesting promising safety of treatment. : EA may effectively reduce the migraine attacks, and the days and intensity of headache, presenting promising safety. However, there was no significant improvement on anxiety-depression symptoms, and no significant difference between high and low frequencies of EA treatment in relieving headache and anxiety/depression symptoms in the patients with migraine. : ChiCTR1800017259

Disability in Migraine: Multicountry Results From the CaMEO-International Study (S41.002)

Disability in Migraine: Multicountry Results From the CaMEO-International Study (S41.002)

Effect of Eptinezumab on Utility Scores in Patients with Migraine: Results from the DELIVER Study (P13-12.011)

Effect of Eptinezumab on Utility Scores in Patients with Migraine: Results from the DELIVER Study (P13-12.011)

Burden of Migraine and Migraine-Associated Symptoms in People with Differing Ethnic and Racial Backgrounds: Results of the OVERCOME (US) Study (S41.003)

Burden of Migraine and Migraine-Associated Symptoms in People with Differing Ethnic and Racial Backgrounds: Results of the OVERCOME (US) Study (S41.003)

Psychometric Evaluation of the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Using Data From Phase 3 Clinical Trials in Patients With Chronic Migraine (CM) and Episodic Migraine (EM) (P8-12.007)

Psychometric Evaluation of the Migraine-Specific Quality of Life Questionnaire (MSQ v2.1) Using Data From Phase 3 Clinical Trials in Patients With Chronic Migraine (CM) and Episodic Migraine (EM) (P8-12.007)

Benefit-Risk Assessment of Atogepant: A Post Hoc Analysis of the ADVANCE Trial (P12-12.001)

Benefit-Risk Assessment of Atogepant: A Post Hoc Analysis of the ADVANCE Trial (P12-12.001)

Bloodletting at auricular dorsal vein combined with auricular point sticking for menstrual migraine of qi stagnation and blood stasis and its effect on serum levels of E2 and 5-HT

To observe the clinical effect of bloodletting at auricular dorsal vein combined with auricular point sticking on menstrual migraine (MM) of qi stagnation and blood stasis, and explore its possible mechanism. A total of 102 cases of MM with qi stagnation and blood stasis were randomly divided into an observation group (51 cases, 3 cases dropped off) and a control group (51 cases, 2 cases dropped off). The patients in the observation group were treated with bloodletting at auricular dorsal vein combined with auricular point sticking. The bloodletting was performed at vein at upper 1/3 of the dorsalis near the ear helix; the auricular point sticking was performed at Pizhixia (AT4), Neifenmi (CO18), Jiaogan (AH6a), Nie (AT2), Zhen (AT3), Shenmen (TF4) and Yidan (CO11). The auricular points of both ears were alternate used. From 7 days before the onset of menstruation, bloodletting at auricular dorsal vein was given once every 7 days, 3 times were taken as a course of treatment, and 1 course of treatment was given; the auricular point sticking was given once every 3 days, and 6 times of treatment were given. The patients in the control group were treated with oral administration of flunarizine hydrochloride capsules. From 7 days before the onset of menstruation, flunarizine hydrochloride was given 2 capsules per time, once a day for 3 weeks. The menstrual headache index and visual analogue scale (VAS) score of the two groups were observed before treatment, one menstrual cycle into treatment and the first and the second menstrual cycle after treatment; the migraine-specific quality of life questionnaire (MSQ) score and the serum levels of estradiol (E2) and 5-hydroxytryptamine (5-HT) were compared before treatment and one menstrual cycle into treatment; the clinical efficacy was evaluated at one menstrual cycle into treatment. Compared before treatment, the menstrual headache index and VAS scores were reduced at one menstrual cycle into treatment and the first and second menstrual cycle after treatment in the two groups (P<0.05), and those in the observation group were lower than the control group (P<0.05). Compared before treatment, the MSQ scores and the serum levels of E2 and 5-HT in the two groups were increased at one menstrual cycle into treatment (P<0.05), and those in the observation group were higher than the control group (P<0.05). The total effective rate was 95.8% (46/48) in the observation group, which was higher than 73.5% (36/49) in the control group (P<0.05). Bloodletting at auricular dorsal vein combined with auricular point sticking could relieve headache intensity, improve the quality of life in patients with MM of qi stagnation and blood stasis, which may be achieved by raising the serum levels of E2 and 5-HT to improve the level of hormone in the body.

Medium-term real-world data for erenumab in 177 treatment resistant or difficult to treat chronic migraine patients: persistence and patient reported outcome measures after 17–30 months

BackgroundMany migraine patients do not respond adequately to conventional preventive treatments and are therefore described as treatment/medically resistant or difficult to treat cases. Calcitonin gene-related peptide monoclonal antibodies are a relatively novel molecular treatment for episodic and chronic migraine that have been shown to be effective in short duration clinical trials in approximately 40–50% of all chronic migraine patients. Patient Related Outcome Measures (PROM) or Quality of Life (QoL) questionnaires are used to help measure response to treatment in migraine. Although some open label extension studies have become available for erenumab, there is a lack of real-world data pertaining to quality of life in the medium to long-term for chronic and treatment resistant migraine patients.MethodsA total of 177 treatment resistant CM patients were started on erenumab (70 mg or 140 mg subcutaneous injection every 4 weeks) in our three specialist Headache Clinics. Of these, 174 had their first injection between December 2018 and October 2019. All patients were evaluated with the following PROM: the Headache Impact Test− 6, Migraine Associated Disability Assessment test and Migraine-Specific QoL Questionnaire, before starting treatment with erenumab and at intervals of 3–12 months after starting treatment. The decision to continue treatment was based on subjective clinical improvement of at least 30% (as reported by the patient), supported with diaries and QoL questionnaires. We present here the QoL measurements for this group of 177 patients. Prior preventive migraine treatments included conventional oral prophylactic medications (such as topiramate, candesartan, propranolol, or amitriptyline), at least two cycles of PREEMPT protocol onabotulinumtoxin A or (in a small number of cases) neuromodulation with single pulse Transcranial Magnetic Stimulation.ResultsOf the 177 patients who started treatment with erenumab, 68/177 (38.4%) stopped during the first year, either due to lack of efficacy (no significant benefit or only minimal improvement) and/or possible side effects. 109/177 (61.6%) patients reported clinically significant improvement after 6–12 months and wished to stay on treatment. Twelve of these 109 patients subsequently stopped treatment in the period between 1 year and up to June 2021 (mainly due to a worsening of their migraine). Therefore, a total of 97/177 patients (54.8%) remained on treatment as of June 2021 (duration of treatment 17–30 months, median of 25 months).ConclusionApproximately 55% of treatment resistant or difficult to treat CM patients who trialled erenumab in our clinics reported a subjective benefit and were still on treatment after 17–30 months.

Circulating exosomal microRNA profiles in migraine patients receiving acupuncture treatment: A placebo-controlled clinical trial.

Acupuncture has a long history of being used in Chinese medicine for the treatment of migraine. However, molecular biomarkers for diagnosis and prognosis of migraine and its treatment are lacking. This study aimed to explore whether acupuncture could regulate differentially expressed exosomal miRNAs between patients with migraine without aura (MWoA) and healthy controls (HCs) and to identify diagnostic biomarkers that helped differentiate MWoA patients from HCs and identify prognostic biomarkers that helped to predict the effect of acupuncture. Here, we isolated serum exosomes from patients with MWoA and HCs before and after true and sham acupuncture treatment. Then, small RNA sequencing and bioinformatics analysis were performed to screen out key miRNAs specifically responding to acupuncture treatment. Pearson's correlation analysis was used to evaluate the correlation between miRNAs and clinical phenotypes. Finally, we applied a machine learning method to identify diagnostic biomarkers of MWoA patients and identify prognostic biomarkers that helped to predict the effect of acupuncture. Small RNA sequencing identified 68 upregulated and 104 downregulated miRNAs in MWoA patients compared to those in HCs. Further, we identified eight upregulated and four downregulated miRNAs in migraine patients after true acupuncture treatment (trAMWoA), but not in the sham acupuncture treatment (shAMWoA) or HC group. Among them, has-miR-378a-5p was positively correlated with time unable to work, study, or do housework due to migraine (p < 0.05), whereas has-miR-605-3p was negatively correlated with the restrictive subscale of the migraine-specific quality of life questionnaire (MSQ) (p < 0.05). We then evaluated the diagnostic and prognostic potential of these 12 miRNAs in patients with MWoA. The combination of serum levels of exosomal has-miR-369-5p, has-miR-145-5p, and has-miR-5,010-3p could serve as diagnostic and prognostic biomarkers for MWoA patients following acupuncture treatment. This is the first study on the serum exosomal miRNA profiles of migraineurs before and after acupuncture treatment. Our results improve our understanding of the molecular functions of miRNAs in MWoA. More importantly, they expand our view of evaluating the clinical outcomes of migraine patients treated with acupuncture, using exosomal RNA markers. Chinese Clinical Trial Registry, ChiCTR2000034417, July 2020.

Study on key outcome indexes in treatment of migraine with acupuncture and moxibustion

To identify the key outcome indexes in treatment of migraine with acupuncture and moxibustion. Using literature research, questionnaire survey and consensus conference, the key outcome indexes in treatment of migraine with acupuncture and moxibustion were screened and prioritized. The critical outcome indexes for the treatment in attack stage of migraine included 6 effectiveness outcome indexes (headache intensity, headache duration, headache relieve time, effectiveness and level of headache relief within 2 h, headache-related quality of life, level of headache relief within 24 h) and 1 safety outcome index (incidence of serious adverse reactions). The critical outcome indexes for prophylactic treatment included 6 effectiveness outcome indexes (headache day, headache frequency, headache intensity, effective rate, headache-related quality of life, health-related quality of life) and 1 safety outcome index (incidence of serious adverse reactions). In terms of the attack stage treatment and prophylactic treatment with acupuncture and moxibustion, the outcome indexes are different, among which, those can directly reflect the conditions of migraine should be optioned in priority. To assess the effectiveness of attack stage, the headache intensity is preferred, using the visual analogue scale (VAS) score, and the preferred time is 2 hours after treatment. Regarding the effectiveness of prophylactic treatment, the headache day, headache frequency and headache intensity should be firstly considered in the assessment, in which, the preferred time for assessment is 12 weeks into treatment, while, the best time for follow-up should be 12 weeks after treatment completion. When the quality of life is considered, the migraine-specific quality of life questionnaire (MSQ) is the top option. For either the attack stage treatment or the prophylactic treatment, the high attention should be laid on the outcome indexes for safety and medical economics evaluation.

The unique role of stigma in migraine-related disability and quality of life.

Stigma is increasingly recognized as an important social feature of living with migraine. Adults with migraine recruited from neurology offices completed the validated Stigma Scale for Chronic Illnesses 8-item version (SSCI-8); two outcome measures (the Migraine Disability Assessment [MIDAS] and the Migraine-Specific Quality of Life Questionnaire v 2.1 [MSQ]); and measures of allodynia (Allodynia Symptom Checklist [ASC-12]), pain cognition (Pain Catastrophizing Scale [PCS]), and psychiatric symptoms (Patient Reported Measurement Information System Anxiety [PROMIS-A] and Depression [PROMIS-D]). Pearson and Spearman correlations evaluated bivariate relationships, and linear (MSQ) and logistic (MIDAS Severe Disability, scores ≥21) regressions evaluated the unique variance associated with SSCI-8 beyond other study variables. Conditional process analysis evaluated mediation hypotheses between study variables. Participants (n=121) reported levels of stigma on par with other chronic illnesses (SSCI-8M=53.0, standard deviation [SD]=7.8), with 25/127 (19.6%) reporting clinically significant levels of stigma (SSCI-8T-score ≥ 60). Higher SSCI-8 scores were associated with higher monthly headache day frequency (r=0.35), MIDAS (ρ=0.41), ASC-12 (r=0.24, p < 0.01), PCS (r=0.46), both PROMIS-A (r=0.43) and D (r=0.42), and lower MSQ subscale scores (Role Restriction r=-0.50; Role Prevention r=-0.48; Emotion Function r=-0.50), all ps <0.001 unless otherwise noted. The SSCI-8 contributed significantly beyond migraine symptoms and other psychological factors for MSQ Emotion Function (5% unique variance) and MIDAS Severe Disability (6% of unique variance). The SSCI-8 mediated relationships between headache frequency and the MSQ subscales and MIDAS Severe Disability. The PCS mediated relationships between the SSCI-8 and MSQ subscales. The PROMIS-D mediated relationships between the SSCI-8 and MSQ Role Restriction and MSQ Role Prevention. Migraine stigma has medium to large associations with migraine outcomes and psychiatric symptoms and is independently associated with migraine disability and emotion-related quality of life. Migraine stigma is an important contributor to the relationship between headache frequency and migraine outcomes.

Effect of acupuncture on migraine without aura: a resting-state functional magnetic resonance study

To observe therapeutic effect of acupuncture on migraine without aura and the changes of brain functional connectivity (FC) using resting-state functional magnetic resonance imaging (rs-fMRI). Thirty-four patients with migraine without aura were included into an observation group and treated with acupuncture at Baihui (GV 20), Xuanlu (GB 5), Shuaigu (GB 8), Taiyang (EX-HN 5), etc. Using G6805-Ⅱ electric acupuncture apparatus, the ipsilateral Fengchi (GB 20) and Shuaigu (GB 8) were connected and stimulated with continuous wave, 2 Hz in frequency and 0.1 mA to 1.0 mA in current intensity, depending on patient's tolerance. Acupuncture stimulation lasted 20 min each time, twice weekly (at the interval>2 days). A total of 6 weeks of treatment (12 times) was required. Matching the gender and age as those of the observation group, 16 healthy subjects were recruited into a control group and no any intervention was provided. The headache days, the score of visual analogue scale (VAS) for headache severity, the total score of headache symptoms, the score of migraine-specific quality of life questionnaire (MSQ), the score of self-rating anxiety scale (SAS), and the score of self-rating depression scale (SDS) were compared before and after acupuncture, and the clinical efficacy was assessed in the observation group. The data of the resting-state functional magnetic resonance were collected in the observation group before and after treatment as well as the control group at baseline. The periaqueductal gray (PAG) was taken as the seed to analyze the effect of acupuncture on the brain FC and the correlation between FC and VAS scores, headache days in the patients of migraine without aura. After treatment, the headache days, VAS score, the total score of headache symptoms, SAS score and SDS score were all reduced (P<0.01); and the scores of the restrictive, preventive, and emotional functional domains of the MSQ were increased (P<0.01) in the observation group compared with those before treatment. The total effective rate was 94.1% (32/34). Compared with the control group, FC between PAG and the right cerebellum Ⅷ was decreased in the observation group before treatment (P<0.05). FC of PAG with the bilateral cerebellum Ⅷ and the left precuneus was increased in the observation group after treatment compared with those before treatment (P<0.05). In the observation group, the FC intensity of PAG and the right cerebellum Ⅷ was negatively correlated with VAS score (r =-0.41, P<0.05) before treatment, while the FC intensity of PAG and the left precuneus was positively correlated with the improvement in headache days (r =0.40, P<0.05) after treatment. Acupuncture is effective on migraine without aura. The brain functional connectivity is abnormal in the patients. The effect onset of acupuncture is obtained probably by regulating the abnormal brain regions and activating brain regions relevant with pain and emotions.