Clinical Evaluation of an Herbal Unani Formulation (Itrifal-e-Ustukhuddus) in the Management of Migraine (Shaqeeqa): A Series of Case Reports.

BackgroundIn Italy, monoclonal antibodies targeting the CGRP pathway are subsidized for the preventive treatment of high frequency and chronic migraine (CM) in patients with a MIgraine Disability ASsessment (MIDAS) score ≥ 11. Eligibility to treatment continuation requires a ≥ 50% MIDAS score reduction at three months (T3). In this study, we evaluate whether a ≥ 50% MIDAS score reduction at T3 is a reliable predictor of response to one-year erenumab treatment.MethodsIn this prospective, open-label, real-world study, 77 CM patients were treated with erenumab 70–140 mg s.c. every 28 days for one year (T13). We collected the following variables: monthly migraine days (MMDs), monthly headache days (MHDs), days of acute medication intake, MIDAS, HIT-6, anxiety, depression, quality of life and allodynia. Response to erenumab was evaluated as: i) average reduction in MMDs during the 1-year treatment period; and ii) percentage of patients with ≥ 50% reduction in MMDs during the last 4 weeks after the 13th injection (RespondersT13).ResultsErenumab induced a sustained reduction in MMDs, MHDs and intake of acute medications across the 12-month treatment period, with 64.9% of patients qualifying as RespondersT13. At T3, 55.8% of patients reported a ≥ 50% reduction in MIDAS score (MIDASRes) and 55.4% of patients reported a ≥ 50% reduction in MMDs (MMDRes). MIDASRes and MMDRes patients showed a more pronounced reduction in MMDs during the 1-year treatment as compared to NON-MIDASRes (MIDASRes: T0: 23.5 ± 4.9 vs. T13: 7.7 ± 6.2; NON- MIDASRes: T0: 21.6 ± 5.4 vs. T13: 11.3 ± 8.8, p = 0.045) and NON-MMDRes (MMDRes: T0: 23.0 ± 4.5 vs. T13: 6.6 ± 4.8; NON-MMDRes: T0: 22.3 ± 6.0 vs. T13: 12.7 ± 9.2, p < 0.001) groups. The percentage of RespondersT13 did not differ between MIDASRes (74.4%) and NON-MIDASRes (52.9%) patients (p = 0.058), while the percentage of RespondersT13 was higher in the MMDRes group (83.3%) when compared to NON-MMDRes (42.9%) (p = 0.001). MMDRes predicted the long-term outcome according to a multivariate analysis (Exp(B) = 7.128; p = 0.001), while MIDASRes did not. Treatment discontinuation based on MIDASRes would have early excluded 36.0% of RespondersT13. Discontinuation based on “either MIDASResor MMDRes” would have excluded a lower percentage (16%) of RespondersT13.ConclusionMIDASRes only partly reflects the 12-month outcome of erenumab treatment in CM, as it excludes more than one third of responders. A criterion based on the alternative consideration of ≥ 50% reduction in MIDAS score or MMDs in the first three months of treatment represents a more precise and inclusive option.Trial registrationThe trial was retrospectively registered at www.clinicaltrials.gov (NCT05442008).Graphical CGRP: Calcitonin Gene Related Peptide. MIDAS: MIgraine Disability Assessment. MMDs: monthly migraine days. MIDASRes: Patients with a MIDAS score reduction of at least 50% at T3. MMDRes: Patients with a MMDs reduction of at least 50% at T3. ResponderT13: Patients with a MMDs reduction from baseline of at least 50% in the last 4 weeks of observation period (after 13 erenumab administrations). T0: First erenumab administration. T3, T6, T9, T12: Follow-up visits at three, six, nine, and twelve months after first erenumab administration. T13: Last visit of the protocol.

Background Therapeutic patient education (TPE) has been understudied for the management of chronic migraine (CM). Objective To study the effects of TPE with standard of care (SOC) versus SOC alone on patient-related outcome measures (PROM) in CM. Methods CM patients who were not on any preventive drugs for the past 3 months, aged 18–65 years, were randomized to receive TPE with SOC versus SOC alone and followed up for 12 weeks. TPE was imparted by a medical student following a rigorous 4-week training program by two senior headache specialists. TPE was imparted in the form of interactive group sessions lasting at least 20 minutes every 2 weeks. Patients in the control group received only SOC and instructions on dosing. The primary endpoint was the change in the Migraine-Specific Quality of Life (MSQOL) scores at Week 12. The key secondary outcomes were changes in the Headache Impact Test-6 (HIT-6) and Migraine Disability Assessment (MIDAS) scores at Week 12. Other secondary endpoints were also assessed. Efficacy analyses were performed in a modified intention-to-treat population who had at least one follow-up visit at Week 4. The trial was registered with the Clinical Trial Registry of India (CTRI/2022/06/04361). Results One hundred twenty-six patients were randomized. One hundred and seventeen patients (57 in the treatment and 60 in the control group) were available for the final efficacy analysis. The treatment group, compared with the control, showed a significant improvement from baseline to Week 12 in primary and key secondary endpoints. The mean change in MSQOL score was −11 (95% CI: −15.8 to −6.1); p -value &lt; 0.001; HIT-6 scores, −6.4 (95% CI: −9.4 to −3.3); p -value &lt; 0.001, and MIDAS scores −8.9 (95% CI: −17.2 to −0.6); p -value = 0.04, favoring the treatment group. Other secondary endpoints also showed superior outcomes for the treatment group. Conclusion TPE as an adjunct to SOC improved migraine-specific quality of life and headache-related disability in patients with CM. Trial Registration: Clinical Trial Registry of India (CTRI/2022/06/04361).

BackgroundHeadache chronicity has been known to elicit deleterious effects on quality of life (QOL). We evaluated the contribution of headache chronicity to QOL in relation to clinical, psychiatric, and psychosocial variables in patients with migraine.MethodsSubjects were recruited from a headache clinic and completed self-report questionnaires including the Migraine Disability Assessment (MIDAS), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and Migraine-Specific Quality of Life (MSQoL). We obtained predictors of MSQoL by multiple regression analyses. A path analysis model was constructed to analyze interrelationships between the variables.ResultsAmong 251 eligible patients, 183 (72.9%) had episodic migraine (EM) and 68 (27.1%) had chronic migraine (CM). Patients with CM had more serious clinical, psychiatric, and poor QOL than did patients with EM. The strongest predictor of the MSQoL score in all patients with migraine was the BDI score (β = -0.373, p < 0.001), followed by the MIDAS score (β = -0.223, p < 0.001), female gender (β = -0.192, p < 0.001), attack duration (β = -0.159, p = 0.001), and headache chronicity (β = -0.130, p = 0.012). Headache chronicity had a direct effect on the MSQoL score and exerted an indirect effect on the MSQoL score through the MIDAS and the BDI scores.ConclusionsChronic migraine appears to impair QOL directly as well as indirectly by provoking disability and depression.

Background. Headache chronification is associated with significant negative impact on health-related quality of life (QOL). Patients with chronic migraine have decreased QOL and increased headache-related disability, than do patients with episodic migraine. The degree to which these outcomes are connected to disease severity, to the pattern of sociodemographic and comorbidity profiles, such as depression, anxiety and sleep disturbances, are unclear. Objective. To assess QOL and to identify predictors of its reduction in patients with chronic migraine. Materials and methods. 160 outpatients with migraine were recruited from a headache center and completed self-report questionnaires including the Headache Impact Test 6 (HIT-6) to assess QOL, Migraine Disability Assessment (MIDAS), Beck depression inventory, Spilberger–Khanin anxiety questionnaire, and Subjective sleep characteristics assessment questionnaire (SSCA). We used multiple regression analyses to obtain QОL predictors and path analysis model to identify relationship between the variables. Results. Patients with chronic migraine (n = 90) had very poor QOL, more severe migraine and comorbid disorders, than did patients with episodic migraine (n = 70). The strongest predictor of the QOL score was the Beck depression inventory score (β = 0.383; p < 0.001) and SSCA questionnaire score (β = –0.341; p < 0.001); followed by the MIDAS score (β = 0.301; p < 0.001), female gender (β = 0.198; p < 0.001), headache intensity (β = 0.173; p < 0.001), attack duration (β = 0.169; p = 0.001), headache frequency (β = 0.150; p = 0.015). Scores of Beck depression inventory, SSCA questionnaire, MIDAS, and headache features (frequency, duration, intensity) had a direct effect on the QOL. Conclusions. Depression and sleep disturbance appear to impair QOL as strong as the severe clinical manifestations of migraine.

The Migraine Disability Assessment (MIDAS) score is used to quantify headache-related disability. In a previous study, we showed that the MIDAS score was highly reliable in population-based samples of migraine headache sufferers in two countries. To examine the test-retest reliability and internal consistency of the five items comprising the MIDAS score and the overall MIDAS score in a population-based sample of both migraine and nonmigraine headache sufferers. Using a clinically validated telephone interview, a population-based sample of migraine and nonmigraine headache sufferers was identified in Baltimore, Maryland, USA. A total of 97 migraine cases and 80 nonmigraine subjects completed the MIDAS questionnaire on two occasions an average of 3 weeks apart. The MIDAS score is derived from five questions about missed time from work (or school) and household work (one question each about missed days and days with at least 50% reduced productivity) and missed days of nonwork activities. Among all headache sufferers the test-retest Spearman's correlations of individual MIDAS questions ranged from 0.67 to 0.73. The Spearman's correlation for the MIDAS score (i.e., sum of lost days and reduced effectiveness days in each domain) was 0.84. Cronbach's alpha, a measure of internal consistency, was 0.83. Mean and median item values and the overall MIDAS scores differed between migraine and nonmigraine cases. Even after adjusting for differences in headache frequency, the mean MIDAS scores differed substantially (i.e., 10.3 points) between migraine cases and nonmigraine cases. The reliability and internal consistency of the MIDAS score are high, as tested in a population-based sample of headache sufferers. MIDAS scores are substantially higher in migraine cases than in non-migraine cases, supporting the validity of the measure.

Managing Migraine

Background: Background: Migraine, a debilitating neurological condition, significantly impacts quality of life. Despite various treatments, some cases remain refractory to conventional therapies. This study explores the efficacy of Botulinum Toxin Type A (BOTOX) injections compared to Conventional Oral Drugs (CODs) in treating refractory migraines, offering potential advancements in migraine management. Objectives: This single-center retrospective cohort study compared the efficacy and safety of Botulinum toxin (BOTOX) injection and Conventional Oral Drugs (COD) for treating the refractory migraine. Methods: Between May and August of 2023, 78 adults with refractory migraine were enrolled at tertiary care center in Islamabad. Their demographic data revealed the mean age of 46.5 years (SD=10.09), gender distribution of 28 males (35.90%) and 50 females (64.10%), and distribution of 27 employed (34.61%) and 51 unemployed (65.30%). Results: Average duration of refractory migraines was 9.72 years and average number of migraines per month was 22. The number of headache days per month decreased from 22 at baseline to 19 after two months and to 12 after three months (p=0.239) as the primary outcome measure (p&gt;0.05). The VAS scores decreased substantially from 7.6 to 5.5 (p=0.049), indicating decrease in headache severity (p&lt;0.05). Scores on Migraine-Specific Quality of Life (MSQ) increased from 43 to 73% (p&gt;0.05). The Migraine Disability Assessment (MIDAS) scores decreased from 66 to 48 (p=0.047) and Headache Impact Test (HIT-6) scores decreased from 69 to 40 (p=0.025), indicating an improvement in disability and quality of life (p&lt;0.05). Injection site pain (n=35), nausea (n=25), dizziness (n=15), fatigue (n=12), parched mouth (n=5), and muscle weakness (n=5) were reported as adverse effects. Conclusion: While BOTOX treatment significantly improved measures of headache severity, disability, and quality of life, patient tolerability and potential distress must be considered when selecting this treatment.

Background and Objectives: Migraine is a chronic neurological disorder affecting approximately 14% of the global population. Beyond physical pain, migraines significantly impact individuals’ quality of life, influencing education, employment, and income levels. Topiramate, a second-generation antiepileptic medication, has demonstrated notable efficacy in reducing the occurrence of chronic migraine. Over the past three decades, extensive research has implicated the neuropeptide calcitonin gene-related peptide (CGRP) in migraine pathogenesis. Erenumab, the first FDA-approved CGRP inhibitor, received approval in 2018. This study aims to compare the clinical efficacy of Erenumab and Topiramate for migraine prevention. Materials and Methods: We conducted a retrospective cohort study of adults with episodic or chronic migraine over a 12-month period, comparing Erenumab (n = 52) and Topiramate (n = 56). Outcomes assessed included changes in the Migraine Disability Assessment (MIDAS) scores from baseline over the last three months of treatment and the proportion of patients achieving a ≥50% reduction in MIDAS scores by the end of the study. Results: The Erenumab group showed significant improvement, with nearly 79% of patients achieving a 50% reduction in their MIDAS score, with a mean reduction of 3.76. Notably, only two patients (3.8.5) discontinued treatment due to adverse events. In contrast, the Topiramate group had over 15% of patients achieve a 50% reduction in MIDAS scores, with a mean reduction of 5.89, and a had discontinuation rate of 14.2% due to adverse events. Conclusions: Both Topiramate and Erenumab are effective for migraine prevention. However, Topiramate has lower tolerability and more side effects, while Erenumab offers better tolerability and safety at a higher cost. Treatment decisions should be individualized based on patient needs, efficacy, safety, and cost considerations.

Botulinum toxins for the prevention of migraine in adults.

To determine the extent to which variation in the Migraine Disability Assessment (MIDAS) score is associated with headache frequency, pain intensity, headache symptoms, gender, and employment status. The MIDAS questionnaire is a 7-item questionnaire (with 5 scored items) designed to measure headache-related disability, to improve physician-patient communication, and to identify patients with high treatment needs. Data from 3 population-based studies (total sample, n = 397) conducted in the United States and the United Kingdom were used to evaluate the relationship between headache features (attack frequency, pain intensity, pain quality, and associated symptoms) and MIDAS score. Data on headache features were collected by telephone using a standardized interview. The MIDAS questionnaire was completed shortly after the telephone interview. General linear models were used to determine the extent to which population variation in the MIDAS score was explained by headache features. Using linear regression, variables for all headache features (ie, headache frequency, pain intensity, pain quality, and associated symptoms) and demographic characteristics explained only 22% of the variation in MIDAS scores. Almost all (19.9%) the explained variance was accounted for by average pain intensity (12.0%), number of headache days (6.1%), and exacerbation of pain with movement (1.8%). When pain intensity and headache frequency were included in the model, no statistically significant differences in MIDAS scores were observed by gender or employment status. Although explaining only 2.1% of the variance, age was significantly associated with MIDAS scores, with those under 25 years demonstrating higher MIDAS scores than other age groups. No other variables (ie, frequency of occurrence of associated symptoms and other measures of quality of pain) were associated with MIDAS scores. Challenges to the utility of the MIDAS as a measure include whether headache-related disability is largely a function of other routine headache features and whether MIDAS is inherently biased based on work status and gender. While the MIDAS score was associated with headache frequency and average pain score, these two headache features explain only a modest proportion of the variation in MIDAS scores. Additionally, gender and work status were not related to MIDAS scores. These findings suggest that the MIDAS score captures information about disability that is not inherent to other headache features and is independent of gender and work status.

Objectives: Migraine affects more than 80 million people in Western Europe. The present study evaluated disability and health‐related quality of life (HRQoL) among patients with episodic migraine (EM) and chronic migraine (CM) who had failed multiple preventive treatments.Materials and Methods: This study was an analysis of cross‐sectional, web‐based survey data from adult patients with migraine (EM and CM) from the United Kingdom, France, and Spain who had self‐reported failure of two or more preventive treatments. Patient characteristics and patient‐reported HRQoL, migraine‐related disability, healthcare resource use (HCRU), and burden of migraine were evaluated by classification (CM and EM) and country (EM only).Results: In this sample of 316 patients (United Kingdom, n = 106; Spain, n = 105; France, n = 105), 76 (24.1%) patients had CM, the mean (standard deviation [SD]) age was 39.5 (12.3) years, and 164 (51.9%) patients were female. Those patients with CM reported greater migraine‐related disability based on Migraine Disability Assessment (MIDAS) scores versus those with EM (mean [SD]: 43.8 [44.7] vs. 23.2 [28.3]), as well as greater pain‐related impact on daily activities and higher HCRU. Among patients with EM, MIDAS scores indicated disability was severe in Spain (mean [SD]: 31.6 [31.1]) and France (24.3 [31.1]) and moderate in the United Kingdom (13.8 [17.9]), while HRQoL was similar across countries. Regarding the burden of EM, higher levels of pain and symptom‐related interference with many aspects of life, including occupational functioning, were reported in the United Kingdom and Spain versus France.Conclusions: Migraine is associated with substantial disability and decreased HRQoL among patients who have failed previous preventive therapies. Although migraine burden varied by country, the results suggest high unmet needs in all countries. Appropriate treatment could reduce migraine‐related burden and HCRU among patients with difficult‐to‐treat migraine.

The aim of the present study was to investigate the efficacy and tolerability of acupuncture (AC), Tanacetum (TAN) or combined treatment on quality of life in women with chronic migraine (CM). A total of 69 women volunteers were randomly divided into 3 groups: AC, acupuncture administered in 20 sessions over 10 weeks (n=22); TAN, at 150 mg/day (n=23); and AC+TAN (n=23). The primary outcome was Short-Form 36 (SF-36) quality of life assessment score. Secondary outcomes included the Migraine Disability Assessment (MIDAS) and visual analogue scale (VAS) score experienced after randomisation. AC+TAN was statistically significantly more effective than AC or TAN alone in overall health-related quality of life (SF-36; p<0.05), on MIDAS score (-35.1 (10.6) AC vs -24.8 (11.7) TAN vs -42.5 (9.8) AC+TAN; p<0.05) and in reducing the mean score of pain on VAS (-5.6 (2.4) AC vs -3.7 (2.1) TAN vs -6.4 (3.1) AC+TAN; p<0.05). The present work shows an improvement of the quality of life and better analgesic effect of acupuncture combined with TAN treatment on migraine pain in women when compared with acupuncture or TAN alone.

Fremanezumab impact on disability and MSQOL in patients with inadequate response to 2-4 classes of preventive medications who reverted from chronic to episodic migraine

Migraine is a type of primary headache with a high degree of associated disability that can present with a variety of indications and co-morbidities. The role of physical therapy treatment in migraine management is largely obscure. To investigate the combine effect of aerobic exercises and therapeutic pain neuroscience education on disability, pain pressure threshold, head posture and quality of life (QoL) in patients having migraine. Subjects were screened by using Migraine Disability Assessment (MIDAS) and after screening total sample of 50 subjects were randomly assigned into two groups: Group A (Experimental, n=25) and Group B (Control, n=25). Migraine disability assessment, pressure algometer, craniovertebral angle (CVA) and migraine specific quality of life were examined before and after 6 weeks of the intervention. Group A were given aerobic exercises and therapeutic pain neuroscience education along with conventional treatment for 45 min 3 days/week for 6 weeks, whereas participants in the Group B performed conventional exercises alone for 20 min 3 days/week for 6 weeks. Significant differences were observed in migraine disability score (P=0.003) and pain pressure threshold (P=0.039, P=0.030 and P=0.025) and improvement in forward head posture (P=0.001) between the groups after the intervention period, signifying greater improvement in the group A. QoL also improved in both the groups after intervention. Main findings of the present study suggest that the therapeutic pain neuroscience education and aerobic exercises combined with conventional treatment together maybe helpful to give better quality of life, reduced disability, increased pain pressure threshold and increased CVA to patients with migraine.

Recent studies evaluated short-term efficacy and safety of peripheral nerve stimulation (PNS) of the occipital nerves for managing chronic migraine. We present 52-week safety and efficacy results from an open-label extension of a randomized, sham-controlled trial. In this institutional review board-approved, randomized, multicenter, double-blinded study, patients were implanted with a neurostimulation system, randomized to an active or control group for 12 weeks, and received open-label treatment for an additional 40 weeks. Outcomes collected included number of headache days, pain intensity, migraine disability assessment (MIDAS), Zung Pain and Distress (PAD), direct patient reports of headache pain relief, quality of life, satisfaction and adverse events. Statistical tests assessed change from baseline to 52 weeks using paired t-tests. Intent-to-treat (ITT) analyses of all patients (N = 157) and analyses of only patients who met criteria for intractable chronic migraine (ICM; N = 125) were performed. Headache days were significantly reduced by 6.7 (±8.4) days in the ITT population (p < 0.001) and by 7.7 (±8.7) days in the ICM population (p < 0.001). The percentages of patients who achieved a 30% and 50% reduction in headache days and/or pain intensity were 59.5% and 47.8%, respectively. MIDAS and Zung PAD scores were significantly reduced for both populations. Excellent or good headache relief was reported by 65.4% of the ITT population and 67.9% of the ICM population. More than half the patients in both cohorts were satisfied with the headache relief provided by the device. A total of 183 device/procedure-related adverse events occurred during the study, of which 18 (8.6%) required hospitalization and 85 (40.7%) required surgical intervention; 70% of patients experienced an adverse event. Our results support the 12-month efficacy of PNS of the occipital nerves for headache pain and disability associated with chronic migraine. More emphasis on adverse event mitigation is needed in future research. Clinical trials.gov (NCT00615342).