Acupuncture versus topiramate in chronic migraine prophylaxis: A randomized clinical trial

Cephalalgia ◽  
2011 ◽  
Vol 31 (15) ◽  
pp. 1510-1521 ◽  
Author(s):  
C-P Yang ◽  
M-H Chang ◽  
P-E Liu ◽  
T-C Li ◽  
C-L Hsieh ◽  
...  

Background: The aim of this study was to investigate the efficacy and tolerability of acupuncture compared with topiramate treatment in chronic migraine (CM) prophylaxis. Methods: A total of 66 consecutive and prospective CM patients were randomly divided into two treatment arms: 1) acupuncture group: acupuncture administered in 24 sessions over 12 weeks (n = 33); and 2) topiramate group: a 4-week titration, initiated at 25 mg/day and increased by 25 mg/day weekly to a maximum of 100 mg/day followed by an 8-week maintenance period (n = 33). Results: A significantly larger decrease in the mean monthly number of moderate/severe headache days (primary end point) from 20.2 ± 1.5 days to 9.8 ± 2.8 days was observed in the acupuncture group compared with 19.8 ± 1.7 days to 12.0 ± 4.1 days in the topiramate group (p < .01) Significant differences favoring acupuncture were also observed for all secondary efficacy variables. These significant differences still existed when we focused on those patients who were overusing acute medication. Adverse events occurred in 6% of acupuncture group and 66% of topiramate group. Conclusion: We suggest that acupuncture could be considered a treatment option for CM patients willing to undergo this prophylactic treatment, even for those patients with medication overuse.

Toxins ◽  
2019 ◽  
Vol 11 (9) ◽  
pp. 504 ◽  
Author(s):  
Gandolfi ◽  
Donisi ◽  
Marchioretto ◽  
Battista ◽  
Smania ◽  
...  

Chronic Migraine (CM) is a disabling neurologic condition with a severe impact on functioning and quality of life. Successful therapeutic management of patients with CM is complex, and differences in therapeutic response could be attributable to genetically determined factors, sensitivity to pharmacological treatment, psychosocial and relational factors affecting the patient’s compliance and approach on the therapeutic treatment. The aim of this prospective observational study was to explore self-efficacy, coping strategies, psychological distress and headache-related disability in a cohort of 40 patients with CM (mean age: 46.73; standard deviation 13.75) treated with OnabotulinumtoxinA and the relationship between these clinical and psychological aspects and acute medication consumption during OnabotulinumtoxinA prophylactic treatment. Patients presented an overall significant reduction in the Headache Index (HI) (p < 0.001), HI with severe intensity (p = 0.009), and total analgesic consumption (p = 0.003) after the prophylactic treatment. These results are in line with the literature. Despite this, higher nonsteroidal anti-inflammatory drugs consumption was associated with higher psychological distress, higher HI with severe and moderate intensity, and worse quality of life. Conversely, triptans consumption was correlated with HI of mild intensity, and problem-focused coping strategies. To conclude, the psychological profile, and in particular, the psychological distress and specific coping strategies might influence the self-management of acute medication.


2014 ◽  
Vol 32 (1) ◽  
pp. 12-16 ◽  
Author(s):  
Mohsen Foroughipour ◽  
Amir Reza Golchian ◽  
Mohsen Kalhor ◽  
Saeed Akhlaghi ◽  
Mohammad Taghi Farzadfard ◽  
...  

Background Migraine is one of the most common types of headache, with significant socioeconomic effects. Prophylactic drugs are used to prevent migraine headaches but are unpromising. Objective To assess the effects of adding acupuncture to conventional migraine prophylaxis. Methods One hundred patients with migraine (41 male, 59 female), in whom prophylactic drugs had not produced a fall of at least 50% in the number of attacks, entered the study. The patients were randomised into two groups, sham and true acupuncture. The patients in both groups continued their prophylactic treatment and received 12 sessions of either true or sham acupuncture. Each session was 30 min and was repeated three times a week. The number of headaches in the two groups was compared at baseline, and at the end of four successive months. Results There was no significant difference in the frequency of attacks between the two groups before intervention. After 1 month, the frequency of attacks each month decreased from 5.1 (0.8) to 3.4 (1.2) in the true acupuncture group, and from 5.0 (0.8) to 4.4 (1.1) in the sham acupuncture group (a significant difference, p<0.001). The frequency continued to decrease in month 2 but increased in months 3 and 4; however, it was still significantly lower than baseline, and the difference remained significant after month 4. Conclusions Acupuncture is applicable as an adjunct to prophylactic drugs in migraineurs in whom the number of attacks does not fall with prophylactic medication.


2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Edoardo Caronna ◽  
Victor José Gallardo ◽  
Alicia Alpuente ◽  
Marta Torres-Ferrus ◽  
Patricia Pozo-Rosich

Abstract Background In daily practice, anti-CGRP monoclonal antibodies (MAbs) may be useful in chronic migraine (CM) with medication overuse (MO), but data is limited. We evaluated their effectiveness in a real-life clinical cohort. Methods This is a prospective study conducted in CM patients with and without medication overuse treated with monthly MAbs during 6 months (erenumab/galcanezumab). We collected headache characteristics, including acute medication intake, through an electronic diary. We compared patients (1) with and without MO at baseline, (2) with and without ongoing MO after treatment, defining MO resolution as < 10 or 15 days/month of acute medication intake, according to analgesic type, during the 6-month treatment. Results Of 139 CM patients completing 6-month treatment with anti-CGRP MAbs, 71.2% (99/139) had MO at baseline. After 6 months, patients with and without MO at baseline had significant and similar proportions of ≥50% reduction in migraine days/month (MO: 63.6% vs. non-MO: 57.5%, p = 0.500). 60.6% (60/99) no longer satisfied MO definition. Reduction in headache frequency compared to baseline occurred in both MO-ongoing and MO-resolution group, although those who stopped overusing had a greater improvement (headache days/month: − 13.4 ± 7.6 vs. -7.8 ± 7.2, p < 0.0001). No differences in MO resolution were observed according to the MAbs used. Baseline lower pain severity was associated with MO resolution (OR [95%]:0.236[0.054–0.975]; p = 0.049). Conclusions In real-life anti-CGRP MAbs are as effective in CM patients with MO as in patients without it and facilitate MO cessation. Reduction in headache frequency and acute medication days/month occurs regardless of whether patients stop overusing or not.


Author(s):  
Varsha Gajbhiye ◽  
Lamture Yashwant R ◽  
Sadama Quazi

Migraine is a common disorder of the paediatric age group. Propranolol has been used in prophylaxis for migraine.  The use of Sodium valproate in the prophylaxis of migraine is not known. It is postulated that it increases the level of GABA in the brain that will decrease events related to migraine in the cortex. All parents of the patient were advised to keep diaries for noting time, date, severity and duration of headache during the study period, which was for a period of 6 wks. The decreased frequency of headache more than in Group A was 68% and propranolol group was 68.89%. In group A(sodium valproate), patients showed a reduction in headache duration and 52% in Group B. 20% of them headache free in Group A and 18% in Group B. Decrease in the severity of headache in Group A was 52% while 50% in Group B. The mean headache frequency before and after treatment was reduced from 8 to 2.5 attacks per month in group A and from 8.2 to 2.6 in group B. The t-value is 11 for group A. Sodium valproate is more effective and safer in migraine prophylaxis as compared with propranolol.


2015 ◽  
Vol 31 (2) ◽  
pp. 70-75
Author(s):  
Muhammad Abdul Momen Khan ◽  
Mohammad Bahadur Ali Miah ◽  
Md Shahidullah ◽  
Md Rafiqul Islam ◽  
Subash Kanti Day ◽  
...  

Background: Anticonvulsants are now commonly used for migraine prophylaxis, among them topiramate, one of the newer anticonvulsants, recently has been demonstrated to be effective as mono-therapy for migraine prophylaxis. Objectives: To observe the efficacy and safety of low dose topiramate in migraine prophylaxis. Methods: This prospective trial was carried out in the Out Patient Department (OPD) & Headache Clinic, Department of Neurology, Bangabandhu Sheikh Mujib Medical University, Dhaka. Total 60 patients around the age range of 18 to 50 years diagnosed as migraine (with aura or without aura) according to ICHD-3 criteria, were recruited as the study population. Total 60 patients were administered by Tab.Topiramate 50 mg/ day. Out of them, total 47 patients had completed the study due to drop out of 13 patients. During trial, three follow up visits were taken, 1st follow up after 4 weeks of baseline information (Before starting prophylactic medication), 2nd follow up after 4 weeks of treatment, 3rd follow up after 8 weeks of treatment. Efficacy of treatment was measured by headache frequency, duration and severity as measured by the VAS. Effectiveness was assessed by comparing baseline & on-treatment migraine status. Results: The mean (SD) age of patients were found 29.72 (9.58) years. Female sex was predominant. The mean (SD) value of frequency of migraine at baseline level with 1st and 2nd follow up were statistically significant [Baseline 9.28 (2.39) vs. 1st FU 7.55 (3.07), p=0.001; Baseline 9.28 (2.39) vs. 2nd FU 4.72 (2.80), p<0.001]. Duration of each episode of migraine ,comparing the mean (SD) value of duration of migraine of baseline level with 1st and 2nd follow up were statistically significant [Baseline 10.85 (5.26) vs. 1st FU 8.06 (4.11) hr, p<0.001; Baseline 10.85 (5.26) vs. 2nd FU 5.53 (2.98) hr, p<0.001]. According to severity of migraine based on VAS in base line period all patients had experienced moderate & severe headache but in 1st follow up, few patients had experienced mild headache from moderate headache, few patients had experienced moderate headache from severe headache & in 2nd follow up, patients had better condition and had experienced mild and moderate headache, no patient had experienced severe headache. In this study, 23.4% patients developed adverse effects. Among the adverse effects, 8.5% develop dizziness, 6.3% drowsiness, 4.2% anorexia & blurring of vision. Conclusion: The present study suggest that low dose topiramate are effective for migraine prophylaxis in reduction of frequency, severity and duration of migraine headache . Bangladesh Journal of Neuroscience 2015; Vol. 31 (2): 70-75


2008 ◽  
Vol 66 (3a) ◽  
pp. 485-487 ◽  
Author(s):  
Renan Barros Domingues ◽  
Esther Angélica Coelho Costa ◽  
Ariovaldo da Silva Jr ◽  
Simone Aires Domingues ◽  
Juliana Cardoso Leal ◽  
...  

This study has evaluated depression in patients with episodic migraine (n=98), chronic migraine without medication overuse (n=23), and chronic migraine with medication overuse (n=57). The Beck Depression Inventory (BDI) was used to evaluate depressive symptoms in these three groups. The mean BDI score obtained in all patients was higher than that observed in asymptomatic subjects (episodic migraine=16.09±11.79, chronic migraine with medication overuse=18.91±12.53, chronic migraine without medication overuse=19.83±14.79). This finding corroborates previous studies suggesting a co-morbid association between migraine and depression. Depression did not seem to be crucial in the transformation of migraine as the median BDI scores did not differ significantly between patients with episodic and chronic migraine. The median BDI scores of the patients with chronic migraine with medication overuse and that patients with chronic migraine without medication overuse were similar as well. Therefore, medication overuse behavior may not be related with depression.


Cephalalgia ◽  
2007 ◽  
Vol 27 (7) ◽  
pp. 814-823 ◽  
Author(s):  
H-C Diener ◽  
G Bussone ◽  
JC Van Oene ◽  
M Lahaye ◽  
S Schwalen ◽  
...  

The aim of this study was to evaluate the efficacy and tolerability of topiramate for the prevention of chronic migraine in a randomized, double-blind, placebo-controlled trial. Chronic migraine is a common form of disabling headache presenting in headache subspecialty practice. Preventive treatments are essential for chronic migraine management, although there are few or no controlled empirical trial data on their use in this patient population. Topiramate is approved for the prophylaxis of migraine headache in adults. Patients (18–65 years) who experienced chronic migraine (defined as ≥15 monthly migraine days) for ≥3 months prior to trial entry and had ≥12 migraine days during the 4–week (28–day) baseline phase were randomized to topiramate or placebo for a 16–week, double-blind trial. Topiramate was titrated (25 mg weekly) to a target dose of 100 mg/day, allowing dosing flexibility from 50 to 200 mg/day, according to patient need. Existing migraine preventive treatments, except for antiepi-leptic drugs, were continued throughout the trial. The primary efficacy measure was the change in number of migraine days from the 28–day baseline phase to the last 28 days of the double-blind phase in the intent-to-treat population, which consisted of all patients who received at least one dose of study medication and had one outcome assessment during the double-blind phase. Health-related quality of life was evaluated with the Migraine Specific Quality of Life Questionnaire (MSQ, Version 2.1), the Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires, and tolerability was assessed by adverse event (AE) reports and early trial discontinuations. Eighty-two patients were screened. Thirty-two patients in the intent-to-treat population (mean age 46 years; 75% female) received topiramate (mean modal dose ± SD = 100 ± 17 mg/day) and 27 patients received placebo. Mean (±SD) baseline number of migraine days per 4 weeks was 15.5 ± 4.6 in the topiramate group and 16.4 ± 4.4 in the placebo group. Most patients (78%) met the definition for acute medication overuse at baseline. The mean duration of treatment was 100 and 92 days for topiramate- and placebo-treated patients, respectively. Study completion rates for topiramate- and placebo-treated patients were 75% and 52%, respectively. Topiramate significantly reduced the mean number of monthly migraine days (±SD) by 3.5 ± 6.3, compared with placebo (-0.2 ± 4.7, P < 0.05). No significant intergroup differences were found for MSQ and HIT-6. MIDAS showed improvement with the topiramate treatment group (P = 0.042 vs. placebo). Treatment emergent adverse events were reported by 75% of topiramate-treated patients (37%, placebo). The most common AEs, paraesthesia, nausea, dizziness, dyspepsia, fatigue, anorexia and disturbance in attention, were reported by 53%, 9%, 6%, 6%, 6%, 6% and 6% of topiramate-treated patients, respectively, vs. 7%, 0%, 0%, 0%, 0%, 4% and 4% of placebo-treated patients. This randomized, double-blind, placebo-controlled trial demonstrates that topiramate is effective and reasonably well tolerated when used for the preventive treatment of chronic migraine, even in the presence of medication overuse.


2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Stephen D. Silberstein ◽  
Joshua M. Cohen ◽  
Michael J. Seminerio ◽  
Ronghua Yang ◽  
Sait Ashina ◽  
...  

Abstract Background We evaluated the efficacy of fremanezumab, a fully humanized monoclonal antibody that selectively targets calcitonin gene-related peptide, in patients with chronic migraine (CM) with and without medication overuse (MO). Methods In a 12-week, phase 3 trial, patients with CM were randomized to fremanezumab quarterly (675 mg/placebo/placebo), monthly (675 mg/225 mg/225 mg), or placebo. Post hoc analyses assessed the impact of fremanezumab in patients with and without MO (monthly use of acute headache medication ≥15 days, migraine-specific acute medication ≥10 days, or combination medication ≥10 days) on efficacy outcomes, including headache days of at least moderate severity (HDs), and six-item Headache Impact Test (HIT-6) and Migraine-Specific Quality of Life (MSQoL) questionnaire scores. Results Of 1130 patients enrolled, 587 (51.9%) had baseline MO. Fremanezumab reduced placebo-adjusted least-squares mean (95% confidence interval) monthly HDs (− 2.2 [− 3.1 to − 1.2] and − 2.7 [− 3.7 to − 1.8]; P < 0.0001) in patients with MO and without MO (quarterly − 1.4 [− 2.3 to − 0.5], P = 0.0026; monthly − 1.4 [− 2.3 to − 0.6], P = 0.0017). Significantly more fremanezumab-treated patients had ≥ 50% reduction in HDs versus placebo, regardless of baseline MO (with: quarterly 70/201 [34.8%], monthly 78/198 [39.4%] vs placebo 26/188 [13.8%]; without: quarterly 71/174 [40.8%], monthly 75/177 [42.4%] vs placebo 41/183 [22.4%]). Fremanezumab improved HIT-6 and MSQoL scores. Significantly more fremanezumab-treated patients reverted to no MO (quarterly 111/201 [55.2%], monthly 120/198 [60.6%]) versus placebo (87/188 [46.3%]). Conclusions Fremanezumab is effective for prevention of migraine in patients with CM, regardless of MO, and demonstrated a benefit over placebo in reducing MO. Trial registration ClinicalTrials.gov NCT02621931 (HALO CM), registered December 12, 2012.


Author(s):  
P. Storch ◽  
P. Burow ◽  
B. Möller ◽  
T. Kraya ◽  
S. Heintz ◽  
...  

AbstractErenumab is a monoclonal antibody, targeted against the calcitonin gene-related peptide (CGRP) receptor. Clinical studies have demonstrated prophylactic efficacy in both episodic (EM) and chronic migraine (CM). The aim of the present study is to evaluate the efficacy of treatment in tertiary headache centers under real-life conditions. In a retrospective analysis, the period of 3 months before and after initiation of erenumab therapy was compared. Relevant parameters (headache days, headache intensity, headache duration, acute medication, previous prophylaxis treatments) were collected from medical charts of all migraine patients (N = 82) who started treatment with erenumab between November 1st 2018 and May 1st 2019 at two tertiary headache centers in Germany. The sample included 68 female (82.9%) and 14 male patients aged between 22 and 78 years (mean 51.1 years, SD 10.5 years). Of these patients, 57.3% met the criteria for CM and 56.9% overused acute medication. Under therapy with erenumab, a significant reduction of headache days was observed from the first month on. The effect was most pronounced in the third month with a decrease in monthly headache days from 16.6 to 11.6 days (p < 0.001). There was also a significant reduction in reported headache intensity (p = 0.004) and average duration of headache attacks (p = 0.016). The 50% responder rate in patients with CM was lower in the first month compared to EM but then increased similarly to EM. Patients with medication overuse (MO) also responded to the therapy. There was a reduction in medication overuse from 57% at baseline to 29% after therapy (p = 0.011). Overall, a positive result of treatment with erenumab can be shown in a highly selected sample with severely affected migraine patients and a refractory course prior to treatment. This re-confirms the clinical trial data also for this highly selected group.


Cephalalgia ◽  
2020 ◽  
pp. 033310242096665
Author(s):  
David W Dodick ◽  
Erin G Doty ◽  
Sheena K Aurora ◽  
Dustin D Ruff ◽  
Virginia L Stauffer ◽  
...  

Introduction Acute medication overuse is prevalent in patients with migraine. Methods In three phase 3, double-blind, randomized, placebo-controlled studies, patients with episodic migraine (EVOLVE-1 and EVOLVE-2) or chronic migraine (REGAIN) were randomized 2:1:1 to monthly subcutaneous injections of placebo or galcanezumab 120 or 240 mg for 3 or 6 months. This subgroup analysis evaluated mean changes in the number of monthly migraine headache days in each treatment among patients with versus without baseline acute medication overuse via mixing modelling with repeated measures. Results The percentages of patients with baseline medication overuse in placebo, galcanezumab 120-mg and 240-mg groups, respectively, were 19.4%, 17.3%, and 19.3% for EVOLVE-1/-2 (pooled; post hoc), and 63.4%, 64.3%, and 64.1% for REGAIN ( a priori). Both galcanezumab doses demonstrated significant improvement compared with placebo for overall least squares mean change in monthly migraine headache days in patients with baseline medication overuse in both the episodic and chronic migraine studies ( p ≤ 0.001). Furthermore, both galcanezumab doses reduced average monthly medication overuse rates compared to placebo ( p < 0.001) in both patient populations with medication overuse at baseline. Conclusions Galcanezumab appears to be effective for the preventive treatment of episodic and chronic migraine in patients who overuse acute medications. Trial registration: ClinicalTrials.gov Identifiers: NCT02614183, NCT02614196, and NCT02614261


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