Efficacy and safety of exogenous beta-hydroxybutyrate for preventive treatment in episodic migraine: A single-centred, randomised, placebo-controlled, double-blind crossover trial

Cephalalgia ◽  
2021 ◽  
pp. 033310242110437
Author(s):  
Niveditha Putananickal ◽  
Elena C Gross ◽  
Anna-Lena Orsini ◽  
Simone Schmidt ◽  
Patricia Hafner ◽  
...  
Keyword(s):  
Treatment Period ◽  
Ketogenic Diet ◽  
Crossover Trial ◽  
Substantial Reduction ◽  
Episodic Migraine ◽  
Prophylactic Effect ◽  
Double Blind ◽  
Migraine Frequency ◽  
Beta Hydroxybutyrate ◽  
Episodic Migraineurs

Background Several studies propose that brain energy deficit might be partially involved in the pathophysiology of migraine. Previously, studies demonstrated that ketogenic diet causes a substantial reduction in migraine frequency. Since the ketogenic diet is restricting and its adherence is difficult, we proposed to supplement ketone bodies exogenously to provide a prophylactic effect in migraineurs. Aim To evaluate the prophylactic effect of exogenous DL-beta-hydroxybutyrate supplementation in episodic migraineurs. Methods A double-blind, placebo-controlled, randomised crossover trial was conducted, involving 41 patients with episodic migraine. Patients were randomised 1:1 into placebo or beta-hydroxybutyrate group before entering the first treatment period. Each treatment period was 12 weeks long, followed by four weeks of washout phase and four weeks of run-in phase before entering into the corresponding second treatment period. The primary endpoint was the number of migraine days in the last four weeks of treatment, adjusted for baseline. Results We observed no clinically significant amelioration of migraine frequency or intensity under DL-beta-hydroxybutyrate treatment as compared to placebo regarding number of migraine days (mean difference [95% CI]: −1.1[−5.07, 2.85]), migraine intensity (0–10 VAS: 1.5[−0.8, 3.7]). Conclusion The selected dose of supplemented exogenous DL-beta-hydroxybutyrate did not demonstrate efficacy in episodic migraineurs. ClinicalTrials.gov Identifier: NCT03132233

Propranolol in the Treatment of Acute Migraine Attacks

Cephalalgia ◽  
1991 ◽  
Vol 11 (4) ◽  
pp. 193-196 ◽  
Author(s):  
Mala Banerjee ◽  
Leslie Findley
Keyword(s):  
Treatment Period ◽  
Crossover Trial ◽  
Double Blind ◽  
Beta Adrenoceptor ◽  
Adrenoceptor Antagonist ◽  
Maximum Period ◽  
Efficacy Assessment ◽  
The Mean ◽  
Acute Attacks ◽  
T Distribution

The efficacy of the beta-adrenoceptor antagonist propranolol in the acute treatment of patients in attacks of either classical (migraine with aura) or common migraine (migraine without aura) headache was assessed in a double-blind placebo-controlled crossover trial with fixed doses. The trial was carried out on 25 patients. The treatment period was set at eight weeks, with the provision of shortening or lengthening it if necessary with a maximum period of seventeen weeks. A minimum of three migraine attacks were treated during each treatment period. Patients were assessed according to: the mean duration and mean severity per treatment period of migraine attacks. The secondary efficacy assessment was made on the basis of the percentage of attacks requiring escape medication per treatment period. The study, based on the t-distribution statistical model with a confidence level of 95%, showed that propranolol had no significant effect in aborting acute attacks of migraine when compared with placebo.

Topiramate in the Preventive Treatment of Episodic Migraine: A Combined Analysis From Pilot, Double-Blind, Placebo-Controlled Trials

CNS Spectrums ◽  
2003 ◽  
Vol 8 (6) ◽  
pp. 428-432 ◽  
Author(s):  
Keith R. Edwards ◽  
Doreen L. Potter ◽  
Shu-Chen Wu ◽  
Marc Kamin ◽  
Joseph Hulihan
Keyword(s):  
Placebo Group ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Common Side Effect ◽  
Double Blind ◽  
Baseline Phase ◽  
Double Blind Placebo ◽  
Migraine Headaches ◽  
Migraine Frequency ◽  
Efficacy Measure

ABSTRACTThe safety and efficacy of medications for preventive treatment of migraine is the subject of current concern and investigation in health care. Two single-center, double-blind, placebo-controlled studies were conducted to evaluate the efficacy and safety of topiramate for migraine prophylaxis. Seventy patients with a diagnosis of migraine were randomly assigned to topiramate-treated and placebo groups. The studies consisted of a 4-week baseline phase, a 6—8 week titration, and 8–12 weeks of maintenance. Topiramate was titrated from an initial dose of 25 mg/day to a target dose of 100 mg BID. The primary efficacy measure, the mean 28-day migraine frequency, was lower in topiramate-treated patients than in the placebo group (3.2 versus 3.8, P=.001). Similarly, topiramate treatment resulted in a significantly greater mean reduction in migraine frequency than did placebo (1.55 versus 0.47, P=.001) and a significantly higher responder rate (35.3% versus 8.3%, P=.008). Paresthesia was the most common side effect reported with topiramate treatment. Other topiramate-associated adverse events included altered taste, memory impairment, diarrhea, and appetite suppression/weight loss. The rates of discontinuation were similar for the topiramate group (n=10) and the placebo group (n=8). These results suggest that topiramate is effective and well tolerated in the preventive treatment of migraine headaches.

scholarly journals A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?

Nutrients ◽  
2019 ◽  
Vol 11 (8) ◽  
pp. 1742 ◽  
Author(s):  
Cherubino Di Lorenzo ◽  
Alessandro Pinto ◽  
Roberta Ienca ◽  
Gianluca Coppola ◽  
Giulio Sirianni ◽  
...  
Keyword(s):  
Ketogenic Diet ◽  
Primary Outcome ◽  
Episodic Migraine ◽  
Responder Rate ◽  
Secondary Outcome ◽  
Very Low Calorie Diet ◽  
Double Blind ◽  
Low Calorie ◽  
Low Calorie Diet ◽  
Calorie Diet

Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort (n = 35) will be presented. Patients who dropped out (n = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced −3.73 (95% CI: −5.31, −2.15) migraine days respect to VLCnKD (p < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by −3.02 (95% CI: −4.15, −1.88) during VLCKD respect to VLCnKD (p < 0.00001). There were no differences in the change of acute anti-migraine drug consumption (p = 0.112) and BMI (p = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.

scholarly journals Low-Dose Naltrexone/Acetaminophen Combination in the Preventive Treatment of Migraine: Findings of a Small, Randomized, Double-Blind, and Placebo-Controlled Clinical Trial with an Open-Label Extension for None-Responders

2021 ◽  
Author(s):  
Annette Channa Toledano
Keyword(s):  
Treatment Period ◽  
Low Dose ◽  
Preventive Treatment ◽  
Episodic Migraine ◽  
Controlled Clinical Trial ◽  
Migraine Prevention ◽  
Open Label ◽  
Double Blind ◽  
The Mean ◽  
Low Dose Naltrexone

We tested low-dose naltrexone/acetaminophen combination for episodic migraine prevention. We randomly assigned patients to naltrexone/acetaminophen (n=6) or placebo (n=6) for a 12-week double-blind treatment. Non-responders continued into open-label treatment with naltrexone/acetaminophen (n=5) for additional 12 weeks. Patients were adults who experienced 5 to 17 (average 9.7) migraine days at baseline. The primary endpoint was the mean change in the monthly migraine days during the last 4 weeks of the double-blind treatment period. The key secondary endpoint was the mean change in the monthly migraine days from the 4–week double–blind follow–up (2nd baseline) to the last 4 weeks of the open–label treatment period. The magnitude of the treatment effect for naltrexone/acetaminophen observed in the double–blind period was 2.2 fewer monthly migraine days than placebo (p=0.43). Four out of 6 (66.7%) naltrexone/acetaminophen-treated patients experienced 75% reduction in migraine days compared to 1 out of 6 (16.7%) placebo-treated patients (p=0.09). In the open-label phase, treatment with naltrexone/acetaminophen (n=5) led to 8.2 fewer mean monthly migraine days (from 11.8 to 3.6), representing 69.5% improvement (p=0.03), and 100% of the patients experienced a 50% reduction in monthly migraine days. Adverse events were mild/moderate and transient, included dry mouth, fatigue, sedation, nausea, and feeling jittery. We postulate that naltrexone′s toll-like receptor (TLR4) antagonism properties prevent pro-inflammatory cytokines′ production in the trigeminal ganglion averting ″overactive nerves″ and migraine. Although this trial used low-dose naltrexone (defined as 1 – 5 mg/day), we postulate mid-dose naltrexone (MDN) (defined as 6 – 10 mg/day) may offer a greater migraine prevention control.

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