The efficacy of magnesium oxide and sodium valproate in prevention of migraine headache: a randomized, controlled, double- blind, crossover study

DOI: https://doi.org/10.1007/s13760-019-01101-x

Abstract-Summary We evaluated the effectiveness of magnesium oxide in comparison with valproate sodium in preventing migraine headache attacks.

After patient randomization into two sequences, the intervention group received magnesium oxide 500 mg and the control group received valproate sodium 400 mg two tablets each day (every 12 h) for 8 weeks.

The primary efficacy variable was reduction in the number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration) per month in the final of 8 weeks in comparison with baseline.

In an intention-to-treat analysis, 31 patients were in group 1 (magnesium oxide–

valproate) and 32 patients were in group 2 (valproate–magnesium oxide).

The mean number of migraine attacks and days per month was 1.72 ± 1.18 and 2.09 ± 1.70, with a mean duration of 15.50 ± 21.80 h in magnesium group and 1.27 ± 1.27 and 2.22 ± 1.96, with a mean duration 13.38 ± 14.10 in valproate group.

This study has shown that 500 mg magnesium oxide appears to be effective in migraine prophylaxis similar to valproate sodium without significant adverse effect. Extended: This research will serve as a base for future studies with a greater

number of participants.

Introduction Results of the previous studies demonstrated a strong association between magne- sium deficiency and migraine attacks [312, 313].

Schoenen et  al. have reported serum and erythrocyte magnesium levels in

between attacks in patients with migraine [314].

4.3 Results

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A number of researchers have reported the effect of magnesium in prophylaxis

of migraine but these studies had different results [315–318].

Some studies have investigated the efficacy of oral magnesium as a prophylaxis of migraine with different doses and various salt forms of magnesium, and its effi- cacy has been compared with placebo and other drugs such as flunarizine, venlafax- ine, indomethacin and nimodipin [316–324].

A meta-analysis has reported that magnesium has beneficial effects in improve- ment of acute migraine attacks and decrease in the frequency and severity of migraine [325].

We evaluated the effectiveness of magnesium oxide in comparison with valpro-

ate sodium in preventing episodic migraine.

Methods This is a single-center, randomized, controlled, crossover trial which is double- blind, 24-week, 2-sequence, 2-period, 2-treatment.

The 4-week baseline period without prophylactic medication before randomiza- tion was used to determine whether patients had ≥2 attacks per month but not more than 15 days with migraine or non-migraine headaches.

After patient randomization into two sequences, the intervention group received magnesium oxide 500 mg and the control group received valproate sodium 400 mg two tablets each day (every 12 h) for 8 weeks.

During this period, the patients did not receive any medication other than analge-

sic in during headache.

The primary efficacy variable was reduction in the number of migraine attacks and number of days with moderate or severe headache and hours with headache (duration) per month in the final 8 weeks in comparison with baseline.

Result The primary outcome was the mean number of attacks and days per month and duration of headache in the final 8  weeks of the treatment period that they were significantly lower during treatment with valproate Na and magnesium oxide in comparison with before treatment (P < 0.05).

Before treatment, the number of migraine attacks was 5.17 ± 2.21 and 5.35 ± 2.01 in group 1 and group 2, respectively, but after treatment, migraine attacks sig- nificantly decreased in two groups and also in both periods (P < 0.001).

The severity of pain in according to VAS score was significantly lower during treatment with valproate Na and magnesium oxide in comparison to before treat- ment but no statistical difference was observed between magnesium and valproate groups (4.65 ± 2.41 and 4.83 ± 2.40, respectively, P > 0.05).

Discussion The results of this study indicate the significant decrease in the number of migraine attacks and days per month, headache duration and the intensity of migraine after treatment but no significant difference in magnesium oxide was found as compared with valproate sodium.

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4 Treatment

Migraine frequency and intensity were significantly lower in magnesium citrate group compared to placebo but there were no significant differences as compared to other prophylactic drugs [316, 318, 326].

Magnesium oxide in combination with riboflavin was used and showed no sig- nificant difference in reducing of number of migraine attacks but the severity of migraine was lower in comparison with placebo [319, 327].

This study demonstrated the efficacy of oral magnesium and valproate in reduc- ing the frequency and intensity of menstrual migraine compared to pretreatment; however, the observed difference between magnesium and valproate in this study was not statistically significant.

Conclusion This study has shown that 500  mg magnesium oxide appears to be effective in migraine prophylaxis similar to valproate sodium without significant adverse effect. This research will serve as a base for future studies with a greater number of

participants.

Acknowledgement A machine generated summary based on the work of Karimi, Narges; Razian, Azadeh; Heidari, Mohammad. 2019 in Acta Neurologica Belgica.

A combination of coenzyme Q10, feverfew and magnesium for migraine prophylaxis: a prospective observational study