Sodium valproate versus dexamethasone for acute migraine headache: a double blind randomized clinical trial

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Sodium valproate versus dexamethasone for acute migraine headache: a double blind randomized clinical trial
Key Take-Away: 
  • In overall, intravenous sodium valproate is not superior to intravenous dexamethasone in treatment of acute migraine attacks.
  • However, in patients with aura, only sodium valproate but not dexamethasone is effective in headache relief.

Migraine stands as one of the most frequent causes of visits to an emergency department. In spite of several parenteral medications available, none of them provides a rapid and complete relief without accompanying adverse effects.

ABSTRACT: 
Background: 

Migraine stands as one of the most frequent causes of visits to an emergency department. In spite of several parenteral medications available, none of them provides a rapid and complete relief without accompanying adverse effects. Many case series and a few randomized controlled trials have been conducted to evaluate the safety and efficacy of intravenous sodium valproate along with published reported of dexamethasone in acute migraine attacks. However, there is a lack of clinical evidence on their comparative efficacy and safety

 

Rationale behind research

  • Despite the impact of sodium valproate and dexamethasone on migraine headache, the efficacy of the two drugs has not been properly investigated and compared
  • Therefore,  study was conducted to assess and compare the benefits and harms of intravenous (IV) sodium valproate and dexamethasone on acute migraine headache in patients who referred to emergency departments
  • Objective

To evaluate and compare the benefits and risks of intravenous (IV) sodium valproate (treatment) and dexamethasone (standard) on acute migraine headache in patients who were referred to emergency departments

Methods: 

 

Study outcomes

  • Primary outcome: Severity of headache measured using the visual analog scale (VAS) of 0 to 10 in AMH patients with aura and without aura. Zero denoted no pain, and 10 denoted the most severe pain that the patient had ever experienced
  • Secondary outcomes: Episodes of any side effects such as nausea, sedation, and face paresthesia
  • Time-points
    • Efficacy: Baseline, 0.5 and 2 hours
    • Side effects: Baseline and 2 hours
Results: 

 

 

Baseline: The two treatment groups were well balanced at baseline with no statistically significant difference in the severity of headache

  • Primary outcome
    • Patients without aura: Both drugs were highly effective in improvement of acute headache with the effects of both drugs being statistically significant at post baseline measurements (P=0.001). Sodium valproate/dexamethasone VAS scores:
      • Baseline:8.20 (7.72, 8.68) / 8.46 (8.05, 8.86)
      • At 0.5 hours: 5.31 (4.74, 5.89) / 5.46 (4.81, 6.11)
      • At 2 hours: 3.66 (2.99, 4.33) / 3.59 (2.84, 4.35)

                

 

Figure 1: VAS Mean Pain Score of Migraine Patients without Aura

  • Patients with aura: Patients responded well to sodium valproate but not to dexamethasone. Sodium valproate/dexamethasone VAS scores:
    • Baseline: 8.50 (7.40, 9.60) / 8.80 (7.76, 9.84)
    • At 0.5 hours: 4.67 (2.40, 6.93) / 7.20 (4.98, 9.42)
    • At 2 hours: 3.50 (1.78, 5.22) / 6.20 (2.43, 9.97)

 

 

Figure 2: VAS Mean Pain Score of Migraine Patients with Aura

  • Secondary outcome: No serious adverse effects were noted in the two groups with only minor adverse effects including nausea, sedation, and face paresthesia being reported by few patients
Conclusion: 

The result indicates that the effects of the two drugs were nearly the same in patients without aura. However, for pain relief in patients with aura, sodium valproate was more effective than dexamethasone.

The results of this trial are consistent with the results from another randomized clinical trial (Foroughipour et al) that showed no significant difference between the therapeutic effect of IV sodium valproate and dexamethasone on migraine headache. More evidence based on large randomized clinical trials is needed to assess the comparative effectiveness of the two drugs in patients with acute migraine headache with aura.

PLoS One 2015 Mar; 10(3):e0120229
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