Use of melatonin versus valproic acid in prophylaxis of migraine patients: A double-blind randomized clinical trial.
Study Goal
The researchers aimed to compare the therapeutic effect of melatonin versus sodium valproate in the prophylaxis of chronic migraine.
Results Summary
Melatonin significantly reduced migraine attack frequency, duration, severity, and MIDAS scores, with efficacy comparable to sodium valproate but with fewer adverse events. The placebo group showed no significant improvements.
Population
Patients with chronic migraine receiving baseline therapy with nortriptyline and propranolol.
Effective Dosage
3 mg melatonin daily.
Duration
2 months.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
3 mg melatonin | decrease | mean of monthly attack frequency | patients with chronic migraine | baseline: 4.2, I: 3.1, II: 2.5 | significantly reduced | #1 |
200 mg sodium valproate | decrease | mean of monthly attack frequency | patients with chronic migraine | baseline: 4.3, I: 3.1, II: 2.3 | significantly reduced | #2 |
placebo | no change | mean of monthly attack frequency | patients with chronic migraine | baseline: 4.1, I: 3.8, II: 3.8 | not significantly reduced | #3 |
3 mg melatonin | decrease | attack duration (hr) | patients with chronic migraine | baseline: 19.8, I: 10.1, II: 8.7 | significantly reduced | #4 |
200 mg sodium valproate | decrease | attack duration (hr) | patients with chronic migraine | baseline: 19.5, I: 10.2, II: 8.8 | significantly reduced | #5 |
placebo | no change | attack duration (hr) | patients with chronic migraine | baseline: 19.6, I: 15.4, II: 14.1 | not significantly reduced | #6 |
3 mg melatonin | decrease | attack severity | patients with chronic migraine | baseline: 7.3, I: 5.4, II: 3.5 | significantly reduced | #7 |
200 mg sodium valproate | decrease | attack severity | patients with chronic migraine | baseline: 7.4, I: 5.3, II: 3.4 | significantly reduced | #8 |
placebo | no change | attack severity | patients with chronic migraine | baseline: 7.3, I: 6.4, II: 6 | not significantly reduced | #9 |
3 mg melatonin | decrease | MIDAS score | patients with chronic migraine | baseline: 15.2, II: 8.9 | significantly reduced | #10 |
200 mg sodium valproate | decrease | MIDAS score | patients with chronic migraine | baseline: 16.1, II: 8.3 | significantly reduced | #11 |
placebo | no change | MIDAS score | patients with chronic migraine | baseline: 16, II: 12.1 | not significantly reduced | #12 |
3 mg melatonin | increase | adverse events | patients with chronic migraine | 2 (5.71%) | had adverse events | #13 |
200 mg sodium valproate | increase | adverse events | patients with chronic migraine | 8 (22.85%) | had adverse events | #14 |
placebo | increase | adverse events | patients with chronic migraine | 1 (2.85%) | had adverse events | #15 |
adjuvant treatment with melatonin | increase | clinical efficacy | patients with chronic migraine | - | was found to be superior to the placebo | #16 |
adjuvant treatment with melatonin | no change | clinical efficacy | patients with chronic migraine | - | had the same clinical efficacy as sodium valproate | #17 |
adjuvant treatment with melatonin | increase | tolerability | patients with chronic migraine | - | had higher tolerability | #18 |
BACKGROUND: Melatonin is known to be effective in curing migraine. OBJECTIVE: This study aimed to investigate the therapeutic effect of melatonin versus sodium valproate in the prophylaxis of chronic migraine. METHODS: This randomized, double-blind, placebo-controlled clinical trial included patients with chronic migraine who were divided into three equal sized groups, and baseline therapy with nortriptyline (10-25 mg) and propranolol (20-40 mg) was used. Patients in groups A, B, and C were adjunctively treated daily with 3 mg melatonin, 200 mg sodium valproate, and a placebo, respectively. The patients underwent treatment for 2 months and follow-up was done at baseline (baseline), first (I) and second month (II). Attack frequency (AF), attack duration, attack severity, Migraine Disability Assessment (MIDAS) score (within 3 months in two steps), analgesic intake, and drug side effects between the groups and during follow-up were compared. RESULTS: The mean of monthly AF (melatonin: baseline: 4.2, I: 3.1, II: 2.5, p = 0.018; valproate: baseline: 4.3, I: 3.1, II: 2.3, p = 0.001; placebo: baseline: 4.1, I: 3.8, II: 3.8 p = 0.211), attack duration (hr) (melatonin: baseline: 19.8, I: 10.1, II: 8.7, p < 0.001; valproate: baseline: 19.5, I: 10.2, II: 8.8, p < 0.001; placebo: baseline: 19.6, I: 15.4, II: 14.1, p = 0.271), attack severity (melatonin: baseline: 7.3, I: 5.4, II: 3.5, p < 0.001; valproate: baseline: 7.4, I: 5.3, II: 3.4, p = 0.000; placebo: baseline: 7.3, I: 6.4, II: 6, p = 0.321), and MIDAS score (melatonin: baseline: 15.2, II: 8.9, p = 0.005; valproate: baseline: 16.1, II: 8.3, p = 0.001; placebo: baseline: 16, II: 12.1, p = 0.44), were significantly reduced in the melatonin and sodium valproate groups, but not in the placebo groups. Adverse events were reported in 11 patients (10.47%): 2 (5.71%) during melatonin treatment, 8 (22.85%) during valproate, and 1 (2.85%) during placebo. CONCLUSION: The adjuvant treatment with melatonin was found to be superior to the placebo and had the same clinical efficacy as sodium valproate, but with higher tolerability. Melatonin may prove to be an efficient substitute for sodium valproate, as a chronic migraine prophylaxis.