Table 4 Results

Gelfand et al. (2020)

Melatonin

 Group 1: Low dose 1-2 mg (n = 42)

 Group 2: High dose 4-8 mg (n = 42)

Independent T-test, Fisher exact

•Change in pain intensity in cm, mean (SD)

•Pain-free rate, n (%)

•Pain-relief rate n(%)

•Adverse events

 Napped

 Nausea

Group 1: 5.1(1.8)

Group 2: 5.6(1.8)

NA

NA

NA

NA

•Group 1: 2.3 (2.1)

Group 2: 2.7 (2.1)

•Group 1: 4/15 (27)

Group 2: 7/17 (41)

•Group 1: 12/15 (80)

Group 2: 16/17 (94)

•Group 1: 9/19 (47)

Group 2: 4/21(67)

•Group 1: 1

Group 2: 0

NA

NA

NA

NA

NA

0.581

0.415

0.482

0.209

NA

•There is no difference in outcomes between Group 1 and Group 2

Gelfand et al. (2017)

Group 1: melatonin 3 mg (n = 13)

Group 2: placebo (n = 13)

Mann–Whitney, χ², and Fisher exact

Mean migraine days

NA

3.6 (0.9)

4.9 (1.7)

 > 0.05

•There is no difference in mean migraine days between Group 1 and Group 2

Alstadhaug et al. (2010)

Group 1: melatonin 2 mg (n = 46)

Group 2: placebo (n = 48)

Paired t-test

Migraine attack frequency

Mean PSQI

PSQI at baseline > 6 (n = 16)

Adverse events

4.2 ± 1.2

6.3 ± 3.8

10.5 ± 2.8

NA

2.8 ± 1.6

4.7 ± 3.2

6.8 ± 4.0

Fatigue and dizziness = 2

Nervousness and nightmares = 1

2.9 ± 1.4

5.6 ± 4.1

9.4 ± 4.0

Eczema = 1

Night sweat 1

Abnormally high dream activity = 1

Dry mouth and irritability = 1

0.75

0.09

 < 0.05

NA

•Poorer sleep quality based on PSQI with baseline > 6 was found higher in Group 2 than Group 1

•There is no difference in frequency of migraine attacks and mean PSQI between Group 1 and Group 2

Ebrahimi-monfared et al. (2017)

Group 1: melatonin 3 mg (n = 35)

Group 2: valproate 200 mg (n = 35)

Group 3: placebo (n = 35)

Post hoc test

•Attack frequency

•Attack duration

•Attack severity

•Number of analgesics

•MIDAS score

•Adverse events

4.2 ± 1.2

19.7 ± 18.5

7.4 ± 1.4

7.33 ± 3.2

15.8 ± 5.1

NA

2.5 ± 1.3

8.7 ± 12.4

3.5 ± 2.6

2.1 ± 2

8.9 ± 2.2

Fatigue = 2

Drowsiness = 1

3.8 ± 1.1

14.1 ± 8.1

6.0 ± 3.2

4.1 ± 1.1

12.1 ± 4.2

Dry mouth = 1

 < 0.05

 < 0.05

 < 0.05

 < 0.05

 < 0.05

NA

•There is no difference in outcomes between Group 1 and Group 2

•Group 1 is superior in decrease of frequency, duration, severity, number of analgesics usage, and MIDAS score than Group 3

Gonçalves et al. (2016)

Group 1: melatonin 3 mg (n = 60)

Group 2: amitriptyline 25 mg (n = 25)

Group 3: placebo (n = 59)

ANOVA

•Number of headache days

•Intensity

•Duration

•Number of analgesics

•Improvement > 50% in headache frequency

•Adverse event

 Sleepiness

 Pruritus

 Dizziness

 Epigastralgia

 Weight gain

 Constipation

7.3 ± 2.8

6.9 ± 1.8

17.8 ± 14.5

4.4 ± 1.6

NA

NA

NA

NA

NA

NA

NA

4.6 ± 2.3

3.6 ± 3.5

10.9 ± 9.5

2.9 ± 1.7

54.4%

11/60

1/60

0/60

2/60

0/60

1/60

6.2 ± 2.5

4.8 ± 3.3

16.2 ± 15.3

3.6 ± 1.2

20.4%

7/59

0/59

1/59

0/59

1/59

4/59

 < 0.05

 < 0.05

 < 0.05

 < 0.05

 < 0.05

NA

NA

NA

NA

NA

NA

•There is no difference in outcomes between Group 1 and Group 2

•Group 1 is superior in decrease of number of headache (days),intensity, duration, number of analgesics usage than Group 3