Objective:

2

To investigate the effect and safety of phytosomal curcumin supplementation on patients with migraine.

Methods:

2

In this randomized

double-blind and placebo-controlled trial

70 patients suffered from migraine without aura were randomized into 2 groups to receive 250 mg/d of phytosomal curcumin (intervention group) or maltodextrin (placebo group) for 8 weeks

35 cases per group. All patients in both groups received their standard treatment and common medications. The severity

duration

frequency of headaches

quality of life (QoL)

mental status

headache impact

and sleep quality of patients were assessed before and after treatment. Adverse effects were also assessed.

Results:

2

Sixty-five patients completed the trial (33 in the intervention group and 32 in the placebo group). Phytosomal curcumin supplementation significantly reduced severity

duration and frequency of migraine attacks

stress score

and headache impact

and improved QoL and sleep quality of patients in the intervention group

compared with the placebo group (

P

<

0.05 or

P

<

0.01). However

it had no significant effect on depression and anxiety scores in the intervention group

compared with the placebo group (

P

>

0.05). No adverse effects had been reported in response to the intervention.

Conclusion:

2

Phytosomal curcumin as a safe supplement had a beneficial effect on migraine symptoms

stress level

as well as the sleep quality and QoL in patients with migraine. (Trial registration No. IRCT20201129049534N2)