Effect of Flaxseed Supplementation on Headache Characteristics and Quality of Life in Patients with Migraine: A Randomized Controlled Trial.

Flaxseed supplementation significantly reduced headache severity compared to control after 8 weeks.

• The flaxseed group showed mean change of -5.0 ± 2.2 in headache severity compared with -1.0 ± 1.9 in the control group (P < 0.001).
• Participants consumed 20 g/d of flaxseed powder (intervention) or roasted wheat powder (control) for 8 weeks.
• The trial included 68 patients with migraine randomized to the two groups.

Flaxseed supplementation significantly improved quality of life as measured by headache impact score.

• The flaxseed group showed a mean change of -15.7 ± 11.0 in headache impact score compared with -2.3 ± 8.1 in the control group (P < 0.001).
• Headache impact score was used as a measure of quality of life.
• The intervention duration was 8 weeks with a daily dose of 20 g flaxseed powder.

Flaxseed supplementation significantly improved sleep quality as measured by the insomnia severity index.

• The flaxseed group showed a mean change of -4.6 ± 6.5 in insomnia severity index compared with -1.6 ± 4.9 in the control group (P = 0.029).
• Sleep quality was a secondary outcome of the trial.
• The difference was statistically significant but had the smallest effect size among the significant outcomes.

Changes in headache frequency and duration were not significantly different between the flaxseed and control groups.

• Headache frequency and duration were primary outcomes of the trial.
• Neither measure showed a statistically significant between-group difference at the end of the 8-week intervention.
• These null findings were consistent across both per-protocol and intention-to-treat analyses.

Changes in psychological states (depression, anxiety, and stress), weight, and blood pressure were not significantly different between groups.

• Depression, anxiety, and stress were secondary outcomes measured as psychological states.
• Weight and blood pressure were also included as secondary outcomes.
• None of these measures showed significant between-group differences after 8 weeks of intervention.

Per-protocol and intention-to-treat analyses yielded identical results.

• Both analytical approaches produced the same pattern of significant and non-significant findings.
• The trial was a randomized controlled design with 68 migraine patients.
• This consistency suggests robustness of the findings regardless of adherence-based exclusions.

The study was designed based on the rationale that flaxseed, as a plant source of omega-3 fatty acids, may exert anti-inflammatory effects relevant to migraine neuroinflammation.

• Migraine is described as a prevalent neurologic disorder linked to neuroinflammation.
• Flaxseed contains omega-3 (n-3) fatty acids that may be converted to long-chain ω-3 fatty acids with known anti-inflammatory potential.
• The control substance was roasted wheat powder, used to match the intervention in appearance or texture.