The effect of flaxseed with or without anti-inflammatory diet in patients with rheumatoid arthritis, a randomized controlled trial.

Purpose: Beneficial effect of long-chain ω-3 fatty acids against symptoms of rheumatoid arthritis (RA) has been indicated in previous studies. We examined the effect of flaxseed and anti-inflammatory diet in patients with RA.

Methods: The 12-week intervention was performed on 120 patients with RA who were randomized to three groups of flaxseed (30 g/day) plus anti-inflammatory diet (AIF group), flaxseed (30 g/day) plus regular diet (RF group), and roasted wheat (30 g/day) plus regular diet (RW group). Disease Activity Score 28-joints (DAS28), health assessment questionnaire (HAQ) disability and pain, quality of life, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), rheumatoid factor, and anti-cyclic citrullinated peptides (anti-CCP) were measured before and after trial. Analysis was performed using per-protocol and intention-to-treat (ITT) approaches.

Results: One hundred and two patients completed the protocol. Flaxseed decreased DAS28 in RF group compared to RW (- 0.87 ± 1.11 vs. - 0.24 ± 0.78; P = 0.014). Pain severity (P ≤ 0.001), morning stiffness (P < 0.05), and disease feeling (P < 0.01) decreased significantly in AIF and RF groups. HAQ disability and quality of life measurements improved in all 3 groups, with a greater extent in AIF and RF groups (P < 0.001) compared to RW. Between-group differences were significant for DAS28, pain scores, and physical and mental health variables. ESR, CRP, anti-CCP, and rheumatoid factor were not different between groups. Results of ITT analysis did not cause much difference.

Conclusions: In conclusion, flaxseed may be used as a helpful adjuvant therapy for patients with RA. Calls are open for examining the effect of anti-inflammatory diet on RA symptoms.

Trial Registration Number: Registered at irct.ir as IRCT20190923044858N1, February 6, 2020.