RESUMO
STUDY OBJECTIVES: An estimated 3% of the population suffers from clinically significant restless legs syndrome. Given the limited pharmacological options in the arsenal, there is a need for a therapeutic agent with a better side effect profile. METHODS: Twelve treatment naïve adults (10 women and 2 men with a median age of 41.5 [32-48.5] years) with primary RLS were recruited in our open-label pilot study; magnesium citrate 200 mg was administered daily for eight weeks. Serum magnesium levels, IRLS, Kohnen QOL scale, and multiple suggested immobilization tests were performed before and after supplementation. Paired t-tests and Wilcoxon signed-rank tests were used for data analysis. Pearson and Spearman's analyses assessed the association between magnesium levels and RLS variables. RESULTS: Participants had a significant reduction in IRLS scores (- 6.67 [2.33-11] p=0.006) and improved Kohnen QOL scores (-8.5 [2.09-14], p=0.014) without notable differences in serum magnesium levels (p=0.3). Average PLMW across all SIT trials (30.40 [5.20, 122.40] to 8.63 [0.32, 17.47] p=0.043) and subjective measures on mSIT also demonstrated improvement. Serum magnesium levels negatively correlated with m-SIT self-reported scores and the PLMW indices. CONCLUSIONS: Despite the limitations of open-label design, our study's positive results indicate the need for a placebo-controlled trial with a larger sample size. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov (NCT04462796).