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제목	Alleviating Restless Legs Syndrome (RLS) in Hemodialysis Patients: Unveiling the Therapeutic Impact of Palm Tocotrienol-Rich Fraction (TRF)
저자	Zulfitri Azuan Mat Daud
출판정보	2024; 2024(1):
키워드
초록	Objectives: Restless legs syndrome (RLS) poses a persistent challenge for maintenance hemodialysis (MHD) patients, significantly impacting their quality of life. In the absence of effective non-pharmacologic interventions, our study aims to investigate the potential of daily supplementation with 300mg of palm tocotrienol-rich-fraction (TRF) over 12 months in improving RLS among MHD patients. Methods: RLS was examined as a secondary outcome in the PATCH (Palm Tocotrienols in Chronic Hemodialysis) study—a randomized, double-blind, placebo-controlled trial involving Malaysian MHD patients (ClinialTrials.gov ID: NCT02913690). Participants received daily supplementation of 300mg TRF (n=170) or placebo (n=166) over 12 months, with compliance monitored through capsule counting. RLS severity was assessed at quarterly intervals (baseline, 3, 6, 9, and 12 months) using the International RLS Study Group rating scale (IRLS). Generalized estimating equations gauged changes in RLS severity over time between TRF and placebo groups. Intention-to-treat (ITT) analysis was implemented for all patients, while a sensitivity analysis focused on MHD patients with RLS at baseline for robustness assessment. Results: Comparable socio-demographic and clinical variables were noted between the TRF and placebo groups (Table 1). The prevalence of RLS at baseline was 14% (47/336), with IRLS scores ranging from 2 (mild) to 33 (very severe). A significant main effect of the group was observed (PGroup=0.003) after adjusting for confounding factors. The mean IRLS score in the TRF group was significantly lower than the placebo group, with sustained benefits manifesting notably after 6-12 months of intervention (Figure 1). The sensitivity analysis further underscored the greater reduction in RLS severity within the TRF group. Conclusions: Daily 300mg TRF supplementation effectively mitigates RLS severity in MHD patients, with a notable and sustained benefit emerging after 6 months. This study signifies a promising avenue for addressing RLS in MHD patients and calls for further exploration into the mechanistic underpinnings of tocotrienol-mediated relief.
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