Effects of herbal medicines containing Paeoniae Radix on patients with restless legs syndrome: A retrospective chart review study.

Background: Restless legs syndrome (RLS) is a neurological disorder characterized by an uncontrollable urge to move the legs during rest. Standard treatments may provide short-term relief but are limited by long-term adverse effects. Herbal medicine containing Paeoniae Radix (HCP) has traditionally been used in Korean medicine to treat RLS symptoms.

Aim: To investigate the clinical effectiveness and safety of HCP in treating RLS.

Methods: This retrospective chart review study included 15 patients with RLS who were treated with HCP between September 2017 and August 2022 at the Kyung Hee University Korean Medicine Hospital. The demographic, disease-related, and treatment-related characteristics, as well as the impressions of each patient, were analyzed. The study also evaluated the changes in the subjective complaints of RLS symptoms, the Korean version of the International Restless Legs Scale (K-IRLS) scores before and after treatment, and the adverse events after HCP administration.

Results: Following HCP administration, 14 patients (93.3%) experienced a decrease in the degree of discomfort associated with their symptoms, with an average reduction to 44.7 ± 35.1% compared to their discomfort levels before taking the drug. After treatment, the mean total K-IRLS score decreased significantly from 23.00 ± 9.75 to 13.93 ± 10.9 (P = 0.005). Among the HCP, a significant reduction in the K-IRLS score was observed in the Gyejibokryeonghwan (26.0 ± 9.7 to 10.0 ± 9.4, P = 0.028) and Jakyakgamchotang (23.2 ± 12.6 to 6.6 ± 4.2, P = 0.042) groups. Additionally, no adverse events were reported.

Conclusion: HCP improved symptoms in RLS patients. These results suggest that HCP may be an effective and safe alternative for RLS. A randomized controlled trial is required to confirm these findings.