Retrospective Study
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Sep 6, 2025; 13(25): 108244
Published online Sep 6, 2025. doi: 10.12998/wjcc.v13.i25.108244
Effects of herbal medicines containing Paeoniae Radix on patients with restless legs syndrome: A retrospective chart review study
Young Seon Lee, Han-Gyul Lee, Seungwon Kwon, Seung-Yeon Cho, Woo-Sang Jung, Seong-Uk Park, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko
Young Seon Lee, Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul 02447, South Korea
Han-Gyul Lee, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Department of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, Seoul 02447, South Korea
Seung-Yeon Cho, Seong-Uk Park, Jung-Mi Park, Chang-Nam Ko, Stroke and Neurological Disorders Center, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital at Gangdong, Seoul 05278, South Korea
Co-first authors: Young Seon Lee and Han-Gyul Lee.
Author contributions: Lee YS and Lee HG wrote the outline as co-first authors; Kwon S was responsible for the conception, supervision and design of the study as co-corresponding authors; Lee YS, Lee HG, Jung WS and Kwon S did the research and data curating; Lee YS, Lee HG, Cho SY, Jung WS, Park SW, Moon SK, Park JM and Ko CN assisted in the draft editing and reviewing all version of the manuscript. All authors provided the final approval of the article.
Supported by Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), the Ministry of Health and Welfare, Republic of Korea, No. RS-2023-KH142002.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (KOMCIRB 2023-01-005, approved on February 27, 2023).
Informed consent statement: Written informed consent was obtained from all participants before the study.
Conflict-of-interest statement: Authors declare no conflict of interests for this article.
Data sharing statement: sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Seungwon Kwon, MD, DKM, PhD, Doctor of Korean Medicine, Associate Professor, Department of Cardiology and Neurology, Kyung Hee University College of Korean Medicine, Kyung Hee University Medical Center, Kyungheedae-ro 23, Dongdaemun-gu, Seoul 02447, South Korea. kkokkottung@hanmail.net
Received: April 10, 2025
Revised: April 25, 2025
Accepted: May 27, 2025
Published online: September 6, 2025
Processing time: 88 Days and 22.3 Hours
Abstract
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.

Keywords: Paeoniae Radix; Restless legs syndrome; International restless legs scale; Herbal medicine; Retrospective chart review study

Core Tip: Restless legs syndrome (RLS) is a chronic condition, but is difficult to manage due to the limitations associated with the long-term use of conventional treatments. This retrospective chart review study demonstrated that herbal medicine containing Paeoniae Radix (HCP) effectively and safely alleviated RLS symptoms. HCP may serve as a promising alternative therapy for patients with RLS. These findings highlight the potential role of herbal medicine in RLS management.