A Real-World Study on the Efficacy and Safety of Citicoline Sodium Capsules for Neurological Outcomes in Acute and Recovery Phases of Ischemic Stroke

Abstract

Background: To evaluate the efficacy, safety, and adherence of oral citicoline sodium capsules in improving neurological outcomes during the recovery phase of ischemic stroke in a real-world setting. Methods: This single-arm, multicenter, real-world observational study enrolled 6496 ischemic stroke patients in the recovery phase from January 2020 through December 2024. Patients received citicoline sodium capsules (200 mg, three times daily) for three months. Outcomes were assessed using NIHSS, mRS, and Barthel Index at baseline, 1, 2, and 3 months. Treatment effectiveness was categorized based on NIHSS improvement as markedly effective (≥90% reduction), improved (60%–89%), effective (30%–59%), or ineffective (<30%). Results: Of the 6496 patients (mean age 61.9±10.6 years; 61.6% male), 85.8% had comorbidities. After three months of treatment, significant improvements were observed in all neurological function measures: NIHSS decreased from 11.6±5.5 to 9.6±6.2, mRS improved from 2.5±1.1 to 2.0±1.1, and BI increased from 51.4±24.0 to 62.8±25.7 (all P<0.001). The total effectiveness rate increased progressively from 9.9% at 1 month to 37.5% at 3 months, while the proportion of severely dependent patients decreased from 27.7% to 11.9%. Treatment adherence remained high (96%–97%) throughout the study period, with only two mild adverse events reported. Conclusions: This real-world study suggests that three-month citicoline therapy provides meaningful improvements in neurological function and daily living activities during stroke recovery, with excellent safety and adherence profiles. Further randomized controlled trials are warranted to confirm these findings and optimize treatment protocols.