Raffinee in the treatment of spinal cord injury: an open-labeled clinical trial.

The purpose of this preliminary clinical trial was to assess the safety and therapeutic trend of Raffinee, a mixture of free radical scavengers derived from natural products, on subacute spinal cord injury (SCI). SCI patients (three females and seven males) were enrolled from three medical centers in Taiwan. Their ages ranged from 18 to 76 years, with an average of 47.6 +/- 19.0 years. There were four incomplete and six complete cases in this study. Standard regimens for SCI at acute stage were given at each hospital. Approximately 7 weeks (35.4 +/- 13.9 days) after SCI, 2 U of Raffinee was given orally before meals three times a day for 6 weeks. Patients received motor, sensory, and activities of daily living (ADL) assessments before and after the treatment with Raffinee every week for 6 weeks. The Wilcoxon signed-ranks test was used for statistical analysis. Significant motor and sensory recovery began in the second week of Raffinee treatment, and significant ADL recovery was also noted in the third week. Functional recovery was more prominent in incomplete cases. Raffinee appeared to be safe in the subacute stage of SCI and may be an effective adjuvant therapy for enhancing functional recovery. Further clinical studies including double-blinded randomized placebo-controlled trials with follow-up for more than 1 year are necessary to validate the effectiveness of Raffinee in SCI.