Wei-Feng Peng1, Xin Wang2, Zhen Hong3, Guo-Xing Zhu3, Bing-Mei Li4, Ze Li5, Mei-Ping Ding6, Zhi Geng7, Zheng Jin8, Ling Miao9, Li-Wen Wu10, Shao-Kang Zhan11. 1. Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China. 2. Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China; The State Key Laboratory of Medical Neurobiology, The Institutes of Brain Science and the Collaborative Innovation Center for Brain Science, Fudan University, Shanghai, China. Electronic address: wang.xin@zs-hospital.sh.cn. 3. Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China. 4. Epilepsy Center of the Second Affiliated Hospital of Guangzhou Medical University, Guangdong Province, China. 5. Department of Neurology, The First Municipal Hospital of Guangzhou, Guangdong Province, China. 6. Department of Neurology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. 7. Department of Neurology, The Sixth People's Hospital of Shanghai Jiaotong University, Shanghai, China. 8. Department of Neurology, The Fifth People's Hospital, Fudan University, Shanghai, China. 9. Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China. 10. Department of Neurology, Peking Union Medical College Hospital, Beijing, China. 11. Institute of Statistics and Public Health, Shanghai Medical College, Fudan University, China.
Abstract
PURPOSE: The comorbidity of depression in patients with epilepsy is common and treatment is still controversial. This pilot study was aimed at evaluating the efficacy and safety of Xylaria nigripes for treating depressive symptoms in patients with epilepsy during 12 weeks of treatment. METHODS: A multicenter, double-blind, placebo-controlled, randomized superiority study was performed. A total of 104 patients with epilepsy who fulfilled the study criteria were randomized 1:1 to receive Xylaria nigripes (the Wu Ling group) or placebo (the placebogroup) treatment in the 12-week period of study. The participants were visited on weeks 0, 2, 4, 8, and 12 of the treatment course. RESULTS: Eighty-one patients finished all of the visits. The primary efficacy endpoint in this study was the total effective rate for depression, which was significantly greater in the Wu Ling group (51.3%, n=39) than in the placebogroup (35.7%, n=42, 0.51-0.36=0.15, 95% CI -0.06 to 0.37, U=2.83, P=0.002) after 12 weeks of treatment. No differences in seizure frequency or changes in severity were found between the Wu Ling and the placebo groups. In addition, the quality of life and seizure worry subscale scores in patients with epilepsy were also improved more notably in the Wu Ling group than in the placebogroup (P<0.05). Most of the adverse effects (AEs) in this study were mild and had no differences between the Wu Ling and the placebo groups. CONCLUSION:Xylaria nigripes could alleviate depressive symptoms within 12 weeks treatment and was well tolerated in patients with epilepsy.
RCT Entities:
PURPOSE: The comorbidity of depression in patients with epilepsy is common and treatment is still controversial. This pilot study was aimed at evaluating the efficacy and safety of Xylaria nigripes for treating depressive symptoms in patients with epilepsy during 12 weeks of treatment. METHODS: A multicenter, double-blind, placebo-controlled, randomized superiority study was performed. A total of 104 patients with epilepsy who fulfilled the study criteria were randomized 1:1 to receive Xylaria nigripes (the Wu Ling group) or placebo (the placebo group) treatment in the 12-week period of study. The participants were visited on weeks 0, 2, 4, 8, and 12 of the treatment course. RESULTS: Eighty-one patients finished all of the visits. The primary efficacy endpoint in this study was the total effective rate for depression, which was significantly greater in the Wu Ling group (51.3%, n=39) than in the placebo group (35.7%, n=42, 0.51-0.36=0.15, 95% CI -0.06 to 0.37, U=2.83, P=0.002) after 12 weeks of treatment. No differences in seizure frequency or changes in severity were found between the Wu Ling and the placebo groups. In addition, the quality of life and seizure worry subscale scores in patients with epilepsy were also improved more notably in the Wu Ling group than in the placebo group (P<0.05). Most of the adverse effects (AEs) in this study were mild and had no differences between the Wu Ling and the placebo groups. CONCLUSION:Xylaria nigripes could alleviate depressive symptoms within 12 weeks treatment and was well tolerated in patients with epilepsy.