PMID- 26076841 OWN - NLM STAT- MEDLINE DCOM- 20160414 LR - 20150616 IS - 1532-2688 (Electronic) IS - 1059-1311 (Linking) VI - 29 DP - 2015 Jul TI - The anti-depression effect of Xylaria nigripes in patients with epilepsy: A multicenter randomized double-blind study. PG - 26-33 LID - S1059-1311(15)00084-9 [pii] LID - 10.1016/j.seizure.2015.03.014 [doi] AB - 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. CI - Copyright (c) 2015 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved. FAU - Peng, Wei-Feng AU - Peng WF AD - Department of Neurology, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Wang, Xin AU - Wang X AD - 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. FAU - Hong, Zhen AU - Hong Z AD - Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China. FAU - Zhu, Guo-Xing AU - Zhu GX AD - Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China. FAU - Li, Bing-Mei AU - Li BM AD - Epilepsy Center of the Second Affiliated Hospital of Guangzhou Medical University, Guangdong Province, China. FAU - Li, Ze AU - Li Z AD - Department of Neurology, The First Municipal Hospital of Guangzhou, Guangdong Province, China. FAU - Ding, Mei-Ping AU - Ding MP AD - Department of Neurology, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang Province, China. FAU - Geng, Zhi AU - Geng Z AD - Department of Neurology, The Sixth People's Hospital of Shanghai Jiaotong University, Shanghai, China. FAU - Jin, Zheng AU - Jin Z AD - Department of Neurology, The Fifth People's Hospital, Fudan University, Shanghai, China. FAU - Miao, Ling AU - Miao L AD - Department of Neurology, Renji Hospital, Shanghai Jiaotong University, Shanghai, China. FAU - Wu, Li-Wen AU - Wu LW AD - Department of Neurology, Peking Union Medical College Hospital, Beijing, China. FAU - Zhan, Shao-Kang AU - Zhan SK AD - Institute of Statistics and Public Health, Shanghai Medical College, Fudan University, China. LA - eng PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20150326 PL - England TA - Seizure JT - Seizure JID - 9306979 RN - 0 (Antidepressive Agents) RN - 0 (Drugs, Chinese Herbal) RN - 0 (wuling) SB - IM MH - Adult MH - Antidepressive Agents/adverse effects/*therapeutic use MH - Comorbidity MH - Depressive Disorder/*complications/*drug therapy/epidemiology MH - Double-Blind Method MH - Drugs, Chinese Herbal/adverse effects/*therapeutic use MH - Epilepsy/*complications/epidemiology MH - Female MH - Humans MH - Male MH - Middle Aged MH - Psychiatric Status Rating Scales MH - Quality of Life MH - Seizures/complications/epidemiology MH - Sleep/drug effects MH - Time Factors MH - Treatment Outcome OTO - NOTNLM OT - Comorbidity OT - Depression OT - Epilepsy OT - Randomized clinical trial OT - Xylaria nigripes EDAT- 2015/06/17 06:00 MHDA- 2016/04/15 06:00 CRDT- 2015/06/17 06:00 PHST- 2015/01/05 00:00 [received] PHST- 2015/03/16 00:00 [revised] PHST- 2015/03/19 00:00 [accepted] PHST- 2015/06/17 06:00 [entrez] PHST- 2015/06/17 06:00 [pubmed] PHST- 2016/04/15 06:00 [medline] AID - S1059-1311(15)00084-9 [pii] AID - 10.1016/j.seizure.2015.03.014 [doi] PST - ppublish SO - Seizure. 2015 Jul;29:26-33. doi: 10.1016/j.seizure.2015.03.014. Epub 2015 Mar 26.