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A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Duliang Soft Capsule in Patients with Chronic Daily Headache.

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机构： [1]Department of Neurology, Chinese PLA General Hospital, Beijing 100000, China. [2]Department of Neurology, The First Affiliated Hospital, Nanjing Medicine University, Nanjing, Jiangsu 210000, China. [3]Department of Neurology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400000, China. [4]Department of Neurology, Nanjing General Hospital of Nanjing Military Command, Nanjing, Jiangsu 210000, China. [5]Department of Neurology, Affiliated Huashan Hospital of Fudan University, Shanghai 200000, China. [6]Department of Neurology, Xiangya Hospital of Central South University, Changsha, Hunan 410000, China. [7]Department of Neurology, The First Hospital of Jilin University, Changchun, Jilin 130000, China. [8]Department of Neurology, Southwest Hospital, Third Military Medical University, Chongqing 400000, China. [9]Department of Neurology, First People's Hospital of Guangzhou, Guangzhou, Guangdong 510000, China. [10]Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing 400000, China. [11]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing 100000, China. [12]Department of Neurology, West China Hospital, Sichuan University, Chengdu, Sichuan 610000, China. [13]Department of Neurology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing 400000, China. [14]Department of Neurology, The Second Hospital of Jilin University, Changchun, Jilin 130000, China. [15]Department of Neurology, Affiliated Hospital of North Sichuan Medical College, Nanchong, Sichuan 637000, China. [16]Department of Neurology, Yongchuan Hospital of Chongqing Medical University, Chongqing 400000, China. [17]Department of Neurology, TCM Hospital of Luzhou Medical College, Luzhou, Sichuan 646000, China. [18]Department of Neurology, Mianyang Central Hospital, Mianyang, Sichuan 621000, China.

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Objective. To investigate the efficacy and safety of traditional Chinese medicine Duliang soft capsule (DSC) in prophylactic treatment for patients with chronic daily headache (CDH). Methods. A multicenter, double-blind, randomized, placebo-controlled clinical study was conducted at 18 Chinese clinical centers. The participants received either DSC or placebo for 4 weeks. The primary efficacy measure was headache-free rate (HFR) in a 4-week period between the pretreatment and posttreatment stages. The secondary efficacy measures were the decrease of headache days, the duration of headache attacks, the frequency of analgesic usage, quality of life, disability, and the headache severity (VAS scores). The accompanying symptoms and adverse events were also assessed. Results. Of 584 CDH patients assessed, 468 eligible patients were randomized. 338 patients received DSC, while 111 patients were assigned in the placebo group. Following treatment, there was a 16.56% difference in HFR favoring DSC over placebo (P < 0.01). Significant differences were also observed between DSC and placebo groups in the secondary measures. However, no statistical difference was found between the two groups in the associated symptoms. No severe adverse effects were observed in the study. Conclusions. DSC might be an effective and well-tolerated option for the prophylactic treatment of patients with CDH.

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出版当年[2014]版：

大类 | 3 区医学

小类 | 2 区全科医学与补充医学

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第一作者机构： [1]Department of Neurology, Chinese PLA General Hospital, Beijing 100000, China.

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