■井舒颗粒(或井舒颗粒),中药,在中国广泛用于治疗神经根型颈椎病;然而,没有随机化,双盲,对照研究验证了其有效性。
■以随机对照试验评价经舒颗粒治疗神经根型颈椎病的疗效和安全性。
■从2015年8月到2017年7月,多中心,随机化,双盲,安慰剂对照试验在中国13家大中型医院进行.
■总共360名和120名患者最初被纳入镜术组和对照组,分别有386名患者完成了研究,净舒组299个,对照组87个。
■评价疗效的主要指标是视觉模拟评分(VAS;0-100分)的疼痛评分。
■所有患者每天3次服用一袋精舒颗粒或安慰剂,共4周,并在第二周和第四周接受了采访。计算治疗后疼痛评分下降和疼痛评分变化率,对相关实验室指标进行了综述,并记录不良反应。
■在每个协议集(PPS)分析中,对照组和颈舒组的基线疼痛VAS评分分别为49.31±6.97和50.06±7.33,组间无显著差异(P>0.05)。虽然两组之间在2周时没有差异,4周时,对照组和颈舒组的疼痛VAS评分相对于基线值分别下降12.86±13.45和22.72±15.08,具有显著的组间差异(P<0.0001)。虽然在完整分析集(FAS)分析中两组之间存在类似的显着差异(P<0.0001),但两组在任何时间点都没有达到最小的临床重要差异。
■荆术颗粒治疗神经根型颈椎病有效。
■这是第一个有前景的,多中心,随机化,双盲,安慰剂对照临床试验证实了颈舒颗粒治疗神经根型颈椎病的临床疗效和安全性,为临床治疗提供依据。
UNASSIGNED: Jingshu Keli (or Jingshu granules), a traditional Chinese medicine, are widely used for treating cervical spondylotic radiculopathy in China; however, no randomized, double-blind, controlled study has verified their effectiveness.
UNASSIGNED: To evaluate the efficacy and safety of Jingshu Keli for the treatment of cervical spondylotic radiculopathy in a randomized controlled trial.
UNASSIGNED: From August 2015 to July 2017, a multicenter, randomized, double-blind, placebo-controlled trial was conducted at 13 large- and medium-sized hospitals in China.
UNASSIGNED: A total of 360 and 120 patients were initially enrolled in the Jingshu and control groups, respectively; 386 patients completed the study, with 299 in the Jingshu group and 87 in the control group.
UNASSIGNED: The main index for evaluating the curative effect was the pain score on a visual analogue scale (VAS; 0-100 points).
UNASSIGNED: All patients were administered a bag of Jingshu Keli or placebo 3 times a day for 4 weeks, and were interviewed at the second and fourth weeks. The decrease in pain scores and rate of change in pain scores after treatment were calculated, related laboratory indices were reviewed, and adverse reactions were recorded.
UNASSIGNED: In the Per Protocol Set (PPS) analysis, the baseline pain VAS scores in the control and Jingshu groups were 49.31 ± 6.97 and 50.06 ± 7.33, respectively, with no significant difference between the groups (P > 0.05). While there were no differences at 2 weeks between groups, at four weeks the pain VAS scores in the control and Jingshu groups decreased by 12.86 ± 13.45 and 22.72 ± 15.08, respectively relative to the values at baseline, with significant group differences (P < 0.0001). While there were similar significant differences between the groups (P < 0.0001) in the Full Analysis Set (FAS) analyses neither group achieved the minimal clinically important difference at any time point.
UNASSIGNED: Jingshu Keli are effective for the treatment of cervical spondylotic radiculopathy.
UNASSIGNED: This is the first prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial that confirmed the clinical efficacy and safety of Jingshu Keli for treating cervical spondylotic radiculopathy, which can provide evidence for clinical treatment.