Tang Chen-Ming, Chen Yuan-Chuan, Huang Yu-Cheng, Meng Yuan, Xia Jing-Chun, Pang Jian, Shi Ying
Shi's Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People's Republic of China.
Institute of Traumatology & Orthopedics, Shanghai Academy of Traditional Chinese Medicine, Shanghai, People's Republic of China.
J Pain Res. 2024 Dec 31;17:4561-4571. doi: 10.2147/JPR.S477969. eCollection 2024.
This trial aimed to investigate the efficacy of Migu capsules in treating osteoporotic low back pain.
In this single-center trial, we randomly assigned patients with osteoporotic low back pain that had lasted for 3 months in a 1:1 ratio to receive Migu capsules alongside Caltrate D in treatment group or to receive Caltrate D only in control group, both for 48 weeks. The primary outcome measure was the intensity of low back pain on a visual analog scale at 24 weeks after enrollment. Secondary outcome measures included the Roland-Morris Disability Questionnaire (RMDQ), bone turnover markers, and bone mineral density.
A total of 100 patients were enrolled, with 50 in each group. At baseline, the mean score for low back pain intensity was 6.2 in the treatment group and 6.1 in the control group. The primary outcome of the low back pain intensity score at 24 weeks was 2.9 in the treatment group and 4.7 in the control group (adjusted mean difference, -1.8; 95% confidence interval, -2.3 to -1.4; <0.001). Secondary outcomes including the score on RMDQ and pain at 48 weeks were in the same direction as the primary outcome. Compared to the control group, the treatment group only showed a difference in bone density after continuous intervention for 48 weeks (<0.05). Three patients experienced a mild adverse event associated with the intake of Migu capsules.
Migu capsules can alleviate bone pain and reduce functional disabilities caused by osteoporotic lower back pain.
本试验旨在研究密骨胶囊治疗骨质疏松性腰背痛的疗效。
在这项单中心试验中，我们将持续存在3个月骨质疏松性腰背痛的患者按1:1比例随机分配，治疗组患者接受密骨胶囊联合钙尔奇D治疗，对照组患者仅接受钙尔奇D治疗，疗程均为48周。主要结局指标为入组后24周时视觉模拟量表上的腰背痛强度。次要结局指标包括罗兰-莫里斯功能障碍问卷（RMDQ）、骨转换标志物和骨密度。
共纳入100例患者，每组50例。基线时，治疗组腰背痛强度的平均评分为6.2，对照组为6.1。治疗组2周后腰背痛强度评分的主要结局为2.9，对照组为4 .(调整后的平均差值为-1.8；95%置信区间为-2.3至-.4；<0.001)。包括RMDQ评分和48周时疼痛在内的次要结局与主要结局方向一致。与对照组相比，治疗组在持续干预48周后仅在骨密度方面存在差异(<0.05)。3例患者出现与服用密骨胶囊相关的轻度不良事件。
密骨胶囊可缓解骨质疏松性下腰痛引起的骨痛并减少功能障碍。
