Migu Capsules in the Treatment of Osteoporotic Low Back Pain in Postmenopausal Women: A Single-Center Randomized Controlled Trial

Chen-Ming Tang,1,2,&ast; Yuan-Chuan Chen,1,2,&ast; Yu-Cheng Huang,1,2 Yuan Meng,1,2 Jing-Chun Xia,1,2 Jian Pang,1,2 Ying Shi1,2 1Shi’s Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China; 2Institute of Traumatology & Orthopedics, Shanghai Academy of Traditional Chinese Medicine, Shanghai, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Jian Pang; Ying Shi, Shi’s Center of Orthopedics and Traumatology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, People’s Republic of China, Email [email protected]; [email protected]: This trial aimed to investigate the efficacy of Migu capsules in treating osteoporotic low back pain.Patients and Methods: 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.Results: 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; P< 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 (P< 0.05). Three patients experienced a mild adverse event associated with the intake of Migu capsules.Conclusion: Migu capsules can alleviate bone pain and reduce functional disabilities caused by osteoporotic lower back pain.Keywords: osteoporotic low back pain, traditional Chinese medicine, osteoporosis, low back pain, Migu capsules