A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Jianyao Migu Granules in the Treatment of Osteopenic Low Back Pain.

PURPOSE: This randomized controlled trial aimed to evaluate the clinical efficacy of Jianyao Migu granules (JYMGG) in the treatment of primary osteopenic low back pain (LBP). PATIENTS AND METHODS: A total of 108 patients with primary osteopenic LBP were randomly divided into the JYMGG group and placebo group. Both groups took 600 mg of oral Caltrate D daily; in addition, the JYMGG group was given oral JYMGG, while the placebo group was given placebo granules. The treatment period was 6 months for both groups. The pre- to post-treatment changes in the bone mineral density (BMD), visual analogue scale (VAS) score, Oswestry disability index (ODI), and bone turnover markers were compared between the two groups. RESULTS: The post-treatment VAS score and ODI were significantly lower than baseline in both groups (P<0.05). In the JYMGG group, the lumbar BMD increased from 0.88±0.07 g/cm2 to 0.90±0.13 g/cm2 and the hip BMD increased from 0.77±0.08 g/cm2 to 0.78±0.10 g/cm2, giving increases of 2.70% and 1.96% respectively, but the differences were not statistically significant. The post-treatment levels of ALP, osteocalcin, P1NP, and β-CTX were increased compared with baseline in both groups, but the differences were not statistically significant. The thyrotropin level was significantly increased after treatment in the placebo group (P<0.05). There were no abnormalities detected in routine blood and kidney function tests performed during the observation period. Some patients showed elevated liver enzymes and gastrointestinal reactions. CONCLUSION: JYMGG effectively relieved the bone pain, and improved the quality of life of patients with primary osteopenic LBP.