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

Abstract

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.