To explore the effects of Shenling-Baizhu Powder combined with modified Guilu-Erxian Decoction on bone metabolism and inflammation response in osteoporosis patients.

A total of 82 patients with osteoporosis of spleen-kidney deficiency, meeting the inclusion criteria in the hospital, were enrolled between June 2018 and October 2019. They were divided into observation group and control group by random number table method, 41 in each group. The control group was treated with oral calcium carbonate D3 tablets and alendronate sodium, while the observation group was treated with Shenling-Baizhu Powder combined with modified Guilu-Erxian Decoction on basis of control group. Both groups were treated for 6 months. Before and after treatment, scores of TCM symptoms were conducted. The bone mineral density (BMD) values of lumbar vertebra L_2-4, femoral neck and distal radius1/3 site were detected by dual-energy X-ray BMD analyzer. The levels of serum tartrate-resistant acid phosphatase 5b (TRACP 5b) and type I C-terminal cross linked peptide (CTX-I) were detected by electrochemiluminescence analyzer. The level of bone gla protein (BGP) was detected by radioimmunoassay. The levels of interleukin 6 (IL-6), interleukin 10 (IL-10), tumor necrosis factor α (TNF-α) and C-reactive protein (CRP) were detected by full-automatic biochemical analyzer. The adverse events during treatment were observed. And clinical curative effect was evaluated.

The differences in response rate between observation group and control group was statistically significant [95.1% (39/41) vs. 78.0% (32/41); χ²=5.145, P=0.023]. After treatment, scores of clinical symptoms (pain in back and loin, soreness and weakness of waist and knees, limb fatigue, debilitation, dizziness and tinnitus, frequent nocturia, loose stools, poor complexion) in observation group were significantly lower than those in the control group (t=14.268, 10.732, 20.720, 7.564, 9.055, 15.975, 10.826, 6.552, all Ps<0.001). After treatment, BMD values of lumbar vertebra L_2-4 (0.89 ± 0.06 g/cm³vs. 0.81 ± 0.04 g/cm³, t=7.104), femoral neck (0.80 ± 0.08 g/cm³vs. 0.72 ± 0.06 g/cm³, t=5.122) and distal radius 1/3 site (0.65 ± 0.12 g/cm³vs. 0.56 ± 0.14 g/cm³, t=3.125) in observation group were significantly greater than those in the control group (P<0.01). After treatment, levels of serum BGP and IL-10 in observation group were significantly higher than those in the control group (t=3.875, 3.714, P<0.01), while levels of TRACP-5b, CTX-I, IL-6, TNF-α and CRP were significantly lower than those in the control group (t=3.169, 5.849, 9.412, 4.606, 5.430, all Ps<0.001).

Shenling-Baizhu Powder combined with modified Guilu-Erxian Decoction can improve clinical symptoms in patients with primary osteoporosis of spleen-kidney deficiency, increase BMD, regulate bone metabolism, alleviate inflammatory response and improve clinical curative effect.

Osteoporosis; Spleen-kidney deficiency; Shenling-Baizhu Powder; Guilu-Erxian Decoction; Bone metabolism; Inflammatory response