Clinical Efficacy of Liuwei Dihuangwan Combined with Aclasta on Osteoporosis and Effect on Quality of Life / 中国实验方剂学杂志

ABSTRACT

ObjectiveTo study the efficacy of Aclasta combined with Liuwei Dihuangwan on osteoporosis and the effect on quality of life. MethodA total of 126 patients with osteoporosis who were treated in the Affiliated Hospital of Shandong University of Traditional Chinese Medicine from September 2019 to September 2020 were classified into the observation group and the control group with the randomized double-blind method. The observation group consisted of 60 patients （26 males and 34 females） with the age of 59-85 years old ［mean： （72.0 ± 6.5） years old］. The control group was composed of 66 patients （31 males and 35 females）， with the age of 62-82 years old ［mean： （73.0±8.2） years old］. The control group was treated with Aclasta， and the observation group Aclasta combined with Liuwei Dihuangwan. After treatment， the effective rate of each group was calculated. Bone mineral density （BMD） was measured in both groups before and after treatment， and serological parameters calcium （Ca）， total 25 （OH） vitamin D3 （VITD-T）， osteocalcin （OC）， serum alkaline phosphatase （ALP）， parathyroid hormone （PTH）， β-collagen special sequence （β-CTX）， and total procollagen 1 N-terminal propeptide （T-P1NP） were also measured. Visual Analogue Scale （VAS） score， Japanese Orthopaedic Association （JOA） score， and Oswestry Disability Index （ODI） score were evaluated. On this basis， the effect was compared between the two groups. ResultThe indexes were insignificantly different between the two groups before treatment. After 6 months of treatment， the two groups showed decrease in VAS score and ODI score （P<0.01）， increase in JOA score （P<0.01）， BMD of lumbar spine and hip joint， elevation of Ca， VITD-T， OC， ALP， and PTH （P<0.05， P<0.01）， and decrease of β-CTX （P<0.01） as compared with before treatment. The level of T-P1NP dropped in the observation group after treatment （P<0.01）.After treatment， the total effective rate of the observation group was 88.3% （53/60）， as compared with the 74.2% （49/66） in the control group （χ2=4.047， P<0.05）. Moreover， after treatment， the observation group demonstrated higher levels of BMD， Ca， VITD-T， OC， and PTH （P<0.05）， lower levels of T-P1NP （P<0.05）， lower VAS score （P<0.01）， and higher JOA score （P<0.05） than the control group， but the ODI score was insignificantly different from that in the control group. ConclusionAclasta combined with Liuwei Dihuangwan is effective on osteoporosis， without increasing the incidence of adverse reactions. In addition， the combination can alleviate pain and improve the quality of life of osteoporosis patients.