Objective To evaluate the clinical efficacy of Chinese patent drugs on primary osteoporosis. Methods The database of EMBASE, PubMed, CNKI, CBM, Wanfang, Weipu, etc., were retrieved by computer, and the randomized controlled trials (RCTs) on the treatment of primary osteoporosis by Chinese patent drug was manually retrieved. The inclusion and exclusion of literature and the extraction of data were all adopted. Uniform standard was applied. The quality of the literature included was evaluated. Rev. Man 5.3 version of meta analysis software was used. Overall efficacy, bone mineral density (BMD) of the lumbar spine and hip, osteocalcin (OC), serum calcium, alkaline phosphatase, type I collagen cross-linked C-terminal peptide (β-CTX), type I collagen N-anterior peptide (PINP), and other bone metabolic indicators were evaluated. BMD of the hip contained Ward triangle and the femoral neck. Results The system evaluation included 41 randomized controlled clinical trials. Among those, 3 were of high quality, 5 were of medium quality, and the rest were of low quality. The 4 084 patients involved were all primary osteoporosis patients, including 2 112 cases in treatment group and 1 970 cases in control group. A total of 31 Chinese patent drugs were used. The total effective rate of Chinese proprietary drug was higher than that of the control group (P<0.05). Some Chinese patent drugs or combined Chinese and Western medicine therapy had a certain effect on increasing BMD and increasing serum bone calcium and the levels of β-CTX and PINP. There was no statistical difference between the ALP level and the S-Ca level (P>0.05). The side effect of Chinese patent drug was not obvious during the treatment process. Conclusion Chinese patent drugs for primary osteoporosis have a certain effect, but the evidence of efficacy is limited. Therefore, more high-quality research is urgently needed to strengthen the evaluation evidence. |