Objective To investigate the efficacy and safety of Qianggu capsule for the treatment of primary osteoporosis and bone loss. Methods A multi-center and open trial study was performed. Patients with primary osteoporosis and bone loss were administered with Qianggu capsule for 12 weeks. The scores of the syndromes of traditional Chinese medicine, BP, HR, routine blood and urine test, ECG, and liver and kidney function were documented before and after the treatment. BMD measurement was performed in a portion of the patients. Results Two thousand and sixty-two 45-75 years old patients were enrolled.Obvious improvement was achieved in terms of back pain, weak legs, aversion to cold and cold limbs,cramp, and frequent nocturia. The total effective rate was 93.8％. No BMD changes of L2-4 and the femoral neck were observed after 12 weeks of the treatment. Total incidence of AEs was 7. 6％ ( 157/2061 ), with absence of SAEs. Drug related AEs included dry mouth 5.19％ (107/2061), constipation 2. 33％ (48/2061 ) , and stomach discomfort 0. 24％ (5/2061). No patients withdrew because of drug-related AEs.Conclusion Qianggu capsule is capable of relieving symptoms of primary osteoporosis and bone loss. In addition, it is of better safety.
NETL
NSTL
万方数据
维普
