| Objective To evaluate the efficacy and safety of Hugu capsule in treating primary osteoporosis of kidney essence deficiency syndrome. Methods A totally 158 patients with primary osteoporosis were randomly divided into an experimental group (n=79) and a control group (n=79). The experimental group was given Hugu capsule orally, while the control group was treated by Xianlinggubao capsule orally. All patients were treated for 12 weeks. SF-36 scale score, bone mineral density (BMD), visual analogue pain score (VAS), TCM symptom score and other safety parameters were observed before and after the trial. Results ① The distribution of age, height, weight, sex, bone mineral density, pain score, SF-36 questionnaire dimension score, total score of TCM syndrome scale and TCM syndrome-single score was balanced between the two groups. ②Changes in the scores of the SF-36 scale before and after treatment: The overall health dimension score was significantly higher in the experimental group than before the treatment, and the difference was statistically significant, while the overall health score of the control group was not significantly different (P>0.05). Moreover, after treatment, the scores of physical health, somatic functional roles, social functions, and somatic pain dimensions of the two groups increased compared with before treatment, and the differences were statistically significant. ③BMD measurement: In the experimental group, lumbar vertebra L2, lumbar vertebra L3, lumbar vertebra L4 and lumbar vertebrae L2-L4 mean bone mineral density were no statistically different before and after treatment (P>0.05). In the control group, there were no significant differences in the bone mineral density of the lumbar vertebra L2, lumbar vertebra L3 and lumbar vertebra L4 before and after treatment (P>0.05), whereas the bone density of lumbar spine L2-L4 decreased after treatment compared with before treatment. ④ Visual analogue pain score (VAS): the pain scores between the experimental group and the control group did not show significant differences, but the pain scores of the two groups at the end of treatment were significantly lower than those at baseline. ⑤TCM syndrome scale score: There was no significant difference between the experimental group and the control group in the TCM syndrome score, but both treatments could reduce the TCM syndrome scale score. ⑥Safety: During the trial, adverse reactions occurred in 1 case (1.47%) in the experimental group and 5 cases (7.46%) in the control group. Conclusion Primary osteoporosis patients with kidney essence deficiency syndrome showed good therapeutic effects after taking Hugu capsule, and had fewer adverse reactions and better safety. |