Objective To observe the therapeutic effect of Gutongling Formula combined with zoledronic acid on malignancy bone metastasis pain. Methods Totally of 67 selected patients of malignancy bone metastasis with a grade II or grade III pain according to WHO standards were randomly assigned to a control group of 33 cases and a treatment group of 34 cases. Basic treatment: analgesic treatment according to three step analgesic ladder was applied to both groups. The control group was treated with intravenous drip of zoledronic acid 4 mg into normal saline once every 4 weeks

while the treatment group was added with Gutongling Formula once dose per day. The treatment course was 8 weeks. Visual analogue scale（ VAS） scores and karnofsky（ KPS） scores were recorded before and after treatments to evaluate the effect. Results After treatment

the VAS of both groups had a significant reduction（ P < 0. 05）

VAS of the treatment group was lower than that of the control group（ P < 0. 05）. The KPS scores of the treatment group were significantly improved after treatment（ P < 0. 05）

while there was no obvious improvement in the control group（ P > 0. 05） and the difference of KPS scores of the treatment group was statistically significant as compared with that of the control group（ P < 0. 05）. The effective rate of pain relieve and quality of life of the treatment group was 64. 71% and 64. 71% respectively

which was notely higher than 36. 36% and 30. 30% of the control group（ P < 0. 05 or P < 0. 01）. Conclusion The combined treatment of Gutongling Formula and zoledronic acid had an obvious analgesic effect and can significantly improve the quality of life of patients comparing with zoledronic acid treatment alone.