Objective,2,To observe the clinical efficacy of internal and external application of Wenyang Sanjie Decoction combined with conventional therapy in the treatment of tumor osseous metastasis pain.,Methods,2,Ninety-three patients with tumor osseous metastasis pain were randomly divided into a control group (,n,=47) and a treatment group (,n,=46). The control group was administered with conventional analgesic therapy, while the treatment group was administed with internal and external application of Wenyang Sanjie Decoction besides the treatment measures of the control group. Both groups were treated continuously for 6 cycles. The frequency of pain outbreaks in the two groups was observed, the changes of pain numeric rating scale (NRS) score, 24-h dosage of oxycodone hydrochloride, laboratory indexes, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Bone Metastases22 (EORTC QLQ-BM22) score were compared, and safety evaluation was also performed.,Results,2,①During the trial, there was one drop-out case in the treatment group, and in the control group one case dropped out and one case was removed. Finally, 90 cases completed the trial, with 45 cases in each group. ②The NRS score decreased in both groups after 2 cycles of treatment, 4 cycles of treatment and 6 cycles of treatment respectively compared with that before treatment (,P,<,0.001); the NRS score of the treatment group was lower than that of the control group after 2 cycles of treatment, 4 cycles of treatment, and 6 cycles of treatment respectively (,P,<,0.05). ③During the whole treatment process, the frequency of painful outbreaks in the treatment group was lower than that in the control group, and the difference was statistically significant (,P,<,0.05). ④Compared with the condition after 3 days of treatment, the 24-h dosage of oxycodone hydrochloride decreased in the treatment group (,P,<,0.001) but increased in the control group (,P,<,0.001) after 4 cycles of treatment and 6 cycles of treatment; the 24-h dosage of oxycodone hydrochloride in the treatment group was lower than that in the control group after 4 cycles of treatment and 6 cycles of treatment (,P,<,0.05). ⑤Compared with the condition before treatment, the serum calcium level was lowered in the treatment group after 4 cycles of treatment (,P,<,0.01); after 6 cycles of treatment the tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) levels was lowered in the treatment group (,P,<,0.01), while the alkaline phosphatase (ALP) level increased in the control group (,P,<,0.01). The IL-6 level in the treatment group was lower than that in the control group after 4 cycles of treatment and 6 cycles of treatment respectively (,P,<,0.05). ⑥Compared with the pre-treatment condition, the scores of pain site, pain degree and dysfunction modules in the EORTC QLQ-BM22 were lowered in the treatment group after 2 cycles of treatment (,P,<,0.01). The intra-group comparison between the condition after 4 cycles of treatment and that after 6 cycles of treatment showed that the scores of pain site, pain degree and dysfunction modules decreased in both groups (,P,<,0.01). After 6 cycles of treatment, the score of dysfunction module in treatment group was lower than that in the control group (,P,<,0.05). ⑦The incidence of adverse reactions in the treatment group was lower than that in the control group, and the difference was statistically significant (,P,<,0.05).,Conclusions,2,Compared with the single use of conventional analgesia, the additional use of internal and external application of Wenyang Sanjie Decoction in the treatment of tumor osseous metastatic pain has achieved a satisfactory result, which could reduce the frequency of pain outbreaks and the dosage of analgesic drugs, and improve the survival quality of patients. The mechanism may be related to the reduction of serum TNF-α, IL-6 and calcium levels.