Objective:To evaluate the efficacy and safety of Longteng Tongluo Tincture combined with three-step analgesic ladder in the treatment of cancer pain. MethodsA total of 100 patients with cancer pain were randomly divided into treatment group and control group, with 50 cases in each group. Both groups were treated based on three-step analgesic ladder. The treatment group was also administered Longteng Tongluo Tincture for external use. The course of treatment in both groups was 8 days, and Numeric Rating Scale (NRS) score changes were observed to quantify pain and evaluate pain-relieving effect accordingly. The morphine equivalent daily consumption, the frequency of pain outbreaks and the onset time of analgesia were observed, and the safety was evaluated simultaneously.  Results:①The total effective rate of pain relief in the treatment group was 65.85%, and the obvious effective rate was 31.70%, which were higher than 44.19% and 18.60% in the control group. In terms of overall pain-relieving effect, the treatment group performed better than the control group (P<0.05). ②The NRS scores of the two groups decreased after treatment compared with those before treatment (P<0.05), and the decrease range of NRS scores in the treatment group was greater than that in the control group (P<0.05). Further stratified comparison showed that NRS scores of patients with various pain degrees in both groups decreased after treatment (P<0.05). Besides, among patients with moderate pain, the difference of NRS scores compared before and after treatment in the treatment group was greater than that in the control group (P<0.05). ③There was no significant difference in morphine consumption on the first day and average morphine equivalent daily consumption between the two groups (P>0.05). Further stratification comparison showed that the average morphine equivalent daily consumption of patients with moderate pain in the treatment group was less than that in the control group (P<0.05). ④There was no significant difference between the two groups in the frequency of pain outbreaks, the mean analgesic onset time and the incidence of adverse reactions (P>0.05).  Conclusion:In the treatment of cancer pain, Longteng Tongluo Tincture and opioid analgesics have synergistic effects. Thus, it is worthy of further promotion as it can reduce the daily average consumption of opioids with good safety, especially for patients with moderate cancer pain.