OBJECTIVE： To observe the clinical efficacy and safety of Cinobufacini capsule in the treatment of tumor patients with intractable hiccup. METHODS： 120 tumor patients with intractable hiccup were randomly divided into observation group （60 cases） and control group （60 cases） according to the random number table. Control group received conventional treatment， treatment of primary disease， and the basic treatment of Methoxy metoclopramide tablets 10 mg， tid and intraorbital pressure on neural network method； observation group additionally received Cinobufacini capsule， 2 capsules once， 3 times a day. 1-week was regarded as a treatment course， and it lasted 4 courses. Clinical efficacy， Karnofsky functional status （KPS） score and disappearance time of hiccup were observed， and the incidence of adverse reactions was evaluated by TESS scale. RESULTS： After treatment， the total effective rate in observation group was significantly higher than control group， the disappearance time of hiccup and TESS score were significantly shorter than control group， the differences were statistically significant（P＜0.05）. Before treatment，there was no significant difference in the KPS score； after treatment，the KPS score in 2 groups was significant higher than before，and observation group was higher than control group，the difference was statistically significant（P＜0.05）. CONCLUSIONS： Both efficacy and safety of Cinobufacini capsule in the treatment of intractable hiccup are good， and it can shorten hiccup duration.