OBJECTIVE: To observe the efficacy and safety of Compound sabal berry tablet combined with tamsulosin in the treatment of benign prostatic hyperplasia complicated with urinary obstruction. METHODS: 86 patients with benign prostatic hyperplasia complicated with urinary obstruction were randomly divided into control group (43 cases) and observation group (43 cases).Control group orally received 0.2 mg Tamsulosin hydrochloride orally disintegrating sustained-release tablet, once every evening. Observation group additionally received 500 mg Compound sabal berry tablet before a meal, 3 times a day. 4-week was regarded as 1 treatment course, and it lasted 3 courses. During the treatment, all patients in the two groups ate light food, avoiding spicy and bland food. The clinical efficacy, TCM symptom scores, interleukin-8 (IL-8), interleukin-10 (IL-10), tumor necrosis factor α (TNF-α), maximum flow rate (Qmax), post-void residual (PVR), the International Prostate Symptom Score (IPSS) scores before and after treatment and the incidence of adverse reactions in the 2 groups were observed. RESULTS: The total effective rate in observation group was significantly higher than control group, the difference was statistically significant (P<0.05). Before treatment, there were no significant differences in the TCM symptom scores, Qmax, PVR, IPSS scores, IL-8, IL-10 and TNF-α between 2 groups (P>0.05). After treatment, TCM symptom scores, IPSS scores, IL-8, IL-10, TNF-α and PVR in 2 groups were significantly lower than before, and observation group was lower than control group, Qmax was significantly higher than before, and observation group was higher than control group, the differences were statistically significant (P<0.05). And there were no severe adverse reactions during treatment. CONCLUSIONS: The efficacy of Compound sabal berry tablet combined with tamsulosin is superior to tamsulosin alone in the treatment of benign prostatic hyperplasia complicated with urinary obstruction, it can reduce the inflammatory reactions and residual urine, with good safety.