Objective: To investigate the effect of Yunnan Baiyao on reduction of intra-operative bleeding of the patients undergoing transurethral resection of prostate (TURP).
Methods: A randomized placebo-control double-blind multi-center trial was conducted. 203 patients with benign prostate hyperplasia (BPH), aged 50 - 80, who were to undergo TURP were randomly divided into 2 groups: Yunnan Baiyao group, given 500 mg Yunnan Baiyao four times daily since the third day before the operation for 3 days, and placebo group, given empty capsules for 3 days. The amount of intra-operative bleeding, bleeding index and bleeding intensity were compared. The side effect of Yunnan Baiyao was also evaluated.
Results: The amount of intra-operative bleeding of the Yunnan Baiyao group was 147 ml +/- 144 ml, significantly less than that of the control group (182 ml +/- 157 ml, P < 0.05). The amount of intra-operative bleeding of the per protocol (PP) population in the Yunnan Baiyao group (n = 58) was 146 ml +/- 116 ml, significantly less than the PP population in the control group (n = 66) (220 ml +/- 207 ml, P = 0.0361). When the weight of the resected prostate tissue was more than 20 gram, the amount of intraoperative bleeding, bleeding index, and bleeding intensity of the ITT population in the Yunnan Baiyao group (n = 60) were all significantly lower than those of the ITT population in the control group (n = 68) (all P < 0.05); the bleeding intensity of the PP population in the Yunnan Baiyao group was 2.4 ml/min +/- 1.8 ml/min, significantly lower than that of the PP population in the control group (3.6 ml/min +/- 3.7 ml/min, P = 0.0072); the bleeding index of the PP population in the Yunnan Baiyao group was 4.7 ml/g +/- 4.6 ml/g, significantly lower than that of the PP population in the control group (7.1 ml/g +/- 8.3 ml/g, P = 0.025). No side effect was found in the 2 groups.
Conclusion: Yunnan Baiyao is effective on reducing the amount of intraoperative bleeding of TURP without side effect.