Randomized clinical trial of Chinese herbal medications to reduce wound complications after mastectomy for breast carcinoma

Background: Ischaemia and necrosis of skin flaps is a common complication after mastectomy. This study evaluated the influence of anisodamine and Salvia miltiorrhiza on wound complications after mastectomy for breast cancer. Methods: Ninety patients undergoing mastectomy for breast carcinoma were divided into three groups. Group 1 received routine wound care, group 2 received intravenous Salvia miltiorrhiza after surgery for 3 days and group 3 similarly received intravenous anisodamine. Skin flaps were observed on postoperative days 4 and 8; areas of wound ischaemia and necrosis were graded and adverse events recorded. Results: There was no difference in demographic characteristics between the groups. At 4 days after surgery the rate of ischaemia and necrosis in groups 2 and 3 was significantly reduced compared with that in control group 1 (median wound score 6.80 versus 23.38, P = 0.002, and 3.76 versus 23 . 38, P < 0.001, respectively). This improvement in groups 2 and 3 continued to postoperative day 8 (both P < 0.001), but wound scores at this stage were better in group 3 than in group 2 (1.82 versus 6 . 92 respectively; P = 0.022). The volume of wound drainage was lower in group 3 than in group 1 (P = 0.004). The incidence of adverse effects was highest in group 3, and two patients in this group discontinued treatment. No significant complications were noted in group 2. Conclusion: Anisodamine and S. miltiorrhiza were both effective in reducing skin flap ischaemia and necrosis after mastectomy, although anisodamine was associated with a higher rate of adverse effects.