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

Abstract

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. 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. 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. 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.