Can intravenous salvia miltiorrhiza extract reduce wound complications after mastectomy among patients with breast carcinoma?
Date of publication of the randomized controlled trial: December 2010
Design
Randomized controlled trial (RCT).
Participants
90 female patients (mean age: 50.2 years) diagnosed with invasive ductal breast carcinoma or ductal carcinoma in situ by histopathological examination of tissue obtained before surgery.
Intervention
20ml intravenous salvia miltiorrhiza extract every 12 hours from the day of operation until 3 days after the surgery.
Comparator
Comparison: Intravenous salvia miltiorrhiza extract versus usual wound care.
Major Outcomes
Outcome 1: Ischaemia and necrosis scores 4 days after the operation. Higher score indicates poorer wound healing;
Outcome 2: Ischaemia and necrosis scores 8 days after the operation. Higher score indicates poorer wound healing;
Outcome 3: Volume of wound drainage measured in milliliter (ml).
Settings
This trial was performed in an inpatient setting.
Comparison    Salvia miltiorrhiza extract versus usual wound care
Main Results
Compared to usual wound care, intravenous salvia miltiorrhiza extract significantly reduced ischaemia and necrosis of the wound 4 days after the operation (p<0.001), and 8 days after the operation (p<0.001) among patients who underwent mastectomy. Compared to usual wound care, patients who received intravenous salvia mitiorrhiza extract had significantly lower volume of wound drainage (p=0.02) as well.
Comparison: Intravenous salvia miltiorrhiza extract versus usual wound care among patients who underwent mastectomy
Outcomes No. of studies (Total number of participants) Median score (interquartile range)/ No. of participants Heterogeneity test (I2) p value Overall quality of evidence*
Intervention Comparator
1 1 (60) 6.80 (1.09 to 17.96)/ 30 23.38 (11.83 to 32.00)/ 30 Not applicable as there is only 1 study. <0.001 Moderate
2 1 (60) 6.92 (1.40 to 15.85)/ 30 26.39 (17.15 to 36.82)/ 30 Not applicable as there is only 1 study. <0.001 Moderate
3 1 (60) 52.44 (43.40 to 58.64)/ 30 58.06 (43.91 to 85.91)/ 30 Not applicable as there is only 1 study. 0.02 High
Keys: NA
Comparison    Salvia miltiorrhiza extract versus usual wound care
Main Results
Compared to usual wound care, intravenous salvia miltiorrhiza extract significantly reduced ischaemia and necrosis of the wound 4 days after the operation (p<0.001), and 8 days after the operation (p<0.001) among patients who underwent mastectomy. Compared to usual wound care, patients who received intravenous salvia mitiorrhiza extract had significantly lower volume of wound drainage (p=0.02) as well.
Comparison: Intravenous salvia miltiorrhiza extract versus usual wound care among patients who underwent mastectomy
Outcomes 1 2 3
No. of studies (Total number of participants) 1 (60) 1 (60) 1 (60)
Median score (interquartile range)/ No. of participants Intervention 6.80 (1.09 to 17.96)/ 30 6.92 (1.40 to 15.85)/ 30 52.44 (43.40 to 58.64)/ 30
Comparator 23.38 (11.83 to 32.00)/ 30 26.39 (17.15 to 36.82)/ 30 58.06 (43.91 to 85.91)/ 30
p value <0.001 <0.001 0.02
Overall quality of evidence* Moderate Moderate High
Keys: NA
Conclusion
Benefits
Compared to usual wound care, intravenous salvia miltiorrhiza extract significantly reduces ischaemia and necrosis conditions of the wound at 4 and 8 days, and also the volume of wound drainage after operation. For Outcome 1-2, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect. For Outcome 3, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect.
Harms
The major adverse effects are dry mouth (Intervention: n=1, Control: n=9) and ruberosis (Intervention: n=2, Control: n=1). The occurrence of dry mouth among patients in intravenous salvia miltiorrhiza group was significantly less frequent (p<0.05).
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/20862715
The synopsis is based on the following article:
Chen J, Lv Q, Yu M, Zhang X, Gou J. Randomized clinical trial of Chinese herbal medications to reduce wound complications after mastectomy for breast carcinoma. British Journal of Surgery. 2010 Dec;97(12):1798-804.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.