Background: The conventional therapy for arteriosclerosis obliterans (ASO) is Western medicine. However, it has some adverse effects and does not respond to some patients, and it is also very expensive.
Objective: To evaluate the efficacy of integrated traditional Chinese (TCM) and Western medicine (WM) in treatment of ASO.
Search strategy: Electronic and manual searches were conducted and the searches ended on May 20, 2009.
Inclusion criteria: We included randomized controlled trials (RCT) evaluating integrated TCM and WM (as treatment group) versus WM used alone (as control group), and no language limits were set.
Data extraction and analysis: Selection of trials for inclusion, assessment for methodological quality, data extraction and data syntheses were conducted according to protocol of a Cochrane systematic review by the authors.
Results: Thirteen RCT were included, which encompassed a total of 968 patients. The results showed that all of the 13 included trials did not report mortality rate of ASO. The studies displayed that the amputation rate in the treatment group was lower than that in the control group, but there was no statistical significance. Ten studies adopted inefficiency analysis and 2 of them showed that the ineffective rate in the treatment group was lower than that in the control group, and the relative risk (RR) and 95% CI were 0.36 [0.13, 0.99]. We performed descriptive analysis on other 8 studies; analyses of secondary outcomes such as intermittent claudication, ankle brachial index, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) showed that integrated TCM and WM therapy was more effective than WM treatment alone; one study showed that WM was better than integrated TCM and WM therapy in decreasing the content of fibrinogen. All of the included trials did not report any critical adverse reactions occurred in the treatment group.
Conclusion: The current evidence shows that integrated TCM and WM therapy is safe and effective in treating ASO, and tends to reduce amputation rate, improve intermittent claudication, decrease the levels of fibrinogen, HDL and LDL, and increase ankle brachial index, without obvious adverse reactions. Due to the low methodological quality of trials included, more prospective, multicenter, large-scale, high-quality RCTs are needed.