Objectives Zhen Wu Decoction (ZWD), a famous classic herbal formula documented in traditional Chinese medicine (TCM), is widely available in China for treating hypertensive patients with kidney yang deficiency and fluid retention syndrome. This systematic review aims to evaluate the effectiveness and safety of ZWD for hypertension.

Methods Cochrane Central Register of Controlled Trials, PubMed, Embase, the Chinese National Knowledge Infrastructure, the Chinese Scientific Journal Database, the Chinese Biomedical Literature Database, and the Wanfang Database were searched from their inception to November 2014. Randomised controlled trials of ZWD used alone or in combination with antihypertensive drugs against placebo, no intervention or antihypertensive drugs in hypertensive patients were identified. Two assessors independently reviewed each trial. The Cochrane risk of bias assessment tool was used for quality assessment.

Results Seven trials involving 472 hypertensive patients were identified. Compared with antihypertensive drugs, ZWD showed no significant effects in lowering blood pressure (BP) (n=177; risk ratio (RR) 1.06; 95% CI 0.87 to 1.28; p=0.58); however, ZWD plus antihypertensive drugs (ZPAD) significantly lowered systolic BP (n=80; weighted mean difference (WMD) −14.00 mm Hg, 95% CI −18.84 to −9.16 mm Hg; p<0.00001), diastolic BP (n=80; WMD −8.00 mm Hg, 95% CI −11.35 to −4.65 mm Hg; p<0.00001), and BP (n=215; RR 1.21, 95% CI 1.08 to 1.37; p=0.001). TCM symptoms and syndromes were significantly improved by either ZWD (n=177; RR 1.58, 95% CI 1.28 to 1.95; p<0.0001) or ZPAD (n=215; RR 1.30, 95% CI 1.14 to 1.49; p=0.0001). Adverse effects were not reported.

Conclusions This systematic review revealed no definite conclusion about the application of ZWD for hypertension due to the poor methodological quality, high risk of bias, and inadequate reporting on clinical data. More rigorously designed trials, especially addressing continuous BP and adverse effects, are warranted.