To elucidate the role of Fuzheng Huayu Capsule, a herbal formula, in the prevention of esophageal variceal bleeding in cirrhotic patients, a multicenter randomized and placebo-controlled trial was carried out. One hundred forty-six cirrhotic patients with esophageal varices were enrolled to compare the probability of upper gastrointestinal bleeding and survival between Fuzheng Huayu Capsule group and controlled group for the duration of 2 years. The results demonstrated that the FZHYC could effectively reduce the risk of variceal bleeding and improve survival rates for cirrhotic patients with varices, especially the combination of the capsule and Propranolol, which presented a better effect; FZHYC could reduce the varices size in patients with small ones. Its effect may be related to the amelioration of hepatic fibrosis.