Objective: To investigate the clinical efficacy of Banxia Xiexin Tang in treatment of helicobacter pylori(Hp)-associated peptic ulcer with syndrome of intermingled heat and cold and observe its effect on serum levels of osteopontin (OPN) and β-catenin. Method: One hundred and ten patients with Hp-associated peptic ulcers at internal digestive wards of our hospital were randomly divided into treatment group and control group (55 cases in each group) referring to random number table. Patients in both groups were given with non-drug therapy with reference to "Diagnosis and Treatment Guidelines for Peptic Ulcer Disease". Patients in control group received therapy of proton pump inhibitors (PPI)

including omeprazole enteric-coated tablets (20 mg

bid)

clarithromycin tablets (500 mg

bid) and amoxicillin capsules (0.5 g

bid). The above drugs were orally taken for 2 weeks. After 2 weeks

Pantoprazole sodium enteric-coated tablets (40 mg

qd) were orally taken for 2 weeks. Patients in treatment group were also treated with Banxia Xiexin Tang (1 dose/d

boiled twice conventionally) for 4 weeks in total based on the treatment in control group. The main symptoms and scores of gastroduodenal mucosa injury were compared before and after treatment in both groups. Hp elimination rates and the clinical curative effects were analyzed for both groups. Serum levels of OPN and β-catenin were detected. Result: Scores of clinical symptom for syndrome of intermingled heat and cold in treatment group were significantly lower than those of control group after treatment (P<0.01). The total effective rate was 96.36% in treatment group

superior to 80% in control group

with statistical differences (P<0.05). After treatment

Hp elimination rate in treatment group was 90.91%

superior to 74.45% in control group

with statistical differences (P<0.05). Scores of gastroduodenal mucosa injury in treatment group were significantly lower than those in control group after treatment (P<0.01). Serum levels of OPN and β-catenin in treatment group were significantly higher than those in control group after treatment

with statistically significant differences (P<0.01). Conclusion: Based on the routine non-drug therapy and triple therapy

Banxia Xiexin Tang add and subtract for Hp-associated peptic ulcer could effectively improve the main clinical symptoms and gastroduodenal mucosa lesions

and increase Hp elimination rates and the clinical curative effects. The mechanism above may be relate to inhibiting serum levels of OPN and β-catenin.