Effect of wu chu yu tang on gastroesophageal reflux disease: Randomized, double-blind, placebo-controlled trial.

BACKGROUND: The main symptoms of gastroesophageal reflux disease GERD are heartburn and acid regurgitation. Proton-pump inhibitors (PPI) are considered to be safe and effective for the treatment of GERD. In traditional Chinese medicine, wu chu yu tang (WCYT) is used to treat nausea after eating, vomiting, and diarrhea. PURPOSE: We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the therapeutic effect of WCYT on GERD using omeprazole as a PPI for the positive control. METHODS: Ninety patients with GERD were randomly assigned to the 1) control group (CG), who received an oral administration of omeprazole (20 mg) once per day and given WCYT placebo (3.0 g) three times per day for 4 weeks continuously; or the 2) treatment group (TG), who received oral administration of omeprazole (20 mg) placebo once per day and WCYT (3.0 g) three times per day for 4 weeks continuously. RESULTS: Seventy-seven patients (37 in CG, 40 in TG) completed the trial. Both Reflux Disease Questionnaire (RDQ) and Gastroesophageal Reflux Disease Questionnaire (GERDQ) scores was less in the second assessment (V2) and in the third assessment (V3) than those in V1 (first assessment; baseline) in the CG and TG groups (all p < 0.001); the score difference of both RDQ and GERDQ between V2 and V1 was similar between CG and TG (p = 1.00, p = 0.54, respectively). The score difference of both RDQ and GERD between V3 and V1 was less in the CG group than those of the TG group (both p = 0.004). CONCLUSION: WCYT has an effect similar to omeprazole for GERD treatment. Furthermore, this effect resulting from WCYT appeared to be maintained for a longer period of time than did that of omeprazole. A study with a larger sample size and longer study period is needed to corroborate our findings.