Lianxia Xiaopi Granules for Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-Blind and...

To evaluate the efficacy and safety of Lianxia Xiaopi Granules (LXXP) in treating functional dyspepsia (FD) with combined cold and heat pattern in Chinese medicine (CM).

A multicenter, randomized, double-blind, and placebo-controlled trial was conducted at 11 centers between April 1, 2021, and October 24, 2022 in China. Using stratified block randomization at a 2:1 ratio, patients diagnosed with FD were randomly assigned to receive either LXXP (3.5 g/bag, equivalent to 8.337 g of raw herbs) or a placebo (3.5 g/bag) 3 times daily for 8 weeks. The primary outcome was dyspepsia symptom response rate. Secondary outcomes included individual dyspepsia symptom response rate, Chinese medicine syndrome efficacy evaluation scale including reduction rate of CM symptom total score, cure and effective rates, and safety analysis. Subgroup analyses were performed according to postprandial distress syndrome (PDS) or epigastric pain syndrome (EPS) subtypes and Helicobacter pylori (Hp) infection status.

A total of 240 participants completed the trial, 160 in the LXXP group and 80 in the placebo group. At week 8, the dyspepsia symptom response rate was significantly higher in the LXXP group than in the placebo group [54.38% (87/160) vs. 32.50% (26/80), P=0.0013]. LXXP significantly improved postprandial fullness, early satiety, and bloating compared with the placebo group (P<0.05). Subgroup analysis showed greater efficacy in PDS and Hp-negative patients (P<0.05). Safety analysis revealed no significant differences in adverse events between the 2 groups.

LXXP effectively improves FD symptoms, particularly in PDS and Hp-negative patients, supporting its application in CM-based treatment. (Trial registration No. ChiCTR2100041993).