• Randomized trial of Aurantii Fructus Immaturus flavonoids for functional dyspepsia. • Aurantii Fructus Immaturus flavonoids significantly improved dyspeptic symptoms. • Patients with spleen-stomach damp-heat syndrome benefited most. • Aurantii Fructus Immaturus flavonoids was well tolerated with no serious adverse events reported. • Study supports Aurantii Fructus Immaturus flavonoids for gastrointestinal issues. : Functional dyspepsia (FD) is a prevalent gastrointestinal disorder with complex pathogenesis. Traditional Chinese Medicine (TCM) classifies FD into syndromes such as liver-stomach disharmony, spleen-stomach damp-heat, and food and drink retention. This study aims to explore the efficacy and safety of Aurantii Fructus Immaturus Flavonoid Tablets (AFIF) in treating these TCM subtypes. : This multicenter, stratified block-randomized, single-dummy, placebo-controlled study enrolled 270 FD patients, classified into the three TCM subtypes. Within each subtype, participants were randomized to receive AFIF or placebo in a 2:1 ratio. Patients in the AFIF group received four tablets (0.29 g per tablet) orally, three times daily, approximately 30 minutes before meals, for 4 consecutive weeks, while the placebo group received matching placebo tablets following the same dosing schedule. The primary endpoint was the improvement in Western medicine clinical symptoms after 4 weeks. Secondary endpoints included TCM syndrome efficacy, gastric emptying rate at 3.5 hours postprandially, and changes in tongue and pulse features. : Of 266 initially enrolled patients, 170 (AFIF=113, placebo=57) were analyzed after excluding two centers due to data quality issues. After 4 weeks, the clinical cure rate was 21.24% in the AFIF group versus 5.26% in the placebo group, with a rate difference of 15.98% (95% CI: 6.46%–25.49%; P = 0.007). The markedly effective rate was 61.06% versus 28.07%, with a difference of 32.99% (95% CI: 18.26%–47.72%; P < 0.001). Among the three TCM syndromes, patients with spleen-stomach damp-heat syndrome showed the greatest benefit from AFIF, with a cure rate of 18.52% and a markedly effective rate of 47.22%. AFIF also improved gastric emptying rate at 3.5 hours postprandially, although the difference compared with placebo was not statistically significant. No drug-related adverse events were reported. : AFIF is safe and effective for treating FD, with the greatest efficacy observed in patients with the spleen-stomach damp-heat TCM subtype. : ISRCTN32262691
Ma et al. (Sun,) studied this question.