Effects of a green tea seed and leaf extract complex on functional dyspepsia: A randomized, double-blind, placebo-controlled trial.

BACKGROUND

and Purpose: Functional dyspepsia is a prevalent gastrointestinal disorder that imposes a considerable socioeconomic burden. This study evaluated the efficacy and safety of a green tea seed and leaf extract complex (TSL) in alleviating functional dyspepsia.

MATERIALS AND

METHODS

A double-blind, randomized, placebo-controlled trial was conducted among 100 adults with functional dyspepsia. Participants were assigned to receive either TSL (n = 50) or placebo (n = 50) at a dose of 500 mg/day for eight weeks. Efficacy was evaluated using validated instruments, including the Gastrointestinal Symptom Rating Scale-Korean version and Gastrointestinal Symptom Score.

RESULTS

At the 8-week follow-up, the TSL group demonstrated a significantly greater improvement in the total Gastrointestinal Symptom Rating Scale score than the placebo group (-5.73 ± 6.27 vs. -2.02 ± 7.09, P = 0.0148). Analysis of the subscores on the Gastrointestinal Symptom Rating Scale revealed significant reductions in reflux (-1.02 ± 1.27 vs. -0.27 ± 1.36, P = 0.0107) and abdominal pain (-1.12 ± 2.14 vs. -0.20 ± 2.00, P = 0.0326) in the TSL group. The Gastrointestinal Symptom Score decreased in both groups, with a more pronounced reduction in the TSL group (-2.63 ± 3.85 vs. -1.09 ± 2.97, P = 0.0481). No significant differences were observed between the groups in the incidence of serious adverse events, and all adverse events were considered unrelated to the study medication.

CONCLUSION

TSL supplementation may be an effective and well-tolerated therapeutic option for the management of functional dyspepsia.