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Effects of a green tea seed and leaf extract complex on functional dyspepsia: A randomized, double-blind,
Su-Young Jung1, Yun-Ah Lee1, Young-Sang Kim2
1Department of Family Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
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.