Digestive Aid as Adjunctive Therapy in Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial
- 1Research Development Center, Sina Hospital, Tehran University of Medical Sciences, Tehran, IRN
- 2Department of Internal Medicine, Sina Hospital, Tehran, IRN
- 3Department of Disaster & Emergency Health, School of Public Health, Tehran University of Medical Sciences, Tehran, IRN
Abstract
Functional dyspepsia (FD) is a common gastrointestinal complaint. This double-blind, placebo-controlled trial aims to determine the efficacy of a six-herb formulation (digestive aid) as a complementary therapy for FD. FD was confirmed based on Rome-IV criteria. Fifty patients were randomly assigned to receive either the digestive aid or a matching placebo for eight weeks, in addition to standard treatment protocols for FD. Dyspepsia symptoms were evaluated using the Leeds Dyspepsia Questionnaire (LDQ). The primary outcome was to compare changes in epigastric pain scores between the two groups from baseline to the end of treatment. The study included 30 (60%) female participants with a mean age of 40.8 (± 7.5) years. The comparison of mean changes in epigastric pain (-1.80 (-2.10, -1.50)), retrosternal pain (-2.12 (-2.40, -1.84)), regurgitation (-0.72 (-1.00, -0.44)), nausea (-1.40 (-1.70, -1.10)), early satiety (-0.88 (-1.16, -0.60)), belching (-1.00 (-1.30, -0.70)), dysphagia (-0.52 (-0.74, -0.30)), and vomiting (-0.40 (-0.64, -0.16)) showed significant improvement in the intervention group from baseline to the end of treatment. While a decrease in all dyspepsia domain scores was observed in the placebo group over the study period, the changes were not statistically significant. Between-group comparisons of mean differences revealed a significantly greater decrease in epigastric pain (-1.48 (-1.90, -1.06)), retrosternal pain (-1.96 (-2.40, -1.52)), regurgitation (-0.60 (-0.96, -0.24)), nausea (-1.32 (-1.72, -0.92)), early satiety (-0.76 (-1.14, -0.38)), belching (-0.84 (-1.24, -0.44)), and dysphagia (-0.40 (-0.68, -0.12)) in the digestive aid group compared to the placebo. The new formulation was well-tolerated with no major side effects during short-term use. Digestive aid, as an adjunct to standard therapy, may help alleviate symptoms in FD.
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BibTeX
@article{jamali2026digestive,
title = {{Digestive Aid as Adjunctive Therapy in Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial}},
author = {Raika Jamali and Amirhossein Aflatoonian and Abbas Keshtkar and Bardia Jamali and Yasaman Zarinfar and Eelia Gholampour Dehaki},
journal = {Cureus},
year = {2026},
month = oct,
doi = {10.7759/cureus.117706},
url = {https://doi.org/10.7759/cureus.117706},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Digestive Aid as Adjunctive Therapy in Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial
AU - Raika Jamali
AU - Amirhossein Aflatoonian
AU - Abbas Keshtkar
AU - Bardia Jamali
AU - Yasaman Zarinfar
AU - Eelia Gholampour Dehaki
PY - 2026
DA - 2026/10/09
JO - Cureus
DO - 10.7759/cureus.117706
UR - https://doi.org/10.7759/cureus.117706
AB - Functional dyspepsia (FD) is a common gastrointestinal complaint. This double-blind, placebo-controlled trial aims to determine the efficacy of a six-herb formulation (digestive aid) as a complementary therapy for FD. FD was confirmed based on Rome-IV criteria. Fifty patients were randomly assigned to receive either the digestive aid or a matching placebo for eight weeks, in addition to standard treatment protocols for FD. Dyspepsia symptoms were evaluated using the Leeds Dyspepsia Questionnaire (LDQ). The primary outcome was to compare changes in epigastric pain scores between the two groups from baseline to the end of treatment. The study included 30 (60%) female participants with a mean age of 40.8 (± 7.5) years. The comparison of mean changes in epigastric pain (-1.80 (-2.10, -1.50)), retrosternal pain (-2.12 (-2.40, -1.84)), regurgitation (-0.72 (-1.00, -0.44)), nausea (-1.40 (-1.70, -1.10)), early satiety (-0.88 (-1.16, -0.60)), belching (-1.00 (-1.30, -0.70)), dysphagia (-0.52 (-0.74, -0.30)), and vomiting (-0.40 (-0.64, -0.16)) showed significant improvement in the intervention group from baseline to the end of treatment. While a decrease in all dyspepsia domain scores was observed in the placebo group over the study period, the changes were not statistically significant. Between-group comparisons of mean differences revealed a significantly greater decrease in epigastric pain (-1.48 (-1.90, -1.06)), retrosternal pain (-1.96 (-2.40, -1.52)), regurgitation (-0.60 (-0.96, -0.24)), nausea (-1.32 (-1.72, -0.92)), early satiety (-0.76 (-1.14, -0.38)), belching (-0.84 (-1.24, -0.44)), and dysphagia (-0.40 (-0.68, -0.12)) in the digestive aid group compared to the placebo. The new formulation was well-tolerated with no major side effects during short-term use. Digestive aid, as an adjunct to standard therapy, may help alleviate symptoms in FD.
SN - 2168-8184
ER -