Evaluation of Adverse Effects and Tolerability of Dietary Ginger Supplementation in Patients With Functional Dyspepsia.

BACKGROUND: Functional dyspepsia (FD) is a prevalent upper gastrointestinal disorder characterized by chronic or recurrent symptoms, including epigastric pain, bloating, and nausea. Ginger (Zingiber officinale), a natural dietary supplement traditionally used to relieve gastrointestinal discomfort, has limited evidence regarding its safety and tolerability in patients with FD. OBJECTIVE: To evaluate the safety, tolerability, and adverse effects of ginger supplementation in patients with FD. METHODS: This open-label clinical trial was conducted at the Internal Medicine Outpatient Department, University of Debrecen. This study was conducted in full compliance with the ethical principles outlined in the Declaration of Helsinki. The study protocol was reviewed and approved by the Ethics Committee of the University of Debrecen (registry reference number: DE RKEB/IKEB 5622-2020). All participants provided written informed consent prior to their inclusion in the study. Fifty patients with FD were initially enrolled, and 47 participants completed the study. Ginger supplementation was administered at a dose of 1080 mg/d in divided doses over 8 weeks. Adverse effects were assessed weekly through clinical evaluations and self-reports, and tolerability was rated by participants at the end of the trial. RESULTS: The study included 47 patients with FD who completed the trial, with a mean (SD) age of 51.49 (14.64) years. Of the participants, 78.7% were females. Ginger supplementation was well tolerated, with mild and transient adverse effects reported, including bloating (14.9%), heartburn (12.8%), and diarrhea (10.6%). None of these adverse events necessitated discontinuation of the treatment. Tolerability was rated as good or excellent by 87.2% of participants, and no severe adverse events were observed. CONCLUSIONS: Preliminary findings suggest ginger is well tolerated and may be a viable complementary dietary therapy, though further research is needed. ClinicalTrials.gov identifier: NCT06313814.