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

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental Pub Date : 2025-01-01 DOI:10.1016/j.curtheres.2025.100792

Lemlem Gebremariam Aregawi PhD , Csiki Zoltan MD, PhD

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引用次数: 0

Abstract

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.

Abstract Image

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功能性消化不良患者膳食补充生姜的不良反应和耐受性评价

背景：功能性消化不良（FD）是一种常见的上消化道疾病，其特征是慢性或复发性症状，包括胃脘痛、腹胀和恶心。生姜（Zingiber officinale）是一种天然膳食补充剂，传统上用于缓解胃肠道不适，关于其在FD患者中的安全性和耐受性的证据有限。目的评价FD患者补充生姜的安全性、耐受性和不良反应。方法本开放临床试验在德布勒森大学内科门诊部进行。这项研究是在完全遵守《赫尔辛基宣言》中概述的伦理原则的情况下进行的。研究方案由德布勒森大学伦理委员会审查并批准（注册参考号：DE RKEB/IKEB 5622-2020）。所有参与者在纳入研究之前都提供了书面知情同意书。最初招募了50名FD患者，47名参与者完成了研究。补充生姜的剂量为1080mg /d，分次服用，持续8周。每周通过临床评估和自我报告评估不良反应，并在试验结束时由参与者评估耐受性。结果该研究包括47例FD患者，他们完成了试验，平均（SD）年龄为51.49（14.64）岁。在参与者中，78.7%是女性。生姜补充剂耐受性良好，报告有轻微和短暂的不良反应，包括腹胀（14.9%）、胃灼热（12.8%）和腹泻（10.6%）。这些不良事件都不需要停止治疗。87.2%的参与者的耐受性被评为良好或优秀，没有观察到严重的不良事件。结论初步研究结果表明，生姜具有良好的耐受性，可能是一种可行的膳食补充疗法，但仍需进一步研究。ClinicalTrials.gov识别码：NCT06313814。

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来源期刊

Current Therapeutic Research-clinical and Experimental 医学-药学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

3 months

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