Territorial Gastroenterology Service, ASL BAT, Andria (BT), Italy.
Division of Surgery, "P. Colombo" Hospital, ASL Roma 6, Velletri (Rome), Italy.
Rev Recent Clin Trials. 2021;16(3):329-334. doi: 10.2174/1574887116666210612034911.
Although FD may affect up to 10% of the general population, the therapy for FD is not standard. Recently, ginger-based food supplements have been proposed in order to restore FD symptoms. Our aim was to assess the efficacy of a new nutraceutical formulation containing extract of gingerol and thymus as a possible natural treatment in managing the symptoms of functional dyspepsia (FD).
We retrospectively analyzed the efficacy and safety profiles of a nutraceutical formulation containing Zingiber officinalis root extract and a standardized Thymus extract. It was administered as 1 ml/day twice a day for 90 days. Patients were assessed at baseline and after 1, 2 and 3 months of treatment, following a month of pharmacological washout by completing a questionnaire reporting the trend of the following symptoms: epigastric pain, epigastric heaviness, early satiety, belching, and regurgitation. Every symptom was assessed by a Visual Analogic Scale (VAS), ranging from 0= absence to 10= maximal severity.
We enrolled 272 patients (99 males and 173 females; median IQR age 49.5, 36-64 yrs). Obesity (BMI>30) was present in 28 (12.5%) patients; smokers were 83 (30.5%); and comorbidities were present in 107 (39.3%) patients. Improvement of symptom scores during treatment and one month after its suspension was extremely significant (p<0.000).
This large study found that nutraceutical formulation could be one of the tools for an empirical approach to treat patients with FD, especially when a non-conventional drug treatment is preferable for the patient and considered suitable by the physician.
功能性消化不良（FD）在普通人群中的发病率可能高达 10%，但其治疗方法并不标准。最近，有人提出使用姜类食品补充剂来恢复 FD 症状。我们旨在评估一种含有姜辣素和百里香提取物的新型营养配方作为功能性消化不良（FD）症状的可能自然治疗方法的疗效。
我们回顾性分析了一种含有生姜根提取物和标准化百里香提取物的营养配方的疗效和安全性。该配方每天两次，每次 1 毫升，持续 90 天。患者在基线时和治疗后 1、2 和 3 个月以及停药 1 个月后进行评估，通过填写问卷报告以下症状的趋势：上腹痛、上腹沉重感、早饱、嗳气和反流。每个症状均通过视觉模拟评分（VAS）进行评估，范围为 0=无到 10=最大严重程度。
我们共纳入 272 例患者（99 例男性和 173 例女性；中位数 IQR 年龄 49.5，36-64 岁）。28 例（12.5%）患者存在肥胖症（BMI>30）；83 例（30.5%）为吸烟者；107 例（39.3%）患者存在合并症。治疗期间和停药后 1 个月，症状评分的改善极为显著（p<0.000）。
这项大型研究发现，营养配方可能是治疗 FD 患者的一种经验方法的工具之一，特别是当患者偏好非传统药物治疗且医生认为合适时。
