Effectiveness and Safety of A Nutraceutical Formulation for the Treatment of Functional Dyspepsia in Primary Care

Author(s): Antonio Tursi*, Marcello Picchio, Walter Elisei, Leonardo Allegretta, Pierluigi Benedicenti, Fabrizio Bossa, Simone Di Bella, Antonio Elefante, Stefano Gallina, Federica Greco, Francesco Maurichi, Antonio Pio Palieri, Antonio Penna, Giuseppe Pranzo, Giovanni Luca Rizzo, Giovanni Brandimarte, Ludovico Abenavoli, Maria Santa Alfieri, Natale Antonino, Carlo Autorino, Pasquale Bellomo, Carlo Casamassima, Basilio Paolo Colucci, Vincenzo De Cristofaro, Rocco Demauro, Pietro Derenzio, Francesco Detommasi, Michele Fazio, Vincenzo Ferrari, Alessio Gallo, Donatella Greco, Vito Lisco, Francesco Lore, Michele Manfredi, Giorgio Marsano, Pasquale Mascoli, Luigi Mazzilli, Giovanni Messa, Giulio Minoretti, Pasquale Misciagna, Francesco Monterisi, Saverio Nappi, Anna Rosa Resta, Pasquale Saponaro, Giovanni Sbarra, Salvatore Scutifero, Vincenzo Selvaggio, Giuseppe Sica, Mario Tarallo, Giancarlo Torelli, Costantino Vigilante, Pasquale Zecchillo

Journal Name: Reviews on Recent Clinical Trials

Volume 16 , Issue 3 , 2021


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Graphical Abstract:


Abstract:

Background: 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).

Methods: 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.

Results: 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).

Conclusion: 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.

Keywords: Nutraceutics, functional dyspepsia, primary care, Thymus extract treatment Zingiber officinalis, gingerol and thymus.

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Article Details

VOLUME: 16
ISSUE: 3
Year: 2021
Published on: 02 July, 2021
Page: [329 - 334]
Pages: 6
DOI: 10.2174/1574887116666210612034911
Price: $65

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