Title:Effectiveness and Safety of A Nutraceutical Formulation for the Treatment of Functional Dyspepsia in Primary Care
Volume: 16
Issue: 3
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 and Pasquale Zecchillo
Affiliation:
- Territorial Gastroenterology Service, ASL BAT, Andria (BT),Italy
Keywords:
Nutraceutics, functional dyspepsia, primary care, Thymus extract treatment Zingiber officinalis, gingerol and thymus.
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.
