1. Effectiveness and Safety of A Nutraceutical Formulation for the Treatment of Functional Dyspepsia in Primary Care
- Author
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Giuseppe Sica, Maria Santa Alfieri, Antonio Pio Palieri, Pasquale Zecchillo, Luigi Mazzilli, Antonio Tursi, Francesco Detommasi, Fabrizio Bossa, Marcello Picchio, Giovanni Brandimarte, Leonardo Allegretta, Vincenzo De Cristofaro, Giovanni Sbarra, Michele Manfredi, Giovanni Messa, Antonio Penna, Pietro Derenzio, Basilio Paolo Colucci, Rocco Demauro, Saverio Nappi, Michele Fazio, Francesco Maurichi, Federica Greco, Francesco Monterisi, Alessio Gallo, Mario Tarallo, Pasquale Bellomo, Costantino Vigilante, Vito Lisco, Walter Elisei, Vincenzo Ferrari, Francesco Lore, Pasquale Saponaro, Antonio Elefante, Natale Antonino, Giorgio Marsano, Giancarlo Torelli, Anna Rosa Resta, Carlo Autorino, Ludovico Abenavoli, Giuseppe Pranzo, Simone Di Bella, Giulio Minoretti, Pierluigi Benedicenti, Stefano Gallina, Carlo Casamassima, Pasquale Mascoli, Salvatore Scutifero, Giovanni Luca Rizzo, Donatella Greco, Pasquale Misciagna, and Vincenzo Selvaggio
- Subjects
Male ,medicine.medical_specialty ,Population ,Primary care ,Epigastric pain ,Drug treatment ,Nutraceutical ,Internal medicine ,medicine ,Humans ,Dyspepsia ,education ,Retrospective Studies ,Pharmacology ,Thymus extract ,education.field_of_study ,Primary Health Care ,business.industry ,General Medicine ,Middle Aged ,medicine.disease ,Obesity ,Abdominal Pain ,Dietary Supplements ,Large study ,Female ,business - 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 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.
- Published
- 2021
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