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

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.

Correlation between sigma2 receptor protein expression and histopathologic grade in human bladder cancer.

Sigma2 (sigma2) receptor proteins are overexpressed in several tissues and tumour cell lines. Although the biomolecular mechanism of this overexpression must be elucidated, sigma2 receptor was considered a potential biomarker for monitoring solid tumour proliferation. In this study, we verified first sigma2 receptor overexpression by saturation analysis with radioligand in six human bladder cancer specimens, then if a possible correlation could be established between sigma2 overexpression and tumour tissue stage and grade. The results displayed that sigma2 receptor protein was normally expressed in human bladder and overexpressed in the case of high-grade transitional cell carcinomas. Moreover, these receptors were undetected in a low-grade squamous cell carcinoma and in a very rare form of anaplastic, large cells plasmacytoid cancer.