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Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies.

ABSTRACT: INTRODUCTION:Fibromyalgia syndrome (FM) is characterized by persistent pain which is often refractory to common analgesic therapies and is particularly disabling. The objective of this study was to evaluate the therapeutic efficacy of duloxetine (DLX) + pregabalin (PGB) in patients suffering from FM and the possible added benefit of the lipid signaling molecule, palmitoylethanolamide (PEA). PEA is well-documented to exert anti-inflammatory, analgesic, and pain-relieving effects at both the preclinical and clinical level. METHODS:A total of 80 patients were recruited in two steps. The first was a retrospective observational study comprising 45 patients. This patient group received DLX + PGB for 6 months. The second step was a prospective observational study with 35 patients. Patients in this cohort began treatment with DLX + PGB at the same dosage as for the retrospective study plus micronized PEA (PEA-m(®); Epitech Group, Italy) and ultramicronized PEA (PEA-um(®); Epitech Group, Italy) for 3 months. Positive tender points (TPs), pain evoked, and pain intensity were evaluated at baseline and after 3 and 6 months in both studies. Statistical analyses were employed for comparison of data within the two studies and between them. RESULTS:The retrospective observational study (DLX + PGB), after 3 months of treatment showed a decrease of positive TPs, pain evoked, and pain intensity. After 6 months of treatment, these parameters had further improvement. In the prospective observational study (DLX + PGB + PEA), PEA introduction after 3 months of therapeutic regimen with DLX + PGB provided a significant improvement in pain symptoms, with a further reduction in the number of TPs and significant reduction in pain, compared to combined DLX + PGB only (p < 0.0001 for TPs and Visual Analog Scale comparisons). None of the patients experienced adverse side effects. CONCLUSION:Our study confirms the efficacy of DLX + PGB and demonstrates as well the added benefit and safety of PEA in the treatment of pain in patients affected by FM.

SUBMITTER: Del Giorno R

PROVIDER: S-EPMC4676767 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPerioperative FLOT (5-fluorouracil, oxaliplatin and docetaxel) has recently become the gold standard treatment for fit patients with operable gastric (GC) or gastroesophageal (GEJ) adenocarcinoma, getting a 5-year overall survival (OS) of 45%, over 23% with surgery alone.MethodsRealFLOT is an Italian, multicentric, observational trial, collecting data from patients with resectable GC or GEJ adenocarcinoma treated with perioperative FLOT. Aim of the study was to describe feasibility and safety of FLOT, pathological complete response rate (pCR), surgical outcomes and overall response rate (ORR) in an unselected real-world population. Additional analyses evaluated the correlation between pCR and survival and the prognostic role of microsatellite instability (MSI) status.ResultsOf 206 patients enrolled that received perioperative FLOT at 15 Italian centers, 124 (60.2%) received at least 4 full-dose cycles, 190 (92.2%) underwent surgery, and 142 (68.9%) started the postoperative phase. Among patients who started the postoperative phase, 105 (51.0%) received FLOT, while 37 (18%) received de-intensified regimens, depending on clinical condition or previous toxicities. pCR was achieved in 7.3% of cases. Safety profile was consistent with literature. Neutropenia was the most common G 3-4 adverse event (AE): 19.9% in the preoperative phase and 16.9% in the postoperative phase. No toxic death was observed and 30-day postoperative mortality rate was 1.0%. ORR was 45.6% and disease control rate (DCR) was 94.2%. Disease-free survival (DFS) and OS were significantly longer in case of pCR (p = 0.009 and p = 0.023, respectively). A trend towards better DFS was observed among MSI-H patients.ConclusionsThese real-world data confirm the feasibility of FLOT in an unselected population, representative of the clinical practice. pCR rate was lower than expected, nevertheless we confirm pCR as a predictive parameter of survival. In addition, MSI-H status seems to be a positive prognostic marker also in patients treated with taxane-containing triplets.

Project description:BackgroundThe demographic changes in Brazil as a result of population aging is one of the fastest in the world. The far-reaching new challenges that come with a large older population are particularly disquieting in low- and middle-income countries (LMICs). Longitudinal studies must be completed in LMICs to investigate the social and biological determinants of aging and the consequences of such demographic changes in their context. Therefore, we designed the Prospective GERiatric Observational (ProGERO) study, a longitudinal study of outpatient older adults in São Paulo, Brazil, to collect data both on aging and chronic diseases, and investigate characteristics associated with adverse outcomes in this population.MethodsThe ProGERO study takes place in a geriatric outpatient clinic in the largest academic medical center in Latin America. We performed baseline health examinations in 2017 and will complete subsequent in-person visits every 3 years when new participants will also be recruited. We will use periodic telephone interviews to collect information on the outcomes of interest between in-person visits. The baseline evaluation included data on demographics, medical history, physical examination, and comprehensive geriatric assessment (CGA; including multimorbidity, medications, social support, functional status, cognition, depressive symptoms, nutritional status, pain assessment, frailty, gait speed, handgrip strength, and chair-stands test). We used a previously validated CGA-based model to rank participants according to mortality risk (low, medium, high). Our selected outcomes were falls, disability, health services utilization (emergency room visits and hospital admissions), institutionalization, and death. We will follow participants for at least 10 years.ResultsWe included 1336 participants with a mean age of 82 ± 8 years old. Overall, 70% were women, 31% were frail, and 43% had a Charlson comorbidity index score ≥ 3. According to our CGA-based model, the incidence of death in 1 year varied significantly across categories (low-risk = 0.6%; medium-risk = 7.4%; high-risk = 17.5%; P < 0.001).ConclusionThe ProGERO study will provide detailed clinical data and explore the late-life trajectories of outpatient older patients during a follow-up period of at least 10 years. Moreover, the study will substantially contribute to new information on the predictors of aging, senescence, and senility, particularly in frail and pre-frail outpatients from an LMIC city.

Project description:ObjectiveTo derive and validate an objective clinical prediction rule for the presence of uncomplicated ureteral stones in patients eligible for computed tomography (CT). We hypothesized that patients with a high probability of ureteral stones would have a low probability of acutely important alternative findings.DesignRetrospective observational derivation cohort; prospective observational validation cohort.SettingUrban tertiary care emergency department and suburban freestanding community emergency department.ParticipantsAdults undergoing non-contrast CT for suspected uncomplicated kidney stone. The derivation cohort comprised a random selection of patients undergoing CT between April 2005 and November 2010 (1040 patients); the validation cohort included consecutive prospectively enrolled patients from May 2011 to January 2013 (491 patients).Main outcome measuresIn the derivation phase a priori factors potentially related to symptomatic ureteral stone were derived from the medical record blinded to the dictated CT report, which was separately categorized by diagnosis. Multivariate logistic regression was used to determine the top five factors associated with ureteral stone and these were assigned integer points to create a scoring system that was stratified into low, moderate, and high probability of ureteral stone. In the prospective phase this score was observationally derived blinded to CT results and compared with the prevalence of ureteral stone and important alternative causes of symptoms.ResultsThe derivation sample included 1040 records, with five factors found to be most predictive of ureteral stone: male sex, short duration of pain, non-black race, presence of nausea or vomiting, and microscopic hematuria, yielding a score of 0-13 (the STONE score). Prospective validation was performed on 491 participants. In the derivation and validation cohorts ureteral stone was present in, respectively, 8.3% and 9.2% of the low probability (score 0-5) group, 51.6% and 51.3% of the moderate probability (score 6-9) group, and 89.6% and 88.6% of the high probability (score 10-13) group. In the high score group, acutely important alternative findings were present in 0.3% of the derivation cohort and 1.6% of the validation cohort.ConclusionsThe STONE score reliably predicts the presence of uncomplicated ureteral stone and lower likelihood of acutely important alternative findings. Incorporation in future investigations may help to limit exposure to radiation and over-utilization of imaging.Trial registrationwww.clinicaltrials.gov NCT01352676.

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Palmitoylethanolamide in Fibromyalgia: Results from Prospective and Retrospective Observational Studies.

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