Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis.

BACKGROUND: The superiority of early drain removal (EDR) versus late (LDR) after pancreaticoduodenectomy (PD) has been demonstrated only in RCTs. METHODS: A meta-analysis was conducted using a random-effects model and trial sequential analysis. The critical endpoints were morbidity, redrainage, relaparotomy, and postoperative pancreatic fistula (CR-POPF). Hemorrhage (PPH), delayed gastric emptying (DGE), length of stay (LOS), and readmission rates were also evaluated. Risk ratios (RRs) and mean differences (MDs) with a 95% confidence interval (CI) were calculated. Type I and type II errors were excluded, comparing the accrued sample size (ASS) with the required sample size (RIS). When RIS is superior to ASS, type I or II errors can be hypothesized. RESULTS: ASS was 632 for all endpoints except DGE and PPH (557 patients). The major morbidity (RR 0.55; 95% CI 0.32-0.97) was lower in the EDR group. The CR-POPF rate was lower in the EDR than in the LDR group (RR 0.50), but this difference is not statistically significant (95% CI 0.24-1.03). The RIS to confirm or exclude these results can be reached by randomizing 5959 patients. The need for percutaneous drainage, relaparotomy, PPH, DGE, and readmission rates was similar. The related RISs were higher than ASS, and type II errors cannot be excluded. LOS was shorter in the EDR than the LDR group (MD - 2.25; 95% CI - 3.23 to - 1.28). The RIS was 567, and type I errors can be excluded. CONCLUSIONS: EDR, compared with LDR, is associated with lower major morbidity and shorter LOS.

[Preparedness for emergencies: strategies to increase the supply of beds and advanced intensive skills]. / Prepararsi alle emergenze: strategie per aumentare l'offerta di posti letto e di competenze intensive avanzate.

. Preparedness for emergencies: strategies to increase the supply of beds and advanced intensive skills. INTRODUCTION: The recent pandemic has highlighted the importance of emergency preparedness plans. In addition to technological and structural resources, it is essential to have professionals with skills that allow them to safely work in intensive care areas. AIM: The aim of the contribution is to propose an intervention model to develop the skills of nurses of operatory theatres or intensive care to enable them to work safely in critical care settings. METHODS: A plan was devised, involving a multiprofessional group to increase the number of beds in the intensive and semi-intensive care areas, as well as to train staff, hypothesising the activities to be reduced by moving staff to different areas. RESULTS: The proposed organisational model could be implemented in other hospitals; it guarantees emergency preparedness and the expansion of the skills of the staff involved. CONCLUSIONS: Nursing staff with advanced skills should be readily available to safely guarantee the expansion of intensive care beds. The current division between intensive and semi-intensive settings could be revised in favour of a single critical care area.

Anthocran® Phytosome®: Prevention of Recurring Urinary Infections and Symptoms after Catheterization.

In this preliminary pilot registry study, we investigated the effects of the oral supplementation of a standardized cranberry extract (Anthocran® Phytosome®, Indena) delivered by a lecithin-based system, for the prophylactic management of recurrent-urinary tract infections (R-UTIs). We included 64 otherwise healthy subjects who underwent a surgical procedure and required post-surgical urinary catheterization for high-risk UTIs or a previous history of R-UTIs. Patients were given supplementation with the standardized cranberry extract at the dose of either 120 mg/day (n = 12) or 240 mg/day (n = 12) or assigned to a control group consisting of standard management (SM; n = 18) or nitrofurantoin administration (n = 22) for 4 weeks. After 4 weeks, patients receiving the standardized cranberry supplementation reported to have a more effective reduction in UTI symptoms, as assessed on the visual analogue scale, compared with patients in the SM or nitrofurantoin groups. The occurrence of hematuria and urine bacterial contamination were decreased among patients treated with the supplement compared with controls (p < 0.05). The cranberry extract was also superior to the control management in terms of recurrence of signs/symptoms, with none of the patients in this group suffering from a R-UTI in the 3 months following the study end (p < 0.05). The supplementation showed an optimal safety profile, with no significant adverse events and no drop-outs in the supplement group. This registry shows that this cranberry extract is effective as a supplementary, preventive management in preventing post-operative, post-catheter UTIs; the product has a good tolerability profile.

Supplementation with a new food grade delivery system of Boswellia and Centella in the intervertebral discs registry: the Sager study.

BACKGROUND: The aim of this registry study was to investigate the potential of a new food-grade formulation of the association of Boswellia serrata and Centella asiatica extracts (Boswellia/Centella Phytosome, [BCP]) in combination with standard management (SM) to produce a faster re-expansion of the intervertebral disks in symptomatic subjects with "flattened" disks in the lower spine, due to wrong posture and compression after repeated trauma. METHODS: The study was designed as a 3-6 months pilot registry. Three groups of subjects were comparable for characteristics and symptoms at baseline: SM+BCP; SM; SM+glucosamine. RESULTS: No side effects were observed. Regarding target measurements at 3 and 6 months, height increased in the BCP group vs. the other two groups. The total spine length improved in the BCP group (P<0.05); in particular at 6 months the increase was doubled with BCP. SM was effective in producing elongation but the association with BCP made spinal elongation faster, more effective, with a better expansion of the intervertebral disks. Regarding ultrasound measurements, BCP was able to significantly ameliorate the posterior disk space (P<0.05) and decreased disk density more than the other groups of the study. Signs/symptoms and mobility were improved with BCP (P<0.05), while rescue medications decreased. The loss of working days was reduced with all managements (significantly more in BCP group than in the other two). CONCLUSIONS: The relative effects on spinal elongation, disk space, signs/symptoms of BCP appeared to double the efficacy of SM, improving symptoms associated to a very good tolerability of BCP.

Quercetin as a possible complementary agent for early-stage COVID-19: Concluding results of a randomized clinical trial.

Background: Quercetin, a natural polyphenol with demonstrated broad-spectrum antiviral, anti-inflammatory, and antioxidant properties, has been proposed as an adjuvant for early-stage coronavirus disease 2019 (COVID-19) infection. Objective: To explore the possible therapeutic effect of quercetin in outpatients with early-stage mild to moderate symptoms of COVID-19. Methods: This was an open-label randomized controlled clinical trial conducted at the department of medicine, King Edward Medical University, Lahore, PK. Patients were randomized to receive either standard of care (SC) plus an oral quercetin supplement (500 mg Quercetin Phytosome®, 1st week, TDS: 2nd week, BDS) (n = 50, quercetin group) or SC alone (n = 50, control group). Results: After one week of treatment, patients in the quercetin group showed a speedy recovery from COVID-19 as compared to the control group, i.e., 34 patients (vs. 12 in the control group) tested negative for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (p = 0.0004), and 26 patients (vs. 12 in the control group) had their COVID-19-associated acute symptoms resolved (p = 0.0051). Patients in the quercetin group also showed a significant fall in the serum lactate dehydrogenase (LDH) mean values i.e., from 406.56 ± 183.92 to 257.74 ± 110.73 U/L, p = 0.0001. Quercetin was well-tolerated by all the 50 patients, and no side effects were reported. Conclusion: Our results, suggest the possible therapeutic role of quercetin in early-stage COVID-19, including speedy clearance of SARS-CoV-2, early resolution of the acute symptoms and modulation of the host's hyperinflammatory response. Clinical Trial Registration: clinicaltrials.gov, identifier NCT04861298.

Efficacy of artichoke and ginger extracts with simethicone to treat gastrointestinal symptoms in endurance athletes: a pilot study.

BACKGROUND: Exercise-induced gastrointestinal (GI) symptoms are frequently reported by athletes during training and competitions. A standardized combination of artichoke leaves and ginger root extracts has shown beneficial effects in managing GI discomfort in otherwise healthy subjects. METHODS: In this pilot study, we assessed the effectiveness of artichoke leaves and ginger root extracts combination associated with simethicone in reducing exercise-related GI symptoms in endurance athletes. The effects of the combination on upper/lower GI and systemic symptoms were assessed at baseline and after 4 weeks through a questionnaire. RESULTS: Fifty endurance athletes took the extracts' combination 320 mg + simethicone 40 mg chewable pills. The extracts combination and simethicone were effective in reducing the mean intensity of upper GI (86.6%) lower GI (85.9%) and systemic symptoms (81.9%), with superior results compared to placebo. The most remarkable effects were reported in the lower GI tract, with a significant decrease in flatulence, intestinal cramps, loose stools and diarrhea. Athletes also benefited from a reduction in belching and bloating and in dizziness, headache and muscle cramps, although the decrease in systemic symptoms was not significant. CONCLUSIONS: The supplementation of standardized artichoke and ginger extracts, combined with simethicone, may be effective in decreasing digestive discomfort and alteration of gastric motility not only in healthy subjects but also in endurance athletes.

Potential Clinical Benefits of Quercetin in the Early Stage of COVID-19: Results of a Second, Pilot, Randomized, Controlled and Open-Label Clinical Trial.

BACKGROUND: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of the ongoing global pandemic known as COVID-19. Based on the potential antiviral role of quercetin, and on its described anti-blood clotting, anti-inflammatory and antioxidant properties, we hypothesize that subjects with mild COVID-19 treated with Quercetin Phytosome® (QP), a novel bioavailable form of quercetin, may have a shorter time to virus clearance, a milder symptomatology, and higher probabilities of a benign earlier resolution of the disease. METHODS: In our 2-week, randomized, open-label, and controlled clinical study, we have enrolled 42 COVID-19 outpatients. Twenty-one have been treated with the standard of care (SC), and 21 with QP as add-on supplementation to the SC. Our main aims were to check virus clearance and symptoms. RESULTS: The interim results reveal that after 1 week of treatment, 16 patients of the QP group were tested negative for SARS-CoV-2 and 12 patients had all their symptoms diminished; in the SC group, 2 patients were tested SARS-CoV-2 negative and 4 patients had their symptoms partially improved. By 2 weeks, the remaining 5 patients of the QP group tested negative for SARS-CoV-2, whereas in the SC group out of 19 remaining patients, 17 tested negatives by week 2, one tested negative by week 3 and one patient, still positive, expired by day 20. Concerning blood parameters, the add on therapy with QP, reduced LDH (-35.5%), Ferritin (-40%), CRP (-54.8%) and D-dimer (-11.9%). CONCLUSION: QP statistically shortens the timing of molecular test conversion from positive to negative, reducing at the same time symptoms severity and negative predictors of COVID-19.

Possible Therapeutic Effects of Adjuvant Quercetin Supplementation Against Early-Stage COVID-19 Infection: A Prospective, Randomized, Controlled, and Open-Label Study.

BACKGROUND: Quercetin, a well-known naturally occurring polyphenol, has recently been shown by molecular docking, in vitro and in vivo studies to be a possible anti-COVID-19 candidate. Quercetin has strong antioxidant, anti-inflammatory, immunomodulatory, and antiviral properties, and it is characterized by a very high safety profile, exerted in animals and in humans. Like most other polyphenols, quercetin shows a very low rate of oral absorption and its clinical use is considered by most of modest utility. Quercetin in a delivery-food grade system with sunflower phospholipids (Quercetin Phytosome®, QP) increases its oral absorption up to 20-fold. METHODS: In the present prospective, randomized, controlled, and open-label study, a daily dose of 1000 mg of QP was investigated for 30 days in 152 COVID-19 outpatients to disclose its adjuvant effect in treating the early symptoms and in preventing the severe outcomes of the disease. RESULTS: The results revealed a reduction in frequency and length of hospitalization, in need of non-invasive oxygen therapy, in progression to intensive care units and in number of deaths. The results also confirmed the very high safety profile of quercetin and suggested possible anti-fatigue and pro-appetite properties. CONCLUSION: QP is a safe agent and in combination with standard care, when used in early stage of viral infection, could aid in improving the early symptoms and help in preventing the severity of COVID-19 disease. It is suggested that a double-blind, placebo-controlled study should be urgently carried out to confirm the results of our study.

The Relevance of Assessing Subjective Experiences of Skin Toxicity During Adjuvant Radiotherapy for Breast Cancer.

PURPOSE: Radiodermatitis is likely to be an inevitable side effect of radiotherapy (RT) but experiencing pain relief during RT might contribute making treatment more acceptable and less impairing. The current study aimed to assess the subjective perceptions and experiences of skin toxicity in a sample of women undergoing adjuvant RT for breast cancer. METHODS: Eighty patients were randomly assigned to one out of two groups: treatment (i.e., a newly developed topical product) and control (i.e., standard-of-care). Patients underwent adjuvant RT for 3 weeks. Clinical assessment of radiodermatitis and self-reported levels of pain, relief, and perceptions of treatment response were collected at the initiation of RT (T1), during RT (T2 and T3), and 2 weeks after treatment completion (T4). To assess changes in skin-related QoL, a subgroup of patients completed the Padua Skin-Related QoL questionnaire at T0 (before the initiation of RT) and at T4. RESULTS: A comparable timing of onset and severity of radiodermatitis during treatment was observed in both groups. The treatment group reported lower levels of pain and higher levels of relief compared to the control group when skin toxicity was at its highest levels (T2 and T3). Independent of the group, levels of perceived improvements in clinical status increased over time, whereas skin-related QoL worsened from T0 to T4. CONCLUSION: Current findings outline the relevance of integrating clinical evaluations of radiodermatitis with patients' subjective experiences of skin toxicity in interventional studies. Moreover, they provide preliminary evidence about the soothing effect of a newly developed topical product, thus supporting its usefulness of as a supportive care.

A sport cream (Harpago-Boswellia-ginger-escin) for localized neck/shoulder pain.

BACKGROUND: Neck/shoulder, sudden pain, or muscular pain (not associated to structural or bone/joints components), due to fascial or muscular strain is common in active subjects, in non-professional athletes and sports performers. The aim of this supplement registry was the evaluation of a cream based on natural, active ingredients for topical application in supporting the improvement of pain and improving head/neck mobility, possibly minimizing the use of systemic drugs. METHODS: The cream includes standardized active ingredients of natural origin as an extract of Harpagophytum procumbes, an extract from Boswellia serrata, a CO2 extract of ginger and escin. Subjects were divided into three groups, all using the standard management (SM) in combination with the Sport Cream or in addition to Flector (diclofenac) patch. RESULTS: The groups were comparable and homogeneous at the baseline. No side effects or skin tolerability issues were observed with the Sport Cream nor with the SM or diclofenac patches. Subjects receiving sport cream + SM reported a significant improvement in pain, stiffness, altered mobility and altered working capacity, with a reduced need for rescue medication (diclofenac) compared to subjects in the other two groups. CONCLUSIONS: Finally, subjects receiving sport cream + SM reported a more remarkable decrease in skin temperature in the affected area associated to an improvement in clinical symptoms.

Oral administration of a lecithin-based delivery form of boswellic acids (Casperome®) for the prevention of symptoms of irritable bowel syndrome: a randomized clinical study.

BACKGROUND: The purpose of this study was to evaluate the long-term efficacy and the safety of a lecithin-based delivery form of boswellic acids from Boswellia serrata (Casperome®) for the prevention of symptoms in otherwise healthy subjects with mild irritable bowel syndrome (IBS). METHODS: The study included 69 otherwise healthy participants with a mild form of IBS who completed a 6-month follow-up period. In total, 34 subjects were assigned to the standard management (SM) group: diet and, if needed, hyoscine butylbromide (Buscopan®) or papaverine hydrochloride + 10 mg of Atropa belladonna extract; 35 subjects were assigned to supplementation with the Boswellia serrata lecithin-based delivery form (one tablet/day; Casperome®). IBS signs and symptoms were evaluated at inclusion (T0), after 3 (T1) and 6 months (T2). The numbers of patients who needed rescue medication were recorded. Adverse events were also evaluated. RESULTS: At baseline, the groups were comparable in terms of demographic and clinical characteristics. At follow-up, compared with the SM group, the Boswellia group showed lower mean score values for almost all self-assed IBS symptoms. A significantly lower need for rescue medications and consultations or medical evaluation/admissions was found in the Boswellia group compared with the SM group. The incidence of minimal adverse events - mainly stipsis - was significantly higher in the SM group. Oxidative stress at T2 was significantly decreased in Boswellia-supplemented subjects. CONCLUSIONS: Boswellia serrata lecithin-based delivery form (Casperome®) appears to be effective and safe in improving signs and symptoms in IBS subjects who are otherwise healthy, particularly in comparison with symptomatic drug treatment that may cause side effects and stiptis.

Quercetin phytosome® in triathlon athletes: a pilot registry study.

BACKGROUND: Oxidative stress is associated with delayed recovery and higher risk of post-training pain in triathlon athletes. Therefore, supplementation with antioxidant compounds may have a role in enhancing recovery. Quercetin presents marked antioxidant activity. In this pilot registry study, we evaluated the effects of the supplementation with a novel proprietary delivery form (phytosome®) of quercetin in amateur triathlon athletes. METHODS: We employed a specific study model of triathlon according to the "Sprint" distance. The individual triathlon training included repetition of the run 8 times in 14 days. A group of athletes used quercetin phytosome® supplementation (one tablet of 250 mg quercetin phytosome® twice daily). A control group did not use supplementation. All subjects attended a baseline measurement run and a second final measurement run at day 14. At the end of the study, subjective performance, post-training pain, cramps, time to full recovery and oxidative stress were measured. RESULTS: In total, 23 subjects used the supplement and 25 did not. No side effects were reported. The improvement of time to complete the run was greater in subjects on quercetin supplementation compared with the control group (-11.3% vs. -3.9%; P<0.05). Training was considered more valuable in the quercetin group compared with controls (P<0.05). Similarly, post-run muscular pain, cramps, localized pain and the post-exercise recovery time were all considered better with the supplementation (P<0.05). Oxidative stress was also reduced (P<0.05). CONCLUSIONS: This pilot study suggests that the oral supplementation with quercetin phytosome® may result in improved training and performance in amateur triathlon athletes.

In vivo validation of the multicomponent powder (Vitachelox®) against the deposition of polluting ions.

PURPOSE: The purpose of this in vivo study is to evaluate the acute clinical application of a multicomponent powder (Vitachelox®), including three naturally occurring standardized extracts rich in polyphenols (grape seed extract, green tea extract, oak wood/bark extract), on healthy volunteers by measuring prevention of any metal deposition within the stratum corneum (SC) following a 6-h exposure period in a polluted environment. PATIENTS AND METHODS: In this in vivo study, we evaluated the skin protective activity of the multicomponent powder formulated in a base emulsion compared to a relevant placebo cream. Using the tape stripping method, SC samples of face skin obtained from 30 healthy volunteers were compared following a 6-h exposure in a polluted area. RESULTS: No statistically significant variations on the amount of heavy metals were found in the samples of SC cells obtained from the hemi-faces treated with the multicomponent powder, with respect to baseline. On the contrary, a significantly higher concentration of heavy metals was found in the cells samples obtained from the hemi-faces treated with the placebo cream. In particular, an increased concentration of heavy metals superior to 100% were found for iron and zinc (+130.2% and +142.6%, respectively; p<0.001). CONCLUSION: This in vivo study validates and extends previous in vitro findings, indicating that the multicomponent powder allows the prevention of any metal deposition within the SC following exposure in a polluted environment. Our results suggest that the test product could play an effective role in counteracting skin damages induced by air pollution.

Efficacy and tolerability of a plant-based, multi-component cream (Ginetrox®) in vulvovaginal disorders of the genitourinary syndrome during menopause.

BACKGROUND: Genitourinary syndrome of menopause (GSM) is a symptomatic condition including vaginal dryness, irritation, dyspareunia and recurrent urinary tract infections which affects 40-54% of post-menopausal women. Although several estrogen-based therapies are available, it is generally preferable to avoid hormonal therapy, particularly in women with mild symptoms or at risk for estrogen-responsive neoplasia. Therefore, the most common treatment options are over-the-counter vaginal creams for symptomatic relief. METHODS: Thirty-three postmenopausal women suffering from GSM were enrolled in this observational study. A multi-component cream (Ginetrox®, Indena, Milan, Italy) was applied on the vestibular area of the vagina for three months. The primary endpoints were: vaginal burning and/or pain, assessed by Visual Analog Scale and dyspareunia, assessed using the Marinoff Score. As a secondary endpoint, vestibular health was evaluated through a four-point scale. Side effects and adherence to treatment were also recorded. RESULTS: Statistically significant improvement was observed in pain scores and dyspareunia at the end of the treatment compared to baseline values. The vestibular health index significantly decreased after 3 months. Tolerability was acceptable. CONCLUSIONS: This preliminary study suggests that the plant-based, multi-component cream Ginetrox® could be effective and safe in counteracting menopause-related vaginal discomfort symptoms.

In-hospital elderly mortality and associated factors in 12 Italian acute medical units: findings from an exploratory longitudinal study.

BACKGROUND: Given the progressive demographic ageing of the population and the National Health System reforms affecting care at the bedside, a periodic re-evaluation of in-hospital mortality rates and associated factors is recommended. AIMS: To describe the occurrence of in-hospital mortality among patients admitted to acute medical units and associated factors. Two hypotheses (H) were set as the basis of the study: patients have an increased likelihood to die H1: at the weekend when less nursing care is offered; H2: when they receive nursing care with a skill-mix in favour of Nursing Aides instead of Registered Nurses. METHODS: Secondary analysis of a prospective study of patients >65 years consecutively admitted in 12 Italian medical units. Data on individual and nursing care variables were collected and its association with in-hospital mortality was analysed by stepwise logistic regression analysis. RESULTS: In-hospital mortality occurrence was 6.8 %, and 37 % of the patients died during the weekend. The logistic regression model explained 34.3 % (R 2) of the variance of in-hospital mortality: patients were six times (95 % CI = 3.632-10.794) more likely at risk of dying at weekends; those with one or more AEDs admissions in the last 3 months were also at increased risk of dying (RR 1.360, 95 % CI = 1.024-1.806) as well as those receiving more care from family carers (RR = 1.017, 95 % CI = 1.009-1.025). At the nursing care level, those patient receiving less care by RNs at weekends were at increased risk of dying (RR = 2.236, 95 % CI = 1.270-3.937) while those receiving a higher skill-mix, thus indicating that more nursing care was offered by RNs instead of NAs were at less risk of dying (RR = 0.940, 95 % CI = 0.912-0.969). CONCLUSIONS: Within the limitations of this secondary analysis, in addition to the role of some clinical factors, findings suggest redesigning acute care at weekends ensuring consistent care both at the hospital and at the nursing care levels.

Soothing and anti-itch effect of quercetin phytosome in human subjects: a single-blind study.

BACKGROUND: We evaluated the ability of quercetin, a natural antioxidant formulated in a specific delivery system, to reduce skin inflammation induced by a variety of stimuli, including UV radiation, stimulation with a histamine solution, or contact with chemical irritants. In particular, we tested the soothing and anti-itch effect of Quercevita(®), 1% cream for external use, a formulation characterized by a phospholipids-based delivery system. PATIENTS AND METHODS: The study was a monocentric, single blind trial that enrolled a group of 30 healthy volunteers. The back of each subject was examined to identify four quadrants with no previous skin damage or naevi that were treated in order to induce a controlled and reversible form of skin stress. The areas were treated as follows: no product; Quercevita(®) 1% cream, 2 mg/cm(2); placebo; positive control (a commercially available topical formulation containing 1% dexchlorpheniramine). RESULTS: Only quercetin phospholipids 1% and dexchlorpheniramine 1% achieved a significant reduction in erythema with comparable results: (-10.05% [P=0.00329] for quercetin phospholipids 1% vs -14.05% [P=0.00046] for the positive control). Moreover, quercetin phospholipids 1% and dexchlorpheniramine 1% were both associated with a significant decrease in mean wheal diameter: (-13.25% and -12.23% for dexchlorpheniramine 1%, respectively). Similar findings were reported for the other tested parameters. CONCLUSION: Quercetin has a skin protective effect against damage caused by a variety of insults, including UV radiation, histamine, or contact with toxic chemical compounds. Indeed, quercetin is able to reduce redness, itching, and inflammation of damaged skin; it may also help restore skin barrier function, increasing hydration, and reducing water loss.

A cosmeceutical formulation based on boswellic acids for the treatment of erythematous eczema and psoriasis.

BACKGROUND: Boswellic acids (BAs) show anti-inflammatory properties in a variety of inflammatory diseases, including rheumatoid arthritis, osteoarthritis, and asthma. A topical administration route is currently used to deliver active compounds in psoriatic and eczematous patients. In this double-blind study we compare a novel BA formulation (containing Bosexil(®), INCI [International Nomenclature of Cosmetic Ingredients]: lecithin, Boswellia serrata resin extract) with a placebo formulation. A third arm of the trial received a formulation of Vaccinium myrtillus seed oil, previously demonstrated as an effective local treatment for psoriatic lesions. METHODS: Patients with psoriasis or erythematous eczema were randomly assigned, in a 1:1:1 ratio, to Bosexil(®), V. myrtillus seed oil, or placebo. In order to evaluate the effects of treatment, the changes of scales and erythema from diagnosis to the end of treatment were scored in psoriatic patients, while changes in itch and erythema were analyzed for erythematous eczema patients. Psoriasis Area Severity Index and Eczema Area and Severity Index scores were also calculated. RESULTS: In patients with psoriasis, scales and erythema improved both with Bosexil(®) and the V. myrtillus seed oil treatment in comparison with placebo. In particular, the treatment with Bosexil(®) formulation improved scales (70% of cases) and erythema (50% of cases) without any case of worsening. In patients with eczema, the administration of placebo did not result in any improvement in 90% of cases, and in the remaining 10% worsened both itch and erythema. Bosexil(®) formulation improved both itch (60% of cases) and erythema (60% of cases) without any case of worsening. V. myrtillus seed oil improved itch and erythema in 66.7% and 77.8% of patients, respectively. CONCLUSION: A topical formulation of Bosexil(®) may be promising for the treatment of psoriasis and erythematous eczema. Long-term studies are recommended to evaluate the adherence to this topical treatment and its clinical benefits in real life.

Reduction of delayed onset muscle soreness by a novel curcumin delivery system (Meriva®): a randomised, placebo-controlled trial.

BACKGROUND: Delayed onset muscle soreness (DOMS) due to eccentric muscle activity is associated with inflammatory responses and production of reactive oxygen species (ROS) that sustain both inflammation and oxidative stress. Curcumin, a powerful promoter of anti-oxidant response, is one of the best-investigated natural products, and is now commercially available as a lecithin delivery system (Meriva®, Indena SpA, Milan) with improved bio-availability. The aim of this study was to test whether curcumin could attenuate damage from oxidative stress and inflammation related to acute muscle injury induced by eccentric continuous exercise. METHODS: This was a randomised, placebo-controlled, single-blind pilot trial. Twenty male healthy, moderately active volunteers were randomised to curcumin given as the Phytosome® delivery system 1 g twice daily (200 mg curcumin b.i.d.) or matching placebo. Supplementation was initiated 48 hours prior to a downhill running test and was continued for 24 hours after the test (4 days in total). Muscle damage was quantified by magnetic resonance imaging, laboratory tests and histological analyses on muscle samples obtained 48 hours after the test. Patient-reported pain intensity was also recorded. RESULTS: Subjects in the curcumin group reported less pain in the lower limb as compared with subjects in the placebo group, although significant differences were observed only for the right and left anterior thighs. Significantly fewer subjects in the curcumin group had MRI evidence of muscle injury in the posterior or medial compartment of both thighs. Increases in markers of muscle damage and inflammation tended to be lower in the curcumin group, but significant differences were only observed for interleukin-8 at 2 h after exercise. No differences in markers of oxidative stress and muscle histology were observed. CONCLUSIONS: Curcumin has the potential for preventing DOMS, as suggested by its effects on pain intensity and muscle injury. Larger studies are needed to confirm these results and further clarify the mechanism of action of curcumin.

Clinical assessment instruments validated for nursing practice in the Italian context: a systematic review of the literature.

AIMS: With the aim to identify the instruments validated for Italian nursing practice, a systematic review of the literature was undertaken. RESULTS: A total of 101 instruments emerged. The majority (89; 88.1%) were developed in other countries; the remaining (14; 13.9%) were developed and validated in the Italian context. The instruments were developed to measure patient's problems (63/101; 62.4%), outcomes (27/101; 26.7%), risks (4/101; 4%) and others issues (7/101; 6.9%). The majority of participants involved in the validation processes were younger adults (49; 48.5%), older adults (40; 39.5%), children (4; 4%), adolescents (3; 3%), and children/adolescents (1; 1%). The instruments were structured primarily in the form of questionnaires (61; 60.4%), as a grid for direct observation (27; 26.7%) or in other forms (12; 11.9%). Among the 101 instruments emerged, there were 1 to 7 validation measures documented with on average 3.2 (95% CI 2.86-3.54) for each instrument. CONCLUSIONS: Developing validation studies giving priority to those instruments widely adopted in the clinical nursing practice is recommended.

A controlled study of a lecithinized delivery system of curcumin (Meriva®) to alleviate the adverse effects of cancer treatment.

A proprietary lecithin delivery system of curcumin (Meriva) was evaluated in a controlled study to assess its efficacy in alleviating the side effects of cancer chemo- and radiotherapy in 160 patients undergoing these treatments. In both cases, a semi-quantitative evaluation of the side effects was carried out using a visual analogue scale, assessing also the plasma free radical status in all patients. Results showed that lecithinized curcumin might alleviate the burden of side effects associated to chemo- and radiotherapy, suggesting that the anecdotal use of various preparations of curcumin as a supportive agent for cancer treatment is well worth a systematic investigation in larger scale clinical trials. The capacity of curcumin to upregulate anti-oxidative responses and downregulate inflammatory pathways could explain its beneficial effect in tempering the prolonged and systemic oxidative and inflammatory effects of cancer treatment, and the beneficial effects observed in the plasma oxidative status in all patients of the treatment group support this view.