Colchicine anti-inflammatory therapy for non-intensive care unit hospitalized COVID-19 patients: results from a pilot open-label, randomized controlled clinical trial.

Systemic inflammation is a hallmark of severe coronavirus disease-19 (COVID-19). Anti-inflammatory therapy is considered crucial to modulate the hyperinflammatory response (cytokine storm) in hospitalized COVID-19 patients. There is currently no specific, conclusively proven, cost-efficient, and worldwide available anti-inflammatory therapy available to treat COVID-19 patients with cytokine storm. The present study aimed to investigate the treatment benefit of oral colchicine for hospitalized COVID-19 patients with suspected cytokine storm. Colchicine is an approved drug and possesses multiple anti-inflammatory mechanisms. This was a pilot, open-label randomized controlled clinical trial comparing standard of care (SOC) plus oral colchicine (colchicine arm) vs. SOC alone (control arm) in non-ICU hospitalized COVID-19 patients with suspected cytokine storm. Colchicine treatment was initiated within first 48 hours of admission delivered at 1.5 mg loading dose, followed by 0.5 mg b.i.d. for next 6 days and 0.5 mg q.d. for the second week. A total of 96 patients were randomly allocated to the colchicine (n=48) and control groups (n=48). Both colchicine and control group patients experienced similar clinical outcomes by day 14 of hospitalization. Treatment outcome by day 14 in colchicine vs control arm: recovered and discharged alive: 36 (75.0%) vs. 37 (77.1%), remain admitted after 14-days: 4 (8.3%) vs. 5 (10.4%), ICU transferred: 4 (8.3%) vs. 3 (6.3%), and mortality: 4 (8.3%) vs. 3 (6.3%). The speed of improvement of COVID-19 acute symptoms including shortness of breath, fever, cough, the need of supplementary oxygen, and oxygen saturation level, was almost identical in the two groups. Length of hospitalization was on average 1.5 day shorter in the colchicine group. There was no evidence for a difference between the two groups in the follow-up serum levels of inflammatory biomarkers including C-reactive protein (CRP), D-dimer, lactate dehydrogenase (LDH), ferritin, interleukin-6 (IL-6), high-sensitivity troponin T (hs-TnT) and N-terminal pro b-type natriuretic peptide (NT pro-BNP). According to the results of our study, oral colchicine does not appear to show clinical benefits in non-ICU hospitalized COVID-19 patients with suspected cytokine storm. It is possible that the anti-inflammatory pathways of colchicine are not crucially involved in the pathogenesis of COVID-19.

Prospective observational study on the complications and tolerability of a peripherally inserted central catheter (PICC) in neuro-oncological patients.

PURPOSE: The use of central venous catheters with peripheral insertion (PICC) has increased rapidly in recent years, particularly in cancer patients. The benefits provided may occasionally be affected by relevant complications, such as infections and thrombotic events, especially in neuro-oncological patients. To date, the risk of PICC-related complications in this subset of patients is unknown, as is tolerability. As a primary objective, this study aimed to collect complications related to PICCs in primary neuro-oncological patients. As a secondary objective, the study aimed to evaluate PICC tolerability. METHODS: Neuro-oncological patients with PICCs that were placed as part of normal clinical practice at IRCCS Neurologico C. Besta were consecutively enrolled in the study. PICC-related complications were recorded immediately (during the procedure), early (within 1 week after PICC insertion), and late (1-3-5 months after PICC placement). At the same time points, all patients were also evaluated for tolerability through interviews with semi-structured, open-ended questions. RESULTS: Sixty patients were enrolled (41 males and 19 females, with a median age of 56.2 years). Excluding loss to follow-up, 33/49 patients developed at least one complication related to the PICC. Immediate complications mainly included hematoma (8), accidental arterial puncture (4), and primary malpositioning (3). Regarding early and late complications, 3 device-related infections, 8 thrombotic events, and 20 mechanical complications were registered. Semi-structured interviews revealed an overall positive experience with the device. The most negative impact was on hygiene habits, with 34 patients becoming caregiver-dependent. Over time, almost all patients became used to the device and perceived greater security during chemotherapy. A strongly negative issue was the difficulty of relying on competently trained healthcare personnel in outpatient setting. CONCLUSION: The results showed a nonnegligible increased thromboembolic risk in neuro-oncological patients with PICCs, almost double that in historical oncological populations. It is essential to extend the study to a greater number of patients to achieve reliable results and to identify patients at high risk. The device seems to be positively accepted by the majority of patients, without affecting activities of daily living.

Interaction study between antiplatelet agents, anticoagulants, thyroid replacement therapy and a bioavailable formulation of curcumin (Meriva®).

OBJECTIVE: The objective of this clinical study is to evaluate possible interactions between antiplatelet agents, anticoagulants, thyroid hormone replacement therapy and a formulation of curcumin (Meriva®) that resulted effective for the complementary treatment of osteoarthritis. PATIENTS AND METHODS: Interaction between antiplatelet agents and Meriva® was evaluated by measuring anti-platelet activity with the in-vivo bleeding-time (BT) in patients assuming acetylsalicylic acid or ticlopidine or clopidogrel from at least 2 years. The BT was evaluated before and after 10 days of supplementation with Meriva®. The interaction between anticoagulants and Meriva® was evaluated in patients using warfarin or dabigatran for previous venous thrombosis. The INR level was evaluated before and after 10 days of supplementation with the curcumin formulation. Thyroid function tests in hypothyroid patients using LT4 replacement therapy (Eutirox®) were evaluated before and after 15 days of supplementation with Meriva®. Similarly, levels of glycemia and glycated hemoglobin were evaluated in diabetic patients in treatment with metformin, before and after 10 days of supplementation with the studied product. RESULTS: After 10 days of supplementation with Meriva® the average BT value was not significantly different for patients assuming acetylsalicylic acid, ticlopidine or clopidogrel at standard dosages. Similarly, after 10 days of Meriva® treatment, the INR level in the two groups of patients assuming warfarin or dabigatran was not statistically different from that observed at baseline. In the analyzed patients assuming LT4 or metformin, no interactions between the therapy and Meriva® were observed. CONCLUSIONS: Results from this non-interaction clinical study suggest that Meriva® does not interfere with the antiplatelet activity of the most common antiplatelet agents nor alters the INR values in stable patients assuming warfarin or dabigatran. Similarly, dosages of LT4 or metformin do not need to be adjusted in case of complementary treatment with Meriva®.

Oral administration of a curcumin-phospholipid formulation (Meriva®) for treatment of chronic diabetic macular edema: a pilot study.

OBJECTIVE: The purpose of this open-label study was to investigate the effect of a curcumin-phospholipid lecithin formulation (Meriva®) on visual acuity and optical coherence tomography (OCT) retinal thickness in patients with chronic diabetic macular edema. PATIENTS AND METHODS: Curcumin-phospholipid lecithin formulation (Meriva®, Indena S.p.A, Milan, Italy) was administered as tablets (Norflo®, Eye Pharma, Genoa, Italy) twice a day. Visual acuity and macular edema as measured by OCT before and after curcumin-phospholipid formulation treatment were assessed. RESULTS: The study included 12 eyes from 11 patients who completed at least a 3-month follow-up period. After 3 months of therapy, no eyes showed reduction in visual acuity, 16% showed stabilization, and 84% showed improvement. The improvement was statistically significant (p = 0.0072). After 3 months of therapy, 92% of eyes showed reduction of macula edema, 8% showed stabilization, and 0% showed an increase (p = 0.009). CONCLUSIONS: Our results, albeit preliminary, suggest that a curcumin-phospholipid formulation (Meriva®), administered as Norflo® tablets, may be feasible in the improvement of visual acuity and reduction of macular edema in patients with diabetic retinopathy.

A novel boswellic acids delivery form (Casperome®) in the management of musculoskeletal disorders: a review.

Standard pharmacological treatment of musculoskeletal conditions is often associated with relevant side effects. Botanical preparations endowed with a good tolerability profile, therefore, could have a role in the management of these disorders. Among different natural products, Boswellia serrata extracts have long been used for the treatment of musculoskeletal disorders, given their marked anti-inflammatory activity and their ability to promote tissue regeneration. However, standard preparations of Boswellia serrata show overall modest pharmacokinetic properties, a limitation which may ultimately lead to reduced efficacy. In an effort to improve the pharmacokinetic properties, Casperome®, a lecithin-based formulation of Boswellia serrata extract representing the whole natural bouquet, has been developed. This formulation was effective in the treatment of Achilles tendonitis, epicondylitis, radiculopathies, ankle sprains and sport injuries as shown in several clinical studies, the majority of which with a randomized design and all evaluating a number of well-recognized parameters of efficacy for the therapy of musculoskeletal disorder. All studies were consistent in showing a prompt decrease of pain and improvement of functionality of the affected area after supplementation with Casperome®, without any relevant adverse effect. Remarkably, these symptomatic improvements were paralleled by reduced plasmatic levels of inflammatory markers and by a diminished need for rescue analgesics. On these bases, Casperome® may have a role in the treatment of musculoskeletal disorders. Clinical studies in other similar conditions (e.g., osteoarthritis) appear warranted to further investigate the efficacy of this botanical product in more specific settings.

Effectiveness of a novel boswellic acids delivery form (Casperome®) in the management of grade II ankle sprains due to sport trauma - a registry study.

OBJECTIVE: In this study, we evaluated a novel delivery form of boswellic acids (Casperome®) in the management of signs and symptoms associated with ankle sprain grade II due to sport trauma. PATIENTS AND METHODS: In this supplement registry study, 72 otherwise healthy subjects with grade II ankle sprain induced by sport activities were advised to either follow a standard management (SM, 37 subjects) for the condition or the SM with the additional daily intake of 1 tablet containing 250 mg Casperome® (35 subjects). Subjects were allowed to use rescue medications (ketoprofen tablets, 25 mg/tablet), and their intake was measured at the end of the management period of 7 days. Each individual was subjected to several non-invasive examinations (self-reported pain at rest and under moderate exercise, range of active and passive movement, presence of local hematomas by ultrasonography) at the following time periods: at inclusion, to evaluate the basal conditions of the subject before the beginning of the study, at day 3 and at the end of the week to evaluate the response differences between the two groups. Additionally, a blood sample from the Casperome® treated subjects (34 out of 35 subjects) was taken at day 7 and analyzed for the systemic concentration of boswellic acids. RESULTS: The 72 individuals recruited in this study spontaneously decided which management to follow, either SM (n=37) or SM+Casperome® (n=35). Supplementation with Casperome® 250 mg/day showed beneficial effects in the reduction of signs and symptoms of ankle sprains evaluated at day 3 and day 7, and was shown to induce measurable plasma level of boswellic acids. Moreover, the supplementary use of Casperome® was well-tolerated and devoid of side effects. CONCLUSIONS: Our pilot registry study showed the effectiveness of Casperome® supplementation in improving recovery after ankle sprain of mild severity (grade II), suggesting a potentially beneficial role in relieving the trauma associated with sport activities and in decreasing the use of rescue drugs.

A naturally-inspired, curcumin-based lecithin formulation (Meriva® formulated as the finished product Algocur®) alleviates the osteo-muscular pain conditions in rugby players.

OBJECTIVE: Curcumin is one of the most investigated phytochemical products because of its low toxicity and its broad spectrum of bioactivity, including anti-inflammatory and analgesic properties. A new delivery form of curcumin, resorting to phosphatidylcholine (Meriva®, formulated as the finished product Algocur®) has been developed to increase its bioavailability. In this study, we tested the efficacy and safety of a Meriva®-based product in rugby players suffering by different osteo-muscular pain conditions PATIENTS AND METHODS: In this pilot study, 50 male rugby players with osteo-muscular pain due to traumatic injuries, physical overload or acute episode of chronic pain were recruited and treated with conventional analgesic drugs (n = 25) or Meriva®-based product (n = 25) for a maximum of 10 days. The pain perception and the functio laesa were evaluated at baseline and after 1, 3, 6, 10 and 20 days from the initiation of the treatment protocol. Treatment tolerability, compliance, and adverse events were also reported. RESULTS: During the study, the analgesic effect decreased in both treated group compared to baseline, starting from the third day of treatment. Similarly, the impaired physical function evaluated after 3, 6, 10 and 20 days improved in Meriva®-based product treated group and in subjects treated with conventional analgesic drugs, compared to the baseline condition. The percentage of excellent adherence to treatment or tolerability was higher in the Meriva®-based product treated group. Only 1 (4%) subject treated with Meriva®-based product experienced adverse events whereas 4 (16%) subjects treated with conventional analgesic drugs reported gastric pain as an adverse event. CONCLUSIONS: Despite the small sample size and the group heterogeneity, this study suggests that the naturally-derived, curcumin-based delivery form, Meriva® (formulated as the finished product Algocur®), could represent a promising safe, analgesic remedy in painful osteo-muscular conditions associated with intense, high impact, physical activities.

The effect of a natural, standardized bilberry extract (Mirtoselect®) in dry eye: a randomized, double blinded, placebo-controlled trial.

OBJECTIVE: Dry eye, a chronic disease of lachrymal fluid and corneo-conjunctival epithelium, could significantly impact visual function, affects quality of life and work productivity. Beside several conventional treatments, nutritional supplements based on bilberry extract have been identified as effective contributors to eye health. Here, we aim at investigating the bioavailability of a standardized bilberry extract, its ability to alleviate dry eye symptoms and its antioxidant potential. MATERIALS AND METHODS: Either bilberry dried standardized extract derived from Vaccinium myrtillus L. fresh frozen fruits (Mirtoselect®) or a highly purified anthocyanin-rich extract, devoid of the non anthocyanin component and supported on maltodextrins, were each orally administrated to 5 male rats. Blood samples were collected at 5, 10, 15, 20, 30, 45, 60, 90, 120 minutes after treatment, processed and analyzed by UV spectrophotometric method. In a parallel analysis, 22 otherwise healthy subjects suffering from dry eye symptoms were enrolled randomly assigned to receive the more bioavailable bilberry extract or placebo. Ophthalmological and clinical examinations including Schirmer's test, pupil constriction, diacron-reactive oxygen metabolites (d-ROMs) test and biological antioxidant potential (BAP) test were performed at inclusion and after the 4-week study period. RESULTS: The area under the curve of plasmatic levels of anthocyanosides in rats resulted 202.34±24.23 µg·min/ml for Mirtoselect® and 130.93±4.93 µg·min/ml for the highly purified anthocyanin-rich bilberry extract, notwithstanding the fact that the highly purified anthocyanin-rich extract group received an anthocyanins dosage much higher than the Mirtoselect® group (354 mg/Kg in anthocyanosides vs. 136 mg/Kg in anthocyanosides). 21 subjects, 11 subjects in the bilberry extract (Mirtoselect®) group and 10 subjects in the placebo group completed the clinical study. Schirmer's test values indicating the volume of tear secretion were significantly improved in the bilberry extract group (p=0.019), whereas no significant changes were observed in the placebo group. A subset analysis revealed that Mirtoselect® could be more effective in subjects with higher tendency of dry eye. In terms of antioxidant potential, the bilberry extract produced significant improvement of BAP (p=0.003) and an increase of modified BAP/d-ROMs ratio, an indicator of overall balance between antioxidant potential and oxidative stress. CONCLUSIONS: Our results suggested that natural, standardized bilberry extract (Mirtoselect®) is a natural more bioavailable delivery form anthocyanins, suggesting a strong matrix effect exerted by the non-anthocyanin component. Furthermore, it can improve tear secretion and plasmatic antioxidant potential in subjects suffering from DED symptoms.

Supplementation with a lecithin-based delivery form of Boswellia serrata extract (Casperome®) controls symptoms of mild irritable bowel syndrome.

OBJECTIVE: Irritable Bowel Syndrome (IBS) is a chronic, gastrointestinal disorder in which abdominal pain or discomfort is associated with defecation or changes in bowel habits. Its multifactorial pathophysiology leads to a variety of available treatments, mainly aimed at controlling symptoms. The management of IBS patients could be optimized by individualized strategies, including non-pharmaceutical approaches. In this study, we evaluated the efficacy and safety of a novel delivery form of Boswellia serrata extracts (BSE) (Casperome®) in patients with IBS. PATIENTS AND METHODS: 71 otherwise healthy subjects with idiopathic IBS were recruited. Participants were assigned to the following management strategies: hyoscine butylbromide; papaverine hydrochloride + A. belladonna extract; supplementation with Casperome®. Predominant IBS symptoms were evaluated at inclusion and at the end of the observational period (4 weeks). The numbers of subjects who needed rescue medication or medical attention/hospital admission were recorded. Adverse events were also evaluated. RESULTS: In all groups, the IBS symptoms investigated, namely abdominal pain, altered bowel movements, meteorism and cramps improved during the observational period. Of note, the number of subjects who needed medical attention significantly decreased only in Casperome®-supplemented group. In addition, Casperome® supplementation was related to a lower incidence of side effects (mainly stypsis). CONCLUSIONS: This preliminary study suggests that Casperome® supplementation could represent a promising alternative approach to manage symptoms associated with IBS in otherwise healthy subjects.

Effects of a curcumin-based supplementation in asymptomatic subjects with low bone density: a preliminary 24-week supplement study.

OBJECTIVE: Osteopenia is a chronic bone condition characterized by decreased calcification, density, or bone mass that, if untreated, can lead to osteoporosis and bone fractures. Although its increasing prevalence, nowadays osteopenia is not adequately prevented and managed. In this study, we evaluated the efficacy, in term of changes in bone density, and safety of an oral formulation based on turmeric phytosome (Meriva®), in subjects suffering from low bone density. PATIENTS AND METHODS: 57 otherwise healthy subjects with low bone density were enrolled in this pilot, supplement study. Informed participants freely decided to follow either a standard management (SM) to control low bone density (control group=28) or SM associated with a curcumin-based oral supplementation (supplement group=29). The bone densities of heel, small finger and upper jaw were evaluated at inclusion and at different time points during the observational period (4, 12 and 24 weeks), in all subjects. RESULTS: The bone density of the heel measured by the Sahara densitometer remarkably improved in the Meriva®-supplemented group, with a significant decrease of ultrasounds transmission values at week 12 (-18.4%) and at week 24 (-21.0%), compared with baseline values. The bone densities of small finger and upper jaw also significantly increased during the study in supplemented subjects, reaching +7.1% and +4.8%, respectively, at week 24, with respect to values at inclusion. Noteworthy, no significant changes of heel, small finger and upper jaw densities were observed in the control group. Last, no safety and tolerability issues were reported during the observational period. CONCLUSIONS: This preliminary study suggests that a curcumin-based supplementation in combination with an appropriate lifestyle could be beneficial in the prevention and management of osteopenia.

Highly standardized cranberry extract supplementation (Anthocran®) as prophylaxis in young healthy subjects with recurrent urinary tract infections.

OBJECTIVE: Several studies have investigated the role of cranberry extract in the prevention of recurrent urinary tract infections (UTIs), on different selected subpopulations at increased risk of UTI. In this registry, we tested the prophylactic effects of an oral supplementation containing a highly standardized cranberry extract (Anthocran®) in young subjects with a previous history of recurrent UTIs, over a 2-months follow-up. PATIENTS AND METHODS: 36 otherwise healthy subjects in juvenile age (between 12 and 18 years of age) suffering by recurrent UTIs were enrolled. Participants received either a standard management (SM) (control group, n=17) or SM associated with an oral daily supplementation (supplementation group, n=19). Oral supplementation consisted in one capsule containing 120 mg of cranberry extract (Anthocran®), standardized to 36 mg proanthocyanidins, for 60 days. The effectiveness in the prevention of UTIs was determined by: the number of UTIs evaluated two months before the inclusion in the registry and during the supplementation period; the number of symptom-free subjects during the registry period. Safety considerations and measurement of adherence to treatment were also performed. RESULTS: The two groups were comparable for age, gender distribution, the days of follow-up and also for the number of UTIs before inclusion. The mean number of UTIs observed during the registry in the supplemented group (0.31±0.2) was significantly lower compared to the control group (2.3±1.3) and to the mean number of UTIs assessed before inclusion (1.74±1.1) (p-value = 0.0001 for both). Moreover, 63.1% of supplemented subjects was symptom-free during the registry period, whereas 23.5% subjects were asymptomatic in the control group (p-value <0.05). CONCLUSIONS: This registry supplement study provides compelling evidence on the efficacy of an oral supplementation, based on a highly standardized cranberry extract (Anthocran®), as prophylaxis in young healthy subjects suffering by recurrent UTIs.

Aescin-based topical formulation to prevent foot wounds and ulcerations in diabetic microangiopathy.

OBJECTIVE: Impairment of the peripheral microcirculation in diabetic patients often leads to severe complications in the lower extremities, such as foot infections and ulcerations. In this study, a novel aescin-based formulation has been evaluated as a potential approach to prevent skin breaks and ulcerations by improving the peripheral microcirculation and skin hydration. PATIENTS AND METHODS: In this registry study, 63 patients with moderate diabetic microangiopathy were recruited. Informed participants freely decided to follow either a standard management (SM) to prevent diabetic foot diseases (n = 31) or SM associated with topical application of the aescin-based cream (n = 32). Peripheral microcirculatory parameters such as resting skin flux, venoarteriolar response and transcutaneous gas tension were evaluated at inclusion and after 8 weeks. In addition, several skin parameters of the foot area, such as integrity (as number of skin breaks/patients), hydration and content of dead cells were assessed at the defined observational study periods. RESULTS: Improvements in cutaneous peripheral microcirculation parameters were observed at 8 weeks in both groups; however, a remarkable and significant beneficial effect resulted to be exerted by the aescin-based cream treatment. In fact, the microcirculatory parameters evaluated significantly improved in the standard management + aescin-based cream group, compared with baseline and with the standard management group. Similar findings were reported for skin parameters of the foot area. CONCLUSIONS: The topical formulation containing aescin could represent a valid approach to manage skin wounds and prevent skin ulcerations in patients affected by moderate diabetic microangiopathy.

A novel lecithin based delivery form of Boswellic acids (Casperome®) for the management of osteo-muscular pain: a registry study in young rugby players.

OBJECTIVE: Several experimental studies and clinical trials support the potential of Boswellia serrata extracts (BSE) for the treatment of various inflammatory diseases. The aim of this registry study was to assess the safety and the efficacy of a novel lecithin-based delivery form of Boswellia serrata extract (Casperome®) in the supportive management of osteo-muscular pain. PATIENTS AND METHODS: 52 healthy young rugby players with acute knee pain and inflammation were recruited. Informed participants freely decided to follow either a standard management (SM) to control joint pain (control group = 27) or SM associated with oral daily supplementation with Casperome® (supplement group =25). Parameters associated with osteo-muscular pain and inflammation, and measurements of joint health and functions were assessed at the inclusion and after a 4-week supplementation. RESULTS: A significant beneficial effect of Casperome® vs SM alone was observed for all the parameters evaluated, namely: local pain on effort; pain-free walking distance (treadmill test); minimal joint effusion; structural damage (joint, tendons, muscles) and intramuscular hematomas; thermal imaging of the anterior knee; Visual Analog Scale for Pain (VAS Pain); need for concomitant drugs and medical attention; measurement of inflammatory biomarkers. CONCLUSIONS: Our registry study suggests that Casperome® supplementation could represent an effective and safe, integrated approach for the treatment of osteo-muscular pain and inflammation.

Managing ulcerative colitis in remission phase: usefulness of Casperome®, an innovative lecithin-based delivery system of Boswellia serrata extract.

OBJECTIVE: Boswellia serrata extracts (BSE) have been traditionally used for the treatment of several inflammatory diseases. The aim of this study was to evaluate the efficacy of a novel delivery form of BSE (Casperome®) in Ulcerative Colitis (UC) during minimally symptomatic remission phase. PATIENTS AND METHODS: In this open-label, observational, registry study, informed participants with UC in remission phase (n = 43) freely decided to receive the oral daily Casperome® supplementation (n = 22) or no supplementation (n = 21) for 4 weeks. Several parameters associated with minimally symptomatic UC in remission were evaluated at the inclusion and the end of the study. RESULTS: A significant beneficial effect of Casperome® was observed for all the parameters evaluated, namely: diffuse intestinal pain, evident and occult blood in stools, bowel movements and cramps, watery stools, malaise, anemia, rectal involvement, number of white blood cells as well as need for concomitant drugs and medical attention. Faecal concentration of calprotectin, a marker of bowel inflammation, resulted ameliorated in Casperome® supplemented patients. CONCLUSIONS: Our study showed that Casperome® supplementation attenuates symptoms associated with mild UC in remission, reducing the use of drugs and medical consultations. Therefore, our study suggests that Casperome® supplementation could represent a promising alternative approach to manage minimally symptomatic UC and maintain the remission phase.

A novel phospholipid delivery system of curcumin (Meriva®) preserves muscular mass in healthy aging subjects.

OBJECTIVE: Curcumin is known to interrupt pro-inflammatory signalling and increases anti-oxidant protection, thus inhibiting the expression of inflammatory cytokines and the expression and function of inducible inflammatory enzymes. Together, these effects contribute to limit the onset and the progression of sarcopenia, due to the major role played by inflammation in the pathophysiology of this disease. This registry study evaluates the effects of Meriva® supplementation in otherwise healthy elderly subjects. PATIENTS AND METHODS: This was a registry, supplement study, conducted in healthy subjects > 65 years with apparent loss of strength and tiredness who freely decided to start one of the following interventions: (1) standard management (exercise, balanced diet including proteins) (n = 33); (2) standard management + Meriva® one tablet/day (n = 31); (3) standard management + Meriva® one tablet/day + other supplementation (n = 22). A number of functional and biochemical parameters were evaluated at baseline and after three months (hand grip, weight lifting, time/distance before feeling tired after cycling, walking and climbing stairs; general fitness, proteinuria, oxidative stress, Karnofsky scale; left ventricular ejection fraction). RESULTS: Significant improvements in all parameters, with respect to baseline values, were observed in the two supplementation groups (p < 0.05 for all comparisons). On the other hand, no improvement was observed in the standard management-only group. At three months, inter-group comparison revealed a statistical advantage in all parameters for both supplementation groups compared with the standard management-only group (p < 0.05 for all comparisons). CONCLUSIONS: Our registry study shows that the addition of Meriva® - either or not combined with other nutritional supplements - to standardized diet and exercise plan contributes to improve strength and physical performance in elderly subjects, potentially preventing the onset of sarcopenia.

Supplementation with high titer cranberry extract (Anthocran®) for the prevention of recurrent urinary tract infections in elderly men suffering from moderate prostatic hyperplasia: a pilot study.

OBJECTIVE: Recently, cranberry extracts have been tested as a nutritional supplementation in the prevention of lower urinary tract symptoms (LUTS) as well as recurrent urinary tract infections (UTIs) in subjects at risk, with mixed results. However, evidence of efficacy should be considered only for well-characterized and standardized products in a more selected study population. Moreover, the efficacy of these interventions in elderly must be further investigated. The aim of this pilot, registry study was to evaluate the prophylactic effects of an oral supplementation containing a highly concentrated and standardized cranberry extract reproducing the natural total profile of cranberry fruits, in elderly men with benign prostatic hyperplasia (BPH), suffering from recurrent UTIs, over a 2-months follow-up. PATIENTS AND METHODS: 43 men (age > 65 years) enrolled in this study freely decided to receive either a standard management (SM) only (n = 21) or SM associated with an oral supplementation (n = 23). Supplementation consisted in a daily administration of one capsule containing cranberry extract (Anthocran®) for 60 consecutive days. The clinical effectiveness in the prevention of UTIs was determined by the number of UTIs in the two months before the inclusion in the registry and during the supplementation period, and the number of symptom-free subjects during the registry period. Safety considerations were also performed. RESULTS: In the supplemented group, the mean number of UTI episodes reported during the registry (0.8 ± 0.5) significantly decreased compared with inclusion time (3.2 ± 1.3), p-value = 0.0001. No significant changes were observed in control, SM-only group. Importantly, the cranberry oral supplementation was superior over SM at reducing the mean number of UTIs (p-value = 0.0062). CONCLUSIONS: These results suggest that cranberry supplementation could be an effective and safe approach, within an SM program, for the prevention of recurrent UTIs in elderly men suffering from BPH avoiding some antibiotic treatments.

Clinical evaluation of safety and efficacy of Boswellia-based cream for prevention of adjuvant radiotherapy skin damage in mammary carcinoma: a randomized placebo controlled trial.

OBJECTIVE: Acute radiation erythema and other skin reactions are common adverse effects experienced by breast carcinoma patients undergoing radiotherapy treatment. Boswellic acids are pentacyclic triterpenes extracted from the resins of the tropical tree Boswellia serrata with strong anti-inflammatory properties. This study was designed to evaluate the safety and the efficacy of the application of a base cream containing boswellic acids in a proprietary formulation (Bosexil(R)) for the prevention and relief of radiation-induced adverse effects in breast cancer patients. PATIENTS AND METHODS: The acute skin reactions were clinically evaluated by visual intensity and computer-assisted skin color analysis, and toxicity was assessed by the Radiation Therapy Oncology Group (RTOG) rating scale. RESULTS: These findings indicate that the use of a boswellia-based cream is effective in reducing the use of topical corticosteroids and is able to reduce the grade of erythema and the skin superficial symptoms, being well tolerated by the patients. CONCLUSIONS: Further studies comparing boswellia cream with other topical agents will be appropriate to confirm the effectiveness of this treatment for breast cancer patients under radiation therapy.

Cranberry supplementation in the prevention of non-severe lower urinary tract infections: a pilot study.

OBJECTIVE: Cranberry extracts have been tested as a nutritional supplementation in the prevention of recurrent lower-urinary tract infections (R-UTIs), with mixed results. This pilot, registry study evaluates the prophylactic effects of oral supplementation with a new well-standardized cranberry extract in patients with R-UTI, over a 2-month follow-up. PATIENTS AND METHODS: All subjects were suggested to take one capsule containing a cranberry extract (Anthocran™) for 60 days and were also given lifestyle advice. Clinical outcomes were compared between patients on cranberry extracts and those who don't take this supplementation. RESULTS: In total, 22 subjects completed the study in each of the two groups. In the cranberry group, the reduction in the frequency of UTI episodes during the study period compared with the two months before the inclusion was 73.3% (p < 0.05). This figure was 15.4% in the control group (p < 0.05; p = 0.012 vs cranberry group). Seven (31.8%) subjects in the cranberry group were symptom-free; no patient was symptom-free in the control group (p < 0.05). The mean duration of UTI episodes was 2.5 ± 1.3 days in the cranberry group, compared with 3.6 ± 1.7 days in subjects not on cranberry (p < 0.05). Three subjects (13.6%) in the cranberry group and 8 (36.3%) in the control group required medical consultation for UTI symptoms (p < 0.05). Urine evaluation was completely negative in 20/22 subjects in the Cranberry group (90.9%) and in 11 control subjects (50.0%; p < 0.005). No adverse events were observed. CONCLUSIONS: These preliminary results, obtained in a field-practice setting, indicates the effectiveness and safety of a well-standardized cranberry extract in the prevention of R-UTI.

Omne Ignotum pro Magnifico: characterization of commercial Bilberry extracts to fight adulteration.

Thanks to their chemical composition, extracts from the bilberry are commonly used to manufacture food, health products, supplements and cosmetics. However, in this field, as in others, "the process is the product" and a careful characterization of the entire supply and production chain, from purity and quality of raw material to extraction procedures needs to be implemented by using validated, sensitive and specific techniques of analysis. This position paper discusses the importance of the characterization of bilberry extracts, in order to fight adulteration.

Meriva®, a lecithinized curcumin delivery system, in diabetic microangiopathy and retinopathy.

BACKGROUND: In the present study, the improvement of diabetic microangiopathy and retinopathy was evaluated in 38 diabetic patients treated with a novel curcumin phospholipids delivery form (Meriva®). METHODS: Diabetes was diagnosed at least 5 years before inclusion and all patients had signs of retinal oedema and of peripheral microangiopathy. Meriva® was administered at the dosage of 2 tablets/day (each tablet containing 500 mg Meriva® corresponding to 100 mg curcumin) for a period of at least 4 weeks in addition to the standard management plan, while a comparable group of subjects (n = 39) followed the standard management plan alone. RESULTS: All subjects (treatment and controls) completed the follow-up period, there were no dropouts and Meriva® showed an optimal tolerability. At 4 weeks, microcirculatory and clinical evaluations indicated an improvement of microangiopathy. In terms of peripheral microangiopathy, in the Meriva® group, there was a significant improvement in the venoarteriolar response (p<0.05) and a decrease in the score of peripheral oedema (p<0.05), a sign typically associated with the failure of the venoarteriolar response. At the retinal level, high-resolution, duplex scanning, used to measure retinal flow, showed improvements in the Meriva® treated patients. The evaluation of retinal oedema (Steigerwalt's scale) showed an improvement associated with improved visual acuity (Snellen scale). There were no clinical or microcirculatory effects in controls. CONCLUSION: These preliminary observations, indicate the value of curcumin, when administered in a bioavailable form as with Meriva®, in the management of diabetic microangiopathy and retinopathy.