Publications (17)18.78 Total impact
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Article: Pycnogenol® Supplementation Improves Health Risk Factors in Subjects with Metabolic Syndrome.
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ABSTRACT: This open, controlled study evaluated the effects of 6 month supplementation with Pycnogenol® maritime pine bark extract on health risk factors in subjects with metabolic syndrome. Pycnogenol® was used with the aim of improving risk factors associated with metabolic syndrome, central obesity, elevated triglycerides (TG), low HDL cholesterol, high blood pressure and fasting blood glucose. Sixty-four subjects (range 45-55 years) presenting with all five risk factors of metabolic syndrome were included, and Pycnogenol® was administered for 6 months. A group of 66 equivalent subjects were followed up as controls. In the 6-month study Pycnogenol® supplementation 150 mg/day decreased waist circumference, TG levels, blood pressure and increased the HDL cholesterol levels in subjects. Pycnogenol lowered fasting glucose from baseline 123 ± 8.6 mg/dl to 106.4 ± 5.3 after 3 months and to 105.3 ± 2.5 at the end of the study (p < 0.05 vs controls). Men's waist circumference decreased with Pycnogenol from 106.2 ± 2.2 cm to 98.8 ± 2.3 cm and to 98.3 ± 2.1 after 3 and 6 months. Women's waist decreased from 90.9 ± 1.6 cm to 84.6 ± 2.1 cm and to 83.6 ± 2.2 cm after 3 and 6 months. Both genders waist circumference reduction was significant as compared to controls at both time points. In addition, plasma free radicals decrease in the Pycnogenol group was more effective than in the control group (-34.6%; p < 0.05). In conclusion, this study indicates a role for Pycnogenol® for improving health risk factors in subjects with metabolic syndrome. Copyright © 2013 John Wiley & Sons, Ltd.Phytotherapy Research 01/2013; · 2.09 Impact Factor -
Article: Thyroid cysts treatment with the sclerosing agent Atossiclerol. Long-term (5 to 15 years) follow-up.
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ABSTRACT: AIM:The aim of this study was to evaluate the long-term efficacy of the sclerosing agent Atossisclerol in the treatment of benign, ecolucent, thyroid cysts. METHODS: Two groups of cysts, one between 1 and 3 cm and a group smaller than 0.99 mm in maximum diameter (range 0.6-0.99) were considered in the inclusion plan. The localization of the cysts was at lobar level. A limited quantity of Atossisclerol (0.5 to 2%) was injected. RESULTS:No side effects were noted. After 5 years in the group treated with the sclerosing agent 93% of the cysts were completely disappeared (vs 60% in controls). However the initial target cyst at 5 and years was completely cured in most patients (>80%) treated with the sclerosing agent; at 10 years more than 90% of the original, sclerosed target cysts were not visible. Another control of most of these patients (53/68) at 15 years indicated that sclerosis of the cyst is safe and allow a better occlusion/obliteration (in almost all patients) of the cyst in comparison with aspiration only (slow recurrence in some 25% of the cysts). CONCLUSION: The sclerosing agent can be re-injected in the same patients without significant reaction or clinical problems or immunological reactions.Panminerva medica 11/2012; · 1.11 Impact Factor -
Article: [Severe intermittent claudication: PGE1 treatment. A 40-week registry, efficacy and costs].
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ABSTRACT: Intermittent claudication (IC) in peripheral vascular disease is characterized by lower limb pain appearing on effort. Treatment with PGE1 has been successfully used to manage IC patients. This registry has evaluated safety and costs of PGE1 in the management of IC. In this study a long-term treatment protocol (LTP), a short-term protocol (STP) and an outpatient (OP), "on-demand" treatment have been compared. A treadmill effort test has been used to evaluate walking distance. The follow up for these three protocols was 40 weeks. PGE1 treatment was associated to a risk reduction plan and to an exercise program. The final analysis has included 252 LTP patients, 223 STP patients and 284 OP patients (total 659 valid cases). A group of 171 comparable patients not treated with PGE1 was used for a parallel comparison. Cardiovascular mortality and morbidity has been evaluated in 731 PGE1 patients completing 24 months of follow up. All protocols have been well tolerated. No side effects were observed. The lower cost has been observed for OP patients. In the long term, mortality and morbidity were lower in patients treated with PGE1 in comparison with patients not treated with PGE1. Considering costs and results (increase in walking distance) and improvement in Karnofsky scale the STP plan appears to be better than LTP for IC patients. The OP, "on-demand" treatment offers further improvements. This last treatment plan is simpler; the plan allows better timing for exercise. The treatment can be used even in non-specialized centers.Minerva cardioangiologica 08/2012; 60(4):405-13. -
Article: Topical formulation of heparin is effective in reducing the symptoms of superficial venous thrombosis: a monocenter, observer-blind, placebo-controlled randomized study.
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ABSTRACT: The aim of the present, randomized, placebo controlled study was to assess the dose-dependent symptom reduction efficacy, safety and tolerability of heparin-spraygel (Viatromb 2.400 IU/g heparin spraygel) in patients with superficial vein thrombosis (SVT) of the lower limbs. A number of clinically relevant objectives; time to onset and intensity of symptoms' reduction reflected also by rescue medication consumption were considered and assessed. Pain reduction between the two time-points (days 0 and 7) was significant within both treatment groups (active drug and placebo). However, subjects treated with active drug reported a mean pain reduction (VAS) of 76.21 mm (93.13% decrease); in subjects treated with placebo it was 50.36 (61.35%) mm (P<0.0001). The difference in pain reduction between the active drug and placebo groups was significant (P<0.05). The proportion of responders (subjects with at least 50%reduction in pain (VAS) on day 7 and day 14) was higher within subjects treated with Viatromb (P<0.05). The extension of erythema, evaluated by planimetry indicated a significantly higher reduction (day 0 to 7 and 0 to 14) in Viatromb-treated subjects in comparison with placebo. In the Viatromb group, the reduction in thrombus size was remarkable towards placebo (P<0.05). Reduction of edema and pain (VRS) had comparable time courses. Both investigator's and subject's global assessment of efficacy were significantly better with Viatromb. No adverse events or reactions were reported during the study and the follow up period. Viatromb was significantly more effective than placebo in the symptomatic treatment of SVT.Panminerva medica 09/2011; 53(3 Suppl 1):3-11. · 1.11 Impact Factor -
Article: Venoruton®: post thrombotic syndrome. Clinical improvement in venous insufficiency (signs and symptoms) with Venoruton®. A five-year, open-registry, efficacy study.
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ABSTRACT: This registry evaluation was conducted in post-thrombotic syndrome (PTS) patients (with a minimum five-year follow up). The study evaluated: 1) variations in peripheral edema with an analogue scoring system; 2) ankle circumference at the PTS limb in comparison with the normal contralateral limb. The difference was expressed in percent increase in circumference measured at the PTS limb; 3) other end-points were observed in a five-year follow-up that created a specific PTS registry. Subjects could follow a management system including: 1) compression; 2) compression and Venoruton® (1 g/day); 3) compression and Venoruton® (2 g/day). The groups of patients with chronic venous insufficiency (CVI) resulted comparable. The occurrence of a new deep venous thrombosis (DVT) episode was considered a drop out. At five years there were four new DVTs (in 90 patients) in the compression group. There was one case (90 patients included) in the compression and HR (1 g) group and no DVT in group 3. The outcome in groups 2 and 3 was significantly better (0.05) than in group 1. The need for surgery or sclerotherapy (for larger varicose veins), the occurrence of lipodermatosclerosis and ulcerations were significantly lower in the HR groups with a better outcome in the higher dose group (P<0.05). The number of ulcerations were also significantly reduced in the HR groups. The difference in ulcerations was significantly better in the higher dose group in comparison with the other groups (P<0.05). The edema score was significantly reduced at five years in the HR groups (P<0.05) in comparison with the compression group. The higher dose resulted more effective in controlling edema. Both edema score and ankle circumference at five years were significantly lower (P<0.05) in the HR-treated groups with a significant decrease in edema score and ankle circumference in the higher dosage group. The study confirms the long-term efficacy of HR in PTS, CVI patients. Controlling signs/symptoms and edema in CVI with HR prevents the most severe complications of CVI including lipodermatosclerosis and venous ulcerations. An early therapeutic program including exercise, risk factor controls, compression an edema-controlling treatment with HR is effective in decreasing the classic complications of PTS syndrome. The important restrictions and difficulties to the use of elastic stockings (in regions with warmer climates) are not applicable to HR that is well tolerated and can be used all the time alone or in association with compression.Panminerva medica 09/2011; 53(3 Suppl 1):13-9. · 1.11 Impact Factor -
Article: Prevention of post thrombotic syndrome with Pycnogenol® in a twelve month study.
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ABSTRACT: Post-thrombotic syndrome is a common complication following deep vein thrombosis. The aim of this twelve month registry study was to compare the efficacy of compression stockings and per oral administration of Pycnogenol® standardized pine bark extract on the severity and incidence of post thrombotic syndrome signs and symptoms. One hundred fifty-six patients with a single, major episode of proximal deep vein thrombosis (DVT) were assigned to one of three groups receiving treatment with either compression stockings (group 1), Pycnogenol® (group 2) or the combination of both (group 3) over an investigational period of one year. The study evaluated treatment on edema using a scoring system, the ankle circumference, and the limb volume as ratio to the healthy contralateral limb. Two new incidents of DVT occurred in the group of 55 patients wearing compression stockings between the third and sixth months, whereas no DVT cases occurred in the two other groups which took Pycnogenol®. The edema symptom score was gradually decreased in all three groups during the one year treatment period. Pycnogenol® was significantly more effective from six months onwards than compression stockings for relieving edema symptoms (P<0.05). Symptoms were more effectively reduced with the combination of Pycnogenol® and compression stockings than with the individual regimen alone (P<0.05). Limb volume and ankle circumference were likewise more effectively reduced with Pycnogenol® plus stockings than with compression stockings alone after six months. Ambulatory venous pressure progressively decreased in all three groups after twelve months treatment as compared to baseline. Compression stockings and Pycnogenol® were of comparable efficacy, there were no significant differences of ambulatory venous pressure between groups following twelve months treatment. Laser Doppler flowmetry at the dorsum of feet showed improved micro-circulation which was further demonstrated by increased pO2 and decreased pCO2. Importantly, none of the patients developed ulcerations during the observational period. This study suggests that Pycnogenol® may have significant long-term protective efficacy for individuals following a thrombotic event. Moreover, Pycnogenol® appears to be at least as effective for post-thrombosis management as compression stockings, while the combination of both is superior. An important aspect is the patient compliance which was found to be much better in the Pycnogenol® group with two drop-outs due to non-medical reasons, whereas in the compression stockings group eighteen patients were lost to follow-up because wearing stockings at higher temperatures is bothersome.Panminerva medica 09/2011; 53(3 Suppl 1):21-7. · 1.11 Impact Factor -
Article: Gore external valve support for superficial saphenous vein incompetence: a 10-year, follow-up registry.
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ABSTRACT: This long-term (10-year) study evaluated the safety and efficacy of expanded polytetrafluoroethylene (ePTFE) external valve support (EVS) implants used for external valvuloplasty in the treatment of incompetence of the proximal long saphenous veins. During a 10-year follow-up, patients with superficial venous disease and venous hypertension due to pure superficial vein incompetence underwent an external valvuloplasty using an EVS with a PTFE suture. Forty-nine patients were included in the EVS group and 47 in the control group. Patients with superficial venous disease and venous hypertension due to pure superficial venous incompetence were randomised into two treatment groups. The first group was treated with what was considered "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with EVS. This report deals with controls treated with ligation as only 6 cases (not mentioned in this report) were treated with stripping. There were no significant differences in the two groups concerning age, sex, or type of venous insufficiency. The procedures focused on only one single limb per patient. 46.9% of limbs treated with EVS developed varices in comparison with 73% in the control group. New surgical procedures (localized ligation) were needed in 32.6% of the EVS patients vs. 55.3% in controls. Sclerotherapy was used in 42% of the EVS patients vs. 72.34% in controls. At 10 years the SFJ was incompetent (reflux) in 2 EVS patients (4%); one after 5 years and one after 7 years. There was no incompetence at the level of the ligated junction in controls. There were 62 incompetent venous sites (1.26 per limb) in the EVS group vs. 96 new incompetent venous sites (2.04 per limb) in controls. In controls 10.63% of the limbs developed minor discolorations and signs due to mild CVI; none was observed in the EVS group. In all ESV implants there was full restoration of competence at 1 year. EVS implants used to correct superficial venous incompetence at 10 years were well tolerated and produced good results on incompetence and on the evolution of varicose veins.Panminerva medica 09/2011; 53(3 Suppl 1):35-41. · 1.11 Impact Factor -
Article: Aescin: microcirculatory activity. Effects of accessory components on clinical and microcirculatory efficacy.
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ABSTRACT: This study was performed to test the hypothesis that the heparin and phosphatidylcholine (PDC) included in Aescin gel formulations had the main role of allowing a better penetration of Aescin without important pharmacodynamic effects. Heparin and PDC should be considered as "enhancers". They do not have - at the dosage used - a specific or independent action. An open, registry study of patients - a group with chronic venous insufficiency (CVI) and a group of patients with diabetic microangiopathy were completed. In patients with CVI and in patients with diabetic microangiopathy, we used a commercial gel preparation containing Aescin, PDC and heparin (group A). The first group of patients used the full complex. The second group used the complex without PDC (group B) and the third (group C) used the complex without heparin. In both studies the different groups of patients were comparable. In CVI patients (mean age 44.5; SD 2.4; range 40-50) venous microangiopathy was present at the perimalleolar region. Aescin produced comparable microcirculatory results with and without the two other components. Transcutaneus PO2 [TcPO2] increased in all groups. Transcutaneus PCO2 (TcCO2) decreases. The increased Laser Doppler Flux (LDF) (typical of CVI) decreased towards normality. The local Plasma Free Radicals [PFR] levels decreased as the result of better skin perfusion (P<0.05). Comparable data were observed in subjects with diabetic microangiopathy (mean age 46.5; SD 3.1). In these patients the compound was applied at the dorsum of the foot. TcPO2 increased with treatment. TcPCO2, skin flux and PFR decreased towards normal levels (P<0.05). In conclusion Aescin improves the microcirculation and PFR. Heparin and PDC - included in the gel - have an ancillary role. An improved perfusion and nutrition of the skin was observed both in diabetic and venous microangiopathy. This may possibly contribute in the reduction of the incidence of ulceration associated with diabetic and venous microangiopathy. Aescin-based products may be included in a more complex management plan, including several systemic and local treatments.Panminerva medica 09/2011; 53(3 Suppl 1):51-5. · 1.11 Impact Factor -
Article: Pycnogenol® improvements in asthma management.
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ABSTRACT: The simplification of the management of asthma in the different clinical phases of this common chronic inflammatory disorder is the main goal of therapy. Pycnogenol®, a standardized extract of French maritime pine bark, inhibits expression of 5-lipoxygenase and consequently decreases leukotriene levels in asthmatic patients. Pycnogenol® anti-inflammatory activities may be supportive when taken in addition to inhalation corticosteroid (ICS), putatively allowing for a reduction in dosage and frequency of ICS administration. This study evaluated the efficacy of Pycnogenol® during a period of six months for improving allergic (mite in house dust) asthma management in patients with stable, controlled conditions. Pycnogenol® was used at a daily dosage of 100 mg, distributed as 50 mg in the morning at 9 am and again in the evening at 9 pm). An individual patient's asthma condition was graded in five steps based on the daily dosage of inhaled fluticasone propionate with step 1 indicating 0 µg and step 5 the maximum dose of 500 µg ICS twice daily. A total 76 patients were enrolled for this study. The group taking Pycnogenol® in addition to ICS and the group taking only ICS were comparable for age, gender and clinical characteristics including FEV1. The analysis of therapeutic ranking steps showed that 55% of patients taking Pycnogenol® improved as judged by passing to a lower ICS dose step. In comparison, only 6% of patients depending exclusively on ICS progressed to a lower (ICS dose) therapeutic step. No deterioration (passage to a higher ICS therapeutic step) was observed in the Pycnogenol® group, whereas in 18.8% of patients depending exclusively on corticosteroids a deterioration requiring a higher dosage step was observed. The passage to different therapeutic steps was statistical significant between groups (P<0.05). Drop-outs were associated entirely to irregularities in follow-up and not due to medical reasons. No serious adverse events were observed in both groups and tolerability of Pycnogenol® was very good. The levels of asthma control in the 6 interventional months as compared to the same period in the previous year were compared. In the Pycnogenol® group, night-awakenings were less frequent, the number of days with PEF<80% were decreased, days with asthma score >1 were lower, requirement for salbutamol and additional asthma medication less frequent, and consultation of general practitioner and specialist required less commonly. All these parameters were statistical significantly improved in Pycnogenol® + ICS group versus the ICS control group where no considerable changes were observed. Various common signs and symptoms were evaluated by visual analog scale, (dry) cough, severity of chest symptoms, wheezing, dyspnea and daytime symptoms. In the ICS-only group values did not improve while they did improve significantly in the ICS + Pycnogenol® group (P<0.05 vs. ICS only group). A decrease by 15.2% of the specific IgE titer was found in the Pycnogenol® + ICS group, whereas the titer increased by 13.4% in the ICS-only group, while IgG1 and IgG4 remained unchanged in both groups. Pycnogenol® administration was effective for better control of signs and symptoms of allergic asthma and reduced the need for medication.Panminerva medica 09/2011; 53(3 Suppl 1):57-64. · 1.11 Impact Factor -
Article: Supplementation with Pycnogenol® improves signs and symptoms of menopausal transition.
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ABSTRACT: The aim of this study was to evaluate the efficacy of Pycnogenol® standardized pine bark extract for alleviation of signs and symptoms associated with menopausal transition. Pycnogenol® was used by 38 women as daily supplement in a dosage of 100 mg over an eight week period and menopausal symptoms were evaluated by means of a scoring system, based on a total number of 33 common signs and symptoms. A parallel control group of 32 comparable women was also followed up for the same period. Pycnogenol® was well tolerated, no side effects were reported and the compliance was very good with 98.6% of tablets used as prescribed. A range of 33 menopausal symptoms were evaluated using a scoring system with values ranging from zero (absent) to maximum 4 (very serious). A subset of six most common symptoms comprising hot flushes, night sweats, mood swings, irregular periods, loss of libido and vaginal dryness showed a decrease from average 2.67/4 to 1.45/4 after 8 weeks supplementation with Pycnogenol®. The control group of women showed no change from initial average 2.72/4 to 2.73/4 after eight weeks. The improvement of symptoms was statistical significant compared to the control group. Further symptoms related to fatigue, sleeping disorders, concentration and memory problems, dizziness, depression and irritability all improved significantly with Pycnogenol® compared to baseline values but did not reach statistical significance compared to the control group of women. The sensation of pain related to headaches, breast pain, the feeling of "electric shocks", tingling extremities, burning tongue and itchy skin all improved significantly after intake of Pycnogenol® for eight weeks compared to baseline. Specifically the sensation of "electric shocks" and digestive problems improved significantly with Pycnogenol® as compared to women in the control group. The presence of elevated oxidative stress in women was investigated measuring capillary blood plasma free radicals. Oxidative stress was significantly lowered after four weeks (P<0.05) and eight weeks (P<0.022) in the Pycnogenol® group while no significant changes were observed in the control group at any time. Pycnogenol® significantly contributed to reduce signs and symptoms associated with menopausal transitions in women investigated in this study. Furthermore, Pycnogenol® improved the quality of life of most women and these benefits may be at least in part attributed to decreased oxidative stress levels.Panminerva medica 09/2011; 53(3 Suppl 1):65-70. · 1.11 Impact Factor -
Article: Pycnogenol® supplementation improves cognitive function, attention and mental performance in students.
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ABSTRACT: This study compared the effects of supplementation with Pycnogenol® on cognitive function, attention and mental performance in students with an 8 week, evaluation study. Pycnogenol® was used in healthy students; the supplement was used with the aim of enhancing "normal" mental performances. Attention, memory, evaluation of executive functions were included and students were also evaluated - in the 8-week study - according to results of the university tests. Fifty-three students (range 18-27 years) were included and Pycnogenol® was administered for 8 weeks. A group of equivalent students were followed up as a control group. In the 8-week study Pycnogenol® supplementation improved sustained attention, memory, executive functions and mood ratings in the students. The improvement was statistically significant. The actual performance on real tests was measured in students undergoing university examinations. The controls failed 9 tests out a total of 84 (10.71%). In the Pycnogenol® group the students failed 7 tests out of 112 (6.25%) with a difference of 4.46% of failures in the Pycnogenol® group that performed, statistically, generally better. The average test score measured by the marks obtained was 23.81 (1.1) in controls vs. 26.1(1.3) (P<0.024) in the Pycnogenol® group (+2.29 equivalent to 7.6%). This study indicates a role for Pycnogenol® to improve cognitive function in normal students.Panminerva medica 09/2011; 53(3 Suppl 1):75-82. · 1.11 Impact Factor -
Article: Osteoporosis of the jaw. Product evaluation: mf Odontovis Calcium®.
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ABSTRACT: The aim of this study was to test mf Odondovis Calcium® as a food supplement in a 3-month product evaluation study measuring how the low jaw bone density, could be improved. The upper jaw density was tested with an ultrasound method, evaluating the grey scale median of the images (GSM). Seventy nine subjects were enrolled; 22 normal subjects (group A) and 57 with upper jaw osteoporosis (according to DEXA values). Patients were divided into 2 groups (group B and C, respectively 28 and 29 cases). These subjects were treated with what was considered the' best treatment' and in the group B only was added mf Odontovis Calcium®, consisting of calcium salts, Vitamin D and physiological modulators with antioxidant activity. This treatment continued for 3 months. The GSM of osteoporotic patients was significantly lower in comparison with GSM in normal subjects. No changes were observed (between the inclusion and 3 month values) in normal subjects and minimal, non-significant changes were observed in control osteoporosis patients. Before-after treatment values of GSM in treatment patients showed a significant increase (P<0.022) at 3 months. The increase in GSM in these patients was significantly higher (P<0.05) in comparison with control patient with osteoporosis. The Tolerability of the product was very good and the compliance corresponded to 98%. the jaw density in patients with osteoporosis is increased in only 3 months with supplementation with mf Odontovis Calcium®. Long-term clinical implications should be observed in more prolonged studies.Panminerva medica 09/2011; 53(3 Suppl 1):83-7. · 1.11 Impact Factor -
Article: Oxidative stress following administration of levothyroxine in subjects suffering from primary hypothyroidism.
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ABSTRACT: Oxidative stress (OS) in subjects with primary hypothyroidism under therapy with L-T4 might be the cause of the side effects commonly found with this treatment. Twenty-four subjects of both sexes (11 M and 15 F), aged between 41 and 61 years, with primary hypothyroidism were assessed. All the subjects were followed for 30 days during the administration of a fixed dose of 75 μg of L-T4. Levels of T4, T3, TSH, hydroperoxides (as measure of OS ), hs-CRP were determined in plasma before and after the treatment. Side effects (anxiety/agitation, sweating, palpitations and headache) and number of days of discomfort were measured for 15 days before and for two subsequent 15-day periods. Administration of L-T4 satisfactorily balanced the hypothyroidism. A high level of hydroperoxides, 370 ± 27.7 U.CARR. (Carratelli Units: 1 U.CARR. = 0.08 mg of H2O2/L), was observed before treatment, and L-T4 administration further increased the level up to 435 ± 39.5 U.CARR (p<0.05). The treatment produces a significant increase in hs-CRP, from 3.2 ± 2.32 to 4.0 ± 1.27 mg/L (P<0.05). Side effects, almost absent at the baseline 15-day control, occurred with high frequencies during the treatment: between 9.6 ± 1.14 days/15 days for sweating and 14.1 ± 0.93 days/15 days for palpitations. Some side effects were found to be linearly correlated with hydroperoxides (r=0.641, P<0.01 and r=0.658, P<0.01 respectively) or with hs-CRP, as in the case of anxiety/agitation (r=0.629, P<0.01). Following L-T4 administration the days of discomfort turned out to be particularly prominent during the two subsequent 15-day controls (3.8 ± 0.75 and 4.8 ± 0.78 days respectively). Primary hypothyroidism and therapy with L-T4 at a dose of 75 μg/day cause OS. Side effects following L-T4 therapy depend on OS and cause daily discomfort and loss of working activity in about 1/3 of the days considered.Panminerva medica 09/2011; 53(3 Suppl 1):95-8. · 1.11 Impact Factor -
Article: Activity of some physiological modulators in reducing the side effects of levothyroxine in patients suffering from primary hypothyroidism.
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ABSTRACT: The use of L-T4 (levothyroxine) in the treatment of primary hypothyroidism causes oxidative stress (OS) and daily discomfort. It is believed that the use of physiological modulators (PMs) may make the treatment more tolerable. Thirty six patients of both sexes (15 M; 21 F) with hypothyroidism were enrolled (age 44-64 years), starting the treatment with LT-4 at the fixed dose of 75 µg/day. Subjects were randomly divided into three groups (A, B and C) of 12 subjects each in a double blind design. Group A was treated with a formula based on bioflavonoids; group B with a formula B based on oligomeric proanthocynidins (OPA); group C with placebo. Treatments continued for 30 days. Plasma levels of T3, T4, TSH, plasma hydroperoxides and hs-CRP, were determined before and after 30 days of treatment. During the treatment anxiety/agitation, sweating, palpitations, headache and daily discomfort were recorded through a daily questionnaire. The same adequate hormone balancing was observed in all three groups (T4, T3, TSH). The hydroperoxide levels in the three groups (A, B and C) were similar at baseline (373 ± 36.1, 384 ± 39.1, 376 ± 24.0 U.CARR. respectively); after 30 days the values were significantly different (of 312 ± 21.0, 273 ± 24.3, and 409 ± 31.7 U.CARR respectively). The levels for hs-CRP at baseline were 3.8 ± 1.41, 3.4 ± 1.34, 3.6 ± 1.03, and 3.8 ± 1.31, 3.2 ± 0.99; and 4.4 ± 0.90 mg/L at 30 days respectively. Both markers were more consistently reduced by Formula B (anova p< 0.05). The incidence of side effects and the number of days of daily discomfort were significantly lower in the same group only (Anova P<0.05). The use of a formula containing OPA with other PMs may limit the incidence of the side effects that occur during the initial phase of L-T4 treatment in hypothyroidism.Panminerva medica 09/2011; 53(3 Suppl 1):99-103. · 1.11 Impact Factor -
Article: TECA (Titrated Extract of Centella Asiatica): new microcirculatory, biomolecular, and vascular application in preventive and clinical medicine. A status paper.
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ABSTRACT: Plant-derived elements used for pharmacological applications constitute an increasing research field. Centella asiatica is widely used mainly as an extract (TECA). Triterpenic fractions, the primary constituents of Centella asiatica, produce a wide range of preventive and therapeutic effects. The modulation of collagen production and deposition in wound healing is of primary importance. TECA is also used to treat several microcirculatory problems, inflammatory skin conditions (leprosy, lupus, varicose ulcers, eczema, atopic dermatitis, psoriasis) and also intestinal problems, fever, amenorrhea and genitourinary conditions. Cognitive functions, anxiety and mental impairment may be also affected by TECA administration. New applications in neurology include nerve growth factor enhancement and applications in neurological degenerative conditions. Interaction with other products is also indicated in this document. The multiplicity of actions of TECA is associated to six important mechanisms, all inter-connected and modulating each other: 1) edema - and capillary filtration - control; 2) a strong antioxidant power, effective on several forms of oxidative stress associated to inflammation or infections and synergic with other antioxidant products; 3) an anti-inflammatory action; 4) a modulation of the collagen production avoiding slower scarring or faster, hyperthrophic scarring and cheloids; 5) a modulating action of local growth factors; 6) a modulation of angiogenesis. This "status" paper - resulting from an expert meeting held in Cobham, Surrey, indicates most of the therapeutic potential of TECA, still to be explored in further studies. The status paper constitutes the basis for a consensus document on TECA to be developed in the next future. This "status" paper opens a new window on an ancient but still partially unexplored product that may become an important value in prevention and treatment of several pre-clinical and risk conditions and in clinically significant disease both as a single products and in association with other 'natural' products.Panminerva medica 09/2011; 53(3 Suppl 1):105-18. · 1.11 Impact Factor -
Article: Ocular and optic nerve ischemia: recognition and treatment with intravenous prostaglandin E1.
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ABSTRACT: Ischemia of the optic nerve, the retina and the choroid are common problems in ophthalmology. This paper presents the different types of ischemia and their treatment with prostaglandin E1 (PGE1), a powerful vasodilator of the microcirculation. This is a review article of various previously published case reports and studies presenting patients with different types of ocular and optic nerve ischemia. Their treatment with intravenous (IV) PGE1 is described. Treatment for acute and chronic problems is presented. The visual acuity and/or the visual fields improved in almost all the treated patients. When measured, the blood flow velocities also improved. No complications due to the use of PGE1 were seen. Treatment with IV PGE1 should be considered in cases of ocular and optic nerve ischemia to immediately restore blood flow to these structures and improve the visual acuity. Intravenous prostaglandin E1 is an effective treatment for ocular and optic nerve ischemia leading to immediate visual improvement.Panminerva medica 09/2011; 53(3 Suppl 1):119-24. · 1.11 Impact Factor -
Article: Potential role of curcumin phytosome (Meriva) in controlling the evolution of diabetic microangiopathy. A pilot study.
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ABSTRACT: The aim of the present study was to evaluate the improvement of diabetic microangiopathy in patients suffering from this condition since at least five years, and whose disease was managed without insulin. Curcumin, the orange pigment of turmeric, has recently received increasing attention because of its antioxidant properties, mediated by both direct oxygen radical quenching and by induction of anti-oxidant responses via Nrf2 activation. This aspect, combined with the beneficial effects on endothelial function and on tissue and plasma inflammatory status, makes curcumin potentially useful for the management of diabetic microangiopathy. To further evaluate this, Meriva, a lecithinized formulation of curcumin, was administered at the dosage of two tablets/day (1 g Meriva/day) to 25 diabetic patients for four weeks. A comparable group of subjects followed the best possible management for this type of patients. All subjects in the treatment and control group completed the follow-up period; there were no dropouts. In the treatment group, at four weeks, microcirculatory and clinical evaluations indicated a decrease in skin flux (P<0.05) at the surface of the foot, a finding diagnostic of an improvement in microangiopathy, the flux being generally increased in patients affected by diabetic microangiopathy. Also, a significant decrease in the edema score (P<0.05) and a corresponding improvement in the venoarteriolar response (P<0.05) were observed. The PO2 increased at four weeks (P<0.05), as expected from a better oxygen diffusion into the skin due to the decreased edema. These findings were present in all subjects using Meriva, while no clinical or microcirculatory effects were observed in the control group. Meriva was, in general, well tolerated, and these preliminary findings suggest the usefulness of this curcumin formulation for the management of diabetic microangiopathy, opening a window of opportunities to be evaluated in more prolonged and larger studies. The molecular mechanisms involved in the beneficial effects of curcumin on microcirculation and edema are also worth investigation.Panminerva medica 09/2011; 53(3 Suppl 1):43-9. · 1.11 Impact Factor
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2011
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Loyola University Chicago
Chicago, IL, USA -
Università degli Studi G. d'Annunzio Chieti e Pescara
Chieti, Abruzzo, Italy -
Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Alessandria, Piedmont, Italy
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