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Xerostomia is a symptom frequently present in patients with type 1 (T1DM) and type 2 diabetes mellitus (T2DM). In the present trial, the activity of an artificial saliva (aldiamed&reg, spray) in comparison to a placebo spray were used to evaluate the xerostomia and the saliva antioxidant capacity (SAT). Sixty patients of both genders with T1DM or T2DM were randomized into two groups of 30 subjects each. The experiment was a double-blind study approved by the Ethics Committee of the &ldquo, G. d&rsquo, Annunzio University&rdquo, of Chieti and Pescara. Moreover, measurements of the stimulated saliva flow rate and the ultrasonography of the submandibular and parotid glands were performed at both the study time points. The results demonstrated statistically significant differences between the treatments in terms of the xerostomia average score. Specifically, the values were at baseline and after 30 days 2.9 &plusmn, 1.31 and 3.0 &plusmn, 1.44 and 1.4 &plusmn, 1.48 and 2.4 &plusmn, 0.99 for aldiamed&reg, spray and the placebo, respectively. Meanwhile, no statistically significant differences were shown between the two groups for the other variables, such as the salivary flow rate, the antioxidant capacity of the saliva, and the ultrasonography of the major salivary glands.

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.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.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.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®.

Supplementation with Mirtogenol® improves the retinal microcirculation and reduces intraocular pressure (IOP) in ocular hypertension, when administrated either alone or in association with an ophthalmic solution (latanoprost). In this study, microcirculatory parameters (perfusion of the circle of Zinn-Haller and retinal circulation) and oxidative stress were tested to assess the effects of Mirtogenol® plus traditional antihypertensive drugs in patients with elevated IOP.88 otherwise healthy patients with increased IOP were followed-up in a supplement registry for 12 weeks. Three groups received; (a) dorzolamide-timolol plus Mirtogenol®; (b) latanoprost drops plus Mirtogenol® or (c) latanoprost only. Oral supplementation consisted of two tablets/day of Mirtogenol® (80 mg of bilberry extract, Mirtoselect® plus 40 mg of Pycnogenol®). IOP, retinal blood flow, perfusion of the circle of Zinn-Haller, and oxidative stress were measured during the registry period.The three study groups were comparable; IOP and ocular blood flow velocity at inclusion were also comparable. Over the study period the decrease in IOP and the improvements in retinal microcirculation were statistically significant for all management groups, with a marginally more evident benefit in Mirtogenol®+latanosprost-treated patients. At 12 weeks, the altered perfusion at the circle of Zinn-Haller was improved in all groups; patients using Mirtogenol® showed a better perfusional pattern compared with subjects using only latanoprost. A reduction in oxidative stress was observed in supplemented subjects at the end of the study period; no significant change was seen in non-supplemented patients. All managements were well-tolerated without side effects.Supplementation with Mirtogenol®, in addition to local ophthalmic treatments, is safe and may contribute as a supplementary management to reach a normal IOP and ocular microcirculatory parameters.

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.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.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.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.

Several experimental studies and clinical trials support the potential of bilberry (Vaccinium myrtillus L) extracts in promoting eye health and circulation. Many active ingredients have been isolated from the berries and leaves of the bilberry plant. However, anthocyanins represent the most widely studied bioactive compounds in this plant.The aim of this registry, supplement study was to evaluate the effects of Mirtoselect® (standardized in 36% anthocyanins and obtained by an industrial extraction process that preserves the full range of the non-anthocyanin components, mainly natural sugars and polyphenols) in different types of retinal vasculopathies. In total, 140 patients with different types of retinopathy spontaneously decided to join one of the following groups: standard management (SM) only (n=38); SM associated with Mirtoselect® supplementation (n=47); SM associated with a generic bilberry extract supplementation (n=55). Retinal circulatory parameters and flow measurements of the retinal vessels were evaluated at the inclusion and after 6-months supplementation.Overall, significant improvements in several retinal circulatory parameters such as retinal blood flow velocity, with respect to the values at inclusion, were observed in both supplementation groups, especially in Mirtoselect® supplementation group. However, at 6 months, inter-group comparison revealed a statistical advantage in all tested parameters for Mirtoselect® supplementation groups. No side effects or tolerability concerns were reported.Our registry study suggests that Mirtoselect® supplementation could represent an effective and safe integrated approach for the treatment of different retinopathies.

A medicated plaster containing diclofenac epolamine (DHEP) and heparin has been recently proposed for the treatment of local trauma (ie, ankle sprains) accompanied by a clinically significant edema and/or hematoma formation, based on the combined antiinflammatory, hemorheologic, and antiedema properties of diclofenac and heparin. The aim of this study was therefore to compare the effects of a combined DHEP/heparin and DHEP alone in 2 clinical experimental models of microangiopathy, in order to provide a pharmacologic rationale for association of diclofenac and heparin. The microcirculation was evaluated by measuring cutaneous blood flow (laser Doppler) and transcutaneous oxygen and carbon dioxide pressures (TcPO2 and TcPCO2) in 10 healthy volunteers before and after producing 2 microcirculatory models of microangiopathy: the models were based on reactive hyperemia (RH) and on local histamine injection, which both produce a significant increase in skin flux and alterations of TcPO2 and TcPCO2. The area of the study was the distal medial leg, treated with placebo, DHEP alone (Flector Tissugel), and DHEP/heparin (Flector Tissugel Heparin). The plasters were applied before producing the microcirculatory models to evaluate the efficacy of DHEP and DHEP/heparin in controlling and limiting vasodilatation and development of microangiopathy. A significant increase in cutaneous flux was obtained with both models. The application of DHEP partially limited the increase in flux and in TcPCO2, as well as the decrease in TcPO2 (which were considered signs of microangiopathy), but the combination DHEP/heparin was significantly more effective than DHEP alone. The inclusion of heparin in the plaster thus improved the control of the microcirculation achieved with diclofenac alone, when an experimental model of venous/arterial hyperemia and microangiopathy was used. In conclusion, DHEP in association with heparin modulates microcirculatory changes better than DHEP alone. It should be interesting to investigate the product in comparable clinical conditions in which it may be useful to act pharmacologically both on inflammation and microcirculatory disturbances that delay the recovery of patients.

The aim of this study was to evaluate the prevention of edema during long-haul flights with an oral, anti-edema and antithrombotic agent (Pycnogenol®, Horphag, Research Management SA, Geneva, Switzerland) in asymptomatic subjects. The assessment of edema was performed by evaluating an analogue scale, the rate of ankle swelling by strain-gauge derived rate of ankle swelling (RAS), and by assessing the ankle circumference variation. The study included 211 subjects; 169 completed the study (88 in the control group and 81 in the Pycnogenol® group). There were no important differences between the two groups (comparable for age, gender, weight, body mass index, and pattern distribution). The edema score, the RAS, and the circumference at inclusion were also comparable. After the flight in those treated with Pycnogenol®, the edema score was increased only by 17.9% (vs. an increase of 58.3% in the control group) (p® group (age 44.5; SD 8) and in 23 in the control group (age 45; SD 9) was increased on average by 91% in the control group and 36% in the Pycnogenol® group (p® group (11% in the control group; p® on edema during long flights when considering subjective and objective data. No unwanted effects were observed.

Shock waves (SW) are used to control pain in different clinical conditions (eg, painful knee, elbow, and shoulder, etc). The effects of SWs may be due to cellular “stunning” (particularly nervous components). It may also be the consequence of unknown metabolic actions on tissues, which may include changes in cellular permeability, the liberation of proteins and mediators locally acting on pain and nerve endings. The aim of this study was to evaluate the reduction in pain and the improvement in microcirculation induced by SW treatment in a 2-week study in patients with chronic limb ischemia (CLI). Of the 32 patients with CLI, 30 (20 with rest pain only, 10 with necrosis) completed the study. The treatment was well tolerated. Foot radiographs performed before and after treatment indicate no bone damage after treatment. Foot (tibial arteries) blood pressure was unchanged after 2 weeks. The increase in laser Doppler flux was significant (p2) increased (p2) decreased (p

The aim of this study was the evaluation of the effects of Aescin + essential phospholipids (AEPL) gel on plasma free radicals (PFRs). In this study, ten patients with venous hypertension, no ulcerations or infections, venous microangiopathy, and varicose veins were treated with topical AEPL applied in a standard protocol. AEPL was applied for 2 weeks, three times daily at the same skin region (perimalleolar internal region at defined distance from the medial malleolus and from the anterior edge of the tibia). In subjects with venous hypertension, PFR values were higher than 420 Carr units. After treatment, the values of PRF decreased to almost normal as an effect of the massage with AEPL gel. The decrease in value was observed in all treatment subjects. A ranking system indicates that the AEPL preparation is active in all subjects who have venous microangiopathy. The decrease in PFR value was greater than 30% in all treatment subjects (p

The aim of this efficacy study was to evaluate the effects of topical aescin + essential phospholipids gel in a histamine model of acute microangiopathy, comparable to microangiopathy observed in chronic venous disease.

The aim of this study was to evaluate the development of edema, and superficial and deep vein thrombosis (DVT) prophylaxis with an oral profibrinolytic agent (Flite Tabs, 150 mg pinokinase, Aidan, Tempe, AZ, USA) in long-haul flights (7-8 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treat ments ; 204 were randomized into 2 groups (active treatment or placebo) to evaluate the effects of prophylaxis with Flite Tabs. An exercise program was used in both groups. The femoral, popliteal, tibial, and superficial veins were scanned with ultrasound before and within 90 minutes after flights. Of the included subjects, 92 of 103 controls and 94 of 101 treated subjects completed the study. Dropouts were due to connection problems. Age, gender, and risk distribution were comparable in the groups. In the treatment group, no DVT was observed. In the control group, 5 subjects (5.4%) had a DVT and there were 2 superficial thromboses (7 events in 92 subjects; 7.6%). At inclusion, edema was comparable in the 2 groups. After flights there was an increase in score in controls (+12%) in comparison with a decrease (-15%) in the Flite Tabs group (the difference in variation was statistically significant). Intention-to-treat analysis for thrombotic events shows 18 failures in controls (11 lost to follow-up + 7 throm botic events) of 92 subjects (19.6%) in comparison with 7 failures (of 94 subjects, equivalent to 7.4%) in the treatment group (p

The study compared, by a prospective, randomized method, 6 treatment options: A: Sclero therapy ; B: High-dose sclerotherapy; C: Multiple ligations; D: Stab avulsion; E: Foam-sclero therapy ; F: Surgery (ligation) followed by sclerotherapy. Results were analyzed 10 years after inclusion and initial treatment. Endpoints of the study were variations in ambulatory venous pressure (AVP), refilling time (RT), presence of duplex-reflux, and number of recurrent or new incompetent venous sites. The number of patients, limbs, and treated venous segments were comparable in the 6 treatment groups, also comparable for age and sex distribution. The occur rence of new varicose veins at 5 years varied from 34% for group F (surgery + sclero) and ligation (C) to 44% for the foam + sclero group (E) and 48% for group A (dose 1 sclero). At 10 years the occurrence of new veins varied from 37% in F to 56% in A. At inclusion AVP was comparable in the different groups. At 10 years the decrease in AVP and the increase in RT (indicating decrease in reflux), was generally comparable in the different groups. Also at 10 years the number of new points of major incompetence was comparable in all treatment groups. These results indicate that, when correctly performed, all treatments may be similarly effective. "Standard," low-dose sclerotherapy appears to be less effective than high-dose sclero and foam-sclerotherapy which may obtain, in selected subjects, results comparable to surgery.

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.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.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% (p0.05). This figure was 15.4% in the control group (p0.05; 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 (p0.05). 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 (p0.05). Three subjects (13.6%) in the cranberry group and 8 (36.3%) in the control group required medical consultation for UTI symptoms (p0.05). Urine evaluation was completely negative in 20/22 subjects in the Cranberry group (90.9%) and in 11 control subjects (50.0%; p0.005). No adverse events were observed.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.

This study evaluates the efficacy of Beanblock®, a standardized extract of Phaseolus vulgaris L., on weight control in healthy overweight subjects on a weight management plan that combined lifestyle and dietary advice.Sixty overweight (BMI 25-30 kg/m2) healthy subjects were enroled. All subjects were instructed to follow a weight management plan, accompanied by dietary advice. Thirty subjects used Beanblock® for at least 12 weeks (50 mg tablets, two times daily). The remaining 30 subjects did not receive any supplementation (management-only). The main endpoints were changes in body weight and waist circumference, with plasmatic oxidative stress, satiey and appetite being also evaluated.At week 12, the supplementation with Beanblock® was associated with a reduction in body weight (from 82.8 ± 9.1 kg to 78.8 ± 8.9 kg; p0.0001) and a decrease of waist circumference from 94.4 ± 10.3 cm to 88.2 ± 10.0 cm (p0.0001). Conversely, only marginal changes were observed in the control group. Oxidative stress was also significantly decreased with Beanblock® (from 380.4 ± 14.8 to 340.7 ± 14.8 Carr Units; p0.0001). Satiety and appetite improved in the supplement group. No side effects were observed and compliance was optimal.Beanblock®, in association with a health management plan, was useful for weight control in mildly overweight healthy subjects.

The involvement of the microcirculation in diabetic microangiopathy (DM) causes of severe incapacitation and ulceration. DM is characterized by a diffuse increase in flux, reduction in venoarteriolar response, associated with increased permeability resulting in edema and altered function of microlymphatics. In DM, skin PO2 is decreased and CO2 increased. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 35 subjects with DM and neuropathy and localized, small (

The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG), in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 8-week study evaluated SVT with an analogue clinical/sympto matic score. SVT was associated with varicose veins. In patients treated with active EG the decrease in score was significantly larger (p < 0.02) than in the placebo group. No intolerance was observed. The decrease in score in the placebo group was due to spontaneous resolution and to skin manipulation and massage. In conclusion local treatment with EG in SVT improves signs/symptoms much faster than placebo. This study confirms earlier observation on the effective, local use of EG in SVT.

Microcirculatory changes in chronic venous insufficiency (CVI) due to venous hypertension produce venous hypertensive microangiopathy (VHM) and lead to ulceration. VHM is charac terized by enlarged, convoluted capillaries; increase in flux, permeability, and edema; and altered microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations in association with microtrauma may cause venous ulcers. The aim of this pilot, cross-over, randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) (single acute application) in 10 subjects with VHM and venous ulcers. The study was structured over 3 days: day 1 was used for the control evalua tion for all patients. One group was randomized for the sequence placebo (day 2) and EG the following day; the second group with the sequence EG (day 2) and placebo (day 3). Indepen dently from the sequence, measurements of flux and PO2 in standard conditions showed positive changes (significant decrease of the abnormally increased flux, PO2 increase) in the EG treatment group. Changes in the placebo group were limited and associated with skin manip ulation. In conclusion, EG acutely improves microcirculation in limbs with VHM and ulceration even with a single application.

The involvement of the microvascular structure in chronic venous insufficiency (CVI) causes venous hypertensive microangiopathy (VHM), which leads to venous ulceration. VHM is char acterized by enlarged and ramified capillaries, increased flux and capillary permeability, edema, and altered function of microlymphatics. TcPO2 is decreased and CO2 increased. This perfu sional paradox is caused by hyperperfusion in the deep skin layers with hypoperfusion of superficial nutritional capillaries. Exchanges in the capillary bed are altered. Nutritional skin alterations eventually lead to venous ulceration. Edema is the consequence of increased capillary pressure, reduced clearance, and by an increased exchange surface of capillaries. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in 22 subjects with VHM due to severe varicose veins, treated with a single application. Measurements of flux, PO2 and PCO2 in standardized conditions of applica tion indicated a significant decrease of the abnormally increased flux and CO2; PO2 increased in the treatment group. Essaven gel, in comparison with placebo and controls acutely improves the microcirculation in VHM even with a single application.

The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in comparison with placebo in 30 patients with superficial vein thrombosis (SVT). The 4-week study evaluated the average skin temperature and an analogue symptomatic score. Below-knee SVT was associated with large varicose veins. In patients treated with active EG the decrease in score and in the average, composite skin temperature was significantly larger than in the placebo and control groups. No intolerance was observed. The decrease in score and temperature in the placebo group was mainly due to skin manipulation and massage. In conclusion, treatment with EG in SVT improves symptoms and decreases skin temperature faster. This study confirms earlier observations on the effective use of EG in SVT.

The involvement of the microcirculation in diabetic microangiopathy (DM) may be the cause of severe incapacitation and ulceration. DM is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased permeability, resulting in edema. In this condition capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local (foot) treatment with Essaven gel (EG) in 15 subjects with DM and neuropathy and treated with local application of EG for 4 weeks. Measurements of composite, average laser Doppler (LDF) flux (ten measurements points), in standardized conditions showed a significant decrease in flux in the EG group. The flux decrease was present even after 1 week after the suspension of treatment. Changes in the control group were not significant. In the placebo group, variations were limited (associated with skin manipulation and gel application). In conclusion local treatment for 4 weeks with standardized application of EG improves the microcirculation in subjects with DM. The changes are detectable even 1 week after the end of the treatment period.

The involvement of the microcirculation in diabetic microangiopathy (DM) may be cause of severe invalidity and ulceration. Diabetic microangiopathy (DM) is characterized by a diffuse increase in skin flux, reduction in venoarteriolar response, and increased capillary permeability resulting in edema; skin PO2 is decreased and CO2 increased. In this condition, capillary exchanges are altered and nutritional alterations eventually lead to skin lesions and ulcers. The aim of this randomized, placebo-controlled study was to evaluate the effect of local foot care and treatment with Essaven gel (EG) in 30 subjects with DM and neuropathy and localized, small (

The involvement of the microcirculation in chronic venous insufficiency (CVI), due to venous hypertension, causes venous hypertensive microangiopathy (VHM) and ulceration. VHM is char acterized by enlarged, convoluted capillaries; microvascular thrombosis; obliteration of some capillaries; increase in flux, permeability, and edema and altered microlymphatics. PO 2 is decreased and CO2 increased. Capillary exchanges are altered and nutritional alterations even tually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate local treatment with Essaven gel (EG) in subjects with venous microangiopathy and ulcers. Measurements of laser Doppler flux, PO2, and PCO2 in standardized conditions showed positive changes (a significant decrease of the abnormally increased flux and CO2 while PO2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo- EG was applied). In conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single acute application.

Essaven gel (EG) is a naturally derived compound indicated for the treatment of impaired venous circulation and, in microcirculatory disorders, hematomas, swelling, sprains, and all minor sport injuries. The aim of this randomized, placebo-controlled, double-blind study was to evaluate the standardized application of EG on normal skin and its effects on the microcircu lation. Standardization of gel application (particularly EG) has been recently described (in healthy subjects and in clinical studies) in defined steps. The results of this study indicate that topical treatment with EG is effective in improving or positively altering the microcircu lation in normal skin both at the deeper capillary levels (thermoregulatory, whole-thickness capillary bed [as shown by laser Doppler flowmetry] as well as at the nutritional capillary layer (as shown by PO2). The application of EG can be standardized to obtain consistent results with topical treatment.

The involvement of the microcirculation in chronic venous insufficiency (CVI) due to venous hypertension causes venous hypertensive microangiopathy (VHM) and venous ulceration. VHM is characterized by the presence of enlarged convoluted capillaries; microvascular thrombosis with obliteration of some capillaries; increase in flux, permeability, and edema; and altered function of microlymphatics. PO2 is decreased and CO2 increased. Capillary exchanges are altered, and nutritional alterations eventually lead to venous ulcers. Edema is associated with increased capillary pressure, reduced clearance, and an increased exchange surface of capillaries, which become tortuous and glomerular-like. The aim of this randomized, placebo-controlled study was to evaluate the effect of local treatment with Essaven gel (EG) in 28 subjects with venous microangiopathy due to severe CVI and ulcers treated with a single acute application. Measurements of laser Doppler flux, PO2 and PCO2 in standardized conditions of application showed positive microcirculatory changes (significant decrease of the abnormally increased flux and CO2 while PO 2 increased) in the EG treatment group. Changes in the placebo and control group were more limited (changes in the placebo group were mainly associated with skin manipulation when placebo-EG was applied). ln conclusion, Essaven gel, in comparison with placebo, acutely improves the microcirculation in VHM even with a single application.

The aim of this study was to evaluate whether TTFCA (total triterpenic fraction of Centella asiatica), was effective, by modulating collagen production, in a period of 12 months, increasing the echogenicity of echolucent plaques at the femoral bifurcation. Hypoechoic atherosclerotic plaques have been found to be associated with an increased evidence of cerebrovascular events. In this type of plaques stromal composition is limited as the collagen component is generally very low; the plaque composition is mainly due to lipid accumulation or thrombosis. The aim of this study was the evaluation of echogenicity of hyperechoic plaques and how it could be modified by a drug acting on the modulation of collagen synthesis. Antiplatelet agents were used in all patients; cholesterol-lowering agents were used in 34% of patients in the treatment group and in 36% in the placebo group. TTFCA was used at the dose of 60 mg thrice daily (oral tablets). Of the 60 included subjects 26 completed the study in the treatment group and 24 in the placebo group. At inclusion the average GSM in the treatment group was 14 (SD 3) and 14.3 (SD 3) in controls. At 12 months GSM was increased up to 22.8 (SD 4) in the treatment group and it was 15 (SD 3) in controls. Considering texture no significant changes were observed in controls while a qualitative increase in homogenicity was observed in the TTFCA group. Plaque size measured at the beginning and at the end of the study showed a median increase in size, in controls (23%; range 0%–44%); it was unchanged in the TTFCA group (variation 7%; 4%–26%). In conclusion in the treatment group plaques increased in echogenicity and in homogenicity; size and stenosis remained unchanged. Modulating the scarring process within echolucent plaques (low echogenicity, high echolucency, with a very low collagen/stromal component), possibly by collagen modulation, makes plaques more stable. This has been achieved and documented in the present study by an increase in the gray-scale median (plaques become more echogenic, more ‘white’). The variation in GSM is generally associated with a lower risk of wall thrombosis, rupture and embolization. These observations indicate a positive action of TTFCA on the stabilization of hypoechoic, low-density femoral plaques

The variation of capillary filtration rate (CFR), ankle circumference (AC), and ankle edema (AE) was evaluated in three groups of patients with venous hypertension (ambulatory venous pressure >42 mm Hg) and in a group of normal subjects before and after treatment for 4 weeks with total triterpenic fraction of Centella asiatica (TTFCA), a venoactive drug acting on the microcirculation and on capillary permeability. Group A (20 patients)was treated with TTFCA 60 mg thrice daily, group B (20 patients) was treated with 30 mg thrice daily; group C (12 patients) was treated with placebo; and group D (10 normal subjects) was treated with TTFCA 60 mg thrice daily in a randomized study. Capillary filtration rate was assessed by venous occlusion plethysmography, ankle edema by a new system called AET (ankle edema tester). Subjective symptoms of venous hypertension were assessed by an analogue scale line considering four symptoms: swelling sensation, restless lower extremity, pain and cramps, and tiredness. CFR, AC, and AE were significantly higher in patients in comparison with normal subjects. After 4 weeks of TTFCA treatment, there was a significant decrease of CFR, AC, and AET time in patients. This was also greater in the higher dose group. No significant change was observed in the placebo group and in normal subjects treated with TTFCA. Symptoms were also significantly improved in the two groups treated with the active drug according to the dose. No significant changes were observed in the placebo group. In conclusion, the improvement of signs and symptoms by TTFCA observed in patients with venous hypertension was well correlated with the improvement of CFR and ankle edema. Dose ranging showed that 180 mg/day is more effective in improving symptoms and CFR.

Noninvasive tests have been developed to provide qualitative and quantitative information that can offer answers to most questions posed in venous diseases. While duplex scanning is used to assess the macrocirculation, microcirculatory methods assess and quantify venous microangiopathy. Laser Doppler flowmetry is used to assess tissue viability and perfusion. Transcutaneous PO2 and PCO2 measurements are used to study venous hypertension, and strain-gauge plethysmography (SGP) is used to assess capillary filtration. In venous hypertension fluid filtration into the extracapillary compartment is increased. The increase in filtration is associated with a decreased venoarteriolar response. To quantify capillary filtration two methods have been developed: venous occlusion plethysmography and rate of ankle swelling. These methods quantify filtration into the extracapillary compartment and therefore are an indication of the formation of edema, which is the most frequent sign of venous hypertension. Other methods such as the vacuum suction chamber and the edema tester can be used to assess changes due to treatment in chronic venous hypertension. These methods have been used and validated in several experimental and clinical studies. The techniques described in this article were used in controlled environmental conditions. Results were consistent with clinical problems and data from previous studies from our group and from data from other investigators.

The aim of this international multicenter trial was to evaluate the effects of a new surgical device (Gore External Valve Support-EVS) and technique for external valvuloplasty of the long saphenous vein (LSV). Patients with superficial venous disease and venous hyper tension due to pure superficial venous incompetence were randomized into two treatment groups, the first treated with "conventional treatment" (ligation or stripping) and the second with external valvuloplasty with the EVS. Patients with uncomplicated varicose veins within the age range of 35-65 years were included. Incompetence with presence of functional cusps at the saphenofemoral junction (SFJ), with vein dilatation were the main inclusion criteria. The EVS comprised of a GORE-TEX® patch material (including a nitinol frame) that is placed around the vein, producing a reduction in the caliber of the vein. Also the vein section becomes elliptical. These combined actions are aimed to reduce incompetence, allowing a better closure of the cusps. The EVS was placed at the SFJ after limited dissection of the vein and ligation of collaterals. The procedure was randomized as an alternative to simple ligation or stripping (according with the procedure commonly used in the center). The associated ligation of distal incom petent veins was allowed. The main outcome measures of the study were evaluated by color-duplex (morphologic findings and evaluation of reflux) and with ambulatory venous pressure (AVP) or air-plethysmography (APG). Main endpoints of the first year of the study and main subject of this report (mainly concerning safety within the first year of follow-up) were considered presence/absence of reflux; patency of the veins; mobility/function of vein cusps; occurrence of thrombosis; tolerability of the device; and increased complexity and operating time needed for the EVS. At 1 year 30 patients had been randomized (14 EVS implanted, 16 controls). Reflux was absent in all EVS patients, all treated veins were patent, and all cusps were mobile. No thrombosis had been observed and the tolerability of the device was very good. The increased complexity required by placing the EVS was limited (5-12 minutes more). In conclusion results of the first year show efficacy and tolerability of the EVS. In selected patients (superficial LSV incompetence, reflux-dilatation, functional SFJ cusps, incompetence mainly due to enlargement of the vein), the EVS could be an effective alternative to "destructive" ligation and/or stripping of the vein. Prolonged follow-up will indicate the clinical poten tials of the EVS.

The aim of this study was to evaluate the macrocirculatory and microcirculatory effects of treatment with lercanidipine, a new antihypertensive agent acting both on blood pressure and microcirculation in patients with moderate essential hypertension and without vascular disease and in patient with hypertension and vascular disease. In hypertensive subjects target-organ damage associated with high blood pressure may now be objectively documented by noninvasive tests. These alterations constitute a model to evaluate not only the pressure effects of antihypertensive treatment but also the normalization of the peripheral microcirculatory network. With color duplex scanning, flow velocity in the central retinal artery and retinal flow velocity can be measured and with use of laser-Doppler-flowmetry, it is also possible to evaluate microcirculation alterations in hypertensive subjects. These evaluation methods are completely noninvasive and may be used to assess the microcirculatory effects of antihypertensive drugs.

Expanded polytetrafluoroethylene (ePTFE) external valve support devices (EVS) have been used successfully in patients to restore valve function in leg veins with incompetent valves when incompetence is due to dilatation of the vein walls or elongation of the valve leaflet edges. To assess tissue response to these devices, the authors implanted 12 of them in dogs, wrapping the devices around veins in the head and neck. The dogs recovered from the implantation procedure uneventfully, and the veins remained patent on color flow Doppler scanning. Gross and histologic evaluations of vein segments and attached EVS devices after sacrifice of the dogs 30 days postoperatively showed that the ePTFE devices did not affect vein patency or the cellular composition or architecture of vein walls. There were no adverse tissue reactions to the EVS and no thrombus formation in the veins to which the EVS had been applied. Tissue attachment to the EVS was apparent in all specimens. These histologic results support clinical experiences indicating that the ePTFE EVS device is safe to use in external valvuloplasty for the treatment of venous incompetence.

In this study, 294 patients with acute proximal DVT (deep venous thrombosis) were randomly assigned to receive intravenous standard heparin in the hospital (98 patients) or low-molecular-weight heparin (LMWH) (nadroparin 0.1 mL [equivalent to 100 AXa IU] per kg of body weight subcutaneously twice daily) administered primarily at home (outpatients) or alternatively in hospital (97 patients) or subcutaneous calcium heparin (SCHep) (99 patients, 0.5 mL bid) administered directly at home. The study design allowed outpatients taking LMWH heparin to go home immediately and hospitalized patients taking LMWH to be discharged early. Patients treated with standard heparin or LMWH received the oral anticoagulant starting on the second day, and heparin was discontinued when the therapeutic range (INR 2-3) had been reached. Anticoagulant treatment was maintained for 3 months. Patients treated with SCHep were injected twice daily for 3 months without oral anticoagulants. Patients were evaluated for inclusion and follow-up with color duplex scanning. Venography was not used. In case of suspected pulmonary embolism (PE) a ventilatory-perfusional lung scan was performed. Endpoints of the study were recurrent or extension of DVT, bleeding, the number of days spent in hospital, and costs of treatments. Of the 325 patients included, 294 completed the study. Dropouts totaled 31 (10.5%); six of the 325 included patients (1.8%) died from the related, neoplastic illness. Recurrence or extension of DVT was observed in 6.1% of patients in the LMWH group, in 6.2% in the standard heparin group, and in 7.1% in the SCHep group. Most recurrences (11/17) were in the first month in all groups. Bleedings were all minor, mostly during hospital stay. Hospital stay in patients treated with LMWH was 1.2 ± 1.4 days in comparison with 5.4 ± 1.2 in those treated with standard heparin. There was no hospital stay in the SCHep group. Average treatment costs in 3 months in the standard heparin group (US $2,760) were considered to be 100%; in comparison costs in the LMWH group was 28% of the standard heparin and 8% in the SCHep group. This study indicated that LMWH and SCHep can be used safely and effectively to treat patients with proximal DVT at home at a lower cost.

A group of 24 patients were considered for noninvasive shock waves thrombolysis (NISWT). Of these, 15 patients gave their informed consent. NISWT was attempted in eight patients (while seven patients were randomized for follow-up only). NISWT was possible in six of seven patients. In one patient randomized for NISWT, local inguinal scarring, due to previous surgery, made impossible the visualization of the femoral vein, and therefore focusing of shock waves (SWs). No side effects were reported in the days after SWs administration during the 4-month follow-up. In patients treated with NISWT it was possible to observe just after the SWs session the presence of echolucent "acoustic holes" and flow (by color and power Doppler) within the "holes." All "echolucent holes" produced at the first session were still present at 4 months, and color flow imaging also detected new flow channels in echogenic areas of thrombi previously not visible. In one patient thrombolysis was achieved after the first treatment, but at 3 and 4 months the thrombus was completely avascular. In conclusion, thrombolysis using SWs was obtained in selected cases and it was still persisting at 4 months in six of the seven treated patients. NISWT appears feasible and promising. These results should be confirmed by larger, prospective trials.

The aim of this study was to evaluate the effects after 10 years of external valvuloplasty of the femoral vein (limited anterior plication or LAP). After informed consent patients with venous hypertension due to deep and superficial venous incompetence were randomized into two treatment groups. Both groups were treated with superficial vein surgery (ligation and section of the major incompetent superficial veins). Group 2 was treated with the same procedure and with LAP. External valvuloplasty of the superficial femoral vein was performed with plication of the anterior vein wall after limited dissec tion of the vein. Results were evaluated with color-duplex scanning and ambulatory venous pressure (AVP) measurements. Endpoints were AVP, refilling time (RT), presence/absence of reflux at the superficial femoral vein, the variation in the diameter of the vein, and quality of life score (QLS). No complications were observed. All femoral veins treated with LAP were competent after 10 years. Significantly lower AVP and longer RT were observed in the LAP group. Also the average diameter of the vein was smaller in the LAP group. Moreover, QLS was significantly better in the LAP group after 10 years. In conclusion, in selected subjects, with moderate deep venous incompetence, functional cusps, or incompetence mainly due to relative enlargement of the femoral vein, LAP may be an effective alternative to external valvuloplasty.

In order to evaluate the effect of triflusal (2-acetyloxy-4-trifluoromethyl benzoic acid), an orally active antiplatelet agent, on arteriosclerosis progression, a pilot, parallel, double- dummy, double-blind clinical trial vs acetylsalicylic acid (ASA) was carried out in patients with subclinical atherosclerotic lesions. The trial consisted of a 2-week run-in placebo phase, followed by a 12-month oral treatment with triflusal (600 mg/day) or ASA (300 mg/day). The primary variable was identified in the ultrasonic biopsy (UB) score; the secondary variables were the UB class changes of each arterial site, the rate of progres sion (ROP), the intima-media thickness (IMT), and the symptoms of arteriosclerosis. Data were evaluated by use of analysis of variance and Chi-square test. Forty-three patients (31 men, 12 women, mean age 62.8 ±8.4 SD) were randomized to triflusal (15 men, 6 women, mean age 64.3 ±6.7) or to ASA (16 men, 6 women, mean age 61.3 ± 9.6) . The analysis of variance on the UB score showed no difference between treat (Abstract continued) ments: the patients' UB scores remained unchanged with no progression, thus indicating that no patient worsened during treatment. When all arterial sites under evaluation are considered, 86% of the sites in the triflusal group and 85% in the ASA group remained unchanged. No relevant change was recorded in vital signs and routine laboratory tests. Gastric disturbances were reported by two and three patients treated with triflusal and ASA, respectively. In conclusion, triflusal appears as effective as ASA in slowing arterio sclerosis progression.

The aim of this registry study was to evaluate the efficacy of Pycnogenol® (Horphag Research Ltd.), a standardized extract from the French maritime pine bark, to control signs/symptoms and prevent complications associated with hemorrhoids in the months after delivery in healthy women.Women with hemorrhoids after their second pregnancy were included within the third month after pregnancy. Pycnogenol dosage was 150 mg/day for 6 months. Symptoms for 4th and 3rd degree hemorrhoids were evaluated.The registry groups were comparable. For 4th degree hemorrhoids, main symptoms were reduced after 6 months in all patients, but the group using Pycnogenol in addition to standard best management showed more improvement. In patients with 3rd degree hemorrhoids, symptoms were reduced in both management groups at 6 months; with Pycnogenol the reduction in symptoms scores was significantly better. At 6 months 18/24 subjects (75%) in the Pycnogenol group were symptom-free in comparison with 14/25 (56%) in controls. In the 4th degree hemorrhoid group, 7/10 patients (70%) in the Pycnogenol group were symptom-free at 6 months in comparison with 4/11 subjects (36%) in the best management group. No significant side effects were observed.Pycnogenol appears to positively affect hemorrhoid signs and symptoms in the months after pregnancy.

The aim of this registry study was to evaluate the effects of Pycnogenol® (French pine bark extract) on improving physical fitness (PF) in normal individuals using the Army Physical Fitness Test (APFT). The study evaluated the efficacy of Pycnogenol, used as a supplement, in improving training, exercise, recovery and oxidative stress.The study was divided into 2 parts. In PART 1 (Pycnogenol 100 mg/day), the APFT was used to assess an improvement in PF during an 8-week preparation and training program. In PART 2 (Pycnogenol 150 mg/day), the study evaluated the effects of Pycnogenol supplementation in athletes in training for a triathlon.PART 1. There was a significant improvement in both males and females in the 2-mile running time within both groups, but the group using Pycnogenol (74 subjects) performed statistically better than controls (73 subjects). The number of push-ups was improved, with Pycnogenol subjects performing better. Sit-ups also improved in the Pycnogenol group. Oxidative stress decreased with exercise in all subjects; in Pycnogenol subjects the results were significantly better. PART 2. In the Pycnogenol group 32 males (37.9; SD 4.4 years) were compliant with the training plan at 4 weeks. In controls there were 22 subjects (37.2;3.5) completing the training plans. The swimming, biking and running scores in both groups improved with training. The Pycnogenol group had more benefits in comparison with controls. The total triathlon time was 89 min 44 s in Pycnogenol subjects versus 96 min 5 s in controls. Controls improved their performing time on average 4.6 minutes in comparison with an improvement of 10.8 minutes in Pycnogenol subjects. A significant decrease in cramps and running and post-running pain was seen in the Pycnogenol group; there were no significant differences in controls. There was an important, significant post-triathlon decrease of PFR one hour after the end of the triathlon with an average of -26.7, whereas PFR in controls increased. In Pycnogenol subjects there was a lower increase on oxidative stress with a faster recovery to almost normal levels (330 for these subjects). These variations in PFR values were interpreted as a faster metabolic recovery in subjects using Pycnogenol.This study opens an interesting new application of the natural supplementation with Pycnogenol that, with proper hydration, good training and nutritional attention may improve training and performances both in normal subjects and in semi-professional athletes performing at high levels in difficult, high-stress sports such as the triathlon.

The aim of this efficacy study was to evaluate local capillary fragility with the vacuum suction chamber (VSC) in patients with chronic venous hypertension due to chronic venous disease. All included patients had important ankle edema due to venous hypertension because of a post-thrombotic syndrome. Severe, deep, venous incompetence was present. The VSC was applied onto the internal perimalleolar region. Negative pressure was applied for a variable period of 2, 4, 6, 8, and 10 minutes. The negative pressure in the plastic chamber (2 cm in diameter)—as previously described—was 50 mm Hg. A group of ten patients (mean age 56 years; SD 4; M:F = 5:5) were studied. The tests were repeated in steps of two tests on different days. Between the two tests, with the VSC applied in different skin areas of the perimalleolar region, an interval of at least 30 minutes was observed.

Aescin and essential phospholipids (AEPL) in a gel was used in a microcirculatory model to assess the effects on skin perfusion in chronic venous insufficiency and severe venous hypertension. The aim of this efficacy study was to evaluate the efficacy of an AEPL gel on the microcirculation measuring transcutaneous skin PO2 and PCO2 in subjects with chronic venous insufficiency, venous hypertension (CVH), and venous microangiopathy. Transcutaneous PO2 and PCO2 were measured at the internal perimalleolar region. After 2 weeks of treatment with AEPL, all TcPO2 individual values were increased and all PCO2 values were decreased (p

During chronic venous insufficiency (CVI), microcirculatory changes, e.g. a decrease in transcutaneous oxygen pressure (tcpO2) and an increase in transcutaneous carbon dioxide pressure (tcpCO2), are implicated in the pathophysiology of trophic disorders leading ultimately to venous ulcers. Daflon 500 mg1, a micronized purified flavonoid fraction, has been shown to improve venous tone, capillary permeability and resistance, and lymphagogue activity at a daily dose of 2 tablets. To assess the effects of Daflon 500 mg on microcirculatory parameters by means of laser Doppler fluxmetry and transcutaneous oxiketry, a 3-month, double-blind, randomized, parallel-group study was carried out in 104 patients divided into 3 groups according to the daily dose: 1 tablet (group 1, n = 34), 2 tablets (group 2, n = 33), on 4 tablets (group 3, n = 37). All patients (mean age 43.7 +/- 13.1 years; 100 females, 4 males) included in the study were affected by mild CVI. They were followed for 90 days with visits at 1 month (day 28) and 3 months (day 90). At inclusion, there were no significant differences between groups as regards biometric data, mean tcpO2 (group 1, 62.7 +/- 4.5 mm Hg; group 2, 64.0 +/- 3.3 mm Hg; group 3, 64.1 +/- 3.5 mm Hg), mean tcpCO2 (group 1, 40.7 +/- 2.5 mm Hg; group 2, 39.3 +/- 2.9 mm Hg; group 3, 40.0 +/- 2.5 mm Hg) and laser Doppler parameters. Fourteen patients withdrew from the study (group 1, n = 4; group 2, n = 3; group 3, n = 7): 9 for reasons not related to treatment, 3 for adverse events, 2 because they were lost to follow-up. From day 0 to day 90, mean tcpO2 significantly increased (p < 0.001) in each group (group 1, 3.0 +/- 2.1 mm Hg; group 2, 2.9 +/- 2.1 mm Hg; group 3, 2.5 +/- 1.6 mm Hg), mean tcpCO2 significantly decreased (p < 0.001) in each group (group 1, 2.6 +/- 2.0 mm Hg; group 2, 1.7 +/- 1.9 mm Hg; group 3, 2.2 +/- 1.5 mm Hg). No significant differences were observed between groups. Laser Doppler parameters remained unchanged from day 0 to day 90 in the 3 groups. Symptoms (discomfort, pain, heaviness, burning sensation) and signs (oedema) of CVI as well as perimetric measurements of calf and supramalleolar area were significantly improved in the 3 groups. In conclusion, during this 3-month study, Daflon 500 mg improved oximetric measurements and did not alter laser Doppler parameters. These data suggest that Daflon 500 mg, at the early stages of CVI, acts favourably on the microcirculatory disturbances also involved in the pathophysiology of more severe stages of CVI.

Skin blood flux and the venoarteriolar response have been studied by laser- Doppler flowmetry (LDF) in 20 postphlebitic limbs and in 20 normal limbs. Histology was also studied with punch biopsy specimens in postphlebitic limbs and in 4 randomly selected, normal volunteers. Skin flux was increased and the venoarteriolar response decreased in all postphlebitic limbs. Also in all patients an apparent increase in the number of capillaries was observed. They appeared dilated and tortuous, and the thick ened capillary wall was surrounded by a pericapillary halo composed of pro tein, neutral polysaccharides, hemosiderin, and fibrin. In conclusion, measurements with LDF differentiate between normal and postphlebitic limbs, corresponding to the histologic finding of an altered capil lary system. Therefore, LDF is useful for defining the degree of microan giopathy due to venous hypertension.

The aim of this study was to evaluate, in a prospective, five-year follow-up study, selective saphenous vein repair (SSVR) (combined use of plication of the incompetent saphenofemoral junction [SFJ] and selective ligature of incompe tent veins). The effects of SSVR were evaluated by ambulatory venous pressure measurements refilling time (RT) and color duplex to detect the number of incompetent venous sites. From a group of 400 consecutive patients studied for venous incompetence 54 subjects were randomized in an SSVR and a control group. Criteria of inclusion were SFJ incompetence with presence of valve cusps and incompetence of two to five venous sites in the territory of the long saphenous. After five years 22 patients in the SSVR group and 21 in the control group completed the study. SSVR increased RT (p < 0.02), and the number of incom petent sites was decreased after five years (p < 0.02). In the control group RT was shorter and the number of incompetent sites increased (p < 0.05) after five years. In conclusion SSVR appears to be an effective, physiological treatment with good long-term (five-year results) on incompetence and on the prevention of new incompetent sites.

Three techniques to treat venous incompetence on an outpatient basis were compared in 138 limbs [107 patients) with superficial venous incompetence. They were treated with the dentist's technique (DT) [Group A, 44 limbs], compres sion sclerotherapy (CS) [Group B, 45 limbs], or the SAVAS [ sectionnement en Ambulatoire des Varices Avec Sclerotherapie] technique [Group C, 49 limbs]. All patients were followed up (five years) with ambulatory venous pressure (AVP) measurements and color duplex scanning. DT consisted of the sectioning under local anesthetic of incompetent veins. CS was done by injecting polidocanol 3% with compression applied for four weeks. The SAVAS was done with a combination of DT and CS with sectioning of the incompetent veins under local anesthetic and retrograde injection in the distal veins of polidocanol 3%. This type of retrograde injection perfuses only incompetent veins. After five years there was a significantly lower refilling time (RT) with AVP in the SAVAS group (average of twenty seconds). RT was 12.5 seconds in group B and fifteen in A. The number of significantly incompetent residual veins was on the average 0.9 in the SAVAS group, significantly lower than in the other two groups. The average cost per treated limb was significantly lower is the SAVAS group. In conclusion, after a five-year follow-up, the SAVAS technique was more effective, its hemodynamic value was superior to DT and CS, and its costs were lower.

We evaluated by angiodynography 228 patients with clinical and 107 with subclinical varicocele and 22 normal subjects studying vein dilatation and reflux peak flow velocity (PFV). PFV was 18 cm/sec in subclinical varicocele, significantly lower than in clin ical varicocele (24 cm/sec). The mean reverse flow (reflux) was also significant ly lower in subclinical varicocele. The study demonstrated that there is a good correlation between the mean duration of reflux (in seconds) and the quantity of reverse flow measured by angiodynography. The correlation between descending phlebography and angiodynography, in a randomly selected group of 69 patients was 100% both in clinical and subclin ical varicocele. In conclusion, angiodynography could be considered the best noninvasive technique to evaluate and quantify varicocele and the effects of treatment on venous dynamics.

Aescin + essential phospholipids (AEPL) topical gels are used for local treatment of venous and microcirculatory alterations (varicose veins, chronic venous insufficiency). Bruises, swelling, thrombophlebitis, and contusions are effectively treated with AEPL. Active ingredients are escinate and essential phospholipids (EPL). The aim of this new study was the evaluation of the efficacy of the effects of AEPL gel on the microcirculation in subjects with chronic venous insufficiency, venous hypertension (CVH), and venous microangiopathy. Patients were assessed measuring skin flux with laser-Doppler flowmetry (LDF). After 2 weeks of local treatment, all individual values (100%) were significantly decreased (p

The aim of this study was to evaluate deep venous thrombosis (DVT) prophylaxis with specific elastic stockings in longhaul flights (11-13 hours), in high-risk subjects. A group of 300 subjects was included; 76 were excluded for several problems including concomitant treatments; 224 were randomized into two groups (stockings vs. controls) to evaluate prophylaxis with below-knee stockings. An exercise program was used in both groups. Scholl (UK) Flight Socks (14-17 mmHg of pressure at the ankle) were used. DVT was diagnosed with ultrasound scanning. The femoral, popliteal, and tibial veins were scanned before and within 90 minutes after the flights. Of the 205 included subjects, 102 controls and 103 treated subjects completed the study. Drop-outs were due to flight connection problems. Age, gender, and risk distributions were comparable in the two groups. In the treatment group (103 subjects; mean age, 42; SD 9; M:F, 55:48), one limited, distal DVT was observed (0.97%). In the control group (102 subjects; mean age, 42.1; SD 10.3; M:F, 56:46), six subjects (5.8%) had a DVT. There were no superficial thromboses. The difference in DVT incidence is significant (p

The aim of this study was to evaluate the prevalence and incidence of venous diseases and the role of concomitant/risk factors for varicose veins (VV) or chronic venous insufficiency (CVI). The study was based in San Valentino in Central Italy and was a real whole-population study. The study included 30,000 subjects in eight villages/towns evaluated with clinical assessment and duplex scanning. The global prevalence of VV was 7%; for CVI, the prevalence was 0.86% with 0.48% of ulcers. Incidence (new cases per year) was 0.22% for VV and 0.18% for CVI; 34% of patients with venous disease had never been seen or evaluated. The distribution of VV and CVI in comparison with duplex-detected incompetence (DI) indicates that 12% of subjects had only VV (no DI), 2% had DI but no VV, 7.5% had DI associated with VV, 2% apparent CVI without DI, 3% DI only (without CVI), and 1.6% both CVI and DI. VV associated with DI are rapidly progressive and CVI associated with DI often progresses to ulceration (22% in 6 years). VV without significant DI (3%) and venous dilatation without DI tend to remain at the same stage without progression for a lengthy time. New cases per year appear to have a greater increase in the working population (particularly CVI) possibly as a consequence of trauma during the working period. In older age (> 80 years), the incidence of CVI tends to decrease. Ulcers increase in number with age. Only 22% of ulcers can be defined as venous (due to venous hypertension, increased ambulatory venous pressure, shorter refilling time, obstruction and DI). Medical advice for VV or CVI is requested in 164 subjects of 1,000 in the population. In 39 of 1,000, there is a problem but no medical advice is requested and in only 61 of 1,000, the venous problem is real. In VV in 78% of limbs, there is only reflux, in 8% only obstruction, and in 14% both. In CVI, 58% of limbs have reflux, 23% obstruction, and 19% both. In conclu sion, VV and CVI are more common with increasing age. The increase with age is linear. There was no important difference between males and females. These results are the basis for future real, whole population studies to evaluate VV and CVI.

The aim of this study was the evaluation of the treatment of venous ulcers with pentoxifylline (PXF) in 12 months. This double-blind, placebo-controlled trial was conducted in GCP. Patients were included after consent and randomized for PXF (400 mg three times daily) or placebo. The number of healed ulcers, the variation in the area of ulceration, and the variation in microcirculatory parameters (laser-Doppler flux and skin PO2) were considered as endpoints. Of the 85 patients included, 80 completed the study (41 in the PXF and 39 in the placebo group). The groups were comparable. Healing occurred in 88% of limbs in the PXF and in 44% in the placebo group (44% difference; p0.02). The average area reduction was 93% in the PXF and 56% in the placebo group. Microcirculation was significantly improved in both groups at 12 months. The decrease in flux and the increase in PO2 were greater in the PXF group (p0.05). Considering the proportion of healed ulcers a better outcome was observed with PXF (p0.02; 12% of nonhealed ulcers in the PXF vs 56% in the placebo group). The ulcerated area decreased 93% in the PXF vs 56% in the placebo group (40% difference; p0.02). Tolerability was comparable (6% in the PXF group and 5% in the placebo group complained for treatment). No important side effects were observed. In conclusion, treatment with PXF in venous ulcers improves healing and microcirculation and should be considered in slow-healing venous ulcers.

The efficacy of Pentoxifylline in vascular inner ear disease (VIED) was studied comparing PXF and placebo in a 4-week study; 40 patients with vascular disease and monolateral loss of hearing, vertigo, dizziness, tinnitus (analyzed with an analogue scale line), and cochlear flow reduction were included. The aims of the study were to study the effects of PXF (1600 mg daily) in VIED considering clinical outcome and cochlear flow. Of the 20 included patients, 19 completed the study. One dropout in the placebo group was due to low compliance. Intention-to-treat analysis indicated an improvement in cochlear flow (p0.05) and a decrease in score in both groups. The cochlear flow increase was 287.5% in the PXF group vs 168% in the placebo group (119.5% difference; p0.02). There was a difference in score decrease (44.1% larger) in the PXF group (p0.05).Between-group analysis favors PXF considering blood flow and symptoms. Results indicate good efficacy and tolerability of PXF in VIED.