Randomised, double-blind, placebo-controlled, assessment of the efficacy and safety of dietary supplements in prehypertension.

We aimed to evaluate efficacy and tolerability of a protocol including lifestyle modifications and a novel combination of dietary supplements in prehypertension. A prospective, double-blind, randomised, placebo-controlled trial was conducted in 176 subjects (103 men, aged 52±10 years), with blood pressure (BP) of 130-139 mm Hg systolic and/or 85-89 mm Hg diastolic entered. After a single-blind run-in period, participants were randomised to twice daily placebo (n=88) or a commercially available combination pill (n=88). Primary endpoints were the differences in clinic BP between the two groups at the end of the trial. Secondary endpoints included intragroup differences in clinic BP during the study period and response rates (that is, BP <130/85 mm Hg or a BP reduction >5 mm Hg on week 12). Baseline characteristics were similar among the treatment groups. At 12 weeks, the supplement group had lower systolic BP (124±9 versus 132±7 mm Hg, P<0.0001) and similar diastolic BP (81±8 versus 82±7 mm Hg, P=0.382) compared to the placebo group. With respect to baseline measures, changes in BP with supplements were statistically significant for systolic (-9.3±4.2 mm Hg, P<0.0001) and diastolic values (-4.2±3.6 mm Hg, P<0.0001). Changes versus baseline in systolic and diastolic BP, conversely, were not different on placebo. The overall response rate at week 12 was significantly greater with supplements than placebo (58% (51 of 88) and 25% (22 of 88), respectively, P<0.0001). This randomised trial shows that combination of supplements with BP-lowering effect is an effective additional treatment to conventional lifestyle modifications for a better control of systolic BP in prehypertension.

Validation of DN4 as a screening tool for neuropathic pain in painful diabetic polyneuropathy.

AIMS: DN4 (Douleur Neuropathique en 4 Questions) is a screening tool for neuropathic pain consisting of interview questions (DN4-interview) and physical tests. It has not formally been validated in diabetes. We evaluated the validity and diagnostic accuracy of DN4 and DN4-interview in identifying neuropathic pain of painful diabetic polyneuropathy. METHODS: In 158 patients with diabetes, the presence of diabetic polyneuropathy and neuropathic pain was assessed using scoring system for symptoms and signs, quantitative sensory testing, nerve conduction studies, pain history, numerical rating scale, and Short-Form McGill Pain Questionnaire. Painful diabetic polyneuropathy was defined as the presence of diabetic polyneuropathy plus chronic neuropathic pain in the same area as neuropathic deficits. A blinded investigator performed DN4. RESULTS: The DN4 score was significantly related to all the neurological and electrophysiological measurements and to Short-Form McGill Pain Questionnaire (ρ = 0.58, P < 0.0001). DN4 and DN4-interview scores showed a high diagnostic accuracy for painful diabetic polyneuropathy with areas under the receiver operating characteristic curve of 0.94 and 0.93, respectively. At the cut-off of 4, DN4 displayed sensitivity of 80%, specificity of 92%, positive predictive value (PPV) of 82%, negative predictive value (NPV) of 91%, and likelihood ratio for a positive result (LR(+) ) of 9.6. At the cut-off of 3, DN4-interview showed sensitivity and specificity of 84%, PPV of 71%, NPV of 92%, and LR(+) of 5.3. CONCLUSIONS: This is the first validation study of DN4 for painful diabetic polyneuropathy, which supports its usefulness as both a screening tool for neuropathic pain in diabetes and a reliable component of the diagnostic work up for painful diabetic polyneuropathy.

Neuropad as a diagnostic tool for diabetic autonomic and sensorimotor neuropathy.

AIMS: The aim of the present study was to determine the diagnostic accuracy of the Neuropad sudomotor test for diabetic cardiovascular autonomic neuropathy (CAN) and diabetic polyneuropathy (DPN), the latter assessed using a multi-level diagnostic approach. METHODS: In 51 diabetic patients, CAN, symptoms and signs of DPN, vibration perception threshold (VPT), cold (CTT) and warm thermal perception thresholds (WTT) were measured. Neuropad response was determined as normal (complete colour change) or abnormal (absent or incomplete colour change). The time until the complete colour change (CCC time) was recorded. RESULTS: CCC time showed significant correlations with all the neurological parameters, the strongest of which were with Valsalva ratio (rho = -0.64, P < 0.0001), symptoms of DPN (rho = 0.66, P < 0.0001), postural hypotension (rho = 0.54, P = 0.0001) and CTT (rho = -0.54, P = 0.0001). CCC time showed moderate diagnostic accuracy for both CAN and DPN: the areas under the receiver operating characteristic (ROC) curves were 0.71 and 0.76, respectively. The diagnostic characteristics of three cut-off values of CCC time, identified by ROC analysis (i.e. 10, 15 and 18 min), were analysed. Compared with 10 min, the 15-min cut-off value provided better specificity (from 27% to 52% and from 31% to 62% for CAN and DPN, respectively) and a better likelihood ratio for negative result (from 0.67 to 0.34 and from 0.58 to 0.33) without lowering sensitivity (from 82% to 82% and from 85% to 80%). CONCLUSIONS: Neuropad is a reliable diagnostic tool for both CAN and DPN, albeit of only moderate accuracy. Extending the observation period to 15 min provides greater diagnostic usefulness.

The echocardiography laboratory in the informatic era.

This article overviews the latest progress in echocardiography in this informatic era. We will present new, different techniques available in clinical settings for qualitative and quantitative evaluation of global and regional left ventricular function, showing their helpfulness in clinical work. We will also report our personal experiences with 3-dimensional (3-D) echocardiography in quantification of left ventricular total mass and left-ventricular dysfunctional mass, and in evaluation of left-ventricular parietal stress. Finally, we will show how the organization of a modern echocardiography laboratory is changing after informatic progress: we will report our personal experiences about transmission of echocardiography data between 2 work stations, located in different places; in this way we can realize an informatic web, which can go out from the single echocardiography laboratories and move toward intradepartment and interdepartment services.

New modalities of regional and global left ventricular function analysis: state of the art.

Study of left ventricular (LV) regional and global function represents a main point of the cardiologic evaluation. This article presents an overview of the state of the art in quantitative analysis of ventricular wall motion and describes the different techniques available in clinical settings; we also present the personal experience of the authors in comparing conventional 2-dimensional (2D) echocardiography with other recently developed, more sophisticated techniques. Conventional 2D echocardiography mainly depends on the operator's ability. Moreover, the physiologic regional pattern of myocardial wall motion in different segments of left ventricle is still not completely known as well as the heart's rotational and translational movements. Qualitative and quantitative transesophageal echocardiography allows a better and more accurate evaluation of regional wall motion, and improves the on-line border detection feasibility even in patients with poor transthoracic echocardiographic window. The automated system for on-line endocardial border detection, color kinesis, and the power Doppler are, at the moment, promising techniques. Using magnetic resonance imaging as a "gold standard" for the study of global and regional left ventricular function, the investigators describe personal experiences with tissue Doppler imaging and a new computerized system for tissue Doppler images postprocessing analysis.

Three-dimensional echocardiographic assessment of the extension of dysfunctional mass in patients with coronary artery disease.

Two-dimensional (2D) echocardiographic estimation of infarcted mass is limited by having only a few selected nonparallel views for data analysis. Volume-rendered three-dimensional (3D) echocardiography may be able to overcome the above limitations, because it uses multiple, parallel 2D images to derive quantitative data. Previous experimental studies demonstrated that 3D echocardiography is an accurate and reproducible method to assess dysfunctional mass. To estimate the accuracy of 3D echocardiography in humans, we evaluated 10 patients who had a single myocardial infarction. All patients underwent 2D and 3D echocardiography using the transesophageal approach, and contrast (gadolinium) magnetic resonance imaging (MRI), considered a reference standard for infarcted tissue detection. The mean extent of dysfunctional mass by MRI was 28 +/- 13 g and by 3D echocardiography was 30 +/- 12 g; the mean difference was 1.9 +/- 2.3 g (p = not significant). Linear regression analysis between the 2 measurements was y = 0.97x - 1.12, r = 0.98. Dysfunctional mass derived from 3D echocardiography reflects the real site and extension of damaged myocardium.