Surgery or Rehabilitation: A Randomized Clinical Trial Comparing the Treatment of Vocal Fold Polyps via Phonosurgery and Traditional Voice Therapy with "Voice Therapy Expulsion" Training.

OBJECTIVE: Phonomicrosurgery is generally considered to be the treatment of choice for removing vocal fold polyps. However, specific techniques of voice therapy may represent, in selected cases and under certain conditions, a noninvasive therapeutic option for the treatment of such laryngeal lesions. The aim of the present study is to longitudinally assess, in terms of clinical outcomes and quality of life, two groups of patients with cordal polyps, treated either with standard surgery plus standard voice therapy or with a specific training of voice therapy alone, which we have called "Voice Therapy Expulsion." STUDY DESIGN: This study is a randomized controlled trial. METHODS: A total of 150 patients with vocal fold polyps were randomly assigned to either standard surgery or "voice therapy expulsion" protocol. The trial was carried out at the Division of Phoniatrics and Audiology of the Second University of Naples and at the Division of Communication Disorders of Local Health Unit (3 Naples South) from January 2010 to December 2013. A thorough phoniatric evaluation, including laryngostroboscopy, acoustic voice analysis, global grade of dysphonia, instability, roughness, breathiness, asthenia, and strain scale, Voice Handicap Index, and Voice-Related Quality of Life, was performed by using standardized tools, at baseline, at the end of the treatment, and up to 1 year after treatment. RESULTS: We found no significant differences between the two experimental groups in terms of clinical outcomes and personal satisfaction. However, "Voice Therapy Expulsion" was associated with higher scores for quality of life at endpoint evaluation. CONCLUSIONS: Besides phonosurgery, this specific "Voice Therapy Expulsion" technique should be considered as a valid, noninvasive, and well-tolerated therapeutic option for the treatment of selected patients with vocal fold polyps.

Effect of a mediterranean-style diet on endothelial dysfunction and markers of vascular inflammation in the metabolic syndrome: a randomized trial.

CONTEXT: The metabolic syndrome has been identified as a target for dietary therapies to reduce risk of cardiovascular disease; however, the role of diet in the etiology of the metabolic syndrome is poorly understood. OBJECTIVE: To assess the effect of a Mediterranean-style diet on endothelial function and vascular inflammatory markers in patients with the metabolic syndrome. DESIGN, SETTING, AND PATIENTS: Randomized, single-blind trial conducted from June 2001 to January 2004 at a university hospital in Italy among 180 patients (99 men and 81 women) with the metabolic syndrome, as defined by the Adult Treatment Panel III. INTERVENTIONS: Patients in the intervention group (n = 90) were instructed to follow a Mediterranean-style diet and received detailed advice about how to increase daily consumption of whole grains, fruits, vegetables, nuts, and olive oil; patients in the control group (n = 90) followed a prudent diet (carbohydrates, 50%-60%; proteins, 15%-20%; total fat, <30%). MAIN OUTCOME MEASURES: Nutrient intake; endothelial function score as a measure of blood pressure and platelet aggregation response to l-arginine; lipid and glucose parameters; insulin sensitivity; and circulating levels of high-sensitivity C-reactive protein (hs-CRP) and interleukins 6 (IL-6), 7 (IL-7), and 18 (IL-18). RESULTS: After 2 years, patients following the Mediterranean-style diet consumed more foods rich in monounsaturated fat, polyunsaturated fat, and fiber and had a lower ratio of omega-6 to omega-3 fatty acids. Total fruit, vegetable, and nuts intake (274 g/d), whole grain intake (103 g/d), and olive oil consumption (8 g/d) were also significantly higher in the intervention group (P<.001). The level of physical activity increased in both groups by approximately 60%, without difference between groups (P =.22). Mean (SD) body weight decreased more in patients in the intervention group (-4.0 [1.1] kg) than in those in the control group (-1.2 [0.6] kg) (P<.001). Compared with patients consuming the control diet, patients consuming the intervention diet had significantly reduced serum concentrations of hs-CRP (P =.01), IL-6 (P =.04), IL-7 (P = 0.4), and IL-18 (P = 0.3), as well as decreased insulin resistance (P<.001). Endothelial function score improved in the intervention group (mean [SD] change, +1.9 [0.6]; P<.001) but remained stable in the control group (+0.2 [0.2]; P =.33). At 2 years of follow-up, 40 patients in the intervention group still had features of the metabolic syndrome, compared with 78 patients in the control group (P<.001). CONCLUSION: A Mediterranean-style diet might be effective in reducing the prevalence of the metabolic syndrome and its associated cardiovascular risk.