Efficacy of a Low-Dose Diosmin Therapy on Improving Symptoms and Quality of Life in Patients with Chronic Venous Disease: Randomized, Double-Blind, Placebo-Controlled Trial.

Raffaele Serra,Salvatore Fregola,Luca Gallelli,Andrea Bitonti,Lucia Muraca,Antonio Loria,Simone Guadagna,Luminița Velcean,Alessandro Gallo,Luca Raimondo,Stefano Candido,Nicola Ielapi

doi:10.3390/nu13030999

Abstract

Chronic Venous Disease (CVD) is a common medical condition affecting up to 80% of the general population. Clinical manifestations can range from mild to more severe signs and symptoms that contribute to the impairment of the quality of life (QoL) of affected patients. Among treatment options, venoactive drugs such as diosmin are widely used in the symptomatic treatment in all clinical stages. The aim of this study is to determine the effectiveness of a new formulated diosmin in relieving symptoms and improving QoL in patients suffering from CVD. In this randomized, double-blind, placebo-controlled, multicenter clinical study, CVD patients with a Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system between C2 and C4 were randomized to receive a bioavailable diosmin (as μsmin® Plus) 450 mg tablet once daily or a placebo for 8 weeks. Clinical symptoms and QoL were monitored using the measurement of leg circumference, visual analogue scale (VAS) for pain, Global Index Score (GIS) and Venous Clinical Severity Score (VCSS). A total of 72 subjects completed the study. From week 4, leg edema was significantly decreased in the active group (p < 0.001). An improvement in the VAS score was observed in the active group compared to placebo at the end of treatment (p < 0.05). GIS and VCSS scores were significantly improved in the active group at week 8 (p < 0.001). No treatment related-side effects were recorded. The results of this study showed that the administration of low-dose μsmin® Plus was safe and effective in relieving symptoms and improving QoL in subjects with CVD.

Highlights

Chronic Venous Disease (CVD) is a very common clinical condition affecting the Western world
The main objectives of the study were the changes in calf circumference and the impact of the active treatment on quality of life, while secondary objectives were the evaluation of CVD-related symptoms including pain, investigator/patient treatment satisfaction and safety
All 72 subjects enrolled completed the study and all of them were included in the intention to treat (ITT) and safety population analysis

Summary

Introduction

Chronic Venous Disease (CVD) is a very common clinical condition affecting the Western world. At different stages of this disorder, general practitioners and specialty doctors have to deal with a wide range of symptoms such as leg pain, swelling, itchiness, restless leg syndrome, a burning sensation, and heaviness. These symptoms may be persistent and have a considerable impact on the quality of life (QoL) of many individuals [1,9,10]. QoL is an important element in the general assessment of any patient

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