Safety of treatment and dietary Supplementation with dioSmin in daily doSeS up to 2000 mg a day

Abstract

Introduction. diosmin is used to treat and alleviate the symptoms of venous insufficiency and haemorrhoids. diosmin-containing medicinal products have been available in poland since the 1990s with the status of drugs available on prescription in the form of flavonoid fraction containing diosmin, as a form subjected to micronisation or nonmicronised. for several years now, diosmin has been present on the pharmaceutical market in the form of over-the-counter medicines (otC), and dietary supplements containing diosmin are available not only in pharmacies, but also in other outlets. great availability of diosmin raises questions about the safety of a treatment without medical or pharmacist’s supervision. the safety of diosmin use in a daily dose of 2000 mg was confirmed in a double-blind, controlled placebo, randomised, three-arm and parallel, phase iii to evaluate the efficacy and safety of diosmin administered for 4 months in the treatment of cellulite. Aim. the aim of the study was to observe the efficacy and safety of micronised diosmin therapy used in a daily dose of 1000 and 2000 mg for a period of four months. Material and methods. the trial involved 327 patients aged 18 to 55 (mean 37.28, standard deviation of 8.587) meeting the inclusion criteria and not meeting the exclusion criteria. the safety analysis includes and shows in a table the measured parameters immediately prior to the first dose, after 2 and 4 months of therapy. Results. no statistically significant deviations from the standard condition in the following parameters present: complete blood count with differential, fibrinogen concentrations, alanine and aspartate transaminase concentration, urea and creatinine concentration, urinalysis. the therapy did not affect the value of systolic and diastolic blood pressure. no significant adverse actions in the studied groups. Conclusions. the results of a clinical trial cited in this work support the use of micronised diosmin in doses up to 2000 mg per day.