The efficacy and tolerability of Avaricon® hemor medical preparation in the treatment of hemorrhoids compared to placebo – a prospective double blind randomized clinical study

Abstract

Introduction. Despite the high incidence of hemorrhoidal disease and the widespread use of numerous topical preparations, there is still a lack of information regarding their efficacy. Therefore, the aim of this study was to assess the efficacy and tolerability of a new topical medical preparation containing sodium hyaluronate, calendula extract, hamamelis extract and mentha piperita essential oil as major components. Material and Methods. This prospective double-blind randomized clinical study included 49 patients with a diagnosis of hemorrhoidal disease. The patients were randomly assigned to two groups: Avaricon ® group that included patients who applied 0.20% Avaricon ® Hemor and a placebo group who applied placebo during 2 weeks. The effects of Avaricon ® Hemor on the symptoms of hemorrhoidal disease, its safety, tolerability as well as compliance and adherence of study patients were analyzed. Results. Our results showed that Avaricon ® Hemor was significantly superior to placebo in controlling most symptoms of hemorrhoidal disease. Conclusion. The tested medical agent showed to be effective with good tolerability and safety profile indicating its possible use in various therapeutic protocols in the management of hemorrhoidal disease.