Efficacy and tolerability of hyaluronic acid, tea tree oil and
methyl-sulfonyl-methane in a new gel medical device for treatment of haemorrhoids
in a double-blind, placebo-controlled clinical trial.
Author(s): Joksimovic N, Spasovski G, Joksimovic V, Andreevski V, Zuccari C, Omini CF.
Affiliation(s): Clinic of Gastroenterohepatology, Medical Faculty Skopje, University of Skopje,
Skopje, Macedonia.
Publication date & source: 2012, Updates Surg. , 64(3):195-201
Topical formulations are widely used in anti-haemorrhoidal treatment, but often
lacking controlled clinical trials. Here, we report the results from a controlled
clinical trial performed with a new gel medical device (Proctoial) containing
hyaluronic acid with tea tree oil and methyl-sulfonyl-methane as major
components. The total number of 36 haemorrhoidal patients (grade 1-3) was
enrolled in a double-blind, placebo-controlled clinical trial and divided into 2
equal parallel groups. The anal pain, pain during defecation, visible bleeding,
pruritus and irritation/inflammation were recorded before and after 14-day
treatment using a visual analogue scale both by the investigators and by the
patients. Safety and tolerability of the treatments were also recorded. The new
gel medical device statistically significantly reduced all the symptoms after the
treatment compared to placebo. The results indicated also a very good
tolerability and safety of the treatments.
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