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

Abstract

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.

Treatment of acne with tea tree oil (melaleuca) products: A review of efficacy, tolerability and potential modes of action

“…Three non-acne clinical studies also report reduced inflammation following application of tea tree oil products for treating haemorrhoids [54], ocular demodecosis [55] and tinea [56]. Of the tea tree oil acne studies, four showed that reductions in inflammatory lesion numbers were greater than reductions for non-inflammatory lesions [16,[19][20][21], whilst a fourth study showed little difference [18].…”

Modulation of Intestinal Epithelial Glycocalyx Development by Human Milk Oligosaccharides and Non‐Digestible Carbohydrates

“…HS can mediate cell signaling by binding numerous extracellular ligands such as fibroblast growth factor and contributes to homeostasis of innate immunity . HA is highly viscous and forms a physical barrier on top of the gut epithelium . In dextran sodium sulfate induced colitis, HA expression is enhanced to support colonic epithelial repair .…”

“…[18,19] HA is highly viscous and forms a physical barrier on top of the gut epithelium. [20,21] In dextran sodium sulfate induced colitis, HA expression is enhanced to support colonic epithelial repair. [22] Inflammatory bowel disease can be caused by modification of the glycosaminoglycan composition and distribution on gut epithelium.…”

Co-analgesic therapy for arthroscopic supraspinatus tendon repair pain using a dietary supplement containing Boswellia serrata and Curcuma longa: a prospective randomized placebo-controlled study

“…The significantly lower pain scores recorded at 1 week and the lower scores found at 2 weeks in the group receiving TendisulfurÒ enhanced rehabilitation, minimized complications, and increased compliance. The ingredients of this nutraceutical preparation have documented analgesic and trophic effects on tendons, muscles, ligaments, and cartilage [22,23,[39][40][41][42][43]. MSM is the first oxidized metabolite of dimethylsulfoxide (DMSO), which seems to have antiinflammatory and chemopreventive properties and to inhibit prostacyclin (PGI2) synthesis and free radical scavenging activity [43][44][45][46].…”