The Authors describe a preliminary clinical investigation on forty patients with oesophagitic and gastric symp-toms, ten of them affected of reflux disease.After oesophagogastroscopy and urea breath test they were submitted to administration of a natural productbased on Hyaluric acid and Chondroitin sulphate. The design of the study was a double blind drug versusplacebo trial. The results, based on symptoms analysis, showed statistically significance effectiveness of thenatural compound against placebo. Also the pre-post treatment endoscopic investigations showed improve-ment of inflammation and healing of the mucosa either in oesophageal or gastroduodenal pathology.
Gastroesophageal reflux disease (GERD) is anacid-related disorder triggered by reflux of ga-stric contents into the oesophagus whose lowersphyncter (LES) becomes incompetent due tomultiple causes. Hearthburn, the most com-mon and distinctive symptom affects roughly20-40% of western people whose 7% complainsof daily symptoms; the seasonal prevalence ofthe disease in the general practice reaches evenmore than 50% of the population, and poten-tial complications enclose erosive oesophagi-tis, Barretts oesophagus and adenocarcinoma.Functional dyspepsia is the commonest causeof dyspeptic symptoms in the world affectingroughly 25% of the population: its main fea-tures are recurrent pain or discomfort in theepigastric area, without coexisting irritablebowel syndrome, or ulcers; very often hyper-chloridric secretion, gastric motility disturban-ces and psychosocial reactivity have been advo-cated in the physiopathology of such a so cal-led gastritis and duodenitis. A very recent pa-per of Tomomitsu et al investigated the asso-ciation between dyspeptic symptoms and en-doscopic appearances enrolling 87 dyspepticpatients and 93 asymptomatic controls1.They found that friability in the antrum andduodenal ulcer scarring were independentlyassociated with dyspeptic symptoms. The logistic regression analysis showed that both of these endoscopic appearances were significan-tly more likely to be associated with dyspep-tic symptoms. Among 18 dyspeptic patientswith friability in the antrum, H. pylori infec-tion was present in only three, and inflamma-tion activity and severity of atrophy in theantrum by the updated Sydney System weremild in most patients. On this basis friabilityin the antrum was almost characterized bynormal or high gastric acid secretion and, po-tentially hypergastrinemia. The symptomatictreatment of oesophagitis and gastritis is pri-marily approached with proton pump inhibi-tors to reduce the acid output and with buffe-ring products that counteracts the hydrogenio-nic damage to the mucosa.A recent our original approach to the problemwas dedicated to identify and use some natu-ral compounds able to buffer the acidity of thegastric fluid, as well as to inhibit the pepsin-induced mucosal rebound damage, but speci-fically addressed to steadily coat the epithelialsurface as long as possible by means of an acti-ve principle able to stimulate the healing pro-cess with a very well known physiological re-pair mechanism.The chemical composition of the compoundinvestigated in our trial encloses Chondroitinsulphate (CS) and Hyaluronic acid (HyA) plusan adhesivity enhancer with the following ra-tionale:a) Chondroitin sulphate is a chemically safeand atoxic glycosaminoglycan family com-ponent with repeated disaccharide unitsmade of glucuronic acid and galactosamine1-beta sulphated group; the molecular struc-ture had been identified by Babkin and Ko-marov, as an effective inhibitor of pepsininduced damage on the gastroduodenalmucosa, being with mucoitinsulphate, amain chemical component of the spontane-ously secreted mucous by the parietal cells2.A primary attempt to Chondrotin sulphatetreatment by mouth in gastroduodenal di-seases was primarily tried on the man byCrandall & Roberts on 22 patients affectedby duodenal peptic ulcer, with a definitesymptoms improvement in 45%3. Levey andSheinfeld, blocked in the Shay-ulcer modelpf the rat, the gastric damage administering25 mg Chondroitin sulphate by mouth4.b) Hyaluronic acid is an other outstanding ato-xic biological molecule, characterized by along dimeric cross-linked sugar (N-acetyl-D-glucosamine) linked with â-glucoronicacid.One of its natural functions is to control epi-thelial cells turnover by means of the CD44and RAHMM receptors and to inactivate thefree radicals and the reactive oxygen species(ROS) in the skin layer5.This molecule has largely been used as an ef-fective skin ulcer healing compound, and se-veral years ago we hypotesized that it mightbe beneficial also in oesophageal erosions andgastroduodenal ulcers6.In a previously unpublished clinical pilot trialwe treated 20 adult patients affected by erosi-ve oesophagitis and reflux with Hyaluronicacid by mouth twice daily along two weeksachieving a 76 % control of the symptoms. Weused a 10% Hyaluronic acid sodium salt witha dynamic viscosity proportional to 4500mPa*s administered with a spoon 3 hours af-ter meals.The plan to mix the molecules of HyA andCS, within an adhesive biopolymer, whichmight increase the mucosal surface adhesivi-ty, was addressed to enhance the mucosa bar-rier either in the oesophagus or in the gastricand duodenal lumen.