Evaluation of the efficacy of a Medical device based on Magnesium alginate, Calcium carbonate, Potassium bicarbonate, Sodium hyaluronate and Chondroitin sulphate in the treatment of Laryngopharyngeal Reflux Disease

Author(s): Mario Notargiacomo, Enrico Maffezzoni, Federico Maffezzoni, Serena Miglio

Continuous exposure to endogenous irritants (hydrochloric acid, pepsin), that characterises the reflux of gastroduodenal contents, initiates phlogistic processes in the mucous membranes of the upper respiratory tract and causes them to become chronic. This results in the characteristic chronic reflux symptoms in the upper respiratory tract and over time, leads to an alteration of the rhino-pharyngeal-laryngeal mucous membranes, which, in combination with the chronic inflammatory factors, leads to the formation of areas of muciparous metaplasia with increasing inflammatory cell infiltrates as the alterations progress.
The treatment of laryngopharyngeal reflux disease (LPR) is based on the use of high-dose proton pump inhibitors (PPIs) for prolonged periods, but clinical experience shows that LPR patients treated with PPIs often complain of dissatisfaction with PPI monotherapy and dissatisfaction with their health-related quality of life. There is therefore a need to identify effective therapeutic approaches to be associated with the use of PPIs.
This retrospective pilot study included 93 subjects divided into two groups: 56 patients with LPR were treated by means of a medical device (Med) containing magnesium alginate, calcium carbonate, potassium bicarbonate, sodium hyaluronate and chondroitin sulphate of fermentative origin, while the other 37 subjects were recruited from the healthy population and were used as a control group. The 56 patients took Med after meals and before bed for 30 consecutive days. At the beginning (T0) and at the end of the 30-day treatment period (T1) and 30 days after treatment discontinuation (T2), symptoms were assessed by means of the Reflux Symptom Index (RSI) and the 22-item Sino-Nasal Outcome Test (SNOT-22), as well as by means of the Reflux Finding Score (RFS) and a cytological survey of the nasal mucosa and an assessment of health-related quality of life by means of the 12-item Short Form Survey (SF-12).
The patients treated with Med improved significantly both clinically and in rhinocytological terms. In particular, the average total scores of RSI, RFS and SNOT-22 were reduced by more than 50%, and the cytological picture improved with the reduction of lymphocyte, neutrophil and goblet cell counts. The benefits obtained by patients treated with Med resulted in a significant improvement in health-related quality of life, as evidenced by the improvement in SF-12 questionnaire scores