Treatment of Laryngopharyngeal Reflux Disease Using an Oral Medical Device: A Clinical Investigation into Signs, Symptoms and Quality of Life of Patients
Enrico Maffezzoni1, Ketty Luciano2, Federico Maffezzoni3,
Stefano Agostini4 and Mario Notargiacomo2*
1Rhinocytoallergology Unit, Istituto Figlie di San Camillo, Cremona, Italy
2Otorhinolaryngology Unit, Melzo Hospital, Milan, Italy
3Clinical psychology, Poliambulatorio Oberdan, Brescia, Italy
4Scientific Writer, Lodi, Italy
*Corresponding Author: Mario Notargiacomo, Otorhinolaryngology Unit, Melzo Hospital, Milan, Italy.
November 04, 2022; Published: November 24, 2022
In recent years, there has been a trend towards the application of alternative therapeutic approaches for the treatment of Laryngopharyngeal reflux (LPR), motivated by the not always satisfactory efficacy of proton pump inhibitors and the risks associated with their long-term use. Based on these premises, this prospective study assesses the results of treating LPR by taking a medical device (MDL) by mouth, aiming to prevent the reflux of gastric contents, and to protect the oesophageal and laryngopharyngeal mucosa. The study was carried out by enlisting 67 subjects divided into two groups: 40 LPR patients were treated for 30 consecutive days with MDL, whilst the other 27 subjects were recruited from the healthy population and used as a healthy control group. Before the start of treatment (T0), at the end of 30 days of treatment (T1) and 30 days after the discontinuation of treatment (T2), symptoms were assessed using the Reflux Symptom Index (RSI), signs were assessed using video laryngoscopy and the Reflux Finding Score (RFS) and health-related quality of life was assessed using the 12-Item Short Form Health Survey (SF-12). At T1, the total RSI and RFS scores improved significantly (p < 0.0001) and remained significantly better than before treatment, even after 30 days of stopping MDL treatment (p < 0.0001). The thick endolaryngeal mucus sign included in the RFS improved so much that, after 30 days of MDL treatment, the figure was not significantly different from that gathered in healthy subjects (p = 0.0765).
Health-related quality of life, as measured by the SF-12 questionnaire, also improved at the end of 30 days of MDL treatment: Physical Component Summary and Mental Component Summary (MCS) index scores improved significantly at T1 (p < 0.0001), confirming the improvement in patients' physical and mental state. At T1, the difference between the MCS index score of patients treated with MDL and that of healthy subjects was no longer significant (p = 0.2015).
Patients treated with MDL gave a positive assessment of the effectiveness of the medical device at the end of the treatment. The study confirmed the safe use of the product.
Keywords: Laryngopharyngeal Reflux; Thick Endolaryngeal Mucus; Magnesium Alginate; Opuntia ficus-indica Extract; Olea europea Extract; Medical Device
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