Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor

Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any documentable cause, are considered as minor disorders for which patients do not receive adequate attention. These disorders may represent extra‐esophageal manifestations of gastro‐oesophagea reflux. Accurate diagnosis and gastro‐oesophageal reflux therapy have been proved as useful to improve patients' quality of life. The aim of the present study was to evaluate, in first diagnosed patients presenting with upper symptoms associated with GERD, the effect of a 6‐week treatment with a combination based on CS, HA and aluminium hydroxide (Gerdoff®), co‐administered with a treatment with PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated with the combination of the two products, the reduction in symptoms frequency by means of a Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients included in the two groups were then classified as responders or non‐responders. Responder patients were defined as those patients that, at the 6th week of treatment, reached a RSI score decreased for at least 50% compared to baseline and an absolute value < 13. Furthermore, the maintenance of the effect of treatment on the extra‐oesophageal symptoms was evaluated after a period of follow‐up lasting 12 weeks, which could be entered only by responder patients randomised in the Gerdoff®‐PPI arm. Patients included in the follow‐up period were randomised to receive Gerdoff® or no treatment (control group). Safety data were also evaluated in the group of patients that continued in the follow‐up period.