Overlapping approach Proton Pump Inhibitors/Nux vomica-Heel as new intervention for gastro-esophageal reflux management: Delphi consensus study

Table 3 Statements

Topic A: GERD disease

(1) The epidemiological and socio-economic impact of GERD is very high

(2) GERD is diagnosed in the presence of typical symptoms (heartburn and/or regurgitation and/or retrosternal pain)

(3) The presence of only atypical symptoms (chest pain, cough, asthma, hoarseness, frequent throat clearing) without the co-presence of typical symptoms, would not be suggestive for GERD diagnosis

(4) Based on the symptoms, GERD can be diagnosed, and the treatment be prescribed by GPs, Otolaryngologists, and Geriatricians other than Gastroenterologists

Topic B: GERD treatment

(5) The most common management strategy for GERD targets heartburn reduction and inducing repair of the inflamed mucosa

(6) In case of GERD, PPIs are the most prescribed drugs for GERD symptoms resolution

(7) The most common adverse effects associated with PPIs are SIBO, gastrointestinal infections, malabsorption, osteoporosis, and neoplasia

(8) The main issue in the clinical management of patients affected by GERD is the symptoms rebound when the PPI therapy is discontinued

(9) PPIs deprescription is advisable when alternative therapies are available

(10) The natural low dose multicomponent medication Nux vomica-Heel is effective in the management of patients affected by acid-related disorders

(11) The prescription of Nux vomica-Heel in patients affected by acid-related disorders is desirable also in light of its high safety and tolerability profile

(12) In patients under long-term treatment with PPI, to clinically manage GERD symptoms, the administration of Nux vomica-Heel in overlapping with the PPI is recommended to reduce and suspend the use of the PPI

(13) In patients presenting GERD symptoms, the use of Nux vomica-Heel can be recommended as maintenance therapy after discontinuing the PPI

(14) In patients who presented GERD symptoms, after remission obtained with PPIs, LDA and symptoms remission can be maintained by a long-term administration of Nux vomica-Heel, 1 tablet sublingually 3 times per day far from meals (as needed 1 tablet every 15 min for no more than 2 h)

(15) In patients under long-term treatment with PPI, the overlapping directions for Nux vomica-Heel and PPI (for the PPI discontinuation) are the following:

First two weeks: PPI at the recommended dose according to the dosage schedule plus Nux vomica-Heel 1 tablet sublingually 3 times a day far from meals (as needed 1 tablet every 15 min for no more than 2 h)

Third week: PPI at the recommended dose according to the dosing schedule on alternate days plus Nux vomica-Heel 1 tablet sublingually 3 times a day far from meals (as needed 1 tablet every 15 min for no more than 2 h)

Fourth week: PPI at the recommended dose according to the dosing scheme two days a week plus Nux vomica-Heel 1 tablet sublingually 3 times a day far from meals (as needed 1 tablet every 15 min for no more than 2 h)

From the fifth week: Nux vomica-Heel 1 tablet sublingually 3 times a day far from meals (as needed 1 tablet every 15 min for no more than 2 h). PPI as needed

GERD: Gastro-esophageal reflux disease; PPIs: Proton Pump Inhibitors; SIBO: Small Intestine Bacterial Overgrowth; LDA: Low Disease Activity; GPs: General Practitioners.