Battaglia E, Bertolusso L, Del Prete M, Monzani M, Astegiano M. Overlapping approach Proton Pump Inhibitors/Nux vomica-Heel as new intervention for gastro-esophageal reflux management: Delphi consensus study. World J Gastroenterol 2024; 30(18): 2467-2478 [PMID: 38764766 DOI: 10.3748/wjg.v30.i18.2467]
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
World J Gastroenterol. May 14, 2024; 30(18): 2467-2478 Published online May 14, 2024. doi: 10.3748/wjg.v30.i18.2467
Overlapping approach Proton Pump Inhibitors/Nux vomica-Heel as new intervention for gastro-esophageal reflux management: Delphi consensus study
Edda Battaglia, Luciano Bertolusso, Marco Del Prete, Marco Monzani, Marco Astegiano
Edda Battaglia, Gastroenterology Unit, ASLTO4, Ivrea 10015, Turin, Italy
Luciano Bertolusso, General Practitioner, ASL CN2, Alba - Bra 12051, Cuneo, Italy
Marco Del Prete, Specialist in Nephrology International Academy of Physiological Regulating Medicine, Milan 20100, Italy
Marco Monzani, Specialist in Endocrinology, Territorial Social and Health Authority of Brianza, Monza 20900, Italy
Marco Astegiano, Gastroenterology Specialist, Retired from Gastroenterology and Hepatology Unit, AOU Città della Salute e della Scienza, Turin 10123, Italy
Author contributions: Battaglia E, Bertolusso L, Del Prete M, Monzani M and Astegiano M contributed to the conception and the process of Consensus and to the writing of the article; All Authors have read and approve the final manuscript.
Supported by Guna S.p.a. (unconditional granted).
Conflict-of-interest statement: Dr. Battaglia reports grants from NZP-UK, personal fees from Europharma, grants from Guna S.p.a., outside the submitted work.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Received: January 21, 2024 Revised: February 28, 2024 Accepted: April 16, 2024 Published online: May 14, 2024 Processing time: 110 Days and 16.8 Hours
Abstract
BACKGROUND
Gastro-esophageal reflux disease (GERD) may affect the upper digestive tract; up to 20% of population in Western nations are affected by GERD. Antacids, histamine H2-receptor antagonists, and Proton Pump Inhibitors (PPIs) are considered the referring medications for GERD. Nevertheless, PPIs must be managed carefully because their use, especially chronic, could be linked with some adverse effects. An effective and safe alternative pharmacological tool for GERD is needed. After the identification of potentially new medications to flank PPIs, it is mandatory to revise and improve good clinical practices even through a consensus process.
AIM
To optimize diagnosis and treatment guidelines for GERD through a consensus based on Delphi method.
METHODS
The availability of clinical studies describing the action of the multicomponent/multitarget medication Nux vomica-Heel, subject of the consensus, is the basic prerequisite for the consensus itself. A modified Delphi process was used to reach a consensus among a panel of Italian GERD specialists on the overlapping approach PPIs/Nux vomica-Heel as a new intervention model for the management of GERD. The Voting Consensus group was composed of 49 Italian Medical Doctors with different specializations: Gastroenterology, otolaryngology, geriatrics, and general medicine. A scientific committee analyzed the literature, determined areas that required investigation (in agreement with the multiple-choice questionnaire results), and identified two topics of interest: (1) GERD disease; and (2) GERD treatment. Statements for each of these topics were then formulated and validated. The Delphi process involved two rounds of questioning submitted to the panel experts using an online platform.
RESULTS
According to their routinary GERD practice and current clinical evidence, the panel members provided feedback to each questionnaire statement. The experts evaluated 15 statements and reached consensus on all 15. The statements regarding the GERD disease showed high levels of agreement, with consensus ranging from 70% to 92%. The statements regarding the GERD treatment also showed very high levels of agreement, with consensus ranging from 90% to 100%. This Delphi process was able to reach consensus among physicians in relevant aspects of GERD management, such as the adoption of a new approach to treat patients with GERD based on the overlapping between PPIs and Nux vomica-Heel. The consensus was unanimous among the physicians with different specializations, underlying the uniqueness of the agreement reached to identify in the overlapping approach between PPIs and Nux vomica-Heel a new intervention model for GERD management. The results support that an effective approach to deprescribe PPIs through a progressive decalage timetable (reducing PPIs administration to as-needed use), should be considered.
CONCLUSION
Nux vomica-Heel appears to be a valid opportunity for GERD treatment to favor the deprescription of PPIs and to maintain low disease activity together with the symptomatology remission.
Core Tip: This Delphi consensus suggests Nux vomica-Heel as a new therapeutic tool for the medical doctor who daily finds himself diagnosing and treating gastro-esophageal reflux disease (GERD). Nux vomica-Heel is a multicomponent/multitarget low dose medication that can be introduced in the patient’s therapeutic plan in overlapping with Proton Pump Inhibitors (PPIs) to progressively reduce the use of PPIs through an appropriate decalage plan. All the statements were approved with a large majority by a panel of gastroenterologists, otolaryngologists, geriatrics, and general practitioners expert in GERD, demonstrating their validity and the importance of the topic covered by the consensus.
