Class 1 6 1 st Year Introdução à Medicina I FMUP

1. Is Esomeprazole the most efficient Proton Pump Inhibitor to relief symptoms and to induce mucosal healing, in patients with Gastroesophageal Reflux Disease? Class 16 1st Year Introdução à Medicina I FMUP 19th December 2007

2. Ana Lopes Andreia Pinto Catarina Melo Diogo Dias Isabel Saavedra João Matias Mariana Ferreira Mariana Mangas Paula Neves Rita Sapage Rui Coelho Teresa Caridade Teresa Tavares Class 16 1st Year Doutor Mário Dinis Ribeiro Introdução à Medicina I FMUP

3. Summary • Introduction to GERD • Research Question and Aim • Methods • Study Design • Papers Selection: • Queries • Number of Abstracts • Inclusion/Exclusion Criteria • Fluxogram • Data to be extracted: • Variables • Quality assessment • Statistical treatment

4. 35% of Portuguese adults refer GERD symptoms Gastroesophageal Reflux Disease (GERD) • Prevalent and chronic condition • Reflux of the stomach contents into the oesophagus • Troublesome symptoms • - heartburn - acid regurgitation • Complications • - haemorrhage, stricture, - Barrett’s oesophagus - adenocarcinoma of the distal oesophagus Adapted from: Maria João Branco, Paulo Nogueira, Teresa Contreiras. Uma observação sobre estimativas da prevalência de algumas doenças crónicas, em Portugal Continental. Julho 2005, Observatório Nacional de Saúde, Instituto Dr. Ricardo Jorge.

5. Proton Pump Inhibitors (PPIs) • mainstay of medical therapy in GERD; • heals esophageal mucosal injury; • highly selective and effective in their action and have few short- or long-term adverse effects. Omeprazole, Lanzoprazole Pantoprazole, Raberprazole Pettit M (2005). Treatment of gastroesophageal reflux disease. Pharm World Sci. 27 (6):432-5.

6. ESOMEprazole (40 mg) • efficacy and safety were reviewed and causes of failure were discussed; • Several studies have shown marginal differences in efficacy between various PPIs regimens. • New - generation PPI; Glatzel D et al (2006). Pantoprazole 40 mg is as effective as esomeprazole 40 mg to relieve symptoms of gastroesophageal reflux disease after 4 weeks of treatment and superior regarding the prevention of symptomatic relapse. Digestion. 74(3-4):145-54.

7. Summary • Introduction to GERD • Research Question and Aim • Methods • Study Design • Papers Selection: • Queries • Number of Abstracts • Inclusion/Exclusion Criteria • Fluxogram • Data to be extracted: • Variables • Quality assessment • Statistical treatment

8. Question of the study • Is esomeprazolemore effective in enduring symptom relief and in healing mucosal injury, relatively to omeprazole, lansoprazole, rabeprazole, pantoprazole, in GERD patients?

9. Aim • To compare efficacy of esomeprazole relatively to the other PPIs, in GERD patients, in • symptoms relief • inducing mucosal healing

10. Summary • Introduction to GERD • Research Question and Aim • Methods • Study Design • Papers Selection: • Queries • Number of Abstracts • Inclusion/Exclusion Criteria • Fluxogram • Data to be extracted: • Variables • Quality assessment • Statistical treatment

11. Methods: Study design • Synthesis’ studies: Sistematic review Metanalysis study • Bibliographic databases: • Medline (http://www.nlm.nih.gov/medlineplus/) • Scopus (http://www.scopus.com) • ISI Web of Knowledge (http://isiwebofknowledge.com/)

12. Methods: Paper Selection - Queries - Pubmed - • (gastroesophageal reflux OR "Gastroesophageal Reflux"[Mesh] OR GERD OR NERD OR non-esophagitis reflux disease OR esophagitis) AND (regurgitation OR heartburn) AND (randomized controlled trial[Publication Type] OR (randomized[Title/Abstract] AND controlled[Title/Abstract] AND trial[Title/Abstract])) AND (omeprazole OR "Omeprazole"[Mesh] OR pantoprazole OR "pantoprazole"[Substance Name] OR rabeprazole OR "rabeprazole"[Substance Name] OR lansoprazole OR "lansoprazole"[Substance Name]) AND (esomeprazole OR "Omeprazole"[Mesh]) NOT (”Barrett esophagus” [Mesh]) 158 articles

13. Methods: Paper Selection - Queries - ISI Web of Knowledge - • ((gastroesophageal reflux OR GERD OR NERD OR non-esophagitis reflux disease OR esophagitis) AND (regurgitation OR heartburn) AND (omeprazole OR pantoprazole OR rabeprazole OR lansoprazole) AND (esomeprazole) NOT (Barrett Syndrome)) 35 articles

14. Methods: Paper Selection - Queries - Scopus - • ((gastroesophageal reflux OR gerd OR nerd OR non-esophagitis reflux disease OR esophagitis) AND (regurgitation OR heartbun) AND NOT (barrett syndrome)) AND (omeprazole OR pantoprazole OR rabeprazole OR lansoprazole) AND (esomeprazole) AND (EXCLUDE(DOCTYPE, "re") OR EXCLUDE(DOCTYPE, "cp")) 57 articles

15. Methods: Paper Selection - Number of Abstracts PUBMED N=215 143 7 ISI 8 15 12 SCOPUS 30

16. Methods: Paper Selection - Inclusion criteria • Studies in Humans; • Studies in adults (19 - 75 years old); • Clinical trials; • Original articles; • Treatment of patients only with PPIs;

17. Methods: Paper Selection - Exclusion criteria • Inaccessibility of data; • Articles published from December of 2007; • Studies in pregnant; • Studies in people with other illnesses beyond GERD;

18. 250 articles found Paper Selection: Fluxogram Start Define a focused review question Define a query Run search on MedLine

19. Are the articles repeated? No Yes 35 articles excluded 215 articles included

20. Do the two reviewers exclud the article? 115 articles excluded Select articles according to inclusion and exclusion criteria Do the two reviewers includ the article? Yes No 100 articles included Yes The two reviewers discuss No End

21. Methods: Data to be Extracted - Variables • Data to collect: • number of participants; number of participants who had abandoned the study • Intention to treat • age and gender; • ethnia; • GERD (NERD vs Esophagitis) • which PPI was esomeprazole compared against; • dose of esomeprazole (20 or 40mg) and other;

22. time of intervention (in weeks) time to outcome primary aim (esomeprazole vs other) mucosal healing (assessment) symptoms relief habits of the participants (ex. smoking) physiological state (ex. menopause) Methods: Data to be Extracted - Variables

23. Methods: Data to be Extracted - Quality assessment • CONSORT - Consolidated Standards of Reporting Trials • QUOROM - Guidelines for Meta-Analyses and Systematic Reviews of RCTs

24. Methods: Data to be Extracted - Statistical treatment • SPSS and specific software for metanalysis (eg.: RevMan)

25. Outcome • If Esomeprazole is: • more effective in symptom relief; • healing and prevention of mucosal injury; than old PPIs.

26. Class 16 1st Year Introdução à Medicina I FMUP Feliz Natal!