Efficacy of low-dose lansoprazole in the treatment of non-erosive gastrooesophageal reflux disease. Influence of infection by Helicobacter pylori.
BACKGROUND
Proton pump inhibitors (PPIs) are the most effective drugs to cure peptic esophagitis and control the symptoms of gastroesophageal reflux disease (GERD). In most patients with GERD esophagitis is not detected by endoscopy, which represents GERD with a negative endoscopy or non-erosive reflux disease (NERD). The influence of infection by H. pylori in the evolution of GERD is controversial since a protective action is identified by some studies, but not all. We conducted a clinical trial to assess the efficacy of lansoprazole 15 mg/day in the initial control of NERD symptoms, and as a secondary endpoint the impact of H. pylori infection on response to treatment.


METHODS
A pilot, single-center clinical trial was conducted--single-blind regarding the experimental medication (unknown to patients), and double-blind regarding the information concerning H. pylori infection. Sixty (60) patients with NERD were initially included, who had suffered from daytime or nocturnal heartburn for 1-2 days in each of the last two weeks. Nine patients were excluded for failing to comply with the study protocol. The 51 remaining patients, 35 women and 16 men, with a mean age of 49 years, comprised the per protocol analysis population. Patients received treatment for two weeks with a capsule of the study medication (15 mg/day of lansoprazole), with daily controls on the presence and severity of daytime and nocturnal heartburn. Treatment was considered effective when, upon completion, patients referred a maximum of one episode of mild heartburn as defined in the protocol, or answered the following question in the affirmative: "Does the medication you are receiving satisfactorily control the symptoms of your disease?". During diagnostic endoscopy we obtained biopsies of the gastric body and antrum to investigate infection by H. pylori by means of a urease test. Treatment efficacy was assessed with no patients or doctors responsible for the study being aware of urease test results.


RESULTS
41 patients (80.3%) reported that treatment had satisfactorily controlled their symptoms, and 34 patients (66.6%) had a maximum of one episode of mild heartburn in the last week. Forty-two (42) patients (82.3%) had infection by H. pylori. No significant differences were observed in the response to treatment between patients with or without H. pylori infection.


CONCLUSIONS
With the limitations of a pilot study, these results suggest that lansoprazole 15 mg/day is an effective treatment in the control of NERD symptoms, that it may be a good initial therapeutic strategy, and that, according to data available, H. pylori infection has no significant effect on the response to treatment.
Castro Fernández
M
M
Department of Gastroenterology, Hospital Universitario de Valme, Seville, Spain. mcastrof@meditex.es
García Díaz
E
E
Larraona
J L
JL
Rodríguez Hornillo
M C
MC
Lamas Rojas
E
E
Núñez Hospital
D
D
Pallarés Querol
M
M
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications* / Q000188:drug therapy*; D016481:Helicobacter Infections / Q000150:complications*; D016480:Helicobacter pylori; D006801:Humans; D064747:Lansoprazole; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010865:Pilot Projects; D054328:Proton Pump Inhibitors; D016037:Single-Blind Method
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D054328:Proton Pump Inhibitors; D064747:Lansoprazole; D009853:Omeprazole