A comparison of five maintenance therapies for reflux esophagitis.
BACKGROUND
Patients with reflux esophagitis have a high rate of relapse within one year after therapy is discontinued.


METHODS
We enrolled 175 adults with endoscopy-confirmed reflux esophagitis in a prospective study comparing five maintenance therapies. All the patients were initially treated with omeprazole (40 mg orally once a day) for four to eight weeks, and healing was confirmed by endoscopy. Participants were then stratified according to their initial grade of esophagitis and randomly assigned to 12 months of treatment with one of the following: cisapride (10 mg three times a day), ranitidine (150 mg three times a day), omeprazole (20 mg per day), ranitidine plus cisapride (10 mg three times a day), or omeprazole plus cisapride. Endoscopy was repeated after 6 and 12 months of treatment; the endoscopists were blinded to the treatment assignments. Remission was defined as the absence of esophageal lesions on scheduled or unscheduled follow-up endoscopy.


RESULTS
In an intention-to-treat analysis, the numbers of patients in continued remission at 12 months were 19 of 35 (54 percent) in the cisapride group, 17 of 35 (49 percent) in the ranitidine group, 28 of 35 (80 percent) in the omeprazole group, 23 of 35 (66 percent) in the ranitidine-plus-cisapride group, and 31 of 35 (89 percent) in the omeprazole-plus-cisapride group. Omeprazole was significantly more effective than cisapride (P = 0.02) or ranitidine (P = 0.003), and combination therapy with omeprazole plus cisapride was significantly more effective than cisapride alone (P = 0.003), ranitidine alone (P < 0.001), or ranitidine plus cisapride (P = 0.03). Ranitidine plus cisapride was significantly better than ranitidine alone (P = 0.05).


CONCLUSIONS
For maintenance treatment of reflux esophagitis, omeprazole alone or in combination with cisapride is more effective than ranitidine alone or cisapride alone, and the combination of omeprazole and cisapride is more effective than ranitidine plus cisapride.
Vigneri
S
S
Institute of Internal Medicine and Geriatrics, University of Palermo, Italy.
Termini
R
R
Leandro
G
G
Badalamenti
S
S
Pantalena
M
M
Savarino
V
V
Di Mario
F
F
Battaglia
G
G
Mela
G S
GS
Pilotto
A
A
D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D020117:Cisapride; D018572:Disease-Free Survival; D004359:Drug Therapy, Combination; D004942:Esophagitis, Peptic / Q000145:classification / Q000188:drug therapy*; D004945:Esophagoscopy; D005260:Female; D006635:Histamine H2 Antagonists / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D010880:Piperidines / Q000627:therapeutic use*; D011446:Prospective Studies; D011899:Ranitidine / Q000627:therapeutic use*; D012008:Recurrence; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome
D000897:Anti-Ulcer Agents; D006635:Histamine H2 Antagonists; D010880:Piperidines; D011899:Ranitidine; D009853:Omeprazole; D020117:Cisapride