Effect of Helicobacter pylori eradication or of ranitidine plus metoclopramide on Helicobacter pylori-positive functional dyspepsia. A randomized, controlled follow-up study.
BACKGROUND
A definitive treatment for functional dyspepsia (FD), and the role of Helicobacter pylori eradication on the course of this disease are controversial.


OBJECTIVE
To investigate the effect of a combination of acid-suppressing and prokinetic drugs or eradication therapy on the course of H. pylori-positive FD.


METHODS
A total of 157 patients with endoscopically-proven H. pylori-positive FD and no response to 4 weeks of antacid therapy were randomly divided into 2 groups. 84 were placed on bismuth subnitrate plus metronidazole and amoxicillin (group A) and 73 received ranitidine and metoclopramide for 4 weeks (group B). The severity of symptoms (7 items) were assessed on a 6-point categorical scale. Group B patients who failed to respond to their medication underwent eradication therapy after 3 months. All patients were followed and assessed for 9 months after the end of therapy by the same clinicians who initiated the therapy.


RESULTS
At the end of the medication period, symptom's score decreased significantly, and to the same extent. At 3-month follow-up moderate or complete response was achieved in 27.4% (group A) and 19.2% (group B) by intention-to-treat analysis. 34 patients of group B, not responding to treatment, underwent eradication therapy and followed as group A. Eradication of H. pylori was successful in 60 of 110 controlled patients (54%). After 9-month follow-up, complete or moderate response was observed in only 30% of 60 patients in whom H. pylori had been eradicated (intention-to-treat analysis), compared to 38% in 50 noneradicated cases (p > 0.05, 95% CI: 19-43 vs. 24-52).


CONCLUSIONS
Eradication therapy with bismuth compound is effective as ranitidine plus metoclopramide in a subgroup of patients with FD not responding to antacid therapy. There is no difference in improvement between patients cured or not cured from H. pylori infection. This suggests that bismuth compounds were effective in FD when used in the eradication regimen. Combination therapy with acid-suppressing drugs plus prokinetic and bismuth seems to hold promise for FD.
Alizadeh-Naeeni
M
M
Department of Internal Medicine, Nemazee Hospital, Shiraz University of Medical Sciences, Shiraz, Iran.
Saberi-Firoozi
M
M
Pourkhajeh
A
A
Taheri
H
H
Malekzadeh
R
R
Derakhshan
M H
MH
Massarrat
S
S
D000328:Adult; D000863:Antacids / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D016099:Endoscopy, Gastrointestinal; D005260:Female; D016481:Helicobacter Infections / Q000175:diagnosis / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008787:Metoclopramide / Q000627:therapeutic use*; D008875:Middle Aged; D011899:Ranitidine / Q000627:therapeutic use*; D016896:Treatment Outcome
D000863:Antacids; D000897:Anti-Ulcer Agents; D011899:Ranitidine; D008787:Metoclopramide