Helicobacter pylori eradication versus prokinetics in the treatment of functional dyspepsia: a randomized, double-blind study.
BACKGROUND
This randomized, double-blind study compared the efficacy of Helicobacter pylori eradication against prokinetics in H. pylori-infected functional dyspepsia patients.


METHODS
Patients with moderately severe or severe dyspepsia fulfilling the Rome II criteria were randomized to either H. pylori eradication for 1 week and 6 weeks of placebo prokinetics or 6 weeks of prokinetics and placebo H. pylori eradication in the first week. Symptoms were assessed at baseline and at 6 and 12 months using the Glasgow Dyspepsia Severity Score (GDSS). Global response to treatment was assessed at 12 months.


RESULTS
Altogether 130 patients were enrolled (H. pylori eradication, 71; prokinetics, 59). The mean baseline GDSS was 9.3 for the H. pylori eradication group and 8.9 for the prokinetic group. At 6 months, the score was 3.6 and 4.1, respectively, and it remained at 3.5 and 3.8, respectively, at 12 months. With H. pylori eradication, 31.0% had complete symptom resolution (GDSS 0 or 1) at 12 months compared with 23.7% with prokinetics (a nonsignificant difference). At 12 months, global symptomatic improvement was seen in 62.0% of the H. pylori eradication group compared with 67.8% of the prokinetics group.


CONCLUSIONS
Both H. pylori eradication and prokinetic therapy resulted in symptom improvement in two-thirds of dyspeptic patients at 1 year. More patients tended to achieve complete symptom relief with H. pylori eradication.
Ang
Tiing Leong
TL
Department of Gastroenterology, Changi General Hospital, 2 Simei Street 3, Singapore, 529889, Singapore.
Fock
Kwong Ming
KM
Teo
Eng Kiong
EK
Chan
Yiong Huak
YH
Ng
Tay Meng
TM
Chua
Tju Siang
TS
Tan
Jessica Yi-Lyn
JY
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D020117:Cisapride / Q000008:administration & dosage / Q000627:therapeutic use; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use; D004294:Domperidone / Q000008:administration & dosage / Q000627:therapeutic use; D018492:Dopamine Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005765:Gastrointestinal Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D064747:Lansoprazole; D008297:Male; D016896:Treatment Outcome
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000890:Anti-Infective Agents; D018492:Dopamine Antagonists; D005765:Gastrointestinal Agents; D064747:Lansoprazole; D004294:Domperidone; D000658:Amoxicillin; D017291:Clarithromycin; D020117:Cisapride