H. pylori: a 5-day quadruple therapy course led to higher cure rates but more diarrhoea than a 7-day triple therapy course

Clinical bottom line (level 1b)

  1. Patients with H. pylori infection who received a 5-day quadruple therapy eradication course compared with a 7-day triple therapy course were more likely to be cured (NNT = 9 at 4 weeks) , but more likely to develop diarrhoea too (NNH = 5 at 4 years) .
Nagahara et al: Aliment Pharmacol Ther 2001; 15 : 417-421
Expires May 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: gastroenterology clinic, university hospital, Japan

160 patients (aged 17 to 73; mean 50, 74% male) with dyspepsia or peptic ulcers and H. pylori infection

Excluded if
  • allergy to study drugs
  • previous course of H. pylori eradication therapy
  • malignancy, hepatic or renal failure
  • pregnancy
  • partial or total gastrectomy

Control Group: (n = 80, 80 analysed): rabeprazole 20 mg twice daily, amoxicillin 750 mg twice daily, and clarithromycin 200 mg twice daily for 7 days
Experimental Group: (n = 80, 80 analysed): rabeprazole 20 mg twice daily, amoxicillin 750 mg twice daily, clarithromycin 200 mg twice daily, and metronidazole 250 mg twice daily for 5 days

98% followed for 4 weeks

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)
ARR
(95% CI)
NNT
(95% CI)
cured 4 weeks 65
(81.3%)
74
(92.5%)
14%
(1% to 29%)
11.3%
(0.932% to 21.6%)
9
(5 to 110)
diarrhoea or soft stool 4 weeks 6
(7.50%)
2
(26.3%)
-250%
(-720% to -49%)
-18.8%
(-30.0% to -7.51%)
-5
(-13 to -3)

Citation

  1. Nagahara A, Miwa H, Yamada T, et al: five-day proton-pump inhibitor-based quadruple therapy regimen is more effective than 7-day triple therapy regimen for Helicobacter pylori infection. Aliment Pharmacol Ther 2001; 15 : 417-421
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, May 2002
Reviewer:

Clinical Question.
Patient H. pylori infection
Intervention or Exposure quadruple therapy
Comparison triple therapy
Outcome cure, diarrhoea