Peptic ulcer: regular pantoprazole prevented ulcers better than triple therapy in elderly patients with H. pylori infections

Clinical bottom line (level 1b)

  1. Elderly patients with H. pylori infection needing to take long-term NSAIDs who received triple therapy compared with regular pantoprazole were more likely to have severe gastrointestinal damage (NNH = 3 at 4 weeks) , but also more likely to clear the infection (NNT = 4 at 4 weeks) .
Pilotto et al: Aliment Pharmacol Ther 2000; 14 : 1077-1082
Expires January 2004

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: acute hospital, Italy

69 patients (aged 60 to 90; mean 75, 56% female) with
  • musculoskeletal pain requiring NSAIDs for at least 1 month
  • dyspeptic symptoms or a history of gastritis or peptic ulcer
  • H. pylori infection


Excluded if
  • aged < 60
  • severe gastroduodenal lesions on initial endoscopy

Control Group: (n = 34, 31 analysed): pantoprazole 40 mg daily for 1 month
Experimental Group: (n = 35, 35 analysed): H. pylori eradication with triple therapy: pantoprazole 40 mg daily, amoxicillin 1 g twice daily and clarithromycin 250 gm twice daily for 1 week

96% followed for 4 weeks
Outcome notes:
  • eradication : histology and 13-C breath test negative

The evidence

Outcome Time to outcome CER EER RRR
(95% CI)		 ARR
(95% CI)		 NNT
(95% CI)
severe gastrointestinal damage on endoscopy 4 weeks 0
(0.0%)		 10
(28.6%)		 %
(% to %)		 -28.6%
(-43.6% to -13.6%)		 -4
(-7 to -2)
eradication 4 weeks 16
(47.1%)		 30
(85.7%)		 82%
(24% to 170%)		 38.7%
(18.3% to 59.1%)		 3
(2 to 5)

Citation

  1. Pilotto A, Di Mario F, Franceschi M, et al: pantoprazole versus one-week Helicobacter pylori eradication therapy for the prevention of acute NSAID-related gastroduodenal damage in elderly subjects. Aliment Pharmacol Ther 2000; 14 : 1077-1082
Search Terms: from ACP Journal Club other articles noted
Contributor: Chris Ball, January 2002
Reviewer:

Clinical Question.
Patient elderly on NSAIDs with H. pylori infection
Intervention or Exposure H. pylori eradication with triple therapy
Comparison pantoprazole
Outcome gastrointestinal damage, H. pylori eradication