Table 2

Ulcer healing, relapse, overall success, and eradication of H pylori

%95% CIn%95% CIn%95% CIn
Ulcer healing week 4
 Intention to treat8373–9068/828980–9567/7593** 85–9870/75
Ulcer relapse
 Life table analysis week 24 relapse4430–576373-150 0–1464103-150 2–1869
 Intention to treat week 24 relapse4028–5325/6363-150 2–154/6493-150 3–186/69
Cumulative overall success week 24
 Life table analysis5138–6382893-150 81–9775873-150 79–9675
H pylorieradication
 Observed rate1 20–81/66923-150 82–9757/62813-150 69–9051/63
 Intention to treat eradication rate2 10–71/74833-150 72–9157/69713-150 59–8151/72
Relapse in relation to H pylorieradication
Duodenal ulcer relapse when:
H pylorieradicated3 0/12/570/51
H pylori not eradicated3 22/562/55/10
 Eradication status unevaluable4 1/30/11/6
H pylori at prestudy not confirmed4 2/30/10/2
H pylori status at relapse
H pyloripositive235/2335/45/66
 Recrudescence/reinfection7 1001/174/5663/48
  • 3-150 p<0.001 v RBC400+placebo; **p<0.041v RBC400+placebo.

  • Informal comparison only performed as patients not re-randomised post-treatment and differential healing rates could introduce bias.

  • Method of calculation

  • All patients included in the eradication analyses were positive prestudy by both CLOtest and UBT.

  • Post-treatment H pylori regative is defined as both CLOtest and UBT negative at least 28 days post-treatment, and H pylori positive is defined as at least one positive result.

  • 1Observed eradication rate is the number of patientsH pylori negative at least 28 days after the end of treatment divided by the number of patients with both an evaluable negative CLOtest and UBT at a visit at least 28 days after the end of treatment, or a single positive test at any time between the end of treatment and before the week 12 visit.

  • 2Intention to treat eradication rate is as above but patients with unevaluable data were assumed to have been unsuccessfully treated and are added to the denominator.

  • 3Analysis includes all healed patients who were defined asH pylori positive at prestudy, entered follow up phase, and for whom H pylori eradication status was available.

  • 4Patients with unconfirmed H pylori status at prestudy or 28 days post-treatment, who were not withdrawn and for whom endoscopic assessments were available.

  • 5One patient per group with ulcer relapse was unevaluable for eradication assessment, but at time of relapse was positive.

  • 6The negative patient was classified as positive at the eradication assessment but then negative at relapse at week 12—no concomitant medication was recorded to explain this anomalous result.

  • 7Reinfection/recrudescence rate is the number of patients defined as H pylori negative at least 28 days after the end of treatment who have at least one positive test at a later week 12 or 24 visit divided by the number of patients defined as H pylori eradicated with at least one later evaluable visit (up to week 24).