RBC400 | RBC400+CLAR | RBC800+CLAR | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|

% | 95% CI | n | % | 95% CI | n | % | 95% CI | n | |||

Ulcer healing week 4 | |||||||||||

Intention to treat | 83 | 73–90 | 68/82 | 89 | 80–95 | 67/75 | 93^{**}
| 85–98 | 70/75 | ||

Observed | 90 | 80–95 | 68/76 | 96 | 88–99 | 67/70 | 97 | 90–100 | 70/72 | ||

Ulcer relapse^{†}
| |||||||||||

Life table analysis week 24 relapse | 44 | 30–57 | 63 | 7^{3-150}
| 0–14 | 64 | 10^{3-150}
| 2–18 | 69 | ||

Intention to treat week 24 relapse | 40 | 28–53 | 25/63 | 6^{3-150}
| 2–15 | 4/64 | 9^{3-150}
| 3–18 | 6/69 | ||

Cumulative overall success week 24 | |||||||||||

Life table analysis | 51 | 38–63 | 82 | 89^{3-150}
| 81–97 | 75 | 87^{3-150}
| 79–96 | 75 | ||

H pylorieradication | |||||||||||

Observed rate^{1}
| 2 | 0–8 | 1/66 | 92^{3-150}
| 82–97 | 57/62 | 81^{3-150}
| 69–90 | 51/63 | ||

Intention to treat eradication rate^{2}
| 1 | 0–7 | 1/74 | 83^{3-150}
| 72–91 | 57/69 | 71^{3-150}
| 59–81 | 51/72 | ||

Relapse in relation to H pylorieradication | |||||||||||

Duodenal ulcer relapse when: | |||||||||||

H pylorieradicated^{3}
| 0/1 | 2/57 | 0/51 | ||||||||

H pylori not eradicated^{3}
| 22/56 | 2/5 | 5/10 | ||||||||

Eradication status unevaluable^{4}
| 1/3 | 0/1 | 1/6 | ||||||||

H pylori at prestudy not confirmed^{4}
| 2/3 | 0/1 | 0/2 | ||||||||

H pylori status at relapse | |||||||||||

H pyloripositive | 23^{5}/23 | 3^{5}/4 | 5/6^{6}
| ||||||||

Recrudescence/reinfection^{7}
| 100 | 1/1 | 7 | 4/56 | 6 | 3/48 |

↵3-150 p<0.001

*v*RBC400+placebo;^{**}p<0.041*v*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.^{1}Observed eradication rate is the number of patients*H 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.^{2}Intention 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.^{3}Analysis includes all healed patients who were defined as*H pylori*positive at prestudy, entered follow up phase, and for whom*H pylori*eradication status was available.^{4}Patients with unconfirmed*H pylori*status at prestudy or 28 days post-treatment, who were not withdrawn and for whom endoscopic assessments were available.^{5}One patient per group with ulcer relapse was unevaluable for eradication assessment, but at time of relapse was positive.^{6}The 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.^{7}Reinfection/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).