Table 2

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

		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 rate¹	2	0–8	1/66		92^3-150	82–97	57/62		81^3-150	69–90	51/63
Intention to treat eradication rate²	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 pylorieradicated³			0/1				2/57				0/51
H pylori not eradicated³			22/56				2/5				5/10
Eradication status unevaluable⁴			1/3				0/1				1/6
H pylori at prestudy not confirmed⁴			2/3				0/1				0/2
H pylori status at relapse
H pyloripositive			23⁵/23				3⁵/4				5/6⁶
Recrudescence/reinfection⁷		100	1/1			7	4/56			6	3/48

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⁴Patients with unconfirmed H pylori status at prestudy or 28 days post-treatment, who were not withdrawn and for whom endoscopic assessments were available.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