# Abstract

 

## Background/Aims First-line therapies against *Helicobacter pylori*, including proton pump inhibitors (PPIs) plus two antibiotics, may fail in up to 20% of patients. 'Rescue' therapy is usually needed for patients who failed the first-line treatment. This study evaluated the eradication rate of bismuth-containing quadruple rescue therapy over a 1- or 2-week period. 

## Methods We prospectively investigated 169 patients with a persistent *H. pylori* infection after the first-line triple therapy, which was administered from October 2008 to March 2010. The patients were randomized to receive a 1- or 2-week quadruple rescue therapy (pantoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d., metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d.). After the 'rescue' therapy, the eradication rate, compliance, and adverse events were evaluated. 

## Results The 1-week group achieved 83.5% (71/85) and 87.7% (71/81) eradication rates in the intention to treat (ITT) and per-protocol (PP) analyses, respectively. The 2-week group obtained 87.7% (72/84) and 88.9% (72/81) eradication rate in the ITT and PP analyses, respectively. There was no significant difference in the eradication rate, patient compliance or rate of adverse events between the two groups. 

## Conclusions One-week bismuth-containing quadruple therapy can be as effective as a 2-week therapy after the failure of the first-line eradication therapy. # RESULTS All randomized 169 patients were eligible for ITT analysis. Among these patients, 85 patients received 1-week PPI+BMT and 84 patients received 2-week PPI+BMT. The main demographic and clinical features of 169 patients according to the two treatment arms are shown in [Table 1](#). Demographic characteristics were similar, except for higher proportion of patients with duodenal ulcers in the 2-week PPI+BMT group, as were symptoms at the initial assessment. Overall, seven patients had protocol violations that excluded them from PP analysis. Among these patients, four patients were in the 1-week PPI+BMT treatment group. Their violations were follow-up loss, inadequately taking medicine and discontinuing the therapy due to intolerable side effects. Thus, seven patients were dropped out from PP analysis. [Fig. 1](#) shows the flow diagram of patients progress through the phases of the study. The 1-week PPI+BMT regimen achieved 83.5% (95% CI, 76% to 91%) eradication rate in ITT analysis and 87.7% (95% CI, 80% to 95%) in PP analysis, while the 2-week PPI+BMT regiment obtained 87.7% (95% CI, 78% to 93%) eradication rate in ITT and 88.9% (95% CI, 82% to 96%) in PP analysis. There was no statistically significant difference between the two treatment modalities ([Table 2](#)). The compliance rates of the 1-week PPI+MBT group were 91.4% 'good' compliance, 9.9% 'well' compliance and 2.5% 'poor' compliance. In the 2-week PPI+MBT treatment group, the compliance rates were 91.4%, 4.6%, and 3.7%, respectively ([Table 2](#)). Overall, 52 patients reported side-effects, i.e., 19 patients (22.4%) in the 1-week PPI+BMT group and 32 patients (38.1%) in the 2-week PPI+BMT group. Diarrhea, headache, vomiting, stool color change, itching, nausea, taste disturbance, and abdominal pain were reported as side effects. There was no statistically significant difference in side effects between the two groups ([Table 3](#)). Only one patient from each group withdrew from the study due to significant side effects. The prevalence of side effects was not significantly increased with treatment duration. In both groups, most patients tolerated well the side effects and continued medication with encouragement from the physician, even when the side effects were rather serious. <figure> <p><img src="" /></p> <figcaption>Flow diagram showing the phases of the study progress. Eradication rates are presented for both the intention to treat (ITT) and per-protocol (PP) analyses in the two groups.<br /> PPI, proton pump inhibitor; BMT, bismuthate, metronidazole, and tetracycline; CI, confidence interval.</figcaption> </figure> ::::table-wrap

::: caption
Demographic Data and Clinical Characteristics of the Two Patient Groups
in the Intention to Treat Analysis
:::

![](<>)

Data are presented as mean±SD or number (%).

PPI, proton pump inhibitor; BMT, bismuthate, metronidazole,
tetracycline.

^\*^p\<0.05.:::: ::::table-wrap
::: caption
The Eradication Rate of and Compliance with the 1-Week and 2-Week
PPI+BMT Quadruple Rescue Therapy
:::

![](<>)

Data are presented as percentage (number/total number).

PPI, proton pump inhibitor; BMT, bismuthate, metronidazole, and
tetracycline; ITT, intention to treat; PP, per-protocol.

^\*^In the ITT analysis, patients without final ^13^C urea breath test
results or rapid urea test results were classified as treatment
failures; ^†^Good compliance was defined as taking more than 85% of the
total medication. Fair and poor compliance were defined as taking 75% to
85% and less than 75% of the total medication, respectively.:::: ::::table-wrap
::: caption
Side Effects of the 1- and 2-Week PPI+BMT Quadruple Rescue Therapy
:::

![](<>)

Data are presented as number (%).

PPI, proton pump inhibitor; BMT, bismuthate, metronidazole, and
tetracycline.::::


Extracted trial result:
Outcome: eradication rate of H. pylori in ITT (binary)
Intervention: 1-week quadruple rescue therapy
Comparator: 2-week quadruple rescue therapy
Intervention events: 71
Intervention group size: 85
Comparator events: 72
Comparator group size: 84
Notes: found in abstract and table, assumed binary because given as percentage of population