Cammarota 2009.
Methods |
Aim of study: to test the hypothesis that a mucolytic pretreatment was able to demolish the biofilm architecture, rendering H pylori–resistant strains more vulnerable to antibiotics. Study design: randomised controlled study, open‐label. Study grouping: parallel group. Unit of allocation: by individuals. Country: Italy. Start date: not available in report. End date: not available in report. Duration of participation: 9 weeks. Ethical approval: approved by the ethics committee of Catholic University of Medicine and Surgery. |
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Participants |
Total number randomised: 40. Method of recruitment: consecutive participants who had a history of at least fourH pylori eradication failures, and were therefore referred to a tertiary endoscopy centre for endoscopic examination and H pylori culture. Informed consent obtained: participants provided written informed consent to participate in the study. Baseline imbalances: groups were similar according to age and gender. Withdrawals and exclusions: none. Subgroups measured: none. Subgroups reported: none. Mean age: group A (49 years), group B (47 years). Gender (M/F): group A (8/12), group B (10/10). Race/ethnicity: not available in report. Severity of condition: not available in report. Comorbidities: not available in report. Diagnostic criteria: two gastric biopsy specimens were used for biofilm demonstration by scanning electron microscopy. A biofilm architecture was defined as a dense accumulation of bacteria within an amorphous matrix. Two additional specimens were used for H pylori culture. Setting: tertiary endoscopy centre, single‐centre, outpatients. Inclusion criteria: participants who had a history of at least 4 H pylori eradication failures. Exclusion criteria: participants affected by serious concomitant illnesses and those with recent or continuing use of antibiotics. |
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Interventions |
Number randomised in each group: group A (n = 20), group B (n = 20). Dose
Duration of treatment period: 7 days. Timing: once a day. Delivery: oral. Providers: not reported. Cointerventions: none. Economic information: not available. Resource requirements: not reported. Integrity of delivery: all participants received intervention. Compliance: all participants received intervention. |
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Outcomes |
Primary outcome: eradication rate. Secondary outcomes
Time points measured and reported
Outcome definition
Person measuring/reporting: not reported. Unit of measurement: % of cure for H pylori eradication. Scales: variable according to outcome. Imputation of missing data: there were no losses. Assumed risk estimates: there were no losses. Power: 80%. |
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Notes |
Publication status: full text. Funding source: the study was funded by the Italian Ministry for University, Scientific, and Technological Research. Conflict of interest: authors declared no conflicts. Contact with authors: we contacted the authors on 26 January 2017 but received no answer. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Patients were assigned randomly, using a computer‐assisted allocation method". Comment: the authors used an appropriate method for sequence generation. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to allow judgement. |
Blinding of participants and personnel (performance bias) Eradication (frequency) | Low risk | Quote: "In an open‐label, randomized controlled trial..."; "...patients underwent urea breath testing to determine their H pylori status". Comment: it is an open label study, but eradication rate was assessed by urea breath test (objective test). |
Blinding of participants and personnel (performance bias) Gastrintestinal adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Blinding of participants and personnel (performance bias) Allergic adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Blinding of participants and personnel (performance bias) Toxic adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Blinding of outcome assessment (detection bias) Eradication (frequency) | Low risk | Quote: "In an open‐label, randomized controlled trial...patients underwent urea breath testing to determine their H pylori status" Comment: it is an open label study, but eradication rate was assessed by urea breath test (objective test). |
Blinding of outcome assessment (detection bias) Gastrintestinal adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Blinding of outcome assessment (detection bias) Allergic adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Blinding of outcome assessment (detection bias) Toxic adverse events | High risk | Quote: "In an open‐label, randomized controlled trial..." Comment: this outcome could be influenced by the lack of blinding. |
Incomplete outcome data (attrition bias) Eradication (frequency) | Low risk | No losses |
Incomplete outcome data (attrition bias) Gastrintestinal adverse events | Low risk | No losses |
Incomplete outcome data (attrition bias) Allergic adverse events | Low risk | No losses |
Incomplete outcome data (attrition bias) Toxic adverse events | Low risk | No losses |
Selective reporting (reporting bias) | Low risk | All proposed outcomes were properly presented. |
Other bias | Low risk | This study seems to be free of other sources of bias. |