Karbasi 2013.
Methods |
Aim of study: to determine the efficacy of NAC on eradication of H pylori infections in participants suffering from dyspepsia. Study design: randomised controlled study. Study grouping: parallel group. Unit of allocation: by individuals. Country: Iran. Start date: not reported. End date: not reported. Duration of participation: 6 weeks. Ethical approval: approved by the ethical committee of the Tehran Islamic Azad Medical University. |
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Participants |
Total number randomised: 60. Method of recruitment: not reported. Informed consent obtained: informed written consent, approved by the ethical committee of the Tehran Islamic Azad Medical University, was obtained from all participants before their participation in the study. Baseline imbalances: the participants were matched for age and sex. Information about other types of imbalances was not available. Withdrawals and exclusions: two participants dropped out from the placebo group for unknown reasons. Subgroups measured: endoscopic findings, age, gender. Subgroups reported: endoscopic findings, age, gender. Mean age: 41.5 ± 13.53 years, range 17 to 76 years overall. Not reported in details about group A or group B. Gender (M/F): group A (14/16), group B ( 14/14). Race/ethnicity: not reported. Severity of condition: dyspepsia. Normal oesophagus, non‐ulcerative oesophagitis, erosive oesophagitis, normal stomach, antral gastritis, pangastritis, erosive gastritis, normal duodenum, erosive duodenitis, duodenitis and duodenal ulcer were observed. Comorbidities: not reported. Diagnostic criteria: diagnosis of positive infection with H pylori was performed on the basis of endoscopic examination and H pylori rapid urease test. Setting: not reported. Inclusion criteria: history of chronic dyspepsia at least for three months, diagnosis of H pylori infection, no participation in clinical studies or not being under treatment with other drugs. Exclusion criteria: withdrawal, severe and debilitating underlying disease, recent consumption of antibiotics, bismuth, NSAID drugs, corticosteroids during the past one month, pregnancy or lactation, and a positive history of surgery or gastric cancer. |
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Interventions |
Number randomised in each group: group A (n = 30) , group B (n = 28). Dose
Duration of treatment period: 14 days. Timing: as described above. Delivery: oral. Providers: not reported. Cointerventions: none. Economic information: not reported. Resource requirements: not reported. Integrity of delivery: not reported. Compliance: not reported. |
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Outcomes |
Primary outcomes: eradication rates, defined as the number of participants with negative urea breath test after treatment. Secondary outcomes: none. Time points measured and reported: four weeks after treatment. Person measuring/reporting: a gastroenterologist. Unit of measurement: ‐ Scales: ‐ Imputation of missing data: not reported. Assumed risk estimates: not reported. Power: not reported. |
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Notes |
Publication status: full text. Funding source: not declared. Conflict of interest: authors declared no conflicts. Contact with authors: we contacted the authors on 26 January 2017 but received no reply. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "In this randomized double‐blinded placebo‐control study 60 patients were enrolled." Comment: insufficient information to allow judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to allow judgement. |
Blinding of participants and personnel (performance bias) Eradication (frequency) | Low risk | Comment: the method used for assessment of eradication was an objective test, unlikely to be influenced by blinding. |
Blinding of participants and personnel (performance bias) Gastrintestinal adverse events | Unclear risk | Comment: the study did not address this outcome. |
Blinding of participants and personnel (performance bias) Allergic adverse events | Unclear risk | Comment: the study did not address this outcome. |
Blinding of participants and personnel (performance bias) Toxic adverse events | Unclear risk | Comment: the study did not address this outcome. |
Blinding of outcome assessment (detection bias) Eradication (frequency) | Low risk | Comment: the method used for assessment of eradication was an objective test, unlikely to be influenced by blinding of assessor. |
Blinding of outcome assessment (detection bias) Gastrintestinal adverse events | Unclear risk | Comment: the study did not address this outcome. |
Blinding of outcome assessment (detection bias) Allergic adverse events | Unclear risk | Comment: the study did not address this outcome. |
Blinding of outcome assessment (detection bias) Toxic adverse events | Unclear risk | Comment: the study did not address this outcome. |
Incomplete outcome data (attrition bias) Eradication (frequency) | Low risk | Comment: there was a loss of 6% (2/30) in the control group. Participants dropped out because of unknown reasons. It is unlikely that this fact could influence the results. |
Incomplete outcome data (attrition bias) Gastrintestinal adverse events | Low risk | Comment: there was a loss of 6% (2/30) in the control group. Participants dropped out because of unknown reasons. It is unlikely that this fact could influence the results. |
Incomplete outcome data (attrition bias) Allergic adverse events | Low risk | Comment: there was a loss of 6% (2/30) in the control group. Participants dropped out because of unknown reasons. It is unlikely that this fact could influence the results. |
Incomplete outcome data (attrition bias) Toxic adverse events | Low risk | Comment: there was a loss of 6% (2/30) in the control group. Participants dropped out because of unknown reasons. It is unlikely that this fact could influence the results. |
Selective reporting (reporting bias) | Low risk | All outcomes that are of interest in this review were presented. |
Other bias | Low risk | This study seems to be free of other sources of bias. |