Lundell 2008.
Methods | Randomised clinical trial | |
Participants | Country: Europe Number randomised: 554 Post‐randomisation drop‐outs: not stated Revised sample size: 554 Average age: 45 years Females: 156 (28.2%) Barretts oesophagus: 60 (10.8%) Hiatus hernia: not stated Body mass index: not stated Inclusion criteria
Exclusion criteria
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Interventions | Participants were randomly assigned to two groups. Group 1: surgery (n = 288) Further details: Laparoscopic Nissen fundoplication Group 2: medical treatment (n = 266) Further details: Esomeprezole 20 mg once daily increased to maximum of 40 mg once daily or 20 mg twice daily. | |
Outcomes | The outcomes reported were GORD‐specific quality of life, proportion with heartburn, reflux, dysphagia and adverse events. | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: This information was not available. |
Allocation concealment (selection bias) | Unclear risk | Comment: This information was not available. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Patients undergoing medical treatment did not have sham surgery. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: This information was not available. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: An intention‐to‐treat analysis was performed. |
Selective reporting (reporting bias) | Low risk | Comment: Important outcomes were reported. |
Other bias | High risk | Quote: "This study was funded by Astrazeneca, Mölndal, Sweden". |