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. 2015 Nov 5;2015(11):CD003243. doi: 10.1002/14651858.CD003243.pub3

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
  1. Adults aged 18–70 years with confirmed GORD, with or without Barret's oesophagus.

  2. History of chronic reflux oesophagitis (> 6 months) or chronic symptomatic GORD (> 6 months) with pathological 24‐h pH metry, according to local standards, and a requirement for long‐term acid suppressive therapy.

  3. All patients were required to have had pH monitoring and manometry within 12 months prior to randomization.

  4. All had to be considered suitable for both surgical treatment and for long‐term management with a PPI (esomeprazole).

  5. Capable of completing quality‐of‐life questionnaires.


Exclusion criteria
  1. Primary need for surgery (e.g. for paraoesophageal hernia or failure of medical therapy to control symptoms adequately) was not eligible to be recruited.

  2. Required PPI treatment for diseases other than GORD.

  3. History of oesophageal, gastric, or duodenal surgery or who had other diseases that might have a negative impact on their subsequent treatment within the study.

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".