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

Mahon 2005.

Methods Randomised clinical trial
Participants Country: United Kingdom
Number randomised: 217
Post‐randomisation drop‐outs: 51 (23.5%)
Revised sample size: 166
Average age: 48 years
Females: not stated
Barretts oesophagus: not stated
Hiatus hernia: not stated
Body mass index: not stated
Inclusion criteria

  1. Symptoms of GORD for at least six months.

  2. Three months minimum of proton pump inhibitor maintenance therapy.

  3. Proven reflux (as measured by 24 hour pH/manometry).

  4. No preference for either surgical or medical treatment.

  5. Between 16 and 70 years old.

  6. Fit for surgery.


Exclusion criteria

  1. Significant oesophageal dysmotility.

  2. Morbid obesity (BMI = 35).

  3. Refused pH testing and manometry.
Interventions Participants were randomly assigned to two groups.
 Group 1: surgery (n = 80)
 Further details: Laparoscopic Nissen fundoplication
 Group 2: medical treatment (n = 86)
 Further details: Proton pump inhibitor adjusted to symptom control.
Outcomes The outcomes reported were health‐related quality of life and gastrointestinal quality of life.
Notes Reasons for post‐randomisation drop‐outs: Lost‐to follow‐up.
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 Unclear risk Comment: This information was not available.
Incomplete outcome data (attrition bias) 
 All outcomes High risk Comment: There were post‐randomisation drop‐outs.
Selective reporting (reporting bias) High risk Comment: Treatment‐related complications were not reported adequately.
Other bias High risk Quote: "This study was funded partly by Janssen Pharmaceuticals relating to physiology studies at the Norfolk Physiology Laboratory in conjunction with their GI Partnership Scheme. Yvette Sharpe performed most of these studies under the supervision of R.L. B.D., D.M. and B. K. were funded partly by Ethicon Endosurgery, UK".

GERD or GORD = gastro‐oesophageal reflux disease
 PPI = proton pump inhibitor