Running head: PROTON PUMP INHIBITORS VS. NISSEN FUNDOPLICATION FOR GERD TREATMENT
Evidence Based Practice Critically Appraised Topic
Proton Pump Inhibitors vs. Nissen Fundoplication for Chronic
Gastroesophageal Reflux Disease (GERD) Treatment
Cara Jahner, RN, BAN, FNP-S
University of Mary
NUR 568
March 7, 2014
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Proton Pump Inhibitors VS. Nissen Fundoplication for Chronic GERD Treatment
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Evidence Based Practice Critically Appraised Topic
Proton Pump Inhibitors vs. Nissen Fundoplication for Chronic
Gastroesophageal Reflux Disease (GERD) Treatment
Cara Jahner, RN, BAN, FNP-S
March 7, 2014
Clinical Scenario
A 53 year old male is seen in the gastroenterology clinic that has been treating with omeprazole
for chronic gastroesophageal reflux disease (GERD) for the past 5 years. He states that he occasionally
has “flair- ups” of his GERD and was wondering what his long-term treatment options were for his GERD
management.
Clinical Question
For adult patients with chronic gastroesophageal reflux disease (GERD), does a Nissen
fundoplication improve GERD symptoms more than medical management with proton pump inhibitors?
Articles
Anvari, M., Allen, C., Marshall, J., Armstrong, D., Goeree, R., Ungar,
W., & Goldsmith, C. (2011). A randomized controlled trial of laparoscopic Nissen fundoplication
versus proton pump inhibitors for the treatment of patients with chronic gastroesophageal reflux
disease (GERD): 3-year outcomes. Surgical Endoscopy, 25(8), 2547-2554.
doi:10.1007/s00464-011-1585-5
Fiocca, R., Mastracci, L., Engström, C., Attwood, S., Ell, C., Galmiche, J., & ... Lundell, L. (2010). Long-Term
Outcome of Microscopic Esophagitis in Chronic GERD Patients Treated With Esomeprazole or
Laparoscopic Antireflux Surgery in the LOTUS Trial. American Journal Of Gastroenterology,
105(5), 1015-1023. doi:10.1038/ajg.2009.631
*Both articles found using Cochrane and Medline databases
Summary and Appraisal of Key Evidence for Article 1
Proton Pump Inhibitors VS. Nissen Fundoplication for Chronic GERD Treatment
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Anvari, Allen, Marshall, Armstrong, Goeree… and Goldsmith (2011), completed a level 1 evidence
randomized controlled trial of adult patients with gastroesophageal reflux disease comparing proton
pump inhibitors and Nissen fundoplication. At the start of the trial there were 180 adult patients,
however 104 of them gave informed consent. There were 52 adults in the titration Proton pump inhibitor
manager group and 52 in the surgical (Nissen fundoplication group). The GERSS tool was chosen to
monitor epigastric pain, heartburn free days, and esophageal acid exposure, pH, and quality of life.
At the 3-year follow up, the surgical patients found that they had more heartburn free days and a
better quality of life. However, the acid exposure or pH monitoring was not significantly different from
the groups. There was an 11.8% treatment failure in the surgical group and 16% treatment failure in the
proton pump inhibitor group.
At the 3-year follow up, only 93 of the 104 patients were available for review. This is considered a
weakness and threat of the study. The strength of the study was the strict following of the GERSS tool,
however the study did not mention what GERSS stood for. The authors did mention there is a debate
about the differing opinions between medical management versus surgery; therefore it is recommended
more research be completed on the topic.
Summary and Appraisal of Key Evidence for Article 2
Fiocca, Mastracci, Engstrom, Attwood, Galmiche… and Lundell (2010) compiled a level 1 evidence
LOTUS study that compare medical management with esomeprazole (titration 20- 40 mg orally) or
laparoscopic anti-reflux surgery in the long-term treatment of chronic reflux disease over a 5 year period.
There were randomized 266 adults in 11 European countries in the proton pump inhibitor
(esomeprazole) group and 246 in the laparoscopic anti-reflux surgery group. Lesions in the distal
esophagus were biopsied at 1, 3, and lastly at 5 years, along with a PH-metry test and a health related
quality of life survey to monitor treatment and remission.
In the esomeprazole group’s estimated GERD remission rates were 92% in the esomeprazole
group and 85% in the laparoscopic anti-reflux surgery group. In the esomeprazole group at 5 years, 16%
of patients complained of heartburn, 13% of acid regurgitation, 5% complained of dysphagia, 28% for
bloating, and 40% for flatulence. These results are compared to the laparoscopic anti-reflux group of 8%
heartburn, 2% acid regurgitation, 11% dysphagia, 40% bloating, and 57% flatulence. Positive Endoscopic
findings were respectively the same in each group around 11%. The PPI group was able to decrease their
average pH, where the surgical group maintained around the same pH.
Proton Pump Inhibitors VS. Nissen Fundoplication for Chronic GERD Treatment
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The strengths of this research study were the thoroughness of the testing and the number of
participants. A weakness of the study was the lack of recommendations for the next study. Therefore
there is an opportunity for more research. There could have been a threat to the research because there
was a disclaimer about a possible conflict of interest, as one of the authors was on the LOTUS steering
committee.
Results and Clinical Bottom Line
Both research studies proved that medical management with proton pump inhibitors and surgery
can be effective for patients. The proton pump inhibitor group seems to be more effective at decreasing
the bloating and discomfort, whereas the Nissen fundoplication group was more effective at relieving
acid reflux and regurgitation. However, it is important to understand that there are known treatment
failures for both the medical and surgical aspect of long term GERD treatment.
Implication for practice
This research has shown that either the proton pump inhibitors or Nissen fundoplication can be
effective at the treatment of chronic GERD. If a patient has failed treatment of proton pump inhibitors or
is running into complications of long term PPI treatment, such as Clostridium difficile, the practitioner
and patient should consider the Nissen fundoplication for a treatment option. Also, if the patient is not
interested in long term PPI use, the surgical route is also an option.
Proton Pump Inhibitors VS. Nissen Fundoplication for Chronic GERD Treatment
References
Anvari, M., Allen, C., Marshall, J., Armstrong, D., Goeree, R., Ungar, W., & Goldsmith, C. (2011). A
randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors
for the treatment of patients with chronic gastroesophageal reflux disease(GERD): 3-year
outcomes. Surgical Endoscopy, 25(8), 2547-2554. doi:10.1007/s00464-011-1585-5
Fiocca, R., Mastracci, L., Engström, C., Attwood, S., Ell, C., Galmiche, J., & ... Lundell, L. (2010). Long-term
outcome of microscopic esophagitis in chronic GERD patients treated with esomeprazole or
laparoscopic antireflux surgery in the LOTUS trial. American Journal Of Gastroenterology, 105(5),
1015-1023. doi:10.1038/ajg.2009.631
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