Evidence comparing Stretta with PPI alone typically shows outcomes at least as
good as PPI alone, but with limited follow up. Comparisons of Stretta to
laparoscopic fundoplication generally favor laparoscopic fundoplication.
In 2003, Corley et al enrolled patients with symptoms at least partially
responsive to proton pump inhibitors, a pH study showing abnormal acid exposure,
and the usual exclusions including severe esophagitis or significant anatomic
defect. The sham procedure involved balloon inflation but no needle deployment
or energy delivery. A total of 64 patients were randomized and partial or
complete 6-month follow-up data were available on 56 patients.
The results of this trial were inconsistent. Although improvement in heartburn
symptoms, quality of life, and general physical quality of life was observed in
the active treatment group compared to the sham group, there were no differences
in medication usage and esophageal acid exposure. Thus in terms of the objective
measures of GERD, the findings are equivocal. In addition, data is also needed
from controlled comparison with other treatment for GERD, such as Nissen
fundoplication to better characterize outcomes relative to the risks involved.
The Med Letter reviewed the effectiveness of the Stretta device. "The Stretta
procedure appears to decrease reflux symptoms, but a decrease in esophageal
exposure to acid has not been clearly demonstrated and it has not been evaluated
at all in the most difficult-to-treat patients, such as those with large hiatal
hernias or high-grade esophagitis. The long-term efficacy and safety of this
procedure are unknown."
In a position paper published in 2008 the American Gastroenterological
Association made the following statement:
Grade Insuff: no recommendation, insufficient evidence to recommend
for or against.
The use of currently commercially available endoluminal anti-reflux procedures
in the management of patients with an esophageal syndrome.
NICE Interventional Procedure Guidance 461 states that the evidence of safety of
endoscopic radiofrequency ablation is adequate in the short and medium term, but
there is uncertainty regarding longer-term outcomes. There is evidence of
symptomatic relief but objective evidence on reduction of reflux is
inconclusive. RF ablation was therefore only to be used under special
arrangements.
There is one study listed on ClinicalTrials.gov (NCT01682265) as actively
recruiting to determine the efficacy of the Stretta procedure.