On 22 November 2011 the American Journal of Gastroenterology gave advance online publication to the findings of a study to evaluate the application of radiofrequency energy (Stretta® therapy) in the treatment of GERD. The data which came from the double blind, sham controlled study confirmed that Stretta® therapy improves the physiology of the LES (lower esophageal sphincter) and that this was the likely cause of the improvement in GERD symptoms.
There have been several studies which have reported relief from the symptoms of GERD following Stretta treatment at the gastro-esophageal junction (GEJ), but these studies did not identify how this improvement was achieved. This study was set up to test the hypothesis that the Stretta therapy alters GEJ resistance.
The study was carried out in a tertiary care center using consecutive GERD patients. All participants in the study underwent two upper gastrointestinal endoscopies at 3 monthly intervals, during which either active or sham radiofrequency treatment was performed in a randomized double-blind manner. Each patient undertook a symptom assessment, endoscopy, manometry, 24 hour esophageal pH monitoring, and a distensibility test of the GEJ both before the start of the study and after 3 months.
The results were measured using a Barostat distensibility test of the GEJ before and after administration of the relaxant sildenafil. Twenty two patients took part in the study with eleven in each group. After three months the sham treatment produce no impact on any of the measures used but the Stretta therapy produced improved symptom score and decreased GEJ compliance. After the administration of sildenafil, GEJ compliance returned again to pre-Stretta level, thereby establishing that GEJ fibrosisis was not causing the improvement.
Mederi Therapeutics who manufacture Stretta are of course delighted by the results of this study and Will Rutan their CEO said,
“These results add to the significant body of research on Stretta. The treatment works exceptionally well to reduce or eliminate symptoms in sufferers of GERD, but exactly how it works is now more clearly understood , with 67 publications supporting Stretta as a safe, effective, and durable treatment, Stretta offers an excellent alternative to invasive surgery.”