Stretta Facts

Studies show that Stretta resolves reflux symptoms and improves quality of life

Overall, Stretta has been shown to be effective in 32 separate clinical studies and a meta-analysis.

The primary endpoint of GERD therapy has been consistently achieved, that is, a high-rate of symptom control over and above PPI therapy. Secondarily, a dramatic decrease or elimination of GERD medication use has also been consistently shown.

A recent meta-analysis[15] of 18 studies and 1441 patients concluded that: (1) Stretta is very effective in GERD symptom relief; (2) Is safe and well-tolerated; and (3) Stretta significantly reduces acid exposure to the esophagus, but does not consistently normalize pH. On this last point it is important to note that even PPIs do not normalize pH in up to 50% of symptomatically controlled GERD patients treated with PPIs[16]. Hence, pH normalization is not necessarily an important clinical endpoint to be applied to Stretta.

The primary outcome of GERD treatment should be rapid and sustained achievement of comprehensive symptom resolution, because this is associated with marked improvement – often normalization – in health-related quality of life[9]. Other desired outcomes are to heal esophageal mucosal damage if it is present and to prevent relapse of erosive esophagitis in the hope that this will reduce the development of complications. Adequate treatment of GERD should either prevent repeated reflux of gastric contents into the esophagus or reduce the damaging effect of gastric acid. The generally accepted outcome measure of efficacy for GERD medical therapy, typically based upon the role of PPI, is symptom control and/or GERD-related quality of life[10]. Stretta has demonstrated consistent attainment of this goal in patients who are well-controlled by PPI but do not wish to take lifelong medications as well as in patients who have partially responded to PPI therapy and do not have a specific surgical indication (i.e., large hiatal hernia).

In a cross-over, randomized trial of 64 patients who were assigned to RF treatment or a sham procedure, those who had undergone the RF procedure were significantly more likely to experience a > 50% improvement in GERD-related quality-of-life scores at six months compared with sham-treated patients (61% vs 30%) and were more likely to be without daily heartburn symptoms (61% vs 33%). The groups had similar median acid exposure times, though acid exposure time was significantly improved when responders (> 30% decrease in heartburn score) were compared with non-responders[11].

In another controlled trial, 36 patients were assigned to a single session Stretta (12 patients), a sham procedure (12 patients), or Streta repeated once if GERD health-related quality of life (HRQL) was not 75% improved after four months (12 patients, 10 of whom underwent a second RF procedure)[12]. Patients who underwent Stretta had greater improvements in quality of life scores at 12 mo than patients who underwent sham therapy, and those treated twice showed a greater improvement than patients who underwent a single treatment. In the single Stretta group, two patients (17%) normalized their quality of life scores, in the double Stretta group seven patients (58%) normalized, and in the sham group no patients normalized. Similar results were seen in the two Stretta treatment groups with regard to the number of patients who were no longer requiring antisecretory drugs.

A nonrandomized, prospective, multicenter study included 118 patients (72 men and 46 women) with chronic heartburn and/or regurgitation who required daily antisecretory medication and exhibited pathologic esophageal acid exposure, a sliding hiatal hernia (≤ 2 cm), and esophagitis (≤ grade 2)[13]. GERD symptom scores, quality of life (short form-36, SF-36), and medication use were assessed at 0, 1, 4, 6, and 12 mo; esophageal acid exposure, motility, and endoscopy were assessed at 0 and 6 mo. At 12 mo, 94 patients were available for follow-up. There were improvements after 12 mo in the median heartburn score (4 to 1, P = 0.0001), GERD score (27 to 9, P = 0.0001), satisfaction (1 vs 4, P = 0.0001), mental SF-36 (46.3 vs 55.4, P < 0.0001), and physical SF-36 (40.9 vs 53.1, P = 0.0001); proton pump inhibitor requirement fell from 88.1% to 30% of patients. Esophageal acid exposure improved significantly (10.2% vs 6.4%, P = 0.0001). There were 10 (8.6%) complications, none of which required therapeutic intervention. The authors concluded that Stretta significantly improves GERD symptoms, quality of life, and esophageal acid exposure and eliminates the need for antisecretory medication in the majority of patients at 12 mo. Follow-up information was available for 94 patients (80%) at 12 mo. Significant improvements were observed in the median heartburn, GERD, and satisfaction scores, and on the mental and physical components of the Medical Outcomes Study SF-36. The proportion of patients requiring proton pump inhibitors fell from 30% to 88%. Esophageal acid exposure improved significantly (from 6% to 10%). The authors noted that the degree of improvement in quality of life was similar to the improvement described following fundoplication. The 24 patients who did not return their questionnaires were counted as treatment failures in the analysis. However, all of the patients were contacted and none had experienced complications. Eighteen of the patients agreed to undergo additional testing that included esophageal manometry. No significant change in any esophageal motility parameter was observed, although there was a trend toward a reduction in the number of transient lower esophageal sphincter relaxations.

In another open trial of 90 patients with non-erosive or mildly erosive disease, the onset of GERD symptom relief after Stretta was less than two mo in 70% or two to six months in 16.7%. The mean GERD-HRQL score was 25.6 (baseline), 7.3 (six months, P < 0.01), and 8.1 (12 mo, P < 0.01). The mean heartburn score was 3.3 (baseline), and 1.2 (12 mo, P < 0.05). The percentage of patients with satisfactory GERD control improved from 31.1% at baseline to 86.7% after treatment, and patient satisfaction improved from 1.4 at baseline to 4.0 at 12 mo (P < 0.01). Medication usage decreased significantly from 100% of patients on PPI therapy at baseline to 76.7% of patients showing elimination of medications or only as-needed use of antacids/H2-receptor antagonists at 12 mo[14].

A recent meta-analysis[15] of 18 studies and 1441 patients concluded that: (1) Stretta is very effective in GERD symptom relief; (2) Is safe and well-tolerated; and (3) Stretta significantly reduces acid exposure to the esophagus, but does not consistently normalize pH. On this last point it is important to note that even PPIs do not normalize pH in up to 50% of symptomatically controlled GERD patients treated with PPIs[16]. Hence, pH normalization is not necessarily an important clinical endpoint to be applied to Stretta.

How Stretta Works

The Stretta system delivers radiofrequency (RF) energy to the muscle between the stomach and esophagus, which remodels and improves the muscle tissue, resulting in improved barrier function and fewer reflux events. Stretta treats the underlying problem that may cause GERD without surgery.

Stretta reduces or eliminates medications and reduces acid exposure

A 10 year follow-up report of patients who had received Stretta therapy published in Surgical Endoscopy February 2014 [r-vii] showed:

 “72 % of patients normalizing GERD symptom scores, 41 % of patients able to remain off regular medication for GERD, 64 % of patients able to reduce medication use by 50 % or greater, and more than 60 % sustained improvement in satisfaction.

 

A minimally invasive option that is less aggressive than invasive surgery and implants

Stretta therapy is a minimally invasive procedure that significantly reduces GERD symptoms, allowing the majority of patients to eliminate or largely decrease use of PPIs. Stretta is an outpatient procedure per­formed in less than 60 minutes, allowing patients to return to normal activities the fol­lowing day. Stretta doesn’t require any incisions, stitches or implants.

 

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