Introduction

To evaluate interim outcomes of a randomized controlled trial comparing Stretta radiofrequency (RF) therapy to conservative management in patients with gastroesophageal reflux disease (GERD), focusing on symptom control, daily PPI reduction, and acid exposure. The study further explores the hypothesis that Stretta may act via neuromodulation rather than mechanical augmentation of the lower esophageal sphincter (LES).

Aims & Methods

This ongoing prospective trial includes patients with non-erosive reflux disease (NERD) or grade A esophagitis (Los Angeles classification), no or minimal hiatal hernia (≤2 cm), and objectively confirmed pathological reflux by impedance-pH monitoring. Patients were randomized to Stretta (n = 20) or conservative therapy (n = 21). Follow-up was scheduled at 3, 6, and 12 months. Only patients with complete paired data were analyzed at each time point. Primary outcomes included symptom scores (GERD-HRQL and Reflux Symptom Index [RSI]) and daily PPI use. Acid exposure time (AET) was a secondary endpoint.

Results

In the Stretta group, 16, 12, and 9 patients completed 3-, 6-, and 12-month follow-up, respectively. In the conservative group, corresponding numbers were 18, 14, and 12. At 12 months, Stretta significantly improved GERD-HRQL (30.7 to 13.2; p = 0.0118), RSI (20.8 to 10.2; p = 0.0018), and reduced mean daily PPI use from 35.6 mg to 0 mg (p = 0.0070). AET did not significantly change (7.8 % to 6.4 %; p = 0.4033). In contrast, the conservative group showed no improvement in GERD-HRQL or PPI use, and RSI significantly worsened (14.1 to 20.1; p = 0.0101).

Conclusion

These interim findings suggest that Stretta therapy provides meaningful symptom relief and reduces the need for daily PPI use in selected GERD patients, even in the absence of acid normalization. This supports a neuromodulatory mechanism rather than mechanical LES augmentation. It is plausible that some GERD patients in this study had overlapping esophageal hypersensitivity, which may explain their positive clinical response. Stretta may thus have therapeutic relevance beyond current indications, particularly in patients with a hypersensitivity phenotype.

Disclosure

Katerina Kostalova has received speaker honoraria from Imedex, the official distributor of the Stretta system in the Czech Republic. No other conflicts of interest are declared by the authors.