Clinical Efficacy Of UES

The Upper Esophageal Sphincter (UES) serves as the critical biological valve preventing the contents of the esophagus from entering the larynx, pharynx, and lungs. Clinical research into UES dysfunction has led to the development of the Reza Band, the first non-invasive medical device designed to mechanically bolster this natural barrier. By applying external cricoid pressure, this therapy addresses the physiological root of Laryngopharyngeal Reflux (LPR).

The UES Pressure Mechanism

The efficacy of the Reza Band is rooted in its ability to increase the internal resting pressure of the UES. In patients with LPR, the UES often fails to maintain a sufficient seal, particularly during sleep when muscle tone naturally relaxes.

• Targeted Application: The device is engineered to apply a precise external force to the cricoid cartilage.
• Pressure Calibration: Clinical guidelines suggest that a pressure of 20-30 mmHg is required to effectively increase the sphincter’s internal barrier.
• Mechanical Reinforcement: This external support compensates for a weak UES, physically blocking the upward travel of gastric acid, pepsin, and bile.
• Nightly Protection: Because reflux events into the throat are most common and damaging during sleep, the mechanical reinforcement is optimized for nocturnal use.

Results From Multi-Center Clinical Trials

The clinical efficacy of UES pressure therapy has been validated through extensive multi-center studies involving leading ENT and gastroenterology specialists. These trials were designed to measure both symptom reduction and overall patient safety.

Quantitative Success Metrics:

1. 86% Success Rate: In clinical trials, 86% of patients achieved a successful outcome, showing a significant reduction in their Reflux Symptom Index (RSI).
2. Rapid Symptom Improvement: Mean RSI scores, which measure the severity of LPR symptoms, dropped from 25.6 to 14.6 after just two weeks of nightly therapy.
3. Symptom Resolution: Specific symptoms such as chronic cough, hoarseness, and the sensation of a "lump" in the throat (globus) showed marked improvement during the study period.

Physician And Patient Satisfaction:

• Physician Approval: 92% of prescribing physicians reported satisfaction with the device’s clinical performance and its ability to manage LPR symptoms without drugs.
• Patient Compliance: Approximately 75% of patients reported high satisfaction with the treatment, citing ease of use and the ability to sleep more comfortably.

A Non-Pharmacological Paradigm Shift

The clinical efficacy of increasing UES pressure offers a significant advantage over traditional chemical treatments like Proton Pump Inhibitors (PPIs).

• Beyond Acid Suppression: While PPIs neutralize stomach acid, they do not stop the physical reflux of non-acidic contents like pepsin, which remains highly irritating to the throat.
• Addressing The Physical Cause: By focusing on UES pressure, the Reza Band treats the physical failure of the sphincter rather than just altering stomach chemistry.
• Reducing Drug Dependence: This mechanical approach provides a validated option for "non-responders" to PPI therapy or those wishing to avoid long-term medication use.
• Safety Profile: Throughout the clinical evaluation process, there were no serious or unexpected adverse events reported, making it a safe long-term management strategy.

Implementation In Clinical Practice

To maintain high efficacy, the application of UES pressure must be managed within a professional medical framework.

• Prescription Only: The Reza Band is a regulated medical device that requires a prescription from a qualified healthcare provider.
• Professional Fitting: Physicians use a specialized sensor to determine the exact anatomy of the patient's neck and set the device dial to the optimal pressure.
• Ongoing Monitoring: Clinical success is best achieved when the device is used as part of a comprehensive treatment plan that includes regular follow-ups with an ENT or gastroenterologist.