Wedge Pillow Versus Evening Proton Pump Inhibitor for Nocturnal Reflux Symptoms: A Noninferiority Randomized Trial

Background Certain patients still experience nocturnal reflux symptoms despite taking a standard morning PPI. This study compares the efficacy of adding a wedge pillow versus an evening PPI to the morning PPI for treating nocturnal reflux symptoms. Methods This noninferiority randomized trial included patients with ≥ 2/week nocturnal heartburn/regurgitation despite morning PPI use for ≥ 4 weeks. Participants were randomized to either a wedge pillow with morning or twice‐daily PPI for 4 weeks. Nocturnal reflux symptoms were assessed using the nocturnal gastroesophageal reflux disease symptom severity and impact questionnaire (NGSSIQ) at Weeks 0, 2, and 4, along with quality of life, daytime sleepiness, and sleep quality. Twenty‐four hour pH‐impedance monitoring was conducted at baseline and Week 4. Wedge pillow compliance was monitored with a pressure‐sensing timekeeper. Results Twenty‐four patients were enrolled with comparable baseline characteristics and severity of nocturnal reflux. At Week 4, NGSSIQ scores were 30.01 ± 1.97 in the wedge pillow group and 36.33 ± 1.96 in the twice‐daily PPI group (mean difference − 6.32; 95% CI −10.28 to 6.21), which falls below the predefined non‐inferiority margin demonstrating non‐inferiority. Sleep quality was better in the pillow group (5.55 ± 0.56 vs. 7.53 ± 0.60, p = 0.001). Although nighttime median bolus contact time was longer in the twice‐daily PPI group [4.3 (2.9–5.4) vs. 7.4 (3.5–15.5) seconds, p = 0.03], other reflux parameters did not show clinically relevant differences between groups. Pillow compliance was high, with 83.3% reporting satisfaction. Conclusion Adding a wedge pillow was not inferior to evening PPI for nocturnal reflux symptoms and was associated with greater improvements in sleep quality, despite the absence of clinically relevant differences in reflux parameters, supporting the wedge pillow as a potential alternative for managing nocturnal reflux symptoms. Trial Registration Thaiclinicaltrials.org: TCTR20240920004