The aim of this study was to measure the efficacy of a positional therapy device (PTD) at reducing proton pump inhibitor (PPI) refractory nocturnal GERD symptoms. Among patients with GERD, nocturnal symptoms are very common. A recent study demonstrated a decrease in nocturnal acid exposure and reflux episodes in healthy volunteers who slept using a PTD. This is a single-center prospective trial involving patients on antisecretory medications with continued nocturnal heartburn and regurgitation. Patients completed the Nocturnal GERD Symptom Severity and Impact Questionnaire (N-GSSIQ) and GERD health-related quality of life questionnaire (GERD-HRQL) at enrollment. Patients were instructed to sleep on the PTD for at least 6 hours a night during the two week study period; subjects continued their baseline anti-secretory medication dose. After 2 weeks, the questionnaires were repeated. A total of 27 patients (16 females and 11 males; age 57.8 +/- 15.1) were recruited. After 2 weeks of PTD use, N-GSSIQ scores significantly improved from baseline, with a mean total score improvement of 39.5 (mean 57.7 [pre] vs. 18.2 [post], P < 0.001). Significant improvement from baseline was also observed for the GERD-HRQL questionnaire (29.8 vs. 16.7, P < 0.001). No adverse events were reported. At 3 months after the trial period, 91% of the subjects continued to use the PTD on a nightly basis. Use of the PTD significantly decreased nocturnal GERD symptoms and improved GERD-HRQL. The PTD was well tolerated during the study period and for 3 months after enrollment.
机构:
So Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Fass, Ronnie
Johnson, David A.
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机构:
Eastern Virginia Med Sch, Div Gastroenterol, Norfolk, VA 23501 USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Johnson, David A.
Orr, William C.
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机构:
Lynn Hlth Sci Inst, Oklahoma City, OK USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Orr, William C.
Han, Cong
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机构:
Takeda Global Res & Dev Ctr Inc, Dept Stat, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Han, Cong
Mody, Reema
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机构:
Takeda Pharmaceut Int Inc, Dept Global Hlth Econ & Outcomes Res, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Mody, Reema
Stern, Kathleen N.
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h-index: 0
机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Stern, Kathleen N.
Pilmer, Betsy L.
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机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Pilmer, Betsy L.
Perez, M. Claudia
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机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
机构:
Stanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USAStanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USA
Gerson, Lauren B.
Fass, Ronnie
论文数: 0引用数: 0
h-index: 0
机构:
Univ Arizona, Sch Med, Div Gastroenterol, Tucson, AZ USA
So Arizona VA Hlth Care Syst, Tucson, AZ USAStanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USA
机构:
So Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Fass, Ronnie
Johnson, David A.
论文数: 0引用数: 0
h-index: 0
机构:
Eastern Virginia Med Sch, Div Gastroenterol, Norfolk, VA 23501 USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Johnson, David A.
Orr, William C.
论文数: 0引用数: 0
h-index: 0
机构:
Lynn Hlth Sci Inst, Oklahoma City, OK USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Orr, William C.
Han, Cong
论文数: 0引用数: 0
h-index: 0
机构:
Takeda Global Res & Dev Ctr Inc, Dept Stat, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Han, Cong
Mody, Reema
论文数: 0引用数: 0
h-index: 0
机构:
Takeda Pharmaceut Int Inc, Dept Global Hlth Econ & Outcomes Res, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Mody, Reema
Stern, Kathleen N.
论文数: 0引用数: 0
h-index: 0
机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Stern, Kathleen N.
Pilmer, Betsy L.
论文数: 0引用数: 0
h-index: 0
机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
Pilmer, Betsy L.
Perez, M. Claudia
论文数: 0引用数: 0
h-index: 0
机构:
Takeda Global Res & Dev Ctr Inc, Dept Clin Sci, Deerfield, IL USASo Arizona VA Hlth Care Syst, Sect Gastroenterol 111G 1, Tucson, AZ 85723 USA
机构:
Stanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USAStanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USA
Gerson, Lauren B.
Fass, Ronnie
论文数: 0引用数: 0
h-index: 0
机构:
Univ Arizona, Sch Med, Div Gastroenterol, Tucson, AZ USA
So Arizona VA Hlth Care Syst, Tucson, AZ USAStanford Univ, Sch Med, Div Gastroenterol & Hepatol, Stanford, CA 94305 USA