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Table 1 Demographics and clinical characteristics of the study patients at screening

From: Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

Characteristics TF group (n = 39) PPI group (n = 21) p values
Male, n (%) 19 (49) 8 (38) 0.587
Age, years 54.5 (10.4) 50.4 (9.8) 0.151
Body mass index, kg/m2 28.3 (3.9) 29.1 (2.8) 0.422
GERD symptom duration, years 12.5 (11.3) 9.4 (5.7) 0.224
PPI therapy duration, years 9.3 (7.2) 8.1 (5.1) 0.686
Quality of life scores off PPIs    
 Reflux Disease Questionnaire (RDQ) score 3.7 (1.1) 4.1 (0.7) 0.122
 Regurgitation (RDQ) score off PPIs 3.5 (1.2) 4.1 (0.9) 0.067
 GERD-HRQL score 32.5 (9.6) 33.7 (8.5) 0.625
 Heartburn score (GERD-HRQL) 22.2 (6.3) 23.2 (4.4) 0.519
 Reflux Symptom Index (RSI) score 25.2 (9.3) 28.6 (7.4) 0.150
Total % time pH <4 10.2 (3.5) 10.6 (3.5) 0.665
Patients on single dose of PPI at entry, n (%) 27 (69) 16 (76) 0.765
  1. GERD, gastroesophageal reflux disease; GERD-HRQL, gastroesophageal reflux disease health related quality of life; PPI, proton pump inhibitor; TF, transoral fundoplication.