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Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD : a randomized , placebo-controlled trial . OBJECTIVES Sleep disturbances are common in patients with gastroesophageal reflux disease ( GERD ) . This study examined the effects of esomeprazole on nighttime heartburn , GERD-related sleep disturbances , sleep quality , work productivity , and regular activities . METHODS This multicenter , randomized , double-blind , placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn ( recorded by patient diary during screening ) . Patients received oral esomeprazole 40 mg ( n = 220 ) or 20 mg ( n = 226 ) or placebo ( n = 229 ) once daily for 4 wk . The primary outcome was relief of nighttime heartburn . Secondary outcomes included resolution of sleep disturbances , sleep quality measured by the Pittsburgh Sleep Quality Index ( PSQI ) questionnaire , and work productivity measured by the Work Productivity and Activity Impairment Questionnaire . RESULTS Nighttime heartburn was relieved in 53.1 % ( 111/209 ) , 50.5 % ( 111/220 ) , and 12.7 % ( 28/221 ) of patients who received esomeprazole 40 mg , esomeprazole 20 mg , and placebo , respectively . Differences ( 95 % CI ) versus placebo were 40.5 % ( 32.4 % , 48.5 % ) and 37.8 % ( 29.9 % , 45.7 % ) and were highly significant ( p < 0.0001 ) . GERD-related sleep disturbances resolved in significantly more ( p < 0.0001 ) patients who received esomeprazole 40 ( 73.7 % ) or 20 mg ( 73.2 % ) than in those who received placebo ( 41.2 % ) . Both esomeprazole groups had greater PSQI global score changes from baseline ( p < 0.0001 vs placebo ) and more ( p < 0.0001 vs placebo ) work hours saved per week per patient compared with baseline ( esomeprazole 40 mg , 11.6 h ; esomeprazole 20 mg , 12.3 h ; placebo , 6.2 h ) . CONCLUSIONS Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity .
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Intervention_Pharmacological
esomeprazole
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
oral esomeprazole
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Intervention_Control
placebo
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Outcome_Physical
nighttime heartburn
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Outcome_Physical
GERD-related sleep disturbances
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Outcome_Physical
sleep quality
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Outcome_Physical
work productivity
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Outcome_Mental
regular activities
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Outcome_Physical
GERD-associated sleep disturbances
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Outcome_Physical
moderate-to-severe nighttime heartburn
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Outcome_Physical
nighttime heartburn
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Outcome_Other
resolution of
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Outcome_Physical
sleep disturbances
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Outcome_Physical
sleep quality
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Outcome_Other
the
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Outcome_Physical
Pittsburgh Sleep Quality Index ( PSQI ) questionnaire
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Outcome_Physical
work productivity
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Outcome_Other
the
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Outcome_Mental
Work Productivity and Activity Impairment Questionnaire
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Outcome_Physical
Nighttime heartburn
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Outcome_Physical
GERD-related sleep disturbances
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Outcome_Physical
PSQI global score
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Participant_Condition
patients with GERD
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Participant_Condition
gastroesophageal reflux disease
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Participant_Age
adults
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Participant_Condition
GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn