The effect of adding duloxetine to lansoprazole on symptom and quality of life improvement in patients with gastroesophageal reflux diseases: A randomized double-blind clinical trial

BACKGROUND: Gastroesophageal reflux disease (GERD) is a common upper gastrointestinal disorder with a negative impact on the quality of life. This study was aimed to assess the effect of adding duloxetine to lansoprazole on the symptom and quality of life improvement in GERD patients. MATERIALS AND METHODS: Seventy adult patients with a complaint of heartburn and regurgitation were enrolled in this randomized trial. Patients with a history of atypical symptoms, advanced systemic disease, medication-induced symptom, structural lesion in endoscopy, allergy to the medication, and unco-operative were excluded. The patients randomly (computer generated table) assigned in Groups A who received lansoprazole 30 mg plus placebo daily and Group B, in which duloxetine 30 mg daily replaced by placebo during 4 weeks. All of participants, care-givers, and outcomes assessors were blinded. Basic demographic data, symptom severity score, depression and anxiety Beck score, and quality of life questionnaire were recorded at the starting and ending of treatment. RESULTS: Fifty-four patients have completed the study. The mean difference of Anxiety Beck score (13, 95% confidence interval [CI] [10–16], P = 0.001) and total raw score of quality of life (7, 95% CI [3.89–10.11], P = 0.043) were significantly improved in Group B. Complete and overall heartburn improvement rates were significantly better in Group B (odds ratio [OR] Adj: 2.01, 95% CI [1.06–2.97] and OR Adj: 1.31, 95% CI [1.05–1.57], respectively). CONCLUSION: We found that the combination of duloxetine and lansoprazole is a safe and tolerable regimen, and it can significantly improve anxiety, heartburn, coffee consumption, the quality of sleep, and life in patients who suffer from the symptoms of GERD.