Randomized, Comparative Study of Standard Dose of Rabeprazole versus Omeprazole in Gerd/Heartburn Symptom Relief

Abstract

Aim and objective: Gastro-esophageal reflux disease (GERD) is becoming increasingly common in Africa and indeed in Nigeria. Data on the efficacy of proton pump inhibitors in patients with GERD are scanty. In this study, we compared symptom relief rate after first dose treatment with Rabeprazole i.e. 20 mg versus omeprazole 20 mg in GERD/Heart burn patients. Materials and Methods: A total of 66 consenting consecutive patients attending the General Out- Patient Department (GOPD) Clinic of the Ekiti State University Teaching Hospital (EKSUTH), Ado-Ekiti, Nigeria presenting with symptoms of GERD/ heartburn were enrolled for the study. At enrolment, severity of symptom was graded on a five-point scale from none (0), mild (1), moderate (2), severe (3) and very severe (4). After enrolment, the patients were blindly randomized into two groups of 33 each which received either 20mg of Rabeprazole (Barole) stat; Rab- group or 20mg of Omeprazole stat; Ome- group. Symptom status was recorded in Case Report Form (CRF) at enrolment and 1hr 30 min after the treatment with stat dose of the proton pump inhibitor. Efficacy of proton pump inhibitor in symptom relief for GERD/heartburn was assessed by observing the degree of symptom relief after 1hr 30 minutes in each of treatment groups. Approval for the study was obtained from the Ethical and Research Committee of EKSUTH. Informed consent was equally obtained from each of the participants. Data obtained were analyzed using scale of comparison. Results: The mean age of the population studied was aged 33.98 ± 9.43 years (age range 18-50 years). 19 (28.8%) were males while 47 (71.2%) were females (M: F of 1:2.5). 25.8% of participants had regurgitation as a symptom in addition to heartburn while 40.9% had other GI symptoms. The mean symptom severity score at baseline were 2.33, 0.36 and 0.52 for heartburn, regurgitation and other symptoms respectively. Two of the Rabeprazole group who had ‘Very severe’ heartburn was after 1hr 30mins downgraded to 1(50%) ‘Mild’ and 1 (50%) ‘Moderate’ while only 1 participant with ‘very severe’ heartburn was downgraded to ‘severe’ heartburn, 1hr 30mins after Omeprazole.Ten in the Rabeprazole group who presented with ‘severe’ heartburn were downgraded 4(40%) to ‘moderate’ and 6 (60%) ‘Mild’ heartburn compare with Omeprazole group where 10 of the participants who had ‘severe’ heartburn were downgraded to 6(60%) and 4(40%) with ‘moderate’ and ‘mild’ heartburn respectively. One of the participants in Rabeprazole group who had ‘Severe’ regurgitation was downgraded to ‘Nil’ regurgitation, while none of the participants in Omeprazole group had ‘severe’ regurgitation. Two of the participants in Rabeprazole group had other symptoms of ‘moderate’ severity that were downgraded to ‘No symptoms’ compared with 5 participants in Omeprazole group with other symptoms with ‘moderate severity’ out of which 3(60%) and 2(40%) were downgraded to ‘mild’ and ‘No symptoms respectively’. Conclusion: Symptomatic relief is one of the primary goals in the management GERD. In this study Rabeprazole (Barole®) is more effective in downgrading the heartburn and other symptoms in GERD within 90 minutes of treatment compared to treatment with Omeprazole.