COMPARISON OF THE EFFICACY OF TWO TREATMENTS IN THE MANAGEMENT OF GASTRO-OESOPHAGEAL REFLUX DISEASE IN TWO TERTIARY INSTITUTIONS IN JOS
Abstract
Background: Lifestyle modification strategies are considered to be of some potential benefit to gastro-oesophageal reflux disease (GORD) patients and are commonly recommended as adjuncts to therapy. The symptomatic beneficial effect of specific recommended changes, the structured - lifestyle modification modalities of avoidance of recumbence for three hours postprandial, adoption of left lateral sleeping position and avoidance of spicy meals by means of patient - reported outcome measures like gastro-oesophageal reflux disease questionnaire (GerdQ) and quality of life in reflux and dyspepsia (QOLRAD) tools needs evaluation.
Objective: The objective was to compare a combination of proton pump inhibitor and structured - lifestyle modification with proton pump inhibitor alone in the treatment of gastrooesophageal reflux disease in the General Out-Patient Clinics of two tertiary health institutions in Jos (Jos University Teaching Hospital and Plateau State Specialist Hospital).
Design: A randomized controlled single-blinded trial that involved 210 patients aged 18 to 50 years with heartburn and/or regurgitation and a GerdQ score of 8 or more who were assigned to the intervention and control groups. The GerdQ tool was also used to monitor treatment. Participants in both groups received a pill, omeprazole 20mg once daily. The intervention group patients in addition, received the structured-lifestyle modification adherence counseling at baseline, 2nd, 4th and 8th week using a structured format for the counseling and adherence check. The QOLRAD tool was used for quality of life assessment.
Results: There was no significant difference in the mean GerdQ and overall mean QOLRAD scores between the control and the intervention groups at the end of eight weeks: 5.95 ± 0.80 versus 5.80 ± 0.81 (p = 0.20) and 34.28 ± 1.17 versus 34.44 ± 0.92 (p = 0.28) respectively. The number of intervention group patients fully and consistently adherent to the structured – lifestyle modification modalities significantly increased at 8th week from baseline: 2 (1.90%) to 24 (23.76%) for all 3 modalities and 15 (14.29%) to 57 (56.44%) for 2 or 3 modalities (p < 0.001). The difference in proportion of participants with missed pills between the control and intervention groups at 8th week was not significant; 47.47% versus 40.59% (p = 0.33). The missed pill days between the two study groups at 8th week was not significant (p = 0.44).
Conclusions: The structured – lifestyle modification modalities of avoidance of spicy meals, avoidance of recumbence for 3 hours postprandial and adoption of left lateral sleeping position as adjuncts to PPI therapy showed no benefit over PPI alone using the GerdQ and QOLRAD tools.