Utilizing the GERD Impact Scale to Evaluate Treatment Effectiveness

Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders in the United States and affects approximately 18.6 million Americans, according to a national healthcare database analysis.

Patients often present with heartburn and acid regurgitation. Symptoms typically seen in patients with GERD have been divided into 2 types: (1) esophageal syndrome and (2) extraesophageal syndrome. Further, GERD has been classified into erosive esophagitis (EE) and non-erosive reflux disease (NERD).

Patients with GERD experience a decrease in quality of life (QOL) due to difficulties in physical, social, and emotional well-being. In order to quantitatively assess symptoms of GERD, patient-reported outcome instruments have been developed. These instruments include the Reflux Disease Questionnaire, GERD-HRQL (Health Related Quality of Life) questionnaire, Gastrointestinal Symptom Rating Scale, and GERD Impact Scale (GIS).

According to researchers, the GIS, designed as a communication tool between patients and clinicians, can provide insight into patients’ QOL in addition to GERD symptoms. “Pearson’s correlation coefficient could measure the relation between the GERD symptoms and the impact of the symptoms,” the researchers noted.

The researchers recently conducted an analysis to assess GERD symptoms, patients’ QOL, and the correlation of symptoms and QOL using the GIS questionnaire in patients with GERD symptoms categorized into EE, NERD, or functional heartburn (FH). The study also examined the responses of GERD symptoms and QOL to treatment with proton pump inhibitors (PPIs). They reported study results in the Journal of Neurogastroenterology and Motility [2013; 19(1):61-69].

A total of 207 patients with symptoms of GERD were enrolled in the prospective study; all patients were given the GIS questionnaire and underwent endoscopy between July 2008 and June 2011. After application of inclusion and exclusion criteria, the final study cohort included 126 patients who underwent upper endoscopy, Bernstein test, and 24-hour esophageal pH testing.

Physicians administered the GIS questionnaire to patients prior to diagnostic evaluation. The GIS is comprised of 9 items, 5 of which relate to GERD symptoms (chest pain, heartburn, acid regurgitation, epigastric pain, and hoarseness). The remaining 4 questions are related to QOL.

The QOL questions are: (1) How often have you had difficulty in getting a good sleep, because of heartburn or acid reflux?; (2) How often have your symptoms prevented you from eating or drinking any of the foods you like?; (3) How frequently have your symptoms kept you from being fully productive in your job or daily activities?; and (4) How often do you take additional unprescribed medication other than what the physician told you to take?

The patients in the study were treated with a standard dose of PPIs (esomeprazole, rabeprazole, pantoprazole, or lansoprazole) for 8 weeks. Following completion of the 8-week treatment period, the same physician repeated the GIS questionnaire.

Of the final study cohort, 62 patients were diagnosed with EE, 34 with NERD, and 30 with FH. There was no significant difference in age among the 3 groups; however, there was a significant difference in sex (the proportion of men was significantly higher in EE patients than in the other 2 groups; P<.001). Consumption of alcohol and history of smoking were also more frequent in the EE group compared with the other 2 groups (P<.001), and patients in the EE group were more likely to have hiatal hernia compared with patients in the NERD and FH groups (19.4% vs 8.8% and 0%, respectively; P=.02). Finally, patients in the EE group were more likely to have a body mass index of ≥25 kg/m² compared with patients in the NERD and FH groups (42.6% vs 34.6% and 14.8%, respectively; P=.01).

The 9 questions on the GIS questionnaire were analyzed by the proportion of frequency >once a week (GIS score of ≤3). Frequency of chest pain was higher in the FH group compared with the EE group and the NERD group (36.7% vs 21.0% and 17.6%, respectively; P=.02). There were no significant differences among the 3 groups in the remaining 4 GERD symptoms.

The proportion of patients in the FH group reporting eating problems and limitation of productive daily activities was higher than those in the EE and NERD groups: 20% and 30%, respectively, in the FH group versus 3.2% and 9.7% in the EE group and 11.8% and 20.6% in the NERD group (P<.05 for both comparisons).

When the researchers evaluated the correlations between the GERD symptoms and the impact of the symptoms on patients’ QOL using Pearson’s correlation coefficient analysis, the results demonstrated that the sum of the scores on the GERD symptoms was significantly correlated with 4 questions on the QOL questionnaire at baseline in the EE and FH groups, but not the NERD group.

Finally, the responsiveness to PPIs was estimated by subtraction of the scores on each question between the diagnostic evaluation and following the 8-week treatment period, using a 5-point Likert scale. The scale ranged from 1 (all of the time) to 5 (none); low scores indicated a severe impairment of daily functioning.

In the EE group, there was improvement in all of the GERD symptoms following the 8-week treatment period (P<.05 for all); in the NERD group, there was improvement in acid regurgitation, epigastric pain, and hoarseness (P<.05 for all). In the FH group, there was no improvement in any of the GERD symptoms.

In the EE group, treatment with PPIs improved sleep disturbance (P=.03) and improved limitation of productive activity in the NERD group (P=.001). There was no change in the FH group.

In conclusion, the researchers said, “The GIS questionnaire showed that different characteristics and symptoms improved after PPI therapy among patients with EE, NERD, and FH, which demonstrated the usefulness of the GIS questionnaire.”