Although the treatment of GERD has three main goals – symptom control, the healing of reflux esophagitis and the prevention of complications – symptom control may be the most important from the patient’s perspective. Long-term management is often required to sustain symptom control, which may be continuous maintenance treatment (daily dosing of acid suppressive therapy) or on-demand therapy (with medication taken only on the days that symptoms occur, until the symptoms subside). There is convincing evidence in the literature that PPIs are superior to H2
RAs for symptom control and healing of reflux esophagitis (32
). PPIs are also effective when given daily or on-demand in patients with GERD without reflux esophagitis and in those with uninvestigated GERD (33
Patient satisfaction with treatment is a valuable outcome because it is a major determinant of the patient’s willingness to continue taking the required medication. It is influenced by many factors, including treatment regimen, general well-being of the patient, the bedside manner of the physician, and the quality of communication between the patient and their physician (34
). The present review has identified an association between overall symptom relief and patient satisfaction, and between patient satisfaction and improvement in HRQoL. Similar associations between treatment satisfaction, treatment efficacy and HRQoL have been observed in other chronic diseases such as diabetes mellitus (35
) and osteoarthritis (36
The correlation between HRQoL and satisfaction is a notable finding of the present review because patient satisfaction can be determined by posing a single question, unlike multidimensional instruments designed to understand treatment effects on HRQoL. Although HRQoL instruments are valuable secondary outcome measures in clinical trials, they are time consuming to administer and, hence, not practical in everyday practice. Instead of using an HRQoL questionnaire, perhaps a single question about satisfaction could be used in addition to questions about the control of specific symptoms.
The present systematic review demonstrates that the highest levels of patient satisfaction with GERD treatment are observed for PPIs compared with other GERD medications. Both of the RCTs that compared PPIs with H2
) showed superior levels of satisfaction with PPIs. No RCTs compared PPIs with prokinetic agents, although the survey data showed that satisfaction levels for PPIs were higher than both H2
RAs and prokinetics. This is in agreement with trial efficacy data comparing PPIs, H2
RAs and prokinetics reviewed by others (37
). Thus, this suggests that higher patient satisfaction correlates with the greater acid control provided by PPIs than by other medications.
The data support the concept that when patients achieve complete or near complete control of their GERD symptoms, their satisfaction with treatment is high. Although PPIs were shown to decrease the frequency and severity of heartburn, only one trial specifically investigated whether there was a correlation between patient satisfaction after treatment and the severity of heartburn at baseline (19
). This study did indeed find that these two factors were correlated. In addition, one survey documented a negative correlation between satisfaction and the frequency of heartburn and/or regurgitation at baseline (29
). However, some patients experienced residual symptoms while on treatment. Moreover, data from several RCTs suggest that symptom control and patient satisfaction are lower with on-demand therapy than with continuous maintenance therapy, suggesting that satisfaction with PPI therapy is reduced in the presence of residual symptoms. This would be a justification for adjusting patient medication, for example, by increasing the dose of PPIs (39
). Partial response to PPIs may also indicate that factors other than acid reflux are contributing to symptoms. These include functional dyspepsia (41
), weakly alkaline or weakly acidic reflux (42
), esophageal hypersensitivity or a combination of these factors (45
Although surveys can be less reliable sources of data than RCTs, they provide insight into the patient’s perspective of treatment in real-life clinical practice. In surveys, the proportion of patients ‘satisfied’ with PPIs tended to be lower than that reported in trials. This difference suggests that patients with a partial response to PPI treatment are more common in unselected populations than in clinical trials. Adherence may also play a role because trials strongly encourage adherence through intensive follow-up – unlike real-life practice. Adherence has been shown to be related to satisfaction in the management of diabetes mellitus, in which lower adherence (eg, difficulty attending follow-up or taking medications [P<0.001]) was associated with lower treatment satisfaction (46
The relationship between patient satisfaction and the clinical end point of symptom resolution was also analyzed. A correlation between satisfaction and symptom control and resolution was documented, although the proportion of satisfied patients was approximately 10% higher than either end point. A recent workshop on the study design of GERD trials (7
) recommended that the absence or near complete relief of previously troublesome symptoms be used to measure treatment efficacy. The data support that patient satisfaction is also of use in assessing the effectiveness of treatment. One interpretation may be that patients can be satisfied despite the persistence of some symptoms, although this was not analyzed in any detail. Interestingly, the same workshop (7
) recommended that a validated measure of patient satisfaction should be considered as a primary outcome measure in on-demand studies.
Although high levels of satisfaction with PPIs were reported in many trials, in some cases, a substantial proportion of patients were ‘not very satisfied’ with their treatment. In real-life clinical practice, as illustrated by the surveys reviewed in the present article, more than one-half of patients were less than completely satisfied with their prescription treatment, and up to one-half of patients who were prescribed PPIs used concomitant OTC remedies to control break through symptoms. This suggests that there is still an unmet need for effective treatment in some patients, which requires further study.
A detailed exploration of the relationship between heartburn scores and patient satisfaction among the studies was limited because no trials specifically stratified patient satisfaction according to this variable. Similarly, symptom relief from PPIs has been demonstrated to be highly predictive of reflux esophagitis healing (47
); however, correlations between healing and satisfaction could not be performed in the present review because the proportions of patients satisfied after treatment were not described separately for different grades of esophagitis at baseline.
Most of the included studies did not use validated treatment satisfaction questionnaires, although the face validity of many of the instruments used was high. Validated questionnaires to measure patient satisfaction with GERD treatment are now available (30
), and use of these in future studies of GERD treatment would enable comparison among studies and further pooling of data for meta-analysis.
The present review had several limitations. The studies used inconsistent thresholds for the severity of GERD symptoms at baseline, although most studies used a baseline severity of at least two to four episodes of heartburn per week. There was also variation among studies in the methods used to measure patient satisfaction. Hence, these differences among studies are described in the review and the data were interpreted with this caveat in mind. In addition, the methods used to measure satisfaction in the studies are likely to result in substantial acquiescent response bias (tendency of individuals to agree with questions), particularly in older respondents, those with less education and those in poorer health (48
). The use of attitude response scales (such as ‘very satisfied’ to ‘very dissatisfied’) skews individual responses to satisfaction questions and inflates reliability estimates (48
). Patients could also interpret the word ‘satisfaction’ variably, reducing the comparability of the results. A study by Vakil et al (49
) indicated that symptom questionnaires using continuous rather than binary variables were easier for patients to understand. It was suggested that terms should be more descriptive, for example, ‘satisfactory relief’ could be replaced with ‘at least partial relief’. Hence, as used in three of the studies (8
), a ‘positive response’ to assess levels of satisfaction may have been less clear to the patients than the use of rating scales. Future studies that use multi-item scales that include balanced positively and negatively worded items may increase score variability and reliability in satisfaction research because they are subject to less acquiescent response bias than studies using attitude response scales (48
The FDA has recently finalized guidance for the development of instruments measuring patient-reported outcomes for use in clinical trials to support label claims (6
). The guidelines emphasize the importance of patient input and incorporating patient feedback in the development of questionnaires and reflect the increasing prominence of assessing the patient experience with treatment. Furthermore, compared with patients, physicians tend to overestimate the benefit of PPI treatment in GERD (50
). Thus, assessing patient satisfaction with treatment should enable a more comprehensive understanding of disease and treatment response than the traditional reliance on objective disease markers, particularly in patients with GERD without reflux esophagitis because the response to treatment is the main outcome measure.
Insight into patient satisfaction may be particularly valuable when the primary outcomes of clinical trials are similar for two treatments. The present systematic review has shown that patient satisfaction correlates with symptom resolution, a primary outcome of clinical trials, and with HRQoL, a secondary measurement of therapeutic success. It would be of great interest for future studies to report how patient satisfaction relates to other clinical end points, such as patient satisfaction individually reported according to the healing of reflux esophagitis, prevention of relapse and adverse effects, in additon to more studies examining satisfaction and changes in individual symptoms such as heartburn frequency and severity.
The patient’s evaluation of their treatment is becoming increasingly important to medical care, particularly for the management of chronic disease. Future research, with a focus on uniformity in the measurement of satisfaction, and further investigation into the relationship between satisfaction and other clinical end points, could contribute to improved patient care and long-term treatment success.