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The Impact of Nocturnal Symptoms Associated With Gastroesophageal Reflux Disease on Health-Related Quality of Life
Christina Farup, MD;
Leah Kleinman, DrPH;
Sheldon Sloan, MD;
Dara Ganoczy, MPH;
Elsbeth Chee, ScD;
Clara Lee, MPH;
Dennis Revicki, PhD
Arch Intern Med. 2001;161:45-52.
ABSTRACT
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Background Two types of reflux episodes have been identified: upright or daytime
and supine or nocturnal. The population-based prevalence of symptoms of nocturnal
gastroesophageal reflux disease (GERD) and the impact of those symptoms on
health-related quality of life (HRQL) have not been established.
Methods A national random-sample telephone survey was conducted to estimate
the prevalence of frequent GERD and nocturnal GERD-like symptoms and to assess
the relationship between HRQL, GERD, and nocturnal GERD symptoms. Respondents
were classified as controls, subjects with symptomatic nonnocturnal GERD,
and subjects with symptomatic nocturnal GERD. The HRQL was assessed using
the Medical Outcomes Study Short-Form 36 Health Survey (SF-36).
Results The prevalence of frequent GERD was 14%, with an overall prevalence
of nocturnal GERD of 10%. Seventy-four percent of those with frequent GERD
symptoms reported nocturnal GERD symptoms. Subjects with nonnocturnal GERD
had significant decrements on the SF-36 physical and mental component summary
scores compared with the US general population. Subjects reporting nocturnal
GERD symptoms were significantly more impaired than subjects reporting nonnocturnal
GERD symptoms on both the physical component summary (38.94 vs 41.52; P<.001) and mental component summary (46.78 vs 49.51; P<.001)
and all 8 subscales of the SF-36 (P<.001). Subjects with nocturnal
GERD demonstrated considerable impairment compared with the US general population
and chronic disease populations. Subjects with nocturnal GERD had significantly
more pain than those with hypertension and diabetes (P<.001)
and similar pain compared with those with angina and congestive heart failure.
Conclusions Nocturnal symptoms are commonly experienced by individuals who report
frequent GERD symptoms. In addition, HRQL is significantly impaired in those
persons who report frequent GERD symptoms, and HRQL impairment is exacerbated
in those who report nocturnal GERD symptoms.
INTRODUCTION
GASTROESOPHAGEAL reflux disease (GERD) is a chronic gastrointestinal
condition characterized by heartburn and regurgitation caused by the reflux
of acidic gastric contents into the esophagus. At least 15% of adults in the
United States report having heartburn once a week or more. Between 35% and
70% of those with heartburn seeking medical care demonstrate evidence of esophagitis
based on endoscopy.1, 2 Individuals
with heartburn or regurgitation often present with additional symptoms associated
with GERD, such as noncardiac chest pain, dysphagia, dyspepsia, and globus
sensation.3 Approximately 78% of patients with
chronic hoarseness and more than 80% of patients with asthma have symptoms
that may be associated with GERD.4
GERD is a motility disorder primarily due to the transient relaxations
of the lower esophageal sphincter. The severity of disease, however, is attributable
to the degree and duration of acid exposure in the esophagus. The development
of 24-hour ambulatory esophageal pH monitoring has enabled researchers to
document the frequency and duration of reflux episodes in patients with GERD.
Using this technology, researchers have identified 2 types of reflux episodes,
upright or daytime GERD and supine or nocturnal GERD.5
Nocturnal reflux episodes occur less frequently, but acid clearance is more
prolonged.6 Patients with GERD and esophagitis
have even more frequent nocturnal episodes than those without esophagitis.7 Data suggest that nocturnal reflux is associated with
the complications of GERD, such as esophageal erosions, ulceration, and respiratory
symptoms.6, 8 In addition, symptoms
of reflux at night have been associated with an increased risk of esophageal
adenocarcinoma (odds ratio, 10.8; 95% confidence interval, 7.0-16.7).9
The presence of GERD has a direct impact on a patient's health-related
quality of life (HRQL). Several recent studies4, 10, 11, 12, 13
have demonstrated the impact of GERD on HRQL in clinical populations. Patients
with GERD had significantly lower scores on all subscales of the Medical Outcomes
Study (MOS) Short-Form 36 Health Survey (SF-36) when compared with the US
general population.4 Effects were most apparent
in the areas of pain, mental health, and social function. A recent population-based
study has provided evidence that the presence of heartburn and other upper
gastrointestinal tract symptoms is associated with decrements in HRQL.14 Subjects reporting severe and/or frequent upper gastrointestinal
tract symptoms demonstrated a poorer HRQL as measured by the Psychological
General Well-Being Scale compared with subjects with no symptoms.15
Studies to date have not adequately documented the prevalence of nocturnal
symptoms associated with frequent GERD symptoms or their impact on HRQL. One
aspect of HRQL that may be impaired because of nocturnal GERD symptoms is
the domain of sleep adequacy. An examination of available disease-specific
HRQL instruments reveals that there is a clear trend toward including sleep
as a separate dimension.16 For example, the
Heartburn-Specific Quality of Life questionnaire includes separate domains
for both sleep and vitality,16 as does the
Quality of Life in Reflux and Dyspepsia.17
Sleep items for the Quality of Life in Reflux and Dyspepsia include difficulty
getting a good night's sleep, tired or worn out because of a lack of sleep,
waking up at night and having difficulty falling asleep, not feeling fresh
and rested, and having trouble getting to sleep. In addition to sleep impairment,
if nocturnal reflux episodes lead to more severe GERD and associated complications,
patients with nocturnal GERD may have greater decrements in other domains
of HRQL compared with patients with GERD without nocturnal reflux episodes.
This study had 2 key objectives: (1) to document the prevalence of nocturnal
symptoms associated with frequent GERD symptoms in a population-based sample
and (2) to examine the relationship between the presence of nocturnal GERD
symptoms and HRQL.
SUBJECTS AND METHODS
A national population-based telephone interview survey was conducted
in fall 1998. The sample included households and members selected randomly
and by convenience (ie, households were contacted at random, but first interviews
were based on availability). Random-digit dialing was used to select the sample.
At the end of the initial interview, respondents were asked to list the age
and sex of all adult permanent household members. Household members were assigned
sequential numbers that were then matched to a random number assignment to
determine a random respondent. If the original respondent did not match the
random respondent, the randomly selected member of the household was then
interviewed. If he or she was not available, the household was telephoned
again. Among households with 2 completed interviews, only the randomly selected
respondent's interview was retained for analysis. To minimize selection bias,
two thirds of the calling time was assigned to evening and weekend hours when
more people are expected to be home and available for interview. The overall
participation rate was 70%.
The objectives of the survey were to estimate the prevalence of frequent
GERD symptoms in a nationally projectable sample, estimate the prevalence
(type, frequency, and duration of episodes) of nocturnal GERD symptoms in
the US general population and to assess the relationship between HRQL and
nocturnal GERD symptoms. Basic demographic information, screening questions
for presence of symptomatic GERD in the past 3 months, frequency and severity
of symptoms, nocturnal symptoms, physician-diagnosed conditions, and HRQL
data were collected.
SUBJECTS
Eligible adults had to be older than 18 years, a permanent member of
the household being called, able to converse in English, and mentally competent.
Not all study participants were asked all interview questions. Participants
who screened negative for presence of GERD symptoms (heartburn and acid regurgitation)
were not asked further questions unless they were part of a random selection
of control participants. Controls were asked about physician-diagnosed conditions
and HRQL. Participants who screened positive for GERD were asked further questions
about symptom frequency and impact on everyday life.
GERD CLASSIFICATION
GERD is defined as "any symptomatic condition or histopathologic alteration
resulting from episodes of gastroesophageal reflux."18
Participants were classified as having symptomatic GERD based on the presence
and frequency of heartburn and acid regurgitation. These symptoms are considered
to be specific for GERD and are generally accepted for use in population research.19, 20, 21 The symptomatic group
was further subclassified into nocturnal and no nocturnal GERD.
Symptomatic GERD
Respondents were asked if they had any of the 4 symptoms in the last
3 months: heartburn or burning sensation in the chest; burning sensation or
burning pain in the throat; fluid or food come back into the throat or mouth;
and an acid, bitter, or sour taste in the mouth. These items were derived
from the GERD Symptom Assessment Scale, a previously validated symptom questionnaire
for GERD.22 Participants symptomatic for GERD
were those who responded positively to 1 of the 4 symptom questions and who reported experiencing any one of the GERD symptom(s)
at least once a week (n = 1284). Presence of symptoms once a week or more
has been used in prior population surveys to define those with frequent GERD.3 This group was asked about severity and frequency
of symptoms, questions for nocturnal GERD, and HRQL.
Nocturnal GERD
Respondents were asked if they had any of these symptoms in the last
3 months: awakened at night by GERD symptoms, awakened at night by coughing
or choking because of fluid, an acid or bitter taste or food in the throat,
having GERD symptoms when lying down to sleep at night, and waking up in the
morning with GERD symptoms. Symptoms were chosen through expert clinical consensus,
since there is no standardized clinical definition of the symptoms of nocturnal
GERD. The nocturnal GERD group (n = 945), a subgroup of the symptomatic GERD
group, was defined as those people who met the case definition for symptomatic
GERD and who responded positively to 1 of the nocturnal
GERD symptoms questions. This group was asked additional questions regarding
the number of nights and times nocturnal GERD symptoms occurred. Respondents
classified in the nocturnal GERD group also answered questions regarding the
impact of nocturnal GERD on their lives.
Controls
Randomly selected subjects (n = 268) who did not meet the screening
criteria for GERD were also asked about physician-diagnosed conditions and
HRQL. These subjects served as a control group for comparison with the subjects
symptomatic for GERD and nocturnal GERD.
HEALTH-RELATED QUALITY OF LIFE
Participants completed the SF-36, a 36-item instrument designed to measure
generic health status. The SF-36 has 8 subscales: physical function, role
limitations–physical, vitality, general health perceptions, pain, social
function, role limitations–emotional, and mental health.23
Two overall summary scores (physical and mental component summary scores)
can also be obtained.19 The reliability and
validity of the SF-36 subscale and summary scores have been demonstrated in
the general population and several chronic disease groups (eg, hypertension,
type 2 diabetes mellitus, congestive heart failure, clinical depression, and
angina).23, 24 Subscale and summary
scores range from 0 to 100, where higher scores reflect a better quality of
life. Normative general population data are available for the SF-36 and were
used in the analyses.
NUMBER OF GERD SYMPTOMS REPORTED
Two symptom scores were constructed based on the number of GERD-related
symptoms reported. The GERD symptom score consisted of the total number of
the 4 GERD-related symptoms per respondent. The nocturnal GERD symptom score
consisted of the total number of the 4 nocturnal GERD-related symptoms per
respondent. These 2 scores range from 0 to 4, with higher scores indicating
a greater number of GERD-related symptoms.
Three other measures of the impact of nocturnal GERD symptoms on everyday
life were included in the survey. Respondents were requested to rate their
level of discomfort with overall nocturnal GERD symptoms on a 0 to 10 scale,
with higher scores indicating greater discomfort. Frustration with sleep loss
was rated on a 7-point scale, with lower scores reflecting greater frustration.
Worry and concern about nocturnal GERD symptoms were evaluated using 2 items,
both rated on 7-point scales, with lower scores reflecting more worry and
concern. These 2 items were totaled and divided by 2, resulting in a score
ranging from 1 to 7.
DATA ANALYSIS
We compared HRQL (as measured by the SF-36 subscale and component summary
scores) of our sample of persons with frequent GERD-like symptoms with the
primary care and chronic disease population sample from the MOS23, 25
using t tests. We also compared mean physical component
summary and mental component summary scores for the GERD sample and US general
population24, 25 stratified by
age in 10-year age groups (18-24 years, 25-34 years, up to 65-74 years) and
sex. Pearson product moment correlations were used to examine the relationship
between selected GERD symptom indicators and the HRQL scores. Analysis of
variance, adjusting for sex, age, and comorbidity, was used to examine the
relationship between GERD symptom severity and mean HRQL scores. Statistically
significant overall mean differences were followed by t tests between pairs of symptom severity groups, with adjustments for
multiple comparisons. Given the large number of statistical tests, statistical
significance and interpretation of findings were based on P<.001.
RESULTS
Overall, 66% of respondents were female, 40% of the respondents were
younger than 40 years, 35% were between the ages of 40 and 59 years, and 24%
of the respondents were older than 60 years (2% refused to provide their age).
Approximately 82% of the respondents were white. The study sample, compared
with the US general population, consisted of more females and more elderly
(Statistical Abstract of the United States, 1997).
The crude prevalence of symptomatic and nocturnal frequent GERD stratified
by sex, age, and race is presented in Table
1. A higher percentage of women experience GERD symptoms. Approximately
15% of women and 13% of men surveyed had symptomatic GERD symptoms. The prevalence
of nocturnal GERD was somewhat lower, with 11% of women and 9% of men affected.
Of the 1284 persons with symptomatic GERD, 945 (74%) had symptoms of nocturnal
GERD. The remaining analysis is limited to 1284 persons with symptomatic GERD
and 268 controls.
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Table 1. Crude Prevalence of Nocturnal Gastroesophageal Reflux Disease
(GERD) and Symptomatic GERD by Sex, Age, and Race*
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The demographic characteristics of these subgroups are shown in Table 2. More than 80% of the respondents
were white, and almost 70% were female. The mean age of symptomatic subjects
was 45.1 years. Subjects without nocturnal GERD symptoms were slightly older
than subjects with nocturnal GERD and controls, but this difference was not
statistically significant. There were no significant differences between groups
in terms of sex, race, or percentage working full-time for pay.
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Table 2. Distribution of Demographic Characteristics Among Selected
Subgroups*
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Heartburn or burning sensation in the chest was the most common GERD
symptom (87%) followed by acid, bitter, or sour taste in mouth (59%); fluid
or food coming back in throat or mouth (42%); and burning sensation or burning
pain in throat (31%) (data not shown). The most common nocturnal symptoms
were "experienced GERD symptoms when laid down to sleep at night"(69%), followed
by "awakened at night by GERD symptoms" (54%), "experienced GERD symptoms
when woke up in the morning" (40%), and "awakened at night by coughing or
choking because of fluid or an acid or bitter taste or food in throat" (29%)
(data not shown).
Age-, sex-, and comorbidity-adjusted (physician-diagnosed conditions)
SF-36 scores for GERD subjects and controls are shown in Table 3. The HRQL of subjects with nocturnal GERD was more impaired
than that of subjects with nonnocturnal GERD and controls. Subjects with nocturnal
GERD were significantly more impaired than nonnocturnal GERD subjects on all
SF-36 domains and the 2 summary scores (P<.001),
and they were significantly more impaired than controls on all HRQL domains
(P<.001). The largest differences (9-11 points)
between GERD subjects with and without nocturnal symptoms were on role limitations–physical,
role limitations–emotional, and pain. GERD subjects without nocturnal
symptoms rated their general health perceptions and vitality significantly
lower than control subjects (P<.001).
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Table 3. Adjusted Medical Outcomes Study Short-Form 36 Health Survey
Scores for Nocturnal Gastroesophageal Reflux Disease (GERD), Nonnocturnal
GERD, and Control Groups*
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COMPARISON OF SUBJECTS WITH GERD SYMPTOMS AND THE US GENERAL POPULATION
Figure 1 shows SF-36 scores
for GERD subjects with nocturnal symptoms compared with published normative
data for the general US population adjusted for age and sex. Although most
scores for the US population were slightly higher than those for subjects
with nonnocturnal GERD (data not shown), the differences were not generally
statistically significant. Nonnocturnal GERD subjects had significantly impaired
vitality compared with the US population and significantly fewer role limitations
due to emotional functioning (P<.001). The physical
component and mental component summary scores show that nonnocturnal GERD
subjects had significantly impaired HRQL compared with the US general population
(P<.001).
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Mean Medical Outcomes Study Short-Form 36 Health Survey (SF-36) scores
for subjects with nocturnal gastroesophageal reflux disease (GERD) and the
US general population adjusted for age and sex. P<.001 for
all scales except role–emotional.
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In contrast, GERD subjects with nocturnal symptoms had significantly
more impaired HRQL compared with the US general population (Figure 1). Nocturnal GERD subjects were significantly more impaired
on all domains of the SF-36 (P<.001) with the
exception of role limitations–emotional. The greatest differences (9-12
points) between nocturnal GERD subjects and the general population were in
physical functioning, role limitations–physical, pain, general health
perceptions, and vitality. Nocturnal GERD subjects also showed significant
impairment on the physical component summary score (P<.001).
COMPARISON OF SUBJECTS WITH GERD AND OTHER CHRONIC DISEASES
Comparisons of mean SF-36 scores for nocturnal GERD subjects and patients
with other chronic diseases (eg, hypertension, type 2 diabetes mellitus, congestive
heart failure, clinical depression, and angina) are presented in Table 4. Compared with patients with hypertension,
nocturnal GERD subjects have significantly more pain and more impaired vitality,
social functioning, and mental health (P<.001).
Nocturnal GERD subjects have significantly fewer physical limitations compared
with patients with diabetes but significantly more pain and more impaired
vitality and mental health (P<.001). Patients
with congestive heart failure have significantly more impaired physical functioning
(P<.001) but have similar pain, vitality, social
functioning, and mental health as subjects with nocturnal GERD. Clinically
depressed patients also have more impaired physical functioning than nocturnal
GERD subjects and more impaired general health perceptions, vitality, social
functioning, role limitations, and mental health (P<.001).
Nocturnal GERD subjects have significantly better physical functioning and
general health perceptions compared with patients with angina (P<.001), but they have similar pain, vitality, social functioning,
and mental health.
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Table 4. Mean Medical Outcomes Study Short-Form 36 Health Survey Scores
for Nocturnal Gastroesophageal Reflux Disease (GERD), Hypertension, Type 2
Diabetes, Congestive Heart Failure, Clinical Depression, and Angina Groups*
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NOCTURNAL GERD SYMPTOM MEASURES AND HRQL
Other measures of nocturnal GERD, such as discomfort with nocturnal
GERD symptoms, frustration with sleep loss, and worry and concern about symptoms,
were associated with HRQL. Correlations between these nocturnal GERD measures
and the SF-36 subscale and summary scores were significant at P<.001. The number of nocturnal GERD symptoms was most strongly
associated with mental health (r = -0.24),
pain (r = -0.23), and general health perceptions
(r = -0.23). Discomfort and distress because
of symptoms was most highly correlated with vitality (r = -0.27), pain (r = -0.26), and
mental health (r = -0.26). Frustration with
symptoms was most strongly associated with impaired vitality (r = 0.34), social functioning (r = 0.34),
and mental health (r = 0.34), whereas concern and
worry about symptoms were most correlated with general health perceptions
(r = 0.35) and mental health (r = 0.35). In general, concern and worry about symptoms were most strongly
correlated with decrements in HRQL.
Table 5 shows SF-36 scores
adjusted for age, sex, and comorbidities by the number of nocturnal GERD symptoms
present. Subjects with a greater number of nocturnal GERD symptoms reported
significantly more impaired HRQL compared with subjects with fewer symptoms
(P<.001). Similarly, subjects with a greater number
of GERD symptoms reported having lower HRQL, as reflected by significantly
lower scores on all domains of the SF-36, compared with subjects with fewer
symptoms (P<.001).
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Table 5. Adjusted Medical Outcomes Study Short-Form 36 Health Survey
Scores by Number of Nocturnal Gastroesophageal Reflux Disease (GERD) Symptoms*
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COMMENT
This population-based study found that the prevalence of frequent GERD
symptoms was 14%, with women reporting slightly higher rates of GERD symptoms
than men. These prevalence rates are comparable to other epidemiologic studies1, 3, 14, 26 in
which, depending on the definition, 9% to 15% of the population suffers from
GERD. No previous epidemiologic studies have estimated the prevalence of nocturnal
GERD symptoms. We found that the overall prevalence of nocturnal GERD symptoms
was 10%, with 74% of persons with GERD symptoms fitting the criteria for nocturnal
GERD. Based on these prevalence rates, it is estimated that close to 38 million
Americans experience GERD symptoms every week and more than 27 million have
nocturnal GERD symptoms. Treatment of nocturnal GERD may be especially difficult,
since gastric acid secretion typically peaks around midnight and, despite
high doses of a proton pump inhibitor, a subset of patients continues to experience
nocturnal acid breakthrough.27 Recent research
has demonstrated that presence of GERD symptoms, especially nocturnal manifestations,
is an important risk factor for esophageal adenocarcinoma.9
As expected, persons with nocturnal GERD reported more impaired HRQL
compared with the controls. The mean differences exceeded 10 points for 5
(62%) of the 8 SF-36 subscales, and a 10-point difference is generally viewed
as clinically significant.4, 23
Physical component and mental component summary scores were both 4 points
lower in subjects with nocturnal GERD. The nocturnal GERD respondents had
mean physical component summary scores (mean = 38.9) that were more than 1
SD below the norm (mean = 50.0) for the US general population.24
More importantly, persons with nocturnal GERD reported impaired functioning
and well-being compared with those with GERD without nocturnal symptoms. These
differences were observed across all 8 subscale scores of the SF-36, with
the greatest impairments in pain and role limitations due to physical problems.
All these mean differences were equal to or larger than 5 points, which may
also be clinically significant.4, 23
The nonnocturnal GERD group was more impaired than controls on measures of
pain, vitality, general health, and mental health. These findings are comparable
to those seen in previous comparisons of generic health status scores between
those with GERD and the general population.4, 12
We demonstrated that respondents with frequent GERD and nocturnal symptoms
have decreased HRQL compared with the US general population. These results
were consistent in both men and women and across all age groups. The largest
impairments were related to pain and role limitations–emotional; respondents
with nocturnal GERD reported lower levels of physical functioning, psychological
well-being, social functioning, vitality, and health perceptions. Most of
these differences were clinically significant, although some were not large.
These HRQL impairments are comparable to those observed in samples of
patients with GERD from clinical trials.4, 11, 28, 29, 30
In general, previous studies in GERD patients have shown that the largest
improvements in HRQL attributable to treatment are in the areas of pain relief,
improved psychological well-being, social functioning, and vitality. Dimenas
et al30 and others4, 31
have found that GERD patients report significantly worse mental health than
the general population.
Health status research studies23, 24, 25, 32
have consistently shown the effect of chronic medical and psychiatric conditions
on HRQL. Persons reporting GERD and nocturnal GERD symptoms appear to have
decrements in HRQL similar to those of persons with other chronic diseases.
Those in the nocturnal GERD symptom group report more pain than persons with
diabetes and hypertension and have comparable pain levels to those with angina.
Social functioning is also impaired. Respondents who reported nocturnal GERD
symptoms also were more likely to experience more psychological distress and
interference with social activities. Similarly, Revicki et al4
also demonstrated that GERD patients had worse emotional well-being and more
pain-related problems compared with other chronic medical disease groups.
Generic HRQL scores varied significantly by the number of symptoms reported
in GERD and nocturnal GERD symptoms. Significant, although small to moderate,
correlations were observed between GERD-related symptoms and the HRQL measures.
However, smaller correlations are often observed in large sample studies compared
with small sample studies because of statistical and distributional reasons.33 Patients with a greater number of GERD-related symptoms,
especially nocturnal symptoms, report more impairments in functioning and
well-being. These results support the discriminant validity of the SF-36 in
GERD populations. The largest differences were seen in measures of pain, mental
health, vitality, and social functioning. These results are consistent with
the findings of several clinical trials that evaluated the impact of treatments
for GERD on HRQL.4, 11, 27, 28
In these clinical trials, the largest and most consistent significant effects
were seen on measures of pain, mental health, and social functioning. The
present study results and those of Revicki et al4
and Chal et al29 indicate that the SF-36 is
responsive enough to detect differences in HRQL in patients with GERD.
This study has several limitations. First, the comparisons of mean SF-36
subscale and summary scores for the US and chronic disease normative groups
and the GERD sample were based on published data.23, 24
There are differences between the MOS and our sample on demographic characteristics
that may have affected the findings. Participants in the MOS were by definition
patients, whereas our study was a population-based national random sample.
The MOS population is slightly older and contains a smaller percentage of
females than the present study sample. Unfortunately, it was not possible
to control for age, sex, race/ethnicity, and education in the comparisons
between the GERD and chronic disease groups from the MOS. Since the chronic
disease groups were for the most part older than the study sample, they were
more likely to have worse SF-36 scores. Therefore, when the nocturnal GERD
group reported significantly lower scores, these are probably true differences,
since we would expect (other things being equal) that older persons would
have lower scores across most SF-36 domains. Furthermore, differences in SF-36
summary scores were seen between the GERD and US general population after
stratifying by age and sex groups. Second, there may be differences in severity
of comorbidity between this study sample and participants in the MOS chronic
disease groups. Severity and extent of comorbidity would likely attenuate
HRQL scores. Third, the study population consisted of a 70:30 male-female
ratio, significantly different from the US general population. This may have
added some bias to the study results. Finally, the structure of the survey
made it impossible to identify only individuals with nocturnal GERD-related
symptoms. Thus, we could only draw conclusions regarding those individuals
with frequent GERD-related symptoms who also had nocturnal symptoms rather
than discussing impairment of HRQL that is directly associated with nocturnal
reflux.
An important strength of this study is that it is population based rather
than clinic based. Most patients with GERD do not seek medical care, so studies
limited to clinic-based populations do not address the broader population
of GERD.34 Therefore, these results may be
generalizable to the larger general population and reflect the burden of illness
for those persons experiencing frequent GERD and nocturnal GERD symptoms.
In conclusion, nocturnal symptoms and problems are very common in persons
with frequent symptoms of GERD. The presence of nocturnal GERD symptoms exacerbates
the impact of this medical condition on HRQL across all domains of functioning
and well-being. Persons with nocturnal symptoms associated with GERD experience
significant impairments in HRQL compared with the US general population. The
effect of nocturnal GERD symptoms on HRQL is greatest on measures of pain,
psychological well-being, and social functioning. The frequency and number
of GERD-related symptoms are directly associated with patient functioning
and well-being, and the impact of nocturnal symptoms adds to this impairment
in HRQL. Effective medical treatment for GERD and nocturnal symptoms will
likely improve patient functioning and well-being that is HRQL.
AUTHOR INFORMATION
Accepted for publication January 20, 2000.
This work was supported by the Janssen Research Foundation, Titusville,
NJ.
From Janssen Pharmaceutica, Inc, Titusville, NJ (Drs Farup and Sloan);
Center for Health Outcomes Research, MEDTAP International, Inc, Bethesda,
Md (Drs Kleinman and Revicki and Ms Ganoczy); and Innovative Medical Research,
Inc, Towson, Md (Dr Chee and Ms Lee). Drs Farup and Sloan are employees of
Janssen Pharmaceutica, Inc, and own stock in Johnson & Johnson, the parent
company of Janssen Pharmaceutica, Inc.
Reprints: Leah Kleinman, DrPH, MEDTAP International, Inc, 2101 Fourth
Ave, Suite 2260, Seattle, WA 98121 (e-mail: Kleinman{at}MEDTAP.com).
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