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Chronic Constipation A Survey of The Patient Perspective
Chronic Constipation A Survey of The Patient Perspective
Results
Of the 24 090 panellists consenting to participate, 557 met eligibility
requirements and took the 45-question survey. The most prevalent
symptom was straining (79%). Hard stool and straining were the top
two severe symptoms, and bloating, straining and hard stool were the
top three bothersome symptoms. Symptoms affected quality of life of
more than half (52%) the respondents. Among those who worked or
went to school, 12% experienced reduced productivity and a mean of
2.4 days of absence in the month before the survey. Most respondents
had used (96%) or were using (72%) constipation relief therapy; how-
ever, nearly half (47%) were not completely satisfied, mainly because of
efficacy (82%) and safety (16%) concerns.
Conclusions
Chronic constipation is common. Individual symptoms are often severe
and bothersome, and many patients are dissatisfied with traditional
treatment options, primarily because of lack of efficacy.
final survey data to reduce the effects of non-sampling pregnant in the year before the survey. Patients were
error (variance and bias). specifically asked whether they had been diagnosed by
a doctor as having cancer or an organic GI disease
[e.g. diverticulitis, diverticulosis, inflammatory bowel
Eligibility
disease (IBD), Crohn’s disease], IBS with constipation
Everyone who agreed to participate in the survey was (IBS-C), or spastic or irritable colon. Participants
asked to complete an online, self-administered, six- reporting abdominal pain, which is the hallmark
question screener to evaluate whether they met entry symptom of IBS, were not excluded unless they had
criteria. been diagnosed by a doctor as having IBS-C or spastic
or irritable colon. Therefore, some participants with
abdominal discomfort/pain were included because they
Inclusion criteria
did not have a doctor diagnosis of IBS or spastic
Recruits were eligible to participate in this study if colon. Anyone taking tegaserod, which was not
they were proficient in the English language, were approved by the US Food and Drug Administration for
18 years of age or older, experienced at least two chronic idiopathic constipation at the time of the sur-
symptoms of constipation in the year before the sur- vey, was also excluded.
vey as defined by Rome II criteria2 (Table 1; the need
for manual manoeuvres to facilitate defecation was
Survey administration
not used as a criterion for constipation in this survey
because of the high degree of patient misinterpret- Panellists meeting entry criteria completed an online,
ation), sought doctor care for constipation symptoms self-administered, 45-question survey. Participants were
in the year before the survey, and had not been diag- directed to read and understand an informed consent
nosed as having irritable bowel syndrome (IBS) or any document, after which they were given the option of
GI disease of organic cause with associated constipa- continuing with the survey. Panellists were also advised
tion. that their participation was voluntary and that they had
the option of not answering specific questions.
As part of the survey, participants were asked to
Exclusion criteria
report on the presence, duration, frequency, severity,
Recruits were not eligible to participate in the survey bothersomeness and impact on QoL of a variety of
if they were pregnant during the survey or had been constipation-related symptoms, including straining,
Table 1. Rome II criteria for functional constipation2 and survey inclusion criteria
The presence of 2 or more of the following for The presence of 2 or more of the following in the year
at least 3 months, which need not be before the survey:
consecutive, in the past 12 months:*
Straining in >25% of defecations Straining in >25% of defecations
Lumpy or hard stool in >25% defecations Lumpy or hard stool in >25% defecations
Sensation of incomplete evacuation in >25% of Sensation of incomplete evacuation in >25% of
defecations defecations
Sensation of anorectal obstruction/blockade in >25% Sensation of anorectal obstruction/blockade
defecations in >25% defecations
Manual manoeuvres to facilitate >25% defecations (e.g. <3 defecations per week
digital evacuation, support of the pelvic floor)
<3 defecations per week Participants with abdominal discomfort who did not have
a doctor diagnosis of irritable bowel syndrome or
spastic colon were included
* Loose stool is not present, and criteria
are insufficient for irritable bowel syndrome
Bothersomeness
Figure 4. Symptoms of
constipation affect quality of
life.
prevented them from working or performing their (1%). Furthermore, 9% of respondents reported missing
daily activities. Within the month preceding the sur- work or school despite their current therapy.
vey, 12% of respondents who worked or went to Those who were taking fibre at the time of the sur-
school reported missing time from work or class vey (n ¼ 268) were asked to rate their level of satis-
(mean, 2.4 days) because of constipation symptoms. faction with this approach. Overall, 80% of these
respondents were not completely satisfied with the
ability of fibre to relieve their bloating, 79% were not
Treatments to reduce constipation symptoms
completely satisfied with the predictability of fibre,
An overwhelming majority (96%) of respondents 66% thought fibre did not completely relieve the mul-
reported that they had at some time used treatment for tiple symptoms of constipation and 50% thought fibre
their constipation symptoms. Overall, 80% tried over- did not completely relieve their constipation (Figure 5).
the-counter (OTC) products, and 35% had tried pre- Furthermore, most (64%) respondents were not com-
scription medication. Most (72%; 385 of 533) respond- pletely satisfied with the ability of fibre to improve
ents reported that they were currently taking their QoL.
medication for their constipation symptoms. Treat- Those who were taking OTC laxatives at the time of
ments included OTC products [including laxatives the survey (n ¼ 146) were asked to rate their attrib-
(27%) and fibre (50%)] and prescription medications utes. Overall, 71% of respondents were not completely
(11%), including prescription laxatives (8% of total satisfied with the predictability of OTC laxatives, 67%
medications taken or 91% of total prescription medi- did not think OTC laxatives completely relieved their
cations). bloating, 60% did not think OTC laxatives completely
relieved the multiple symptoms of constipation and
44% did not think OTC laxatives completely relieved
Treatment satisfaction
their constipation (Figure 5). Moreover, most (68%)
Overall, 47% of respondents were not completely satis- respondents were not completely satisfied with the
fied with their current constipation treatment. Most ability of OTC laxatives to improve their QoL.
(82%) respondents reported their reason for dissatisfac- Those who were taking prescription laxatives at the
tion was efficacy related, including does not work time of the survey (n ¼ 42) were asked to rate their
well (39%), inconsistent results (25%), continuous level of satisfaction with these products. Overall, 75%
dosage (7%), still requires laxative use (3%), not fast of respondents were not completely satisfied with the
acting (1%) and does not treat infrequent bowel predictability of prescription laxatives, 52% did not
movements (2%). Other reasons for dissatisfaction think prescription laxatives were completely effective
included safety and adverse effect concerns (16%), in relieving their bloating, 50% did not think prescrip-
price and cost issues (3%), taste (2%) or inconvenience tion laxatives were completely effective in relieving
their constipation and 50% did not think prescription (79%), hard stool (71%), abdominal discomfort (62%),
laxatives were completely effective in relieving the bloating (57%) and feeling of incomplete evacuation
multiple symptoms of constipation (Figure 5). In addi- after a bowel movement (54%) were reported at fre-
tion, nearly half (44%) of respondents were not com- quencies similar to those reported for infrequent bowel
pletely satisfied with the ability of prescription movements (57%). The varied manifestations that
laxatives to improve their QoL. patients experience often necessitate use of multiple
medications targeted at individual symptoms, increas-
ing the potential for adverse effects and drug interac-
Optimal product attributes
tions. Of the many steps involved in evaluating and
Respondents rated certain key attributes of a medica- treating a patient with constipation, elucidating the
tion for constipation as extremely or very important, symptom that the patient views as most bothersome
including effective relief of constipation (straining/ is among the most important in developing a treat-
hard, infrequent stool; 80%), effective at improving ment goal and initiating a treatment plan. This sur-
the quality of bowel movements (79%), well tolerated vey revealed that patients often rate the severity and
(74%), predictable response time (73%), relief of mul- bothersomeness of individual symptoms in a rank
tiple symptoms (71%), appropriate for long-term use order similar to that for prevalence. Identifying the
(71%) and effective relief of bloating (64%). key symptom(s) to target (in terms of underlying cause
and treatment options) is therefore a critical first step
in developing a realistic action plan that attempts to
DISCUSSION
minimize the number of therapeutic agents used.
The findings from this survey are consistent with those The pathophysiology of some forms of constipation
reported previously with regard to the high prevalence has been well described, and a number of subtypes,
of constipation, its multifaceted symptoms, its often- including normal-transit constipation, slow-transit
times bothersome nature that, for many, results in a constipation and defecatory disorders, have been char-
negative impact on QoL, and the generally low level acterized based on underlying pathophysiological
of satisfaction with the efficacy and tolerability pro- mechanisms.16, 17 Patients with slow-transit constipa-
files of traditional treatment options.1, 6, 15, 16 Three tion report, among others, symptoms of straining,
findings were of particular relevance to the treatment hard/lumpy stool and infrequent defecation, and they
of patients with constipation: (i) the symptom that exhibit reduced gut transit when assessed using radio-
patients view as most bothersome often correlates opaque markers or scintigraphy. Patients with normal-
directly with the symptom they view as most severe transit constipation also report symptoms of straining,
and prevalent; (ii) severity and bothersomeness, and hard/lumpy stool and infrequent defecation; however,
the occurrence of additional symptoms, increase as the they exhibit normal motility upon testing. Treatment
duration of symptoms lengthens and (iii) patients are for these patient groups is generally pharmacological.
often poorly satisfied with symptom relief achieved Patients with defecatory disorders, who report exces-
with fibre and with OTC and prescription laxatives. sive straining, feelings of incomplete evacuation and
The clinical implications of these findings are import- manual manoeuvring for a bowel movement, fre-
ant to consider. quently have anorectal obstruction or abnormal
Although constipation is often regarded simply as coordination of pelvic and abdominal muscles (dyssy-
infrequency of bowel movements, it is actually a mul- nergia). Biofeedback therapy or surgery is often
tiple-symptom complex that varies in chronicity and recommended. Although each subtype has its own
intensity from one patient to another, necessitating an characteristics, significant overlap typically exists
individualized treatment approach. Although partici- among the groups. Determining the presence of these
pants in this survey met inclusion criteria based on abnormalities requires specific testing, which is usually
Rome II criteria for functional constipation, among not undertaken in clinical practice. In this survey, the
them symptoms associated with constipation, inclu- specific subtype of constipation was not elicited. How-
ding some not included in the Rome criteria, were ever, straining was reported as one of the most
reported. This result is consistent with previous reports frequent symptoms of constipation. Excessive strain-
in which patients with constipation reported a wide ing, feelings of incomplete evacuation, the need to
variety of symptoms.5 Indeed, in this survey, straining apply perineal or vaginal pressure or the need for
direct digital evacuation of stool are all common dissatisfaction among patients.16, 17 Regardless, a need
symptoms observed in patients with defecatory disor- clearly exists for effective, well-tolerated treatment
ders. It is possible that some survey participants had options that target multiple symptoms of constipation.
an unrecognized defecatory disorder that contributed When asked what product attributes were most import-
to their constipation. Given that patients with defeca- ant to them, respondents rated effective relief of con-
tory disorders do not respond to fibre and frequently stipation symptoms (straining; hard/lumpy, infrequent
do not improve with OTC laxatives, the inclusion of stool), improvement in quality of bowel movements,
significant numbers of participants with defecatory tolerability, predictable response time, multisymptom
disorders could have contributed to the observed lack relief, long-term use and efficacy in alleviating bloat-
of efficacy of traditional treatment options. Con- ing as most imperative. Treatments that fulfil at least
versely, the prevalence of a defecatory disorder is con- several of these attributes are likely to play an import-
siderably less common than normal-transit ant role in the treatment of constipation.
constipation, in which straining is also a typical symp-
tom. In a population-based survey such as this, the
CONCLUSIONS
presence of undiagnosed defecatory disorders probably
does not contribute significantly to the lack of satis- Results of this survey confirm that constipation is a
faction with traditional therapy observed in this study. prevalent condition that negatively impacts patients’
For many patients, constipation is a chronic condi- daily lives, often necessitating doctor office visits and
tion. In this survey, almost one quarter (21%) of pharmacological treatment. Proactive elucidation of
respondents reported experiencing symptoms for the symptoms that patients consider most bothersome
10 years or more. A notable finding regarding the dur- is an important step in developing a targeted treatment
ation of any symptom was that the severity and both- plan. For numerous reasons, patients are often unsatis-
ersomeness, as well as the occurrence of additional fied with the symptom relief achieved from traditional
symptoms, increased as symptom duration lengthened. treatment approaches, such as bulking agents and lax-
This observation may reflect several factors, including atives. These findings highlight an important unmet
development of constipation-associated complications need for treatment options that target the multiple
and increasing abnormality over time. The clinical symptoms of constipation. Fortunately, the armamen-
implication of these findings is that patients with tarium of effective, well-tolerated therapeutic options
chronic symptoms of constipation often require more is expanding. New and emerging treatments for consti-
aggressive therapy, including the use of prescription pation are likely to fill an important void for many
products. patients, particularly those who experience symptoms
Constipation imposes a heavy economic burden on on a chronic basis and who may require a more
patients and society, with sales of laxatives alone aggressive treatment approach.
accounting for several hundred million dollars each
year.16 Despite the common view of constipation as a
ACKNOWLEDGEMENTS
disorder that can be self-treated with the large arm-
amentarium of OTC treatment options, poorly con- Authors’ declaration of personal interests: Dr Johanson
trolled constipation-related symptoms account for is a consultant for Boehringer Ingelheim, Microbia,
approximately 2.5 million doctor visits per year, with Prometheus, Sucampo, Takeda and Theravance and a
85% of patients receiving prescriptions during these member of the speakers bureaus for Novartis, Sucampo
visits.18 This survey confirmed the fact that many peo- and Takeda. Jeffrey Kralstein is an employee of Novar-
ple are disappointed with the efficacy and safety pro- tis Pharmaceuticals Corporation.
files of traditional treatment approaches. Respondents Declaration of funding interests: this study was
tried a variety of OTC and prescription agents, and funded in full by Novartis. The writing of this paper
only half were satisfied with any particular option. For was funded in part by Novartis. Initial data analyses
most, a lack of efficacy was the leading reason for were undertaken by Knowledge Networks and received
dissatisfaction. Severe slow-transit constipation that funding from Novartis. Writing support was provided
is refractory to traditional pharmacological therap- by Cathy R. Winter, PhD, and Maribeth Bogush, PhD,
ies could be one of the reasons for the observed and funded by Novartis.
functional status and quality of life in pation is less effectively treated than
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