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From Medscape Gastroenterology

Expert Interview

Advances in the Treatment of Chronic Constipation: An Expert Interview With Lawrence R. Schiller, MD

11/10/2004

Editor's Note:
Chronic constipation is a common clinical problem. It generally refers to unsatisfactory defecation, as defined in terms of alterations in the frequency, size, consistency, and ease of passage of stool. Although reports of prevalence vary depending on whether estimates are derived from self-reports or are based on the Rome criteria, chronic constipation accounts for approximately 2.5 million physician visits each year in the United States. Medscape spoke with Lawrence R. Schiller, MD, Program Director, Gastroenterology Fellowship, Baylor University Medical Center, Dallas, Texas, to discuss the clinical impact of this problem upon the patient and the healthcare industry alike, and the current challenges facing the physician treating the patient with chronic constipation.

Medscape: Although physicians generally relate constipation with decreased stool frequency, patients often apply this term to a number of defecatory complaints. How would you clinically define chronic constipation and how does the multiple-symptom nature of this disorder affect the healthcare industry?

Dr. Schiller: The definitions that really matter are the ones that individual patients have for this group of defecation problems. Physicians must take the time to understand what the patient means by the complaint of "constipation." The main features that patients describe in their definitions include altered consistency ("hard" or "lumpy" stools), small stool size (diameter or volume), and infrequency of defecation. It is important to realize that these changes are relative to the patients' usual habits, and are not necessarily those cited in published criteria. In addition, a variety of coexisting symptoms, such as bloating, abdominal distension, and discomfort or pain, influence patients when they report the symptom of "constipation" to their physicians.

The diverse nature of patients' definitions makes the study of constipation and its treatment difficult. To introduce some uniformity to the definition of constipation for research purposes, the Rome II committee has set forth criteria for a diagnosis of chronic functional constipation. These criteria include a chronicity definition (at least 3 months' duration) and 2 or more specific alterations in defecation occurring at least 25% of the time (fewer than 3 bowel movements per week, hard or lumpy stools, straining with evacuation, a sensation of incomplete evacuation, a sense of anorectal obstruction, and the use of manual maneuvers to assist defecation). In addition, criteria for irritable bowel syndrome are not present. Operationally, this means that abdominal pain is not a prominent symptom. It is important to realize that patients who complain of chronic constipation may or may not meet these criteria. To the extent that they do, they will behave like other patients who meet criteria and have been studied in research projects. Patients who do not meet these specific criteria may still respond to treatments for constipation, but with less certainty.

The impact of constipation on the healthcare system is substantial. Patients presenting with chronic constipation require at least some evaluation. The variety of presenting symptoms may cause excessive evaluation if the physician does not recognize the connected nature of these complaints.

Medscape: What can you tell us about patients' overall satisfaction with the traditionally available treatment options (bulking agents, laxatives) for chronic constipation?

Dr. Schiller: Last spring a consumer panel of more than 37,000 Americans selected to be representative of the US population was queried about chronic constipation.[1] Over 24,000 individuals consented to be questioned and 4680 (19%) had 2 or more Rome II symptoms of chronic constipation. A total of 1147 respondents had sought medical attention for constipation in the previous year and of these, 557 were not diagnosed as having irritable bowel syndrome with constipation or some other gastrointestinal disease-causing constipation. Only 4% of these patients had never been treated with over-the-counter or prescription drugs; 80% had tried over-the-counter remedies and 35% had tried prescription drugs.

Only half of the respondents were satisfied with their current treatments. Lack of efficacy was the reason for dissatisfaction cited by 82% of those unhappy with their therapy. Major problems with efficacy included both the agents not working well enough as well as inconsistency of results. Sixteen percent of respondents cited side effects as the reason that they were dissatisfied with the results of treatment.

When asked about the effect of specific products on quality of life, 64% of individuals were dissatisfied with fiber, 68% were dissatisfied with over-the-counter laxatives, and 44% were dissatisfied with prescription laxatives. Thus, from the patients' viewpoints, there was plenty of room for improvement in the treatment of constipation.

Medscape: A study presented during the 69th Annual Meeting of the American College of Gastroenterology assessed the primary care physician's perception of the clinical impact of chronic constipation as a medical condition and looked at its effect on patients' lives as well as physicians' impressions of the current therapeutic armamentarium. What can you tell us about this study, and what were the key findings with respect to the physicians' vs patients' perceptions regarding the clinical impact and unmet medical needs in this setting?

Dr. Schiller: In April 2004, approximately 8000 primary care physicians listed in an American Medical Association database were contacted about participating in a survey about constipation; 461 were screened for eligibility. The main eligibility criteria were being board-certified or board-eligible in family practice or internal medicine, having been in practice for 2-40 years, spending 75% or more of the time in clinical practice, and treating 5 or more patients with constipation each week. Three hundred and eleven eligible physicians then completed a 37-question survey administered by trained interviewers.[2]

Physicians reported that their typical patients had symptoms for 2-3 years, but 17% had typical patients with symptoms for 10 or more years. Two thirds of the physicians reported that their typical patients had 1-2 bowel movements per week.

The vast majority of physicians felt that constipation was at least somewhat severe as a medical condition (83%), was at least somewhat bothersome (98%), and had at least some impact on their patients' quality of life (95%). Physicians reported that abdominal discomfort or pain, straining, bloating, and hard stools were at least as important as infrequency of defecation as causes of severity, "bothersomeness," and decreased quality of life. Gas, the sensation of incomplete evacuation, rectal pain, and urgency were also cited as problematic for patients with constipation.

Surveyed physicians believed that worsening symptoms, frustration with symptom control, and frustration with current treatment were the main reasons that patients consulted with them for constipation. Most of these physicians were dissatisfied with the ability of fiber products (58%) and over-the-counter laxatives (63%) to improve quality of life in these patients. Even existing prescription laxatives were unsatisfactory in the opinion of 42% of the physicians surveyed; 90% wished that there were better treatment options for these patients.

Thus, while most physicians view constipation as an important medical problem for their patients, they are dissatisfied with the available treatments and wish that they had better therapeutic options for these patients.

Medscape: Results of a survey conducted to examine the prevalence of constipation, the symptoms that patients include in their description of constipation, and patients' satisfaction with the current treatment options were also presented during this year's meeting. What can you tell us about this study and what were the key findings?

Dr. Schiller: The prevalence of chronic constipation has been estimated to be as high as 28% of the adult population in the United States, based on a number of surveys over the years, as recently reviewed by Higgins and Johanson.[3] To reexamine the prevalence of this condition using modern definitions of constipation and its symptoms, we took advantage of an existing large panel of consumers selected to be representative of the US population who regularly participate in Internet-based surveys.[1] Of the 37,000 individuals in this panel, 24,090 consented to be questioned about their bowel habits. A total of 4680 of these individuals (19%) met Rome II criteria for functional constipation: experiencing 2 or more symptoms (fewer than 3 bowel movements per week, hard or lumpy stools, straining with evacuation, a sensation of incomplete evacuation, a sense of anorectal obstruction, and the use of manual maneuvers to assist defecation) more than 25% of the time for at least 3 months. This estimate of prevalence is very much in keeping with older estimates in the literature.

We next looked at the 1147 of these individuals who sought attention from a physician for constipation during the last year. About half of these subjects were diagnosed as having some gastrointestinal disease or irritable bowel syndrome that was causing their constipation, leaving a pool of 557 participants with "functional constipation" who were queried in more detail about their symptoms.

The percentages of men and women in this select group were nearly identical to those in the pool of 24,090 who consented to enter the study (56% women and 44% men), indicating that the prevalence of constipation was roughly equal between the sexes. There was an enhancement in the proportion of older individuals in the select constipation group (27% vs 17% >/= 65 years of age), suggesting that constipation is more common in the elderly.

A majority of the respondents (72%) reported that they had constipation for 5 years or less, but 21% described symptoms that lasted 10 years or longer. Half of respondents reported having 2 or fewer bowel movements per week, but the other half had 3 or more bowel movements per week, a "normal" stool frequency. Straining during evacuation was the most common defining symptom (reported by 77%), followed by lumpy or hard stools (73%), sensation of incomplete evacuation (58%), fewer than 3 bowel movements per week (47%), and the sensation of blocked defecation (40%).

Constipation degraded quality of life, with 52% of respondents claiming that it had at least some impact on their lives; 12% of those employed or going to school missed time from work or class because of constipation symptoms.

Almost all of the respondents (96%) had tried some treatments for constipation, with 80% having tried over-the-counter remedies and 35% having used prescription drugs for constipation. Yet only 53% of individuals were completely satisfied with their treatment. Those respondents who were dissatisfied cited ineffectiveness and inconsistency of effect as the main reasons for their unhappiness; 16% cited side effects as the reason for their dissatisfaction. These results suggest that a substantial proportion of patients with constipation want and need better treatments.

Medscape: Were there any other data presented during the meeting that would help put this information into clinical context? Also, how do you view the path forward in terms of the treatment of chronic constipation?

Dr. Schiller: There were several other studies presented during this year's meeting of the American College of Gastroenterology that addressed chronic constipation.

An analogous population survey conducted in Canada[4] showed very similar findings as the US patient survey mentioned above, although the prevalence rates for lower gastrointestinal tract symptoms were somewhat lower than in the US study. Important to note is that a large proportion of Canadians with constipation were dissatisfied with their therapies.

A survey of constipated patients in Alabama addressed a problem not covered in our study (discussed above) -- the problem of medication-associated constipation.[5] Of 329 subjects with self-reported constipation, 195 (59%) were taking drugs associated with constipation, such as antidepressants, pain medications, and calcium-channel blockers. Clearly, clinicians must take a careful drug history when evaluating patients with constipation.

Another study looked at bloating and gaseousness in patients with functional constipation or irritable bowel syndrome with constipation.[6] Lower abdominal bloating was present in 90% of the patients in this study. Constipated patients with lower abdominal bloating were likely to have upper abdominal bloating as well. There were only modest associations with belching and flatulence in the constipated patients.

Several reports highlighted the impact of constipation on healthcare utilization. Using the California Medicaid database, healthcare expenses during the period around a first physician encounter for constipation were compiled.[7] Gastrointestinal-related procedures and laboratory tests accounted for most of the $18 million spent over 15 months on 76,854 individuals. Nearly 0.6% of these patients were hospitalized for constipation. This somewhat surprising statistic was confirmed in another study that documented over 38,000 admissions primarily for constipation, nationally.[8] Of course, most physician encounters with patients for constipation occur in the outpatient or emergency room setting; more than 5.7 million constipation-related visits occurred in outpatient venues in 2001 according to another study abstract.[9]

The impact of constipation on quality of life was addressed in a study involving patients with refractory constipation.[10] SF-36 questionnaires were administered to 31 patients with constipation who were referred to a pelvic floor laboratory and showed significantly lower quality-of-life scores than healthy controls. Work productivity and activity impairment was demonstrated in a subanalysis of our patient survey data.[11]

A systematic review of traditional therapy for chronic constipation pointed out the lack of evidence to support most currently used treatments.[12] The ineffectiveness of current treatments was examined in a study of 1660 HMO (health maintenance organization) patients, 334 of whom met Rome II criteria for functional constipation.[13] These patients had less improvement than patients with other functional bowel disorders when treated with therapies that included diet changes, exercise, reducing life-stress, laxatives, and antispasmodics.

It is fairly clear from these reports that clinicians need to do a better job in treating chronic constipation so that we can improve our patients' quality of life and reduce losses in productivity and healthcare-related expenses. Fortunately, new agents are being developed and introduced that make these goals feasible. For example, tegaserod has recently been approved by the US Food and Drug Administration for the treatment of chronic constipation in men and women. Studies have shown that this agent improves constipation symptoms in significantly more patients than placebo and is well tolerated by most patients with chronic constipation. Tegaserod works by stimulating peristalsis via its effects on 5-HT4 receptors in the enteric nervous system. Because slow transit is the mechanism underlying most cases of constipation, tegaserod provides targeted therapy. I expect that additional drugs that target other physiologic activities of the gut will eventually allow us to provide satisfactory results for more patients with chronic constipation.

References
Schiller LR, Dennis E, Toth G. An Internet-based survey of the prevalence and symptom spectrum of chronic constipation. Am J Gastroenterol. 2004;99:S234. [Abstract #723]
Schiller LR, Dennis E, Toth G. Primary care physicians consider constipation as a severe and bothersome medical condition that negatively impacts patients' lives. Am J Gastroenterol. 2004;99:S234. [Abstract #724]
Higgins PD, Johanson JF. Epidemiology of constipation in North America: a systematic review. Am J Gastroenterol. 2004;99:750-759.
Hunt R, Dhaliwal S, Tougas G, et al. Lower GI symptoms: A Canadian prescriptive drug study assessing prevalence, impact, and satisfaction with treatments. Am J Gastroenterol. 2004;99:S227. [Abstract #703]
Rutland TJ, Adeniji OA, Di Palma JA. Prevalence of medication-associated constipation. Am J Gastroenterol. 2004;99:S103. [Abstract #320]
Williams M, Wessinger S, Soanier J, et al. Bloating and gaseousness in healthy subjects and patients with constipation. Am J Gastroenterol. 2004;99:S287. [Abstract #879]
Singh G, Kahler K, Bharathi V, et al. Adults with chronic constipation have significant health care resource utilization and costs of care. Am J Gastroenterol. 2004;99:S227. [Abstract #701]
Martin BC, Barghout V. National estimates of constipation-related hospitalizations in the United States. Am J Gastroenterol. 2004;99:S244. [Abstract #753]
Martin BC, Barghout V. National estimates of office and emergency room constipation-related visits in the United States. Am J Gastroenterol. 2004;99:S244. [Abstract #754]
Robson K, Barrett R, Liberman RF. Psychological profiles and quality of life in patients with refractory constipation. Am J Gastroenterol. 2004;99:S278. [Abstract #852]
Bracco A, Kahler K. Burden of chronic constipation must include estimates of work productivity and activity impairment in addition to traditional healthcare utilization. Am J Gastroenterol. 2004;99:S233. [Abstract #719]
Ramkumar DP, Rao SS. Systematic review: the efficacy and safety of traditional medical therapies for chronic constipation. Am J Gastroenterol. 2004;99:S278. [Abstract #853]
Palsson OF, Whitehead WE, Levy RL, et al. Constipation less effectively treated than other functional bowel problems in a health maintenance organization (HMO). Am J Gastroenterol. 2004;99:S287. [Abstract #878]

Disclosure: Lawrence R. Schiller, MD, has disclosed that he has received grants for clinical research from GlaxoSmithKline, Procter & Gamble, and Novartis, and has received grants for educational activities from AstraZeneca, Procter & Gamble, and TAP Pharmaceuticals. He has served as an advisor or consultant for Salix Pharmaceuticals, Novartis, McNeil, and Boehringer Ingelheim. He has also served on the Speaker's Bureau for AstraZeneca, Procter & Gamble, Novartis, and TAP Pharmaceuticals.

Medscape Gastroenterology 6(2), 2004. � 2004 Medscape

http://www.medscape.com/viewarticle/492110?src=mp

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