Constipation Clinical Trials, Diagnosis, and Treatment

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Constipation

Constipation, costiveness, or irregularity, is a condition of the digestive system where a person (or animal) experiences hard feces that are difficult to egest. It may be extremely painful, and in severe cases (fecal impaction) lead to symptoms of bowel obstruction. The term obstipation is used for severe constipation. Causes of constipation may be dietary, hormonal, anatomical, a side effect of medications (e.g. some painkillers), or an illness or disorder. Treatments consist of changes in dietary and exercise habits, the use of laxatives, and other medical interventions depending on the underlying cause.

Current Research

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Signs and symptoms

Constipation is one of the most common digestive complaints. It varies greatly between different people, as each person's bowel movements differ. Rate of defecation is not in itself a problem, as infrequent defecation without problems is not abnormal. Constipation is most common in children and older people, and affects women more than men. In children, constipation can lead to soiling (enuresis and encopresis). In common constipation, the stool is hard and difficult and painful to pass. Usually, there is an infrequent urge to void. Straining to pass stool may cause hemorrhoids and anal fissures, which are themselves painful. In later stages of constipation, the abdomen may become distended and diffusely tender and crampy, occasionally with enhanced bowel sounds. The definition of constipation includes the following:

infrequent bowel movements (typically 3 times or less per week)
difficulty during defecation (straining during more than 25% of bowel movements or a subjective sensation of hard stools), or
the sensation of incomplete bowel evacuation.

Severe cases ("fecal impaction") may feature symptoms of bowel obstruction (vomiting, very tender abdomen) and "paradoxical diarrhea", where soft stool from the small intestine bypasses the impacted matter in the colon.

Diagnosis

The diagnosis is essentially made from the patient's description of the symptoms. Bowel movements that are difficult to pass, very firm, or made up of small rabbit-like pellets qualify as constipation, even if they occur every day. Other symptoms related to constipation can include bloating, distention, abdominal pain, or a sense of incomplete emptying.

Inquiring about dietary habits may reveal a low intake of dietary fiber or inadequate amounts of fluids. Constipation as a result of poor ambulation or immobility should be considered in the elderly. Constipation may arise as a side effect of medications (especially antidepressants and opiates). Rarely, other symptoms suggestive of hypothyroidism may be elicited.

During physical examination, scybala (manually palpable lumps of stool) may be detected on palpation of the abdomen. Rectal examination gives an impression of the anal sphincter tone and whether the lower rectum contains any feces or not; if so, then suppositories or enemas may be considered. Otherwise, oral medication may be required. Rectal examination also gives information on the consistency of the stool, presence of hemorrhoids, admixture of blood and whether any tumors or abnormalities are present.

X-rays of the abdomen, generally only performed on hospitalized patients or if bowel obstruction is suspected, may reveal impacted fecal matter in the colon, and confirm or rule out other causes of similar symptoms.

Chronic constipation (symptoms present for more than 3 months at least 3 days per month) associated with abdominal discomfort is often diagnosed as irritable bowel syndrome (IBS) when no obvious cause is found. Physicians caring for patients with chronic constipation are advised to rule out obvious causes through normal testing.

Colonic propagating pressure wave sequences (PSs) are responsible for discrete movements of content and are vital for normal defaecation. Deficiencies in PS frequency, amplitude and extent of propagation are all implicated in severe defecatory dysfunction. Mechanisms that can normalise these aberrant motor patterns may help rectify the problem. Recently the novel therapy of sacral nerve stimulation (SNS) has been utilized for the treatment of severe constipation.

Causes

The main causes of constipation include:

Hardening of the feces
- Improper mastication (chewing) of food
- Insufficient intake of dietary fiber
- Dehydration from any cause or inadequate fluid intake
- Medication, e.g. diuretics and those containing iron, calcium, aluminum
Paralysis or slowed transit, where peristaltic action is diminished or absent, so that feces are not moved along
- Hypothyroidism (slow-acting thyroid gland)
- Hypokalemia
- Injured anal sphincter (patulous anus)
- Medications, such as loperamide, opioids (e.g. codeine & morphine) and certain tricyclic antidepressants
- Severe illness due to other causes
- Acute porphyria (a rare inherited condition)
- Lead poisoning
Dyschezia (usually the result of suppressing defecation)
Constriction, where part of the intestine or rectum is narrowed or blocked, not allowing feces to pass
- Stenosis (Strictures)
- Diverticula
- Tumors, either of the bowel or surrounding tissues
- Retained foreign body or a bezoar
Psychosomatic constipation, based on anxiety or unfamiliarity with surroundings.
- Functional constipation
- Constipation-predominant irritable bowel syndrome, characterized by a combination of constipation and abdominal discomfort and/or pain
Smoking cessation (nicotine has a laxative effect)
Abdominal surgery, other types of surgery, childbirth

Treatment

In people without medical problems, the main intervention is to increase the intake of fluids (preferably water) and dietary fiber. The latter may be achieved by consuming more vegetables and fruit and whole meal bread, and by adding linseeds to one's diet. The routine non-medical use of laxatives is to be discouraged as this may result in bowel action becoming dependent upon their use. Enemas can be used to provide a form of mechanical stimulation.

In alternative and traditional medicine, colonic irrigation, enemas, exercise, diet and herbs are used to treat constipation. The mechanism of the herbal, enema, and colonic irrigation treatments often include the breakdown of impacted and hardened fecal matter.

Laxatives

Laxatives may be necessary in people in whom dietary intervention is not effective or is inappropriate. Most laxatives can be safely used long-term, although some are associated with cramping and bloatedness and can cause the phenomenon of melanosis coli.

Physical intervention

Constipation that resists all the above measures requires physical intervention. Manual disimpaction (the physical removal of impacted stool) is done for those patients who have lost control of their bowels secondary to spinal injuries. Manual disimpaction is also used by physicians and nurses to relieve rectal impactions. Finally, manual disimpaction can occasionally be done under sedation or a general anesthetic—this avoids pain and loosens the anal sphincter.

Many of the products are widely available over-the-counter. Enemas and clysters are a remedy occasionally used for hospitalized patients in whom the constipation has proven to be severe, dangerous in other ways, or resistant to laxatives. Sorbitol, glycerin and arachis oil suppositories can be used. Severe cases may require phosphate solutions introduced as enemas.

Prevention

Constipation is usually easier to prevent than to treat. The relief of constipation with osmotic agents, i.e. lactulose, polyethylene glycol (PEG), or magnesium salts, should immediately be followed with prevention using increased fiber (fruits, vegetables, and grains) and a nightly decreasing dose of osmotic laxative. With continuing narcotic use, for instance, nightly doses of osmotic agents can be given indefinitely (without harm) to cause a daily bowel movement.

Recent controlled studies have questioned the role of physical exercise in the prevention and management of chronic constipation, while exercise is often recommended by published materials on the subject.

In various conditions (such as the use of codeine or morphine), combinations of hydrating (e.g. lactulose or glycols), bulk-forming (e.g. psyllium) and stimulant agents may be necessary to prevent constipation.

Epidemiology

Depending on the definition employed, constipation occurs in 2% of the population; it is more common in women, the elderly and children

In Animals

Hibernating animals can experience tappens that are usually expelled in the spring. For example, bears eat many foods that create a "rectal plug" before hibernation.

Canines may also experience constipation, which they usually attempt to rectify by ingesting grass and other plant materials.

(adapted from Wikipedia, the free encyclopedia http://en.wikipedia.org/wiki/Constipation)

Findings From Current Research

Lubiprostone: A New Drug for the Treatment of Chronic Idiopathic Constipation

Authors: Baker DE.

College of Pharmacy, Washington State University Spokane, Spokane, Washington, USA.

Lubiprostone offers an additional alternative for patients with chronic idiopathic constipation. Lubiprostone is more efficacious than placebo in the treatment of chronic idiopathic constipation. In placebo-controlled clinical trials, lubiprostone therapy was generally well tolerated and was not associated with severe adverse effects; however, the high incidence of nausea may be problematic for some patients. The nausea may be alleviated or minimized by administering the dose with food, and some patients may require a dosage reduction to 24 mug once daily. The key limitations of the placebo-controlled clinical trials include the absence of information regarding the duration of the constipation and previous types of therapies that had been used to treat the constipation and the absence of an active control group. Comparative studies with other therapies (eg, saline laxatives, polyethylene glycol) used for constipation are necessary to determine the clinical and economic value of this agent relative to other forms of therapy.

Journal: Rev Gastroenterol Disord. 2007 Fall;7(4):214-22.
Adapted from PubMed; click here to access full journal article.

Diagnosis and Treatment of Constipation in Children: A Survey of Primary Care Physicians in West Virginia

Authors: Whitlock-Morales A, McKeand C, DiFilippo M, Elitsur Y.

Department of Pediatrics, Gastroenterology Division Joan C. Edwards School of Medicine, Marshall University, Huntington, USA.

A questionnaire was mailed to all PCPs practicing in West Virginia. Demographics, clinical practice, treatment, referral practices, and familiarity with the constipation guideline were recorded. Results were compared between pediatricians (Ps) and family practitioners (FPs). Out of 718, 210 (78 Ps and 112 FPs) completed the survey. Compared to FPs, Ps reported a higher number of children diagnosed with constipation in their clinics. All PCPs prescribed various treatment modalities for constipation, but Ps used more lavage therapy (P< 0.001). Most of the PCPs referred patients to specialists for treatment failure (85%), and preferred to co-manage their patients (58%). The majority (67-86%) of physicians were not familiar with the published clinical guidelines for constipation in children. Most PCPs in West Virginia are not familiar with the clinical guideline for constipation in children. An educational campaign for constipation in children is clearly warranted.

Journal: W V Med J. 2007 Jul-Oct;103(4):14-6.
Adapted from PubMed; click here to access full journal article.

Researching the Management of Constipation in Long-Term Care: Part 1

Authors: Castledine G, Grainger M, Wood N, Dilley C.

Institute of Ageing and Health, Birmingham.

The management of constipation is a problem in any healthcare setting, for a variety of reasons. These include the lack of a unified definition of constipation, differences in bowel habit between individuals, the lack of literature on assessment of constipation and nursing research into the condition, and the numerous risk factors. A good knowledge and understanding of these factors, which can help not only in dealing with constipation, but also in preventing it and maintaining the individual's comfort and health, is essential. This two-part article describes a research study carried out in nine care homes, among patients of various ages with a variety of chronic conditions. The aim of the study was to investigate and improve bowel care in long-term care settings. Part 1 presents the background to the study, including the definition, causes, risk assessment and management of constipation, which focuses on the role of health education and the use of laxatives. The main part of the study and implications for practice will be presented in part 2.

Journal: Br J Nurs. 2007 Oct 11-24;16(18):1128-31.
Adapted from PubMed; click here to access full journal article.

Researching the Management of Constipation in Long-Term Care. Part 2

Authors: Grainger M, Castledine G, Wood N, Dilley C.

Institute of Ageing and Health, Birmingham.

The management of constipation is a problem in any healthcare setting. Constipation can affect all individuals; older people and those suffering from disabilities and long-term chronic conditions, such as Parkinson's disease and rheumatoid arthritis, are particularly vulnerable. This two-part article is based on a research study carried out in nine care homes, among patients of various ages with a variety of chronic conditions. The aim of the study was to investigate and improve bowel care in long-term care settings. The background to the study, including the definition, causes, risk assessment and management of constipation, were discussed in Part 1 (Castledine et al, 2007). Part 2 presents the main part of the study. Results show that appropriate education of staff improves their knowledge and practice in dealing with constipation. The importance of educating and training all members of the care team, especially healthcare assistants, in the management of bowel care is highlighted. An evidence-based approach using a constipation risk assessment, management of constipation flow chart and an interventions tool are identified as key factors in the ongoing care of patients in long-term settings.

Journal: Br J Nurs. 2007 Oct 25-Nov 7;16(19):1212-7.
Adapted from PubMed; click here to access full journal article.

Constipation in Pregnancy: Prevalence, Symptoms, and Risk Factors

Authors: Bradley CS, Kennedy CM, Turcea AM, Rao SS, Nygaard IE.

Department of Obstetrics and Gynecology, University of Iowa Carver College of Medicine, University of Iowa, Iowa City, Iowa 52242, USA. catherine-bradley@uiowa.edu

OBJECTIVE: To prospectively estimate constipation prevalence and risk factors in pregnancy. METHODS: We enrolled healthy pregnant women in this longitudinal study during the first trimester. At each trimester and 3 months postpartum, participants completed a self-administered bowel symptom questionnaire, physical activity and dietary fiber intake measures, and a prospective 7-day stool diary. Constipation was defined using the Rome II criteria (presence of at least two of the following symptoms for at least one quarter of defecations: straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction, manual maneuvers to facilitate defecation, and fewer than three defecations per week). Generalized linear logistic models explored factors associated with constipation during pregnancy. RESULTS: One hundred three women were enrolled with mean (+/-standard deviation) age of 28 (+/-5) years; 54% were nulliparous and 92% white. Constipation prevalence rates were 24% (95% confidence interval [CI] 16-33%), 26% (95% CI 17-38%), 16% (95% CI 8-26%), and 24% (95% CI 13-36%) in the first, second, and third trimesters and 3 months postpartum, respectively. Additionally, irritable bowel syndrome (by Rome II criteria) prevalence rates were 19% (95% CI 12-28%), 13% (95% CI 6-23%), 13% (95% CI 6-23%) and 5% (95% CI 1-13%) in the first, second, and third trimesters and 3 months postpartum, respectively. In multivariable longitudinal analysis, iron supplements (OR 3.5, 95% CI 1.04-12.10) and past constipation treatment (OR 3.58, 95% CI 1.50-8.57) were associated with constipation during pregnancy. CONCLUSION: Constipation measured using the Rome II criteria affects up to one fourth of women throughout pregnancy and at 3 months postpartum. LEVEL OF EVIDENCE: II.

Journal: Obstet Gynecol. 2007 Dec;110(6):1351-7.
Adapted from PubMed; click here to access full journal article.

Risk Factors for Chronic Constipation and a Possible Role of Analgesics

Authors: Chang JY, Locke GR, Schleck CD, Zinsmeister AR, Talley NJ.

Mayo Clinic College of Medicine, Rochester, MN 55905, USA.

Constipation has an estimated prevalence of 15% in the general population. However, the etiopathogenesis of this condition remains relatively obscure. This study sought to identify potentially novel risk factors for chronic constipation. A valid self-report questionnaire was mailed to an age- and gender-stratified random sample of Olmsted County, Minnesota residents aged 30-64 years. A logistic regression model that adjusted for age, gender and somatic symptom score (SSC) was used to identify factors associated with chronic constipation. People reporting symptoms of irritable bowel syndrome (IBS) were excluded. Of the 892 eligible subjects, 653 (73%) returned the survey. Among the 523 subjects not reporting IBS symptoms, chronic constipation was reported by 93 (18%) of the respondents. Chronic constipation was significantly associated with use of acetaminophen [>or=7 tablets per week, OR = 2.7 (1.1-6.6)]; aspirin [OR = 1.7 (1.0-2.7)]; non-steroidal anti-inflammatory drugs [OR = 1.8 (1.1-3.0)]; and SSC. No association was detected for age, gender, body mass index, marital status, smoking, alcohol, coffee, education level, food allergy, exposure to pets, stress, emotional support, or water supply. Chronic constipation is associated with use of acetaminophen, aspirin and non-steroidal anti-inflammatory drugs. The explanation of these associations requires further investigation.

Journal: Neurogastroenterol Motil. 2007 Nov;19(11):905-11.
Adapted from PubMed; click here to access full journal article.

Review of the Treatment Options for Chronic Constipation

Authors: Johanson JF.

University of Illinois College of Medicine, Rockford, Illinois, USA. johnfj@uic.edu

Constipation is a common gastrointestinal motility disorder that is often chronic, negatively affects patients' daily lives, and is associated with high healthcare costs. There is a considerable range of treatment modalities available for patients with constipation; however, the clinical evidence supporting their use varies widely. Nonpharmacologic modalities, such as increased exercise or fluid intake and bowel habit training, are generally recommended as first-line approaches, but data on the effectiveness of these measures are limited. The clinical benefits of various traditional pharmacologic agents (many of which are available over the counter, such as laxatives and fiber supplements) remain unclear. Although these modalities may benefit some patients with temporary constipation, their efficacy in patients for whom constipation is chronic is less well defined. Some studies suggest benefit with psyllium, polyethylene glycol, and lactulose; however, the use of other agents, such as calcium polycarbophil, methylcellulose, bran, magnesium hydroxide, and stimulant laxatives, is not supported by strong clinical evidence. More recently, newer agents have been approved for the treatment of patients with chronic constipation on the basis of comprehensive clinical investigation programs. Tegaserod, with its well-established clinical profile, and lubiprostone, the latest addition to the treatment armamentarium, represent the new generation of therapies for chronic constipation. This article reviews the efficacy and safety of traditional therapies used in the management of the multiple symptoms associated with chronic constipation and discusses recently approved and emerging therapies for this disorder.

Journal: MedGenMed. 2007 May 2;9(2):25.
Adapted from PubMed; click here to access full journal article.

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