Practice Guidelines
ACG Releases Updated Practice Guidelines for Ulcerative Colitis in Adults
The American College of Gastroenterology's Practice Parameters Committee has issued updated practice guidelines for the treatment of ulcerative colitis in adults. The guidelines were generated by an expert panel's review of published evidence and outline the preferred approaches to the treatment of patients with ulcerative colitis, a chronic disease characterized by diffuse mucosal inflammation of the colon and marked by bloody diarrhea, rectal urgency, and tenesmus. Ulcerative colitis affects 250,000 to 500,000 people in the United States each year resulting in steep hospital and drug costs as well as lost work. The full text of the updated practice guidelines, which originally appeared in the July 2004 issue of the American Journal of Gastroenterology, is available at http://www.acg.gi.org/physicians/guidelines/UlcerativeColitisUpdate.pdf.
The quality of evidence on which a recommendation is based is as follows:
Grade A: Homogenous evidence from multiple well-designed randomized (therapeutic) or cohort (descriptive) controlled trials, each involving a number of participants to be of sufficient statistical power.
Grade B: Evidence from at least one large well-designed clinical trial with or without randomization, from cohort or case-control analytic studies, or well-designed meta analyses.
Grade C: Evidence based on clinical experience, descriptive studies, or reports of expert committees.
Diagnosis and Management
In patients with persistently bloody diarrhea, rectal urgency, or tenesmus, stool examinations, sigmoidoscopy, and biopsy should be performed to confirm the presence of colitis and to exclude the presence of infectious etiologies. When obtaining the patient's history, the clinician should inquire about factors known to exacerbate symptoms of ulcerative colitis, such as recent or past smoking cessation or use of nonsteroidal anti-inflammatory drugs.
Because infectious agents can produce symptoms indistinguishable from ulcerative colitis, microbiologic analyses for bacteria, parasites, and amoebas should be performed. In particular, infection with Escherichia coli O157:H7 and Clostridium difficile (in patients who have been recently hospitalized or who have received antibiotics) should be excluded.
Proctosigmoidoscopy or colonoscopy will reveal the mucosal changes characteristic of ulcerative colitis: loss of the typical vascular pattern, granularity, friability, and ulceration. These changes usually appear in the distant rectum and proceed proximally to involve part or all of the colon, although isolated cecal inflammation may be seen.
If a diagnosis of Crohn's disease is being considered, radiographs of the small bowel will help distinguish it from ulcerative colitis. The diagnosis may be Crohn's disease if histology finds noncaseating granulomas or microscopic focality. In patients with acute onset of bloody diarrhea, mucosal biopsy may help distinguish ulcerative colitis from infectious colitis. In patients who have ulcerative colitis, the following occur: the mucosa more commonly demonstrates separation, distortion, and atrophy of crypts; inflammatory cells in the lamina propria; neutrophils in the crypt epithelium; elevated plasma cells near the crypt bases; and basilar lymphoid aggregates.
Management
Treatment for ulcerative colitis seeks to improve quality of life by inducing and maintaining remission of symptoms and inflammation. The extent of the proximal margin of inflammation, assessed by endoscopy, is either distal (limited to below the splenic flexure and within reach of topical therapy) or extensive (extending proximal to the splenic flexure, requiring systemic medication). Because an important criterion for treatment of ulcerative colitis is quality of life, patients' quality-of-life concerns should be elicited, particularly as they relate to function in school, at work, or in personal relationships. Management should be tailored to meet these concerns.
Clinical and endoscopic findings will allow the clinician to assess the disorder's severity, which is characterized as mild (fewer than four stools daily, with or without blood, no systemic signs of toxicity, normal erythrocyte sedimentation rate [ESR]); moderate (more than four stools daily, minimal signs of toxicity); severe (more than six bloody stools daily, evidence of toxicity [fever, tachycardia, anemia, elevated ESR]); or fulminant (more than 10 stools daily, continuous bleeding, toxicity, abdominal tenderness and distension, blood transfusion requirement, colonic dilation on abdominal plain films).
Patients with mild or moderate distal colitis may be treated with: oral aminosalicylate (ASA) (4 to 6 g per day of sulfasalazine in four divided doses; 2 to 4.8 g per day of mesalamine in three divided doses [Evidence A]; 6.75 g per day of balsalazide in three divided doses); topical mesalamine (suppositories, 500 mg twice a day, or enemas, in doses of 1 to 4 g); or topical steroids (100-mg hydrocortisone enema or 10 percent hydrocortisone foam). The combination of oral and topical ASAs is more effective than either alone (oral mesalamine, 2.4 g per day and 4 g per day mesalamine enema) (Evidence A). If patients do not respond to mesalamine enemas or suppositories, oral prednisone (up to 40 to 60 mg per day) should be administered.
Patients with mild or moderate extensive colitis should begin therapy with oral sulfasalazine in daily doses titrated up to 4 to 6 g per day, or an alternative ASA in doses up to 4.8 g per day of the active 5-ASA moiety. Oral steroids should be reserved for patients whose disease does not respond to other therapies or for patients with troubling symptoms that demand immediate improvement, and patients who receive steroids should be observed for signs of toxicity. When the inflammation extends beyond the reach of topical therapy, oral therapy should be used, with sulfasalazine at 4 to 6 g per day being the first line of treatment. At this dosage, 80 percent of patients will experience clinical remission or improvement within four weeks.
Treatment with transdermal nicotine patches (15 to 25 mg per day) has resulted in improvement and remission in patients with mild or moderate ulcerative colitis, but the success rate of this treatment is lower than that of traditional ASA therapy. Unsurprisingly, this treatment provides more benefit to ex-smokers and is better tolerated by them. Nicotine (15 mg per day) was not effective in maintaining remission.
Maintenance of Remission
Maintenance regimens are required after the acute attack is controlled. Patients with extensive or relapsing disease will need maintenance therapy.
Mesalamine suppositories (500 g twice a day) are effective in maintaining remission in patients with proctitis. Mesalamine enemas (2 to 4 g) are effective in patients with distal colitis, even if they receive the drug as infrequently as every third night. The following drug regimens were all found to be effective in maintaining remission in distal disease: sulfasalazine, 2 g per day; olsalazine, 1 g per day, Eudragit-S-coated mesalamine, 3.2 g per day, balsalazide, 3 to 6 g per day. The combination of oral mesalamine (1.6 g per day) and mesalamine enema (4 g twice a week) is more effective than oral mesalamine alone. Topical corticosteroids have not been proved effective for maintaining remission.
In patients with mild to moderate extensive colitis, remission is maintained by treatment with sulfasalazine (2 to 4 g per day, with the highest dose most effective but the least well tolerated), olsalazine, mesalamine, or balsalazide. If patients do not respond to this first-line therapy, steroids may be administered. Azathioprine (1.5 to 2.5 mg per kg per day) or 6-Mercaptopurine may be useful as steroid-sparing agents for steroid-dependent patients and for maintenance of remission not adequately sustained by ASA, and occasionally for patients who are refractory to steroids but not acutely ill.
In general, patients should not be chronically treated with steroids because of their toxic adverse effects, but if they are, postmenopausal women should receive calcium supplements (1,000 to 1,500 mg per day) and vitamin D (800 units per day) to stave off osteoporosis. All patients receiving steroids should stop smoking, limit alcohol intake, and increase their activity levels.
Management of Severe Colitis
Severe colitis refractory to drug treatment should be treated medically with intravenous cyclosporine (Evidence A) or surgically with colectomy (Evidence C); the latter treatment involves hospitalization and is beyond the scope of primary care practice.
Cancer Surveillance
Patients with ulcerative colitis are at increased risk for colorectal cancer, with the degree of risk related to the duration of disease and its anatomic extent. Patients with ulcerative colitis with a family history of colorectal cancer have a fivefold higher risk of cancer compared with matched controls, although data suggest that cancer risk is reduced in patients who take at least 2 g per day of ASA. Patients who have colitis for eight to 10 years should receive annual or biannual surveillance colonoscopy with regular biopsies (Evidence B). The finding of high-grade dysplasia in flat mucosa is an indication for colectomy; the finding of low-grade dysplasia in flat mucosa may be an indication for colectomy to prevent progression to a higher grade of neoplasia (Evidence B).
Compared with non-colitis-associated colorectal cancer, colitis-associated cancers are more often multiple, broadly infiltrating, anaplastic, and uniformly distributed throughout the colon, and they seem to arise from flat mucosa. Colitis-related tumors also occur in younger patients. High- and low-grade dysplasia standards should be used to diagnose dysplasia. Colonoscopic biopsy diagnosis of dysplasia in flat mucosa often indicates concurrent or future cancer. Patients with high-grade dysplasia should undergo colectomy; patients with low-grade dysplasia should consider it, because the five-year predictive value of the presence of low-grade dysplasia for either cancer or high-grade dysplasia is as high as 54 percent.
Practice Guideline Briefs
Guidelines for Cardiovascular Disease Prevention in Women
The American Heart Association (AHA) has developed new guidelines for the prevention of cardiovascular disease in women who have a wide range of risk factors. The recommendations, "Evidence-Based Guidelines for Cardiovascular Disease Prevention in Women,” are available online at http://circ.ahajournals.org/cgi/content/full/109/5/672.
• Lifestyle Interventions. The AHA panel recommends that women be encouraged consistently not to smoke and to avoid environmental smoke. Women should exercise a minimum of 30 minutes most days of the week. Weight maintenance or reduction should be encouraged through a balance of physical activity, caloric intake, and behavior programs when indicated to maintain a body mass index between 18.5 and 24.9 kg per m2 and a waist circumference of less than 35 in (88.9 cm). Healthy eating patterns should be encouraged, including eating a variety of fruits, vegetables, grains, low-fat or nonfat dairy products, fish, legumes, and sources of protein that are low in saturated fat. Intake of saturated fat should be limited to less than 10 percent of total calories and cholesterol intake should be kept below 300 mg per day. Omega-3 fatty acid and folic acid supplementation should be considered in high-risk women. Women with recent acute coronary syndrome, coronary intervention, or new-onset or chronic angina should participate in a comprehensive risk-reduction program, such as cardiac rehabilitation or a physician-guided, home- or community-based program.
• Major Risk Factor Interventions. Lifestyle approaches should be used to maintain blood pressure below 120/80 mm Hg. Pharmacotherapy is indicated when blood pressure is 140/90 mm Hg or above; this threshold is even lower in women with blood pressure-related target organ damage or diabetes. Thiazide diuretics should be part of the drug regimen in most patients. Lifestyle approaches should be encouraged to maintain optimal levels of lipids and lipoproteins: low-density lipoprotein (LDL) cholesterol levels of less than 100 mg per dL (2.60 mmol per L), high-density lipoprotein (HDL) levels of more than 50 mg per dL (1.30 mmol per L), triglyceride levels less than 150 mg per dL (1.7 mmol per L), and non-HDL-cholesterol levels (i.e., total cholesterol minus HDL cholesterol) of less than 130 mg per dL (3.36 mmol per L).
In high-risk women or when LDL cholesterol levels are elevated, saturated fat intake should be limited to less than 7 percent of total calories, and cholesterol to less than 200 mg per day. Trans fatty acid intake should be reduced. LDL-lowering therapy (preferably statins) and lifestyle interventions should be started simultaneously in high-risk women with LDL cholesterol levels of at least 100 mg per dL. Statin therapy alone should be started in high-risk women with LDL cholesterol levels of less than 100 mg per dL, unless contraindicated. Niacin or fibrate therapy should be started when HDL cholesterol levels are low or non-HDL cholesterol levels are high in high-risk women.
• Preventive Drug Regimens. Aspirin (75 to 162 mg per day) or clopidogrel therapy should be used in high-risk women unless contraindicated. In intermediate-risk women, aspirin therapy can be considered as long as blood pressure is controlled. Beta blockers should be used indefinitely in all women who have had a myocardial infarction or who have chronic ischemic syndromes. Angiotensin-converting enzyme (ACE) inhibitors should be used in high-risk women. Angiotensin-receptor blockers should be used in high-risk women with clinical evidence of heart failure or an ejection fraction of less than 40 percent who cannot tolerate ACE inhibitors.
• Prevention of Atrial Fibrillation and Stroke. Warfarin should be used in women with chronic or paroxysmal atrial fibrillation to maintain the International Normalized Ratio at 2.0 to 3.0, unless the patient is considered to be at low risk for stroke or high risk for bleeding. Aspirin (325 mg per day) should be used in women with chronic or paroxysmal atrial fibrillation with a contraindication to warfarin or at low risk for stroke.
• Class III Interventions. Combined estrogen plus progestin hormone therapy and other forms of menopausal hormone therapy should not be used to prevent cardiovascular disease in postmenopausal women. Antioxidant supplementation should not be used to prevent cardiovascular disease, and routine use of aspirin in low-risk women also is not recommended.
Benefits of Omega-3 Fatty Acids
Consumption of fish oil can help reduce deaths from heart disease, but its effects on other outcomes are inconclusive, according to evidence reports from the Agency for Healthcare Research and Quality (AHRQ). The reports are available online at http://www.ahrq.gov/clinic/epcindex.htm#dietsup.
An analysis of 10 randomized controlled trials (RCTs) and nine other studies addressed the effects of omega-3 fatty acids on respiratory outcomes. The AHRQ could not conclude whether omega-3 fatty acids are an efficacious adjuvant or monotherapy in improving respiratory outcomes in adults or children.
Six studies were analyzed to determine the role of omega-3 fatty acids in primary prevention of asthma. Dietary fish consumption appears to serve as primary prevention for asthma in pediatric populations. However, asthma prevalence and fish intake were significantly and positively related in studies that included Asian adolescents. Another study found no association between adult asthma onset and dietary fish intake.
In terms of cardiovascular benefits, a number of studies show that fish consumption and fish and alpha linolenic acid (ALA) supplementation reduces all-cause mortality and various cardiovascular outcomes, although the evidence is strongest for fish and fish oil. The effects on specific outcomes (especially myocardial infarction [MI] and stroke) are uncertain, and the optimal quantity and type of omega-3 fatty acid, and the optimal ratio of omega-3 to omega-6 fatty acid remain unknown. The most significant benefit may be in reducing sudden cardiac death. Four of six RCTs found a benefit, one found no benefit, and one found harm, although all six were thought to be poorly designed. Adverse events from fish oil and ALA supplementation appear to be minor.
Overall, strong evidence shows that fish oils have a strong, dose-dependent beneficial effect on triglyceride levels. There also is evidence of possible small beneficial effects on blood pressure and coronary artery restenosis after angioplasty, exercise capacity in patients with coronary atherosclerosis, and heart rate variability, particularly in patients with recent MI. Omega-3 fatty acids do not appear to affect total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, fasting blood sugar, or glycosylated hemoglobin levels, and they had no effect on plasma insulin levels and insulin resistance in patients with type 2 diabetes.
Assisted Reproductive Technology Statistics
More than 40,000 infants were born in 2001 as a result of assisted-reproductive technology (ART) procedures, according to data from the Centers for Disease Control and Prevention. The report, "Assisted Reproductive Technology Surveillance-United States, 2001,” is available online at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5301a1.htm.
Most of the women who underwent ART used freshly fertilized embryos from their own eggs (75 percent of the 107,587 ART procedures performed in 2001). A total of 14 percent used thawed embryos from their own eggs, 8 percent used freshly fertilized embryos from donor eggs, and 3 percent used thawed embryos from donor eggs. Although the average live-birth rate for ART-transfer procedures performed among women who used their own freshly fertilized eggs was 33 percent, live-birth rates ranged from 41 percent among women younger than 35 years to 7 percent among women older than 42 years. The highest success rates were reported in patients who used donor eggs and freshly fertilized embryos (56 percent pregnancy rate, 47 percent live-birth rate, and 27 percent singleton live-birth rate).
Nearly one half of ART procedures using freshly fertilized embryos from the patient's own eggs were performed in women younger than 35. Tubal factor, male factor, and endometriosis were more common in younger women; overall, 10 to 13 percent of couples had unexplained infertility, 10 to 17 percent had multiple female factors, and 17 to 21 percent had both male and female factors.
In all, the 29,344 live-birth deliveries resulted in 40,687 infants; the number of infants born was higher than the number of deliveries because of multiple-birth deliveries.
AHA Report on Response to Cardiac Arrest
The American Heart Association (AHA) has developed a medical emergency response plan for schools to reduce the incidence of life-threatening emergencies and maximize the chances of survival. The report, "Response to Cardiac Arrest and Selected Life-Threatening Medical Emergencies,” is available online at http://circ.ahajournals.org/cgi/content/full/109/2/278.
Life-threatening emergencies can occur in students and adults and can be the result of preexisting health problems, violence, unintentional injuries, natural disasters, and toxins. Each year, more than one third of schools may have an emergency that involves an adult and requires the activation of the emergency medical services system. Schools now have fewer nurses, and nurses often rotate between schools, leaving some schools without professional medical care for hours or days each week. The AHA and other professional organizations have recommended school emergency response plans to increase the potential of saving lives and make the most efficient use of school equipment and personnel.
The core elements of the plan include effective and efficient communication throughout the school campus; a coordinated and practiced response plan; risk reduction through safety precautions and identification of potential high-risk situations; training and equipment for first aid and cardiopulmonary resuscitation; and implementation of a lay rescuer automated external defibrillator program in schools that have an established need.
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