Cochrane Briefs
Laxatives for Hemorrhoids?
Clinical Question
Are laxatives effective for the treatment of symptomatic hemorrhoids in adults?
Evidence-Based Answer
Fiber has a consistent beneficial effect in the treatment of symptomatic hemorrhoids for up to three months' follow-up as measured by overall symptoms and bleeding.
Practice Pointers
Hemorrhoid treatment options include medical management, rubber-band ligation, sclerotherapy, coagulation, and surgical hemorrhoidectomy depending on the type of hemorrhoid and the frequency and severity of symptoms. The goal of first-line medical management is to minimize constipation and associated straining. Clinical practice guidelines recommend the use of fiber despite inconclusive evidence about its effectiveness in improving symptoms.
Alonso-Coello and colleagues reviewed the literature and identified seven randomized controlled trials comparing the effectiveness of fiber versus placebo in adults 23 to 71 years of age with symptomatic hemorrhoids. The trials studied several types of fiber including ispaghula husk, Plantago ovata or psyllium, sterculia, and unprocessed bran for a treatment duration of one to 18 months. Study size ranged between 28 and 92 participants with a mean of 50. Six of the seven trials assessed the degree of improvement of individual symptoms (e.g., bleeding, pain, itching, prolapse) or overall symptoms measured at six weeks' and three months' follow-up. One study examined rubber-band ligation plus fiber versus rubber-band ligation alone for third-degree hemorrhoids (defined as hemorrhoids that prolapse with straining but are reducible) and measured recurrence rate and the need for repeat procedures at 18 months.
The results of five studies reporting overall symptoms were pooled and showed a 53 percent reduction in the risk of persistent symptoms or lack of improvement. Of those taking fiber, 16 to 40 percent did not improve compared with 23 to 61 percent of those taking placebo. The four studies that reported bleeding as an individual outcome found a trend or a significant difference in favor of the fiber group. Pooled analysis of the two studies evaluating pain or discomfort showed a nonsignificant trend in favor of fiber. Likewise, the pooled analysis of three studies showed a nonsignificant difference between fiber and placebo for persistent pro-lapse. The two studies that evaluated itching did not find a significant difference between the groups. The one study examining rubber-band ligation plus fiber versus rubber-band ligation alone reported that the number of long-term recurrences was fewer overall in the group that received fiber (15 versus 45 percent, respectively) at 18 months' follow-up.
The most common side effects with fiber were gastrointestinal symptoms, typically starting at the study onset, and these generally were not severe enough for participants to discontinue fiber. The rate of side effects varied considerably among studies, with some studies reporting no side effects and others reporting up to a 50 percent incidence of gastrointestinal bloating.
The American Gastroenterological Association recommends adequate water and fiber intake as the main-stay of medical management and suggests that topical steroids and analgesics also may be useful in relieving hemorrhoidal symptoms.1
Are Atypical Antipsychotics Safe in Patients with Alzheimer's Disease?
Clinical Question
Are atypical antipsychotic medications safe and effective for the treatment of behavioral and psychological disturbances in patients with Alzheimer's disease?
Evidence-Based Answer
Although the atypical antipsychotic medications risperidone (Risperdal) and olanzapine (Zyprexa) are modestly efficacious in reducing aggression, routine use is not justified. Both drugs are associated with serious adverse cerebrovascular events and extrapyramidal symptoms. Use of atypical antipsychotics in dementia significantly increases mortality (odds ratio [OR] = 1.7).
Practice Pointers
More than 50 percent of persons with Alzheimer's disease experience behavioral and psychological disturbances, which often are the stimulus for placement in residential or nursing home care. Antipsychotic medications have been used widely to mitigate these symptoms in patients with Alzheimer's disease, despite their known adverse effects. Because much data remain unpublished by pharmaceutical companies, the risk of serious adverse events from the use of atypical antipsychotics is not widely recognized.
Ballard and Waite systematically reviewed the published and unpublished literature on atypical antipsychotics in patients with Alzheimer's disease and found 16 randomized, double-blind studies that evaluated these agents. They concluded that, compared with placebo, there was a significant improvement in aggression in patients treated with risperidone or olanzapine and an improvement in psychosis in patients treated with risperidone. However, risperidone was associated with a significantly higher incidence of serious adverse cerebrovascular events (OR = 3.64; 95% confidence interval [CI], 1.72 to 7.69) and extrapyramidal side effects (for 2 mg daily, OR = 3.39; 95% CI, 1.69 to 6.80). Other adverse effects included somnolence, upper respiratory tract infections, edema, urinary tract infections, and fever. There were insufficient data to examine the impact of these medications on cognitive function.
In April 2005, the U.S. Food and Drug Administration (FDA) completed a meta-analysis1 of clinical studies assessing the use of atypical antipsychotics for the treatment of behavioral disorders in older patients with dementia. The results demonstrated a high death rate in patients treated with atypical antipsychotics compared with those receiving placebo.1 The FDA subsequently requested that the manufacturers of these drugs add a boxed warning to their drug labeling describing this risk and noting that these drugs are not approved for this indication.1
In practice, limited use of atypical antipsychotics in patients with Alzheimer's disease may be considered when patients display a serious, life-threatening risk to themselves or others. Nonpharmacologic treatment options include educating caregivers about managing behavioral symptoms, using lighting to reduce nighttime confusion and restlessness, simplifying tasks, and adhering to predictable routines.2 Sensory enhancement, social contact, behavior therapy, and environmental interventions3 also may decrease the occurrence of agitated behaviors. A clinical guideline3 on the nonpharmacologic management of dementia from the University of Iowa Gerontological Nursing Interventions Research Center is available at http://www.guideline.gov.
Source
Ballard C, et al. Atypical antipsychotics for aggression and psychosis in Alzheimer's disease. Cochrane Database Syst Rev. 2006;(1):CD003476.
REFERENCES
1. U.S. Food and Drug Administration. Public Health Advisory. Deaths with antipsychotics in elderly patients with behavioral disturbances. April 11, 2005. Accessed May 9, 2006, at: http://www.fda.gov/cder/drug/advisory/antipsychotics.htm.
2. California Workgroup on Guidelines for Alzheimer's Disease Management. Guidelines for Alzheimer's disease management. Los Angeles, Calif.: Alzheimer's Association of Los Angeles, Riverside and San Bernardino Counties, 2002. Accessed May 9, 2006, at: http://www.guideline.gov/summary/summary.aspx?ss=14&doc_id=3157&string=.
3. McGonigal-Kenney ML, Schutte DL. Non-pharmacologic management of agitated behaviors in persons with Alzheimer disease and other chronic dementing conditions. Iowa City, Iowa: University of Iowa Gerontological Nursing Interventions Research Center, Research Dissemination Core, 2004. Accessed May 9, 2006, at: http://www.guideline.gov/summary/summary.aspx?ss=14&doc_id=6221&string=.
The series coordinator for AFP is Clarissa Kripke, M.D., Department of Family and Community Medicine, University of California, San Francisco.
Copyright © 2006 by the American Academy of Family Physicians.
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