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At least 451 records · Page 25Linked to original sources
PubMed2003

Incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery in relation to use of alosetron hydrochloride.

OBJECTIVE: Alosetron hydrochloride (Lotronex), a potent selective 5-hydroxytryptamine(3) receptor antagonist, was approved in February, 2000 in the United States for the treatment of diarrhea-predominant irritable bowel syndrome (IBS) in women. Marketing was suspended in November, 2000, after reports of colonic ischemia and serious complications of constipation. We sought to compare the incidence of colonic ischemia, hospitalized complications of constipation, and bowel surgery among alosetron users and a cohort of patients with IBS who did not use alosetron. METHODS: We sought outcomes of colonic ischemia, hospitalized complications of constipation, and bowel surgery in 3,631 Lotronex users and 2,480 comparison IBS subjects using diagnoses, procedures, and drugs recorded in the UnitedHealthcare insurance claims database, and validated these by chart review. The initial assessment was to last for 3 yr beginning with the start of alosetron treatment and was to include 10,000 Lotronex users; however, the observation period ended by December 31, 2000, after suspension of marketing. RESULTS: There were 3631 alosetron users among members of UnitedHealthcare from March through December, 2000, and we identified 2480 comparison IBS-only patients; follow-up time averaged about 5 months in both groups. There were no instances of colonic ischemia in either cohort. Thirty instances of bowel surgery occurred, giving rates of 10.2/1000 person-yr in the alosetron cohort and 11.8/1000 person-yr in the IBS/no alosetron cohort. There were three cases of hospitalized complications of constipation. The incidence rates were essentially the same in alosetron users (1.24/1000 person-yr) and in IBS patients with no alosetron use (0.92/1000 person-yr). CONCLUSIONS: Alosetron users did not differ from IBS patients not using alosetron in the incidence of bowel surgery or hospitalized complications of constipation; there were no cases of colonic ischemia. The statistical upper limit of colonic ischemia rates in alosetron users was 2.28/1000 person-yr. Because of the market withdrawal, the size of the cohort and the duration of follow-up were smaller than originally planned; consequently, the statements about the safety of alosetron were necessarily limited. On June 7, 2002, the Food and Drug Administration approved alosetron for reintroduction in the U.S. market for women with severe diarrhea-related IBS.

Adolescent↗
PubMed2005

Tegaserod for the treatment of chronic constipation: a randomized, double-blind, placebo-controlled multinational study.

OBJECTIVES: Chronic constipation is a common, persistent disorder with limited effective treatment options. This study investigated the efficacy, safety, and tolerability of tegaserod in the treatment of chronic constipation. METHODS: After a 2-wk baseline period, patients were randomized to double-blind treatment of 12 wk with tegaserod (2 or 6 mg b.i.d.) or placebo. Response during weeks 1-4 (primary variable) was defined as an increase in complete spontaneous bowel movement (CSBM)/wk. Secondary variables included response during weeks 1-12, patient evaluation of individual symptoms, and global assessment of bowel habits and constipation. RESULTS: One thousand two hundred and sixty-four patients were randomized to tegaserod or placebo. Responder rates for the primary efficacy variable were 35.6% for tegaserod 2 mg b.i.d. (p= 0.0059 vs placebo), 40.2% for 6 mg b.i.d. (p < 0.0001 vs placebo) and 26.7% for placebo. The number needed to treat was 7.3 for the 6 mg b.i.d. dose compared with 11.1 for tegaserod 2 mg b.i.d. Tegaserod 6 mg b.i.d. reduced straining, abdominal bloating/distension, and abdominal pain/discomfort during the 12-wk treatment period compared with placebo (p < 0.05 for all symptoms). Significant improvements were also seen in stool form and in global assessment of bowel habits and constipation. The most common adverse events, headache and abdominal pain, were more frequent with placebo than with tegaserod. CONCLUSIONS: Tegaserod was efficacious in relieving symptoms of chronic constipation and was well tolerated.

Chronic Disease↗
PubMed2006

Incidence of ischemic colitis and serious complications of constipation among patients using alosetron: systematic review of clinical trials and post-marketing surveillance data.

BACKGROUND: Ischemic colitis and serious complications of constipation have been reported in association with the use of alosetron, which is approved for women with severe diarrhea-predominant IBS who have failed conventional therapies. This systematic review calculated the incidence of these adverse events in alosetron-using patients in clinical trials and post-marketing surveillance. METHODS: A panel of experts in epidemiology and functional bowel disorders reviewed clinical trial report forms and FDA MedWatch forms of each reported case of ischemic colitis or serious complications of constipation. Experts were blinded about whether patients used alosetron or placebo. Using pre-specified criteria, experts rated the likelihood of an accurate diagnosis and an association between medication use and adverse events. Cases that were not consistent with the reported diagnosis or not possibly associated with medication use were eliminated from calculation of incidence rates of adverse events. RESULTS: Pooled data from clinical trials indicate an increased rate of ischemic colitis among alosetron-using patients compared to placebo-using patients (0.15%vs 0.0%, respectively, p = 0.03), but there was no significant difference in the rate of serious complications of constipation. All (19/19) alosetron-using patients with ischemic colitis had reversible colitis without long-term sequelae. Based on post-marketing surveillance data, the post-adjudication rate of ischemic colitis is 1.1 per 1,000 patient-years of alosetron use and the rate of serious complications of constipation is 0.66 per 1,000 patient-years of alosetron use. CONCLUSION: The incidence of ischemic colitis and serious complications of constipation is very low and is rarely associated with long-term sequelae or serious morbidity.

Carbolines↗
PubMed2006

Efficacy of tegaserod in chronic constipation in men.

OBJECTIVES: Chronic constipation/idiopathic constipation is highly prevalent in western countries and traditional treatments are suboptimal. This multicenter study evaluated the efficacy and safety of tegaserod, a selective 5-HT(4) agonist and promotility agent, in men with chronic constipation. METHODS: After screening and baseline phases, men with chronic constipation were randomized to receive either tegaserod 6 mg twice daily or placebo in a double-blind manner for 12 wk. Patients recorded symptoms using a diary. Primary efficacy variable was the response rate for an increase in complete spontaneous bowel movements (CSBMs) during the first 4 wk of double-blind treatment. Other efficacy measures included patient assessment of symptoms and satisfaction with symptom relief. Safety and tolerability were also evaluated. RESULTS: In total, 322 patients were randomized to tegaserod (N = 158) or placebo (N = 164). Increases of at least one CSBM per wk during the first 4 wk of treatment observed for tegaserod compared with placebo (40.5%vs 29.3%, P= 0.03) were sustained throughout the 12-wk treatment period. Response rate for CSBM was also superior for tegaserod (P= 0.04 vs placebo) over the treatment period. Benefits for tegaserod over placebo were also observed for some secondary efficacy variables, however, statistical significance was not achieved at all weeks. Frequency of adverse events was similar with tegaserod and placebo. CONCLUSIONS: Tegaserod 6 mg twice daily was effective and well tolerated in the treatment of chronic constipation in men. Tegaserod provided rapid relief of constipation within 1 wk and the effects were sustained for up to 12 wk.

Administration, Oral↗
PubMed2005

The role of glial cells and apoptosis of enteric neurones in the neuropathology of intractable slow transit constipation.

BACKGROUND: Idiopathic slow transit constipation is one of the most severe and often intractable forms of constipation. As motor abnormalities are thought to play an important pathogenetic role, studies have been performed on the colonic neuroenteric system, which rules the motor aspects of the viscus. AIMS: We hypothesised that important neuropathological abnormalities of the large bowel are present, that these are not confined to the interstitial cells of Cajal and ganglion cells, and that the previously described reduction of enteric neurones, if confirmed, might be related to an increase in programmed cell death (apoptosis). PATIENTS AND METHODS: Surgical specimens from 26 severely constipated patients were assessed by conventional and immunohistochemical methods. Specific staining for enteric neurones, glial cells, interstitial cells of Cajal, and fibroblast-like cells associated with the latter were used. In addition, gangliar cell apoptosis was evaluated by means of indirect and direct techniques. Data from patients were compared with those obtained in 10 controls. RESULTS: Severely constipated patients displayed a significant decrease in enteric gangliar cells, glial cells, and interstitial cells of Cajal. Fibroblast-like cells associated with the latter did not differ significantly between patients and controls. Patients had significantly more apoptotic enteric neurones than controls. CONCLUSION: Severely constipated patients have important neuroenteric abnormalities, not confined to gangliar cells and interstitial cells of Cajal. The reduction of enteric neurones may in part be due to increased apoptotic phenomena.

Adult↗
PubMed1988

Neurophysiological dysfunction in young women with intractable constipation.

Fifteen women with intractable chronic idiopathic constipation dating from adolescence were investigated by anorectal manometry, neurophysiological evaluation of the conus medullaris and external anal sphincter. Comparison was made with 25 asymptomatic female control subjects. Urological disturbances were common amongst the constipated, in five of whom incidental lumbosacral spinal dysraphism was found. No differences in sphincter pressures or the rectosphincteric reflex were demonstrable between the two groups. Rectal defecatory sensation was blunted and the compliance was increased in the constipated group. The latency of the pudendo-anal reflex was significantly prolonged in idiopathic constipation, two women having an absent reflex (greater than 100 ms). Mean motor unit potential duration of the external anal sphincter was not significantly prolonged in the eight constipated women tested. A central neurogenic deficit is postulated in some women with this disorder.

Adult↗
PubMed1989

Relationships between symptoms, menstrual cycle and orocaecal transit in normal and constipated women.

Because severe constipation is a disorder largely confined to young women, the possibility that menstrually related factors contribute to disturbed gastrointestinal motor function has been raised. It has also been reported that normal menstruating women show changes in upper gut transit between the follicular and luteal phases of the menstrual cycle and that patients with constipation show prolonged transit. We therefore studied relationships between symptom severity and orocaecal transit during the menstrual cycle in a group of 14 constipated women and a series of control groups comprising seven normal menstruating women, five postmenopausal women, and eight normal men, to determine whether phases of the menstrual cycle were associated with alteration in symptoms or transit. A regular menstrual cycle was reported by 13 of the 14 patients (range 26-30 days) and by all the menstruating female volunteers. Seven patients noted variation in constipation during the menstrual cycle, in all cases this comprised an improvement in symptoms just before or during menstruation. No consistent relationship between symptom severity and follicular or luteal phase was noted. Repeated orocaecal transit measurements in the four study groups showed no consistent differences (greater than 0.05) between groups or during the menstrual cycle (mean change weeks 1-4, -10 +/- 20 min). These findings are inconsistent with the hypothesis of a progesterone related effect upon orocaecal transit in either normal or constipated women.

Adult↗
PubMed1993

Constipation in early childhood: patient characteristics, treatment, and longterm follow up.

Little is known about chronic constipation in infants, toddlers, and preschool children and longterm outcome after treatment. The symptoms of 174 children < or = 4 years of age, who were evaluated for chronic constipation, are reported in this study together with the long-term outcome in 90 of them. Initial symptoms were infrequent bowel movements in 58%, painful bowel movements in 77% often with screaming, and severe stool withholding manoeuvres in 97%. The treatment of chronic idiopathic constipation consisted of education, faecal disimpaction, prevention of future impaction, and promotion of regular bowel habits with dietary fibre and milk of magnesia, and finally toilet training of the preschool child. Longterm outcome could be evaluated in 90 patients (52%) (mean (SD) 6.9 (2.7)) years after initial evaluation. Fifty seven children (63%) had recovered, defined as no soiling with > or = 3 bowel movements per week, while not receiving treatment. The recovery rate of children < or = 2 years of age was significantly higher than in children > 2 to 4 years of age. Thirty three children (37%) had not recovered. Constipation recurred as soon as laxatives were discontinued in 31 (94%) of them. Laxatives were still used by 33% of the children who had not recovered, 39% had < 3 bowel movements per week, 48% had faecal soiling, 45% had stool withholding, 27% complained of abdominal pain, 73% passed large stools, and 45% still on occasions clogged the toilet with their large stools. Symptoms of chronic constipation persisted in one third of our patients, 3-12 years after initial evaluation and treatment. Children who had not recovered deserve continued follow up, to reinforce and adjust treatment and to prevent faecal soiling.

Age Factors↗
PubMed2002

Pan-colonic decrease in interstitial cells of Cajal in patients with slow transit constipation.

BACKGROUND: Interstitial cells of Cajal (ICC) are required for normal intestinal motility. ICC are found throughout the human colon and are decreased in the sigmoid colon of patients with slow transit constipation. AIMS: The aims of this study were to determine the normal distribution of ICC within the human colon and to determine if ICC are decreased throughout the colon in slow transit constipation. PATIENTS: The caecum, ascending, transverse, and sigmoid colons from six patients with slow transit constipation and colonic tissue from patients with resected colon cancer were used for this study. METHODS: ICC cells were identified with a polyclonal antibody to c-Kit, serial 0.5 microm sections were obtained by confocal microscopy, and three dimensional software was employed to reconstruct the entire thickness of the colonic muscularis propria and submucosa. RESULTS: ICC were located within both the longitudinal and circular muscle layers. Two networks of ICC were identified, one in the myenteric plexus region and another, less defined network, in the submucosal border. Caecum, ascending colon, transverse colon, and sigmoid colon displayed similar ICC volumes. ICC volume was significantly lower in the slow transit constipation patients across all colonic regions. CONCLUSIONS: The data suggest that ICC distribution is relatively uniform throughout the human colon and that decreased ICC volume is pan-colonic in idiopathic slow transit constipation.

Adolescent↗
PubMed1996

Paradoxical puborectalis contraction is a feature of constipation in patients with multiple sclerosis.

OBJECTIVE: To study the disturbed anorectal physiology associated with constipation in multiple sclerosis. METHODS: Anorectal function in 10 patients with clinically definite multiple sclerosis and constipation has been compared with 10 normal persons and 11 patients with idiopathic constipation, without multiple sclerosis. RESULTS: All 10 constipated patients with multiple sclerosis had difficulty evacuating barium paste during defaecography. In four of these there was complete failure of puborectalis relaxation when straining to defaecate, and in another four there was incomplete puborectalis relaxation. There was no evidence of lower motor neuron involvement of pelvic floor muscles in the multiple sclerosis group. CONCLUSIONS: Paradoxical puborectalis contraction is common in patients with multiple sclerosis in whom constipation is a symptom. This may be a feature of the disturbed voluntary sphincter control mechanism, analogous to detrusor sphincter dyssnergia in the bladder.

Adult↗
PubMed2002

A novel treatment for constipation-predominant irritable bowel syndrome using Padma Lax, a Tibetan herbal formula.

BACKGROUND AND AIMS: Padma Lax, a complex Tibetan herbal formula for constipation was evaluated for safety and effectiveness in treating constipation-predominant irritable bowel syndrome in a 3-month double-blind randomised pilot study. METHODS: Patients were recruited from Hadassah Hospital's Gastroenterology clinic, using the Rome I Criteria for irritable bowel syndrome, and the international consensus criteria for constipation. Symptom severity was evaluated monthly by patients and gastroenterologist, using categorical and numerical rating scales. A patient diary recorded daily stool habit and trial medication. RESULTS: In 61 patients, (34 Padma Lax, 27 placebo), significant improvement was demonstrated after 3 months in the Padma Lax group compared to placebo in constipation, severity of abdominal pain, and its effect on daily activities, incomplete evacuation, abdominal distension and flatus/flatulence. A global assessment indicated that significantly more Padma Lax patients, compared to placebo, rated the current treatment superior to previous therapies tried for irritable bowel. Laboratory parameters displayed no clinically significant changes. Side effects, primarily loose stools in 7 Padma Lax patients responded well to lowering treatment dosage from 2 to 1 capsule/day. CONCLUSIONS: Padma Lax is a safe and effective treatment for constipation-predominant irritable bowel syndrome and may offer an alternative to the current multi drug approach.

Colonic Diseases, Functional↗
PubMed2006

[Treatment of a tetraplegic patient with chronic constipation with the Tibetan remedy Padma Lax--a case report].

BACKGROUND: In spinal cord injuries disturbed defecation, constipation and their concomitant disorders are frequent clinical symptoms. They may severely impair the quality of life of the affected patients. The presented case study and two more case reports, summarized in table form, outline therapeutic difficulties and therapy options in the treatment of constipation in paraplegic patients. CASE REPORT: A 69-year-old male patient with tetraplegia below C4 suffered from disturbed defecation, constipation with recurrent co-prostasis and pronounced meteorism which impeded breathing. Padma Lax was applied for several months, and constipation and the concomitant meteorism were noticeably reduced. CONCLUSION: The herbal preparation based on a formula from Tibetan Medicine may offer new therapeutic options in the care and treatment of patients with severe constipation. This report could also give first indications for controlled clinical studies in tetraplegic patients.

Aged↗
PubMed1985

A study of constipation in the elderly living at home.

A cross-sectional survey of bowel habit has been carried out on 201 elderly patients living at home. Although symptoms of constipation were common, reported bowel frequency was similar to younger people. Constipation was most clearly associated with poor mobility and depression. Digital rectal examination was generally unreliable as an indicator of constipation. Using the abdominal radiograph as the final arbiter, true constipation was present in less than half of those complaining of constipation.

Aged↗
PubMed1992

Infant constipation: maternal knowledge and beliefs.

One hundred mothers who delivered infants at a rural community hospital between March and July 1990 were surveyed during their postpartum hospital stay to determine their opinions and expectations concerning constipation in infancy. Thirty-eight percent of multiparous mothers reported constipation in their previous children, which resolved with all home treatments given. Only 23% of the mothers reporting constipation mentioned this to their physicians. All mothers significantly underestimated stool frequency from ages birth to one week, relative to previously published norms. Mothers overestimated stool frequency at one week to one month, but this difference was not statistically significant. The most frequent description of constipation was inability to pass stool; pain was rarely mentioned. Most mothers agreed with the statement, "Constipation is dangerous for babies." Mothers reported learning about stool habits from previous personal experience, written materials, and their own mothers; impact of health-care professionals on their knowledge was minimal. The opinions and expectations of newly delivered mothers can be used to develop patient education and anticipatory guidance material to improve teaching and relieve parental anxiety about infant stool habits.

Adolescent↗
PubMedDate not supplied

A constipation assessment scale for use in pediatric oncology.

Constipation is prevalent in pediatric oncology patients because of treatment with vinca alkaloids and/or narcotics and lifestyle changes secondary to disease process. Sequelae of constipation include anorexia, nausea, vomiting, abdominal pain, emergency department visits, and a decrease in quality of life. There are no reliable instruments to measure constipation in children. A pilot study (N = 21) evaluating the presence and severity of constipation and the reliability and validity of a modified version of the adult Constipation Assessment Scale (CAS) in children with cancer was conducted. Patients receiving weekly vinca alkaloids and/or narcotics = 2 times per day were recruited. Initial bowel function assessments included standardized nursing and nutrition assessments, history/physical review, and baseline CAS score repeated at 1 hour to assess test-retest reliability. Subsequent assessments included CAS administered 3 times per week and daily patient bowel diaries. Test-retest reliability was evident (r = .93; P = .000). Acceptable construct validity was indicated by a difference in mean CAS scores (t = 4.4, P <.001). Patients reported difficulty with CAS questions and response selections. Symptoms asked on CAS were often not viewed as a problem.

Adolescent↗
PubMed1995

Cisapride for the treatment of chronic idiopathic constipation.

Cisapride appears to be useful as therapy for chronic constipation that is not associated with underlying organic abnormalities or pregnancy and that is refractory to other treatments, such as increased dietary fiber intake or bulk laxatives. Dosages of cisapride that have demonstrated efficacy in chronic constipation range from 5 mg po tid to 20 mg po bid. Treatment for 8-12 weeks may be necessary for an optimal effect to occur. Further studies are needed to evaluate the most effective dosage regimen for the treatment of constipation and to compare the efficacy and cost-efficiency of cisapride with those of conventional therapy. Until these studies are completed, cisapride should not be recommended routinely for patients with constipation. However, it may be a viable option for patients with chronic idiopathic constipation that is refractory to conventional therapy.

Chronic Disease↗
PubMed2006

Long-term efficacy and cost-effectiveness of polyethylene glycol 3350 plus electrolytes in chronic constipation: a retrospective study in a disabled population.

OBJECTIVES: The efficacy and safety of treatments for constipation in severely intellectually disabled patients and their associated cost-effectiveness are an under-investigated area of clinical practice. Aiming to address this, the objectives of the study were to evaluate the efficacy and tolerability of polyethylene glycol 3350 plus electrolytes (Movicol; PEG+E) by comparing clinical data collected before and after its introduction to a stable population of residents of a mental health care, long-stay institution. The study also attempted an economic evaluation of the use of PEG+E in this setting. RESEARCH DESIGN AND METHODS: This was a retrospective study of 54/66 severely intellectually and physically disabled residents of a specialist unit at La Milétrie University Hospital, Poitiers, France, who suffered regularly from constipation. A total of 54 residents were treated with PEG+E (1-3 sachets a day) for 24 months. The number of stools, episodes of diarrhoea (defined as frequent stools, not necessarily watery), body weights and blood biochemistry were recorded. Data were compared with those recorded during the 21 months preceding the introduction of PEG+E for 16/54 residents who had been treated regularly with a range of other interventions for the relief of constipation. The monthly use and costs of laxatives, enemas and suppositories was obtained from hospital pharmacy records, and the total hospital costs before and after the introduction of PEG+E treatment was calculated. RESULTS: The mean (+/- standard deviation) number of stools per patient per month was significantly greater following the introduction of PEG+E (24.9 +/- 6.3) compared to before its use (12.4 +/- 3.4) (p < 0.001). The mean (+/- standard deviation) monthly number of episodes of diarrhoea per patient before and after the introduction of PEG+E was 0.1 +/- 0.1 and 6.3 +/- 2.9, respectively (p < 0.001). Treatment with PEG+E was not associated with adverse effects on body weight or blood biochemistry values. Introduction of PEG+E and its increasing use reduced the total hospital medical ward expenditure on laxatives from 3788 to 1767 Euros per month. CONCLUSIONS: PEG+E is effective in the clinical management of constipation in an institutional setting. Furthermore, long-term intensive therapy with PEG+E was not associated with adverse effects on body weight or blood biochemistry values. Although the time periods over which the economic data and the efficacy and safety data were collected did not directly correspond, this study indicates that use of PEG+E in the management of constipation in people with severe intellectual disability may be cost-effective, reducing hospital laxative costs.

Adult↗
PubMed2001

Opioid antagonists in the treatment of opioid-induced constipation and pruritus.

OBJECTIVE: To describe the role of opioid antagonists in the treatment of opioid-induced constipation and pruritus. DATA SOURCES: A MEDLINE search was performed (1966-February 2000) for narcotics and opioid antagonists. Results were limited to English-language and clinical trials. Background information was obtained from pharmacology and pharmacotherapy references and review articles. Hand searching of selected bibliographies yielded several references. STUDY SELECTION AND DATA EXTRACTION: Studies were reviewed that examined the use of naloxone, naltrexone, and methylnaltrexone for opioid-related constipation and pruritus. Selected citations included various clinical trials and case series. DATA SYNTHESIS: Opioid agents are used for cancer and nonmalignant pain. Peripheral opioid receptor stimulation due to endogenous (i.e., endorphins) or exogenous (i.e., morphine) stimulants may result in negative adverse effects, including constipation and pruritus. Adjuvant agents, such as laxatives and antihistamines, are often used to treat these adverse effects, but are themselves associated with adverse effects and are sometimes ineffective. Opioid antagonists have demonstrated reversal of peripheral opioid receptor stimulation. Clinical trials show adequate maintenance of pain control, as well as decreases in opioid-induced constipation and pruritus. CONCLUSIONS: Opioid antagonists offer a therapeutic alternative to conventional adjuvant agents, with the risk of loss of analgesia at higher doses. Methylnaltrexone offers the advantage of peripheral action only, therefore not reversing analgesia. Results are promising; however, larger clinical trials are necessary before opioid antagonists become the standard of care for opioid-induced constipation and pruritus.

Clinical Trials as Topic↗