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PubMed2005

Clinical approach to diseases of ileal pouch-anal anastomosis.

Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for ulcerative colitis (UC) patients with medically refractory disease or dysplasia. IPAA significantly improves quality of life in UC patients who require surgery. However, certain inflammatory and noninflammatory diseases can develop after the surgery, including pouchitis, Crohn's disease of the pouch, cuffitis, and irritable pouch syndrome. The etiology and pathogenesis of these disease conditions of IPAA are largely unknown. Accurate diagnosis and classification are important for appropriate management. Endoscopic evaluation is the most important tool for the diagnosis and differential diagnosis.

Adrenal Cortex Hormones↗
PubMed2006

Tacrolimus is safe and effective in patients with severe steroid-refractory or steroid-dependent inflammatory bowel disease--a long-term follow-up.

OBJECTIVE: We and others have reported the use of tacrolimus in refractory inflammatory bowel disease (IBD). Little is known about its long-term efficacy and safety. METHODS: In this retrospective, observational single center study the charts of 53 adult patients with steroid-dependent (n = 18) or steroid-refractory (n = 35) IBD, Crohn's disease (CD) (n = 11), ulcerative colitis (UC) (n = 40), or pouchitis (PC) (n = 2) were reviewed. Tacrolimus (0.1 mg/kg body weight per day) was administered orally in all and initially intravenously in 2 patients (0.01 mg/kg body weight per day), aiming for serum trough levels of 4-8 ng/mL. Forty-one of 53 (77.1%) patients were receiving concomitant azathioprine. The mean treatment duration was 25.2 +/- 4.6 SD months (0.43-164 months). Patients were followed for a mean of 39 +/- 4.1 SD months (5-164 months). Response was evaluated using a modified clinical activity index (M-CAI). RESULTS: Thirty-one UC (78%), 10 CD (90.1%), and both PC (100%) patients experienced an immediate clinical response or went into remission at 30 days. A statistically significant drop on the M-CAI was documented for UC and CD patients. Nine UC patients (22.5%) underwent colectomy between 1.6 and 41.3 months following initiation. Mean colectomy-free survival was 104.8 +/- 15.5 (95% CI 74.4-135.2) months (limited to 164.4 months). Cumulative colectomy-free survival was estimated 56.5% at 43.8 months. Steroids were reduced or discontinued in 40 of 45 UC and CD patients (90%) taking steroids. Side effects included a temporary rise of creatinine (n = 4, 7.6%), tremor or paresthesias (n = 5, 9.4%), hyperkalemia (n = 1, 1.9%), hypertension (n = 1, 1.9%), and opportunistic infections (n = 2, 3.8%). CONCLUSION: Long-term tacrolimus therapy appears safe and effective in refractory IBD.

Adult↗
PubMed2006

Risk factors for clinical phenotypes of Crohn's disease of the ileal pouch.

BACKGROUND: Crohn's disease (CD) of the pouch can occur in patients with colectomy and ileal pouch-anal anastomosis (IPAA) originally performed for a preoperative diagnosis of ulcerative colitis. The clinical presentations of CD of the pouch are inflammatory, fibrostenotic, and fistulizing. Risk factors for clinical phenotypes of CD of the pouch have not been characterized. METHODS: A total of 78 eligible patients with CD of the pouch together with 294 nonselected non-CD patients with IPAA seen in the Pouchitis Clinic were enrolled, including 28 with inflammatory CD, 18 with fibrostenotic CD, and 32 with fistulizing CD. The clinical phenotypes of CD were diagnosed based on a combined assessment of clinical, endoscopic, radiographic, and histologic features. Three separate analyses were performed, and for each analysis, the outcome of interest was having one of the phenotypes versus not having it. A stepwise selection multivariable logistic regression analysis was used. RESULTS: In the multivariable analysis, the risk factor for inflammatory CD was higher afferent-limb endoscopy scores (hazard ratio [HR] 1.87 95% confidence interval [CI] 1.54-2.27); the risk factors for fibrostenotic CD were higher afferent-limb (95% CI 1.81-3.48, HR 2.51) and higher cuff (95% CI 1.01-1.84, HR 1.36) endoscopy scores; and for fistulizing CD the risk factors were younger age (95% CI 0.93-0.99, HR 0.96), female gender (95% CI 1.35-6.97, HR 3.07), a preoperative diagnosis of indeterminate colitis (95% CI 1.72-9.34, HR 4.00), and no use of nonsteroidal antiinflammatory drugs (95% CI 1.31-8.25, HR 3.28). CONCLUSIONS: Each of the three phenotypes of CD of the pouch was associated with certain risk factors, suggesting that each of these diseases has a different etiology and disease process. The identification and management of some of the modifiable risk factors may reduce CD-related morbidity.

Adult↗
PubMed2004

Salvage surgery after restorative proctocolectomy.

Restorative proctocolectomy is now the elective surgical procedure of choice for most patients with ulcerative colitis or familial adenomatous polyposis. There are four causes of failure including acute and chronic sepsis, poor function for mechanical or functional reasons, mucosal inflammation (including pouchitis and retained rectal mucosa) and neoplastic transformation. Failure rates themselves range from 5% to nearly 20%. Followed over a period of 20 years, the failure rate can be summarised approximately as 5% at five years, 10% at ten years and 15% at 15 years.

Digestive System Surgical Procedures↗
PubMed2006

Antibiotics and probiotics in treatment of inflammatory bowel disease.

Many experimental and clinical observations suggest that intestinal microflora plays a potential role in the pathogenesis of inflammatory bowel disease (IBD). Manipulation of the luminal content using antibiotics or probiotics represents a potentially effective therapeutic option. The available studies do not support the use of antibiotics in ulcerative colitis (UC). Antibiotics are effective in treating septic complications of Crohn's disease (CD) but their use as a primary therapy is more controversial, although this approach is frequently and successfully adopted in clinical practice. There is evidence that probiotic therapy may be effective in the prevention and treatment of mild to moderate UC. In contrast, a lack of successful study data at present precludes the widespread use of probiotics in the treatment of CD. Both antibiotics and probiotics appear to play a beneficial role in the treatment and prevention of pouchitis and further trials are warranted to fully quantify their clinical efficacy.

Animals↗
PubMed1999

Ileoanal anastomosis with reservoirs: complications and long-term results.

OBJECTIVE: To determine the rate of complications of ileoanal pouch anastomosis, their treatment and their influence on a successful outcome. DESIGN: A computerized database and chart review. SETTING: Three academic tertiary care health centres. PATIENTS: All 239 patients admitted for surgery between 1981 and 1994 with a diagnosis of ulcerative colitis and familial adenomatosis coli. INTERVENTIONS: Sphincter-saving total proctocolectomy and construction of either S-type of J-type ileoanal reservoir. OUTCOME MEASURES: Indications, early and late complications, incidence of pouch excision. RESULTS: Of the 239 patients, 228 (95.4%) were operated on for ulcerative colitis and 11 (4.6%) for familial polyposis coli. One patient in each group was found to have a carcinoma not previously diagnosed. Twenty-eight patients had poor results: in 17 (7.1%) the ileostomy was never closed or was re-established because of pelvic sepsis or complex fistulas, sclerosing cholangitis or severe diarrhea; 11 (4.6%) patients required excision of the pouch because of anal stenosis, perirectal abscess-fistula or rectovaginal fistula. Three patients died--of suicide, and complications of liver transplantation and HIV infection. Thus, 208 patients maintained a functioning pouch. The early complication rate (within 30 days of operation) was 57.7% (138 patients) and the late complication rate was 52.3% (125 patients). Pouchitis alone did not lead to failure or pouch excision. Emptying difficulties in 25 patients with anal stenosis were helped in 2 by resorting to intermittent catheterization. Patients with indeterminate colitis had a higher rate of anorectal septic complications, and all patients having Crohn's disease after pouch construction had complicated courses. CONCLUSIONS: The complication rate associated with ileoanal pouch anastomosis continues to be relatively high despite increasing experience with this technique. Overall, however, a satisfactory outcome was obtained in 87% of patients.

Abscess↗
PubMedDate not supplied

[Colorectal neoplasms in patients with ulcerative rectocolitis. Their surgical treatment and follow-up].

Patients with ulcerative colitis (UC), especially those with a long-term standing or severe disease, show a higher incidence of colorectal neoplasms. Dysplasia represents the most important risk-factor for malignancy in patients with UC. From 1989 to 1999, 71 patients with UC, were surgically treated at our Institution. Indications for surgery were: non responding disease or refractory bleeding in 61; pathologic evidence of severe dysplasia during endoscopic surveillance in 5 patients, evidence of a neoplasm in the remaining 5 patients. Operative mortality was 1.4%. Infections of the surgical wound has been the most common postoperative complication. In 4 cases pouchitis has been reported. In 7 patients because of progression of the proctitis a second surgical treatment has been made. When surgical treatment is indicated in the course of ulcerative colitis, several operations may be performed. In the large majority of patients, total colectomy, mucosectomy and ileal pouch-anal anastomosis is the procedure of choice.

Adenocarcinoma↗
PubMed2001

Ileal pouch-anal anastomosis for ulcerative colitis: the University of Puerto Rico experience.

OBJECTIVE: To review the experience with ileal pouch-anal anastomosis surgery for ulcerative colitis at the University Hospital. BACKGROUND: As many as 40% of patients with ulcerative colitis (UC) and 75% with Crohn's disease (CD) require some surgery for their disease. The number of patients referred to our clinics for evaluation and management of Inflammatory Bowel Disease (IBD) has risen in the past seven years. A multidisciplinary IBD service has been created at the University Hospital for the care of these patients, leading to a dramatic increase in the number of surgeries performed for IBD. Over the past decade the ileal pouch-anal anastomosis (IPAA) has emerged as the procedure of choice in most patients with ulcerative colitis requiring total colectomy for management of their disease. Even though the procedure is associated with a considerable morbidity rate, it has become very popular since it avoids the need for a permanent stoma and presumably rids the patient of disease and subsequent cancer risk. RESULTS: Twenty-five patients were identified as having IPAA for ulcerative colitis between 1993-2000. Indications for surgery were intractability and toxic megacolon. Complications were pouchitis in 11/25 (44%), anastomotic stricture in 6/25 (24%), small bowel obstruction in 4/25 (16%), and pouch failure in 2/25 (8%). Other complications included wound abscess in 1/25 (4%), and sexual dysfunction in 1/25 (4%) patients. There was no mortality; the patients' quality of life was rated as greatly improved in 14 of 17 patients interviewed (82.4%) and 16 of 17 said they would recommend the surgery to others (94.1%). CONCLUSIONS: The results of IPAA surgery, morbidity, mortality, and patient satisfaction in our series were similar to other centers around the world.

Adolescent↗
PubMed2003

Assessment of mucosal inflammation and circulation in response to probiotics in patients operated with ileal pouch anal anastomosis for ulcerative colitis.

BACKGROUND: Pouchitis is a common and troublesome condition, and a disturbed microbiological flora and mucosal blood flow in the pouch have been suggested as possible causes. Laser Doppler flowmetry (LDF) has been used successfully to measure gastric and colonic mucosal perfusion in humans. The aim of this study was to evaluate the effect of intervention with probiotics on ileal pouch inflammation and perfusion in the pouch, assessed by endoscopy, histology, fecal calprotectin and LDF. METHODS: A fermented milk product (Cultura; 500 ml) containing live lactobacilli (La-5) and bifidobacteria (Bb-12) was given daily for 4 weeks to 10 patients operated with ileal-pouch-anal anastomosis (IPAA) for ulcerative colitis (UC). Mucosal perfusion was measured with LDF and the degree of inflammation was examined at predefined levels of the distal bowel by endoscopy and histology. Stool samples were cultured for lactobacilli and bifidobacteria and calprotectin were measured before and after intervention. RESULTS: The LDF measurements were reproducible in the pelvic pouch at each of the predefined levels, but did not change after intervention. The mucosal perfusion was reduced in the distal compared to the proximal part of the pouch. Calprotectin levels did not change significantly after intervention. The median endoscopic score for inflammation was significantly reduced by 50% after intervention, whereas the histological score did not change significantly. CONCLUSION: The results suggest that probiotics primarily act superficially, with change of gross appearance of the mucosa at endoscopy, but without significant effect on histological picture, mucosal perfusion or faecal calprotectin, during a relatively short period of 4 weeks.

Adolescent↗
PubMed2005

Restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis and familial adenomatous polyposis: twenty years follow-up in 174 patients.

BACKGROUND: Restorative proctocolectomy with ileal pouch-anal anastomosis has become the surgical procedure of choice for patients with ulcerative colitis and familial adenomatous polyposis. OBJECTIVES: To evaluate the long-term functional outcome of patients who underwent this surgical procedure. METHODS: We performed this observational study in 174 consecutive patients: 146 with UC and 28 with FAP. The patients, 91 males and 83 females with a mean age of 34.1+/-10.6 years (range 6-67 years), underwent the procedure between January 1984 and January 2004 (mean follow-up 64.8 months, range 1-240 months). The indications for surgery were intractable disease in 124 patients (71%), dysplasia in 36 (21%), severe bleeding in 8 (5%), and perforation in 6 (3%). RESULTS: A protective ileostomy was performed in 140 patients (96%) with UC and 12 (43%) with FAP. An urgent three-stage procedure was necessary in 14 patients (8.4%). A mucosal proctectomy was performed in 94 (54%), and a double stapling technique in 80 (46%). Mean length of hospital stay was 9.4+/-6.6 days (range 5-34 days, median 8). Complications included pelvic sepsis in 7 patients (4.2%), anastomotic leakage in 8 (4.8%), bowel obstruction in 22 (13.2%), incisional hernia in 12 (7.2%), anastomotic stenosis that usually responded to manual dilatation in 46 (27.6%), pouchitis in 106 (61%), recto-vaginal fistula in 3 (1.8%), retrograde ejaculation in 3 (1.8%), and impotence in 2 (1.2%). There was no mortality in this group of patients. The median number of bowel movements per 24 hours was six in UC patients and five in FAP patients, with at least one bowel movement during the night. Complete daytime and night-time continence was documented in 124 patients (71%). Overall satisfaction was 95%. CONCLUSIONS: Restorative proctocolectomy with ileal pouch-anal anastomosis confers a long-term good quality of life to both UC and FAP patients, and the majority of patients are fully continent with five to six bowel movements per day.

Adenomatous Polyposis Coli↗
PubMed2005

[Role of intestinal flora in inflammatory bowel disease and probiotics place in their management].

The pathogenic role of certain microorganism of intestinal flora has been demonstrated in experimental colitis in animals and strongly suspected in inflammatory bowel disease in human, especially in Crohn's disease and pouchitis. Probiotics are living non pathogenic microorganisms that, upon oral ingestion exert benefits on human health by modulating enteric flora or by stimulation of local immune system. The aim of this article is to remind the role of intestinal flora in inflammatory bowel disease, the mechanism of inflammation induced by this flora and to review through the literature, the different clinical studies performed with probiotics in human.

Animals↗
PubMed1997

Totally stapled restorative proctocolectomy.

BACKGROUND: Totally stapled restorative proctocolectomy (TSRP) has simplified ileoanal pouch surgery but few reports exist concerning experience with the technique. A retrospective study of operative and functional data in a consecutive series of patients undergoing TSRP was undertaken. METHODS: TSRP with J pouch formation was attempted in 103 patients between 1988 and 1995 (for ulcerative colitis (87 patients), familial adenomatous polyposis coli (nine), slow transit constipation (six) and hereditary non-polyposis colorectal cancer (one). Three technical failures resulted in 100 patients available for assessment. Case notes were reviewed together with functional assessment by clinical interview and/or postal questionnaire. RESULTS: Median operating time was 200 min, intraoperative blood loss 360 ml and hospital stay 12 days. There were no operative deaths. All but five patients (95 per cent) had loop ileostomy formation with subsequent reversal. There were 29 complications, six of which required further surgical intervention. Six pouches were excised and two patients had a temporary defunctioning ileostomy. Five patients were rediagnosed as having Crohn's disease, of whom four underwent subsequent pouch excision. Pouchitis (in the absence of Crohn's disease) occurred in eight patients (8 per cent). In 60 patients with at least 12 months of established function, median day and night stool frequencies were 5 and 1 respectively. Functional evaluation in 49 patients (82 per cent) revealed regular use of antidiarrhoeal medication in 21, urgency in 17, and total continence by day and night in 37 and 35 respectively. Fifty-three patients (88 per cent) were satisfied with the overall long-term outcome. CONCLUSION: TSRP is safe, has simplified a technically difficult operation and gives good long-term functional results.

Adenomatous Polyposis Coli↗
PubMed1998

[Complications and late outcome of restorative proctocolectomy].

The restorative proctocolectomy with ileoanal pouch is a sophisticated operative procedure with considerable postoperative complications. The main problems are postoperative ileus (11%), anastomotic stricture (9%), local septic complications (13%) and pouchitis (29%). A variety of other complications also occur. Most of the problems can be successfully managed by conservative or surgical treatment. In only 2.5% (n = 15/593) was final pouch extirpation necessary. Postoperative function showed elevated stool frequency (6 per day) and slightly compromised stool continence. Most patients confirm good quality of life.

Adenomatous Polyposis Coli↗
PubMed2002

Similar functional results and complications after ileal pouch-anal anastomosis in patients with indeterminate vs ulcerative colitis.

HYPOTHESIS: Patients who undergo ileal pouch-anal anastomosis (IPAA) for indeterminate colitis (IC) have a pouch complication and pouch loss rate only slightly higher than that associated with ulcerative colitis (UC). The functional outcome in patients with IC is no different from that in patients with UC. DESIGN: Retrospective review of prospectively gathered data comparing complication rates and outcomes of patients with IC vs UC who have undergone IPAA at a single institution during 19 years. SETTING: University teaching hospital. PATIENTS: Between July 1, 1982, and July 1, 2001, 723 patients underwent IPAA, 644 for colonic inflammatory bowel disease. A further breakdown of the latter group revealed 79 patients (12.3%) with IC and 565 (87.7%) with UC. These 2 patient populations were compared with regard to postoperative complications, pouch loss, and functional outcome. MAIN OUTCOME MEASURES: Patients with IC and UC were compared with regard to pouch complications, such as J-pouch leak, fistula, cuff abscess, stricture, redo IPAA, Crohn diagnosis, and pouch loss. They were also compared with regard to 24-hour stool frequency and nighttime incontinence at 1, 3, 6, and 9 months after surgery. RESULTS: Approximately 98% of patients had 1 year of follow-up and 89% had long-term follow-up (mean, 78.5 months). Patients with IC were compared with those with UC with regard to pouch complications, such as cuff abscess (1.3% vs 1.6%), J-pouch leak (5.1% vs 2.3%), intra-abdominal abscess (0% vs 1.1%), stricture (7.6% vs 4.8%), and fistula (2.5% vs 1.6%). These 2 groups were also compared with regard to small bowel obstruction (6.3% vs 5.5%), pouchitis (34.2% vs 25.0%), eventual diagnosis of Crohn disease (1.3% vs 0.7%), redo IPAA (1.3% vs 0.9%), and eventual pouch loss (2.5% vs 1.2%). An evaluation of functional results revealed no significant differences between the 2 groups with regard to 24-hour stool frequency or nighttime incontinence. The pathologists classified patients with IC into 3 groups: IC but favor UC (group 1), IC but favor Crohn (group 2), and IC (group 3). Most of the postoperative complications occurred in group 1 patients, but the only pouch loss occurred in those in group 2. CONCLUSIONS: The incidences of pouch complications after IPAA were slightly higher in the IC group compared with the UC group, but the differences were not statistically significant. Functional results were the same in both groups. Pouch loss was high in group 2 patients, but was otherwise not significantly higher in the IC group overall (P =.36). Most patients with IC can undergo IPAA and expect an outcome equivalent to that of patients with UC.

Adult↗
PubMed1993

Long-term results of the ileoanal pouch procedure.

Many surgeons consider the ileoanal pouch procedure to be the procedure of choice for patients who require surgery for ulcerative colitis and familial adenomatous polyposis. To determine long-term results, 460 patients (mean +/- SD age, 31 +/- 9 years) who underwent the ileoanal pouch procedure from 1980 through 1991 were prospectively observed by computerized registry. The leading indication for operation was ulcerative colitis (n = 382; 83%). A J-shaped reservoir was created in 434 patients (94%). More than 5 years after ileostomy closure, the mean number of bowel movements was 5.8 +/- 2.2, and 13% of patients had leakage. Most patients (94%) were satisfied with their results. Sixteen patients (3.5%) required recreation of a permanent stoma for pouch failure. Complications (major and minor) occurred in 266 patients (58%) and included obstruction (n = 94; 20%), pouch fistula (n = 26; 6%), anastomotic stricture (n = 40; 9%), anastomosis separation (n = 14; 3%), and pouchitis (n = 83; 18%). Modifications in technique and increased operative experience have significantly decreased the incidence of obstruction (P = .05) and pouch-related complications (P = .004). Despite complications, long-term results are acceptable, and patient satisfaction remains high.

Adult↗
PubMed1993

Prospective assessment of functional results after ileal J pouch-anal restorative proctocolectomy.

OBJECTIVE: To document the functional results of 50 consecutive patients who underwent hand-sewn ileal J pouch-anal restorative proctocolectomy for ulcerative colitis between 1988 and 1991 (mean follow-up, 18.1 months; range, 6 to 48 months). DESIGN: Patients recorded their observations daily over 1 week. The patients completed these weekly diaries every 3 months for the first year and then at 18, 24, 36, and 48 months after ileostomy closure. STUDY PARTICIPANTS: Fifty patients (mean age, 31 years; 24 males). SETTING: The University of Chicago (Ill). RESULTS: Stool frequency at 3, 6, 12, and 24 months was 6.3 +/- 2.1, 5.5 +/- 2.4, and 5.1 +/- 1.9, and 5.9 +/- 1.6 per day, respectively, without urgency. Fifty-four percent were perfectly continent; 18% had occasional spotting (one or two leaks per week); 12% had minor leakage (three to seven per week); and 16% had major leakage (more than seven per week). In these three groups, loss of solid feces never occurred in 84%, 88%, and 65% of patients, respectively. Females had more severe incontinence than males, but continence improved over time for both sexes. Twenty-two percent of female patients developed dyspareunia; no males developed impotence, but 19% had retrograde ejaculation. The probability of experiencing pouchitis increased with time from 15% at 6 months to 40% at 12 months, and 50% after 24 months. CONCLUSIONS: These results represent an accurate assessment of patient function after ileal J pouch-anal anastomosis. We encourage the use of a prospective, patient-completed protocol to obtain a realistic assessment of functional results.

Adolescent↗
PubMed1996

Long-term results after colectomy and ileoanal pull-through procedure in children.

OBJECTIVE: To review the clinical experience with colectomy and ileoanal pull-through procedure in children from 1 hospital. DESIGN: Since 1977, 116 children 18 years of age or younger underwent colectomy and ileoanal pull-through procedure at University of California-Los Angeles Medical Center. Ninety-four children had ulcerative colitis, 17 had familial polyposis coli, and 5 had Hirschsprung disease. Sixty-two children had a lateral pouch, 47 a J-pouch, and 7 a straight pull-through. A diverting ileostomy was used for 4 months for all patients except 9 with polyposis coli and 2 with Hirschsprung disease. During the same period, an additional 414 patients older than 18 years underwent the ileoanal pull-through procedure. RESULTS: Forty-eight children (41%) developed complications; the most common was pouchitis, which occurred in 18 patients with ulcerative colitis. Forty-two children underwent reoperation; 38 had ulcerative colitis. There were no deaths. Six children (5.2%) (3 with Crohn disease) required a permanent ileostomy. Six straight pull-throughs were converted to J-pouches because of stool frequency; 19 patients with lateral pouches underwent pouch reconstruction or spout resection because of stasis. With a mean follow-up of 7.1 years, 107 children (92.2%) were progressing well. CONCLUSIONS: Ulcerative colitis is a more severe disease in children. The ileoanal pull-through procedure is the preferred operation for children with ulcerative colitis, polyposis coli, and selected patients with Hirschsprung disease. The J-pouch is preferred because of simplicity of construction and scarcity of complications.

Adenomatous Polyposis Coli↗
PubMed2005

Cyclosporine A for induction of remission in severe ulcerative colitis.

BACKGROUND: Ulcerative colitis (UC) is characterized by a life-long chronic course with remissions and exacerbations. Approximately 15% of patients have a severe attack requiring hospitalization at some time during their illness. These patients are traditionally treated with intravenous corticosteroids, with a response rate of approximately 60%. The patients who do not respond to steroid treatment usually require surgical removal of the large bowel (proctocolectomy or colectomy with an anal pouch). This surgical procedure essentially cures the patient from the disease but is associated with complications such as pouchitis. Few alternative treatments exist for severe ulcerative colitis: immunosuppressive medications (such as azathioprine) have a slow onset of action and are therefore usually ineffective. Antibiotics are not proven to be effective and biological treatments such as infliximab are still under investigation. The introduction of cyclosporine-A (CsA) for use in patients with severe ulcerative colitis (UC) has provided an alternative to patients previously facing only surgical options. Cyclosporine acts mainly by inhibiting T lymphocyte function, which is essential for the propagation of inflammation. Unlike most other immunosuppressive agents, CsA does not suppress the activity of other hematopoietic cells, does not cause bone marrow suppression and has a rapid onset of action. This reviews aims to systematically assess the effectiveness and safety of CsA for severe UC. OBJECTIVES: This review aimed to evaluate the effectiveness of cyclosporine A for patients with severe ulcerative colitis. SEARCH STRATEGY: Electronic searches of The Cochrane Library (Issue 1, 2004), EMBASE (1980-2004), and MEDLINE (1966-2004); hand searching the references of all identified studies; contacting the first author of each included trial. SELECTION CRITERIA: Randomised clinical trials comparing cyclosporine A with placebo or no intervention to obtain and maintain remission of idiopathic ulcerative colitis. DATA COLLECTION AND ANALYSIS: Two reviewers independently appraised the quality of each trial and extracted the data from the included trials. Relative risks (RR) with 95% confidence intervals (CI) were estimated. The reviewers assumed an intention to treat analysis for the outcome measures. MAIN RESULTS: Only two randomized controlled trials were identified that satisfied the inclusion criteria. These two trials could not be pooled for analysis because of major differences in design and patient populations. In the first trial, 11 patients received intravenous cyclosporine (4 mg/kg) and 9 received placebo. Two of 11 in the treatment group failed to respond to therapy compared with nine of nine in the placebo group (RR 0.18, 95% CI 0.05 - 0.64). However, 3/11 and 4/9 eventually underwent colectomy in the treatment and placebo groups respectively and follow-up was less than a month. In the second trial 15 patients were treated with intravenous cyclosporine and 15 with intravenous methylprednisolone. Five of 15 patients in the cyclosporine group failed to respond to therapy as compared to 7/15 in the methylprednisolone group (RR 0.71, 95% CI 0.29 - 1.75). After 1 year 7/9 responders in the cyclosporine group were still in remission compared with 4/8 in the steroid group (p > 0.05) and the colectomy rate was similar in both groups. The mean time to response in the cyclosporine group in the 2 trials was short (7 days and 5.2 days). These results should be interpreted with caution given the small numbers of trials and patients evaluated for comparison, and limited follow-up (few weeks in one trial to a year in the other). The precise assessment of the occurrence of adverse events was difficult because the trials described different adverse reactions, which reversed after discontinuation of cyclosporine. There was no evidence in the trials reviewed that cyclosporine was more effective than standard treatment for preventing colectomy but this effect cannot be excluded due to the small sample size and rarity of this outcome. Additional limitations of current research include lack of data on quality of life, costs and long-term results of cyclosporine therapy. AUTHORS' CONCLUSIONS: There is limited evidence that cyclosporine is more effective than standard treatment alone for severe ulcerative colitis. The relatively quick response makes the short-term use of cyclosporine potentially attractive, but the long-term benefit is unclear, when adverse events such as cyclosporine-induced nephrotoxicity may become more obvious. There is a need for additional research on quality of life, costs and long-term results from cyclosporine therapy in severe ulcerative colitis.

Colitis, Ulcerative↗