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PubMed1979

Flexible sigmoidoscopy as a screening procedure for neoplasia of the colon.

Two hundred asymptomatic United States veterans older than 40 years of age were evaluated with a flexible sigmoidoscope plus Hemoccult stool tests. Mean distance and time for the former were 56.4 centimeters and 7.4 minutes, respectively. There were no complications. Polyps greater than or equal to 0.5 centimeter in diameter were found in 11.9 per cent of those older than 50 years. No polyps of this size were found in patients younger than 50 year of age. Results of Hemoccult tests were negative in 83.3 per cent of those with polyps. A flexible sigmoidoscope is a safe, rapid and effective means of identifying that portion of the asymptomatic adult population having colonic polyps. For this purpose, it is vastly more sensitive than Hemoccult stool testing. Because of the relationship between colonic polyps and carcinoma, this technique may prove invaluable in the identification of those patients with an increased potential for the development of carcinoma of the colon.

Adult↗
PubMed1996

Feasibility of high-volume screening sigmoidoscopy using a flexible fiberoptic endoscope and a disposable sheath system.

OBJECTIVES: Sigmoidoscopy is an effective screening test for colorectal cancer but has yet to have a major impact on mortality because, in part, of inadequate utilization by physicians. To address concerns of inefficient use of time and resources, we examined the feasibility of high volume, single-day flexible sigmoidoscopy (FS) screening sessions using an innovative fiberoptic sigmoidoscope with a disposable sheath system. METHODS: All City of Boston employees over the age of 50 yr (n = 6137) were invited by mail to undergo a screening FS at Boston City Hospital (BCH). Respondents (n = 564) were contacted by phone by the program coordinator on receipt of a prepaid postcard and were scheduled (n = 227) consecutively into 15-min slots on 1 of 6 1/2-day (3-h) weekend sessions. Preregistration was completed at BCH during the week before each session and included enrollment, completion of a brief risk questionnaire, documentation of informed consent, and bowel prep instructions. Procedures were performed by three physician endoscopists rotating among four endoscopy rooms per session. Each room was staffed with a nurse to aid in patient care and a technician to set up equipment. RESULTS: A total of 198 of the 227 (87%) scheduled patients underwent screening FS during the three sessions. Physicians performed a mean of 3.5 procedures per room per hour, or 4.7 procedures per hour overall, with a mean depth of scope insertion of 51 +/- 10 cm and a mean procedure time of 4.7 +/- 3.3 min. Equipment set-up time and patient turnaround time averaged 4.6 +/- 1.7 min and 11.0 +/- 6.0 min, respectively. Polyps were detected in 29 (14.6%) patients, and a Dukes' A cancer was detected in one (0.5%). The only complication was a cardiac arrhythmia. A crude estimate of direct costs approximated $ 75 per examination. CONCLUSION: High volume, single-day FS using the fiberoptic sigmoidoscope with a disposable sheath system offers an effective strategy for enhancing physicians compliance, and possibly patient compliance, with screening sigmoidoscopy through more efficient use of time and resources.

Aged↗
PubMed2004

Transdermal nicotine for induction of remission in ulcerative colitis.

BACKGROUND: Ulcerative colitis is largely a disease of nonsmokers. Intermittent smokers often experience improvement in their symptoms while smoking. Nonsmokers with ulcerative colitis who begin smoking may go into remission. Randomized controlled trials were developed to test the efficacy of transdermal nicotine for the induction of remission in ulcerative colitis. OBJECTIVES: (1) To determine the efficacy of transdermal nicotine for induction of remission in ulcerative colitis. (2) To assess adverse events associated with transdermal nicotine therapy for ulcerative colitis SEARCH STRATEGY: The MEDLINE (via PubMed) and EMBASE databases were searched using the search criteria "ulcerative colitis" and "transdermal nicotine" or "nicotine" to identify relevant papers published between 1970 and December 2003. Manual searches of reference lists from potentially relevant papers were performed to identify additional studies. Abstracts from major gastroenterological meetings were searched to identify research submitted in abstract form only. The Cochrane Central Register of Controlled Trials and the Cochrane Inflammatory Bowel Disease Group Specialized Trials Register were also searched. SELECTION CRITERIA: We included only randomized controlled trials in which patients with active mild to moderate ulcerative colitis were randomly allocated to receive transdermal nicotine (15 to 25 mg/day) or a placebo or another treatment (corticosteroids or mesalamine). DATA COLLECTION AND ANALYSIS: Data extraction and assessment of the methodological quality of each trial were independently performed by each author. Any disagreement among reviewers was resolved by consensus. The primary outcome measure was the number of patients achieving clinical or sigmoidoscopic remission as defined by the primary studies (e.g. no symptoms of ulcerative colitis), and expressed as a percentage of the patients randomized (intention to treat analysis). Secondary outcomes included clinical response, adverse events and withdrawal because of adverse events. MAIN RESULTS: Seven studies were identified, five of which met the inclusion criteria. A meta-analysis of two trials in which 71 patients were randomized to nicotine and 70 to placebo showed a statistically significant benefit for nicotine treatment. After four to six weeks of treatment 19 of 71 patients treated with transdermal nicotine were in clinical remission compared to 9 of 70 treated with placebo (OR=2.56, 95% CI 1.02-6.45). In the same group of patients improvement or remission was noted in 29 of the 71 patients assigned to nicotine compared to 14 of 70 patients assigned to placebo (OR=2.72, 95% CI 1.28 - 5.81). For patients with left sided colitis the odds ratio was 2.31 (95% CI 1.05-5.10). When transdermal nicotine was compared to standard medical therapy no significant benefit for nicotine was observed. After four to six weeks of standard therapy (oral prednisone or mesalamine), 34 of 63 patients were in clinical or sigmoidoscopic remission compared to 33 of 66 patients treated with transdermal nicotine (OR=0.77, 95% CI 0.37-1.60). A meta-analysis of all five studies which included 137 patients treated with transdermal nicotine and 133 patients treated with a placebo or standard therapy demonstrated no statistically significant benefit of nicotine therapy (OR=1.23; 95% CI 0.71-2.14). Patients treated with transdermal nicotine were significantly more likely to withdrawal due to adverse events than patients treated with placebo or standard medical therapy (OR=5.82, 95% CI, 1.66 - 20.47) and were significantly more likely to suffer from an adverse event than patients treated with placebo or standard medical therapy (OR=3.54, 95% CI, 2.07 - 6.08). REVIEWERS' CONCLUSIONS: The results of this review provide evidence that transdermal nicotine is superior to placebo for the induction of remission in patient's with ulcerative colitis. The review did not identify any significant advantage for transdermal nicotine therapy compared to standard medical therapy. Adverse events associated with transdermal nicotine are significant and limit its use in some patients.

Administration, Cutaneous↗
PubMed1998

Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: results of a multicentered placebo-controlled trial. The U.S. PENTASA Enema Study Group.

The safety and efficacy of mesalamine enemas were determined ina dose-ranging study enrolling 287 patients with ulcerative proctitis and proctosigmoiditis in a double-blind, placebo-controlled, multicenter trial. Patients were randomized to receive placebo, 1, 2, or 4 g in 100 ml mesalamine (PENTASA) enemas h.s. for 8 weeks. Efficacy was assessed by clinical, sigmoidoscopic, and histologic improvement, as well as by induction of remission. Sixty-seven percent, 65%, and 75% of patients receiving 1-, 2-, and 4-g enemas were markedly improved according to the physician's global assessment compared with 27% of patients treated with placebo. The mean improvement in sigmoidoscopic index was 5.8, 5.9, and 6.4 points (on a 15-point scale) for the 1-, 2-, and 4-g enema groups compared with a decrease of 1.8 points for the placebo group. Improvement in biopsy scores was observed in 47, 55, and 59% of 1-, 2-, and 4-g groups contrasted with 27% of the placebo-treated patients. All three doses were significantly more effective than placebo in reducing symptoms and trips to the toilet compared with placebo. No dose-response relation was demonstrated. The safety profile was similar to that of placebo. In conclusion, mesalamine enemas are effective as a single agent in the short-term treatment of distal ulcerative colitis without an apparent dose response between 1 and 4 g nightly.

Acute Disease↗
PubMed1987

4-Aminosalicylic acid retention enemas in treatment of distal colitis.

Forty-five of 47 patients with distal ulcerative colitis completed a two-week double-blind, randomized, controlled trial to determine if 4-aminosalicylic acid (4-ASA) enemas, 1 g bid or 2 g bid, were therapeutically effective compared to placebo. Forty-one patients enrolled because they were refractory to or had side effects during conventional therapy with sulfasalazine or corticosteroids. Proctoscopic examination was done before and after two weeks of treatment. Patients kept daily diaries assessing: blood in stools, mucus in stools, tenesmus, abdominal pain, loss of appetite, fatigue, weight loss, and malaise. Severity of each symptom ranged from 0 (absent) to 3 (severe). A total severity score was calculated from the above for each patient. At the end of the two-week study, 35 patients elected to take 4-ASA in an open-label trial for one year. 4-ASA enemas in the 1-g bid but not the 2-g bid dosage were significantly more effective in improving symptoms than placebo: P less than or equal to 0.05. Neither dose of 4-ASA enema was better than placebo in improving the sigmoidoscopic appearance at the end of two-weeks. Forty-six percent of patients had complete resolution of all signs and symptoms in the open-label trial and 31% were better but still had sigmoidoscopic evidence of disease, a total response rate of 77%. Side effects were similar in the placebo and 4-ASA groups. We conclude that 4-ASA enemas in a dose of 1 g bid are safe and effective in the treatment of distal ulcerative colitis.

Adult↗
PubMed1981

Rectal biopsy in Crohn's disease.

Rectal biopsies from a series of 35 patients with radiologic evidence of Crohn's disease were assessed histologically and classified according to the type of lesions identified. These were then correlated with the sigmoidoscopic findings and site of radiologic involvement. Overall, 40% of the biopsies were abnormal, and in 28% the changes were highly suggestive of Crohn's disease. Granulomas were identified in 15%. Differences between sigmoidoscopic interpretation and histologic diagnosis were present in 11% of cases. This yield of positive biopsies is similar to earlier reports but is approximately double the numbers recorded by the National Cooperative Crohn's Disease Survey. It is concluded that rectal biopsy may confirm the diagnosis in unselected cases of Crohn's disease and provide useful information in patients where the diagnosis was not previously established. In our hands rectal biopsy was an extremely safe diagnostic procedure.

Biopsy↗
PubMed1989

Failure of 5-aminosalicylic acid enemas to improve chronic radiation proctitis.

Radiation proctitis is a well-known complication of abdominal and pelvic radiation. Conventional medical and surgical treatment often is disappointing. 5-Aminosalicylic acid (5-ASA) is the active component in sulfasalazine and is effective in the treatment of distal ulcerative colitis. Four patients with radiation proctitis were treated with 4 g 5-ASA by enema nightly for two to six months. Patients were seen monthly, interviewed, and a sigmoidoscopic exam performed. No change was seen in the degree of mucosal inflammation on follow-up sigmoidoscopic exams. Three patients noted no change in their symptoms of bleeding, pain, or tenesmus. One patient noted initial improvement, but this was not sustained. 5-ASA enemas do not appear to be effective in the treatment of radiation proctitis.

Aminosalicylic Acids↗
PubMed1986

An assessment of inflammation in the reservoir after restorative proctocolectomy with ileoanal ileal reservoir.

The significance of inflammation of the mucosa of the ileal reservoir after restorative proctocolectomy is not known although in some cases it appears to be associated with symptoms when the condition has been referred to as pouchitis. This investigation has aimed to determined the prevalence of inflammation, to define pouchitis and to examine some factors which might be related to inflammation. Mucosal biopsies from the ileal reservoir were studied in 90 patients at up to 62 months after closure of the ileostomy. A histological grading system (0-6) was used to assess the severity of inflammation. Some degree of chronic and acute inflammation was found in 87% and 30% of cases respectively. The prevalence of a grade of 4 or more was 23% and 3.5%. There was a correlation between severity of chronic and acute inflammation. Severe histological acute inflammation (grade 4-6) was associated with sigmoidoscopic features of inflammation and with increased frequency of defaecation. Of 55 patients sigmoidoscoped by one clinician, 6 (11%) had pouchitis which was characterised by macroscopic inflammation of the reservoir, diarrhoea and a histological grade of 4 or more. The severity of chronic inflammation was not related to frequency of defaecation. Histological inflammation could not be correlated with the type of reservoir, residual volume after evacuation of a known volume of stool substitute introduced per anum into the reservoir or compliance of the reservoir. Acute inflammation was significantly more severe in patients with ulcerative colitis than in those with familial adenomatous polyposis.

Adenomatous Polyposis Coli↗
PubMed2001

Nurse-led direct access endoscopy clinics: the future?

BACKGROUND: Many studies have shown that rectal bleeding is a good indicator of underlying colorectal pathology, and that ost of the lesions in patients presenting with rectal bleeding lie in the left side of the colon [1, 5, 9, 12, 23, 26]. The recent acceptance of the nurse-practitioner by the National Health Service may allow the use of nurse-endoscopists to develop throughout the United Kingdom. This study aimed to audit a unique nurse-led direct-access nurse-endoscopy service with regard to its efficacy and cost effectiveness, and to monitor patient satisfaction and direct referrals from the primary health sector. METHODS: A nurse-led open-access flexible sigmoidoscopy (OAFS) service for patients reporting fresh rectal bleeding was established at our center in February 1996. A prospective audit of sigmoidoscopic findings and a retrospective analysis of referral patterns from local general practitioners were conducted. A questionnaire survey of both patient and general practitioner satisfaction also was conducted at the same time. RESULTS: Since February 1996, 706 patients have been referred to our service. Rectal bleeding was by far the most common cause for referral, representing the dominant symptom in 92% of the referrals received. Although 99% of the patients underwent a complete sigmoidoscopic examination, 16% of these examinations were limited because of several factors combined. A cause for bleeding was identified in 91% of the patients, with 24% of them experiencing subsequent significant pathology. Of the patients surveyed, 99% were satisfied with the service provided. The results also show nurse-led OAFS to be a more effective use of financial resources, costing $90 less per patient than general practitioner referrals sent to a consultant for further action. CONCLUSIONS: Rectal bleeding is a good indicator of underlying colorectal disease. Most of the significant lesions presenting with this symptom are found in the left side of the colon. A nurse-led OAFS is safe, effective, and acceptable to patients. It also is more cost effective than a consultant-led service.

Abdominal Pain↗
PubMed1986

Azodisal sodium in the treatment of ulcerative colitis. A study of tolerance and relapse-prevention properties.

One hundred sixty patients intolerant of or allergic to sulfasalazine (Salazopyrin, Azulfidine) participated in an open tolerance study of azodisal sodium (Dipentum). More than 4 of every 5 patients tolerated azodisal sodium well, but 12.5% of patients stopped medication because of diarrhea. Even after 7 patients who had also experienced diarrhea when taking sulfasalazine were excluded, there still remained a group of patients (9.8%) who had to discontinue azodisal sodium because of diarrhea. Apart from this, only minor side effects occurred. No serious drug-related changes were seen in hematologic or biochemical parameters. Male fertility appeared to be unaffected. One hundred two patients, who were in clinical and sigmoidoscopic remission, took part in a double-blind, placebo-controlled maintenance trial. Of these, 23.1% of the patients treated with azodisal sodium and 44.9% of the patients treated with placebo had a clinical and sigmoidoscopic relapse during a 6-mo trial period (p = 0.02). Azodisal sodium appears to be an effective agent for the maintenance treatment of ulcerative colitis.

Adolescent↗
PubMed1988

Sigmoidoscopy and mortality from colorectal cancer: the Kaiser Permanente Multiphasic Evaluation Study.

The Kaiser Permanente Multiphasic Evaluation Study is often cited as evidence from a randomized trial that screening sigmoidoscopy reduces mortality from colorectal cancer. To examine the role of sigmoidoscopy in this reduction, we reviewed the 110 incident cases of colorectal cancer occurring among the 10,713 subjects from randomization in 1964 through 1982. Tumor stage at diagnosis, location, mode of discovery, and current mortality status were determined for each. We also reanalyzed chart review data for the years 1965 through 1974 to assess the difference in exposure to sigmoidoscopy between groups. Study group subjects, who were urged to have annual multiphasic health checkups (MHC), had both a lower cumulative incidence (4.3 vs 6.7 cases per 1000 persons) and a better stage distribution (86 vs 54% Stage B or better) than nonurged control subjects for colorectal cancers arising within reach of the sigmoidoscope. The lowered incidence accounted for two-thirds of the total difference in mortality. No appreciable difference in removal of colorectal polyps was seen between groups. Only a slight excess in exposure to sigmoidoscopy was seen in the study group (30 vs 25% of subjects examined at least once between 1965 and 1974), which was unlikely to account for more than a small fraction of the study group's decrease in mortality. Although the Multiphasic Evaluation Study did find a significantly lower mortality from colorectal cancer in the study group, it did not achieve a substantial difference in exposure to sigmoidoscopy. Its results are therefore inconclusive with respect to sigmoidoscopy and should not be used as evidence either for or against sigmoidoscopic screening.

Adult↗
PubMed2005

Plasma fibrinogen in ulcerative colitis: the effect of disease activity and nicotine therapy in a randomised controlled trial.

BACKGROUND: Smoking increases plasma fibrinogen and cardiovascular risk whereas transdermal nicotine may not. Fibrinogen is an acute phase protein and may reflect disease activity in ulcerative colitis. AIMS: To examine the effect of topical nicotine on plasma fibrinogen and any relationship between fibrinogen and ulcerative colitis disease activity. PATIENTS: Forty-eight non-smokers with moderately active ulcerative colitis. METHODS: Patients were randomised to 6 mg nicotine enema or placebo for 6 weeks, followed by open nicotine therapy for 4 weeks. Plasma fibrinogen was measured at baseline and after 6 and 10 weeks; at each assessment sigmoidoscopy with a rectal biopsy was performed. RESULTS.: At 6 weeks median plasma fibrinogen was 3.30 g/l on nicotine compared to 3.05 g/l on placebo, P = 0.90 when adjusted for baseline values. There was a correlation between fibrinogen and the UC disease activity index (UCDAI) at weeks 0 and 10, P = 0.036 and 0.033, respectively, and between fibrinogen and sigmoidoscopic grade at each assessment, P = 0.014, 0.021 and 0.034. Changes in fibrinogen did not correlate with changes in disease severity. CONCLUSIONS: There was no significant effect of nicotine enemas, in either direction, on plasma fibrinogen-this was raised in moderately active UC and correlated with the sigmoidoscopic grade of colitis and the UCDAI; however, fibrinogen was not sufficiently sensitive to be of practical clinical value.

Colitis, Ulcerative↗
PubMed1999

Screening for colorectal cancer with flexible sigmoidoscopy by nonphysician endoscopists.

PURPOSE: Screening with sigmoidoscopy reduces the risk of death from colorectal cancer. Only 30% of eligible patients have undergone sigmoidoscopy, in part because of a limited supply of endoscopists. We evaluated the performance and safety of screening sigmoidoscopic examinations by trained nonphysician endoscopists in comparison with board-certified gastroenterologists. SUBJECTS AND METHODS: Asymptomatic patients 50 years or older without evidence of fecal occult blood and no personal history or family history of a first-degree relative with colorectal cancer under age 55 years were offered sigmoidoscopy. All examinations were performed either by a gastroenterologist or a trained nonphysician endoscopist at a staff model health maintenance organization. Outcomes included the depth of examination, number and histology of polyps, and complications. RESULTS: Nonphysicians performed 2,323 sigmoidoscopic examinations, and physicians performed 1,378 examinations. The mean (+/-SD) depth of sigmoidoscopy examinations performed by nonphysicians was 52 +/- 10 cm compared with 55 +/- 9 cm (P <0.001) in physicians. Nonphysicians detected neoplastic polyps in a greater proportion of patients (7.8%) than physicians (5.8%), but this difference was not significant after adjusting for differences in the age, sex, and family history of the patients (P = 0.35). No major complications occurred. The cost per examination, including the nonphysician training cost, was lower for nonphysicians ($186 per examination) than for physicians ($283 per examination). CONCLUSIONS: Appropriately trained nonphysicians may be capable of performing safe and effective screening for colorectal cancer with flexible sigmoidoscopy. An increased use of nonphysicians to perform sigmoidoscopy may increase the availability and reduce the cost of the procedure.

Aged↗
PubMed1976

The double contrast enema in ulcerative and Crohn's colitis.

One hundred double contrast enema examinations using a colonic activator (veripaque in the preliminary cleansing enema and 51 conventional barium enema examinations without a preliminary veripaque enema have been performed on 94 patients with either ulcerative colitis or Crohn's disease of the colon. The severity of the disease at barium enema examinations has been graded and compared with the severity of the disease found at sigmoidoscopy. In the double contrast examination, there was agreement between the radiological and sigmoidoscopic findings in 77% of cases and a disagreement of one grade in the remaining 23% of cases. The double contrast enema demonstrated lesions in the colon proximal to the range of the sigmoidoscope of a greater severity than that seen at sigmoidoscopy in 30% of cases. It was not found possible to use the same grading method with the conventional enema, and unless frank ulceration is present, it is considered that the conventional enema is unreliable in assessing the state of the colonic mucosa. It is concluded that the double contrast enema, using a colonic activator in the preliminary cleansing enema, causes no greater risk of complications than either the conventional enema or sigmoidoscopy.

Barium Sulfate↗
PubMed1996

Evaluation of per-procedure equipment costs in an outpatient endoscopy center.

BACKGROUND: As disposable endoscopes become available, we need baseline costs associated with reusable instruments to make financially intelligent choices. Accordingly, we analyzed the per-use cost of several types of gastrointestinal endoscopes at our institution. METHODS: Records of 44 gastrointestinal endoscopes were analyzed. Data defined included purchase price, repair and cleaning expense (labor and materials), and number of uses. The labor cost per-use associated with endoscope cleaning was estimated by taking an average time required to clean an endoscope multiplied by the technician's salary. RESULTS: The average number of years of endoscope use varied from 4.6 to 6.9 years contingent on the type of endoscope. For flexible sigmoidoscopes, the average total cost per use was $8.35, and for colonoscopes the cost was $21.81. For gastroscopes and diagnostic and therapeutic duodenoscopes, costs were $20.99, $49.15, and $45.16, respectively. CONCLUSIONS: (1) Excluding costs associated with the procedure itself (admit-recovery, drugs, disposable equipment, and procedural personnel), total peruse scope cost ranged from a low of $8.35 for the flexible sigmoidoscope to $49.15 for the diagnostic duodenoscope. (2) The most important variables associated with per-use endoscope cost included number of uses, initial purchase price, and repair costs. (3) Techniques such as the above can be used to define per-procedure costs for a particular practitioner or institution.

Costs and Cost Analysis↗
PubMed1997

Long-term efficacy of bismuth carbomer enemas in patients with treatment-resistant chronic pouchitis.

BACKGROUND: Mucosal inflammation of the ileal pouch (pouchitis) is the major long-term complication after ileal pouch-anal anastomosis for ulcerative colitis. Broad-spectrum antibiotics are the mainstay of treatment, however, 15% of patients with pouchitis have a chronic, treatment-resistant disease. AIM: To determine the safety and efficacy of bismuth carbomer enemas in achieving and maintaining remission in treatment-resistant chronic pouchitis. METHODS: Twelve patients with treatment-resistant chronic pouchitis were treated nightly for 45 days with enemas containing elemental bismuth complexed with carbomer. Diagnosis of pouchitis and response to treatment were evaluated with the Pouchitis Disease Activity Index (PDAI), which includes clinical, sigmoidoscopic and histological criteria. Serum bismuth concentrations were determined by atomic absorption. RESULTS: Ten of 12 patients (83%) went into remission, with a significant decrease of mean total PDAI score from 12 (range 9-15) to 6 (4-15) (P < 0.002), and were continued on bismuth carbomer enemas administered every third night for 12 months. Patients were monitored clinically, sigmoidoscopically and histologically every 2 months for evidence of recurrence (increase > or = 2 in the clinical symptom portion of the PDAI). Six of 10 patients (60%) were able to maintain remission throughout the 12-month trial; 4/10 had an exacerbation, two of which occurred soon after discontinuing daily treatment. Serum bismuth levels were negligible in all patients and no side-effects were registered. CONCLUSIONS: Our findings suggest that bismuth carbomer enemas are safe and effective in achieving and maintaining remission in patients with treatment-resistant chronic pouchitis.

Acrylic Resins↗
PubMed2002

A double-blind comparison of balsalazide, 6.75 g, and sulfasalazine, 3 g, as sole therapy in the management of ulcerative colitis.

BACKGROUND: Sulfasalazine is accepted therapy for active ulcerative colitis, but side-effects and intolerance are common. Balsalazide is an azo-bonded pro-drug which also releases 5-aminosalicylic acid into the colon, but uses an inert carrier molecule. AIM: To compare the safety and efficacy of sul- fasalazine, 3 g, with balsalazide, 6.75 g, in the initial daily treatment of mild to moderate ulcerative colitis. METHODS: A randomized, multicentre, double-blind, parallel group study was performed, with a treatment duration of 8 weeks. Patients on previous maintenance treatment were excluded. The trial medication was the sole treatment for the colitis. Efficacy was assessed by patient diaries, symptom assessment, sigmoidoscopic appearance and histology. RESULTS: Fifty patients were recruited: 26 allocated to the balsalazide group and 24 to the sulfasalazine group. More patients withdrew due to adverse events in the sulfasalazine group (nine patients vs. one patient in the balsalazide group, P=0.004). Improvement occurred in both groups, with a tendency to a faster response with balsalazide. Of the patients taking balsalazide, 61% achieved clinical and sigmoidoscopic remission. CONCLUSIONS: Balsalazide, 6.75 g, is effective as the sole treatment for patients with mild to moderately active ulcerative colitis, with significantly fewer withdrawals due to side-effects than in a similar group of patients taking sulfasalazine, 3 g.

Administration, Oral↗
PubMed2002

A double-blind, randomized, placebo-controlled trial of essential fatty acid supplementation in the maintenance of remission of ulcerative colitis.

BACKGROUND: Essential fatty acid supplementation has been found to ameliorate certain chronic inflammatory diseases. This effect is thought to be mediated through the modulation of eicosanoid synthesis. Pro-inflammatory eicosanoids have been implicated in ulcerative colitis. AIM: To investigate the possible therapeutic benefit of essential fatty acids in quiescent ulcerative colitis to reduce the frequency of disease relapse. METHODS: A randomized, double-blind, placebo-controlled study was performed with a treatment duration of 12 months. Patients with quiescent disease received either trial medication (gamma-linolenic acid, 1.6 g, eicosapentaenoic acid, 270 mg, and docosahexaenoic acid, 45 mg, per day) or placebo (sunflower oil, 500 mg/day). The primary end-point was disease activity, assessed by a previously validated clinical index, sigmoidoscopic appearance and histology. RESULTS: Sixty-three patients were randomized, 31 to receive essential fatty acid treatment and 32 to receive placebo. Disease relapse rates were similar at 12 months (placebo, 38%; essential fatty acids, 55%), as were changes in sigmoidoscopic grade from baseline. CONCLUSIONS: The supplementation of the diet with this combination of essential fatty acids does not prolong the period of disease remission of ulcerative colitis.

Administration, Oral↗