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PubMed1992

An Eudragit-coated prednisolone preparation for ulcerative colitis: pharmacokinetics and preliminary therapeutic use.

Prednisolone metasulphabenzoate, a steroid with poor colonic absorption, was coated with the pH-dependent acrylic resin Eudragit S, as a means of delivering an orally administered preparation to the proximal colon. The therapeutic potential of delivering this steroid with potentially less systemic side-effects to the proximal colon was assessed in extensive ulcerative colitis. Plasma and urine prednisolone profiles in 6 healthy volunteers confirmed minimal absorption from Eudragit S-coated prednisolone metasulphabenzoate compared to prednisolone acetate: peak plasma prednisolone concentrations 29 +/- 21 ng/ml vs. 570 +/- 185 ng/ml (P less than 0.01), area under curve measurements 204 +/- 214 vs. 2724 +/- 1236 ng.h/ml (P less than 0.01). Prednisolone metasulphabenzoate coated with Eudragit S (30-60 mg daily) was then administered for 12 weeks to 12 patients with colonoscopically proven extensive ulcerative colitis in relapse. Symptoms, sigmoidoscopic appearances and rectal histological abnormalities all improved during therapy. Complete clinical remission occurred in 7 patients, a partial response in 2 patients and no response in 3 patients. Cortisol responses to tetracosactrin demonstrated no significant adrenal suppression following treatment. Eudragit S-coated prednisolone metasulphabenzoate may be a useful treatment for extensive ulcerative colitis, without risk of systemic steroid side-effects.

Acrylic Resins↗
PubMed1992

Oral or intravenous erythromycin has no effect on human distal colonic motility.

Erythromycin is a prokinetic agent for the lower oesophageal sphincter, the stomach, the gallbladder and the small bowel, acting directly on motilin receptors. Its effect on pressure activity of the human colon has not been investigated. Eight healthy volunteers were studied on 2 occasions and given intravenous or oral erythromycin, or placebo in a single-blind, randomized crossover study. Sigmoid pressure activity was measured using a 4-lumen water perfused system placed sigmoidoscopically at 50, 45, 30 and 15 cm from the anal verge. The pressures were analysed for activity index (mmHg.min) for the 35 cm colonic study segment using dedicated software. No significant difference was found in the activity index following oral erythromycin (500 mg) or placebo, or following intravenous erythromycin 1.8 mg/kg or placebo. A further 8 subjects were studied in a single-blind crossover study to determine the effect of oral erythromycin (500 mg) b.d. on colonic transit, measured with radio-opaque markers and a single abdominal X-ray. Mean or segmental colonic transit times were not statistically significantly different (Student's paired t-test) in the subjects on placebo or erythromycin. This lack of effect of erythromycin on the distal large intestine may indicate the absence of receptors for motilin in that part of the gut.

Administration, Oral↗
PubMed1992

Short report: comparison of two doses of balsalazide in maintaining ulcerative colitis in remission over 12 months.

In a four-centre prospective double-blind trial, 108 patients with ulcerative colitis in remission were randomized to receive balsalazide in doses of 3 g or 6 g/day for 12 months. The patients were assessed at 3-monthly intervals clinically, sigmoidoscopically and with routine haematology and biochemistry. Remission rates of 77% (3 g/day) and 68% (6 g/day) at 12 months were not significantly different. Intolerance reactions leading to withdrawal from the study occurred in only 9 patients (8%), all occurring in the first 7 weeks of the study. Balsalazide is therefore both highly effective in maintaining remission in ulcerative colitis and well tolerated in both conventional and high dosage (the latter equivalent to 5.5 g/day of sulphasalazine). In this study no distinct advantage in maintenance of remission has been found for the higher dose of balsalazide.

Adult↗
PubMed1993

A randomized controlled study of evening primrose oil and fish oil in ulcerative colitis.

In a placebo-controlled study, 43 patients with stable ulcerative colitis were randomized to receive either MaxEPA (n = 16), super evening primrose oil (n = 19), or olive oil as placebo (n = 8) for 6 months, in addition to their usual treatment. Treatment with MaxEPA increased red-cell membrane concentrations of eicosapentaenoic acid (EPA) at 3 months by three-fold and at 6 months by four-fold (both P < 0.01), and doubled docosahexaenoic acid (DHA) levels at 6 months (P < 0.05). Treatment with super evening primrose oil increased red-cell membrane concentrations of dihomogamma-linolenic acid (DGLA) by 40% at 6 months (P < 0.05), whilst treatment with placebo reduced levels of DGLA and DHA at 6 months (both P < 0.05). Clinical outcome was assessed by patient diary cards, sigmoidoscopy and histology of rectal biopsy specimens. Super evening primrose oil significantly improved stool consistency compared to MaxEPA and placebo at 6 months, and this difference was maintained 3 months after treatment was discontinued (P < 0.05). There was however, no difference in stool frequency, rectal bleeding, disease relapse, sigmoidoscopic appearance or rectal histology in the three treatment groups. Despite manipulation of cell-membrane fatty acids, fish oils do not exert a therapeutic effect in ulcerative colitis, while evening primrose oil may be of some benefit.

Aged↗
PubMed2004

Low molecular weight heparin (tinzaparin) vs. placebo in the treatment of mild to moderately active ulcerative colitis.

BACKGROUND: Heparin has anti-inflammatory and immunomodulatory activity which may be of therapeutic benefit in the treatment of ulcerative colitis. AIM: To test whether low molecular weight heparin, given subcutaneously, would provide a significant therapeutic response compared with placebo in the treatment of mild to moderate ulcerative colitis. STUDY DESIGN: A prospective, double-blind, randomized, placebo-controlled, multi-centre trial comparing tinzaparin 175 anti-Xa IU/kg/day (innohep, LEO Pharma) subcutaneously for 14 days followed by tinzaparin 4500 anti-Xa IU/day subcutaneously for 28 days with placebo, administered subcutaneously once daily for up to 42 days. The primary outcome measure was the mean change in colitis activity from baseline to the end of study treatment assessed by the sum of scores of stool frequency, rectal bleeding, sigmoidoscopic appearance and histology. Secondary outcome measures included changes in individual activity indices and laboratory parameters. Patients were assessed at weekly intervals for 6 weeks and within 1 week of completing treatment. RESULTS: One hundred patients with active ulcerative colitis (up to six bloody stools per day, no fever, no tachycardia or systemic disturbances) were randomized. Forty-eight received tinzaparin and 52 received placebo. The difference in the mean percentage change in colitis activity from baseline to end of treatment (tinzaparin-placebo) was not statistically significant (P = 0.84). There was no difference between tinzaparin and placebo in any secondary outcome measure. One major bleed (rectal), occurred in a patient receiving placebo. CONCLUSION: This is the largest trial to date of heparin in ulcerative colitis. The results show no benefit of low molecular weight heparin over placebo in mild to moderately active ulcerative colitis.

Adolescent↗
PubMed2006

Treatment of haemorrhagic radiation-induced proctopathy using small volume topical formalin instillation.

BACKGROUND: Between 2 and 5% of patients undergoing pelvic radiotherapy develop chronic radiation proctopathy, occurring as a result of damage to the rectal mucosa during the treatment. Rectal bleeding of varying severity can occur as a consequence. There have been no formal trials of treatment for haemorrhagic radiation proctopathy and a variety of methods are currently used. AIM: In a retrospective study of 20 patients treated at a single centre, we assessed the efficacy of small volume topical formalin instillation to control bleeding from radiation proctopathy. METHOD: Patients were treated by a single operator using 20 mL of a 5% solution of formalin instilled into the rectum via a flexible sigmoidoscope for 3 min. Patients were followed up for an average of 22.7 months (range: 2-69). RESULTS: A single session of formalin treatment was effective in 13 of 20 (65%) patients and a further four (20%) patients responded to a second treatment. No complications of the treatment was identified. CONCLUSION: Small volume formalin instillation therapy appears to be safe and effective in the context of haemorrhagic radiation proctopathy. The technique is simple, inexpensive, quick and requires no sedation. We suggest that it should be considered as a first line for patients presenting with this distressing condition.

Administration, Topical↗
PubMed1979

A nitroindanedione mast cell stabiliser in the treatment of ulcerative colitis: a controlled trial.

An orally absorbed mast cell stabiliser (BRL-10833) has been compared with placebo in a double-blind controlled trial in twenty-five patients with ulcerative colitis; patients received each treatment for one month. There was no significant clinical improvement in symptoms or sigmoidoscopic findings with the drug but there was significant improvement in the histological appearance of rectal biopsies during active treatment.

Adult↗
PubMed1982

The effect of disodium cromoglycate on rectal mucosal histamine release, eosinophil exudation and disease activity in active ulcerative colitis.

Disodium cromoglycate has been reported to benefit some patients with active ulcerative colitis. We have investigated the effect of cromoglycate in high dose on rectal mucosal mast cell degranulation (assessed indirectly by measurement of mucosal histamine release, using in vivo rectal dialysis, and the eosinophil content of the rectal inflammatory exudate) and on disease activity in eight patients in relapse. Although cromoglycate (1600 mg by mouth daily for 2 weeks) did not affect histamine release, it reduced (P less than 0.05) the eosinophil content of the exudate towards normal. Stool frequency also fell (P less than 0.05) but other aspects of bowel habit, sigmoidoscopic appearance, rectal mucosal potential difference and electrolyte transport were unaltered. Pre-treatment values of histamine release and eosinophil exudation could not be used to predict the response to cromoglycate. The reduction in eosinophil exudation produced by the drug could be due to inhibition of mast cell release of chemotactic factors other than histamine; the therapeutic effect of cromoglycate was unimpressive.

Adult↗
PubMedDate not supplied

A prospective randomized double blind trial comparing prednisolone and 4-aminosalicylic acid enemas in acute distal ulcerative colitis.

A prospective double blind and randomized study was conducted to compare 4-aminosalicylic acid (4-ASA) and prednisolone-21-phosphate enemas in inducing remission in patients with acute distal ulcerative colitis. Patients with ulcerative colitis distal to the splenic flexure as assessed by flexible colonoscopy, barium enema and histology were included in the study. Of 40 consecutive patients, 20 were randomized to each of the two treatment groups. Clinical evaluation was done weekly; sigmoidoscopy and histology were performed at entry and at the end of 4 weeks. Therapy was discontinued in four patients treated with prednisolone enemas due to worsening of symptoms. The clinical improvement was significant in the remaining patients (P less than 0.001) and was similar in the two groups (P greater than 0.1). Sigmoidoscopic and histological improvement were better with 4-ASA than with prednisolone enemas. No adverse effects were observed in any of the patients treated. The present study suggests that 4-ASA is a safe and effective treatment for inducing remission in acute distal ulcerative colitis.

Acute Disease↗
PubMed2005

Association between adenomas of rectosigmoid colon and metabolic syndrome features in a Chinese population.

BACKGROUND AND AIMS: Metabolic syndrome (MS) consists of a cluster of diseases, including obesity, dyslipidemia, hyperglycemia and high blood pressure. The purpose of the present study was to assess the association of MS with adenomas of the rectosigmoid colon, a well-established precancerous lesion. METHODS: A total of 4938 Taiwanese patients (2891 men and 2047 women with a mean age of 50.1 years), who had a physical examination at our hospital between January 2001 and October 2002, were enrolled in this study. All patients underwent a sigmoidoscopic examination to 60 cm from the anus. A modified National Cholesterol Education Program (NCEP) definition of MS was used in this study, in which body mass index (BMI) was substituted for the waist circumference measurement. RESULTS: Overall, 14% of patients had an elevated fasting glucose, 27% had high blood pressure, 14% had an increased triglyceride (TG) level, 8% had low high density lipoprotein (HDL) cholesterol, and 18% were obese. Rectosigmoid polyps were present in 17% of patients, among whom 568 received polypectomy. Pathological findings were hyperplastic in 138 subjects, adenomas in 341, carcinomas in 10, and other benign lesions in 79. In patients without polyps, the adjusted mean TG level and calculated BMI level were lower than those in patients with adenomas. No such difference existed, however, between patients without polyps and those with hyperplastic polyps. The odds ratio of adenomas in situ as compared to either a polyp-free state or the presence of hyperplastic polyps increased significantly with the number of MS diagnostic criteria the patient exhibited. CONCLUSION: Our study shows that MS is associated with rectosigmoid adenomas in a Chinese population. In patients with rectosigmoid polyps, the coexistence of MS may portend an increased risk of adenomas.

Adenoma↗
PubMed1978

The significance of widening of the presacral space at contrast radiography in inflammatory bowel disease.

The width of the presacral space was measured prospectively at various levels in 100 persons without organic colonic or rectal disease who had barium enema X-ray examinations. A standard technique was employed. The most consistent measurement was obtained at the level opposite the S3-S4 disc space; readings varied between 2 mm and 16 mm. Using 16 mm as the upper limit of normal, and a similar technique of barium enema examination, the width of the presacral space at the S3-S4 disc level was measured in 66 patients with inflammatory bowel disease (ulcerative colitis--49; Crohn's colitis--17). The width did not correlate with the severity of the disease process as indicated by sigmoidoscopic examination in proximity in time to the radiological examination. There was a relationship between increased width of the presacral space and the duration of the disease process.

Adolescent↗
PubMed1993

Pneumomediastinum following transanal excision of a rectal tumour.

A 45 year old male underwent full thickness transanal excision of a recurrent rectal villous adenoma. On the evening of surgery he developed an unexplained fever of 38.9 degrees C. Plain X-rays revealed a significant pneumomediastinum and pneumoretroperitoneum. This was thought to be due to passage of intrarectal air into the mesorectum and extravasation along tissue planes. The patient was managed with restricted fluids by mouth, an antidiarrhoeal agent, intravenous antibiotics, and frequent clinical and radiological observations. During the following 48 hours the fever settled and the pneumomediastinum resolved by the tenth postoperative day. Sigmoidoscopic examination at this time showed a healing rectal wound. This case illustrates a potential consequence of pelvic surgery and emphasizes the extent of the visceral space that exists as a continuum between the pelvis, abdomen, thorax and neck. This is an unusual complication with a dramatic radiological appearance, but one that can be managed successfully with expectation of a completely benign course.

Adenoma↗
PubMed2005

Endoscopic laser ablation of advanced rectal carcinoma--a DGH experience.

BACKGROUND: Patients with inoperable advanced rectal carcinoma require palliation for local symptoms. Endoscopic Nd-Yag laser ablation is a valid palliative treatment option in patients with advanced rectal carcinoma who are poor operative risks due to coexistent multiple comorbidities. METHODS: All patients who cannot undergo radical surgery due to various factors such as tumour size, poor risk patients, distant metastasis and refusal to undergo surgery were offered palliation with endoscopic Nd-YAG laser ablation. Indications included troublesome bleeding, local recurrence, mucous discharge and impending obstruction. Patients were admitted on the day of treatment, phosphate enema given for bowel preparation and endoscopic ablation done through a flexible sigmoidoscope under intravenous sedation with midazolam. All patients were discharged the next day after overnight observation. Patients were reviewed every 3 months and laser ablation repeated if deemed necessary. RESULTS: Eleven patients (7 males, 4 females; mean age 83.6 years, range 77-90 years) underwent endoscopic laser ablation in a District General Hospital --8 for rectal carcinoma, 2 for rectosigmoid tumour and 1 for recurrent tubulovillous adenoma. The number of treatment episodes varied from 1 to 12 with symptom free interval from 2 to 18 months between treatment episodes. There were 3 failures, one patient required defunctioning colostomy, one patient was referred for radiotherapy due to persistent symptoms and in one patient laser treatment had to be abandoned due to local extent. There were no immediate post-treatment complications, but one patient developed incontinence after 5 episodes which might be attributable to tumour infiltration. DISCUSSION: Endoscopic laser ablation is a practical and feasible alternative to other palliative treatment modalities in the management of this unfortunate category of patients due to low morbidity and mortality, short hospitalization and low complication rates.

Adenoma, Villous↗
PubMed1998

Clinical status of ulcerative colitis in patients who smoke.

OBJECTIVES: Ulcerative colitis (UC) is largely a disease of nonsmokers. There are few patients who are current smokers, but we have identified a group and reviewed their clinical status, disease activity, and nicotine exposure to examine whether they remain well controlled while smoking. METHODS: Fifty-one patients from three centers with verified UC were reviewed. RESULTS: Thirty of the group were men; mean age 50 yr, with a mean age of onset of 37 yr. Twenty-two patients had proctosigmoid disease, 12 involvement of left colon, and 17 total colitis. All were current smokers; 41 were cigarette smokers averaging 17 daily. At the onset of colitis 30 were nonsmokers, 25 of them were ex-smokers and 19 developed colitis within 2 yr of stopping smoking. Twenty-eight believed smoking improved disease activity and none felt smoking had a detrimental effect on their UC. Eleven were receiving no medication for UC, 40 were receiving 5-ASA (5-aminosalicylic acid) preparations, and only two took oral steroids. All were in clinical remission, with the exception of one patient; mean St. Marks score was 1.5, out of a possible total of 22. Sigmoidoscopic grades were inactive in all patients except three. Histological assessment showed significant activity in only five. Median serum nicotine was 8 ng/ml (range, 0.4-24.4), median serum cotinine 180 ng/ml (range, 20-453), with corresponding salivary cotinine of 255 ng/ml (range, 34-683). Median rise in nicotine 2 min after a cigarette in 35 patients was 12.1 ng/ml (range, 0.4-44). CONCLUSIONS: Because most current smokers with UC have inactive disease, smoking may contribute to the clinical remission in these patients.

Adult↗
PubMed1998

Endoscopic evaluation of chronic human immunodeficiency virus-related diarrhea: is colonoscopy superior to flexible sigmoidoscopy?

OBJECTIVES: In patients with chronic human immunodeficiency virus (HIV)-related diarrhea undergoing lower endoscopy, the decision to perform flexible sigmoidoscopy or colonoscopy is controversial. The purpose of this study is twofold: 1) to evaluate the diagnostic yield of colonoscopy in a large group of patients with chronic HIV-related diarrhea and negative stool studies, and 2) to determine whether colonoscopy is superior to flexible sigmoidoscopy in this setting. METHODS: All HIV-infected patients with chronic diarrhea who were referred for diagnostic colonoscopy at Bellevue Hospital Center between January 1992 and December 1996 were identified. Patient charts, pathology reports, and endoscopy records were reviewed. RESULTS: During the 5-yr study period, 317 consecutive patients with chronic unexplained diarrhea undergoing colonoscopy were identified. A potential cause of diarrhea was found in 116 patients (36.6%). Cytomegalovirus was the most common pathogen detected (24%). The yield of colonoscopy was significantly higher in patients with a CD4 count of <100 cells/mm3 than in those with higher CD4 counts (44.8% vs 6.4%, p < 0.0001). Thirty percent of pathogens and 75% of lymphomas were identified only on biopsies taken from the proximal colon, well beyond the reach of the flexible sigmoidoscope. Importantly, 94% of the pathogens that were found only in the proximal colon were organisms for which effective therapy is currently available. CONCLUSIONS: Colonoscopy is superior to flexible sigmoidoscopy in HIV-infected patients with chronic unexplained diarrhea. If flexible sigmoidoscopy had been performed instead of colonoscopy, 30% of pathogens would have been missed and 75% of lymphomas would have escaped detection.

AIDS-Related Opportunistic Infections↗
PubMed1998

A case of ischemic colitis associated with pheochromocytoma.

A 40-year-old woman was admitted because of abdominal pain and diarrhea. She sometimes experienced paroxysmal hypertension, sweating, headache, and palpitation. Sigmoidoscopic findings showed well-demarcated diffuse mucosal edema, hyperemia, and easy touch bleeding from distal descending colon up to the splenic flexure area. Barium x-ray showed loss of haustral marking, thumb printing appearance, and diffuse luminal stenosis in the transverse, descending, and sigmoid colon. On the abdominal computed tomogram, a 3.8-cm sized well-enhanced right adrenal mass was incidentally found. Twenty-four hour urinary excretion of vanillyl mandelic acid, norepinephrine, and normetanephrine were increased. Iodine131 metaiodobenzylguanidine scan showed hot uptake on the right adrenal gland compatible with pheochromocytoma. Exploratory laparotomy was done under the impression of ischemic colitis associated with pheochromocytoma. Adrenalectomy and resection of the stenotic left colon were performed. After surgery, pain subsided, blood pressure fell gradually, blood sugar and catecholamine level became normal, and bowel habit returned to normal.

Adrenal Gland Neoplasms↗
PubMed1999

Comparison of the color of fecal blood with the anatomical location of gastrointestinal bleeding lesions: potential misdiagnosis using only flexible sigmoidoscopy for bright red blood per rectum.

OBJECTIVE: Flexible sigmoidoscopy has been recommended for diagnosis of patients with bright red rectal bleeding. The purpose of this study was to determine whether lesions associated with bright red hematochezia are located in the distal 60 cm of the colorectum and, therefore, in reach of a flexible sigmoidoscope. METHODS: Three hundred-twelve consecutive patients presenting with hematochezia were shown a card containing three shades of red and asked to choose the color most representative of their fecal blood. Patients then underwent colonoscopy. The colonoscopist noted the length of the scope inserted when bleeding lesions were found. RESULTS: Of 217 patients with bright red hematochezia, 181 bled from the distal 60 cm of the colon, 20 had more proximal lesions (including eight with cancer), and 16 had no lesion found. However, 140 patients with rectosigmoid neoplasms or nonbleeding nonneoplastic lesions (e.g., hemorrhoids, diverticula, vascular anomalies, and fissures) if found by sigmoidoscopy would have subsequently required full colonoscopic surveillance. It was calculated that the average per patient medical charges employing an initial colonoscopic approach would save $12 or $116 over one beginning with sigmoidoscopy (depending on whether sigmoidoscopy is performed in an office setting or endoscopy suite, respectively), and would reduce the probability of perforation slightly. CONCLUSION: A diagnostic approach to hematochezia beginning with colonoscopy should be more effective, safer, and less costly than one beginning with flexible sigmoidoscopy, even when the blood is bright red.

Adolescent↗
PubMed2000

Defining the role of fiberoptic sigmoidoscopy in the investigation of patients presenting with bright red rectal bleeding.

OBJECTIVE: This study was done to determine whether sigmoidoscopy could theoretically constitute sufficient investigation for some patients with bright red rectal bleeding. METHODS: One hundred and forty-three patients undergoing investigative colonoscopy for bright red rectal bleeding and whose source of bleeding was identified were studied. The investigation took place in a large urban hospital over an 11-month period. Data obtained included changes in stool pattern, characteristics of the bleeding, lesions identified, and the distance of the lesion from the anus. RESULTS: In patients younger than 55 yr, all serious lesions except for one malignancy in a patient with massive bleeding lay within 60 cm of the anus and theoretically within reach of the fiberoptic sigmoidoscope. The mixing of red blood with stool was commonly due to distal lesions, especially hemorrhoids. CONCLUSIONS: In young persons with bright red rectal bleeding, fiberoptic sigmoidoscopy may prove to constitute appropriate initial investigation.

Adolescent↗