Additional publications in query "colitis and bismuth"

Title

Is maintenance therapy always necessary for patients with ulcerative colitis in remission?

Author

Ardizzone S; Petrillo M; Imbesi V; Cerutti R; Bollani S; Bianchi Porro G

Source

Aliment Pharmacol Ther, 1999 Mar, 13:3, 373-9

Abstract

BACKGROUND: The efficacy of sulphasalazine and mesalazine in preventing relapse in patients with ulcerative colitis is well known. It is less clear how long such maintenance should be continued, and if the duration of disease remission is a factor that affects the risk of recurrence. AIM: To determine whether the duration of disease remission affects the relapse rate, by comparing the efficacy of a delayed-release mesalazine (Asacol, Bracco S.p.A., Milan, Italy) against placebo in patients with ulcerative colitis with short- and long-duration of disease remission. METHODS: 112 patients (66 male, 46 female, mean age 35 years), with intermittent chronic ulcerative colitis in clinical, endoscopic and histological remission with sulphasalazine or mesalazine for at least 1 year, were included in the study. Assuming that a lower duration of remission might be associated with a higher relapse rate, the patients were stratified according to the length of their disease remission, prior to randomization into Group A (Asacol 26, placebo 35) in remission from 1 to 2 years, or Group B (Asacol 28, placebo 23) in remission for over 2 years, median 4 years. Patients were treated daily with oral Asacol 1.2 g vs. placebo, for a follow-up period of 1 year. RESULTS: We employed an intention-to-treat analysis. In Group A, whilst no difference was found between the two treatments after 6 months, mesalazine was significantly more effective than placebo in preventing relapse at 12 months [Asacol 6/26 (23%), placebo 17/35 (49%), P = 0.035, 95% Cl: 48-2.3%]. In contrast, in Group B no statistically significant difference was observed between the two treatments, either at 6 or 12 months [Asacol 5/28 (18%), placebo 6/23 (26%), P = 0.35, 95% Cl: 31-14%] of follow-up. Patients in group B were older, and had the disease and remission duration for longer, than those in Group A. CONCLUSIONS: Mesalazine prophylaxis is necessary for the prevention of relapse by patients with ulcerative colitis in remission for less than 2 years, but this study casts doubt over whether continuous maintenance treatment is necessary in patients with prolonged clinical, endoscopic and histological remission, who are at very low risk of relapse.  

 Title

Bismuth carbomer foam enemas for active chronic pouchitis: a randomized, double-blind, placebo-controlled trial.

Author

Tremaine WJ; Sandborn WJ; Wolff BG; Carpenter HA; Zinsmeister AR; Metzger PP

Source

Aliment Pharmacol Ther, 1997 Dec, 11:6, 1041-6

Abstract

BACKGROUND: Bismuth carbomer liquid enemas are equivalent to mesalamine enemas for active distal ulcerative colitis. AIMS: In this study, the efficacy and safety of bismuth carbomer foam enemas for active chronic pouchitis was determined in a placebo-controlled trial. PATIENTS: Forty adult patients with active chronic pouchitis were randomly assigned into either concurrent therapy for pouchitis or no concurrent therapy. Topical corticosteroids and mesalamine were withdrawn prior to the study. METHODS: Patients received either bismuth carbomer (270 mg elemental bismuth) (n = 20) or placebo (n = 20) foam enemas for 3 weeks. Clinical assessment was performed at baseline and at 3 weeks using the pouchitis disease activity index score which incorporates symptoms, endoscopy and histology. Serum bismuth concentrations were determined by atomic absorption spectrophotometry. RESULTS: At 3 weeks nine of 20 patients (45%) in both the bismuth and placebo groups had improved. Ten patients discontinued prematurely because of worse diarrhoea (three in each group) or abdominal cramping after enema use (one from the bismuth group and three from the placebo group). No other side-effects were noted. Serum bismuth concentrations were negligible in all patients. CONCLUSIONS: Bismuth carbomer foam enemas (270 mg bismuth) nightly for 3 weeks are safe but not efficacious for active chronic pouchitis.  

 Title

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

Author

Gionchetti P; Rizzello F; Venturi A; Ferretti M; Brignola C; Peruzzo S; Belloli C; Poggioli G; Miglioli M; Campieri M

Source

Aliment Pharmacol Ther, 1997 Aug, 11:4, 673-8

Abstract

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.  

  Title

A practical guide to the management of distal ulcerative colitis.

Author

Ardizzone S; Porro GB

Source

Drugs, 1998 Apr, 55:4, 519-42

Abstract

This article reviews the role of corticosteroids, sulfasalazine and mesalazine (5-aminosalicylic acid, mesalamine), immunosuppressive agents and alternative novel drugs for the treatment of distal ulcerative colitis. Short cycles of traditional, rectally administered corticosteroids (methylprednisolone, betamethasone, hydrocortisone) are effective for the treatment of mild to moderately active distal ulcerative colitis. In this context, their systemic administration is limited to patients who are refractory to either oral 5-amino-salicylates, topical mesalazine or topical corticosteroids. Of no value in maintaining remission, the long term use of either or topical corticosteroids may be hazardous. A new class of topically acting corticosteroids [budesonide, fluticasone, beclomethasone dipropionate, prednisolone-21-methasulphobenzoate, tixocortol (tixocortol pivalate)] represents a valid alternative for the treatment of active ulcerative colitis, and may be useful in the treatment of refractory distal ulcerative colitis. Although there is controversy concerning dosage or duration of therapy, oral and topical mesalazine is effective in the treatment of mild to moderately active distal ulcerative colitis. Sulfasalazine and mesalazine remain the first-choice drugs for the maintenance therapy of distal ulcerative colitis. Evidence exists showing a trend to a higher remission rate with higher doses of oral mesalazine. Topical mesalazine (suppositories or enemas) also is effective in maintenance treatment. For patients with chronically active or corticosteroid-dependent disease, azathioprine and mercaptopurine are effective in reducing either the need for corticosteroids or clinical relapses. Moreover, they are effective for long term maintenance remission. Cyclosporin may be useful in inducing remission in patients with acutely severe disease who do not achieve remission with an intensive intravenous regimen. Existing data suggest that azathioprine and mercaptopurine may be effective in prolonging remission in these patients. The role of alternative drugs for the treatment of distal ulcerative colitis and its different forms is reviewed. In particular data are reported concerning the effectiveness of 5-lipoxygenase inhibitors, topical use of short chain fatty acids, nicotine, local anaesthetics, bismuth subsalicylate enema, sucralfate, clonidine, free radical scavengers, heparin and hydroxychloroquine.

Title

Innovations in topical therapy.

Author

Richter F; Scheppach W

Source

Baillieres Clin Gastroenterol, 1997 Mar, 11:1, 97-109

Abstract

Topical therapy can be considered the standard treatment for distal ulcerative colitis. The group of drugs of first choice are the aminosalicylates which are effective in inducing remission in acute disease as well as in preventing relapse. Corticosteroids appear to be slightly less effective and have no proven benefit in maintenance therapy. With new topical steroids, such as budesonide, systemic effects can be minimized. The major role of corticosteroids is to complement aminosalicylates, when necessary. The new topical compounds appear to be especially valuable when there is a long-term requirement for corticosteroids. With the vast majority of patients obtaining remission with standard treatment, it is difficult to make the case for alternative substances. Short-chain fatty acids, local anaesthetics and bismuth compounds seem to be the most promising innovations in topical therapy although their equivalence or even superiority to mesalazine has not been established.

  Title

The topical treatment of distal ulcerative colitis.

Author

Ardizzone S; Porro GB

Source

Eur J Gastroenterol Hepatol, 1996 Jun, 8:6, 599-602

Abstract

In the absence of a definitively curative medical treatment of distal ulcerative colitis, the major objective of drug therapy is to optimize the quality of life by rapidly suppressing the symptoms of inflammation, without introducing major side effects. Conventional steroids administered topically decrease inflammation in about two-thirds of patients with active distal ulcerative colitis after 3-4 weeks of therapy. However, the risk of the systemic side-effects associated with their prolonged use discourages long-term treatment with these drugs. Enemas containing topically acting steroids are likely to replace conventional steroid enemas in the near future, especially in those patients who need long-term or high-dose therapy. The efficacy, safety and acceptance of rectal formulations of 5-aminosalicylic acid (5-ASA) in the short-term treatment of active ulcerative colitis are now well established. This 5-ASA enemas may be the best initial treatment when the disease is limited to the distal colon. Combination therapy of a topical corticosteroid with 5-ASA enema is a promising treatment for patients with active distal ulcerative colitis. Lignocaine, bismuth subsalicylate and short-chain fatty acids are new drugs under investigation with as yet unproven value. Better information concerning the natural history of the disease and a more careful definition of subgroups of patients may make it possible to personalize dosage, formulation and duration of the active medical treatment for patients with distal ulcerative colitis.

 Title

Pharmacokinetics and toxicity of bismuth compounds.

Author

Slikkerveer A; de Wolff FA

Source

Med Toxicol Adverse Drug Exp, 1989 Sep, 4:5, 303-23

Abstract

Inorganic bismuth salts are poorly soluble in water: solubility is influenced by the acidity of the medium and the presence of certain compounds with (hydr)oxy or sulfhydryl groups. The analysis of bismuth in biological material is not standardised and is subject to large variation; it is difficult to compare data from different studies, and older data should be approached with caution. The normal concentration of bismuth in blood is between 1 and 15 micrograms/L, but absorption from oral preparations produces a significant rise. Distribution of bismuth in the organs is largely independent of the compound administered or the route of administration: the concentration in kidney is always highest and the substance is also retained there for a long time. It is bound to a bismuth-metal binding protein in the kidney, the synthesis of which can be induced by the metal itself. Elimination from the body takes place by the urinary and faecal routes, but the exact proportion contributed by each route is still unknown. Elimination from blood displays multicompartment pharmacokinetics, the shortest half-life described in humans being 3.5 minutes, and the longest 17 to 22 years. A number of toxic effects have been attributed to bismuth compounds in humans: nephropathy, encephalopathy, osteoarthropathy, gingivitis, stomatitis and colitis. Whether hepatitis is a side effect, however, is open to dispute. Each of these adverse effects is associated with certain bismuth compounds. Bismuth encephalopathy occurred in France as an epidemic of toxicity and was associated with the intake of inorganic salts including bismuth subnitrate, subcarbonate and subgallate. In the prodromal phase patients developed problems in walking, standing or writing, deterioration of memory, changes in behaviour, insomnia and muscle cramps, together with several psychiatric symptoms. The manifest phase started abruptly and was characterised by changes in awareness, myoclonia, astasia and/or abasia and dysarthria. Patients recovered spontaneously after discontinuation of bismuth. Intestinal lavage, forced diuresis and haemodialysis have been tried without positive effects on the clinical condition of the patient or on blood bismuth concentration, and the use of dimercaprol as an antidote has produced reports of both positive and negative findings. To confirm the diagnosis of bismuth encephalopathy, it is essential to find elevated bismuth concentrations in blood, plasma, serum or CSF. A safety level of 50 micrograms/L and an alarm level of 100 micrograms/L have been suggested in the past, but no proof is available to support the choice of these levels.(ABSTRACT TRUNCATED AT 400 WORDS)

Title

Rectal bismuth subsalicylate as therapy for ulcerative colitis.

Author

Ryder SD; Walker RJ; Jones H; Rhodes JM

Source

Aliment Pharmacol Ther, 1990 Aug, 4:4, 333-8

Abstract

In a prospective open study, 15 patients with ulcerative colitis which was unresponsive to conventional therapy were treated with enemas containing bismuth subsalicylate (700 or 800 mg b.d.). Nine out of the 15 patients showed a significant clinical response, and 6 had gone into complete clinical remission after 8 weeks treatment. Sigmoidoscopoic appearances of the rectal mucosa showed improvement in 9 out of 15 patients at 2 weeks, and 11 out of 15 at 8 weeks. The mucosa appeared sigmoidoscopically normal in 6 out of 15 at 8 weeks. It proved possible to reduce the oral prednisolone dosage from a median of 15 mg/day (range 10 to 35 mg/day) to 6 mg/day (range 0 to 18 mg/day) after 8 weeks of treatment; 5 patients were no longer taking oral steroids at this time. Rectal bismuth subsalicylate appears likely to be an effective therapy in ulcerative colitis and controlled trials are now required.

 Title

Comparison of bismuth citrate and 5-aminosalicylic acid enemas in distal ulcerative colitis: a controlled trial.

Author

Pullan RD; Ganesh S; Mani V; Morris J; Evans BK; Williams GT; Rhodes J

Source

Gut, 1993 May, 34:5, 676-9

Abstract

An enema that contained a complex of bismuth citrate and polyacrylate was compared with 5-aminosalicylic acid (5-ASA) enemas for treatment of distal ulcerative colitis. The multicentre trial involving 63 patients was randomised and double blind with enemas given over four weeks; clinical, sigmoidoscopic, and histological assessments were made. Improvements were seen in both treatment groups. Clinical remission was seen in 18 of 32 patients treated with 5-ASA and 12 of 31 patients treated with bismuth citrate-carbomer (chi 2 1.94; p = 0.16). Sigmoidoscopic remission occurred in 20 of 32 patients in the 5-ASA group and 15 of 31 patients given bismuth (chi 2 1.27; p = 0.26). Improvement of rectal biopsy histology by at least one grade was seen in 16 of 32 patients in the 5-ASA group and 14 of 31 patients with bismuth (chi 2 0.15; p = 0.70). Analysis of covariance gave no significant difference between groups, although there was a trend favouring 5-ASA. There was no evidence of bismuth accumulation during the trial. Bismuth enemas may offer a new therapeutic option in distal ulcerative colitis.

 Title

Pharmacotherapy of inflammatory bowel disease.

Author

Reynolds PD; Hunter JO

Source

Dig Dis, 1993 Nov, 11:6, 334-42

Abstract

The standard treatments for inflammatory bowel disease have been aminosalicylates and corticosteroids, administered both systemically and topically. They are frequently extremely effective, especially at higher doses. Unfortunately steroid side effects are too frequent and agents with low systemic bioavailability (budesonide, beclamethasone and tixocortol) are being investigated. Azathioprine, although a useful adjunct to steroids, has occasional and unpredictable severe side effects. Cyclosporin is an important new therapy in severe refractory disease. Several new phospholipid mediator inhibitors, mepacrine, zileuton, and ridogrel, may be useful in moderate colitis. Other topical treatments, butyrate, acetarsol and bismuth subsalicylate, can be beneficial in refractory distal disease. Quadruple antimycobacterials, antioxidants and antimicrobials warrant further study, while newer immunosuppressives such as methotrexate, FK 506 and monoclonal antibodies against helper T lymphocytes show some early promise.

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