Mesalazine (5-Aminosalicylic Acid) Suppositories in the Treatment of Ulcerative Proctitis or Distal Proctosigmoiditis: A Randomized Controlled Trial

Campieri, Massimo; Franchis, Roberto de; Porro, G. Bianchi; Ranzi, T; Brunetti, G; Leggett, Barbara A.

doi:10.3109/00365529008997590

Cited by 89 publications

(61 citation statements)

References 14 publications

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“…Mesalamine suppositories in a dose of 500 mg twice daily or 1,000 mg once daily are eff ective in the treatment of proctitis ( 103 ), and maintenance of remission ( 104 ), whereas mesalamine enemas in doses of 1 -4 g may be able to reach as proximal as the splenic fl exure and are eff ective in inducing ( 105,106 ) and maintaining ( 107 -109 ) remission in distal colitis. Topical corticosteroids, available in the United States as a 100 mg hydrocortisone enema, or as a 10 % hydrocortisone foam, are eff ective in acute therapy of distal colitis ( 110 -112 ) but have not proven eff ective in maintaining remission ( 77 ).…”

Section: Recommendations For Management Of Mild -Moderate Distal Colitismentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,154

977

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Guidelines for clinical practice are aimed to indicate preferred approaches to medical problems as established by scientifi cally valid research. Double-blind placebo controlled studies are preferable, but compassionate-use reports and expert review articles are used in a thorough review of the literature conducted through Medline with the National Library of Medicine. When only data that will not withstand objective scrutiny are available, a recommendation is identifi ed as a consensus of experts. Guidelines are applicable to all physicians who address the subject regardless of specialty training or interests and are aimed to indicate the preferable but not necessarily the only acceptable approach to a specifi c problem. Guidelines are intended to be fl exible and must be distinguished from standards of care, which are infl exible and rarely violated. Given the wide range of specifi cs in any healthcare problem, the physician must always choose the course best suited to the individual patient and the variables in existence at the moment of decision. Guidelines are developed under the auspices of the American College of Gastroenterology and its Practice Parameters Committee and approved by the board of trustees. Each has been intensely reviewed and revised by the Committee, other experts in the fi eld, physicians who will use them, and specialists in the science of decision analysis. The recommendations of each guideline are therefore considered valid at the time of composition based on the data available. New developments in medical research and practice pertinent to each guideline will be reviewed at a time established and indicated at publication to assure continued validity. The recommendations made are based on the level of evidence found. Grade A recommendations imply that there is consistent level 1 evidence (randomized controlled trials), grade B indicates that the evidence would be level 2 or 3, which are cohort studies or case -control studies. Grade C recommendations are based on level 4 studies, meaning case series or poor-quality cohort studies, and grade D recommendations are based on level 5 evidence, meaning expert opinion.

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Section: Recommendations For Management Of Mild -Moderate Distal Colitismentioning

confidence: 99%

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Kornbluth

Sachar

2010

American Journal of Gastroenterology

1,154

977

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“…being the optimum dosage. 3,4,7,9 The preliminary results of the present open study suggest that the use of this new mesalazine microgranule 1 g suppository represents an ef®cient strategy for the topical treatment of ulcerative proctitis and distal proctosigmoiditis.…”

Section: Discussionmentioning

confidence: 99%

“…8 A dose-ranging trial demonstrated that mesalazine suppositories 500 mg b.d., represent the optimal dose in active proctitis. 9 Recently a new mesalazine 1 g suppository (Pentasa; Yamanouchi Pharma S.p.A., Milano, Italy) has been developed, from which the active ingredient, included in microgranules, is gradually released. This new suppository is small and has an oblong shape with a double apex, which facilitate its retention and retrograde spread.…”

Section: Introductionmentioning

confidence: 99%

Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis

Gionchetti

Rizzello

Venturi

et al. 1997

Aliment Pharmacol Ther

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Background:Mesalazine suppositories at 500 mg b.d. are a safe and effective treatment for patients with ulcerative proctitis or distal proctosigmoiditis. Recently a mesalazine 1 g suppository (Pentasa) has been developed.Methods:Fifty patients with active ulcerative colitis extending not beyond 20 cm from the anus on sigmoidoscopy, participated in a randomized single‐blind study comparing the efficacy, tolerance and acceptance of the new Pentasa mesalazine 1 g suppository, given once daily versus Claversal mesalazine 500 mg suppository b.d.Results:After 2 weeks, clinical remission was observed in 16 of 25 (64%) in the Pentasa group and in 7 of 25 (28%) in the Claversal 500 mg b.d. treated group; sigmoidoscopic remission occurred in 13 of 25 (52%) in the Pentasa group and in six of 25 (24%) in the Claversal group (P < 0.01). After 4 weeks, clinical and sigmoidoscopic remission were observed, respectively, in 84 and 76% of patients treated with Pentasa suppositories, and in 80 and 72% of patients treated with Claversal suppositories 500 mg b.d. (P= N.S.). The patients' evaluation for tolerability and practicality showed that the Pentasa suppository was significantly superior to the Claversal suppository.Conclusions:Pentasa 1 g suppository once daily induces a quicker clinical and sigmoidoscopic remission, and was better tolerated, than the Claversal 500 mg suppository b.d., and it may represent an advance for the topical treatment of distal proctosigmoiditis.

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“…As regards tolerability, none of the participating patients complained of adverse reactions attributable Intestinal segment of maximum spread and regional distribution of radioactivity (% dose) of the radiolabelled mesalazine enema at 4 h after dosing. For patients 1, 3, 5, 6, 9, 10, the disease extended to the rectum/sigmoid; for patients 2,4,7,8,11 to the distal descending colon and for patient 12 to the transverse colon.…”

Section: Resultsmentioning

confidence: 99%

Retrograde colonic spread of a new mesalazine rectal enema in patients with distal ulcerative colitis

Gionchetti

Venturi

Rizzello

et al. 1997

Aliment Pharmacol Ther

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Background: Rectal treatment with mesalazine enemas is the first‐line therapy for distal ulcerative colitis. In order to improve the benefits of rectal therapy, a new 60 mL 5‐ASA rectal gel enema preparation has been developed using a device which excludes direct contact of the inert propellant gas with the active drug. The purpose of the present study was to assess by scintigraphy the colonic distribution of this new mesalazine rectal gel enema. Methods: Twelve patients with active ulcerative colitis were administered 4 g of the mesalazine rectal enema labelled with 100 MBq technetium sulphur colloid (99mTc‐SC). Anterior scans of the abdomen were acquired at intervals for 4 h. Scans were analysed to evaluate the extent of retrograde flow and homogeneity of distribution of the radiolabelled enema in the rectum, sigmoid, descending and transverse colon. In addition, plasma levels of 5‐ASA and Ac‐5‐ASA were measured for 6 h. Results: All patients retained the entire rectal gel throughout the course of the study without reporting adverse events. In 11 out of 12 patients (92%) the gel had spread homogeneously beyond the sigmoid colon and had reached the upper limit of disease in all cases. The maximum spread (splenic flexure) was observed in 6 out of 12 patients (50%) within the first 2 h. The systemic absorption of mesalazine and its metabolite Ac‐5‐ASA was low. Conclusions: The new mesalazine enema represents an adequate alternative and a further technological improvement in the topical treatment of distal ulcerative colitis.

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Mesalazine (5-Aminosalicylic Acid) Suppositories in the Treatment of Ulcerative Proctitis or Distal Proctosigmoiditis: A Randomized Controlled Trial

Cited by 89 publications

References 14 publications

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Ulcerative Colitis Practice Guidelines in Adults: American College of Gastroenterology, Practice Parameters Committee

Comparison of mesalazine suppositories in proctitis and distal proctosigmoiditis

Retrograde colonic spread of a new mesalazine rectal enema in patients with distal ulcerative colitis

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