A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis

William J. Sandborn, William J. Tremaine, Kenneth W. Schroeder, Kenneth P. Batts, George M. Lawson, Betty L. Steiner, Jay M. Harrison, Alan R. Zinsmeister

Research output: Contribution to journalArticle

122 Citations (Scopus)

Abstract

Background/Aims: Uncontrolled studies suggest that cyclosporine administered as an enema may be of benefit for left-sided ulcerative colitis and safer than intravenous or oral administration. The efficacy and safety of cyclosporine enemas for left-sided ulcerative colitis in a placebo-controlled trial was assessed. Methods: Steroid and mesalamine enemas were withdrawn before the study. Forty patients were assigned to 1 of 4 strata: no concomitant therapy, oral steroids, oral salicylates, or oral steroids and salicylates. After stratification, patients were randomized to nightly treatment with 350 mg cyclosporine (n = 20) or placebo (n = 20) enemas. Clinical response was determined at baseline and 4 weeks by endoscopy, physician assessment, and a patient diary of daily symptoms. Trough blood cyclosporine levels were measured by high-performance liquid chromatography. Results: At 4 weeks, 8 of 20 patients (40%) who received cyclosporine showed clinical improvement compared with 9 of 20 patients (45%) who received placebo. One patient receiving cyclosporine had reversible neutropenia attributable to sulfasalazine, and another patient receiving cyclosporine was unable to tolerate the enema vehicle. No other toxicity was noted during the trial. Blood cyclosporine levels were detectable in only two patients. Conclusions: Cyclosporine enemas administered in a dosage of 350 mg/day for 4 weeks are not efficacious in mildly to moderately active left-sided ulcerative colitis.

Original languageEnglish (US)
Pages (from-to)1429-1435
Number of pages7
JournalGastroenterology
Volume106
Issue number6
StatePublished - 1994

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Enema
Ulcerative Colitis
Cyclosporine
Placebos
Salicylates
Steroids
Mesalamine
Sulfasalazine
Neutropenia
Intravenous Administration
Endoscopy
Oral Administration
High Pressure Liquid Chromatography
Physicians
Safety
Therapeutics

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Sandborn, W. J., Tremaine, W. J., Schroeder, K. W., Batts, K. P., Lawson, G. M., Steiner, B. L., ... Zinsmeister, A. R. (1994). A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis. Gastroenterology, 106(6), 1429-1435.

A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis. / Sandborn, William J.; Tremaine, William J.; Schroeder, Kenneth W.; Batts, Kenneth P.; Lawson, George M.; Steiner, Betty L.; Harrison, Jay M.; Zinsmeister, Alan R.

In: Gastroenterology, Vol. 106, No. 6, 1994, p. 1429-1435.

Research output: Contribution to journalArticle

Sandborn, WJ, Tremaine, WJ, Schroeder, KW, Batts, KP, Lawson, GM, Steiner, BL, Harrison, JM & Zinsmeister, AR 1994, 'A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis', Gastroenterology, vol. 106, no. 6, pp. 1429-1435.
Sandborn WJ, Tremaine WJ, Schroeder KW, Batts KP, Lawson GM, Steiner BL et al. A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis. Gastroenterology. 1994;106(6):1429-1435.
Sandborn, William J. ; Tremaine, William J. ; Schroeder, Kenneth W. ; Batts, Kenneth P. ; Lawson, George M. ; Steiner, Betty L. ; Harrison, Jay M. ; Zinsmeister, Alan R. / A placebo-controlled trial of cyclosporine enemas for mildly to moderately active left-sided ulcerative colitis. In: Gastroenterology. 1994 ; Vol. 106, No. 6. pp. 1429-1435.
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AU - Lawson, George M.

AU - Steiner, Betty L.

AU - Harrison, Jay M.

AU - Zinsmeister, Alan R.

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