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REPLY
Treatment of Ulcerative Colitis with 5-Aminosalicylic Acid
Lloyd R. Sutherland;
Gary May; and
Eldon Shaffer
15 October 1993 | Volume 119 Issue 8 | Pages 858-859
IN RESPONSE:
Dr. Sninsky highlights a few of the difficulties and arbitrary decisions often required when conducting a meta-analysis of studies that differ in form, entry criteria, definitions of outcome, and design. We intentionally included in the meta-analysis studies of Dipentum and Pentasa that combined remission and improvement; to exclude such studies would have resulted in an unacceptable loss of patient data. In our discussion, we stated that no 5-aminosalicylic acid preparation was superior to another; however, in response to Dr. Sninsky's comments, we created a new Table 1, which reports all studies comparing 5-aminosalicylic acid with placebo in terms of the combined complete remission and improvement data. Although our results reflect the data of Schroeder and colleagues [1], our results for Dr. Sninsky's study [2] are not as optimistic because we used the more conservative intention-to-treat analysis rather than the per-protocol analysis. The pooled odds ratio for the combined data, 2.16 (95% CI, 1.73 to 2.78), is essentially unchanged.
Difficulties in analyzing the data underscore the lack of a universally accepted disease activity index. Although Sninsky and colleagues used a composite scoring system, it has not yet been validated in any other study. Our dose-response data support Dr. Sninsky's contention that higher doses of any 5-ASA offer an important therapeutic advantage for patients with active ulcerative colitis.
1. Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalycylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987; 317:1625-9.
2. Sninsky CA, Cort DH, Shanahan F, Powers BJ, Sessions JT, Pruitt RE, et al. Oral mesalamine (Asacol) for mildly to moderately active ulcerative colitis. Ann Intern Med. 1991; 115:350-5.
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