Margaret A.WinkerMDIndividualAuthorPhil B.FontanarosaMD, Senior EditorIndividualAuthor
To the Editor.—In discussing the treatment of ulcerative colitis, Dr Peppercorn1 states, "Sulfasalazine, mesalamine, and olsalazine have been proven to be effective in active ulcerative colitis," and he cites 3 studies. The first was a double-blind, placebo-controlled study by Dick et al2 using sulfasalazine and placebo pills. Clearly, it is impossible to blind a study using a placebo for sulfasalazine since nausea and headache are common early in the treatment when using sulfasalazine, and urine becomes a deep yellow-brown. The second study3 evaluated olsalazine against sulfasalazine. If sulfasalazine has not been proven effective, it hardly makes sense to compare it with olsalazine, unless one considers the former a placebo. The third study4 compared a coated oral 5-aminosalicylate agent preparation with a placebo. However, the adverse effects for the 4.8-g daily dose occurred in 55% of patients compared with 73% at a dose of 1.6 g daily and 61% for placebo. At best, the lack of dose response by rate of adverse effects, together with the high incidence of placebo adverse effects, raises questions about study validity.
Steinberg H. Child Maltreatment. JAMA. 1998;280(5):422. doi:10-1001/pubs.JAMA-ISSN-0098-7484-280-5-jbk0805