[Diagnostic decision in gastroenterologic patients. An armchair investigation].
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Biomedical subjects
Publications and source records attributed to P Riis.
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In an attempt to improve the relapse-preventing effect of salazosulphapyridine (SASP) and to encircle the part of the molecule essential for therapeutic actin, methyl-SASP was compared to SASP in a controlled double-blind trial without cross-over. The patient group comprised 33 patients with ulcerative colitis who had been symptom-free for 1--6 months on continuous treatment with SASP (on an average 2 g daily). The daily doses were SASP 1 g X 3 and methyl-SASP 125 mg x 3. Thirty patients completed the trial, 14 on SASP and 16 on methyl-SASP. Applying clinical criteria, the relapse rate after 6 months was 0.14 in the SASP group and 0.69 in the methyl-SASP group. The difference is highly significant. The blood concentrations of SASP, methyl-SASP, sulphapyridine (SP), and methyl-sulphapyridine (methyl-SP) were measured after 3 and 6 months. The methyl-SASP concentration was on an average twice as high as that of SASP, and the methyl-SP on an average 1/10 of SP (the differences are significant). It is concluded that whereas SASP showed a relapse-preventing effect in ulcerative colitis in this study comparable to that previously reported, the effect of methyl-SASP was only comparable to that of placebo, and the active substance in SASP does not seem to be unsplit SASP.
In an attempt to improve the ratio between therapeutic effect and side effects of salazosulphapyridine (SASP), methyl-salazosulphapyridine (methyl-SASP) was compared with SASP in a randomized controlled double-blind trial, without cross-over, in patients with active ulcerative colitis. The patient group comprised 53 patients. The daily doses were 1 g SASP x 3 and 125 mg methyl-SASP x 3. The methyl-SASP group comprised 26 patients, the SASP group 27 patients. The treatment period was 4 weeks. Applying clinical symptoms (bowel movements, registered by the patients on special charts), clinical condition (assessed by the patient), proctoscopic signs, and registration of side effects, it is concluded that methyl-SASP had an effect on ulcerative colitis indistinguishable from that of SASP. The rate of side effects was significantly less in the methyl-SASP group. The blood concentrations of SASP, methyl-SASP, sulphapyridine, and methyl-sulphapyridine were estimated at start during, and at the end of the trial. The methyl-SASP concentration was on an average twice as high as that of SASP, and the methyl-sulphapyridine on an average 1/13 of sulphapyridine, the differences being significant. It is concluded that methyl-SASP presents an improvement in the effect/side effect ratio when dealing with symptomatic ulcerative colitis. The discrepancy between the outcome of the present trial and the lack of effect in a controlled trial on the relapse-preventing effect of methyl-SASP is at present unexplained. A type II error in the present trial (or a type I error in the prophylactic one) is a possibility, or the patient-group selected for the present trial had a spontaneously benign course, cases demanding prednisone or colectomy having been excluded.
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